bioihbjkbjnl/mcl2 huggingface dataset:
Single Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      BMS-820132 is an investigational new drug being developed by BMS for treating Type 2
      diabetes. The purpose of this study is to test the safety/tolerability (potential side
      effects) of single doses of the investigational new drug, as well as the amount of study drug
      in the blood, in subjects with type 2 diabetes.
    


Intervention name(s): BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132; BMS-820132; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral Solution, Oral, 0.3 mg, once daily, 1 day; Oral Solution, Oral, 1.0 mg, once daily, 1 day; Oral Solution, Oral, 3 mg, once daily, 1 day; Oral Solution, Oral, 10 mg, once daily, 1 day; Oral Solution, Oral, 30 mg, once daily, 1 day; Oral Solution, Oral , 75 mg, once daily, 1 day; Oral Solution, Oral, 150 mg, once daily, 1 day; Oral Solution, Oral, 300 mg, once daily, 1 day; Capsule, Oral, (TBD), once daily, 2 days; Oral Solution, Oral, 0mg, once daily, 1 day; Capsule, Oral, (TBD), once daily, 2 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling
      and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in
      women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group
      which receives bone marker feedback or 2)a group which does not receive feedback on the
      results. The study will also assess patient satisfaction with treatment with once monthly
      Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size
      is 500+ individuals.
    


Intervention name(s): ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]
Intervention type(s): Drug; Drug
Intervention description(s): 150mg po monthly for 6 months (+ feedback); 150mg po monthly for 6 months (- feedback)
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this trial was to establish the dose-response of T2 (the amplitude of the
      first response of second twitch to train of four (TOF) stimulation, expressed as percentage
      of control first twitch,T1) in Japanese and Caucasian participants. Part A: Japanese
      Participants
    

Detailed description: 
      For most surgical procedures a depth of neuromuscular block of 1-2 twitches after
      TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the
      anesthesiologist might decide to either give (another) maintenance dose of rocuronium or
      vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to
      reverse the neuromuscular block. Sugammadex (Org 25969) has been shown in previous trials to
      greatly reduce the time to full recovery when administered at reappearance of T2, both after
      rocuronium- and vecuronium-induced neuromuscular blockade. The current trial P05956 was
      conducted in Japan and set up to establish the dose-response relationship of sugammadex given
      during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in
      Japanese participants. In addition to recovery time, also pharmacokinetics and safety of
      sugammadex were evaluated.
    

Intervention name(s): sugammadex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of sugammadex (0.5 to 4 mg/kg) IV was administered.; After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.04 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of placebo IV was administered
Other intervention name(s): Org 25969
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts.
      Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II
      will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or
      may be staggered.
    


Intervention name(s): MK-2748; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment; Placebo tablets, orally, once daily for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Necessity for Repetitive Education of Behavioral Modification
Condition: Patients Who Had the Urine Volume at Nighttime More Than One Third of Total Daily Urine Volume (NPU) and Voided More Than Two Times at Nighttime (Nocturia)
MeSH terms: Nocturia
Study type: Observational

Summary: 
      Few studies have reported the efficacy of repetitive education for behavioral modification as
      the first-line therapy for patients with nocturnal polyuria (NPU). The aim of this study is
      to investigate the efficacy of repetitive education for behavioral modification as the
      first-line therapy in the patients with NPU and to show whether a single education for
      behavioral modification is sufficient for the patients.
    

Detailed description: 
      Even though behavioral modification therapy seems to be effective, it is not usually
      recommended for patients with nocturia because much patience and understanding is required
      for the patients to follow the therapy. Few studies have reported the efficacy of repetitive
      education for behavioral modification as the first-line therapy for patients with nocturia
      and nocturnal polyuria (NPU). Furthermore, no report demonstrated the evidence about how many
      times or how long the education for behavioral therapy should be performed and how long will
      the education effect would continue. The aim of this study is to investigate the efficacy of
      repetitive education for behavioral modification as the first-line therapy in the patients
      with NPU and to show whether a single education for behavioral modification is sufficient for
      the patients.
    

Intervention name(s): education for behavioral modification
Intervention type(s): Other
Intervention description(s): a systematized 30-minutes education program for behavioral modification (SBMP) by watching videos and discussion with a specialized continence nurse practitioner.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had the urine volume at nighttime more than one third of total daily urine
        volume (NPU) and voided more than two times at nighttime (nocturia)
      
Keywords: Behavior modification, Behavior therapy, Nocturia, Polyuria, Quality of life
Pharmacological Profile of Different Quercetin Formulations
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      This study aims to evaluate the pharmacokinetics of quercetin in healthy participants after
      the administration of different formulations in a single- and multiple-dose phase. In the
      single-dose study, plasma uptake (AUC0-24 and Cmax) of standard quercetin is compared with
      that of LipoMicel®-a novel food-grade delivery form of quercetin. In the multiple dose study,
      accumulating plasma concentrations of formulated quercetin are observed over 72hrs, after
      repeated doses of LipoMicel treatments (AUC0-72).

      At least ten healthy adults participate in an open-label, diet-controlled, crossover, plasma
      uptake study. Participants receive three different doses (250 mg, 500 mg or 1000 mg) of
      quercetin aglycone orally.
    

Detailed description: 
      Objective of this study is to investigate the pharmacokinetic profile of formulated quercetin
      (LipoMicel®), administered at three different doses, in healthy participants and compare it
      with that of a standard formulation. The pharmacokinetics of the different quercetin
      treatments are observed over 24hrs after a single orally administered dose of quercetin
      (e.g., using AUC0-24 and Cmax). Furthermore, the accumulating plasma concentrations of
      formulated quercetin are monitored over a 72hr period (e.g., using AUC0-72), following
      multiple orally administered doses of LipoMicel treatments (250 mg-1000 mg) plus the
      circulating metabolites of quercetin are determined in the human plasma.
    

Intervention name(s): Quercetin LipoMicel (250 mg); Quercetin LipoMicel (500 mg); Quercetin LipoMicel (1000 mg); Regular/standard Quercetin (500 mg)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Quercetin LipoMicel® soft-gels. Total dose of 250 mg of quercetin; Quercetin LipoMicel® soft-gels. Total dose of 500 mg of quercetin; Quercetin LipoMicel® soft-gels. Total dose of 1000 mg of quercetin; Total dose of 500 mg of quercetin
Intervention MeSH terms: Quercetin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Gum Chewing on Math Scores in Adolescents
Condition: Academic Achievement in Math
Study type: Interventional

Summary: 
      Context: Gum chewing has been shown to increase cognitive functioning. With the rise in
      standardized testing of school-age children and the concurrent attempts to improve their
      scores, finding simple and inexpensive methods to bolster performance is needed.

      Objective: To examine the effects of gum chewing on standardized test scores and class grades
      in a group of 8th grade math students.

      Design: Math classes were randomized to a gum chewing (GC) condition that provided students
      with gum during class and testing, or a control condition with no gum (NG) provided during
      class and testing. This study was conducted during the Spring 2008 school semester.

      Setting: A charter school in Houston, TX.

      Participants: All students enrolled in eighth grade math at the charter school were
      approached for recruitment in this study. A total of 108 (94%) students participated.
      Participants were between the ages of 13 and 16.

      Main Outcome Measures: The Texas Assessment of Knowledge and Skills (TAKS), the Woodcock
      Johnson III Tests of Achievement (WJ-III), and math class grades were used to assess any
      differences in academic performance between the GC and NGC conditions. For purposes of this
      study, only the math sections of the WJ-III and TAKS, which are both standardized tests, were
      assessed.

      Our primary hypothesis was that adolescents in a gum chewing (GC) condition would have
      significantly improved standardized test scores and math grades compared to adolescents in a
      non-gum chewing (NG) control condition.
    


Intervention name(s): Gum Chewing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Oral Hygiene Related Self-efficacy, General Self-efficacy and Daily Plaque Control
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Observational

Summary: 
      The objectives are a) to determine the scores of general self-efficacy (GSE) and oral hygiene
      related self-efficacy (OHSE) b) to evaluate the relations between the scores of GSE and OHSE
      c) to examine the changes in OHSE scores and the relationship between OHSE and PI scores
      after motivation and oral hygiene instructions. OHSE scores could be an indicator in
      predicting daily plaque control of patients. Also, it may be needed to show greater interest
      about motivation and oral hygiene instructions especially for smokers and OHSE-low group
      patients.
    

Detailed description: 
      All study patients (n=210) between the ages of 35 to 60 with inflammatory periodontal
      diseases filled out questionnaires regarding GSE and OHSE. Subgroups including OHSE-low
      (n=26) and OHSE-high (n=26) groups were selected after performing "cut off" on OHSE scores of
      all study patients. In both subgroups, plaque index (PI) values were determined, and
      motivation and oral hygiene instructions were performed at baseline. PI measurements and OHSE
      questionnaire were repeated at 1 and 3 months.
    

Intervention name(s): motivation and and oral hygiene instructions
Intervention type(s): Behavioral
Intervention description(s): Motivation and oral hygiene instructions were received OHSE-high and OHSE-low groups. After showing the modified-Bass tooth brushing technique and interdental cleaning on the model, patients were followed up while brushing and flossing their teeth to correct misapplications. It was advised to brush teeth twice a day and use the interdental cleaning devices once a day.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Gingivitis and periodontitis patients
The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence
Condition: Urinary Incontinence; Treatment
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      We aimed to evaluate the efficacy of locally applied injectable platelet-rich fibrin in women
      with stress urinary incontinence. We searched whether there was a decrease in the severity of
      urinary incontinence after the injection of platelet-rich fibrin.

      The participants will answer questionnaires about urinary incontinence before and after the
      injectable platelet-rich fibrin treatment.
    

Detailed description: 
      Female patients with pure stress urinary incontinence who gave written informed consent after
      being informed about the study were included in the study. Two tubes of venous blood samples
      taken from the patients were centrifuged and injectable platelet-rich fibrin was prepared.
      The obtained autologous material was injected into the patient within one minute after
      preparation, without applying a local anesthetic. The injection was given to the anterior
      wall of the vagina, approximately 1.5 cm below the urethral meatus, coinciding with the
      mid-urethral region, and the dose was applied to three adjacent points. The procedure was
      repeated three times at one-month intervals. Before and after the procedure, ICIQ-SF, UDI-6,
      and IIQ-7 questionnaires were filled and the severity of urinary incontinence was recorded.
    

Intervention name(s): Local applied injectable platelet-rich fibrin in women with stress urinary incontinence
Intervention type(s): Other
Intervention description(s): Injectable platelet-rich fibrin was prepared by centrifuging venous blood taken from women with stress urinary incontinence and applied locally to the anterior vaginal wall of the patients.
Intervention model: Single Group Assignment
Intervention model description: Thirty patients with pure stress urinary incontinence were included in the study. Autologously prepared injectable platelet-rich fibrin from the patients was applied locally. The procedure was repeated for the same patient three times with an interval of one month. The severity of urinary incontinence was evaluated and recorded by filling out questionnaires before and after the procedure.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary Stress Incontinence; Platelet-Rich Fibrin; Questionnaire
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment
      duration in patients with secondary progressive multiple sclerosis (Core Part) followed by
      extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability
      and efficacy (Extension Part).
    


Intervention name(s): BAF312; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.25, 0.5, 1, and 2 mg film-coated tablets; Film-coated tablets
Intervention MeSH terms: Siponimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Secondary Progressive Multiple Sclerosis
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the mean serum sodium after 48 hours of
      therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill
      children requiring IV maintenance fluid administration.
    

Detailed description: 
      In patients without possibilities of oral intake, maintenance fluids provide electrolytes and
      water. Since the original descriptions by Holliday and Segar, the recommended standard
      maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.

      However hyponatremia has become increasingly recognized in hospitalized children suggesting
      that Holliday and Segar's recommendations are frequently inappropriately applied.

      It has been described augmented intersticial lung water in patients receiving hypotonic
      maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically
      ill children receiving hypotonic maintenance solutions.

      More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the
      great majority of hospitalized children due to nausea, stress, pain, and/or surgical
      interventions.

      It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance
      intravenous (IV) solution, to avoid the development of hyponatremia.

      There are not studies in critically ill children evaluating the effect of isotonic solutions
      on sodium levels.
    

Intervention name(s): hypotonic; isotonic
Intervention type(s): Drug; Drug
Intervention description(s): 0.45% NaCl/5% dextrose IV maintenance fluids; 0.9% NaCl/5% dextrose IV maintenance fluids
Other intervention name(s): half saline/5% dextrose; normal saline/5% dextrose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyponatremia; maintenance solutions; pediatrics
Serum Amyloid A Protein And Fetuin A Levels
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Observational

Summary: 
      The purpose of this study was to evaluate acute phase proteins (APPs) Fetuin-A and Serum
      Amyloid A (SAA) levels in gingival crevicular fluid (GCF) and serum samples in periodontal
      health and disease.
    

Detailed description: 
      The study population consisted totally 60 subjects consulted to Bulent Ecevit University,
      Faculty of Dentistry, Department of Periodontology whose age and sex were matched.

      According to study design, subjects were divided into three groups based on their periodontal
      parameters. Patients suffering from chronic periodontitis formed the group 1 (n: 20),
      patients with plaque induced gingivitis formed the group 2 (n:20) and periodontal healthy
      patients were inserted in group 3 (n:20).

      After gently drying the area, GCF was sampled with filter paper using the intracrevicular
      method (Periopaper, ProFlow, Inc., Amityville, New York, USA).Two milliliters (ml) of
      peripheral blood was collected from each individual with sterile syringe from the antecubital
      fossa by venipuncture, and to separate serum component sample centrifuged at 3000g for 5 min,
      and immediately stored at -40°C until assayed.

      The quantity of Fetuin-A and SAA protein concentration in the samples were analyzed by
      sandwich enzyme-linked immunosorbent assay (ELISA) procedures using commercially available
      kits.

      The Spearman's rank correlation test was used to detect the relationship between GCF and
      serum SAA and Fetuin-A with GI and CAL. All tests were performed using statistical software
      (SPSS Inc., version 22.0, Chicago, IL, USA). The mean ± standard deviation with mean rank
      values were calculated for each parameter, based on the patients as the statistical unit. P <
      0.05 was considered to be statistically significant.
    

Intervention name(s): Fetuin-A; Serum Amyloid A
Intervention type(s): Biological; Biological
Intervention description(s): Acute phase protein; Acute phase protein
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population consisted totally 60 subjects whose age (28-45) and sex (33 men, 27
        female) were matched.
      
Biospecimen description: 
      Gingival crevicular fluid and Serum
    
Keywords: Serum Amyloid A; Fetuin-A; gingival crevicular fluid; serum; periodontal diseases