bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Vitamin D Status on in Vitro Fertilization (IVF) Outcomes
Condition: Vitamin D Status
Study type: Observational

Summary: 
      Infertility is a common and psychologically devastating problem for 20% of Canadian couples.
      Approximately, 20% of infertile couples are diagnosed with unexplained infertility and left
      without an explanation for their inability to have a baby. Pathological uterine receptivity
      and embryo implantation are hypothesized mechanisms underlying sub-fertility in these
      couples. Embryo implantation requires a complicated sequence of events involving the
      differentiation of endometrial cells to attain uterine receptivity and the synchronized
      interaction between maternal and embryonic tissues. Vitamin D has been hypothesized to play a
      role in this poorly understood process. Vitamin D is a known regulator of signal transduction
      pathways involved in embryo implantation and its receptors are involved in calcium-regulation
      in various reproductive tissues including, the ovary, uterus, and placenta. In Canada, the
      prevalence of Vitamin D insufficiency is approximately 34-50%. The goal of the proposed study
      is to determine the prevalence of vitamin D insufficiency in an infertile population and
      whether this prevalence is higher than in average Canadian reproductive age women. More
      importantly, we will investigate whether vitamin D insufficiency in our infertile population
      translates to impaired implantation and reduced clinical pregnancy rates. Insight into
      vitamin D's role in reproduction is essential not only to provide scientific understanding of
      the mechanism underlying embryo implantation, but also because vitamin D supplementation
      could provide an easy and safe means of treating infertility.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing IVF at Mount Sinai Hospital
      
Keywords: Vitamin D; In vitro Fertilization
Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA
Condition: Cardiovascular Diseases; Atherosclerosis; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Arteriosclerosis; Myocardial Ischemia
Study type: Observational

Summary: 
      To assess the associations of serum sex hormones with the presence and progression of
      subclinical atherosclerosis.
    

Detailed description: 
      BACKGROUND:

      Throughout their lifetime, men are at higher risk of coronary heart disease (CHD) than women,
      however, after menopause this difference is attenuated. This observation suggests that
      endogenous sex hormones could be associated with CHD risk. There is some evidence indicating
      that the effect of sex hormones on CHD risk could be mediated, in part, by alterations in
      lipid levels or other CHD risk factors. However, other evidence supports an independent
      relationship of circulating hormone levels with CHD risk.

      DESIGN NARRATIVE:

      The study, which is ancillary to MESA, will examine the associations of serum sex hormone
      concentrations with the presence and progression of subclinical atherosclerosis in 3,259 male
      and 2,802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis
      (MESA). Subclinical atherosclerosis will be identified using both coronary artery calcium
      (CAC) and carotid intimal-medial wall thickness (IMT). Progression will be identified by the
      change in CAC over 3.5 years. Circulating concentrations of total (and free) testosterone
      (T), dehydroepiandrosterone (DHEA), 17 beta-estradiol (E2), and sex hormone binding globulin
      (SHBG) in stored serum samples collected at the MESA baseline exam will be assessed.
      Laboratory results will be merged with existing demographic, anthropometric, lifestyle, CHD
      risk factor, and subclinical disease data collected in MESA. Cross-sectional and prospective
      methods of statistical analysis will be used to assess the proposed associations. MESA is
      particularly well suited for disentangling the effects of hormonal factors and CHD risk
      factors on subclinical atherosclerosis because of the availability of high-quality data,
      serum samples, and CAC and IMT measurements in a large multi-ethnic population of men and
      women.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample of African-American, Chinese-American, Caucasian, and Hispanic residents
        drawn from six regions in the United States: Baltimore City and Baltimore County, Maryland;
        Chicago, Illinois; Forsyth County, North Carolina; Los Angeles County, California; New
        York, New York; and St. Paul, Minnesota.
Tolerability and Potential Efficacy of LTh(αΚ) in Subjects With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A single center, double-blind, randomized, dose-escalation study to assess the safety,
      tolerability and efficacy of 3 doses of AD17002 in comparison to placebo. Subjects will be
      randomized at 3:1 ratios in each of 3 cohorts to receive AD17002 or placebo.
    

Detailed description: 
      A single center, double-blind, randomized, dose-escalation study to assess the safety,
      tolerability and efficacy of 3 doses of AD17002 in comparison to placebo. Subjects will be
      randomized at 3:1 ratios in each of 3 cohorts to receive AD17002 or placebo. The following
      treatment cohorts are featured in a dose-escalating manner:

      A. Cohort 1 will comprise 16 subjects who will receive, in a double-blind manner, either 20
      μg AD17002 (n=12) or placebo (n=4) on Study Day 1, 8, and 15.

      B. Cohort 2 will comprise 16 subjects who will receive, in a double-blind manner, either 40
      μg AD17002 (n=12) or placebo (n=4) on Study Day 1, 8, and 15.

      C. Cohort 3 will comprise 16 subjects who will receive, in a double-blind manner, either 60
      μg AD17002 (n=12) or placebo (n=4) on Study Day 1, 8, and 15.

      A total of 16 subjects in cohort 1 will receive the assigned study preparation before the
      remainder of the Cohort. Study drug administration to the next subject for the first 8
      subjects in the cohort 1 will be separated for at least one day elapse (at least 24 hrs). The
      progression to the next cohort will take place after the SRT review the whole follow-up
      period safety data of previous cohort.
    

Intervention name(s): AD17002; Formulation Buffer
Intervention type(s): Biological; Other
Intervention description(s): LTh(αK) as immunomodulator; Formulation buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bispectral Index Throughout Esophageal Cancer Operation
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      The investigators try to conduct a study to assess the impact of changing patients' lateral
      decubitus position on BIS readings during esophageal cancer operation. Also, the
      investigators evaluate the effects of one-lung ventilation and total lung ventilation on BIS
      value with inhalation agent.
    

Detailed description: 
      Bispectral index (BIS) was developed to monitor a patient's level of consciousness under
      general anesthesia. Several factors have been found to alter BIS readings without affecting
      the depth of anesthesia.Changing a patient's position (head up and head down) significantly
      affects the BIS values, which might affect the interpretation of anesthetic depth.

      During esophageal cancer surgery, there were several factors which could affect to BIS
      values.First, the surgical positions are consisted with supine and lateral decubitus position
      more than 1 h. Thus, the investigators compare the BIS value of both side on supine and
      lateral decubitus position by both side approach. Second, the one lung ventilation was
      applied for surgical filed. It alters the oxygenation and the cerebral flow. Because of these
      effects, the BIS monitoring can differ by the period of surgery. Thus, in this study, the BIS
      value of both side monitor throughout the surgery.
    

Intervention name(s): BIS
Intervention type(s): Device
Intervention description(s): All patients applied BIS on both side (Left and Right)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bispectral index; lateral decubitus position; one lung ventilation
A Trial Evaluating the Long-term Safety and Tolerability of Centanafadine Sustained-release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety and tolerability of centanafadine
      sustained-release tablets, administered twice daily in the treatment of adults with attention
      deficit hyperactivity disorder (ADHD).
    

Detailed description: 
      This open-label study will assess the overall safety and tolerability of 400 mg total daily
      dose centanafadine sustained-release tablets in subjects, over the course of approximately 52
      weeks. This study will accept rollover subjects from both the 405-201-00013 and 405-201-00014
      trials. For individuals that did not participate in one of the studies mentioned above, they
      will be able to enroll if they meet the inclusion criteria as outlined below.
    

Intervention name(s): Centanafadine SR
Intervention type(s): Drug
Intervention description(s): 200 mg, BID, oral tablets
Other intervention name(s): EB-1020
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Centanafadine; ADD; ADHD
The Effect of Home-based Velocity Training in Individuals With Total Knee Replacement
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      The purpose of this study will be to find out the effect of two different interventions on
      muscle strength, ability to produce muscle force quickly (power), daily function, and number
      of steps and physical activity an individual with total knee replacement do daily.

      The research hypotheses for this study will be as follows:

        -  For individuals who are at least 6 months post-total knee replacement, home-based
           high-velocity training exercises will result in significantly greater improvements in
           muscle strength and power compared to those who receive a walking program only.

        -  For individuals who are at least 6 months post-total knee replacement, home based
           high-velocity training exercises will result in significantly greater improvements of
           daily function(eg. sit to stand, climb a set of stairs)than those who receive a walking
           program only.

        -  For individuals who are at least 6 months post-total knee replacement, home based
           high-velocity training exercises will result in significantly greater improvements in
           physical activity behavior (eg. number of steps per day)compared to those who receive a
           walking program only.
    


Intervention name(s): Exercises plus walking program; Walking only program
Intervention type(s): Other; Other
Intervention description(s): Exercise group Consist of functional exercises such as mini-squats, sit to stand, and exercises with use of thera-bands. For each exercise, participants will be taught to perform the concentric phase forcefully and as fast as they can and return to the initial position slowly and with control. Participants will be asked to perform the exercises 3 times per week as a home exercise program daily throughout the 8-week intervention period. Additionally, they will be asked to wear a pedometer daily throughout the 8-week intervention to monitor steps. A step goal will be provided to gradually increase daily to become "somewhat active" or "active" by the end of the 8-week intervention.; Participants will be asked to wear a pedometer and instructions for use just as the exercise group. They will also will given a step goal just as the participants in the exercise group and will similarly be asked to record number of steps form their pedometer in a daily log along with the minutes of moderate and vigorous physical activity throughout the 8-week intervention period.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Power; muscle strength; total knee replacement; physical activity behavior
Seattle-PAP Bubble Nasal CPAP and Work of Breathing
Condition: Respiratory Distress Syndrome In Premature Infants; Bronchopulmonary Dysplasia; Newborn Primary Sleep Apnea
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Sleep Apnea, Central; Premature Birth
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators propose to test the hypothesis that Seattle bubble nasal continuous
      positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth
      weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway
      pressure.
    

Detailed description: 
      The primary outcome variable is work of breathing (WOB) over a two hour period, estimated
      from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the
      distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in
      pleural pressures during breath cycles. The following endpoints would also be assessed:
      Oxygen saturations and Fraction of Inspired Oxygen (FiO2) needed to keep saturations in
      acceptable ranges, Heart Rates (HR), transcutaneous carbon dioxide (TcPCO2), and respiratory
      rates throughout the 6 hour study period.

      Objective determination of when an infant requires more or less respiratory support is
      difficult, but measurements of pressure-rate products as estimates of work of breathing,
      using esophageal catheters, can estimate an infant's respiratory effort. However, objective,
      simple-to-use, low cost, and non-invasive methods and tools to determine an infant's
      respiratory effort do not exist currently.

      This study also is designed to test the hypothesis that infants' chest and abdominal
      movements can be assessed quantitatively from video images in ways that can be correlated
      with intrathoracic pressures, as measured with esophageal catheters.
    

Intervention name(s): Seattle-PAP
Intervention type(s): Device
Intervention description(s): We propose to test the hypothesis that by introduction of variation in airway pressure Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) reduces work of breathing in very low birth weight infants more effectively than standard bubble nasal continuous positive airway pressure.
Other intervention name(s): Sea-PAP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bubble nasal continuous positive airway pressure (Bn-CPAP); work of breathing; pressure-rate products
Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants,
      in a current environmental context different from that of the seventies and eighties. It has
      a split mouth design. 4OO subjects are included and the duration of follow up is 2 years.
    

Detailed description: 
      This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants,
      in a current environmental context different from that of the seventies and eighties. This
      study assesses the cost-effectiveness of sealants according to the individual caries risk.
      This study takes place in Nice, Marseille and Paris (France) and the patients are to be
      enrolled both in the dental hospitals and in the private practice. In the hospitals, the
      subjects are recruited directly by the headmasters of the pediatric dentistry or public
      health departments in the three dental schools. In private practice, the head of the
      department of pediatric dentistry and / or public health dentistry, of each dental school
      chooses 4 to 6 private practitioners who are used to place dental sealants in their daily
      practice. They recruit the subjects among their own patients. The type of study corresponds
      to randomized clinical trial (Split mouth design) in which the tooth is the statistical unit
      (one pair of molars considered for each included patient). This study has a direct benefit
      for individuals. The number of necessary subjects is 328; the sample size is 400. The
      follow-up duration is 2 years. The treatment is a pit and fissure sealant on one randomized
      tooth by pair of permanent molars (Split mouth design). Sealant material is set up in
      accordance with the usual practice of each practitioner. Occlusal exams are conducted every 6
      months. The effectiveness of dental sealants and the retention of sealing materials are
      statistically analyzed according to both the individual caries risk and the clinical protocol
    

Intervention name(s): pit and fissure sealant
Intervention type(s): Other
Intervention description(s): pit and fissure sealant on one randomized tooth by pair of permanent molar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sealant; pit; child; over; 6 years old; least
Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy
      for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions
      are well established as safe and effective agents for gut cleansing and Norgine has
      successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and
      safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient
      acceptance.

      Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in
      subjects' compliance with gut preparation procedure. The study medication NRL0706 is
      identical to the PEG+E-containing gut lavage solution commonly used in clinical practice,
      with the exception that the flavour has been modified from lemon to orange. This study is to
      investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706
      (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for
      colon cancer screening.
    


Intervention name(s): NRL0706
Intervention type(s): Drug
Intervention description(s): Patients receive 1 litre of NRL0706 solution followed by 0.5 litre of clear liquid during the afternoon/evening prior to colonoscopy. Patients receive 1 litre of 0706 solution followed by 0.5 litre of clear liquid during the morning of colonoscopy.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency
Condition: Immunologic Deficiency Syndrome
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune
      Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
    

Detailed description: 
      This is an open-label, single-arm, historically controlled, prospective, multicenter phase
      III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin
      Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.

      Subject will be infused every 21 to 28 days according to their previous IVIG treatment
      schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject
      treated every 21 days will receive 17 study IVIG infusions.

      Duration of treatment:The total duration of treatment is 12 months.
    

Intervention name(s): Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™
Intervention type(s): Drug
Intervention description(s): IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.
Other intervention name(s): IGIV; Immune Globulin Intravenous (Human) 5% Liquid
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IGIV; Primary Immune Deficiency; Immunoglobulin G
Gastric Emptying Study After Administration of a High Caloric Sip Feed
Condition: Enteral Nutrition
Study type: Interventional

Summary: 
      Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by
      using the paracetamol absorption method in healthy volunteers.
    


Intervention name(s): ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)
Intervention type(s): Dietary Supplement
Intervention description(s): Single, oral administration of nutritional supplement under fasting condition within 2 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: food for special medical purposes
Safety, Tolerability and Pharmacokinetics of KUC 7483 Tablets in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability and pharmacokinetics of KUC 7483
    


Intervention name(s): KUC 7483 CL; Placebo; High fat meal
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment