bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of perampanel during the
      Maintenance Period of the Core Study following oral suspension administration given as an
      adjunctive therapy in pediatric participants from 1 month to less than 4 years of age with
      epilepsy.
    

Detailed description: 
      This is a multicenter, open-label study comprised of pretreatment, treatment (core study),
      and extension phases that is designed to evaluate the PK of an oral suspension of perampanel
      (maximum dose must not exceed 12 milligrams per day [mg /day] for participants taking
      non-enzyme-inducing antiepileptic drug [non-EIAED] or 16 mg/day for participants taking
      EIAED) when given as an adjunctive therapy in participants ranging from 1 month to less than
      4 years of age with epilepsy. The Pretreatment Phase will last up to 2 weeks, during which
      participants will be assessed for their eligibility to participate in the study. The
      Treatment Phase will consist of 3 periods: Titration (12 [for participants taking non-EIAED]
      to 16 weeks [for participants taking EIAED]), Maintenance (4 weeks), and Follow-Up (4 weeks;
      only for those participants who complete the Maintenance Period but do not continue into the
      Extension Phase and those participants who discontinue study participation). Extension Phase:
      The Extension Phase will consist of 2 periods: Maintenance (32 weeks [for participants taking
      EIAED]; 36 weeks [for participants taking non-EIAED]) and Follow-Up (4 weeks).

      The maximum total duration of treatment for each participant will be 52 weeks and the maximum
      total duration of the study for each participant will be 58 weeks (2 weeks Pretreatment+52
      weeks of treatment+4 weeks Follow-up).
    

Intervention name(s): perampanel
Intervention type(s): Drug
Intervention description(s): oral suspension.
Other intervention name(s): E2007
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; refractory partial seizures
Non-invasive Pain Monitoring in Post-operative Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      During the current pain monitoring system the patient is awake and he/she is asked to give a
      numerical scale rating from 0 (no pain) to 10 (extreme pain). The purpose is to correlate the
      non-invasive measurements of the prototype device ANSPEC-PRO with these numbers to develop
      later a method/algorithm for automatic evaluation of pain (objective measurement of pain).
      The measurement is done using standard ECG electrodes placed in the hand palm of the patient.
      The patient feels nothing during the observations, perhaps irritation of skin may occur as
      result of long time measurement. As a comparison to the investigators prototype, a commercial
      device is also used in (randomly selected) patients, i.e. the MedStorm device.

      The study will try to answer the following questions:

        -  Are the measurements with the ANSPEC-PRO correlated with the NRS values?

        -  What is the (mathematical) relationship between the measured values and the NRS?

        -  Is there difference between the two devices in measuring pain levels? And what is this
           difference if pain alleviation medication is given to the patient?

        -  A number of 26 patients is envisaged for this study, equally distributed to be evaluated
           with the two devices.
    


Intervention name(s): ANSPEC-PRO
Intervention type(s): Device
Intervention description(s): Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU
Other intervention name(s): MEDSTORM
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients planned for operation, between 18 and 70 years old, not pregnant, not in chronic
        pain and not taken anticonvulsants or antidepressants.
      
Keywords: skin impedance; pain monitoring; observational study; PACU/ICU
Effects of Tanzberger Versus Pelvic Floor Muscle Exercises on Urinary Incontinence
Condition: Urinary Incontinence; Menopause
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Randomized clinical trial (RCT) will be conducted to compare the effects of Tanzberger
      exercises and pelvic floor muscle training on urinary incontinence and quality of life in
      post_menopausal females suffering from urine incontinence in which data will be collected
      from Razahat Medical Centre, Lahore via International Consultation on Incontinence
      Questionnaire-Urinary Incontinence-Short Form score (ICIQ-UI-SF) and incontinence quality of
      life (IQOL) Questionnaire. Sample size of 34 patients will be taken. Non_probability
      convenient sampling will be used. A written consent form will be taken from participants
      meeting inclusion criteria and will be randomly allocated into two groups through lottery
      method, to either the PFMs group or Tanzberger exercise group. Treatment will be given three
      times a week. International Consultation on Incontinence Questionnaire, Urinary
      Incontinence-Short Form Questionnaire and Incontinence quality of life will be used to
      measure quality of life. All participants in both groups will be evaluated before and after
      the treatment programs. Total duration of study will be six months. Data will be analyzed by
      using SPSS 21
    

Detailed description: 
      Urinary Incontinence is defined by the International Continence Society (ICS) as the
      involuntary loss of urine through urethra which is distressing and disabling condition mainly
      affecting the social and psychological well-being of an individual. Due to the embarrassing
      nature of incontinence, it is both underreported and under diagnosed. It affects women's
      quality of life. Tanzberger technique using Swiss ball strengthen levator ani muscles which
      play role in closing urethra. Pelvic floor muscle exercises are safe and efficient treatment
      option to treat urinary incontinence and improves quality of life. The significance of this
      study is, PMFs training and Tanzberger exercises will be executed in comparison to treat
      post-menopausal women who are facing with unhygienic and social embarrassing health disorder
      of Urinary Incontinence.
    

Intervention name(s): Tanzberger Exercises; Pelvic floor muscle training
Intervention type(s): Other; Other
Intervention description(s): It consists of patients who will receive Tanzberger exercise 3 sessions per week for 4 weeks. e.g. Rolling on the ball forward, Back to back sitting.; It consists of patients who will pelvic floor muscles exercise 3 sessions per week for 4 weeks. e.g. Assisted heel drop, Bridge, Dead Bug, Bird DOG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pelvic floor muscle training; Tanzberger Exercise; Urine Incontinence
Retention of Bonded Amalgam Sealants Versus Resin-based Sealants
Condition: Incipient Enamel Caries; Fissure, Dental
MeSH terms: Dental Fissures
Study type: Interventional

Summary: 
      Dental caries, is one of the major public health problem in Pakistan. Dental sealants are
      known cost effective preventive measure of dental caries as compared to other preventive
      measures. Resin based sealants, is a proven treatment of pits and fissure sealants but
      retention is still problem. This trial will assess the use of amalgam sealants as an
      effective and retentive preventive measure in preventing dental caries in children as
      compared to the standard resin-based sealants. The findings of this randomized controlled
      trial will be used to raise awareness among the health care professionals, help them to
      choose amalgam sealants as an effective caries prevention method thereby reducing the burden
      of cost as amalgam is cheaper material compared to resin-based sealants.

      The research question Is there any difference in the six months retention of bonded amalgam
      sealants compared to resin-based sealants among 12 to 16 years old children in Karachi
    

Detailed description: 
      Objective:

      To compare the six month retention of bonded amalgam sealants with that of resin-based
      sealants among 12 to 16 year old children in Karachi

      Methods:

      The study design will be parallel group, equivalence randomized controlled trial. Aim is to
      determine the equality of the Amalgam sealants retention compared to resin based sealants
      retention.

      Outcome:

      The primary outcome will be Retention, divided into Complete Retention, Partial Retention and
      Dislodgement of the sealant material.
    

Intervention name(s): Amalgam sealant; Resin based sealant
Intervention type(s): Procedure; Procedure
Intervention description(s): Amalgam sealant placed on incipient enamel caries and deep enamel fissures.; Resin based sealant placed on incipient enamel caries and deep enamel fissures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.
Masking: None (Open Label)
Primary purpose: Health Services Research
Effect of Vyvanse on Driving in Young Adults With ADHD
Condition: Attention Deficit/Hyperactivity Disorder(ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to assess the benefice of Vyvanse on the factors that
      cause impairments in driving behavior in individuals with ADHD using a driving simulation
      aimed at examining the factors that cause impairments in driving behavior in individuals with
      ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages
      18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show
      lower velocity (speed) scores and spend less time driving over the posted speed limit in the
      driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD
      treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing
      peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser
      likelihood of driving through stop signs and solid red traffic lights without slowing down
      when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with
      Vyvanse will exhibit more focused visual attention on details in the visual field when
      compared to subjects taking a placebo while driving. In addition, young adults with ADHD
      treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when
      compared to subjects taking a placebo.
    


Intervention name(s): Vyvanse; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vyvanse 30, 50, or 70 mg daily; Placebo 30, 50, 70 mg daily
Other intervention name(s): Lisdexamfetamine
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; young adults; driving; Vyvanse; lisdexamfetamine
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the
      drug) and pharmacodynamics (ie, how the drug affects the body) of 2 different doses of
      canagliflozin (JNJ-28431754) in healthy Indian volunteers.
    

Detailed description: 
      This study will be an open-label (all volunteers and study staff know the identity of the
      assigned treatment), randomized (the treatment is assigned by chance), single center, single
      dose, 2-way cross-over study (all volunteers switch from one treatment to another) to assess
      the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being
      investigated for the treatment of type 2 diabetes mellitus) in healthy Indian volunteers. The
      study will consist of 3 phases: a single screening phase, a baseline phase of 2 days per
      period, and an open-label treatment phase that includes 2 treatment periods (Periods 1 and
      2). During Period 1, volunteers will be randomly assigned to receive a single dose of either
      200 mg (Treatment A) or 300 mg (Treatment B) of canagliflozin on Day 1. During Period 2,
      volunteers will receive the dose of canagliflozin (Treatment A or B) that they did not
      receive during Period 1. The duration of each treatment period will be 4 days and each
      treatment period will be separated by a 14 day washout period (when no medication is given).
      Each volunteer will participate in the study for approximately 45 days.
    

Intervention name(s): Canagliflozin (JNJ-28431754) 200 mg; Canagliflozin (JNJ-28431754) 300 mg
Intervention type(s): Drug; Drug
Intervention description(s): One 200 mg tablet taken orally (by mouth) on Day 1.; One 300 mg tablet taken orally (by mouth) on Day 1.
Other intervention name(s): JNJ-28431754; JNJ-28431754
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Indian
Pilot Study Comparing 10hz vs Theta Burst Stimulation
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore
      potential biomarkers of treatment response
    


Intervention name(s): 10Hz; iTBS
Intervention type(s): Device; Device
Intervention description(s): Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System; Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of LY2216684 in Healthy Participants Receiving Albuterol or Propanolol
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of LY2216684 on heart rate of
      participants receiving Albuterol and Propranolol. Information about any side effects that may
      occur will also be collected.
    


Intervention name(s): LY2216684; albuterol; propranolol; placebo for LY2216684; placebo for albuterol; placebo for propranolol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): administered orally; administered orally; administered orally; administered orally; administered orally; administered orally
Intervention MeSH terms: Phenylethyl Alcohol; Propranolol; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and antiviral activity of
      ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267
      also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin
      (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without
      cirrhosis.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and
      antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and
      ABT-333 with and without ribavirin (RBV) in treatment-naive, noncirrhotic participants with
      chronic hepatitis C virus genotype 1a (HCV GT1a) infection.
    

Intervention name(s): ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule; Capsule
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Viekira PAK
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Hepatitis C Virus; Hepatitis C Genotype 1a; Hepatitis C; Treatment-Naïve; Interferon-Free; Paritaprevir; Ombitasvir; Dasabuvir; Ribavirin; Viekira PAK
Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being
Condition: Mindfulness; DNA Methylation; Learning and Memory; Stress; Psychological Well-being
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of a mindfulness-based intervention on
      DNAmethylation, cognitive functions, stress response, and well-being in healthy female
      adults.
    

Detailed description: 
      After being informed about the study and potential risks, all volunteers giving written
      informed consent will undergo a 1-3 week screening period to determine eligibility for study
      entry. At week 0, volunteers who meet the eligibility requirements will be randomized in a
      1:1 ratio to the active control group (8-week, 2 hours/week of lectures) or mindfulness-based
      intervention (8-week, 2 hours/week of mindfulness meditation training).
    

Intervention name(s): Mindfulness meditation training; Active control
Intervention type(s): Other; Other
Intervention description(s): Mindfulness-based intervention encompasses different practices which intend to exercise awareness by using mindfulness meditation training moment by moment. Thus, practices such as mindful breathing, compassionate communication, loving-kindness, self-compassion, mindful listening, dealing with difficulties, the 3 step meditation, walking meditation, body scan with progressive relaxation, thoughts, emotions, gratitude, and sounds and breathing will be teaching to participants. Mindfulness training will be conduct by two instructors with more than 30 years' experience in meditation practices (Zen and Tibetan Buddhist approach to mind-training) and extensive mindfulness teaching and practices (> 5 years each) experiences.; Participants will receive lectures that provide cognitive and sensorial stimulus which does not specifically involve awareness training (meditation). Lesson topics include science.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Switching From Adalimumab to Infliximab
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Switching to Adalimumab has proven to be efficacious in Crohn's disease (CD) patients with
      intolerance or loss of response to Infliximab. Currently there are no studies on the efficacy
      of switching to Infliximab in patients with loss of response or primary non-response to
      Adalimumab. Even in rheumatology, where switching between all classes of anti-TNFα
      biologicals is common practice, there are no scientific data on switching from humanized to
      chimeric anti-TNFα antibodies.

      The purpose of this study is to document the efficacy of such a switch and to identify the
      possible predictive factors for success.

      If treatment with Adalimumab fails (despite optimal dose and interval) and the treating
      physician therefore decided to switch to infliximab, the patient may be enrolled in this
      observational study. At regular intervals (every Remicade), the patient will be clinically
      re-evaluated. The disease activity score will be calculated: Crohn's disease activity index
      (CDAI). At regular intervals, the results of interim blood tests will be documented (3x). The
      succession will be 1 year. At week 10, 26 and 52, additional serum samples will be taken for
      determination of antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab
      (week 0) and Infliximab (week 10, 26 and 52) will be determined.

      For this study there is no specific therapy change. The study wants only to document the
      results of a therapy switch that, in current clinical practice, is made by the treating
      physician.
    


Intervention name(s): Adalimumab and Infliximab
Intervention type(s): Drug
Intervention description(s): Patients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab switch to Infliximab.
Intervention MeSH terms: Adalimumab; Infliximab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with moderately to severely active Crohn's disease with primary non-response or
        loss of response to Adalimumab, switch to Infliximab.
      
Biospecimen description: 
      At regular intervals, the results of interim blood tests will be documented (3x).

      After 10, 26 and 52 weeks, additional serum samples will be taken for determination of
      antibodies against Adalimumab and Infliximab. The serum levels of Adalimumab (week 0) and
      Infliximab (week 10, 26 and 52) will be determined.
    
Keywords: Chrohn's disease; Moderate to severely active Crohn's disease patients