bioihbjkbjnl/mcl2 huggingface dataset:
Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and
      adult participants (12 to 80 years, inclusive) with refractory partial onset seizures
      maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
    


Intervention name(s): Placebo; Rufinamide
Intervention type(s): Drug; Drug
Intervention description(s): For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 placebo tablets twice daily.; For the titration phase, Rufinamide will be administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
Other intervention name(s): E2080; BANZEL
Intervention MeSH terms: Rufinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Staccato Alprazolam in Panic Attack
Condition: Treatment of Induced Panic Attack
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      We are developing Staccato™ Alprazolam for the treatment of Panic attacks associated with
      panic disorder. This study will provide an initial assessment of efficacy, and to continue to
      describe the tolerability and pharmacokinetics, of a single inhaled dose of Staccato
      Alprazolam on a doxapram-induced panic attack in patients with panic disorder.
    

Detailed description: 
      The study will be conducted at multiple centers. A total of 42 male and female panic disorder
      patients will be studied. The first 6 subjects will receive Staccato Alprazolam 1 mg open
      label to validate the dose selection. The remaining 36 subjects will be treated with either
      Staccato Alprazolam at the chosen dose; or with Staccato Placebo in a double blind,
      randomized order.
    

Intervention name(s): Inhaled placebo; Inhaled alprazolam 1 mg; Inhaled alprazolam 2 mg; IV doxapram
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Staccato Alprazolam Placebo; Inhaled Staccato Alprazolam 1 mg; Inhaled Staccato Alprazolam 2 mg; 0.5 mg/kg doxapram IV approximately 10s after receiving inhaled alprazolam or placebo
Intervention MeSH terms: Alprazolam; Doxapram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Staccato™ Alprazolam, Panic Attack, Inhaled alprazolam
Ebselen as an add-on Treatment in Hypo/Mania
Condition: Bipolar Disorder; Bipolar Disorder, Manic
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of a 'lithium like' drug called ebselen (SP-1005) versus
      placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder.
      Half of the participants will receive ebselen and the other half placebo. The trial, will
      last a total of four weeks.
    

Detailed description: 
      Ebselen, a new drug for mania

      Bipolar disorder, formerly known as manic depression, is a condition that affects mood, which
      can swing from one extreme to another.

      Typically, there will be periods of:

        -  Depression - very low mood and energy levels

        -  Mania or hypomania (less severe) - very high mood and overactive energy levels

      A drug called lithium, used to stabilise mood, is an important treatment for bipolar disorder
      but has a number of problematic side effects, is not well tolerated by patients and requires
      careful monitoring. To replace lithium with other, safer medicines would have clear
      advantages. The investigators are interested in an antioxidant medicine(substance that may
      prevent or delay cell damage) called ebselen which has been shown to work in a similar way as
      lithium and the investigators are investigating whether it might help improve recovery from
      manic episodes.

      The present study aims to see whether ebselen, used as an 'add-on' treatment can help
      stabilise mood in patients experiencing high mood (hypo/mania). Sixty patients experiencing
      hypo/mania will be given in a randomised order (similar to tossing a coin) either ebselen or
      placebo (dummy) in addition to their usual medication for three weeks after which the add-on
      treatment will be stopped. A final follow up visit will take place one week after the study
      medication has been stopped. Participants can be in or outpatients and mood will be monitored
      with questionnaires and interviews. Activity will also be monitored with the use of an
      actiwatch (similar to a wrist watch) which will be worn continuously throughout the study. A
      single blood sample will be optional and occur after the first week of treatment to check
      plasma levels of ebselen and inflammatory markers. A positive outcome in this trial will be
      followed by longer term studies of ebselen in bipolar disorder.
    

Intervention name(s): Ebselen; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Ebselen is an opaque capsule containing 200 mg of ebselen is a selenium-based GPx mimic and IMPase inhibitor.; Placebo is identical in appearance to the ebselen capsules
Other intervention name(s): SPI-1005; PZ-51; Ebselene; Ebselenum; Ebseleno; Harmokisane; Dummy
Intervention MeSH terms: Ebselen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This study will be a prospective, multicenter clinical trial in which a total of 400 subjects
      will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of
      15 clinical sites participating. Qualified subjects will provide informed consent for entry
      into the study.
    

Detailed description: 
      The loss of near vision and the ability to perform tasks that require near vision is part of
      the normal aging process. This natural transformation in the eye occurs as a result of the
      loss of accommodation of the crystalline lens, a condition known as presbyopia. Presbyopia,
      characterized by a progressive, age-related loss of accommodation (i.e., the lens ability to
      focus clearly over a wide range of distances), is most prevalent of all visual deficiencies,
      affecting 100% of the population over the course of a normal life span. Loss of accommodation
      begins early in life and, for an emmetropic eye, generally culminates in a complete loss of
      functional near vision.

      ReVision Optics has developed the Raindrop corneal inlay for the correction of near vision.
      The Raindrop is a 2mm corneal inlay, as small as a pinhead, thinner than a human hair and
      about 1/500th of a droplet of water. The inlay is the same refractive index as the human
      cornea. The inlay is placed in the non-dominant eye,centered over the pupil after a corneal
      flap (LASIK)has been made. The Raindrop is expected to provide presbyopic subjects with
      improvement of near and intermediate vision.
    

Intervention name(s): The Raindrop Near Vision Inlay
Intervention type(s): Device
Intervention description(s): The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
Other intervention name(s): Presbylens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: presbyopia; LASIK; loss of accommodation; Emmetrope
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions
Condition: Hypothalamic-pituitary Lesions; Craniopharyngiomas
MeSH terms: Craniopharyngioma; Adamantinoma; Pituitary Diseases; Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      In children treated for intracranial lesions, the 2 factors of the obesity are : the location
      of the lesion (hypothalamic-pituitary region) and craniopharyngiomas
    

Detailed description: 
      Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are
      craniopharyngiomas with one or three cases per 1 million children each year.

      One major problem remains unsolved : the obesity

      This study is performed to optimize the management of the children with
      hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the
      surgery
    

Intervention name(s): DIAZOXIDE
Intervention type(s): Drug
Intervention MeSH terms: Diazoxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypothalamic-pituitary lesions; Craniopharyngioma; Obesity; Diazoxide; Hyperinsulinemia; Pediatric neurosurgery; Oncology; Pituitary; Hypothalamus
A Study of HM11260C in Healthy Male Subject
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design.
      Five ascending dose cohorts are planned.
    

Detailed description: 
      Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics
      of single subcutaneous dose of HM11260C in healthy male subjects.
    

Intervention name(s): HM11260C; HM11260C; HM11260C; HM11260C; HM11260C
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): HM11260C 0.5mcg/kg or Placebo; HM11260C 2mcg/kg or Placebo; HM11260C 4mcg/kg or Placebo; HM11260C 8mcg/kg or Placebo; HM11260C 14mcg/kg or Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Exendin-4
Memantine and Changes of Biological Markers and Brain PET Imaging in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      In AD, tau protein is abnormally hyperphosphorylated. Significant changes of
      hyperphosphorylated tau levels in CSF are found in AD patients. It has been shown in vitro
      that memantine can reverse abnormal hyperphosphorylation of tau in hippocampal neurons of
      rats. A statistically significant reduction of CSF phosphorylated tau at a preliminary 1-year
      follow-up was observed, from median 126 (interquartile range 107-153) to 108 (88-133) ng/l (p
      = 0.018). No statistically significant differences of total tau or Aβ42 were found
      (Gunnarsson MD, 2007).

      FDG-PET has the unique ability to estimate the local cerebral metabolic rate of glucose
      consumption, thus providing information on the distribution of neuronal death and synapse
      dysfunction in AD in vivo (Herholz K. 2003). Synaptic dysfunction and loss induce a reduction
      in neuronal energy demand that results in decreased glucose metabolism. Hypometabolism in AD
      is thought to reflect loss of synaptic activity and density (Herholz K. 2003; Mielke R, et
      al. 1998).

      Another biological markers such as inflammatory factor and APOEε4 also play a part in the
      onset of AD (Glodzik-Sobanska L, 2007).
    

Detailed description: 
      1. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on
           biological markers of subjects with Alzheimer's disease.

        2. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on
           18[F]-FDG-PET of brain in subjects with Alzheimer's disease.

        3. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on
           cognitive function in subjects with Alzheimer's disease.

        4. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on
           measures of behavior and activities of daily living of subjects with Alzheimer's
           disease.

        5. To investigate the effects of daily dosing of memantine for 24 weeks versus placebo on
           short term memory.
    

Intervention name(s): Memantine
Intervention type(s): Drug
Intervention description(s): Initially memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day
Other intervention name(s): Memantine hydrochloride
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; tau protein; PET; Memantine
Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
Condition: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      Critically ill patients with sepsis undergo several physiological alterations that can alter
      the distribution, metabolism, and elimination of drugs. Some patients with sepsis may realize
      enhanced cardiac output leading to increases in glomerular filtration that result in
      increasing drug clearance. This clinical state is referred as Augmented Renal Clearance
      (ARC). Importantly, many beta-lactam antibiotics can be adversely affected by ARC, and some
      of these agents required increasing dosage to compensate for enhanced clearance.
      Imipenem-relebactam is a new broad spectrum antibiotic. This study is designed to assess the
      pharmacokinetics of both components, imipenem and relebactam, in critically ill patients with
      ARC.
    

Detailed description: 
      This is a single center, open-label study to determine imipenem-relebactam pharmacokinetics
      in critically ill patients with Augmented Renal Clearance (ARC). Twelve patients with
      suspected ARC will be enrolled to ensure complete pharmacokinetic data in at least eight
      patients with confirmed ARC. Confirmation of ARC will be established by eight hour urine
      creatine determination. Each participant will receive a single dose of imipenem-relebactam
      (500mg/250mg) followed by six blood samples over a 6 hour interval to determine
      concentrations. Non-compartmental and population pharmacokinetic analyses will be determined
      to assess the effects of ARC on imipenem and relebactam pharmacokinetic parameters.
    

Intervention name(s): Imipenem-relebactam
Intervention type(s): Drug
Intervention description(s): After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
Intervention MeSH terms: Imipenem; Relebactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: beta-lactam; pharmacokinetics
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Condition: Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK
      134612 in healthy infants, when co-administered with other infant vaccines, on three
      different dose schedules.
    

Detailed description: 
      This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to
      the update of enrollment, a secondary outcome measure, intervention and exclusion criteria
      sections.
    

Intervention name(s): Meningococcal vaccine GSK 134612; SynflorixTM; Infanrix-IPV/HiberixTM
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal conjugate vaccine; serogroups A,C, W-135 or Y; meningococcal diseases; Immunogenicity; Neisseria meningitidis; co-administration; routine vaccines
Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment
Condition: Ketosis Prone Diabetes; Diabetes Ketoacidosis; Hyperglycemia
MeSH terms: Diabetes Mellitus; Hyperglycemia; Ketosis; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The study intends on enrolling 48 subjects with diabetes. Diabetic subjects that no longer
      need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called
      metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active
      medication). Subjects on pills will be followed for 3½ years and undergo blood tests at
      specified intervals to assess their ability to make insulin. These studies will allow a
      better understanding of the factors that lead to high blood sugar in patients with
      ketosis-prone diabetes mellitus (KPDM) and direct the best diabetes treatment for this
      patient population.

      Hypothesis: Metformin therapy or sitagliptin therapy compared to placebo, will improve β-cell
      function, insulin sensitivity, and allow for a longer period of time prior to encountering an
      insulin-deficient relapse after discontinuation of insulin therapy.
    


Intervention name(s): metformin; placebo; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.; The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.; The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.
Other intervention name(s): Glucophage; Januvia
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Influence of Vitamin-B-complex on Cognitive Ability of Kindergarten Kids
Condition: Healthy
Study type: Interventional

Summary: 
      Vitamin-B and Folic intake of Kindergarten kids in Germany is only 50-70% of the official
      recommendations. In studies with adults it has been found that for example providing people
      suffering from Alzheimer´s disease improved their mental and cognitive abilities when
      provided with a high intake of these vitamins.The hypothesis is, that kindergarten kids, 4-6
      years of age, could also improve mentally from a recommended intake of B-vitamins and Folic
      Acid.

        1. screening study: The urine of 1200 kindergarten kids will be analyzed for metabolites of
           these vitamins, and the 250 kids with the lowest results will be invited for a
           randomized double blind intervention study.

        2. intervention study: Participating kids will get an one hour mental and cognitive testing
           before and after the intervention. The intervention will be one portion of the
           recommended dosage of a vitamin B complex and folic acid , given in a drink (milk, tea,
           etc). The assumption is, that the treatment group will perform better than the placebo
           group in the second test phase.
    


Intervention name(s): Vitamine-B and Folic Acid Complex, calcium; calcium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 90 days of intake, will be given in drink (e.g. tea, milk, juice). Dosage within official recommendations for kindergarten kids; according to protocol
Intervention MeSH terms: Calcium, Dietary; Folic Acid; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: B-vitamins; Folic-Acid; kindergarten kids; cognitive tests; Healthy kids; second part low urine vitamine-B-metabolites
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib
      administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2
      tablets under fasted conditions.
    


Intervention name(s): Sotorasib
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Other intervention name(s): AMG 510
Intervention MeSH terms: Sotorasib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sotorasib; AMG 510
A Bite Force Study Comparing Two New Test Adhesives With Currently Marketed Denture Adhesive
Condition: Denture Retention
Study type: Interventional

Summary: 
      The objective of this 4-treatment, 4-period, randomized, crossover, proof of principle bite
      force study will be to compare bite force measurements over a 12 hour period across two
      (test) cream denture adhesives, with a currently marketed cream denture adhesive (positive
      control), and a negative/no treatment control.
    

Detailed description: 
      This will be a 4-treatment, 4-period, randomized, crossover, proof of principle bite force
      study which will compare bite force measurements over a 12 hour period across two cream
      denture adhesives with a currently marketed cream denture adhesive (positive control), and a
      negative/no treatment control. A short questionnaire regarding the flavor and texture
      characteristics of each denture adhesive after a single use will also be administered to give
      an indication of participant satisfaction of these attributes.
    

Intervention name(s): Test Product 1; Test Product 2; Reference Product; Negative Control
Intervention type(s): Device; Device; Device; Other
Intervention description(s): Test adhesive 1 with a thin nozzle; Test adhesive 2 with a thin nozzle; Adhesive Cream; No adhesive
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care