bioihbjkbjnl/mcl2 huggingface dataset:
18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study
Condition: Cognition Disorders
MeSH terms: Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled in
      the LEARN-Tau study. The study designed to evaluate the imaging characteristics of
      18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database of
      18F-AV-1451.

      The study will run in parallel to the LEARN study. In this study, participants will undergo
      up to four (4) 18F-AV-1451 PET scans over a 4.5 year period. Imaging visits will occur at the
      throughout the participant's participation in the LEARN study (corresponding to LEARN Visit
      1, between Visit 4 and 6, Visit 8, and Visit 11).

      The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain over
      time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of older
      individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451 and
      any side effects that might be associated with it.

      Site investigators, participants, and study partners will not be informed of the results of
      the 18F-AV-1451 PET scan results as they relate to the study; however, any findings that may
      be of potential medical concern will be provided for appropriate follow-up.
    


Intervention name(s): 18F-AV-1451
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: tau; cognition; longitudinal; cognitive decline; observational; imaging
Motor Imagery Technique on Lower Limb Function Among Stroke Patients.
Condition: Spasticity as Sequela of Stroke; Gait, Hemiplegic; Quality of Life
MeSH terms: Stroke; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      To determine the effects of motor imagery technique on lower limb function among stroke
      patient.

      To determine the effects of motor imagery technique on lower limb spasticity among stroke
      patients.

      To determine the effects of motor imagery technique on gait among stroke patients.

      To determine the effects of motor imagery technique on quality of life among stroke patients
    

Detailed description: 
      Stroke affected the functional capacities and the state of health thus altered quality of
      life.
    

Intervention name(s): Motor imagery technique; Conventional Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): The patient will sit on chair in a quiet room. The patients will be observing motor performance in video, motor performance video will consist of (1) knee flexion and extension movement, (2) sitting to standing movement, (3) stepping movement, (4) walking, (5) climbing and descending stairs.
Addition to motor imagery, the patients will be provided the passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.; It includes passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gait; Lower Limb function; Motor imagery
The Effect of Losartan on Emotional Processing in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This experimental medicine study explores whether a single dose of losartan (50mg) versus
      placebo affects the processing of positive and negative stimuli, using fMRI.
    

Detailed description: 
      Losartan has been shown to accelerate fear extinction in animals and to prevent the
      development of anxiety disorders in humans, emphasising its potential to possibly enhance
      exposure therapy in humans. This study explores the basic effects of losartan on emotional
      processing, to identify neural mechanisms by which the drug might have synergistic effects on
      psychological treatment in humans.

      In a double-blind between-groups design, 30 healthy volunteers will be randomised to a group
      receiving a single dose of losartan (50mg) versus placebo, and this study will measure the
      effects of probing renin-angiotensin function on emotional information processing, using
      functional magnet resonance imaging (fMRI). Such knowledge will ultimately be essential for
      the development of more effective pharmaco-psychological treatment approaches for anxiety
      disorders.
    

Intervention name(s): Losartan; Placebo
Intervention type(s): Drug; Other
Intervention description(s): blood pressure medication; non-active sham intervention
Other intervention name(s): Losartan Potassium
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, placebo-controlled experimental medicine study, where healthy volunteers are randomised to receiving either a single dose of losartan (50mg) or matching placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: losartan; emotional processing; anxiety; magnet resonance imaging; MRI
Application of Stress Ball and Non-stress Test With Pregnant Women
Condition: Anxiety; Pregnancy Related
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This research was planned as a randomized controlled experimental study to reduce the anxiety
      expectant mothers feel when on a non-stress test.
    

Detailed description: 
      Fetal well-being is assessed by evaluating fetal heart rate (FHR) patterns. The primary aim
      is to identify fetuses at risk of intrauterine death or neonatal complications and, if
      possible, intervene (usually by delivery) to prevent these adverse outcomes. The most
      commonly used method for this purpose is the non-stress test. Non-stress test (NST) is a
      non-invasive fetal evaluation method. The NST is evaluated for at least 20 minutes while the
      expectant mother is lying supine or left-side.

      Although it is a painless procedure, it takes about 20 minutes, and the pregnant woman stays
      in the same position throughout the procedure, creating although there are many methods to
      reduce stress, it is thought that a cheap and easily accessible stress ball can be used as a
      method of distraction or distraction. Although there are studies investigating the
      effectiveness of stress balls in managing various disease groups and symptoms in the
      literature, no study has been found to examine the NST effectiveness of stress balls. This
      research was planned as a randomized controlled experimental study to reduce the stress felt
      by women who had a non-stress test during pregnancy by applying a stress ball during the
      procedure. anxiety for the pregnant woman. The fact that the pregnant woman has high anxiety
      during the procedure affects the test result and may increase the false-positive rate and
      cause false evaluation. This increase in the false-positive rate in NST results may lead to
      an increase in an operative delivery. However, it is the midwives' responsibility to
      eliminate the situations that cause anxiety in pregnant women, which may affect the NST
      result before and during the procedure.
    

Intervention name(s): stress ball
Intervention type(s): Other
Intervention description(s): The woman is usually laid in the last side position during the procedure. A stress ball will be given to the right hand of the participants during the NST procedure (average 15-20 minutes). This stress ball will be squeezed for 2-3 seconds, and then the hand and arm will be told to relax. This process will be repeated throughout the NST. Hospital protocol will also be applied to these participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: anxiety; pregnancy; stress ball; non-stress test
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers
Condition: Healthy Volunteers; Anti-Bacterial Agents; Methicillin-Resistant Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics
      of single dose of N-Rephasin® SAL200 in healthy male subjects.
    

Detailed description: 
      The purposes of this study are to evaluate the pharmacokinetics, and pharmacodynamics and
      safety of an experimental intravenous medication, N-Rephasin® SAL200 in healthy male.
      Participants will include 36 male volunteers. Participants will be grouped according to
      dosage of N-Rephasin® SAL200 including placebo (0 mg/kg). Study procedures include: check of
      vital signs, reporting any experienced side effects, physical examination including
      assessment of the cardiovascular system, and blood sample collection for monitoring of
      pharmacokinetics, pharmacodynamics and antibody production etc. Participants will be involved
      in study related procedures for up to 50 days after injection.
    

Intervention name(s): N-Rephasin® SAL200; INT200-Placebo
Intervention type(s): Biological; Other
Intervention description(s): continuous intravenous infusion over 60 minutes; Formulation buffer for continuous intravenous infusion over 60 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: N-Rephasin® SAL200; endolysin; Placebo
A Study of the Cardiac Effects of Danicopan in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, double-blind, double-dummy, placebo- and positive-controlled, 2-arm
      (Treatment Arm and Control Arm), parallel study to evaluate the effect of ACH-0144471
      (danicopan) on the QT interval in healthy adult participants.
    

Detailed description: 
      Participants randomized to the Treatment Arm received all 3 doses of danicopan in a single
      ascending fashion over 3 periods (Treatment Sequence ABC). A single oral dose of danicopan
      was administered with a moxifloxacin-matching placebo on Day 1 of each period.

      Participants randomized to the Control Arm were further randomized to receive 1 of 2
      treatment sequences (Treatment Sequences EFG or IJK). A single oral dose of
      danicopan-matching placebo was administered with moxifloxacin or with moxifloxacin-matching
      placebo, as per the assigned randomization scheme, on Day 1 of each period.
    

Intervention name(s): Danicopan; Moxifloxacin-matching Placebo; Danicopan-matching placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Danicopan tablets administered as a single oral dose.; Moxifloxacin-matching placebo was administered as a single oral dose.; Danicopan-matching placebo was administered as a single oral dose.; Moxifloxacin 400 mg was administered as a single tablet oral dose.
Other intervention name(s): ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; Avelox
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a double-dummy, placebo- and positive-controlled study.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Danicopan; ALXN2040; ACH-0144471; Electrocardiogram; QT Interval; Concentration-QT
Standard Deviation of the Distance Between the Sural Nerve and Achilles Tendon by Ultrasound
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to define the standardization of the distance between the Sural
      nerve & Achilles tendon, in otherwise healthy persons and athletes.
    

Detailed description: 
      The distance between the two anatomic structures is measured by US and data is analyzed to
      define the standardized distance in the population in order to avoid damage to the sural
      nerve while repairing an Achilles tendon rupture using the percutaneous methode.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        otherwise healthy persones, age 18-60, community sample.
      
Keywords: achilles tendon; sural nerve; distance; US; ultrasound; Distance between Sural nerve and the Achilles tendon
HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals
Condition: Cervical Cancer Screening
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The proposed study will examine the implementation of a Human Papillomavirus (HPV)
      self-sampling intervention for unscreened and under-screened transgender men and
      transmasculine individuals living in South Florida. The study will enroll participants to
      receive this cervical cancer screening intervention in community venues. The purpose of this
      study is to pilot the self-sampler for feasibility and acceptability within this underserved
      population.
    


Intervention name(s): HPV self-sampling
Intervention type(s): Behavioral
Intervention description(s): Participants will be provided with education regarding cervical cancer screening, as well as instructions regarding how to use the HPV self-sampler. Participants will also receive referrals to trans-competent healthcare providers for follow-up screening and care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effects on Growth of an Extensively Hydrolyzed Formula Fed to Term
Condition: Growth
Study type: Interventional

Summary: 
      The purpose of this study is to assess growth in infants who are fed an extensively
      hydrolyzed formula.
    


Intervention name(s): Extensively hydrolyzed infant formula
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Observational Prospective Study With Probiotic Supplementation on Infants With FGDI
Condition: Functional Gastrointestinal Disorders; Infantile Colic; Functional Constipation
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Colic; Constipation
Study type: Observational

Summary: 
      This observational prospective study evaluates the safety, tolerability and efficacy of a
      probiotic formula in infants with functional gastrointestinal disorders (FGDI)
    

Detailed description: 
      Functional gastrointestinal disorders (FGDIs) affect one out of two infants during the fist
      six months of life and do not have an organic cause. Infant colic, so-called excessive crying
      syndrome, and functional constipation are among the most common paediatric FGDIs.

      FGDIs pathophysiology is multifactorial and may include phycological factors and alterations
      of the gut physiology including gut microbiota dysbiosis.

      Probiotics are proposed as a potential treatment for FGDIs. However, evidence is limited.

      A probiotic formula composed of strains Bifidobacerium longum CECT 7894 and Pediococcus
      pentosaceus CECT 8330 is tested in this study.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10^9 cfu/day)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population selected from primary care clinic.
      
Keywords: FGDI; probiotic
A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets
Condition: Root Resorption
MeSH terms: Root Resorption
Study type: Interventional

Summary: 
      Aim: The aim of the study was to evaluate and compare the extent of root resorption in the
      maxillary and mandibular anterior teeth during orthodontic treatment with the use of
      different types of brackets. Materials and methods: The study consisted of 21 patients (11
      males and 10 females) within the age group of 16-25 years, having bimaxillary protrusion.
      They were divided into three groups. In Group 1- Conventional brackets, Group 2-
      Self-ligation brackets:Smart Clip (Passive), and in Group 3 Self-ligation brackets: Empower
      (Active) were bonded. Computed Tomography scans and Orthopantomograms were taken before start
      of treatment and after six months of retraction. Root resorption is computed as the
      difference between the pre treatment total tooth length and the post treatment total tooth
      length.
    


Intervention name(s): conventional brackets; smart clip passive self ligating brackets; Empower active self ligating brackets
Intervention type(s): Device; Device; Device
Intervention description(s): conventional brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.; smart clip passive self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.; Empower active self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Shape Up! Adults Study
Condition: Healthy
Study type: Observational

Summary: 
      Identify the unique associations of body shape to body composition indices in a population
      that represents the variance of sex, age, BMI, and ethnicity found in the US population.

      Describe the precision and accuracy of 3DO scans to monitor change in body composition and
      metabolic health interventions.

      Estimate the level of association of 3DO to common health indicators including metabolic risk
      factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength) by
      gender, race, age, and BMI.

      Investigate holistic, high-resolution descriptors of 3D body shape as direct predictors of
      body composition and metabolic risk using statistical shape models and Latent Class Analysis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit a stratified sample of 720 participants, approximately 360 from each site,
        using the following equally-weighed stratifications: sex, age (18-40, 40-60, 60-80 years),
        BMI (less than 25, 25-30, 30 and above) and ethnicity (White, Black, Mexican-American,
        Asian and Native Hawaiian or Other Pacific Islander).

        Within this sample, we will include up to 36 participants with very low and high BMI by
        special recruitments from our facilities Anorexia Nervosa (AN) and bariatric surgery
        clinics. The remainder of the participants will be recruited as a sample of convenience
        using local advertisements around our facilities.
Postpartum HPV Vaccination
Condition: HPV-Related Malignancy
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore,
      greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer
      disproportionately affects women of color in both incidence and mortality. Due to low HPV
      vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are
      necessary in order to maximize the cancer prevention potential of this vaccine. The
      puerperium is a time period when women are engaged in the healthcare system and have almost
      universal access to affordable health care. Two prior studies have shown that postpartum HPV
      vaccination is acceptable to patients, and high rates of vaccination were achieved in these
      primarily Hispanic populations. However, data show that the immune response in young women is
      less robust than in adolescents, and no studies have examined immunogenicity in postpartum
      women specifically. We propose an HPV vaccination pilot study in women who receive postpartum
      care at University of Alabama at Birmingham (UAB) hospital. We will examine the
      acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.
    


Intervention name(s): Gardasil9
Intervention type(s): Drug
Intervention description(s): Gardasil 9
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Effect of Probiotics on Gingivitis: Part 2
Condition: Gingivitis; Chronic
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The aim of the study is to assess the effect of oral probiotics containing Streptococcus
      salivarius M18 on gingivitis and oral hygiene in young adults.
    

Detailed description: 
      This will be a double-blind, randomized, placebo-controlled two-arm parallel-group study of
      the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral
      hygiene. The groups will include young adults with gingivitis diagnosed clinically. To assess
      the effect of oral probiotics, the following parameters will be used: gingival health
      (gingival index, GI; gingival bleeding index, GBI) and oral hygiene level (the Turesky
      Modification of the Quigley-Hein Plaque Index, TMQHPI).
    

Intervention name(s): Dentoblis; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): dissolve the tablets in the mouth once a day for 4 weeks; dissolve the tablets in the mouth once a day for 4 weeks
Other intervention name(s): Probiotic: Streptococcus salivarius M18
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment double-blind, randomized, two-arm parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment