bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Epicatechin-rich Cocoa on Collagen Synthesis
Condition: Collagen Synthesis
Study type: Interventional

Summary: 
      This study will investigate the effects of dietary supplementation of epicatechin-rich cocoa
      in humans on collagen synthesis and power-based performance outcomes (rate of force
      development).
    

Detailed description: 
      The investigators have recently completed a study looking at the expression of the collagens
      following consumption of increasing doses of epicatechin in rats . This data clearly shows
      that increasing doses of epicatechin, either 0.5 mg.kg-1 delivered once, twice, or three
      times a day, or 2 mg.kg-1 once a day, results in increasing expression of the fibrillar
      collagens (I, III, and V). This preliminary data suggests that epicatechin-rich chocolate
      supplementation can increase collagen expression in humans and that this may improve force
      transfer. From this background, the hypothesis proposed is that supplementation with
      epicatechin-rich chocolate will increase rate of force development and performance in
      athletes. Therefore, this simple nutrition intervention has the potential to simultaneously
      improve performance, decrease injuries and accelerate return to competition through improved
      collagen synthesis.
    

Intervention name(s): Epicatechin-rich cocoa dose response; Epicatechin-rich cocoa vs placebo on performance
Intervention type(s): Other; Other
Intervention description(s): Subjects consume randomized doses of 0, 1, 2, 3 mg epicatechin/kg from epicatechin-rich cocoa. The optimal dose of epicatechin-rich chocolate will be the dose which have the greatest increase PNIP levels.; An optimized dose of epicatechin-rich cocoa or placebo will be given for 3 weeks alongside a prescribed power-based training program. In a randomized parallel design the effect of the optimal dose of epicatechin-rich chocolate, compared to placebo, on maximal isometric squat force, RFD, and jump testing will be quantified.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Arm 1 of the project will employ a randomized single-blinded crossover design with subjects completing all 4 of the epicatechin-rich chocolate trials (0, 1, 2 and 3 mg.kg-1). Arm 2 will use a randomized parallel double-blind design with neither the subjects nor the investigators knowing who is on which treatment (optimized epicatechin-rich chocolate dose or Dutch processed/epicatechin depleted placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Pre-symptomatic Screening of Visual Acuity in Pre-school Students
Condition: Visual Acuity; Refractive Errors; Low Vision; Vision Disorders
MeSH terms: Vision, Low; Vision Disorders; Refractive Errors
Study type: Observational

Summary: 
      The present research process is a prospective, non-interventional clinical study that will be
      conducted -under the auspices of the Democritus University of Thrace (DUTH)- in the
      pre-school students of the city of Alexandroupolis, Greece.

        -  The study aims to assess the visual acuity of the kindergarten students.

        -  The measurement of monocular best-spectacle corrected visual acuity will be performed
           using a web-based visual acuity chart
    

Detailed description: 
      Study protocol will adhere to the tenets of the Declaration of Helsinki and written informed
      consent will be obtained by the legal guardians of all participants.

      The measurement of the visual acuity (monocular and binocular) will be performed using DDART,
      a digital visual acuity tool that has been developed and validated by the Democritus
      University of Thrace and is also an approved Category 1 Medical Device by the country's
      National Organization for Medicines, via a web-based digital chart in a high-resolution
      screen. The same environmental lighting conditions and the same screen brightness will be
      applied. The examination will be performed at the same predetermined viewing distance.

      Finally, according to each participant's visual acuity, appropriate instructions will be
      given for further examinations directly to the legal guardians in order to comply with the
      GDPR.
    

Intervention name(s): Diagnostic Test: Distance Visual Acuity Examination
Intervention type(s): Other
Intervention description(s): Best spectacle-corrected distance visual acuity and reading capacity of pre-school students in Alexandroupolis, Greece will be examined via a web-based digital visual acuity chart
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pre-school students aged 5-7 years old
      
Keywords: kindergarten; distance visual acuity; pre-school students; reading capacity
Feasibility Study of Family Teamwork Peer-Delivery
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to 1) convene African American and Latino Community Coalitions
      to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and
      Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators
      and barriers to parental involvement in diabetes management for African American and Latino
      parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and
      integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility,
      satisfaction, and preliminary outcomes of the FT-P program among African American and Latino
      parents of school-aged children (5-9 years) withT1D.

      A randomized pilot trials will be conducted with African American and Latino families to
      examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will
      be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard
      diabetes care or to standard diabetes care alone after completion of baseline assessment
      using a random numbers table generated by a program created through Baylor College of
      Medicine's Institute for Clinical Training and Research data management specialists.
    


Intervention name(s): Family Teamwork-Peer Delivery
Intervention type(s): Behavioral
Intervention description(s): Children with T1D and their parent will participate in 6 in-person FT-P group sessions during a 12-month period. Parents will also participate in monthly telephone support calls with a Parent Leader during the 12-month intervention period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Health disparities; Family teamwork; Peer-delivered intervention; Facilitators to diabetes management; Barriers to diabetes management; Community-based intervention
Effectiveness and Adherence to an Online Sleep Program
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This research will examine the effectiveness of a 6-week online sleep program (Go! To Sleep)
      which provides a set of various psycho-educational materials and behavioral techniques to
      reduce insomnia symptoms, improve sleep, and improve quality of life.
    


Intervention name(s): Go! to Sleep
Intervention type(s): Behavioral
Intervention description(s): The online program provides various tools for the delivery of the intervention including:
Daily articles
Daily activities to help get the sleep you need
Daily sleep improvement recommendations
Audio recorded relaxation exercises
Daily e-mails from your program coach
Personal progress charts
An online sleep log and daily sleep score
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Insomnia; Sleep; Stress; Online program; Web-based program; Cognitive Behavioral Therapy for Insomnia (CBT-i)
Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with
      diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent
      (furosemide) will decrease the urine protein, which is a sign of disease, more than an
      angiotensin converting enzyme inhibitor alone.
    


Intervention name(s): Addition of furosemide 20 mg oral bid to baseline regimen
Intervention type(s): Drug
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Progressive Goal Attainment Program for Veterans
Condition: Mental Disorders; Worries; Pain or Disability
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of the Progressive Goal Attainment
      Program (PGAP) in improving employment outcomes and community engagement among U.S. veterans
      with disabilities.
    

Detailed description: 
      Veterans with disabilities often have low self-esteem and motivation, significant depression
      and a belief that their disability precludes them from gainful employment. The Progressive
      Goal Attainment Program (PGAP) is specifically designed to target these psycho-social risk
      factors of disability. PGAP is a structured, 10-week intervention that focuses on helping
      clients develop a planned activity schedule to assist them in resuming desirable life
      activities, including employment. The PGAP for Veterans Project will test the feasibility of
      delivering PGAP to U.S. military veterans. The research will focus on the best means of
      service delivery, staffing needs and how to coordinate PGAP in a larger veteran service
      system. MDRC will also gather information on the target population, recruitment methods, the
      feasibility of scaling and replication, and employment outcomes among the sample. Two hundred
      veterans will be enrolled and randomly assigned into the study across two sites: Errera
      Community Care Center within (part of the VA Connecticut Health Care System) and the Michael
      DeBakey VA Medical Center in Houston, Texas.
    

Intervention name(s): Progressive Goal Attainment Program
Intervention type(s): Behavioral
Intervention description(s): The Progressive Goal Attainment Program (PGAP) is a behavioral intervention originally developed in Canada at McGill University in order to increase return to work and community integration for individuals who receive worker's compensation. PGAP is the first disability program that is specifically designed to target the psycho-social risk factors of disability. The premise behind PGAP is that inactivity and attitudinal barriers increase work disability, and these issues are a primary cause of unemployment for individuals with physical and mental disabilities. PGAP is a structured, 10-week intervention that focuses upon helping clients develop a planned activity schedule to assist them in resuming desirable life activities.
Other intervention name(s): PGAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Perceived Disability; Mental Wellness; Employment; Social Integration and Engagement; Goal Achievement
Can Short Latency Afferent Inhibition Give us Clues to Better DYT 1 Dystonia Treatments?
Condition: DYT-1; DYT1; DYT 1; Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Observational

Summary: 
      This is a research study using transcranial magnetic stimulation (TMS) to investigate
      interactions between the sensory system and the motor cortex in primary generalized dystonia
      (DYT1 dystonia) subjects who undergo deep brain stimulation (DBS) surgery.

      The sensory system is the body's sense organs - smell, sight, sound, etc. - and the motor
      cortex is the part of your brain where nerve impulses control voluntary muscle activity.
    

Detailed description: 
      The cause of DYT1 dystonia is not clear. DYT1 dystonia symptoms include abnormal posture or
      repetitive twisting movements affecting one body part; in some patients, the entire body can
      twist and contort painfully. Magnetic resonance imaging (MRI) studies are normally used to
      evaluate changes in brain structure in DYT1 dystonia. Transcranial magnetic stimulation (TMS)
      is a painless, non-invasive method to test how your brain conducts electrical messages to the
      rest of your body, including your muscles.

      If you are a DYT1 dystonia patient, then this study involves up to three visits. The first
      visit (before DBS surgery) will last about 4 hours and the second and third visits (after DBS
      surgery) will last about 4 hours as well. These visits will include a complete physical and
      neurological exam, video recorded dystonia and mood rating scales, followed by
      electromyography (EMG) and TMS sessions. Subjects who have already undergone DBS surgery may
      participate in applicable visits based on the length of time since their DBS surgery.

      If you are a control subject, this study involves one visit, about 4 hours long. This visit
      will include TMS and EMG sessions.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects scheduled to undergo pallidal deep brain stimulation surgery for DYT1 dystonia
        will be enrolled up to 12 months for this pilot trial. Genetic test results confirming DYT1
        gene mutation will be reviewed prior to consenting research subjects. Patients who are
        diagnosed with DYT1 dystonia and are candidates for DBS surgery will be indentified as
        candidates for the research study. Additionally, subjects who have already undergone DBS
        surgery will be identified as candidates.
      
Keywords: DYT-1; DYT1; DYT 1; dystonia; DBS; deep brain stimulation; TMS; transcranial magnetic stimulation
"A Clinical Study for Evaluating the Effect of a Plant Sterol-enriched Fermented Dairy Product on Blood Lipoprotein Profile in Japanese Adults"
Condition: Subjects With High LDL-Cholesterol
Study type: Interventional

Summary: 
      INVESTIGATE THE EFFECT OF A 12-WEEK CONSUMPTION PERIOD OF SINGLE DOSE A DAY OF A PLANT
      STEROLS-ENRICHED FERMENTED DAIRY PRODUCT ON BLOOD LIPOPROTEIN PROFILE IN JAPANESE ADULTS WITH
      HIGH LDL-C.
    


Intervention name(s): 1-Fermented Dairy Product with Phytosterols (test); 2-Fermented dairy Product with No Phytosterols (control)
Intervention type(s): Other; Other
Intervention description(s): 1- 1 bottle of test product/day; 2-1 bottle of control product/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Japanese Subjects, High LDL-C, fermented-dairy products, phytosterols
Phase 2a Study of MVA-BN-RSV Vaccination and RSV Challenge in Healthy Adults
Condition: RSV Infection
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety,
      Immunogenicity and Efficacy of the Recombinant MVA-BN®-RSV Vaccine against Respiratory
      Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants
    


Intervention name(s): MVA-mBN294B; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): MVA-BN-RSV (nominal titre 5 x10*8 Inf.U per 0.5 mL) as intramuscular injections. Liquid frozen suspension, single dose of 0.5ml.; TBS (Placebo) as intramuscular injections (0.5ml)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily
      compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet
      therapy or combination of diet and exercise therapy.
    


Intervention name(s): Anagliptin; Anagliptin; Placebo of Anagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Anagliptin 100mg, tablet, BID; Anagliptin 100mg, tablet, BID; Placebo of Anagliptin 100mg, tablet, BID
Intervention MeSH terms: Anagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CWP-0403; type 2 DM; Efficacy; Safety; Phase 3
Acute Effects of Static Stretching Intensity and Duration on Muscle Viscoelastic Properties and Proprioception
Condition: Static Stretching
Study type: Interventional

Summary: 
      The purpose of this study is to compare the acute effects of different duration and intensity
      of static stretching exercises on the viscoelastic properties of the hamstring muscle and the
      knee proprioception.
    

Detailed description: 
      Traditionally stretching exercises have been used by health professionals as a means of
      preventing injuries by increasing performance and increasing joint flexibility. Kubo et al.
      suggest that the potential mechanism of decreased risk of injury with increased flexibility
      is a change in the viscoelastic properties of the muscle-tendon unit. Muscle fibers and
      tendons contain proprioceptors. These receptors provide information about joint angle, muscle
      length and muscle tension. There are two stretch-related proprioceptors that transmit
      information to the central nervous system about muscle tension. These receptors are muscle
      spindles (respond to changes in the length) and golgi tendon organs (respond to changes in
      the tension). For this reason, interactions between muscle tension, muscle-tendon unit,
      viscoelasticity and proprioceptive tissue (muscle spindles and golgi tendon organ); it
      becomes important when you think about how stretching exercises affect proprioception,
      flexibility and increase or decrease of joint range of motion. In the literature, four
      stretching parameters have been defined as important to influence the potential for
      increasing or decreasing the flexibility of a joint: intensity, duration, frequency and
      stretching position. The focus of this study we plan on is the intensity and duration of
      stretching.

      Exercise warming exercises before sportive activity and cooling exercises afterwards are
      widely suggested and applied. Determining the relationship between stretch severity and
      duration and viscoelastic properties and proprioception will contribute to the effective
      creation of training programs.
    

Intervention name(s): Static Stretching Exercise
Intervention type(s): Other
Intervention description(s): Each intervention group received a different duration and intensity of static stretching exercise protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Static Stretching; Stiffness; Proprioception; Healthy adults
Impact of Mothers Touch Program to Improve Maternal Health After Birth
Condition: Post Partum Depression; Quality of Life
MeSH terms: Depression, Postpartum
Study type: Interventional

Summary: 
      After the child birth most women experience major health issues such as depression, severe
      fatigue, back pain, perineal pain, mastitis, urinary or faecal incontinence, sexual problems
      and relationship problems with partners. That all lead to poorer emotional and mental health
      and factors contributing isolation, exhaustion and physical health problems.

      'Sava Mahina (6-week period) is a traditional practice for postpartum women in India, which
      include special diet, lifestyle and supportive care. The current multicenter randomized
      controlled trial (RCT) aims to evaluate outcomes of Indian postpartum care on women.
    


Intervention name(s): Mothers Touch Program; Usual Care Program
Intervention type(s): Other; Other
Intervention description(s): Mothers Touch Program with bed rest, Relaxation program to reduce stress, massage for mother and infant, gently physical exercise and special dietary program each week.; Usual care group had advice, support and educational program delivered by midwife, or physicians.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To investigate the safety and tolerability of BI 1026706 in male and female healthy
           subjects and osteoarthritis (OA) patients following oral administration of repeated
           rising doses

        -  To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and
           female healthy subjects and OA patients

        -  The assessment of pharmacodynamics in OA patients
    


Intervention name(s): BI 1026706; Placebo to BI 1026706
Intervention type(s): Drug; Drug
Intervention description(s): Multiple Rising Doses (oral solution, tablet); Multiple Rising Doses (oral solution / tablet, identical to active treatment)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Pilot Study Testing the Efficacy of a Needling Device for the Treatment of Acne Scars
Condition: Acne Scars
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the efficacy of a needling device for
      treatment of acne scars.
    

Detailed description: 
      We are investigating a needled micro-roller for use in improving the appearance of acne
      scars. The study is being conducted under the direction of Dr. Murad Alam of Northwestern
      University, Department of Dermatology.

      The needles on the micro-roller are designed to create small holes in the top and mid layers
      of skin in order to induce the formation of more collagen, which would in turn help improve
      the appearance of acne scars. To qualify for the study, you must have at least 2 large areas
      of the face with acne scars.

      The study is designed such that one part of your face, which has acne scars, will be treated
      with the device on 3 separate occasions, spaced 2 weeks apart at our clinic in Chicago at
      Northwestern. We would also ask you to return at 3 months and at 6 months to have photographs
      taken.

      If you are interested in participating, we would like to get you involved as soon as possible
    

Intervention name(s): needling treatment
Intervention type(s): Procedure
Intervention description(s): Needling treatment applied to half of the face at each study visit
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment