bioihbjkbjnl/mcl2 huggingface dataset:
Study of Fluoxetine in Adults With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      This is a study to determine the effect of fluoxetine in the treatment of adult autism and on
      functional ability and behavior associated with autism. Evidence suggests abnormal serotonin
      function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.
    

Detailed description: 
      Eligible patients will undergo comprehensive evaluation. Informants familiar with the patient
      will also provide information. Patients will be randomized to receive treatment or placebo.
      During the 12-week treatment there will be weekly monitoring for the first 4 weeks and
      biweekly monitoring for the next 8 weeks. The drug dosage will be increased each week as
      tolerated by the patient. Serum levels of fluoxetine and norfluoxetine will be documented at
      Week 12.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Adult, Autism
A Study of Dopamine Type 2 (D2) Receptor Occupancy Following a Single Oral Dose of OROS Paliperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to estimate the relationship of D2-receptor occupancy to
      plasma concentration and to assess the safety of OROS paliperidone.
    

Detailed description: 
      This is a single-center, single-dose, open-label, Phase-1 Positron Emission Tomography (PET)
      study in 4 healthy volunteers, 2 men and 2 women. After screening, healthy eligible
      volunteers will be hospitalized in the study unit from study Day 2 to Day 4. On Day 1 (the
      day before hospitalization), volunteers will enter the study unit from 5:00 p.m. to 8:00 p.m.
      for baseline prolactin blood sampling and sedation assessment. Each volunteer will have a
      control magnetic resonance imaging (at screening) and 3 PET measurements using the
      radioligand [11]C raclopride to measure central D2 receptor occupancy in the putamen. Blood
      samples to measure plasma concentrations of paliperidone will be collect immediately before
      and at scheduled time points after dose administration on Day 2, and immediately before,
      halfway through, and immediately after the PET-2 and PET-3 measurements. Serum prolactin
      levels will be measured immediately before and at several scheduled time points after dose
      administration, and immediately before and after each PET measurement. At scheduled time
      points, supine and standing blood pressures, pulse, sensorium changes, temperature, and
      degree of sedation will be recorded, volunteers will be questioned about adverse events, and
      they will be evaluated for extrapyramidal symptoms (EPS). Adverse events will be recorded and
      followed throughout the study. The rationale for the study design is based on previous PET
      studies with risperidone, which indicated that PET measurement of D2 receptor occupancy after
      a single dose of medication is useful in predicting an effective clinical dose range. Single
      oral dose (6 mg) of OROS paliperidone
    

Intervention name(s): OROS paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; mood disorders; antipsychotic drugs; dopamine; receptor occupancy; OROS paliperidone
Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the persistence of immunity to hepatitis B in healthy children aged
      7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life,
      and also their ability to mount an immune response to the challenge dose of Engerix-B™
      Kinder.
    


Intervention name(s): Engerix-B™ Kinder
Intervention type(s): Biological
Intervention description(s): Intramuscular, single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immune response; Engerix-B™Kinder; Persistence; challenge dose
In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study mainly compared the response of the artificial carious enamel lesions to
      remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel,
      MHDP and Buffer solutions.

      The lesions were then remineralised in an in situ model, with crossover and double blind
      design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of
      each demineralising protocol during 3 experimental phases (3 days each). The experimental
      phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care (fluoride
      dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F and
      dentifrice- 1,100 ppm F, NaF).

      During the 3-day phase, the appliance was only removed during the main meals (four times a
      day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals,
      before replacing the appliance in the mouth, the subjects were advised to perform oral
      hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and
      dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from
      Crest Procter & Gamble, Cincinnati, OH, USA) according to the phase and dental floss
      (Sanifill, São Paulo, Brazil).

      The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the
      first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of
      solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects were
      advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to
      Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before
      the in situ study for 6h and then removed.

      The enamel remineralization was quantified using transverse microradiography (% mineral
      recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were
      submitted to statistical analysis (p<0.05).
    


Intervention name(s): Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study; Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study; Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study
Intervention type(s): Other; Other; Other
Intervention MeSH terms: Fluorides; Fluorides, Topical; Sodium fluoride topical preparation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children
Condition: HIV Infection
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC
      (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD)
      with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of
      combination antiretroviral therapy.
    


Intervention name(s): ABC Twice Daily; ABC Once Daily; 3TC Once Daily; 3TC Twice Daily
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Lamivudine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; paediatric; Abacavir; lamivudine
Bispectral Index to Guide Intubation in Pediatric Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      This prospective study aimed to determine the minimal level of Bispectral index needed for
      quality laryngoscopy before ear, nose and throat surgery in children.
    

Detailed description: 
      -  Children will received intra-rectal premedication based on midazolam 0.4mg

        -  Children will be monitored according to standard guidelines

        -  One blinded anesthesiologist will be in charge of anesthesia induction and the other one
           will be in charge of data collection (end tidal sevoflurane concentration, sevoflurane
           minimal alveolar concentration, bispectral index) and guidance of induction according to
           the predetermined bispectral index (up and down allocation)
    

Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention description(s): After at least 4 minutes of stable inspired sevoflurane concentration, that concentration will be titrated to obtain a targeted bispectral index (BIS) level required for perform laryngoscopy. This level was initially set at 40, based on a preliminary study showing that such level of BIS was obtained at the laryngoscopy after common general anesthesia induction. For the next patients, BIS target was set according to a sequential allocation method (up and down).
Intervention MeSH terms: Sevoflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
Condition: Hypoxic-Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy
      will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic
      encephalopathy after hospital discharge.
    

Detailed description: 
      Infants with perinatal history of moderate to severe Hypoxic ischemic encephalopathy HIE will
      receive 10 injections of cerebrolysin IM. Assessment of neurodevelopment will be done before
      , 3 and 6 months after therapy
    

Intervention name(s): Cerebrolysin®
Intervention type(s): Drug
Intervention description(s): injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Other intervention name(s): Nerve Growth Factor
Intervention MeSH terms: Cerebrolysin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypoxic Ischemic Encephalopathy (HIE); Perinatal Asphyxia; Nerve growth factor; Cerebrolysin; Cerebral palsy
A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
Condition: Menopause
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares the effects of 12 weeks of treatment with transdermal versus oral
      estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal
      women.
    


Intervention name(s): Premarin® (oral) vs. Alora® (transdermal)
Intervention type(s): Drug
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopause; Testosterone; Androgens; Sex Hormone Binding Globulin; Thyroid function; Cortisol
High Fiber Rye Foods for Body Weight and Body Fat Reduction
Condition: Obesity; Overweight
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The overall aim of this study is to investigate whether a diet rich in rye fiber from
      wholegrain rye, compared to refined wheat, as part of a hypo-caloric diet leads to larger
      weight loss and lower body fat content after 12 weeks of intervention.
    


Intervention name(s): Cereal products based on rye; Cereal products based on wheat
Intervention type(s): Other; Other
Intervention description(s): Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.; Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of Application of Pulse Electrical Stimulation Around Eye in Glaucoma Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation
      around eyes of glaucoma patients.
    

Detailed description: 
      Duration of study period(per participant): Screening period(0-4weeks), Intervention
      period(16weeks) Patient needs to visit site at least 5 times(Screening, V2, V3, V4, V5). V2
      can be done with screening visit. Visit 3, 4, 5 is 2weeks, 6weeks, and 16weeks after visit
      2(Baseline).
    

Intervention name(s): Pulse Electrical Stimulation
Intervention type(s): Device
Intervention description(s): Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Spinal Plasticity to Enhance Motor Retraining After Stroke
Condition: Stroke; Cerebrovascular Accident; Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The objective of this project is to study the effects of an emerging noninvasive
      neuromodulation strategy in human stroke survivors with movement-related disability. Muscle
      weakness after stroke results from the abnormal interaction between cells in the brain that
      send commands to control movement and cells in the spinal cord that cause muscles to produce
      movement. The neuromodulation strategy central to this project has been shown the strengthen
      the physical connection between both cells, producing a change in movement potential of
      muscles weakened by stroke.
    

Detailed description: 
      Stroke is a leading cause of serious long-term disability in the United States with 795,000
      individuals suffering a new or recurrent stroke each year. In most cases, disability is
      associated with incomplete motor recovery of the paretic limb. Full recovery is often not
      achieved, creating a need for neuromodulation strategies that target the physiological
      mechanisms impaired by stroke to fully harness the adaptive capacity of the nervous system.
      The neuromodulation protocol that will be tested in these experiments will target connections
      between the brain and spinal cord with noninvasive stimulation to enhance movement potential
      of the hand. Individuals who experienced a single stroke at least 6 months ago may be
      eligible to participate.
    

Intervention name(s): Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS)
Intervention type(s): Procedure
Intervention description(s): This study is a novel approach to studying neuroplasticity after stroke. Previous work in humans with incomplete spinal cord injury demonstrates that the resulting plasticity transiently enhances motor output, indicating that there is also therapeutic potential. This study will attempt to induce bi-directional plasticity in corticospinal-motoneuronal synapses serving an intrinsic hand muscle of the hemiparetic limb. Control experiments will be completed to provide evidence of the neurophysiological mechanism(s) mediating the effect and to examine behavioral effects.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Transcranial magnetic stimulation targeting the region of the brain responsible for voluntary movement control and electrical stimulation to a peripheral nerve innervating hand muscles will be triggered at an interval that elicits action potentials arriving in a set sequence and predetermined delay in the spinal cord.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Neuromodulation; Transcranial magnetic stimulation (TMS); Electrical stimulation
Effect of Venglustat in Patients With Renal Impairment
Condition: Healthy Volunteers; Polycystic Kidney, Autosomal Dominant
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics
      (PK) of Venglustat following a single dose.

      Secondary Objective:

      To assess the tolerability of Venglustat given as a single dose in subjects with mild,
      moderate and severe renal impairment in comparison with matched subjects with normal renal
      function.
    

Detailed description: 
      Approximately 41 days, including a 21-day screening period, a 1-day treatment period,
      followed by a 9-day period of plasma sampling for assessment of primary endpoints.
    

Intervention name(s): Venglustat GZ/SAR402671
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Hard Capsule Route of administration: Oral
Intervention MeSH terms: Venglustat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of SHOOT Exercise Program on Shooting Performance, Muscular Strength and Endurance
Condition: Athletes
Study type: Interventional

Summary: 
      The aim of this study is; to create a special exercise program that will improve the
      performance of shooting athletes and to examine the effect of this exercise program on
      shooting performance, muscular strength and endurance of air pistol athletes.
    

Detailed description: 
      Air pistol shooting is an Olympic sport that requires precise and accurate shooting at the
      target sign. Many are the factors that can influence performance in Olympic pistol shooting.
      The ability to stabilize the gun is crucial for performance in Olympic pistol shooting and is
      thought to be related to the shooters muscular strength. Krasilshchikov, Zuraidee, and Singh
      suggest that the implementation of a physical conditioning program together with technique
      training is essential for the improvement of the ability to stabilize the pistol.

      Books and journals specialized in Olympic shooting suggest that general physical condition
      programs, as well as specific strength exercises are necessary in order for performance to be
      improved. Al Wadi examined the effect of strength exercises on shooting performance and
      physical parameters with the 8-week station training method with female air pistol shooters
      in 2015. They found that this exercise program increased arm and waist strength and
      endurance, the kinetic balance changed positively, and there was a significant correlation
      between physical variables and shooting performance. However, the study of Belinchon reports
      that some factors regarding the physical condition of the Spanish Olympic shooters are
      inferior when compared to athletes of other sports. There is therefore the need for further
      study on the importance of physical conditioning in Olympic shooting.
    

Intervention name(s): SHOOT exercise group; routine training group
Intervention type(s): Procedure; Procedure
Intervention description(s): In addition to routine training, the experimental group will be done a progressive resistance band exercise program (SHOOT) created for shooters, 3 days a week for 8 weeks, accompanied by a physiotherapist.; The control group will continue their routine training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups, one control and one exercise group
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: exercises; muscle strength; shooting; shooters
Inspiratory Muscle Training, Autonomic Dysfunction and Blood Pressure
Condition: Hypertension
MeSH terms: Respiratory Aspiration; Autonomic Nervous System Diseases; Primary Dysautonomias; Hypertension
Study type: Interventional

Summary: 
      This study finds the effectiveness of inspiratory muscle threshold loading training among
      adults with hypertension. A sample of hypertensive subjects was divided into two groups -
      inspiratory muscle training (IMT) - group (inspiratory muscle training was prescribed) and
      sham-group (no load was prescribed during IMT). Both groups had training sessions comprising
      seven cycles of two minutes bouts of breathing counter to an inspiratory load, each bout
      parted by one minute of unloaded recovery. Treatment session was performed for three times
      per week for a total of six weeks. Measurement of each of the variables (blood pressure,
      resting heart rate (RHR), heart rate variability (HRV)) was taken at baseline and after the
      six-week intervention.
    

Detailed description: 
      The present study aimed to examine the outcome of interval inspiratory muscle training at 70%
      load on blood pressure, resting heart rate and autonomic dysfunction in the hypertensive
      adults.

      Participants were divided into two groups: IMT and sham. In IMT group, the threshold loading
      inspiratory muscle trainer from POWERbreathe was used with 70% IMT threshold. In Sham group,
      IMT was unloaded.
    

Intervention name(s): Inspiratory muscle training.; Sham inspiratory muscle training.
Intervention type(s): Other; Other
Intervention description(s): Interval inspiratory muscle training was performed using the inspiratory muscle trainer.; Interval inspiratory muscle training was performed using the unloaded inspiratory muscle trainer.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group pretest-posttest parallel design.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Interval Inspiratory Muscle Training; Hypertension; Autonomic Dysfunction; Blood Pressure
Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to explore a new approach in assessing the effectiveness of
      acupuncture therapy in the treatment chronic pain conditions.
    


Intervention name(s): Acupuncture; Sham Acupuncture
Intervention type(s): Other; Other
Intervention description(s): Subjects receive 6 acupuncture treatments for neck or back pain.; Subjects receive 6 sham acupuncture treatments for neck or back pain.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Pain; Pain management