bioihbjkbjnl/mcl2 huggingface dataset:
Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia
Condition: Lasik in Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      this is an interventional prospective clinical study which was conducted to evaluate the
      efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of
      Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate
      myopia.
    

Detailed description: 
      This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in
      which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was
      used. Keratometric, refractive, and aberrometric measurements were compared preoperatively
      and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy
      pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness
      measurement.
    

Intervention name(s): Visumax femtosecond laser; Moria M2 microkeratome (MK)
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Family Meal Duration and Children's Eating Behavior
Condition: Feeding Behavior; Eating; Child Behavior; Family Relations
Study type: Interventional

Summary: 
      The goal of this study is to test whether a longer meal duration could improve the diet
      quality of children. To answer this question we want to take an experimental approach by
      implementing a longer family meal duration to examine differences in children's eating
      behavior. The family dinner within a laboratory setting will be video taped and the main
      outcome is children's fruit and vegetables consumption.
    

Detailed description: 
      Parent-child pairs have two dinner in a laboratory setting. The study design is a
      within-subject design: In the control condition they have as much time as they usual. In the
      intervention condition they have 50% more time than usual. Order of the two condition is
      counter balanced. The lab dinner reflects a typical German dinner which consists of bread,
      cheese, cold meat and fruits and vegetables. Additionally a dessert is served after the main
      meal. The foods served reflect food preferences of the child. All dinners are video taped.
      Key outcome variables are consumption of fruits and vegetables, dessert, eating rate and
      amount time engaged in positive and negative social interaction
    

Intervention name(s): Longer meal duration
Intervention type(s): Behavioral
Intervention description(s): Participants have 50% more time to eat than usual
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Incidental Findings Information on Lung Cancer Screening Intent
Condition: Neoplasm of Lung; Decision Support Techniques; Mass Screening
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This online randomized controlled trial seeks to determine if inclusion of incidental
      findings information in a lung cancer screening decision aid affects screening intent among
      screening-eligible individuals. Participants will view either a decision aid with incidental
      findings information or without and indicate their intent to pursue lung cancer screening.

      Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen
      among participants.
    


Intervention name(s): Lung Cancer Screening Decision Aid with Incidental Findings Information; Lung Cancer Screening Decision Aid without Incidental Findings Information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening.; The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Incidental Findings
Incidence of Iron Deficiency Anemia in Toddlers
Condition: Healthy Infants
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Observational

Summary: 
      The frequency of iron deficiency anemia was extensively studied in infants on the first year
      of life. There is not enough information about the frequency of iron deficiency during the
      second and third years of life. In a previous study performed in Israel and published in
      Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there
      is reasonable to study the iron deficiency frequency beyond this age.
    

Detailed description: 
      The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of
      400 toddles from age 18 months to 36 months.

      Two groups of children will be included, 200 children from Jewish origin and 200 from non
      Jewish origin, mostly Arabs.

      A questionnaire that included demographic characteristics, nutrition and iron supplementation
      in the first year, growth status, and laboratory results will be filled for each patient.

      The laboratory analysis will include complete blood count and serum ferritin analysis.

      Children that were previously diagnosed suffering from iron deficiency, children suffering
      from chronic diseases or were born premature will not be included in the study.
    

Intervention name(s): Questionnaire filling and laboratory analysis
Intervention type(s): Other
Intervention description(s): A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.
The laboratory analysis will include complete blood count and serum ferritin analysis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group
        of 400 toddles from age 18 months to 36 months.

        Two groups of children will be included, 200 children from Jewish origin and 200 from non
        Jewish origin, mostly Arabs.

        Children that were previously diagnosed suffering from iron deficiency, children suffering
        from chronic diseases or were born premature will not be included in the study.
      
Keywords: Infants; Iron Deficiency; Anemia; Healthy infants that attend the pediatric community clinics
Visual Guidelines and Tutoring in Pediatric Urological Surgery
Condition: Hypospadias; Undescended Testis; Hydrocele; Ureteropelvic Junction Stenosis; Anxiety
MeSH terms: Hypospadias; Cryptorchidism
Study type: Interventional

Summary: 
      The aim of this study is checking impact of visual guidelines (picture book) and tutoring in
      pediatric urologic surgery
    

Detailed description: 
      The number of operations in pediatric urology performed on the basis of one day surgery has
      been increased tremendously over the last years. The shortening of the hospital admission
      intends to increase the efficacy of the health system, however at the same time puts an
      additional burdening regarding the postoperative care on the parents of the operated
      children. The parents often have no or has little experience with regards to the basic
      medical education. The lack of the proper tutoring in terms of possible complications, normal
      postoperative period may cause unnecessary patients and parents anxiety, visit to the
      emergency room or calls to the medical stuff, and in some case delay medical attention which
      can cause major surgery related complications. Visual guidelines and tutoring of the patients
      upon surgery may avoid these undesirable effects of the early hospital discharge

      Patients and methods:

      The investigators are proposing prospective study of 3 groups of patients which undergo the
      most often urological surgery Group 1 penile surgery, Group 2 inguinal surgery. Group 3 renal
      surgery required nephrostomy tube leave or drainage. Each group will be divided into two
      subgroups (20 patients each) with and without visual tutoring prior to the surgery. Visual
      tutoring will include the photograph pictures reflecting different stage of the convalescent
      period following surgery. The parents will be asked to answer on questionnaire regarding the
      level of anxiety before surgery, immediately after surgery, week and 3-6 months after
      surgery. The number of parents calls to the hospital staff, emergency or outpatient clinic
      visit will be recorded and compared between two groups. The statistical analysis will
      performed utilizing Graph Pad Prism version 5.00 for Windows, (Graph Pad software, San Diego,
      California, chi square and Fisher test), considering p value of <0.05 as significant).
    

Intervention name(s): Picture book; Standard preoperative education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team; Arm with standard, verbal explaining for a parents about perioperative site/wound view
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; penile; inguinal; kidney parents; anxiety
Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995
      in Subjects with Diabetic Nephropathy.
    


Intervention name(s): MT-3995; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Nephropathy
The Potential Impact of Clindamycin on Neurosurgery Patients.
Condition: Neurologic Complication; Neurosurgery
Study type: Interventional

Summary: 
      A prospective, open-label, single center, controlled trial. 44 patients that underwent
      neurosurgery or presented meningitis signs, for whom Clindamycin add-on therapy to assess its
      effect on neurological complication in relation to Neuron-specific enolase (NSE) and
      Neurotensin biomarkers levels.
    

Detailed description: 
      1. This is a prospective, open-label, single center, controlled trial. 44 patients that
           underwent neurosurgery or presented meningitis signs, for whom Clindamycin add-on
           therapy is prescribed (900 - 1200 mg twice daily) will be recruited from Alexandria
           University Main Hospital.

        2. Whole blood samples will be collected for Analyses of Neuron-specific enolase (NSE) and
           Neurotensin will be detected by ELISA.

        3. All patients will be assessed for complete blood count (CBC), kidney function, liver
           function, Methodology

             -  Patients will be enrolled if they underwent surgery or presented with clinical
                signs of meningitis.

             -  All enrolled 44 patients will be divided into two groups; Group I are patients who
                will receive clindamycin added-on therapy. Group II patients will be managed with
                the standard regimen.

             -  Complete physical, laboratory, and radiological assessment will be done for all
                patients

             -  All patients will be followed up during 2 weeks period.

             -  Serum samples will be collected for measuring the biomarkers.
    

Intervention name(s): Clindamycin 600 mg; standard regimen
Intervention type(s): Drug; Drug
Intervention description(s): Clindamycin 900 - 1200 mg TWICE per day during 2 weeks period.; standard regimen
Other intervention name(s): Dalacin 600 mg; Placebo
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All enrolled 44 patients will be divided into two groups; Group I are patients who will receive clindamycin added-on therapy. Group II patients will be managed with the standard regimen.
Masking: None (Open Label)
Primary purpose: Supportive Care
Beta-glucan, Product Claims and Satiety
Condition: Healthy
Study type: Interventional

Summary: 
      This is a digital clinical trial to investigate satiety and consumer preference in responses
      to three test breakfast bars with varying level of dietary fiber, beta-glucan, and product
      packages (with or without product claims) in healthy adults.
    


Intervention name(s): Foods with beta-glucan from oats and barley
Intervention type(s): Other
Intervention description(s): Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image
Other intervention name(s): Food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Pharmacodynamic Effects of a Single Oral Dose of GS-0976 (NDI-010976) in Healthy Adult Subjects
Condition: PD Effects of GS-0976 (NDI-010976) on Fractional DNL
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the pharmacodynamic (PD) effects of GS-0976
      (NDI-010976) on fractional de novo lipogenesis (DNL) following a single oral dose
      administration in overweight and/or obese, but otherwise healthy, male adults.
    


Intervention name(s): GS-0976; Placebo; 1-13C acetate; Fructose solution
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Capsule(s) administered orally; Capsule(s) administered orally; 10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours; Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
Other intervention name(s): NDI-010976
Intervention MeSH terms: Firsocostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: fractional de novo lipogenesis; DNL; pharmacodynamic; pharmacokinetic
Intestinal Microbiota Survey of Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Polycystic Ovary Syndrome is kind of disease with unclear etiology. Recent studies on
      intestinal microbiota have raised the possibility that dysbiosis of intestinal microbiota
      maybe a novel theory for the development of Polycystic Ovary Syndrome. Hence, the
      investigators will compare the intestinal microbiota composition and diversity in PCOS with
      age, BMI-matched control and then assess whether intestinal microbiota modification is
      associated with clinical and biological parameters.
    

Detailed description: 
      The goal of this study is to investigate and compare the composition of the intestinal
      microbiota in patients with PCOS and age, BMI-matched control. In addition, the investigators
      will investigate the relationship between alterations in the intestinal microbiota, clinical
      phenotype, biochemical analysis, body composition, inflammation and food consumption habit.
      The investigators hypothesize that alterations in the intestinal microbiota are associated
      with increased immune activation and progression of PCOS. Based on this hypothesis, the
      investigators propose the following aims:

      Aim 1. Identify and enroll cohort with PCOS and age, BMI-matched control to study the role of
      intestinal microbiota on the development of PCOS.

        1. Enroll participants at Drum Tower Hospital. Identify and classify participants through
           initial clinical evaluation, collect clinical metadata, obtain and process blood and
           stool samples for analysis.

        2. Characterize the intestinal microbiota through quantitative PCR and high throughput
           sequencing analysis of stool specimens in participants.

      Aim 2. Compare sequencing results and metagenomic analysis for study groups with particular
      attention to bacterial composition and metabolic capacity associated with energy harvest,
      lipid and carbohydrate transport, enhancement of epithelial barrier integrity and systemic
      inflammation.
    

Intervention name(s): Blood Draw; Stool collection
Intervention type(s): Other; Other
Intervention description(s): Blood sample will be drawn from participants at study entry.; Stool will be collected from participants at study entry.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Polycystic Ovary Syndrome patients and age, BMI-matched women.
      
Keywords: Polycystic Ovary Syndrome; Intestinal Microbiota
Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir
      (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus
    


Intervention name(s): Faldaprevir; Faldaprevir; Cyclosporine; Tacrolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Biofeedback for Speech Sound Disorders
Condition: Speech Sound Disorders
MeSH terms: Speech Sound Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Children with speech sound disorders will receive speech therapy using real-time images of
      the tongue from ultrasound. These images will be used to cue the child to change the tongue
      position when producing speech sounds.
    


Intervention name(s): Ultrasound visual feedback
Intervention type(s): Behavioral
Intervention description(s): Real-time visual displays of the tongue are used to cue participants to modify the tongue position/shape as they articulate speech sounds
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      A randomized double blinded controlled study including infants at the age of 1 month .
      Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or
      L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain
      (Control group). The primary outcome of the study is the body weight gain of infants.
      Secondary outcomes are incidence of infections, symptoms related with intestinal function,
      and fecal microbiota
    


Intervention name(s): Lfer; Bifido; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716; Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263; Standard infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: infant nutrition; probiotic
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting
      healthy humans
    


Intervention name(s): Methylprednisolone
Intervention type(s): Drug
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Keywords: AQP-2; Methylprednisolone; Urinary concentrating ability
Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma
Condition: Exposure to Magnetic Field; Uterine Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      The purpose of this study is to determine predictive factors in the pelvic magnetic resonance
      in the response of arterial embolization of uterine leiomyoma.
    

Detailed description: 
      This study followed symptomatic premenopausal women with uterine leiomyoma who underwent
      uterine artery embolization (UAE). Treatment was accompanied by magnetic resonance imaging of
      both the volume of the entire uterus and the leiomyomas one month before and six months after
      UAE. This patients were treated at the Uterine Leiomyoma Sector of the Department of
      Obstetrics and Gynecology, Medicine College of the University of São Paulo. In this study,
      the investigators examined 179 leiomyomas in 50 patients.
    

Intervention name(s): Magnetic Resonance Image
Intervention type(s): Procedure
Intervention description(s): The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroids was determined, and their location in the myometrium. Perfusion and the characterization of the T2 signal were also evaluated.
Other intervention name(s): Magnetic Resonance Image with a high-field scanner; Siemens Magnetom 3-Tesla
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women from the Leiomyoma Service, with eligible criteria and chose this kind of treatment
        between september 2008 and march 2009.
      
Keywords: Leiomyoma; uterine artery embolization; magnetic resonance imaging