bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Single Dose, Open-Label Pharmacokinetic Study and Single-Blind, Placebo-Controlled Dose Escalation Study of NFC-1 in Adolescents With Attention-Deficit Hyperactivity Disorder
Condition: Attention-deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting
      genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study are
      to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral
      administration of NFC-1 and to evaluate safety and tolerability and to obtain evidence for
      the effect of NFC-1 on ADHD severity and global functioning during and following four weeks
      of continuous treatment. Exploratory analyses will be performed to assess effect size of
      specific mGluR-network genes on ADHD based on responsiveness of patients to NFC-1. This study
      will be conducted at a single clinical site, the Jefferson University Hospital PKU
      (Philadelphia, PA).
    


Intervention name(s): NFC-1
Intervention type(s): Drug
Intervention description(s): Single-dose, open label administration to assess safety, tolerability, and pharmacokinetics in adolescents with ADHD and continuous daily administration for four weeks with weekly escalation to evaluate safety, tolerability, and impact on ADHD severity.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
Condition: Dry Eye Syndromes; Hypovitaminosis D
MeSH terms: Rickets; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Avitaminosis; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Dry eye disease is multifactorial, ocular inflammatory condition causing irritation, stinging
      sensation, uneasiness and blurring. Non-Sjogren syndrome occurs due to absent or dysfunction
      of lacrimal gland. Fat soluble vitamin D act as an agent against inflammation and its
      deficiency may result in various inflammatory diseases including dry eye. Purpose of this
      study is evaluation of vitamin D3 supplementation role in treating non-Sjogren dry eye along
      with conventional treatment by using artificial tears in patients with hypovitaminosis D. A
      prospective study was conducted in Rural health center(RHC) Buchal Kalan on 108 patients
      presenting with non-Sjogren dry eyes and low serum vitamin D levels. Patients were subjected
      to the following examination; best corrected visual acuity (BCVA), slit-lamp examination,
      applanation tonometry, fundoscopy, tear breakup time (TBUT) after fluorescein staining,
      Schirmer tear test, numerical pain rating scale (NPRS) and ocular surface disease index
      (OSDI) score on day 0, 15, 30, 60 and 90. Vitamin D levels was assessed by
      electrochemiluminescence immunoassay (ECLIA) based analyzer. The sample was randomly divided
      into two groups by non-probability purposive sampling. Group 1 received only artificial tears
      4times/day while group 2 were given oral vitamin D3 supplementation of 6000 international
      unit (IU) daily along with artificial tears. Impact of oral vitamin D3 supplementation on
      non-Sjogren dry eyes was assessed by comparing means of ocular parameters of both groups over
      different period of time by using Mann-Whitney Test and Friedman Test.
    


Intervention name(s): Vitamin D; Artificial tear
Intervention type(s): Drug; Drug
Intervention description(s): New treatment option for dry eye patients with low serum vitamin D Level; Conventional dry eye treatment
Intervention MeSH terms: Vitamin D; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial tears.; Dry eye syndrome.; vitamin d deficiency.
Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Condition: Pain Alleviation; Dilatation and Evacuation; Laminaria Placement
MeSH terms: Dilatation, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      To examine whether application of lidocaine spray in cervical preparation for second
      trimester dilatation and evacuation alleviates pain and is superior to current protocol of
      preparation without analgesia and superior to placebo.

      a double- blind, randomized, placebo- controlled trial, performed at a single tertiary
      medical center. Eligible participants aged 18 and older and about to undergo dilation &
      evacuation of the uterus between 12 to 24 weeks of gestation. Participants will be randomized
      using computer generated allocation to receive 10% Xylocaine (lidocaine group) spray or
      normal saline 0.9% (placebo group), applied identically topically to the endocervix and
      ectocervix before laminaria insertion. The primary outcome will be the participant's reported
      pain score immediately after the first laminaria was inserted as measured on a 10 cm visual
      analog scale (VAS). Secondary outcomes wiil be reported pain scores at speculum removal, 15
      minutes after speculum insertion and immediately before the D&E procedure.
    


Intervention name(s): Lidocaine; placebo comparator
Intervention type(s): Drug; Other
Intervention description(s): will local application of lidocaine to the cervix alleviate pain of laminaria insertion
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lidocaine; laminaria; dilatation and evacuation; pain
Leg Muscle Activity Measured Via Electromyography in Back Squat Variations
Condition: Surface Electromyography; Muscular Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of the study is to see how different forms of the squat exercise change my body's
      leg muscle activity. Four forms of the traditional back squat will be used: traditional back
      squat, barefoot squat, box squat, and traditional back squat with chains.
    

Detailed description: 
      Resistance exercise has various benefits that promote health and reduce the chance of chronic
      disease, but the biggest benefit may be found in the effects on maintaining muscle mass
      throughout the aging process. The implications resistance training has on an individual's
      ability to function throughout the day with less fatigue whilst performing tasks at an easier
      level can all be related to improved strength and endurance that comes with resistance
      training. Furthermore, how the nervous system adapts and sends signals to the working muscles
      are of great interest as neuromuscular adaptations help in coordination, balance, and
      agility. Variations of the same style of exercise have been theorized to improve and/or
      change the adaptations that can occur. Thus, the purpose of this study would be to assess
      surface electromyography (sEMG) activations on 4 anatomical sites simultaneously during the
      squat exercise under varying conditions.
    

Intervention name(s): Traditional Back Squat; Barefoot Back Squat; Box Squat; Traditional Back Squat with Chains
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will complete traditional back squat in this four treatment crossover design.; Participants will complete barefoot back squat in this four treatment crossover design.; Participants will complete box squat in this four treatment crossover design.; Participants will complete traditional back squat with chains in this four treatment crossover design.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete all four trials in a crossover design. A one week washout period is required between treatments.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Electromyography; Resistance trained
Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      The aim of this study is to assess the impact of different environmental factors on the
      ability for a thermistor-based epitympanic thermometer to accurately read the temperature of
      a normothermic individual and thereby estimate their feasibility and reliability in the
      austere pre-hospital setting.
    

Detailed description: 
      The aim of this study is to assess the impact of different environmental factors on the
      ability for a thermistor-based epitympanic thermometer to accurately read the temperature of
      a normothermic individual and thereby estimate their feasibility and reliability in the
      austere pre-hospital setting.

      Healthy volunteers will be recruited. As reference value for core temperature we will use a
      standard rectal probe (Mon-a-Therm, General purpose Temperature Probe 12Fr/Ch, Covidien)
      attached to an external monitor. The study will be in a field setting in the mountains of
      Hemsedal, Norway.

      For measuring the epitympanic temperature we will use the Metraux Thermometer (Walpoth,
      Galdikas et al. 1994). The Metraux Thermometer is widely used in pre-hospital care in Norway
      and internationally. The ear-sensor will after induction of anaesthesia be inserted according
      to the manufacturers specifications in the auditory canal and activated. The sensor is two
      tiny and soft metal wires covered in a plastic wrapping integrated in a soft rubber earplug.
      The depth of the measuring point is pre-set from the manufacture to be approximately 10 mm
      from the tympanic membrane. The display will then show the epitympanic temperature in
      real-time.

      The volunteers will be exposed to four different scenarios. 1. Ambient air with no protection
      of head/measuring site. 2. Ambient air with local protection of measuring site. 3. Snow in
      the ear-canal before placing the thermometer (to resemble avalanche conditions). 4 Cold water
      in the ear canal (to resemble water immersion/submersion).

      The temperature will be measured in degrees Celsius. A baseline will be established before
      exposing the volunteers to the different environmental factors. After exposure the
      temperature will be recorded every 15 seconds for a total of 10minutes.
    

Intervention name(s): metraux epitympanic thermometer
Intervention type(s): Device
Intervention description(s): accuracy of epitympanic temperature measurement in different environmental settings
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: hypothermia; pre-hospital; epitympanic; temperature
Postoperatively Treated Patients With Lower Limb Fracture With or Without an Anti-gravity Treadmill
Condition: Muscle Degeneration
Study type: Interventional

Summary: 
      The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®)
      compared to a standard rehabilitation protocol in patients with tibial plateau or ankle
      fractures with six weeks of partial weight bearing.
    


Intervention name(s): anti-gravity treadmill (alter G®); standardized physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Patients in the experimental arm will be treated with manual lymphatic drainage, cryotherapy and a fixed protocol of training in an anti-gravity treadmill (alter G®). The protocol is designed parallel to standard physiotherapy with a frequency of two to three times a week with duration of about 20 minutes for six weeks.; Patients in the control arm will be treated with manual lymphatic drainage, cryotherapy and 20 minutes of physiotherapy two to three times a week for six weeks. Physiotherapy will be done according to a standardized protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation, anti-gravity treadmill
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults
Condition: Tetanus; Acellular Pertussis; Diphtheria
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this follow-up study is to evaluate the persistence of antibodies against all
      the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to
      assess immunogenicity and safety of another dose of Boostrix, administered in this study.
      This protocol posting deals with objectives and outcome measures of the extension phase. The
      objectives and outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00109330).
    

Detailed description: 
      Subjects were previously vaccinated with either Boostrix or a control Td vaccine in study
      NCT00109330. Only subjects who were part of the primary study will be invited to participate
      in this study. All subjects will receive a single dose of Boostrix at Visit 1 (Day 0) and
      subjects will be observed till Visit 2 (Day 30) for safety in terms of solicited adverse
      events (during 4 days post vaccination), unsolicited adverse events (during 31 days post
      vaccination) and serious adverse event (during the trial period). A blood sample will be
      collected from all subjects before vaccination (Visit 1) and one month after vaccination
      (Visit 2) for antibodies estimation.

      This summary has been updated following Protocol amendment 2 dated 03 October 2013. The
      protocol is being amended to facilitate enrolment by:

        -  - Extending the window period for re-vaccination from ± 6 months to ± 300 days from the
           Year 10 time point.

        -  - Extending the recruitment period from 6 months to 14 months. The format of
           non-inferiority criterion of the first co-primary objective has been updated to keep it
           aligned with the format of non-inferiority criterion of the second co-primary objective.
    

Intervention name(s): Boostrix
Intervention type(s): Biological
Intervention description(s): Single dose intramuscular administration.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Booster; Tdap; Immunogenicity; Repeat dose; Safety; BoostrixTM; Persistence
Psychosocial Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The aim of the study is to research psychosocial and socioeconomic factors among families
      that might affect glycemic control in children and adolescent with type 1 diabetes mellitus.
      These factors might be: living conditions, structure of the family, socioeconomic status,
      divorces and parent's own glycemic control status (if parent's type 1 diabetes mellitus is
      present in the family).
    

Detailed description: 
      This study is going to clarify if there are some socioeconomical or psychosocial factors that
      might influence child's type 1 diabetes mellitus glycemic control. Study population consists
      of 300-350 diabetic children aged 1-16 years who have diabetic controls at Tampere University
      Hospital and their families. Required information is going to be collected with 2
      questionnaires, wich families are kindly asked to fill in.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Type 1 diabetic children aged 1-16 years followed at Tampere University Hospital and their
        parents . Child's disease duration minimum 1 year.
      
Keywords: Glycemic control; Children; Psychosocial and socioeconomic factors
Phenylacetate in Treating Children With Recurrent or Progressive Brain Tumors
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of phenylacetate in treating children with
      recurrent or progressive brain tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of phenylacetate in terms of response rate and time to
      progression in children with recurrent or progressive brain tumors, or with previously
      untreated poor prognosis brain tumors. II. Assess the toxicity of phenylacetate in these
      patients treated at the maximum tolerated dose. III. Determine the correlation between serum
      steady state phenylacetate levels and toxicity or response in these patients.

      OUTLINE: Patients are stratified by histologic type (anaplastic astrocytoma and glioblastoma
      multiforme vs brain stem glioma vs medulloblastoma and primitive neuroectodermal tumors vs
      ependymoma vs low grade glioma vs others). Patients receive phenylacetate as a continuous
      intravenous infusion on days 1-28. Courses of treatment are given continuously without rest.
      Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
      are followed weekly.

      PROJECTED ACCRUAL: A total of 9-30 patients per stratum will be accrued for this study in 2
      years.
    

Intervention name(s): phenylacetate
Intervention type(s): Drug
Intervention MeSH terms: Phenylacetic acid
Primary purpose: Treatment
Keywords: recurrent childhood brain tumor; childhood high-grade cerebral astrocytoma; untreated childhood brain stem glioma; recurrent childhood brain stem glioma; recurrent childhood supratentorial primitive neuroectodermal tumor; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood medulloblastoma; recurrent childhood ependymoma
Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major
Condition: Thalassemia; Iron Overload
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to investigate the use of amlodipine, a drug that blocks the uptake of
      calcium into cells, in the prevention and treatment of iron overload in patients with
      thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and
      other organs, blocking these channels might help to prevent the accumulation of iron in these
      tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine
      and 30 will serve as controls receiving placebo in a randomized double-blind fashion.
      Patients will be monitored through one year. Monitoring will occur through the measurement of
      blood ferritin as well as live and heart T2* by MRI initially, at 6 and 12 months.
    


Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention description(s): 5mg PO initially; may be reduced to 2.5mg PO if side effects
Other intervention name(s): norvasc
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magnetic resonance imaging; Thalassemia; Iron overload
Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind),
      three part study. The primary objective of the study is to characterize the safety, and
      tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28
      daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single and
      multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day, repeat-dose,
      dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose study in
      obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available prior to
      escalation decisions. Data from Parts 1 and 2 will be available prior to initiation of the
      three parallel cohorts in Part 3. A dose escalation meeting will be held to review these data
      and document the decision to proceed as planned or make any alterations in dosing, if
      indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30 subjects,
      respectively.
    


Intervention name(s): GSK3008356; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This intervention is available as 0.5, 1, 5, and 25 mg white oral tablet. The formulation will be used to administer dose of 5 mg, 10 mg, 30 mg, 45 mg, 75 mg, 90 mg, 125 mg, 180 mg, 200 mg, and 250 mg total daily dose during the study.; This intervention is available as white oral tablet. The formulation will be used as a matching placebo for GSK3008356 during the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dose escalation study; Safety; Pharmacodynamics; Pharmacokinetics; GSK3008356; Tolerability
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Condition: Paroxysmal Atrial Fibrillation; Catheter Ablation Strategies
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      to assess the near-term (12 months) efficacy of pulmonary vein isolation.
    

Detailed description: 
      The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein
      isolation using a standard approach compared to application of an additional acute procedural
      endpoint of unexcitability along the ablation line.
    

Intervention name(s): catheter based pulmonary vein isolation
Intervention type(s): Device
Intervention description(s): catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment