bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate
           (ADP)-induced platelet aggregation after administration of a standard dose regimen of
           clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and
           female subjects

      Secondary Objectives:

        -  Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg
           loading dose followed by 150 mg/day for 4 days)

        -  Compare the pharmacokinetic profiles of clopidogrel active metabolite between the
           selected groups of genotyped subjects and the 2 dose regimen
    

Detailed description: 
      The total study duration per subject is 10-12 weeks broken down as follows:

        -  Screening: 2 to 40 days before the first dosing

        -  Period 1: 7 days including 5 days treatment

        -  Washout: At least 14 days after the last dosing

        -  Period 2: 7 days including 5 days treatment

        -  End of study: 7 to 10 days after the last dosing
    

Intervention name(s): CLOPIDOGREL; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablets
Route of administration: oral; Pharmaceutical form: matching tablets
Route of administration: oral
Other intervention name(s): SR25990
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: healthy subjects
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is

        -  To compare the single oral dose bioavailability of test product, Trandolapril 4 mg
           Tablets of Dr. Reddy's and Mavik® 4 mg Tablet of Abbott Laboratories, in healthy, adult,
           human subjects, under fed conditions to assess bioequivalence.

        -  To monitor adverse events and ensure safety of subjects.
    

Detailed description: 
      An open label, randomised, two-treatment, two-sequence, two-period, two-way
      cross-over,single-dose bioequivalence study of Trandolapril4 mg Tablets manufactured by Dr.
      Reddy's Laboratories Ltd., Generics, India comparing with the Mavik® 4 mg Tablets (containing
      trandolapril 4 mg) manufactured by Abbott Laboratories, North Chicago, IL 60064, US; in
      healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Trandolapril; Mavik
Intervention type(s): Drug; Drug
Intervention description(s): Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited; Mavik® 4 mg Tablets of Abbott Laboratories, USA.
Other intervention name(s): Mavik® 4 mg Tablets
Intervention MeSH terms: Trandolapril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Trandolapril
The Associations Between Sedentary Behaviour and Impact Characteristics on Bone Health
Condition: Bone Health
Study type: Observational

Summary: 
      To investigate associations between sedentary and active behaviour with bone health and
      functional ability, and to associate mechanical loading at the lumbar spine and hip in
      sedentary and active individuals with bone mineral density.
    

Detailed description: 
      Significant proportions of adults engage in sedentary behaviour for prolonged periods of time
      which is generally regarded as having deleterious effects on health. However, far less is
      known about its specific effects on bone health. Exercise has been proposed as a method of
      improving bone health, as impact forces generated as the foot contacts the ground during
      physical activity have the potential to aid bone maintenance and development.

      The properties of bone are regulated through the amount mechanical loading, frequency of
      loading and duration of loading endured, which can create an osteogenic effect. These
      variables can be quantified via accelerometry which records the magnitude, rate and duration
      of accelerations experienced at the site on the body where the accelerometer is worn.
      Although there is a vast amount of literature where accelerometers have been used to monitor
      physical activity, there is a lack of studies that use accelerometers to determine the most
      effective exercise for bone, especially in relation to the lumbar spine. Exploring the bone
      health and loading characteristics of sedentary and low and highly active non-sedentary
      individuals will provide evidence upon which to base future interventions that are likely to
      be of benefit for bone health in sedentary populations.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Sedentary and non-sedentary populations.
      
Keywords: sedentary; non-sedentary; populations
A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a long term extension to study 137OB-201 which is designed to examine the effect of
      pramlintide on body weight and its safety and tolerability in obese subjects.
    


Intervention name(s): pramlintide acetate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg; subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate
Other intervention name(s): Symlin
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; weight loss; Amylin; pramlintide
Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The aim was to test if interpersonal relationships group strategies provided by nursing can
      promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in
      hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A
      10 patients (8 women), underwent to a health educational orientation program
      (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings).
      Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days
      during 4 months (3 meetings). Both groups received the same content guidelines (healthy
      lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline
      (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL
      questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30
      days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120
      days.
    


Intervention name(s): Program Health Education
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Hypertension; Nursing; Therapeutic compliance; Quality of life; Health education
An Open-label, Single-dose Study to Determine the Metabolism and Excretion of [14C]E2006 in Healthy Male Subjects
Condition: Metabolism and Excretion
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the metabolism and excretion of [14C]E2006 in
      healthy male subjects.
    

Detailed description: 
      This is an open-label, single-dose study in healthy male subjects. The study will have 2
      phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will
      consist of a Screening Period and a Baseline Period, during which each subject's eligibility
      will be determined and assessments will be conducted.
    

Intervention name(s): E2006
Intervention type(s): Drug
Intervention description(s): Single oral 10mg dose of 100 uCi [14C]E2006
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolism and Excretion
Brain Imaging Study in Menopausal Women With and Without Major Depressive Disorder
Condition: Menopause; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in
      menopausal women with major depressive disorder and healthy subjects using nuclear magnetic
      resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects
      before and after estrogen replacement, and after fourteen days of medroxyprogesterone
      administration; and 2) in depressed menopausal subjects before and after treatment of their
      depression with antidepressant alone, estrogen alone or antidepressant plus estrogen.
      Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels.
      Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and
      pregnenolone sulfate.
    


Intervention name(s): MDD diagnosis and Estrogen treatment; MDD diagnosis and Fluoxetine treatment; MDD diagnosis with both Estrogen and Fluoxetine treatment; No depression and estrogen treatment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause.; Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone.; Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined.; Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.
Intervention MeSH terms: Fluoxetine; Estrogens
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: menopause; women; major depressive disorder; Magnetic Resonance Spectroscopy
Effects of Local Insulin on Varicose Ulcers for Wound Healing
Condition: Chronic Venous Disease; Varicose Ulcer; Wound Healing; Insulin; Angiogenesis
MeSH terms: Varicose Ulcer; Ulcer; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is
      divided into two (side A and B). Half of the wound's surface is treated locally with insulin
      (Glargine) applied at an approx depth of 3-4 mm. Treatment with insulin is administered for 7
      days. Biopsy specimens of the two sides are obtained on days 0 and 7. A thermographic
      photograph of the wound is taken at days 0 and 7. The number of blood vessels and fibroplasia
      is evaluated as the main outcome.
    

Detailed description: 
      A randomized, split-plot, double-blind, placebo-controlled trial. Chronic Varicose Ulcers
      measuring more than 4 cm in any of its dimensions, and that comply with candidate criteria
      are included in the present study. A split-mouth model is used.

      The ulcer is divided into two (sides A and B). The side in which treatment is applied is
      randomized. Half of the wound's surface is treated locally with insulin (Glargine) applied at
      an approx depth of 3-4 mm. Both halves are covered with dressings and compression therapy is
      applied. Treatment with insulin is administered for 7 days. Biopsy specimens of the two sides
      are obtained on days 0 and 7. A thermographic photograph of the wound is taken at days 0 and
      7, as control of the local temperature of the wound. This is to asses the process of healing
      and to correlate with our outcome measures. The number of blood vessels will be evaluated as
      the main outcome. Fibroplasia and thermal asymmetry between wound sides will be evaluated as
      secondary outcomes.
    

Intervention name(s): Insulin Glargine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Half of the wound surface is injected daily with topical glargine insulin; Half of the wound surface is injected daily with topical saline solution
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment Randomized split-plot design
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Varicose Ulcer; Wound Healing; Insulin; Angiogenesis
Evaluation and Physical Therapy for Patients With Degenerated Cervical Spine
Condition: Degenerated Cervical Spine; Spinal Diseases
MeSH terms: Spinal Diseases
Study type: Observational

Summary: 
      The specific aims are as follows:

        1. To investigate the degree of impairment, such as range, proprioception, sensation, and
           electromyography (EMG) pattern of healthy, older subjects.

        2. To investigate the relationship of these impairment measurements, the functional outcome
           and disability in patients with cervical spondylosis.

        3. To develop an exercise program with an emphasis on proprioception, stability and
           coordination for patients with neck-shoulder complaints to decrease the impairment and
           increase the functions of patients.
    


Intervention name(s): Therapeutic exercise
Intervention type(s): Behavioral
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects aged 20-75 year-old will be recruited. One hundred participants are anticipated to
        be recruited in this study.
      
Keywords: degenerated cervical spine; assessment; physical therapy
The Effectiveness of At-home , In-office and Combined Dental Bleaching System ：A Randomized Controlled Clinical Trial
Condition: Tooth Bleaching
Study type: Interventional

Summary: 
      This randomized controlled clinical trial aimed to investigate the effectiveness of at-home ,
      in-office and combined dental bleaching system.
    

Detailed description: 
      The participants with at least one maxillary tooth demonstrating shade A3 or darker will be
      recruited and randomly allocated into 4 groups according to the different tooth bleaching
      protocol：at-home bleaching for group 1,in-office bleaching for group 2 ,combined bleaching
      for group 3 and group 4.Participates in group 1 will receive two weeks of at-home tooth
      bleaching （Lasts 14 days and at least 8 hours every day ）with 10% Carbamide
      peroxide(Opalescence PF 10%) , group 2 will receive two sessions （with a 1- week interval ）of
      in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)，group 3 will
      receive one week of at-home tooth bleaching （Lasts 7 days and at least 8 hours every day ）and
      then the eighth day receive one session of in-office tooth bleaching , group 4 receive one
      session of in-office bleaching and lasts 7 days at-home bleaching start on the eighth day .
      Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade
      Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second
      bleaching session (T3), 1 month after the completion of bleaching (T4). CIEDE2000 colour
      difference (△E00), the Whiteness Index for Dentistry (WID) and Tooth sensitivity (TS) will
      also be calculated. The data will be statistically analysed through repeated ANOVA and
      Tukey's test (α = 0.05).
    

Intervention name(s): different combined of tooth bleaching procedure
Intervention type(s): Procedure
Intervention description(s): The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effect of Gabapentin on Postoperative Morphine Consumption After Sleeve Gastrectomy
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The evidence regarding effects of pain modulator like gabapentin on postoperative pain after
      sleeve gastrctomy is sparse. Gabapentin has anti-hyperalgesic and postoperative
      opioid-sparing properties.This study will highlight the effectiveness of preoperative use of
      gabapentin for postoperative pain management in morbidly obese patients.
    

Detailed description: 
      Research Problem: Laprocopic sleeve gastrectomy is the most common surgical procedure
      performed for reducing weight in morbidly obese patients. Laparoscopic surgery is considered
      to be less invasive than open surgery. The treatment of pain in obese patients is a
      challenge. Administering opioids, can have an increasing effect of respiratory depression in
      patients already at risk of sleep apnea. The evidence regarding effects of pain modulator
      like gabapentin on postoperative pain after sleeve gastrctomy is sparse. Gabapentin has
      anti-hyperalgesic and postoperative opioid-sparing properties. The analgesic effect of
      gabapentin appears to be related to the surgical procedure undertaken, a more
      procedure-specific evaluation is needed for different types of surgeries..

      Research Significance: This study will highlight the effectiveness of preoperative use of
      gabapentin for postoperative pain management in morbidly obese patients.

      Research Objectives: To evaluate the effect of preoperative administration of gabapentin on
      postoperative pain, postoperative morphine consumption and preoperative anxiety in patients
      coming for laparoscopic sleeve gastrectomy.

      Research Methodology:

      Inclusion criteria: ASA I and II, Age 18-50 years, either sex, Planned Surgical procedure
      laparoscopic sleeve garstectomy, BMI 30-45 . Exclusion criteria: Patients taking any
      sedative, tranquillizers , history of sleep apnoea ,contraindications to gabapentin, Methods
      Patients will be randomly assigned into two groups, Group-Control and , Group- Gabapentin of
      25 each. Anesthesia and postoperative course will be standardized. VAS scale will be used for
      assessment of preoperative anxiety and postoperative pain. Post operatively pain assessment
      and morphine consumption will be performed for 24 hours in PACU and ward
    

Intervention name(s): Gabapentin; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Observation of the Effects of Guideline-driven Lifestyle Interventions, Including Use of a Red-yeast Based Nutraceutical
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Observational

Summary: 
      The objective of the present multinational, multicentre, prospective, scientific study is to
      confirm that prescription of a low-dose red yeast-based nutraceutical.
    

Detailed description: 
      The objective of the present multinational, multicentre, prospective, scientific study is to
      confirm that prescription of a low-dose red yeast-based nutraceutical significantly increases
      the LDL-C lowering effect of guideline-driven lifestyle interventions in subjects with
      hypercholesterolemia at low-moderate cardiovascular risk not requiring a drug therapy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects to be enrolled are subjects already in primary prevention for CVD for raised LDL-C
        and who, according to the intervention strategies recommended in Table 5 of the ESC/EAS
        guidelines (lifestyle interventions, consider drug if uncontrolled) had been prescribed, in
        the previous 3 months, only dietary advices and physical exercise.
Vibration and During Heel Lance Procedures in Newborns
Condition: Heel Lance Procedures
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of applying vibration on pain during heel lance
      procedures in newborns.

      .
    

Detailed description: 
      Methods: This randomized, controlled, experimental study. The study sample consisted of 56
      newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent
      a heel lance procedure at the specified center, whose parents agreed to participate in the
      study and who had reached gestational age 38 and older were enrolled in the study. In the
      vibration group, a vibrating device was used for approximately 30 seconds before the heel
      lance procedure and continued throughout the procedure. No interventions were made on the
      newborns in the control group. Two nurses were employed for the heel lance procedure both for
      the experimental and control groups. One nurse performed the heel lance procedure for all
      newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the
      nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five
      minutes after the procedure, as well as by two specialists through observation of the video
      footage of the procedures using the NIPS. The heel lance procedure was performed by the same
      nurse both in the vibration and control groups.
    

Intervention name(s): a vibrating device
Intervention type(s): Device
Intervention description(s): vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: newborns; vibration; pain; heel lance