bioihbjkbjnl/mcl2 huggingface dataset:
Altered Calcium and Vitamin D in PMDD or Severe PMS
Condition: Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome
Study type: Interventional

Summary: 
      Osteoporosis has become one of the most widely recognized disorders of our times affecting an
      estimated 25 million women in this country. Recent evidence has suggested that premenstrual
      syndrome (PMS) is associated with a calcium deficiency state and bone loss. This may place
      premenopausal women at greater risk for osteoporosis. An entity such as PMS may be an
      important physiological marker of a calcium disturbance. The purpose of this investigation is
      to understand more completely the extent to which calcium balance is disturbed in severe PMS
      or Premenstrual Dysphoric Disorder (PMDD) by utilizing new tools to assess calcium and bone
      turnover. The long term objective is to elucidate the pathophysiology of PMDD or severe PMS
      as it relates to calcium hormones and bone markers. The experimental design involves the
      comparison between women witn severe PMS and asymptomatic controls.
    


Intervention name(s): Measures of calcium and bone turnover
Intervention type(s): Procedure
Intervention MeSH terms: Calcium
Intervention model: Parallel Assignment
Primary purpose: Diagnostic
Keywords: Premenstrual Dysphoric Disorder; Severe Premenstrual Syndrome; Calcium metabolism; Vitamin D; Bone Markers; Premenopausal; Menstrual Cycle
An Analysis of Diabetes Control in Puerto Rico
Condition: Diabetes Mellitus; Arterial Hypertension; Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Hypercholesterolemia
Study type: Observational

Summary: 
      Project: An analysis of Diabetes Control in Puerto Rico Hypothesis: This project seeks to
      determine the causes for: i) poor adherence to prescribed treatment by patients, ii) low
      compliance by providers with national guidelines iii) barriers impose by health insurance in
      control of diabetes mellitus iv) effectiveness of a disease management program for treatment
      adherence by patients.
    

Detailed description: 
      Method (s) The study will consist of three phases:

      i) assessment phase,

      ii) multimedia health education campaign for patients, providers and local health insurances
      for adherence improvement

      iii) reassessment phase.

      Target Population:

      Phase I: 600 Hispanic, male and female, residents of Puerto Rico with a diagnosis of type 1
      and 2 diabetes mellitus older than 18 of age.

      Phase II: 600 patients identified in phase I with individualize health education
      interventions on the importance of adherence to prescribed medical treatment. 2) Spanish
      speaking population of Puerto Rico, health service providers, and health insurance companies
      through a multimedia health education campaign.

      Phase III: reassessment of the 600 patients of Phase I.

      Data Collection Tools:

      i) Demographic information will be obtained by an interview questionnaire. Patients will be
      assigned a control number automatically by the data system.

      ii) Laboratory blood samples for A1C, lipids (total cholesterol, triglycerides and HDL
      cholesterol), and serum creatinine.

      iii) A comprehensive educational adherence program with different media strategies such as:
      radio spots, newspaper articles, public service announcements, telemedicine services.

      Data Analysis: Data will be analyzed using SPSS for Windows.
    

Intervention name(s): Epidemiological intervention
Intervention type(s): Other
Intervention description(s): An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This epidemiologic study will analyzed a 600 type 1 and 2 Diabetic patients under
        medication. The populations to be analyzed is composed of female and male subjects under
        therapy with anti diabetic medication. The population will be selected from four high
        density cities in the Island of Puerto Rico. Puerto Ricans are considered as hispanic
        populations with a mix of white hispanic, african people on a basis of indians ancestry.
        Subjects will be invited to participate in the study.
      
Keywords: Diabetes mellitus
Using Virtual Reality to Train Children in Pedestrian Safety
Condition: Street-crossing Ability; Pedestrian Safety
Study type: Interventional
Phase: Phase 3

Summary: 
      Pedestrian injuries are among the leading causes of morbidity and mortality in American
      children ages 7-8, but existing behavior-oriented interventions achieve only modest success.
      One limitation to existing interventions is that they fail to provide children with the
      repeated practice needed to develop the complex perceptual and cognitive skills required for
      safe pedestrian activity.

      Virtual reality (VR) offers a highly promising technique to train children in pedestrian
      safety skills. VR permits repeated unsupervised practice without risk of injury; automated
      feedback to children on success or failure in crossings; adjustment of traffic density and
      speed to match children's skill level; and an appealing and fun environment for training. The
      proposed research is designed to test the efficacy of virtual reality as a tool to train
      child pedestrians in safe street-crossing behavior.

      A randomized controlled trial will be conducted with four equal-sized groups of children ages
      7-8 (total N = 240). One group will receive training in an interactive and immersive virtual
      pedestrian environment. The virtual environment, already developed, has been demonstrated to
      have face, construct, and convergent validity. The second group will receive pedestrian
      safety training via video and computer strategies that are most widely used in American
      schools today. The third group will receive what is judged to be the most efficacious
      treatment currently available, individualized behavioral training at streetside locations.
      The fourth and final group will serve as a no-contact control group. All participants in all
      groups will be exposed to a range of field- and laboratory-based measures of pedestrian skill
      during baseline and post-intervention visits, as well as during a six-month follow-up
      assessment. Primary analyses will be conducted through linear mixed models designed to test
      change over time in the four intervention groups. We hypothesize all children in active
      learning groups will increase pedestrian safety skills, but the largest increase will be
      among children in the virtual reality group.
    


Intervention name(s): virtual pedestrian environment; computer and video; streetside training
Intervention type(s): Device; Device; Behavioral
Intervention description(s): a computer-driven virtual pedestrian environment; various computer-based and video-based programs such as Otto the Auto and WalkSafe; one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pedestrian safety; street-crossing ability; road-crossing; children; injury prevention
University of Alabama at Birmingham (UAB) Pediatric CBD Program
Condition: Epilepsy; Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various
      doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating
      debilitating, drug-resistant epilepsy.
    

Detailed description: 
      The specific goals of this phase I dose finding study, conducted in consecutively enrolled
      patients 1-19 years of age, are to prospectively and longitudinally assess the safety and
      tolerability, including cognitive effects, of Cannabidiol (CBD) at various doses between 5
      mg/kg/day and 25 mg/kg/day, with additional titration in some cases up to 50 mg/kg/day. In
      order to participate in the study, participants will need to fulfill the inclusion and
      exclusion criteria.

      The goal of the study is to fulfill the mandate of "Carly's Law" and to provide patients with
      debilitating epileptic conditions with access to CBD as an add-on treatment. Other care
      including routine neurological care unrelated to participation in the CBD study will need to
      be provided by patients' primary/current treating neurologist.
    

Intervention name(s): Epidiolex
Intervention type(s): Drug
Intervention description(s): Epidiolex oral solution (100 mg/mL CBD concentration) with inactive ingredients including anhydrous ethanol, sesame seed oil, strawberry flavor, and sucralose).
Other intervention name(s): Cannabidiol; CBD
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Urine Sample Collection From Non Pregnant Peri and Post-menopausal Women
Condition: Pregnancy
Study type: Observational

Summary: 
      This is a sample collection study, participants will be required to collect one (if last
      menstrual period ≥12 months) or two (if last menstrual period <12 months) urine samples and
      return them to the study site, together with collection sample information. Participants
      having a menstrual cycle within the last 6 months will also be required to provide follow-up
      information on pregnancy status and date of next menstrual bleed.
    

Detailed description: 
      Each subject will be provided with a urine sample collection container, a transport
      container, barcode labels, prepaid envelopes and a full set of study instructions, together
      with the materials required to facilitate the collection of a follow-up urine sample and
      completion of follow up form, where applicable.

      Subjects admitted into the study that are unsure of their pregnancy status will be provided
      with a marketed Clearblue HPT, to test for pregnancy prior to beginning the study. If a
      subject informs the trial site that they have become pregnant prior to urine sample
      collection, they will be withdrawn from the study and no urine sample will be collected. The
      subject will return their materials to the study site, and the co-ordinator will complete the
      exit form.

      Subjects will be required to collect a urine sample, label their sample (as soon as
      collected) with the appropriate bar-coded label provided and return this to the study site.
      Where it is not possible to return the sample as soon as collected, urine samples must be
      stored in a domestic fridge in the container provided for a maximum of 1 week and then sent
      to the study site at their earliest convenience.

      Subjects will receive follow-up to establish pregnancy status unless ≥ 12 months from their
      last menstrual period (LMP). On completion of the study, subjects will be reimbursed for
      their participation.

      It is anticipated that sample collection will be carried out remotely (i.e. at the volunteers
      home) but volunteers may attend the study site for sample collection should they require.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Urine samples collected and stored
    
Keywords: Pregnancy
Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on
      Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol
    

Detailed description: 
      This study has an open-label, one-sequence, multiple drug administration design. The purpose
      of this study is as follows;

      To evaluate the change of the result of Isoproterenol Sensitivity Test according to
      Cytochrome P450 2D6 genotype after the multiple administration of carvedilol
    

Intervention name(s): Carvedilol; Isoproterenol Sensitivity Test
Intervention type(s): Drug; Other
Intervention description(s): Day 1 to 3 : Carvedilol 12.5 mg qd
Day 4 to 8 : Carvedilol 25 mg qd
Day 9 to 11 : Carvedilol 12.5 mg qd; Day 0, 1, 8 : Isoproterenol Sensitivity Test
Intervention MeSH terms: Carvedilol; Isoproterenol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carvedilol; CYP2D6; Isoproterenol Sensitivity Test
Cognitive Training for Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional

Summary: 
      Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits
      that interfere with learning, socialization and emotion regulation. Extensive research
      focused on the animal models of FXS show that targeted pharmacological agents can normalize
      synaptic connectivity and reverse cognitive and behavioral deficits. This translational work
      has led to multiple national and international controlled trials in humans with FXS now
      underway. However, in contrast to the heavy focus on medication treatments, there have been
      no controlled trials to empirically-validate cognitive or behavioral interventions for FXS.
      The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the
      efficacy of Cogmed, a cognitive training program proven to enhance working memory and
      executive/frontal function in a variety of clinical populations. Demonstration of effective
      Cogmed training for FXS would represent a major advance in the field, one that may also
      generalize to other forms of intellectual disability. Furthermore, it is critical to
      determine whether the targeted pharmacological treatments can accelerate learning and
      cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for
      testing hypotheses focused on combined efficacy of medication and cognitive training.
    


Intervention name(s): Working Memory Training
Intervention type(s): Other
Other intervention name(s): Cogmed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Neck Strength Training on Health-related Quality of Life in Females With Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether intensive one-year neck strength training
      can enhance health related quality of life in females with chronic neck pain.
    


Intervention name(s): Neck endurance training; Stretching
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy
Condition: Movement Disorders
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      The management of functional psychogenic movement disorders (FNPMD) is challenging for
      neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme
      can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance
      imaging studies have demonstrated abnormalities in motor control at cortical level,
      hyperactivity of limbic system and disturbance of connectivity between these two systems
      leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a
      possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis
      2011, Garcin, 2013).

      In this protocol our objectives are twofold :

        1. to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind
           randomized controlled study

        2. to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD
    


Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): Study 1 : 5 daily sessions of rTMS 1 Hz, 95% x resting motor threshold (RMT) applied on M1 / sham
Study 2 : 3 weekly sessions of rTMS 1 Hz, 95% x RMT on M1 combined with ericksonian hypnosis session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Determine the Effect of an Anti-IgE Agent on Inflammatory Cells in the Skin of Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic
      dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study
      tried to explore whether the depletion of IgE from blood and skin might result in a change of
      immunological parameters and might alter the clinical course of the disease.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Omalizumab
Keywords: Serum IgE levels; inflammatory cells in the skin; inflammatory cells in the blood; IgE; IgE depletion; atopic dermatitis; atopic eczema; Omalizumab
The GoodNEWS Lifestyle Enhancement Program
Condition: Cardiovascular Disease; Hypertension; Diabetes; Obesity
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study will train Lay Health Promoters (LHPs) from African-American churches to
      administer healthy living lessons and activities to their congregations in order to improve
      overall health and address cardiovascular disease. The primary hypothesis is that LHP
      training combined with a well supported maintenance strategy will be more effective than LHP
      training alone in reducing risk factors for cardiovascular disease.
    

Detailed description: 
      The GoodNEWS Trial is an 18-month effectiveness trial with an 18-month extended maintenance
      study, among 20 African-American and low-income congregations participating in the GoodNEWS
      faith-based lay health promotion program. After training, congregations will be randomized to
      either GoodNEWS with a health maintenance intervention (GoodNEWS-I) or GoodNEWS program alone
      (GoodNEWS-PA). The maintenance intervention combines elements of the medical care model and
      features of community-based support. Primary data collection will occur at baseline, 18, and
      36 months with the two primary outcomes being levels of physical activity as measured by 7-
      Day Physical Activity Recall (PAR) and dietary change as measured by the Diet History
      Questionnaire (DHQ). The primary hypothesis is that the maintenance group will significantly
      increase physical activity and healthy eating behavior compared to the program only group. We
      also hypothesize that lipoprotein and glucose levels, and blood pressure will be
      significantly improved over baseline in the GoodNEWS-I group and that these changes will be
      significantly greater than in the GoodNEWS-PA group. At the end of the trial, both groups
      will continue in an 18-month extended maintenance study.
    

Intervention name(s): Lay Health Promoter (LHP) with maintenance
Intervention type(s): Behavioral
Intervention description(s): Lay Health Promoters (LHPs) and their congregations will join an existing social and organizational support network, comprised of LHPs and congregations who are part of an active community health improvement collaborative.
Other intervention name(s): Faith-Based Intervention; Faith-Based Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Community-based Participatory Research (CBPR); Vulnerable population; High-risk population; African-Americans; Health Disparities; Clinical Trial
Genetic Determinants of Cardiovascular Response to Coffee Drinking
Condition: Caffeine
Study type: Interventional

Summary: 
      Cardiovascular and neuropsychologic effects of coffee are still debated. The precise
      mechanism underlying the actions of caffeine on the cardiovascular and neuropsychologic
      systems is incompletely understood and a considerable variability in the response to coffee
      drinking was observed, in part ascribable to a genetic trait.

      The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of
      coffee and explore whether such effects are influenced by the genetic asset of caffeine
      metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by
      polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine
      receptors (by polymorphisms of adrenergic receptors).
    

Detailed description: 
      Coffee is among the most widely consumed beverages worldwide. Despite the relationship
      between coffee consumption and the incidence of cardiovascular disease has been studied
      extensively, the effects of this drink on the cardiovascular apparatus and its role as a risk
      factor for coronary heart disease are still debated. Moreover, the effect of coffee on
      attention, sleep changes, anxiety and panic disorders was studied but a great variability was
      observed.

      Many of the known or suspected cardiovascular and neuropsychologic effects of coffee have
      been attributed to caffeine. The main mechanism of action of caffeine is to antagonize
      adenosine receptors; a secondary effect is the inhibition of phosphodiesterases, with the
      subsequent accumulation of cyclic adenosine monophosphate and a intensification of the
      effects of catecholamines.

      It is also well known that there is a considerable variability in the cardiovascular and
      neuropsychologic response to coffee drinking, explaining the inconsistency between different
      effects observed in the various studies. This variability may have a genetic basis.

      The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of
      coffee and explore whether such effects are influenced by the genetic asset of caffeine
      metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by
      polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine
      receptors (by polymorphisms of adrenergic receptors).
    

Intervention name(s): Coffee; Decaffeinated coffee
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 40 mL dose of a decaffeinated preparation spiked with the addition of caffeine, at a dose of 3 mg/kg; 40 mL dose of decaffeinated coffee
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: coffee; caffeine; blood pressure; nutrigenetics; gene polymorphisms; Acute Cardiovascular and Neuropsychologic Effects