bioihbjkbjnl/mcl2 huggingface dataset:
Calcium Supplementation for a Healthy Weight (CaSHeW)
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D)
      supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese
      adults.
    

Detailed description: 
      The prevalence of obesity and levels of overweight is rising worldwide. In the United States,
      63% of men and 55% of women are now overweight or obese. Recent epidemiological data and
      clinical trials have shown that a small daily increase in calcium or dairy products may
      result in annual losses in body weight and body fat. Data from clinical studies suggest that
      a 1000 mg per day increase in calcium intake is associated with an 8 kg difference in mean
      body weight and that calcium intake explains about 3% of the variance in body weight.

      The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D)
      supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese
      adults.

      Otherwise healthy overweight and obese men and women ages 18 to 65 years with a BMI between
      25 and 35 kg/m2 will be randomized into one of the following experimental groups (36 in each
      group):

        1. Regular OJ: one 8 fluid oz serving three times/day (control)

        2. Regular OJ fortified with Calcium (350 mg/8 fluid oz serving) and Vitamin D3 (100 IU/8
           fluid oz serving): one 8 fluid oz serving three times/day (treatment)

      Subjects will receive either orange juice (OJ) (control) or OJ fortified with calcium and
      vitamin D3 (treatment) for 16 weeks. The study will involve 6 outpatient study visits to the
      study center.

      Primary endpoint: Change in body weight after 16 weeks Secondary endpoint: Visceral fat
      change after 16 weeks as measured by single slice CT scan
    

Intervention name(s): Orange Juice fortified with Calcium and Vitamin D; Orange juice without Ca or VitD; Nutritional Counseling
Intervention type(s): Dietary Supplement; Dietary Supplement; Behavioral
Intervention description(s): Three 240 mL glasses of orange juice fortified with 350 mg Ca and 100 IU of D per serving; Three 240 mL glasses of orange juice without Ca or VitD; Individual and group nutritional counseling by a registered dietitian
Other intervention name(s): Minute Maid regular calorie orange juice; Minute Maid regular calorie orange juice
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Body Weight; Dietary Supplement; Calcium; Vitamin D
Incidence of Urinary Tract Infection After Urodynamic Investigation
Condition: Neurogenic Bladder
MeSH terms: Infections; Urinary Tract Infections; Urinary Bladder, Neurogenic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the incidence of urinary tract infection after
      urodynamic investigation and to identify the involved germs.
    

Detailed description: 
      Patients with neurogenic bladder dysfunction after spinal cord injury need lifelong urologic
      control examinations with CMG (urodynamic examination). The manipulation may cause urinary
      tract infections which have to be treated. Patients often noticed an infection after a CMG
      examination. Aim of this study is the determination of the infection rate and germs. Also
      should be noticed the pre-interventional infections and differences between the causing
      germs. Simultaneously the investigators test the reliability of the quicktest for urinary
      infection. Additionally the investigators will examine the Quality of Life in patients with
      neurogenic bladder dysfunction.
    

Intervention name(s): urodynamic examination
Intervention type(s): Procedure
Intervention description(s): Standard urodynamic investigation according to the ICS standard, Good urodynamic practice.Following insertion of 8 F transurethral catheter, retrograde filling of the bladder (20 mL/min) with body warm saline.
Current recording of pabd. , pves and pdet., subsequently pressure flow study. Additionally imaging with fluoroscopy to detect possible vesico ureteral renal reflux.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: urinary tract infection; urodynamics; spinal cord injury
A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.
Condition: Skin Care
Study type: Interventional

Summary: 
      This study aims to determine the local cutaneous and ocular tolerance of 3 developmental
      skin-care products; a serum, a lotion, and a cream in healthy female subjects with clinically
      evaluated sensitive facial skin for 21 days.
    

Detailed description: 
      This will be a randomized, non-comparative, single-blind (evaluator), 3-arm, parallel-group,
      single-center, clinical 'in-use' study to determine the local cutaneous and ocular tolerance
      profiles of 3 developmental cosmetic facial skincare products; a serum, lotion, and cream in
      healthy females with clinically-evaluated sensitive skin as determined by a positive response
      to a Lactic Acid Stinging Test (LAST) with signs or symptoms of cutaneous irritation and no
      ophthalmological conditions. Assessments will be performed and recorded for 21 days.
    

Intervention name(s): Serum; Lotion; Cream
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will topically apply the serum to the face as per normal home use application in place of their current facial serum product.; Participants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product.; Participants will topically apply cream to the face as per normal home use application in place of their current facial cream product.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a randomized, 3-arm parallel group study.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glycerol; Niacinamide; Skin Care
Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques
Condition: Labor Pain; Analgesia
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      To estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of
      patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor.
    

Detailed description: 
      The primary objective of our study is to use a biased coin up-down allocation methodology to
      estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of
      patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction
      or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for
      each technique with adequate precision to inform the optimal doses.
    

Intervention name(s): Bupivacaine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Local Anesthetic Agent
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial Using Biased Coin Design to Determine Effective Dose for 90% (ED90) of Subjects
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dural Puncture Epidural Technique; Epidural Technique; Neuraxial Labor Analgesia; Bupivacaine; Local Anesthetic Agent
Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants
Condition: Preterms With Gestational Age Ranging From 30 to 35 Weeks
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The intestinal flora is a complex ecosystem which is known to play various important
      functions in the gut. Recent data have reported a delay in intestinal colonization in
      preterm. Modulating the intestinal flora through dietary supplementation with probiotics or
      prebiotics has been shown to improve digestive and general outcomes in full-term infants.The
      aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and
      the mucosal inflammatory responses to a fermented milk in preterm infants.
    

Detailed description: 
      This prospective, randomized, double-blind, controlled study evaluated the safety and effect
      on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm
      infants. Preterm infants with a gestational age (GA) ranging from 30 to 35 weeks and whose
      mother chose formula feeding were enrolled during their first three days of life. Both
      parents provided informed written consent. Infants were randomly assigned to receive either
      the fermented preterm formula (FPF) or, as a control, a formula adapted for preterm infants
      (PF). The PF was formulated to meet the nutritional needs of preterm infants. The FPF was
      identical, except for a manufacturing process including a fermentation step with two
      probiotic strains, Bifidobacterium breve C50 and Streptococcus thermophilus 065, inactivated
      by heat at the end of the manufacturing process. This process conferred a probiotic/prebiotic
      activity.For each neonate, background information about the pregnancy and neonatal parameters
      were collected. Anthropometric parameters (weight, height, head circumference);
      gastrointestinal tolerance parameters (abdominal distension, gastric residuals, rectal
      bleeding, NEC); drug administration; and intake of formula and mother's milk were recorded
      twice a week until discharge. Stools were collected twice a week from diapers for
      microbiological analysis and measurement of fecal inflammatory markers. All samples were
      immediately stored at -80°C.
    

Intervention name(s): Milk with probiotic and prebiotic activities; Milk without probiotic and prebiotic activities
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Comparison of two different formula for preterm infants; Comparison of formula for preterm infants
Other intervention name(s): Comparison of formula for preterm infants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Premature birth,; infant,; infant formula,; bacterial colonization,; Bifidobacterium,; calprotectin
The Effect of Mood Induction in Body Image Through Virtual Reality
Condition: Sadness; Happiness
Study type: Interventional

Summary: 
      The effect of emotional induction of sadness (vs. joy) on the mental representation of the
      body image through the virtual reality
    

Detailed description: 
      The general objective of this study is to analyze the impact of emotional induction (sadness
      vs. joy) on the two dimensions (perceptive and affective) of body image with the help of
      virtual reality. Thus, it is hypothesized that a negative emotional induction may partially
      explain the change in body image measures.
    

Intervention name(s): Sadness induction; Happiness induction
Intervention type(s): Other; Other
Intervention description(s): Sadness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.; Happiness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Within subjects design. Each participant will be tested, in a counterbalanced way, through both (sadness vs. joy) conditions
Masking: Single (Participant)
Primary purpose: Screening
Cognitive Function and Fatigue in Colorectal Cancer (CRC) Patients After Chemotherapy
Condition: Cognition; Fatigue; Colorectal Neoplasm
MeSH terms: Colorectal Neoplasms; Fatigue
Study type: Observational

Summary: 
      This is a prospective, longitudinal cohort study to evaluate fatigue and cognitive function
      in patients with colorectal cancer (CRC) treated with chemotherapy, and in patients with the
      same malignancy, that do not receive chemotherapy. A self-report questionnaire for fatigue
      (the FACT-F), and validated tests of cognitive function, will be applied at predetermined
      times before, during and after chemotherapy, to determine the incidence, severity and
      duration of these symptoms. Comparisons will be made in changes in cognition for individuals,
      as well as between the chemotherapy and the control group. Mechanisms that might lead to
      fatigue and/or cognitive decline will be investigated.
    

Detailed description: 
      We will undertake a prospective, longitudinal controlled study of fatigue and cognitive
      function in 120 patients with localized CRC who receive 5FU-based adjuvant chemotherapy. Each
      patient will be evaluated at baseline and at 6, 12 and 24 months for fatigue (using the
      FACT-F questionnaire) and for cognitive function, using validated tests: these will comprise
      both traditional neuropsychological tests and the computerised CANTAB™, a which is less
      dependent on fluency in English. Results during and after chemotherapy will be compared with
      the pre-chemotherapy assessment (so that each patient acts as their own control). Since
      baseline evaluation may be confounded by the recent diagnosis and surgery we will include an
      independent control group of 120 patients who have undergone surgery for CRC but who do not
      receive chemotherapy. Patients found to have cognitive change will be offered further
      comprehensive neuropsychological assessment. We will also evaluate quality of life (QOL)
      using the FACT-G questionnaire and anxiety and depression using the General Health
      Questionnaire (GHQ). Blood tests including hormone levels, cytokines, homocysteine,
      procoagulants and apo-lipoprotein E-є4 allele status will evaluate possible mechanisms.
      Finally, since chemotherapy for CRC is evolving to include the more toxic drugs oxaliplatin
      and irinotecan, we will perform a parallel pilot study evaluating pts with early recurrent or
      metastatic CRC who receive these drugs, using similar methods of evaluation.
    

Intervention name(s): Neuropsychological Testing
Intervention type(s): Behavioral
Intervention description(s): neuropsychological testing with traditional tests, CANTAB and six elements test as well as questionnaires
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        colorectal cancer patients aged 18-75
      
Biospecimen description: 
      cytokines, genotyping apoE, EUC, LFTs, sex hormones, coagulation factors
    
Keywords: cognitive function; fatigue; colorectal cancer; chemotherapy; cognitive impairment
Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program
Condition: Healthy
MeSH terms: Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 1

Summary: 
      Many plasma donation centers have Tetanus immunization programs that are implemented in order
      to collect plasma with high levels of tetanus antibodies. The immunization program requires
      participants to receive multiple tetanus vaccinations over a period of time with the goal of
      hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a
      tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus
      disease.

      The Tetanus vaccine previously used for these programs is no longer being manufactured.
      Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this
      purpose. The only other FDA approved Tetanus vaccines currently available for adults in the
      US are combination vaccines that also immunize against Diphtheria and/or Pertussis.

      In this study, the investigators will evaluate two vaccines that are combinations of Tetanus
      and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis
      antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur
      (Tenivac).

      The package insert for these vaccines indicates they should be administered to previously
      vaccinated people once every 10 years. However, this study will evaluate whether they are
      safe and effective for dosing every 90 days.

      The investigators hypothesize that at least 25% of study subjects will have a positive
      response to at least one of the five planned doses. Each vaccine will be evaluated
      separately.
    


Intervention name(s): Tetanus and Diphtheria (Td) Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Plasma; Plasma Donor; Plasma Donation; Tetanus; Td; Immunoglobulin; Hyper-immunization
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions(DDI) Among Osteoarthritis Patients
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized
      opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one
      other prescription drug metabolized via the CYP450 system were evaluated for an incident
      drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic
      drug-drug interaction (DDI).
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        retrospective database analysis
      
Keywords: retrospective database analysis in osteoarthritis patients
Intravenous Fosfomycin Pharmacokinetics Study
Condition: Bacterial Infection; Multiple-drug Resistance; Pathogen Resistance
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The
      treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous
      (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to
      undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five
      sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten
      additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An
      evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at
      the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes
      at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling
      timepoint, with blood sampling volume that is adequate for testing. The objectives of the
      study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of
      IV-infused ZTI-01.
    

Detailed description: 
      This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The
      treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous
      (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to
      undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five
      sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten
      additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An
      evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at
      the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes
      at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling
      timepoint, with blood sampling volume that is adequate for testing. The objectives of the
      study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of
      IV-infused ZTI-01.
    

Intervention name(s): Fosfomycin disodium
Intervention type(s): Drug
Intervention description(s): Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt.
Intervention MeSH terms: Fosfomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adults; Fosfomycin Disodium; Healthy; Intrapulmonary; Intravenous; Pharmacokinetics; Phase 1; ZTI-01
Injection Rate and Erector Spinae Plane Block
Condition: Postoperative Pain; Breast Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To evaluate the effect of injection rate on the block sensory level in the ESP block.
    

Detailed description: 
      Many women experience severe acute postoperative pain after breast cancer surgery. Regional
      techniques are frequently used as a part of multimodal analgesia in breast surgery.
      Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the
      postoperative opioid requirement for postoperative pain management. In this study, we aimed
      to evaluate the effect of injection rate on the block sensory level in the ESP block.
    

Intervention name(s): Standard group; Long group
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.; Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erector spinae plane (ESP) block; Postoperative Pain; Breast Surgery