bioihbjkbjnl/mcl2 huggingface dataset:
A Limited Food Effect Study of Gabapentin 800 mg Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin
      Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by
      Parke-Davis following a single oral dose (1 x 800 mg tablet) or (2 x 400 mg capsules) in
      healthy adult male volunteers under non-fasting conditions, and will compare the differences
      in plasma levels after dosing the test formulation with and without food.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, single-dose, three-way crossover under
      fed and fasting conditions

      Official Title: A Limited Food Effect Study of 800 mg Gabapentin Tablets versus 400 mg
      Gabapentin Capsules

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Gabapentin 800 mg tablets, single dose (1 tablet); NEURONTIN® 400 mg capsules, single dose (2 capsules); Gabapentin 800 mg tablets, single dose (1 tablet)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products under fasting conditions; B: Active comparator Subjects received Parke-Davis formulated products under non-fasting conditions; A: Experimental Subjects received Purepac formulated products under non-fasting conditions
Other intervention name(s): Gabapentin; Gabapentin; Gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Gabapentin; Healthy subjects
Perception of Stressful Social Stimuli After Trauma Exposure.
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      Post-traumatic stress disorder is associated with altered processing of sensory stimuli. The
      clinical phenotype PTSD has predominantly been described for the visual and auditory sensory
      modalities. However, PTSD symptoms such as intrusive memories are often evoked by olfactory
      and tactile cues in the environment. Moreover, little is known about whether aberrant
      responses to social olfactory and tactile stimuli are also present in a subclinical
      population.The purpose of this study is to compare trauma-exposed subjects (e.g. childhood
      maltreatment) with non-exposed controls in the processing of olfactory and tactile stimuli.
      This sensory characterizations hold potential to identify potential biomarkers for the course
      of trauma-related disorders and to inform trauma therapies focusing on sensory integration.
    


Intervention name(s): Processing of social olfactory and tactile stimuli
Intervention type(s): Behavioral
Intervention description(s): Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population will consist of trauma-exposed subjects and healthy controls without
        trauma-exposure.Patients and healthy controls will be recruited from the Bonn area.
A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Condition: Recreational Drug Use; Prescription Drug Abuse (Not Dependent)
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the abuse potential of study drug lasmiditan.

      Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as
      well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any
      active drug) to determine the potential for drug abuse. The dosages will be in tablet form
      and will be taken orally (by mouth).

      This study will last about 55 days, including screening. Screening will occur within 28 days
      prior to qualification phase.
    


Intervention name(s): Lasmiditan; Alprazolam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY573144
Intervention MeSH terms: Alprazolam; Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluate the Effect of TPN171H on the QT/QTc Interval in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose orally administered, dose-escalation, single-center, randomized,
      double-blind, placebo-parallel controlled clinical study evaluating the effect of TPN171H
      tablets on QT/QTc interval in healthy subjects.The main objective was to evaluate the effect
      of TPN171H tablets on QT/QTc interval in healthy Chinese subjects after a single oral
      administration.
    

Detailed description: 
      This trial was a single-center, randomized, double-blind, placebo parallel controlled trial
      of TPN171H tablets with single oral administration, dose escalation, in healthy Chinese
      subjects.

      This trial plans to set up 4 dose groups, and a total of 32 healthy adult subjects are
      expected to be enrolled. All subjects will receive a single oral dose under fasting state,
      and complete 3 days of PK blood sampling, 12-lead ECG examination and other safety checks.
      The trial was sequential according to the principle of dose escalation, that is, the next
      dose group was tested on the premise that the safety and tolerability of the previous group
      were good.
    

Intervention name(s): TPN171H 10 mg Group; TPN171H 30 mg Group; TPN171H 40 mg Group; TPN171H 50 mg Group
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 6 subjects will receive TPN171H 10 mg, orally; 2 subjects will receive placebo, orally.; 6 subjects will receive TPN171H 30 mg, orally; 2 subjects will receive placebo, orally.; 6 subjects will receive TPN171H 40 mg, orally; 2 subjects will receive placebo, orally.; 6 subjects will receive TPN171H 50 mg, orally; 2 subjects will receive placebo, orally.
Other intervention name(s): TPN171H 10 mg; TPN171H 30 mg; TPN171H 40 mg; TPN171H 50 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TPN171H tablets; QT/QTc Intervals
Aerobic Exercise for Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This is randomized controlled trial that investigated the effect of aerobic exercises in
      women with fibromyalgia. The study was performed in Abu-kabir central hospital - Al Sharquia,
      Egypt. The sample was recruited from the rheumatology department in Abu-kabir central
      hospital- Al Sharquia. Sixty women were included in the study based on the inclusion
      criteria. The first group (study group) included 30 participants who received aerobic
      exercise in addition to the prescribed medications. The second group (control group) included
      30 participants who received the prescribed medications only. The outcome measures included
      visual analogue scale, Fibromyalgia Impact Questionnaire and cholesterol level. Assessment of
      outcomes were performed at baseline and after the end of treatment program.
    


Intervention name(s): Aerobic exercise; Fibromyalgia Agents
Intervention type(s): Other; Drug
Intervention description(s): The patients in this group participated in aerobic exercise training for 45 minutes, three sessions per week for 6 weeks. They underwent the proper warm up to minimize the risk of musculoskeletal injury .The training session started by a proper warm up for 5 min in the form of mild stretching for the involved muscle group to prepare the exercised muscles and improve blood supply for skeletal muscle to prevent fatigue or injury. Patients in this study group performed aerobic exercise (in the form of treadmill training) All sessions were supervised to ensure correct technique and monitor the appropriate amount of exercise. The training session ended by a proper cooling down for 5 min to prevent fatigue or injury.; tricyclic antidepressants (low evening doses), and mostly when needed, low doses of: analgesics, muscle relaxants, hypnotics, and tranquilizers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not bedtime snacks are necessary to
      prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1
      diabetes who are using intensive insulin therapies, either multiple injections of insulin or
      insulin pump.

      We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well
      adjusted and delivered, especially by use of insulin pump which is considered the "gold
      standard" for overnight blood glucose control.
    

Detailed description: 
      Nocturnal hypoglycemia is a significant side effect of insulin replacement therapy and can
      lead to many problems including coma and death in the most extreme cases and deterioration of
      glycemic control. Strategies to prevent nocturnal hypoglycemia include development of newer
      insulins and delivery systems and the use of specific bedtime snack compositions. Detection
      of nocturnal hypoglycemia, as it occurs in everyday life, has been a problem since most
      episodes go unnoticed and therefore untreated leading to a very dangerous situation. With the
      recent availability of technology which allows for continuous glucose monitoring , it has
      been made possible to detect nocturnal hypoglycemia as it occurs in daily life. As well, this
      technology allows for the possibility of better titration of therapy.

      Therefore, the goal of our study was to use continuous glucose monitoring technology as a
      tool to optimize titration of insulin therapy and as a means to detect nocturnal hypoglycemia
      as it occurs in daily life. Specifically, we sought to compare the use of insulin pump
      therapy with no bedtime snacks and using a new type of insulin called an analogue(lispro)
      versus multiple daily injections of insulin, using the same type of insulin analogue, and
      with and without bedtime snacks. Therefore, we compared 3 groups: 1) insulin pump with no
      bedtime snacks; 2) multiple injections with bedtime snacks and 3) multiple injections with no
      bedtime snacks. The groups were primarily compared for the occurrence and frequency of
      nocturnal hypoglycemia. Other comparisons included: long term glycemic control (A1c), weight
      and body composition and quality of life.
    

Intervention name(s): Bedtime snacks
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nocturnal hypoglycemia; Bedtime snacks; Continuous glucose monitoring; Continuous subcutaneous insulin infusion; CSII; Intensive therapy
Postoperative Consequences of Intraoperative NOL Titration
Condition: Anesthesia; Adverse Effect
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery
      characteristics.
    

Detailed description: 
      Previous work has shown that NOL accurately quantifies nociception during general
      anesthesia.6 Presumably, titrating opioids to NOL will therefore provide individual guidance
      so that patients will be given about the right amount. Patient given the right amount will
      presumably awaken quickly when anesthesia is done, and have good initial pain control in the
      PACU. To the extent that NOL titration facilitates optimal opioid dosing, patients are likely
      to have better PACU experiences - which would be an important outcome that clinicians and
      regulators are likely to take seriously.
    

Intervention name(s): Routine opioid management; PMD-200 Nol-guided opioid administration
Intervention type(s): Drug; Device
Intervention description(s): Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.; PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
Other intervention name(s): Fentanyl; PMD-200 NOL
Intervention MeSH terms: Fentanyl; Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely
      psychotic adults with schizophrenia
    

Detailed description: 
      This is a multicenter, randomized, double-blind, parallel-group, flexibly-dosed, study
      evaluating the efficacy and safety of SEP-363856 in acutely psychotic adult subjects with
      schizophrenia using SEP-363856 (50 or 75 mg/day [ie, once daily]) versus placebo over a
      4-week treatment period. Primary hypoathesis to be tested: H0: μSEP = μPBO versus H1: μSEP ≠
      μPBO, where μSEP and μPBO are the mean changes from Baseline at Week 4 in PANSS total score
      for the SEP-363856 and placebo arms, respectively. Subjects who complete study SEP361-201 may
      be eligible to enroll in the open-label extension study SEP361-202.
    

Intervention name(s): SEP-363856; Placebo - Cap
Intervention type(s): Drug; Drug
Intervention description(s): One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks; One Placebo capsule daily for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Proof of concept, open-label single center study for the donation of HCV positive kidneys to
      HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission
      upon transplantation.
    

Detailed description: 
      The study objective is to determine if the administration of grazoprevir and elbasvir (with
      or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV
      infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative
      recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment
    

Intervention name(s): elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)
Intervention type(s): Drug
Intervention description(s): Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor
Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).
Other intervention name(s): Zepatier
Intervention MeSH terms: Grazoprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemodialysis; peritoneal dialysis; renal failure; kidney transplant
Study Evaluating The Mass Balance And Metabolic Disposition Of SKI-606
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the mass balance, metabolic disposition, and identification of
      metabolites following single oral administration of [14C]-SKI-606 in healthy male subjects.
    


Intervention name(s): SKI-606
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effectiveness of mirtazapine in reducing anxiety in children
      with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
    

Detailed description: 
      One of the areas receiving very little attention in Pervasive Developmental Disorders (PDDs)
      is that of anxiety. Anxiety is common in PDD, but has not yet been fully characterized. The
      primary objective of this study is to conduct a preliminary placebo-controlled trial of
      mirtazapine for the treatment of anxiety associated with PDDs. We hypothesize that
      mirtazapine will be safe and well tolerated.
    

Intervention name(s): Placebo; Mirtazapine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to placebo will receive placebo for duration of the study; Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg per week for subjects weighing less than 50 kg and up to 15 mg per week for subjects weighing more than 50 kg depending on efficacy and tolerability.
Other intervention name(s): Sugar pill; Remeron
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autistic Disorder; Asperger's Disorder; Pervasive Developmental Disorder
Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once
      daily added to the regimen of patients with inadequate glycemic control on metformin
      monotherapy
    


Intervention name(s): sitagliptin phosphate; Comparator: metformin; Comparator: metformin; Comparator: Antidiabetic Standard of Care
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sitagliptin 100 mg Once a day (QD) for 24 weeks; metformin 850 mg Twice a day (BID) for 24 weeks; metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks; Patient can take any oral antidiabetic drug (other than metformin)
Other intervention name(s): sitagliptin; metformin; metformin
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tissue Plasminogen Activator & Plasminogen Activator Inhibitor Type-1 In Gingival Tissues Of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will
      be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by
      quantitative reverse transcription polymerase chain reaction in the gingival tissues of
      chronic periodontitis in an attempt to investigate whether the expression of these proteins
      could be involved in the disease pathogenesis or not, and to assess as well if their
      expression will be affected by the applied surgical periodontal treatment.
    

Detailed description: 
      30 subjects were enrolled in this study and divided into: Group I (Control Group): 10
      periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients
      suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD.
      Gingival samples were collected from all subjects at baseline and at 3 months after OFD from
      the CP patients. Then, Hematoxylin and eosin (H&E) stained slides were examined and gene
      expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse
      transcription polymerase chain reaction (RT-PCR).
    

Intervention name(s): Open Flap Debridement
Intervention type(s): Procedure
Intervention description(s): Full thickness flaps are elevated to fully expose the periodontaldefects. Defects are then fully debrided and the roots are carefully planned. Flaps are repositioned and sutured to obtain primary closure of the interdental space. This will be done for chronic periodontitis patients
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population includes 30 subjects recruited from the outpatient clinic of Oral Medicine
        & Periodontology department, Faculty of Dentistry, Cairo University. Ages range from 30-50
        years old.