bioihbjkbjnl/mcl2 huggingface dataset:
Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
Condition: Fatigue; Musculoskeletal Pain; Cognitive Decline
MeSH terms: Musculoskeletal Pain; Fatigue; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the use of adjunctive pregnenolone for the following:

        1. fatigue that has limited usual activity,

        2. musculoskeletal pain involving 2 or more regions of the body and,

        3. cognitive symptoms (memory, concentration, or attentional difficulties by self-report)
           in Veterans deployed to the Gulf War theatre of operations between 1990 and 1991.
    


Intervention name(s): Pregnenolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days; Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregnenolone; Gulf War Veteran; Fatigue; Musculoskeletal Pain; Cognitive Decline; Placebo Control
Far-infrared Ray Effect on CV12 Acupoint
Condition: Reaction of Far Infrared Ray; Reaction of Skin Temperature
Study type: Interventional

Summary: 
      The purpose of the present study was to investigate the effect of far-infrared ray at CV12
      acupoints area on the skin temperature and skin blood flow of palm central area of right
      hand, and the correlation between them.
    

Detailed description: 
      The purpose of the present study was to investigate the effect of far-infrared ray at CV12
      acupoints area (the center is CV12 acupoints and the diameter is 10 cm) on the skin
      temperature and skin blood flow of palm central area of right hand, and the correlation
      between them.
    

Intervention name(s): far-infrared ray
Intervention type(s): Procedure
Intervention description(s): The duration of far-infrared ray is 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy and Safety of Bicifadine in the Treatment of Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this placebo-controlled clinical trial are to evaluate the
      analgesic efficacy and safety of bicifadine at three oral dose levels compared with placebo
      in patients with moderate to severe chronic low back pain.

      The secondary objectives are to investigate the dose-response relationship of three dose
      levels of bicifadine, to evaluate the clinical meaningfulness of bicifadine efficacy, to
      evaluate the effect of bicifadine on function and general quality of life, to describe the
      population pharmacokinetics of bicifadine in patients with chronic low back pain, and to
      evaluate safety following discontinuation of bicifadine treatment.
    


Intervention name(s): Bicifadine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bicifadine; chronic low back pain
Intensive Computerized Brain Training (ICBT) in Youth With Early Onset Psychosis (EOP)
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether an intensive computerized intervention
      targeted on improving central auditory and visual processing and executive functioning can be
      implemented in youths aged 10-19 with psychotic spectrum disorders, what developmental
      modifications are needed particularly for the younger participants, and whether it is
      possible to develop an appropriate, blinded control intervention.
    

Detailed description: 
      The purpose of this study is to provide a foundation for future rigorous study of an
      intervention that translates what we know about refinement of synaptic connections in
      response to environmental stimuli to an individualized intervention that directly improves
      neurocognitive functioning in youths with early onset psychosis(EOP). We will conduct a pilot
      randomized control study that determines the feasibility, tolerability and acceptability of
      Intensive Computerized Brain Training (ICBT) in youth with EOP.

      Participants: Seventy youths, aged 10 years to 19 years inclusive will be assessed in the
      study. Forty youths with EOP will be randomly assigned to ICBT or an equally intense
      computerized game activity and 20 will be age, gender and race matched youths with no major
      psychiatric illnesses. We will allow for up to 5 EOP screen failures and up to 5 healthy
      control screen failures.

      Procedures (methods): The forty participants with EOP will be randomly assigned to treatment
      with ICBT or equally intense video game play that also involves attention to sensory stimuli
      and requires increasingly skilled responses. A computer generated randomization schedule will
      be used to make assignments. Outcomes will be assessed at baseline, completion of the
      intervention (typically week 20), 3 after completing the intervention (typically month 8) and
      7 months after completing the intervention(typically month 12). The other 20 youths, who
      comprise the typically developing comparison group known as healthy controls, will not
      participate in the computer activity or regular monthly psychiatric visits and will not
      complete satisfaction questionnaires. Up to 10 subjects may not be eligible to participate in
      the study.
    

Intervention name(s): ICBT Program
Intervention type(s): Other
Intervention description(s): Intensive Computerized Brain Training.
Other intervention name(s): Posit Science
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early Onset Psychosis; Laptop Computer; Brain Training
Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The Product is a machine learning software, that utilizes AI to provide real-time guidance to
      acquire diagnostic-quality ultrasound views of the heart.
    

Detailed description: 
      Participants are healthcare professionals, who are not performing echocardiography on a
      routine basis. Participants attend a short training session to learn the software, then have
      a memory-decay period, followed by an individual simulated-use scanning session, lasting up
      to 60 minutes with a Moderator at the heart institute.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        28-34 study participants will be recruited to meet at least one of the following
        professions:

          -  Attending Physicians and/or Medical Residents

          -  Registered Nurses (RNs), Nurse Practitioners (NPs) and Physician Assistants (PAs)

          -  Medical assistants (CMAs)
A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of the study drug known as LY3090106
      in healthy participants and in participants with RA who are having an inadequate response to
      methotrexate (MTX). The study will investigate how the body processes the study drug and how
      the study drug affects the body. The study will last about 3 months for each participant.
    


Intervention name(s): LY3090106 - SQ; LY3090106 - IV; Placebo - SQ
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered SQ.; Administered IV.; Administered SQ.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Lifestyle Therapy for Youth With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased
      physical activity and dietary changes) for the management of glycemia and cardiometabolic
      risk factors in children and adolescents with type 2 diabetes (T2DM).

      Our hypothesis is that education regarding healthy lifestyle changes will significantly
      reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary
      hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions
      in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL
      cholesterol, serum triglycerides and apolipoprotein B.
    

Detailed description: 
      Youth between the ages of 10-20 years living with type 2 diabetes and not currently on
      insulin therapy will be randomly assigned to either a lifestyle intervention group or a
      control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to
      take part in healthy living education sessions involving physical activity, healthy cooking,
      healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning
      and end of the 16 weeks the investigators will measure the participants' blood sugars,
      height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also
      take a picture of their kidney, heart and blood vessels using ultrasound. Those youth
      assigned to the control group will receive the 16 week intervention following their 16 week
      control period.
    

Intervention name(s): Lifestyle Counselling
Intervention type(s): Behavioral
Intervention description(s): Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Type 2 Diabetes; Peer mentorship
Exercise Intolerance in Renal Failure
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with chronic kidney disease have profound exercise intolerance which contributes to
      an increased risk of cardiovascular disease. The investigators have found that chronic kidney
      disease patients have an exaggerated increase in blood pressure during certain forms of
      exercise that could certainly contribute to exercise dysfunction as well as cardiovascular
      risk. The investigators will test the mechanisms underlying this exaggerated blood pressure
      response, as well as the potential benefits of short-term tetrahydrobiopterin (BH4) with
      folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney
      disease. The investigators will test whether short-term treatment with tetrahydrobiopterin
      (BH4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular
      health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.
    


Intervention name(s): Tetrahydrobiopterin; Placebo; Folate
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Tetrahydrobiopterin (BH4) 200 mg PO BID for 12 weeks; 2 placebo pills PO BID for12 weeks; Folate 1 mg daily for 12 weeks
Other intervention name(s): Kuvan; Folic Acid
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Community Agriculture Nutritional Enterprises (CANE) Meal Program
Condition: Diet, Healthy; Life Style, Healthy
Study type: Interventional

Summary: 
      Previous adult participants of the Tanglewood to Table walking program will be recruited to
      enroll in the CANE Meal Program. This program will encourage participants to pick up a
      healthy meal from the CANE Kitchen each week for five weeks. The meal will consist of at
      least one serving of fruit or vegetables. At each meal, educational materials will be
      distributed, including the recipe for healthy meals and nutrition handouts that are linked to
      the recipes. Additional information about the ways the nutrients in the meal may help protect
      from the negative effects of environmental pollutants will be included. Surveys, blood
      pressure, height, weight, waist circumference and carotenoid status will be assessed before
      and after the program.
    


Intervention name(s): CANE Meal Program
Intervention type(s): Behavioral
Intervention description(s): Participants will be encouraged to pick up a healthy meal from the Community Agriculture Nutritional Experience (CANE) Kitchen in Whitesburg, Kentucky once a week for five weeks. The meals will consist of at least one serving of a fruit or a vegetable. At each meal, education materials will be distributed, including the recipe for the healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fruits; vegetables; exercise; community; education
Normal Values for 3D High Resolution Anorectal Manometry in Children
Condition: Children; Anorectal Disorder
MeSH terms: Rectal Diseases
Study type: Interventional

Summary: 
      Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry
      equipment and has been recently introduced into clinical practice. It is the most precise
      method to assess the anal sphincter pressure function and may be crucial for planning and
      controlling surgical procedures of the anorectal area. Normal values in pediatric population
      have not been established.

      The aim of this study is complex evaluation of anorectal function in children without
      symptoms from lower GI tract and establishment of normal values.
    


Intervention name(s): 3D high resolution anorectal manometry
Intervention type(s): Device
Intervention description(s): Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Oral Health of Individuals Who Attended a Mother-child Dental Care Program - Longitudinal Study
Condition: Health Behavior
Study type: Observational

Summary: 
      The aim of this longitudinal study was to assess the oral health of individuals attending a
      mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the
      control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the
      individuals who attended the PPPWB had better oral health status than the control group. When
      the two phases of the study were compared, it was noted that the individuals in the second
      phase had better oral health, although they had a higher score for gingival bleeding.
    

Detailed description: 
      The aim of this longitudinal study was to assess the oral health of individuals attending a
      mother-child dental care program (PPPWB). Letters were sent to the 343 children who were
      examined in phase 1. One hundred and thirty nine individuals returned for the oral
      examination - experimental group (40.5%). The control group consisted of 139 individuals who
      did not receive dental care from the PPPWB. These individuals were paired to the experimental
      group according to their age and socio-demographic characteristics. Gingival bleeding (GBI)
      and DMFT indices were used in order to determine the children's oral health status. The mean
      DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74,
      respectively. It was concluded that the individuals who attended the PPPWB had better oral
      health status than the control group. When the two phases of the study were compared, it was
      noted that the individuals in the second phase had better oral health, although they had a
      higher score for gingival bleeding.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Letters were sent to 343 of the examined children, inviting the guardians to take their
        children for an oral health assessment at the children's dental clinic at UFPI. The number
        of children that returned for an examination was 139, and these individuals comprised the
        experimental group.

        Control Group After assessing the characteristics of the experimental group, the control
        group was determined and consisted of 139 individuals (93 females and 46 males) who were
        paired to the experimental group according to their socio-demographic characteristics and
        age but who had not attended the PPPWB.

        The study hypothesis is that individuals who attended the PPPWB have better oral health
        than those who did not attend it.
      
Keywords: Dental caries; Epidemiology; Gingivitis; Oral health
Quality of Life in a Representative Swedish Population
Condition: Quality of Life
Study type: Observational

Summary: 
      Cohort descriptive study of quality of life and body functions in a reference population of
      Swedish inhabitants from age 30 to age 89. The population was selected to be representative
      for the general Swedish population and 500 in each 10 year group, 250 men and 250 women.

      The population is contacted and asked for informed consent, whereafter a questionnaire of
      about 200 questions, used in a number of studies in clinical studies and trials, are sent
      out.

      The results will be used as reference values to our patient cohorts
    

Detailed description: 
      Individuals contacted by letter with information about the study and it's aim. The next step
      is a telephone contact from the study secretariate where the person can ask for more detailed
      information and put questions to the reserach nurse. The call leads up to a question to the
      person, if the questionnaire can be sent. If yes, the questionnaire is posted includeing the
      consent form and an pre-paid return envelope. After two weeks a thank you/reminder letter is
      sent out, and if no reply one more phone call is made two weeks further on.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Swedish cohort aged 30-89, representatvie for entire Swedish population age 30 -89
      
Keywords: health related quality of life
Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the
      lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses
      administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the
      non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines.
      The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by
      demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across
      three production lots.
    


Intervention name(s): Liquid Rotavirus Vaccine
Intervention type(s): Biological
Intervention description(s): Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine
Other intervention name(s): ROTASIIL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liquid rotavirus vaccine; LBRV-PV; Gastroenteritis; Diarrhoea
Pharmacogenetic Study of Different Hormone Therapies in Recent Menopause Women
Condition: Postmenopause
Study type: Interventional

Summary: 
      This is cross-over, randomized clinical trial, with objective to evaluate the effects of
      low-dose oral hormone therapy and non-oral hormone therapy on endothelial function markers
      (fibrinogen, von Willebrand factor, c-reactive protein), natriuretic peptide and on
      anthropometric, metabolic and hormonal variables in early and healthy postmenopausal women
      and analyzing polymorphisms in the estrogen receptor gene and FTO polymorphisms

      Patients will be randomized to receive oral hormone treatment or non-oral hormone treatment

      The investigators hypothesis is that a different genotypes in the receptor estrogen gene and
      FTO may have an influences on treatment response in metabolic markers and cardiovascular risk
    


Intervention name(s): Estradiol and Progesterone; Estradiol and Drospirenone
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg/day intranasal estradiol daily or 1,5 mg/day transdermal estradiol and 200 mg/day vaginal micronized progesterone for 14 days/month; oral estradiol 1mg and drospirenone 2 mg/day
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment