bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Condition: Pharmacology, Clinical
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg
      capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150
      mg (Reference) administered under fasting conditions in order to assess bioequivalence
      Secondary Objectives: To assess safety and tolerability in form of adverse events and
      clinical parameters (systolic/diastolic blood pressure, pulse rate, body temperature,
      physical examination, electrocardiogram, clinical laboratory testing, and overall
      tolerability) and to assess further pharmacokinetic parameters of fluconazole
    

Detailed description: 
      Clinical pharmacology
    

Intervention name(s): Fluconazole (BAYT006267) 150 mg capsules; Fluconazole 150 mg capsules (DiflucanTM)
Intervention type(s): Drug; Drug
Intervention description(s): Fluconazole 150 mg; Fluconazole 150 mg
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fluconazole; bioequivalence; capsule
A Study to Evaluate the Effects of a Turmeric and Black Cumin Seed Formulation on Cholesterol Levels
Condition: Cholesterol Health
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of a turmeric and black cumin seed
      formulation on cholesterol levels.
    

Detailed description: 
      This study is a randomized, single-blind, placebo-controlled study to evaluate the effects of
      a turmeric and black cumin seed formulation on cholesterol levels. Each subject will receive
      a specific dose of the formulation or placebo twice daily. Participants will undergo
      assessments of blood tests, vital signs, body weight, waist circumference, hip circumference
      and waist-to-hip ratio with completion of a questionnaire.

      The primary objective of the study is to assess the effects of the turmeric and black cumin
      seed formulation on fasting levels of Total Cholesterol.

      Secondary objectives include assessment of the effects of turmeric and black cumin seed
      formulation on: fasting levels of: LDL Cholesterol, parameters in the NMR LipoProfile®,
      Oxidized LDL, Triglycerides, HDL cholesterol, C-reactive protein, blood glucose, Insulin and
      Hemoglobin A1c, as well as the assessments of the values/scores of body weight, waist
      circumference, hip circumference, waist-to-hip ratio, blood pressure and the SF-36 survey
      scores.
    

Intervention name(s): Turmeric and Black Cumin Seed; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Turmeric and Black Cumin Seed formulation; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids
Condition: Rheumatoid Arthritis; Osteoporosis; Osteopenia
MeSH terms: Arthritis; Arthritis, Rheumatoid; Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was to investigate the efficacy of oral monthly ibandronate in the management of
      glucocorticoid induced osteoporosis in women with rheumatoid arthritis.
    

Detailed description: 
      Glucocorticoid therapy is associated with a number of significant side effects, of which bone
      loss resulting in glucocorticoid-induced osteoporosis and an increase in fracture risk is the
      most serious. However studies show that many patients treated with glucocorticoids do not
      receive treatment to prevent bone loss. There exist 5 large randomized controlled clinical
      trials providing evidence that the bisphosphonates etidronate, alendronate, and risedronate
      are effective in both the prevention and the treatment of glucocorticoid-induced
      osteoporosis. Significant increases in BMD with bisphosphonate treatment, most consistently
      observed in lumbar spine, were seen in patients with many different glucocorticoid-treated
      disorders; most often RA and polymyalgia rheumatica, and occurred generally irrespective of
      patient age, sex and menopausal status in women. In addition, statically significant
      reductions in the absolute risk and relative risk of incident radiographic vertebral
      fractures were demonstrated after 1 year of treatment with risedronate. A similar significant
      reduction in the risk of incident radiographic vertebral fractures was seen in alendronate
      treated patients who completed 2 years of a study of alendronate in the prevention and
      treatment of glucocorticoid-induced osteoporosis. There exists a data about Ibandronate which
      reported that intermittent intravenous ibandronate reduced vertebral fracture risk in
      corticosteroid-induced osteoporosis. However, there is no report about oral monthly
      ibandronate. Current oral bisphosphonates, which are given either daily or weekly, are
      associated with stringent, inconvenient dosing schedules. Less frequent dosing may provide
      great acceptability. The objective of this study was to investigate the efficacy of oral
      monthly ibandronate in women receiving long-term glucocorticoids.
    

Intervention name(s): Ibandronate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): monthly dosage of ibandronate 150mg; monthly dosage of placebo
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rheumatoid arthritis; Glucocorticoid induced osteoporosis; Vertebral fracture
Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant
Condition: Meniscus; Degeneration; Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This is a prospective, multi-center, open label, non-randomized study, evaluating the
      treating of medial meniscus deficiency with the NUsurface Meniscus Implant.
    


Intervention name(s): NUsurface Meniscus Implant
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NUsurface; Meniscus; Knee; KOOS
Oxytocin and Approach-avoid in Grief
Condition: Prolonged Grief Disorder; Bereavement
Study type: Interventional

Summary: 
      This is a completed project which was initiated prior to January 18,2017

      Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach
      (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive
      avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and
      recover from their loved one's death. Due in part to conflicting evidence, little mechanistic
      understanding of how these behaviors develop in grief exists. We sought to (1) identify
      behavioral differences between CG and non-CG groups based on implicit bias for grief-,
      deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in
      shaping approach/avoidance bias.

      Methods: Widowed older adults with (n = 17) and without (n = 22) CG completed an
      approach/avoidance task measuring implicit bias for personalized, non-specific,
      grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design,
      each participant attended both an intranasal oxytocin session and a placebo session. Aims
      were to (1) identify differential effects of CG and stimulus type on implicit
      approach/avoidance bias [placebo session], and (2) investigate interactive effects of CG,
      stimulus type, and oxytocin vs. placebo on approach/avoidance bias [both sessions].
    


Intervention name(s): Syntocinon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Synthetic oxytocin spray, 24 IU per spray.; Placebo spray with no active ingredient.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Basic Science
Keywords: Oxytocin; Approach/Avoid; Older adults; Complicated Grief
OCAST Cessation Study
Condition: Tobacco Smoking Behavior; Cigarette Smoking Behavior; Second Hand Tobacco Smoke; Tobacco Use Cessation
Study type: Interventional

Summary: 
      The long-term goal is to improve the quality of life of children and their parents who smoke
      tobacco by facilitating parental smoking cessation in a way that is easy to administer yet
      effective. We aim to accomplish this goal by administering an interactive computer-based
      program that will facilitate motivation and readiness to engage in smoking cessation by
      providing personalized feedback about the financial and health effects of the parent's
      smoking. We will compare the changes in motivation and readiness to quit smoking after the
      parent has taken the computer-based program and compare them to the changes in motivation and
      readiness to quit in parents who receive only information about the Oklahoma Tobacco
      Helpline. We will also measure salivary cotinine levels in both parents and children, to
      objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis
      is that our computer-based program will cause a greater increase in motivation and confidence
      to quit smoking in the group that receives the customized feedback than the group that
      receives only information about the Tobacco Helpline. We also predict that both parent and
      child cotinine levels will show a greater decrease in the group randomized to receive
      personalized feedback.
    


Intervention name(s): Personalized Feedback
Intervention type(s): Behavioral
Intervention description(s): Personalized feedback reflecting the participant's current level of nicotine addiction, money spent on cigarettes, time spent smoking, and health effects of smoking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: smoking; quit smoking; smoking cessation; smoking study; secondhand smoke; smokers
Straberi Microneedling For Atrophic Acne
Condition: Atrophic Acne Scar
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      This pilot study will expand knowledge and application needling using the Straberi
      microneedling device for the improvement of Atrophic Acne Scarring
    

Detailed description: 
      This pilot study will expand the knowledge and application of needling using the Straberi
      microneedling device and its safety and benefits for improving the appearance of atrophic
      acne scarring. The pilot aims to objectively measure skin quality using the Derma Scan,
      photographs, and provide objective data showing improvement by way of the Goodman and Barons
      quantitative scar scale.
    

Intervention name(s): Straberi
Intervention type(s): Device
Intervention description(s): The patient's entire face will be treated with the Straberi microneedling devise.
The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm
Other intervention name(s): microneedling
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Participants in the Straberi microneedling trial are those who are seeking improvement for atrophic acne scaring.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: microneedling; atrophic acne; epistamp; universal skincare institute
PHase IV Clinical Trial of Ceftriaxone Sodium and Sulbactam Sodium for Injection (CRO-SBT)
Condition: Respiratory Tract Infections; Urinary Tract Infections in Children
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and efficacy of treatment of children with acute bacterial infection
      disease with Ceftriaxone Sodium and Sulbactam Sodium for Injection in the condition of widely
      used, and provide the basis of adjusting the dosage regimen for children in particular.
    

Detailed description: 
      Ceftriaxone sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the
      former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive
      inhibition of β-lactamase.The antimicrobial effect of Ceftriaxone can be enhanced by the two
      combined. The compound specifically aims to the mechanism of bacterial resistance, extending
      the life of Ceftriaxone in the treatment-resistant pathogen infections.
    

Intervention name(s): Ceftriaxone Sodium and Sulbactam Sodium for Injection
Intervention type(s): Drug
Intervention description(s): daily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days
Other intervention name(s): weipufen
Intervention MeSH terms: Ceftriaxone; Sulbactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pregabalin and Remifentanil - Analgesia and Ventilation
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this experimental study on healthy volunteers we explored the effect of pregabalin alone
      and in combination with remifentanil on acute experimental pain and ventilatory function.
    

Detailed description: 
      Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual
      analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering
      respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon
      dioxide tension (mmHg).

      Side effects such as nausea and sedation were registered.
    

Intervention name(s): Pregabalin; Remifentanil; sugar pill, saline infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): hard capsule, 150 mg, 2 times, 2 days; 50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL; hard capsule, 150 mg, 2 times, 2 days, saline infusion
Other intervention name(s): Lyrica; Ultiva; Laktose monohydrat; NaCl 0,9%
Intervention MeSH terms: Pregabalin; Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: analgesia; acute experimental pain; cold pressor test; pregabalin; remifentanil
Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      For both induction of remission and in maintenance of remission, different doses and
      treatment durations are used in practice. The aim of this study is to assess how mesalazine
      is used in clinical practice, at which doses and for how long and how these differences
      impact the patient disease state and work productivity.
    


Intervention name(s): mesalazine
Intervention type(s): Drug
Other intervention name(s): Pentasa
Intervention MeSH terms: Mesalamine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Out-patient clinics in the Netherlands
Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the
      deep cervical flexor muscles on pain and perceived disability in patients with chronic neck
      pain.

      Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor.

      Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.
    

Detailed description: 
      The study will be carried out at the Faculty of Nursing and Physiotherapy of the University
      of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and
      randomly assigned into two intervention groups. The first group will perform a somatosensory
      exercise program and a second group will perform activation and endurance-strength exercises
      of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6
      sessions of physical therapy and daily home exercise. The variables pain, pressure pain
      threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia,
      quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment,
      post-treatment and a follow-up at 3 months.
    

Intervention name(s): Therapeutic exercises
Intervention type(s): Other
Intervention description(s): A somatosensory training and an endurance-strength training protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A single center, parallel, randomized, blinded rater, controlled clinical trial will be conducted. The 25 requirements proposed by the CONSORT declaration will be followed.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain; chronic pain; therapeutic exercise; proprioception; motor control
Safety and Efficacy of a Natural Health Product in Reducing Cholesterol and Triglyceride Levels.
Condition: LDL Cholesterol; Triglycerides
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of a natural health product
      among participants with elevated LDL cholesterol and triglyceride levels.
    

Detailed description: 
      Cardiovascular Disease [CVD] is one of the primary causes of illness, disability and death in
      Canada and in the United States. Hypercholesterolemia and hypertriglyceridemia are
      significant risk factors for the development of cardiovascular disease.

      The investigational product used in this trial, has been specially formulated to help reduce
      elevated triglycerides and LDL cholesterol levels, and may provide a natural alternative in
      the prevention of CVD.

      This study is a prospective, 12 week study, where participants will be randomized to receive
      the treatment, placebo, or a comparator product for a period of 12 weeks. Blood lipids will
      be analysed at baseline, week 6 and week 12.
    

Intervention name(s): Placebo; Investigational Product 1; Investigational Product 2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Two capsules, twice daily with meals for 12 weeks.; Two capsules, twice daily with meals for 12 weeks.; Two capsules, twice daily with meals for 12 weeks.
Other intervention name(s): Soybean Oil; Mfr. Product Code: 31237-NNM; Mfr. Product Code: 31214-NNM; Mfr. Product Code: 31236-NNM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Hypertriglyceridemia; Fish Oil; Red Yeast Rice
Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with
      and without energy restriction.
    


Intervention name(s): NES With Energy Restriction; NES Without Energy Restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.; The NES will be administered based upon the individual's calculated daily energy requirement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; nutrition; diet; foods
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      ISIS-GCGRRx in combination with metformin versus placebo
    


Intervention name(s): ISIS-GCGRRx- Dose Level 1; ISIS-GCGRRx- Dose Level 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once weekly dosing for 26 weeks; once weekly dosing for 26 weeks; once weekly dosing for 26 weeks
Other intervention name(s): Isis 449884; Isis 449884
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
DESHYDRAT : Assessment of the Prevalence of Dehydration Among 9 to 11 Year-old Children
Condition: Dehydration
MeSH terms: Dehydration
Study type: Observational

Summary: 
      The aim of the study is to determinate the prevalence of moderate dehydration among children
      aged 9 to 11 who are going to school.
    

Detailed description: 
      Many children have a limited caloric intake at the breakfast with a limited amount of water
      intake. There is no data about the prevalence of dehydration in children who are regularly
      going to school in France.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        500 children aged 9-11
      
Biospecimen description: 
      Urine