bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Core Performance on Functional Parameters in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is
      often damaged in multiple sclerosis (MS). Researches on postural control in people with MS
      (PwMS) have revealed that reduced somatosensory conduction may adversely affect some
      functions. PwMS have increased postural sway in upright posture than healthy people. They
      move closer and slower when reaching out or taking a step. Trunk controls are weak and
      postural responses are delayed. The activation of core muscles is very important for an
      effective trunk control. Because the core region is considered a kinetic link that
      facilitates the transfer of torque and angular momentum between the upper and lower
      extremities during body movements. The decrease in core stability affects both trunk control
      and the quality of limb movements due to the kinetic chain in the body. There are a limited
      number of studies in the literature showing that core stability is reduced in PwMS. Our
      knowledge about the effects of this reduction on function in PwMS is very limited.
    

Detailed description: 
      The aim of this study is to evaluate core strength and endurance and determine its effect on
      postural control, knee muscle strength, physical capacity and fatigue parameters in
      individuals with MS. Also relationship between these parameters will investigate.
    

Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): Assessment of core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People with MS followed in the Neurology Department of Bakirkoy Prof. Dr. Mazhar Osman
        Education and Research Hospital for Psychiatric and Neurological Diseases will be included.
      
Keywords: Multiple sclerosis; core stability; postural control; isokinetic strength; physical capacity; fatigue
Comparative Efficacy of Dental Flossing Before or After Tooth Brushing on Interproximal Plaque Reduction and Fluoride Retention in That Area
Condition: Dental Devices, Home Care
Study type: Interventional

Summary: 
      This randomized controlled crossover trial conducted on 25 dental students. in the
      preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and
      toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were
      instructed the proper techniques of brushing and flossing.The study was performed in two
      treatment sessions and a 48 hour washout period. They passed through the sessions in a
      randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all
      oral hygiene for 24 hour. At the first session , they flossed first followed by brushing
      (floss-brush group) and at the other session they used dental floss after brushing
      (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque
      reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was
      collected for measuring fluoride. Differences between the two groups were analyzed with mixed
      model test.
    


Intervention name(s): Flossing before Brushing; Brushing before Flossing
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Study Evaluating the Pharmacokinetics and Relative Bioavailability of Emraclidine Immediate-Release Tablets in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate plasma concentrations of emraclidine following
      single dose oral administration of different emraclidine immediate release (IR) tablets in
      healthy participants.
    


Intervention name(s): Treatment A: Emraclidine 30mg IR tablets (reference); Treatment B: Emraclidine 30mg IR test tablets 1; Treatment C: Emraclidine 30mg IR test tablets 2; Treatment D: Emraclidine 30mg IR test tablets 3
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IR oral tablets; IR oral tablets; IR oral tablets; IR oral tablets
Other intervention name(s): CVL-231; CVL-231; CVL-231; CVL-231
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 4-period, 4-sequence crossover study. The 4 treatments are A- 30 milligrams (mg) emraclidine IR tablets (reference); B- 30 mg emraclidine IR test tablets 1; C- 30 mg emraclidine IR test tablets 2; D- 30 mg emraclidine IR test tablets 3. Participants will be randomized to 1 of 4 treatment sequences. Each participant will be administered each of the 4 treatments exactly once, i.e.,1 treatment per period and there will be a 7 day washout period between each treatment.
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand if multiple oral doses of BMS-986166 are safe and
      well tolerated in healthy patients.
    


Intervention name(s): BMS-986166; Placebo matching BMS-986166
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
L-arginine add-on Therapy in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This study evaluates the addition of L-Arginine to the usual regimen in the treatment of
      schizophrenia in adults. As a requisite of crossover design, half of the participants started
      with L-Arginine and the other half with placebo and switched over after a three weeks use and
      one week of a washout period.
    

Detailed description: 
      L-arginine is the precursor of nitric oxide (NO), a neuromodulator of dopamine,
      gamma-aminobutyrate (GABA) and glutamate systems. Nitric oxide donors which increase NO
      levels at the cellular level could improve N-methyl-D-aspartate (NMDA) receptor dysfunction.
      Using L-arginine could bypass the blocked NMDA receptors and improve the therapeutic efficacy
      by reversing the dysfunction.

      The investigators proposed that using L-Arginine, a dietary supplement in most cultures,
      might constitute a safe option as an add-on treatment which may display beneficial effects on
      positive, negative, cognitive and affective symptoms associated with schizophrenia.
    

Intervention name(s): L-Arginine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Experimental supplement; Placebo capsules in the same color and shape with the experimental supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; L-Arginine; nitric oxide; drug augmentation
Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long
      term among clinically stable patients. The study will also assess the long term effectiveness
      of lurasidone as compared to an active comparator.
    


Intervention name(s): Lurasidone HCl; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 40 - 120mg per day; Risperidone
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lurasidone; Schizophrenia; Latuda
US-guided OOP Internal Jugular Vein Vs IP Supraclavicular Subclavian Vein Catheterization in ICU
Condition: Central Venous Catheter
Study type: Interventional

Summary: 
      Patients were randomly divided into two groups: ultrasound-guided (US-guided) out-of-plane
      internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV)
      catheterization.

      For OOP-IJV cannulation, the transducer was placed to identify IJV in short-axis view. The
      needle was introduced at an angle of 60° to the skin surface, and advanced under real-time US
      guidance until visualizing the tip of the needle inside the vein.

      For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid
      caudally following the IJV until getting the best long-axis view of the SCV. Using an
      in-plane approach, the needle was inserted at the base of the transducer at a 30° angle and
      advanced under the long axis under real-time US guidance targeting the SCV.
    

Detailed description: 
      Patients were randomly divided into two groups: ultrasound-guided (US-guided) out-of-plane
      internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV)
      catheterization.

      For OOP-IJV cannulation, the transducer was placed on transverse position over the patient's
      neck at the level of the cricoid cartilage to identify IJV and carotid artery (CA) in
      short-axis view. The vein was then centered on the screen. The skin puncture was made in the
      center of the US image using a needle attached to a syringe. The needle was introduced at an
      angle of 60° to the skin surface, perpendicular to the transducer, and advanced under
      real-time US guidance toward the IJV until visualizing the tip of the needle inside the vein.

      For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid
      caudally following the IJV until the junction of the subclavian vein (SCV) and IJV was
      reached in the supraclavicular fossa. The probe was then turned slightly and tilted
      anteriorly to get the best long-axis view of the SCV and the brachiocephalic vein (BCV).

      Using an in-plane approach, the needle attached to a syringe was inserted at the base of the
      transducer at a 30° angle and advanced strictly under the long axis of the US probe from
      lateral to medial. The needle point was then guided under real-time US guidance targeting the
      SCV.

      In both groups, catheterization was done through Seldinger technique.
    

Intervention name(s): Catetherization approach
Intervention type(s): Device
Intervention description(s): Out of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety and Effectiveness of Propagermanium in Diabetic Kidney Disease Participants Receiving Irbesartan
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be evaluating the safety and efficacy of propagermanium for the treatment of
      participants with DKD who are already taking irbesartan by:

        -  monitoring symptoms that participants may experience while on the study,

        -  measuring levels of protein in participant's urine and kidney function during the course
           of the study,

        -  measuring the levels of propagermanium and irbesartan that enters into participant's
           urine and blood, and

        -  comparing the propagermanium outcomes to participants' pre-study and placebo outcomes.

      Eligible participants will randomly be assigned to one of two arms to receive both the
      propagermanium and placebo in different orders as follows, either:

      Treatment Period 1 taking a propagermanium capsule twice a day for 12 weeks, followed by a
      six week washout period followed by Treatment Period 2 taking a placebo capsule twice a day
      for 12 weeks.

      OR Treatment Period 1 taking a placebo capsule twice a day for 12 weeks, followed by a six
      week washout period followed by Treatment Period 2 taking a propagermanium capsule twice a
      day for 12 weeks.
    


Intervention name(s): Propagermanium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Immediate release capsule; Placebo capsule
Other intervention name(s): PPG; repagermanium; DMX-200
Intervention MeSH terms: Propagermanium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, Randomised, Placebo-Controlled, Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal
      intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home
      management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in
      the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be
      randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.

      The study will run in three phases; a preparatory phase to set up and obtain baseline
      morbidity data from a cross-sectional survey; an intervention phase and a post intervention
      phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study
      children randomly selected will receive three full treatment courses of AS+AQ intermittently
      during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs)
      will administer all courses of IPTc. The first dose of each course will be directly observed
      by the CDDs who will educate mothers or caregivers to administer subsequent doses
      appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors
      to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria
      and other secondary outcomes will be compared with those of another cohort of 546 study
      children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ
      when necessary during the observation period.
    


Intervention name(s): Amodiaquine plus Artesunate co-administration
Intervention type(s): Drug
Intervention description(s): Under the Home Management of Malaria (HMM) strategy the Community Drug Distributors (CDD) will treat all children under 5 years presented to them with measured fever or a history of fever with AQ plus AS co-administered. Children under 12 months receive 75mg of AQ co-administered with 25mg of AS daily for three days. Children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days.
Asymptomatic children under 5 years in the Intermittent Preventive Treatment (IPTc) clusters will receive additional AQ plus AS co-administered during high malaria transmission season. Those under 12 months will receive 75mg of AQ co-administered with 25mg of AS daily for three days; and children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days.
Intervention MeSH terms: Artesunate; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Tele-Yoga Therapy for Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Chronic pain is highly prevalent and associated with a large symptom burden, that is had been
      more concerning during Covid-19 outbreak and lockdown. Benefits of yoga in chronic pain
      management are very well known. With this background we developed Tele-Yoga therapy program
      and evaluated the success of this single arm study.
    


Intervention name(s): Tele-Yoga Therapy
Intervention type(s): Other
Intervention description(s): Yoga practices combining with joint loosening exercises (Sukshma Vyayama), postures (Asana), breathing exercises (Pranayama), relaxation techniques and chanting ( A, U, M, and AUM { ૐ}) syllable chants meditation. Each session ended with home practice exercises given to the participants to practice everyday.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Tele-Yoga Therapy; Chronic Pain
Evaluation of Functions of Swallowing and Voice in Ankylosing Spondylitis Patients
Condition: Ankylosing Spondylitis; Swallowing Disorder.Other Specified; Voice Alteration
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Deglutition Disorders
Study type: Observational

Summary: 
      In this study was to determine whether changes that occurred over time had an impact on the
      swallowing and voice functions depend of Ankylosing spondylitis patients.
    

Detailed description: 
      This study was carried out at the University of Health Sciences Okmeydani Training and
      Research Hospital, Department of Otorhinolaryngology. Study was performed on 30 patients and
      30 healthy subjects (Group 2) who were diagnosed with ankylosing spondylitis using modified
      New York criterion. The patients were asked to fill the EAT-10 and flexible endoscopic
      swallowing evaluation was performed. Voice recordings were taken from the patients to
      evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
    

Intervention name(s): flexible endoscopic evaluation of swallowing; The analysis of voice
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.; Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study was performed on 30 patients who were diagnosed with ankylosing spondylitis using
        modified New York criterion.
      
Keywords: Ankylosing spondylitis, swallowing, voice
Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare addition of dexmedetomidine or fentanyl to
      bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar
      spine operations as regard hemodynamic stability, postoperative pain control and adverse
      effects.
    


Intervention name(s): Bupivacaine; Fentanyl; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%; Plus 50 µg fentanyl; Plus 50 µg dexmedetomidine
Other intervention name(s): Local anesthetic; Opioid; alpha 2 sympathomimetic
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Bupivacaine; Anesthetics, Local; Anesthetics; Sympathomimetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety
Condition: Neuro-Degenerative Disease
MeSH terms: Neurodegenerative Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in
      healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography
      (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial
      scans acquired every 3 minutes for two hours. Vital signs (VS), electrocardiograms (ECGs) and
      clinical laboratory tests of intrernal organ function will be acquired before and at several
      timepoints after administration of the radiopharmaceutical. Radiation exposures will be
      estimated with the MIRD Formalism.
    

Detailed description: 
      Vital signs (VSs) will be measured, electrocardiograms (ECGs) will be acquired, and blood
      will be sent to the clinical laboratory for safety assessments before a single dose,
      intravenous (IV) administration of 555 MBq of Carbon-11 butanol. VSs will be re-measured,
      ECGs will be acquired again, and more blood will be sent to the clinical laboratory for
      repeat safety assessments after 2 hours of whole body (WB) scanning. WB scanning will consist
      of imaging acquisition sweeps of 200 cm from head-to-toe over 180 secs (3 min). Up to 40
      sweeps per imaging session will be performed. The subjects will then be given a rest period
      ("coffee break") for about two hours, after which the entire sequence of events will be
      repeated. The primary outcome measure will be related to radiation safety derived from the
      areas under the time-activity curves (AUCs) for internal organs. Co-primary clinical safety
      measures will include changes in VSs, ECG parameters such as the PR and corrected QT
      intervals, and clinical laboratory tests, such as proteins that reflect renal and hepatic
      function. Secondary endpoints will include the time-activity curves (TACs) and total volumes
      of distribution (VT) in several brain regions. The results should allow calculation of the
      repeatability coefficients (RCs) under zero-biological-change conditions. RC values will be
      essential for understanding whether future measurements of effect sizes in response to
      therapeutic maneuvers or the differences between groups are meaningful.
    

Intervention name(s): Carbon 11 Butanol
Intervention type(s): Drug
Intervention description(s): Two sequential administrations of a PET tracer
Other intervention name(s): [11C]Butan-1-Ol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science