bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic profile, safety, and
      tolerability of ramelteon in adolescents with insomnia, children with Attention Deficit
      Hyperactivity Disorder (ADHD) associated with insomnia and gender- and race-matched healthy
      adults.
    

Detailed description: 
      Ramelteon is a treatment for insomnia approved for use in the United States (US) in July 2005
      and in the Philippines and Indonesia in 2008. It is currently under development in the
      European Union (EU) and Japan. Ramelteon is marketed in the US as ROZEREM® for the treatment
      of insomnia characterized by difficulty with sleep onset in patients over 18 years of age.

      In adolescents, the form of sleep onset and/or sleep maintenance insomnia, defined as
      psychophysiologic insomnia, is similar to adults, and more appropriate for treatment with
      pharmacological intervention when compared to insomnia in children younger than 12 years of
      age. In psychophysiologic insomnia, the individual develops conditioned anxiety around
      difficulty falling or staying asleep, which leads to heightened physiologic and emotional
      arousal and further compromises the ability to sleep. In children over the age of 12,
      insomnia is more likely to be persistent and have identifiable consequences. In addition,
      there is less variability in normative sleep data for this age group than in younger
      children.

      Sleep disturbances are also common in children. Specifically, insomnia associated with ADHD
      in children is very common with a reported prevalence of 28% in medication-free children with
      ADHD.

      This study is to characterize the pharmacokinetics (PK) and safety profile of a 4 or 8 mg
      dose of ramelteon in adolescents who are between 12 to 17 years of age (prior to the 18th
      birthday) with insomnia characterized by difficulty with sleep initiation, and in pediatrics
      who are between 6 to 11 years of age who have insomnia associated with ADHD. These profiles
      will be compared with those of healthy adults aged 18 to 50 years who are matched by race and
      gender receiving an 8 mg dose of ramelteon. This open-label study is designed in accordance
      with the recommendations of the FDA and ICH guidances for pediatric PK studies.
    

Intervention name(s): Ramelteon
Intervention type(s): Drug
Intervention description(s): Ramelteon tablets, orally for one day only.
Other intervention name(s): TAK-375; Rozerem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Sleep Initiation and Maintenance Disorders; Drug Therapy
Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of
      age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also
      evaluate the immune response against hepatitis B one month after vaccination (challenge
      vaccination) with a stand alone monovalent hepatitis B vaccine.

      Primary objectives:

        -  To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after
           last priming dose in subjects having received hepatitis B vaccine at birth and a
           hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during
           A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2])

        -  To evaluate the immune response against hepatitis B one month after vaccination with a
           stand alone monovalent hepatitis B vaccine (challenge vaccination).

      Secondary objectives:

        -  To describe serious adverse events (SAEs) reported throughout the trial after
           administration of hepatitis B vaccine.
    

Detailed description: 
      Subjects age 9 to 10 years who had received 3 injections of Hexaxim® or Infanrix® hexa and
      have completed the A3L12 study will be invited to participate in this study. They will
      receive one dose of Euvax-B® vaccine at Day 0.
    

Intervention name(s): Euvax B®: Hepatitis B vaccine; Euvax B®: Hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Euvax B®; Euvax B®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine; Euvax-B®; Hexaxim®; Infanrix® hexa
Inter Individual Variation in Weight Loss Response to Exercise
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The identification and characterization of individuals who vary in their response to
      exercise-induced weight loss is important. Weight loss in response to exercise is variable
      and it remains unknown who will succeed, why, and more importantly how to improve weight loss
      efficacy.

      This study will examine changes in behavioural, metabolic, physiological and biochemical
      variables in response to a 12 week supervised exercise programme and evaluate their
      association with weight loss in overweight and obese sedentary individuals.

      Our hypothesis is that changes in the plasma levels of appetite related hormones undermine
      the inter individual variation in weight loss in response to exercise.

      This study will improve the understanding of variability to exercise-induced weight loss and
      allow more individually tailored and appropriate strategies for weight management programmes.
    

Detailed description: 
      Purpose - To identify predictors of weight loss in overweigh/obese volunteers following a 12
      week supervised exercise programme, and to characterise the variability in weight loss
      response.

      Method - Longitudinal study aiming to identify predictors of weight loss in response to a
      12-week exercise programme in healthy overweight/obese volunteers.

      Subjective and objective measures of appetite, cardiovascular fitness, anthropometry, body
      composition, resting metabolic rate (RMR), fat and carbohydrate oxidation in the fasting
      state will be measured at baseline, before participants enroll for the study and after the
      exercise intervention.

      The preload/test-meal paradigm (using a high and low-energy preload: HEP vs LEP) will be used
      to assess short-term appetite control before and after the exercise intervention following a
      randomized single-blinded crossover design. Moreover, the long-term effects of exercise on
      cytokine plasma levels and fasting and postprandial levels of appetite related
      hormones/metabolites will also be assessed at baseline and end of the study. Participants
      will act as their own controls throughout the study.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 12-week supervised exercise programme (5 times /week at 75% maximal Heart Rate)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Appetite; Body composition; Energy compensation
Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of RGH-896 in patients with
      diabetic peripheral neuropathic pain.
    


Intervention name(s): RGH-896; RGH-896; RGH-896; pregabalin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 45 mg TID, capsules, 14 weeks.; 30 mg TID, capsules, 14 weeks.; 15 mg TID, capsules, 14 weeks.; 100 mg, TID, capsules, 14 weeks.; TID, capsules, 14 weeks.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetic; peripheral; neuropathic; pain; chronic; diabetes
Feasibility of IPL Combined With RF for Treatment of DED Due to MGD
Condition: Dry Eye Disease; Meibomian Gland Dysfunction
MeSH terms: Dry Eye Syndromes; Eye Diseases; Meibomian Gland Dysfunction
Study type: Interventional

Summary: 
      The purpose of this single-arm pilot study is to evaluate the feasibility and safety of
      combination therapy of intense pulsed light (IPL) and (Radiofrequency) RF for treatment of
      Dry eye disease (DED) due to Meibomian gland dysfunction (MGD).
    

Detailed description: 
      In the past several years, a large number of studies have demonstrated that several sessions
      of IPL followed by MGX lead to a long-term reduction in signs and symptoms of DED due to MGD,
      however benefits for the patient are expected only after 2 or 3 sessions. On the other hand,
      several researchers reported that application of RF around the eyelids provide immediate
      relief of DED symptoms (unpublished observations: Dr. Chantel Garcia). The efficacy of RF for
      reduction of DED signs and symptoms was also demonstrated in two clinical studies and one
      animal model of obstructive MGD. Despite the small number of studies with RF, these
      preliminary results suggest that the combination of IPL, MGX and RF could provide immediate
      symptomatic relief together with long-term improvement of signs and symptoms of DED. In
      addition, combination therapy might be useful to increase the efficacy of monotherapy RF or
      monotherapy IPL.

      The purpose of this single-arm pilot study is to evaluate the feasibility and safety of
      combination therapy of IPL and RF for treatment of DED due to MGD. As far as we know this is
      the first study of its kind. Results of this current study will be useful to choose the most
      effective outcome measures, to estimate the risk to benefit ratio, and to anticipate the
      effect size. In the future, such information will be essential for evaluating the merits of
      this approach, by designing a powered and randomized controlled study.

      .
    

Intervention name(s): IPL_RF_MGX
Intervention type(s): Device
Intervention description(s): intense pulsed light followed by Radiofrequency followed by meibomian gland expression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine,
      a known anti-spasticity medication, has been shown in a previous study to improve sleep and
      next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this
      improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with
      resulting improvement in quality-of-life (i.e.,improvements in next-day functioning,
      cognition and movement) may also be seen in a similar patient population, i.e., children with
      traumatic brain injury (TBI).
    

Detailed description: 
      Sublingual tizanidine, a novel test formulation of the known effective antispasticity agent,
      has been shown to have a unique pharmacokinetic profile [(i.e., nearly twice the
      bioavailability/AUC), but with little or no increase in peak plasma levels (Cmax), as
      compared to oral tizanidine (Zanaflex)]. When administered nightly to CP (Cerebral Palsy)
      patients to more effectively reduce the muscle spasms that disrupt sleep, it was shown to
      improve sleep efficiency, decrease sleep fragmentation and improve the sleep cycle. This
      improvement in night-time sleep was translated into a potential improvement in next-day
      functioning (improvement in next-day measures of spasticity and movement).

      It is hypothesized that a similar type of improvement in sleep with consequent positive
      impact on next day improvement in spasticity, cognition and function, may also be manifest in
      a similar patient population, children with traumatic brain injury.
    

Intervention name(s): Sublingual Tizanidine HCl
Intervention type(s): Drug
Intervention MeSH terms: Tizanidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Actigraphy; Spasticity, Cognition and Functioning
Clinical Evaluation of Lyral® Dose Response Study
Condition: Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine optimal allergen dose as the lowest concentration
      eliciting positive reactions in 70-90% of subjects. Frequency of positive, negative, doubtful
      and irritant reactions, and concordance with a corresponding reference allergens will be
      captured.
    

Detailed description: 
      This is a single-center, randomized study to compare the diagnostic performance and safety of
      ascending doses (0.10 mg/cm², 0.20 mg/cm² and 0.40 mg/cm²) of hydroxyisohexyl 3-cyclohexene
      carboxaldehyde (Lyral®) in 20 adult subjects with a past positive patch test to Lyral® or
      Fragrance Mix 2.
    

Intervention name(s): Lyral®
Intervention type(s): Biological
Intervention description(s): Alergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control
Other intervention name(s): Lyral Allergen Panel (experimental)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Patch Test; Allergy Testing; Contact dermatitis; Lyral allergen; Fragrance Mix allergen
Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
Condition: HIV
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of
      elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected
      virologically suppressed adolescents 12 to < 18 years of age.
    


Intervention name(s): E/C/F/TAF
Intervention type(s): Drug
Intervention description(s): 150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food
Other intervention name(s): Genvoya®
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria
Condition: Hereditary Orotic Aciduria
MeSH terms: Purine-Pyrimidine Metabolism, Inborn Errors
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol has two parts - the Main Study which is 42 days in length and the Treatment
      Extension which allows the patients who complete the Main Study to continue receiving
      treatment with uridine triacetate. The purpose of this study is to replace oral
      administration of uridine with oral administration of uridine triacetate in patients with
      hereditary orotic aciduria who have received (or would reasonably be expected to receive)
      clinical benefit from treatment with exogenous uridine. It is also to document the continued
      clinical benefit of exogenous uridine when patients are switched from oral administration of
      uridine to oral administration of uridine triacetate.
    

Detailed description: 
      Data to be collected during the Main Study include demographic, baseline disease information
      and medical history including all prior disease-directed therapy. In addition, vital signs,
      laboratory values and adverse events information will be collected and recorded. Urine
      samples will be obtained and measured for orotic acid and orotidine levels. Systemic levels
      of uridine will be evaluated from plasma samples collected at set timepoints.

      Upon successful completion of the Main Study and entry into the Treatment Extension, physical
      exams and vital signs will be performed every six (6) months. Additionally, plasma samples to
      measure systemic levels of uridine and urine samples to measure levels of orotic acid and
      orotidine will be collected every (6) six months.
    

Intervention name(s): uridine triacetate
Intervention type(s): Drug
Other intervention name(s): PN401 (Company Code Name); 2',3',5'-tri-O-acetyluridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Cardiovascular Efficacy of Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD
Condition: Chronic Hemodialysis (ESRD)
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a pilot study designed to compare the safety and cardiovascular effects of 26
      weeks of combination hydralazine/isorsorbide dinitrate therapy with placebo therapy in
      patients receiving chronic hemodialysis.

      The investigators hypothesize that treatment of chronic hemodialysis (ESRD) patients with a
      combination of hydralazine/isosorbide dinitrate compared with placebo is safe and that it
      will improve heart function as well blood flow/blood vessel supply.
    

Detailed description: 
      Sixteen patients receiving maintenance hemodialysis will be randomized to 26 weeks of therapy
      with combination hydralazine/isosorbide dinitrate or placebo. Study medications will be
      titrated to goal dose during the first 4 weeks and maintained at goal dose (as tolerated)
      between weeks 4-26. A final study visit to assess symptoms after drug discontinuation will
      occur 4 weeks after drug discontinuation.

      Study duration-Maximum of 32 weeks with 26 weeks of active therapy.

      Efficacy Measures -Tissue Doppler echocardiography and myocardial perfusion scanning using
      radioactive NH3 PET will be assessed at weeks 0 and 26.

      Safety Measures-Adverse events rates including inter- and intra-dialytic hypotension,
      ,cardiovascular death and gastrointestinal symptoms will be assessed throughout the duration
      of the study.
    

Intervention name(s): Hydralazine/Isorsorbide Dinitrate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.
Target Dose:
Hydralazine 75 mg 3x day Isorsorbide Dintrate 40 mg 3x/day
Allowable Dosage Forms:
ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35 mg-3x/day ISD/HY 40 mg/75 mg-3x/day
Dose Titration:
ISD/HY will be administered at a starting dose ISD/HY 10 mg/10-3x/day and titrated to ISD/HY 20 mg/35 mg-3x/day after 4 days and to ISD/HY 40 mg/75 mg-3x/day at 4 weeks. Dose will be decreased as necessary for dose-limiting side effects.; Placebo titration will mimic titration of active study arm
Other intervention name(s): Apresoline; Isordil
Intervention MeSH terms: Hydralazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hemodialysis; ESRD; Cardiovascular Disease; Isosorbide Dinitrate; Hydralazine
Response of Topical Capsaicin in Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 4

Summary: 
      It has been postulated that Alopecia Areata (AA) is, at least in part, a neurologically
      mediated disease. Research supporting this theory includes the finding that nerves
      surrounding the hair follicles are collapsed. We want to take this research a step further
      and show that not only are these perifollicular nerves collapsed, but that their function is
      also impaired.
    

Detailed description: 
      To assess the function of perifollicular scalp nerves in AA we will look at the response of
      these nerves to the topical medication capsaicin. Under normal circumstances topical
      capsaicin is known to target nerves in the peripheral nervous system causing short-term
      release of the neuropeptide Substance P (SP) as well as long-term transient depletion of SP.
      We expect the AA patients will respond abnormally to topical capsaicin treatment.
    

Intervention name(s): Capsaicin
Intervention type(s): Drug
Intervention MeSH terms: Capsaicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly
      dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated
      by oral antipsychotics and with acute symptom of schizophrenia.
    

Detailed description: 
      This is a 13-week, open-label (all people know the identity of the intervention), single-arm
      (one group of patients), multicenter, prospective, interventional study in Chinese patients.
      In a prospective, interventional study, the patients identified receive a treatment during
      the course of the research study and are followed forward in time for the outcome of the
      study. In China, there is still insufficient information about effectiveness, tolerability,
      and dosage strategy for directly switching from previous oral antipsychotics (drugs that are
      helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in
      patients with acute symptoms. Acute symptoms are quick and severe form of illness in its
      early stage. In addition, there is also lack of information about bridging acute phase to
      long-term treatment. In this study, patients with multiple types of acute schizophrenia will
      be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks.
      After the acute treatment, the patients will continue to receive the prescribed medication
      and will be followed up for an additional 52 weeks to assess the outcomes related to
      long-term treatment.
    

Intervention name(s): Paliperidone Palmitate
Intervention type(s): Drug
Intervention description(s): One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone Palmitate; Oral Antipsychotics; Invega Sustenna