bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to compare the pharmacokinetic characteristics of
      GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.

      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption
      by Extending the Absorption Site.

      To overcome the shortcomings of the currently existing sustained release drug delivery
      technologies the investigators have recently developed a novel drug delivery system to enable
      a drug to be dissolved irrespective of the surrounding environment and further absorbed up to
      colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
    

Detailed description: 
      Basically, this system is a triple-layered tablet, comprised of upper and lower layers that
      swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that
      rapidly draw water into the tablet core simultaneously.

      The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself)
      functions as an additional media which enables additional and later drug release out of the
      dosage form. This serves to overcome the shortage of surrounding media that has been reported
      to be one of the key reasons for mal-absorption of a drug in colon.

      As the middle layer induces a rapid water draw into the tablet core, the penetrated water
      also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and
      controls drug release.

      At virtually the same time, the swollen upper and lower layers form to surround a lateral
      side of the middle layer, which can, in turn, further control drug release.

      This relatively rigid swollen matrix structure makes drug release not affected by surrounding
      mechanical flux, which can provide relatively consistent in vivo drug release irrespective of
      degree of gastrointestinal motility.
    

Intervention name(s): Pregabalin 150mg; Pregabalin 75mg
Intervention type(s): Drug; Drug
Intervention description(s): GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day); Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)
Other intervention name(s): GLA5PR GLARS-NF1 tab.150mg; Lyrica Capsule 75mg
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy of the 4MD Micro Needling Device in the Treatment of Acne Scars
Condition: Acne Scarring
MeSH terms: Cicatrix
Study type: Observational

Summary: 
      The objective of this post market clinical follow-up study is to assess the safety and
      effectiveness of the 4MD microneedling device in reducing scarring of atrophic acne scars.

      The Primary endpoint was to show a reduction in acne scarring in accordance with the Acne
      Scar Assessment Scale as used by Skinpen (Bellus Medical (DEN160029)).

      Goodman and Baron and Jacob acne scar assessment and classification will also be utilized
      Safety endpoint: incidence of adverse events and side effects
    

Detailed description: 
      This is a post market study involving 22 healthy patients. Screening data was reviewed to
      determine eligibility. After informed consent, confidentiality and photographic release
      forms, participants who meet all inclusion criteria and none of the exclusion criteria were
      entered into the study. Each patient underwent 2 micro needling sessions 4 weeks apart using
      the 4MD microneedling device and individual sterile microneedling cartridge (16, 3mm,
      33-gauge surgical grade stainless steel needles, arranged in a circular pattern) Patients
      were assessed at baseline and at week 8. If the assessing physician deemed a 3rd treatment
      was necessary, the patient underwent the third treatment and would be assessed 4 weeks after
      the 3rd microneedling treatment Routine VECTRA photography was taken at Baseline, and at the
      final assessment (4 weeks after what was deemed the last treatment).

      Patients' VECTRA photography was used to assess acne scarring at baseline and 4 weeks after
      the last treatment using the Acne Scar Assessment Scale (DEN160029) by Karnick et al.
      Assessment was carried out by the principle investigator and 2 blinded physicians.

      After each treatment, patients completed a treatment experience assessment and patient
      diaries including self-assessment of side effects from the day of the treatment to day 7.

      The number, type, and severity of adverse events were recorded during the duration of the
      study period.
    

Intervention name(s): Micro needling
Intervention type(s): Device
Intervention description(s): All patients were treated with a 16 needle, 3mm, 33-gauge surgical grade stainless steel needle cartridge. The operator began treatment using a depth of (1mm) and a frequency setting of 4 (corresponding to 120 Hz). Needle depth and frequency was adjusted until pin-point bleeding occured, the minimum and maximum depth used to create pinpoint bleeding was recorded. The operator began treatment using a minimum depth of 1mm and a frequency setting of 4 (corresponding to 120 Hz). Needle depth and frequency was adjusted until pin-point bleeding occurred.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male & females; 18 to 65 years of age with signs of post-acne facial atrophic
        scarring.
Evaluation of Malondialdehyde in Periodontal and Cardiovascular Disease
Condition: Metabolic Disease
MeSH terms: Cardiovascular Diseases; Metabolic Diseases
Study type: Observational [Patient Registry]

Summary: 
      Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the
      known interaction of periodontitis and coronary heart disease (CHD). The investigators
      compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD)
      on saliva and serum MDA levels.
    

Detailed description: 
      The aim of this study was to evaluate a possible association between both saliva and serum
      MDA levels in patients with CP and with CHD and if the serum MDA levels are mediated by serum
      CRP
    

Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        32 healthy subjects, 34 patients with CP, 33 patients with CHD and 34 patients with CP and
        CHD. Lipid profile and levels of MDA and C-reactive protein (CRP) were evaluated.
Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg
      with respect to salicylic acid.
    


Intervention name(s): PA32540; aspirin component of PA32540; Ecotrin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The 325 mg aspirin component of PA32540; 325 mg Ecotrin
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: PK
Turkish Version of the Child Perceptions Questionnaire 8-10
Condition: Dentist-Patient Relations
Study type: Observational

Summary: 
      The Child Perceptions Questionnaire (CPQ) is a widely used reliable measurement that provides
      for practitioners to assess child's current emotional, social, and functional well-being. The
      aim of the present study was to develop a translated version of CPQ8-10 into Turkish language
      and evaluate its reliability, validity, and reproducibility.
    

Detailed description: 
      The CPQ8-10 was translated into Turkish as recommended in the literature. The intraclass
      correlation coefficient (ICC) was used for the test-retest reliability. The internal
      consistency was evaluated using Cronbach's alpha Coefficient. Construct validity and
      discriminant validity were calculated, exploratory factor analysis (EFA) and confirmatory
      factor analysis (CFA) were employed.
    

Intervention name(s): Pre-test procedure; Test re-test
Intervention type(s): Other; Other
Intervention description(s): The Turkish version of CPQ8-10 was subjected to a preliminary test on a group of 20 children, who were not included in the final study, in order to discuss the intelligibility of the items and to determine comprehension problems for children of this age group; The Turkish version of CPQ8-10 was administered to 50 children who were asked to complete the questionnaire on their own without any assistance. These 50 children were interviewed for a second time within two weeks to measure the reliability of the test-retest
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Cross-sectional study. Patients applied for RTE University, Department of Pediatric
        Dentisry
Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to learn how the male hormone , testosterone, affects pituitary
      hormones in younger and older men. The pituitary is a gland in the brain that secretes
      hormones, some of which normally control growth and fertility.
    

Detailed description: 
      Concentrations of bioavailable testosterone decline by 1.0-1.5% annually as men age. Reduced
      systemic testosterone availability is associated with decreased muscle mass, strength and
      aerobic capacity, decreased bone-mineral density and increased risk of hip fracture, waning
      sexual interest, inpaired spatial cognition and increased risk of visceral obesity, impaired
      glucose tolerance and coronary artery disease. Luteinizing hormone (LH) secretion often fails
      in healthy older individuals. In addition, aging is marked by an acceleration of LH pulse
      frequency, loss of high-amplitude LH pulses and disorderly release of LH and testosterone, as
      measured by the approximate entropy statistic. The mechanisms that underlie such complex
      adaptations are not known, but appear to involve multiple loci of regulatory failure.
    

Intervention name(s): Ketoconazole, Dexamethesone, Androgel,GnRH
Intervention type(s): Drug
Intervention MeSH terms: Ketoconazole; Testosterone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to determine the overall analgesic efficacy and safety of a
      fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in
      subjects who are experiencing post operative pain following surgical extraction of 3 or more
      third molar teeth. A review of any reported adverse events will also be completed.
    


Intervention name(s): FDC IBU/APAP 250 mg/500 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): FDC IBU/APAP 250 mg/500 mg; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ibuprofen, acetaminophen, pain, molar extraction
Leucine-enriched Formulas in Patients With Tumor-induced Sarcopenia
Condition: Sarcopenia; Cancer
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Currently there is a lack of evidence for recommending specific oral supplements (OS) for
      nutritional support in patients with cancer, including leucine-enriched supplements.
    

Detailed description: 
      Appropriate clinical trials that compare anthropometric and biochemical changes in
      nutritional parameters and clinical outcomes in patients with cancer-induced sarcopenia are
      required
    

Intervention name(s): Standard hypercaloric hyperproteic oral nutritional supplement; Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement; Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sarcopenia; Cancer
Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions: A Prospective Cohort Study
Condition: Wound Dehiscence; Incision
MeSH terms: Wounds and Injuries; Surgical Wound
Study type: Observational

Summary: 
      This study is designed to see different abdominal incisions complication among neonates,
      infants and children and to find risk factors for developing wound dehiscence
    


Intervention name(s): laparatomy
Intervention type(s): Procedure
Intervention description(s): all abdominal procedures which are approached by different incisions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all patients from neonatal age until 18 years old who were planned to undergo abdominal
        surgery.
      
Keywords: abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who
      have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may
      benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus
      placebo with PEG and RBV.
    


Intervention name(s): Alisporivir; Peginterferon alfa-2a; Ribavirin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ALV 200 mg soft gel capsules administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose; ALV placebo soft gel capsules administered orally
Other intervention name(s): DEB025; ALV; Pegasys®; PEG; Copegus®; RBV; ALV Placebo
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Cyclophilin inhibitor
Investigating the Effect of Whole-fruit Coffee Extract on Exercise Performance
Condition: Caffine and Endurance Performance
Study type: Interventional

Summary: 
      Caffeine is a widely used efficacious supplement by both the general public, and athletes,
      with the goal of improving performance. The effects of caffeine alone are well known, but it
      is not clear whether a multi-ingredient supplement (containing both caffeine and polyphenols)
      can affect exercise performance.

      This study aims to determine if a low dose of caffeine, in the form of a whole-fruit coffee
      extract also containing polyphenols, can improve exercise performance compared to a placebo
      condition, with a secondary objective of identifying if this supplement can improve post
      exercise refuelling (glycogen resynthesis).

      Participants will consume either the supplement or a placebo before engaging in an exercise
      protocol. Muscle biopsies will then be obtained so as to measure subsequent glycogen
      resynthesis, with multiple blood samples being taken through the day. The following morning
      another biopsy will be taken before the exercise protocol will be repeated.

      This research will inform us of the efficacy of caffeine and polyphenols on improving
      exercise performance.
    


Intervention name(s): CoffeeBerry Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A Coffeeberry supplement containing 200mg Caffeine and 14mg polyphenols, manufactured by FutureCeuticals Inc.,; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Observational

Summary: 
      Bexsero™ is a four component serogroup B meningococcal vaccine (4CMenB) licensed in Europe,
      Canada, and Australia in 2014. Prelicensure studies and post marketing surveillance data
      showed that 4CMenB has a high reactogenicity especially when coadministered with other infant
      routine vaccines [1-2]. While this suggests that coadministration causes an interaction
      resulting in a greater risk of adverse events following Immunization (AEFI) only the AEFI
      after the 4CMenB dose and not those occurring after routine vaccine immunizations were
      reported, underestimating the total risk associated with immunization at separate visits. For
      financial and practical reasons, coadministration of infant vaccines is preferred to separate
      visits. Separate visits may however be preferred if the sum of the AEFI risk at each visit is
      significantly smaller than the risk with coadministration and/or if the AEFI has a lesser
      severity. The purpose of this study is to recalculate the risk of occurrence and severity of
      AEFI with the coadministration of Bexsero™ and routine vaccines compared to separate
      injections to assess the interaction occurring with co-administration. Investigators will
      also estimate the risk of recurrence of AEFI at subsequent immunizations with the 4CMenB and
      assess if this risk varies with separate or coadministration with routine vaccines. To
      achieve these purposes, investigators will perform a secondary analysis of the data of three
      randomized controlled trials (clinicaltrials.gov identifiers: NCT00657709, NCT00847145 and
      NCT00721396) that evaluated 5025 children aged 2 to 14 months of whom 4535 were randomized to
      receive 3 to 4 doses of 4CMenB concomitantly or alternatively with routine vaccinations
      (DTaP-Inactivated polio virus -HepatitisB/Haemophilus influenzae type b [Infanrix Hexa™],
      Pneumococcal conjugate vaccine, 7 valent [Prevenar™] or Measles-Mumps-Rubella-Varicella
      vaccine [Priorix-Tetra™]) [1,2].
    


Intervention name(s): 4CMenb; diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB; conjugated pneumococcal vaccine; MMRV
Intervention type(s): Biological; Biological; Biological; Biological
Other intervention name(s): Bexsero; Infanrix Hexa; Prevenar; Priorix Tetra
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy children aged 2 to 14 months selected to participate in clinical trials assessing
        the safety and immunogenicity of 4 component meningococcal serogroup B vaccine (4CMenB) in
        Austria, Belgium, Czech Republic, Finland, Germany, Italy, Spain, United Kingdom.
      
Keywords: vaccine safety; interaction
To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 Days
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1467335 in healthy male and female subjects following oral administration of multiple rising
      doses over 28 days.

      Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement
      biomarkers of BI 1467335 after multiple dosing.
    


Intervention name(s): BI 1467335; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Spirometry in Esophageal Intubation
Condition: Esophageal Intubation
Study type: Observational

Summary: 
      The primary objective of the study is to describe the pressure patterns during esophageal and
      tracheal ventilation and to validate the diagnostic algorithm.
    


Intervention name(s): tracheal ventilation with regular tube; ventilation after intubation with special tube
Intervention type(s): Other; Other
Intervention description(s): Description of the pressure waveforms during tracheal ventilation; Description of the pressure waveforms during esophageal ventilation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA I & II patients
      
Keywords: pressure pattern; esophageal and tracheal ventilation.; esophageal intubation.
MK3207 for Treatment of Acute Migraines (3207-005)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to demonstrate the effectiveness and appropriate dosage level of
      MK3207 in the treatment of acute migraine.
    


Intervention name(s): MK3207- 2.5 mg; MK3207- 5 mg; MK3207- 10 mg; MK3207- 20 mg; MK3207- 50 mg; MK3207- 100 mg; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Arm 1: MK3207 2.5 mg taken after migraine onset.; Arm 2: MK3207 5 mg taken after migraine onset.; Arm 3: MK3207 10 mg taken after migraine onset.; Arm 4: MK3207 20 mg taken after migraine onset.; Arm 5: MK3207 50 mg taken after migraine onset.; Arm 6: MK3207 100 mg taken after migraine onset.; Placebo taken after migraine onset.
Other intervention name(s): MK3207; MK3207; MK3207; MK3207; MK3207; MK3207
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment