bioihbjkbjnl/mcl2 huggingface dataset:
Taurine in Peripartum Cardiomyopathy
Condition: Peripartum Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Taurine as an adjunct for early left ventricular recovery in peripartum cardiomyopathy
    


Intervention name(s): Taurine Solution; Normal Saline
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Taurine Solution; Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Levetiracetam (Keppra) on Alcohol Consumption
Condition: Alcohol Abuse; Drug Abuse
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional

Summary: 
      The overall goals of this study are to (1) expand knowledge about interactions of
      levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in
      moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to
      measure postural control (which has been used as a marker of intoxication) and the effects of
      levetiracetam on postural control.
    

Detailed description: 
      The investigators propose a 42-day, double-blind, placebo-controlled crossover study in light
      to moderate and heavy alcohol users who are social drinkers.

      The specific aims are to:

        1. Determine if levetiracetam alters daily alcohol consumption by comparing the mean drinks
           consumed per day during levetiracetam administration compared with the mean drinks per
           day consumed during placebo administration.

        2. Obtain blood that will be banked for future genetic analysis of polymorphisms in genes
           that may predict the level of response to alcohol or effects of levetiracetam on alcohol
           consumption.

        3. Test whether the AccuswayTM platform can detect changes in body sway in light to
           moderate or heavy social drinkers and in subjects taking levetiracetam versus placebo.
    

Intervention name(s): Levetiracetam (Keppra); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Group A: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days.
Group B: Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: keppra; levetiracetam; alcoholism; genetics; subjective report
Hemodynamic Monitoring With Mixed Venous Saturation
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      In this study the investigators aim to evaluate the utility of a continuous mixed venous
      saturation monitoring compared to a clinical examination in a group of critically ill
      patients.
    

Detailed description: 
      We will compare possible difference in terms of sensibility and specificity regarding the
      continuous mixed venous saturation monitoring compared to clinical examination in a group of
      critically ill patients.
    

Intervention name(s): Mixed venous saturation monitoring
Intervention type(s): Procedure
Intervention description(s): Mixed venous saturation monitoring
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critically ill patients with a central venous catheter
      
Keywords: Hemodynamic monitoring; Mixed venous saturation; Critically ill patients
Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      Regenerative medicine-based approaches for caries treatment focus on biomimetic
      remineralization of initial carious lesions as a minimally invasive therapy using
      Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white
      spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling
      Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish
      (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.
    


Intervention name(s): Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR; Fluoride varnish (DURAFLOR
Intervention type(s): Other; Other
Intervention description(s): The WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR; A very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture
Intervention MeSH terms: Listerine; Fluorides; Fluorides, Topical; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Symfony Toric Intraocular Lens Visual Outcomes
Condition: Cataract Bilateral; Astigmatism Bilateral
MeSH terms: Cataract; Astigmatism
Study type: Interventional

Summary: 
      In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott
      Medical Optics) helping to improve the sharpness of vision at near, intermediate and far
      distances reducing the need of glasses after cataract surgery. It is available in both a
      non-toric version and a toric version for patients with astigmatism. The difference between
      this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal
      IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points;
      therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was
      compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better
      intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near
      vision (Symfony patients were able to read two additional, progressively smaller lines
      compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a
      MIOL is the visual performance at near.B One option to deal with this potential shortcoming
      is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred
      to as nano-vision or mini mono-vision.
    


Intervention name(s): Presbyopia and astigmatism correcting intraocular lens
Intervention type(s): Device
Intervention description(s): The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
fMRI Guided TMS Enhancement of Associative Memory Networks
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility and
      explore the neurophysiologic and clinical effects of repetitive transcranial magnetic
      stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of a
      control group will be used to see whether epilepsy patients, who suffer from a higher degree
      of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can benefit
      from a TMS intervention can benefit as much as a healthy matched population. Investigators
      will also be looking at functional connectivity between the hippocampus and cortical regions
    


Intervention name(s): MagStim RapidStim2
Intervention type(s): Diagnostic Test
Intervention description(s): Repetitive transcranial magnetic stimulation (TMS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: cognitive dysfunction; memory loss; non-invasive transcranial magnetic stimulation (TMS); rTMS; Magstim Rapid2
Feasibility and Validity of A Novel Computer Based Battery of Assessments in the Elderly
Condition: Computerized Assessment Feasibility and Validity
Study type: Observational

Summary: 
      While standard pencil-and-paper test have continued to be useful for the monitoring of
      cognition, mood, and life space (LS) in the elderly they do have considerable limitations.
      Use of these pencil-and-paper tests requires that individuals come to the clinic for
      assessments, which results in significant clinical costs and practical limitations in the
      conducting of assessments in large numbers of individuals, and provides a time consuming and
      non-automated means of quantifying and recording changes in brain function. It is
      increasingly recognized that there is a need to develop valid and reliable computer based
      assessments to allow for the remote assessment of cognition, mood, and other parameters.
      Development of computerized based assessments will significantly increase the scale, scope,
      and speed with which cognition and mood can be measured in the elderly.

      Helping Hands Technology LLC (HHT) has developed a number of web based assessments of
      cognition, mood, and LS. These new computerized assessments will be developed using new
      technology, and are based on the general principles found in existing pencil-and-paper based
      assessments of cognition, mood, and LS. In addition, HHT is developing proprietary means of
      reporting the results of the computerized assessments in an easy to use narrative format.
      This study will focus on quantifying the feasibility and validity of using HHT computerized
      assessments.
    

Detailed description: 
      See Brief Summary Section.
    

Intervention name(s): HHT-G; HHT-D; Geriatric Depression Scale (DGS); MMSE
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Helping Hands Technology global cognitive function assessment; Helping Hands Technology depression assessment; Geriatric Depression Scale (DGS); Mini Mental State Exam
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will undergo screening to confirm eligibility, completion of initial screening
        form, and MMSE evaluation. Study subjects were enrolled with MMSE scores between 29-30,
        inclusive (healthy/control), 25-28, inclusive (mild cognitive impairment), and 10-24
        (dementia).
      
Keywords: computerized assessments; mood; cognition
Investigating Consumers Perception and Acceptance of Whey Beverages
Condition: Individual Difference; Food Sensitivity; Food Preferences
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Brief Summary: This study aims to investigate whether protein fortification of beverages
      causes mouthdrying and mucoadhesion and whether this is influenced by saliva flow.
    

Detailed description: 
      To investigate whether whey protein beverages causes mouthdrying and reduces acceptability
      compared with a control beverage (whey permeate beverage) and to determine whether
      manipulating salivary flow rates influences mouthdrying.

      To determine whether mucoadhesion is a probable cause of mouthdrying.
    

Intervention name(s): Liquid Model
Intervention type(s): Behavioral
Intervention description(s): To study the perception of whey beverages using sensory methods (rating drying as well as discrimination tests "which is the stronger in drying")
Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein and whey permeate beverages.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study involves both a crossover design where each participant tastes both the control product and the protein fortified product with an appropriate break between the two sessions. The study will be conducted single blind as it not feasible to blind the researcher. Each participant will attend 2 study visits and all foods will be presented with random blinding codes.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Mouthdrying; Saliva Flow; Mucoadhesion; Oral Nutritional Supplements
Implementing Fit Kit Colorectal Cancer (CRC) Screening in High Risk Populations
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to understand best strategies for engaging high risk populations
      in a primary care setting to improved adherence to colorectal cancer screening guidelines.
      The results will be used to identify best practices that are scalable to other high-risk
      populations who are due or overdue for colorectal cancer (CRC) screening.
    

Detailed description: 
      This is a prospective implementation science study that will test 4 different approaches to
      increase colorectal cancer screening in a local primary care setting that provides services
      to individuals who are under-resourced. The interventions will include reminders from primary
      care providers with and without additional information and/or services to help complete
      colorectal cancer screening. A review of electronic medical records will be used to identify
      baseline information assessing risk factors and personal and family CRC history. For arm 3 of
      the study, participants may elect to enroll in our existing health navigation program. If so,
      additional baseline information will be collected, including information on Social
      Determinants of Health (SDOH). For arm 4 of the study, a questionnaire will be used to assess
      knowledge about colorectal cancer screening. The questionnaire will be repeated after the
      intervention (informational video). For all arms of the study, the primary outcome
      (engagement on CRC screening, receipt of CRC screening, results of CRC screening) will be
      collected through EPIC.
    

Intervention name(s): CRC screening reminder; CRC Reminder & Short message; CRC Reminder and Navigation Program; CRC Reminder & CRC education
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening; Participants randomized to the CRC Reminder & short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening; Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance; Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Health Screening
Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase
      their vitamin D2 content are actually a good source of vitamin D when consumed daily with a
      meal (lunch). The mushrooms will be provided cooked along with a meal which will be a
      standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in
      vitamin D status affects the immune system by decreasing it's level of activation, which may
      be abnormally elevated in vitamin D deficiency.
    

Detailed description: 
      Volunteers will be asked to consume a standard meal (lunch) containing one serving of
      mushrooms daily for six weeks (7 days per week). With the meal, they will also need to take
      one capsule. The capsule will be either a placebo or will contain vitamin D. The purpose of
      the vitamin D in the capsule is to determine if the vitamin D from the mushrooms is absorbed
      as well as vitamin D from a capsule. The total dose of vitamin D that volunteers will receive
      each day from mushrooms and capsule together will always be the same and will be one of three
      doses: (1) little or no vitamin D (placebo); (2) 400 IU, which is near the current
      recommended intake and (3) 1,000 IU, which is up to five-fold higher than the current
      recommended intake, depending on your age. Both levels of vitamin D are safe. In addition to
      consuming the meals and taking the capsules, up to 20 mL (4 teaspoons) of blood will be drawn
      at three times during the study just before the mushroom-containing lunch is provided: (1) at
      the beginning of the study before the first meal; (3) after three weeks; (3) at the end of
      the study. The purpose of the blood draw is to measure vitamin D in your blood and to measure
      the level of activation of your immune system by measuring markers of immune activation.
    

Intervention name(s): 1,000 IU vitamin D2; placebo capsule; mushrooms; UVB-treated mushrooms, 400 IU vitamin D2; UVB-treated mushrooms, 1,000 IU vitamin D2
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other; Other
Intervention description(s): capsule containing 1,000 IU vitamin D2; 0 IU vitamin D2; untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA; UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA; UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D
Pilot Study of Probiotics in Pre-diabetic Adolescents
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity; Prediabetic State
Study type: Interventional

Summary: 
      This study evaluates the feasibility and effect of probiotics on glycemic control in obese
      adolescents.
    

Detailed description: 
      Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2
      diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic
      dysfunction and prevent/delay development of T2D. The investigators will test probiotics to
      improve insulin sensitivity and preserve beta cell function in obese children.

      The probiotic strains are known to improve glycemic control.
    

Intervention name(s): Vivomixx; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 900 billion of the following probiotic strains: L. acidophilus DSM24735; L. plantarum DSM24730; L. paracasei DSM24733; L. delbrueckii supsp. bulgaricus DSM24734, S. thermophilus DSM24731, B. longum DSM24736, B. breve DSM24732, and B. infantis DSM24737) maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive); maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560)
Condition: Inflammatory Bowel Disease; Crohn's Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      This observational study will evaluate the social cost and quality of life of participants
      who have had Crohn's Disease for at least 6 months and have active disease despite drug
      therapy. Participants are followed for a total of 18 months.
    

Detailed description: 
      Participants for this study will be enrolled from 25 gastroenterology sites, even spread
      across Italy. Each center will enroll between 10 and 40 participants each.
    

Intervention name(s): Observational Studies: participants treated according to the real clinical practice.
Intervention type(s): Other
Intervention description(s): No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
Other intervention name(s): Crohn's Disease Participants
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Crohn's Disease for at least 6 months who have active disease despite drug
        therapy and are seen at one of 25 gastroenterology centers spread across Italy.
      
Keywords: EuroQOL (EQ-5D)
Misoprostol for Second Trimester Termination of Pregnancy
Condition: Abortion, Induced
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3
      hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable
      pregnancy
    


Intervention name(s): Vaginal misoprostol; Buccal misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): 400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.; 400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
Other intervention name(s): Cytotec; Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: misoprostol; Labor, Induced; Pregnancy Trimester, Second; Abortion, Induced