bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this research is to determine what supplemental doses of vitamin D may be
      necessary to raise serum levels to optimal levels and how vitamin D supplementation and
      changes in vitamin D status impact cardiovascular risk factors in schoolchildren.
    

Detailed description: 
      Research suggests that vitamin D, known mainly for its role in bone health, may have other
      roles in the body and that vitamin D deficiency may contribute to certain chronic diseases,
      such as cardiovascular disease. Recently, vitamin D has received growing attention due to the
      increased awareness of possible deficiencies among certain populations at risk of vitamin D
      deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural
      sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D
      intakes should be increased to 600 IU/day for children ages 1-18. However, even with these
      recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL.
      Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of
      Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain
      an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are
      already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as
      living at a northern latitude, having high obesity rates, and where a large proportion of the
      population are Latino or African American; and 2) whether serum concentrations of 25(OH)D
      over 30 ng/mL in children prevent health risks.
    

Intervention name(s): Vitamin D3; Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects are told to take vitamin D daily for 6 months.; Subjects are asked to take vitamin D orally, daily for six months.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Blood lipids
Glycemic Monitoring in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes
      recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2
      diabetes. Increasing evidence supports treating early glucose abnormalities in cystic
      fibrosis patients to target CF specific outcomes, including lung function and nutrition
      (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in
      the 'prediabetic' state are unclear. A more accurate characterization of blood sugar
      variability in youth with and without CF will help the investigators better interpret
      continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and
      more accurately identify those individuals at greatest risk for disease progression.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and Adolescents ages 6-25, without diabetes. Out of 160 people, 45 will be healthy
        controls, 45 with Cystic Fibrosis (normal glucose tolerance), and 70 with Cystic
        Fibrosis-related diabetes or pre-diabetes.
      
Biospecimen description: 
      Alternative markers of glycemia, including fructosamine, glycated albumin, and
      1,5-anhydroglucitol, Oral Glucose Tolerance Test (OGTT) derived markers of insulin secretion
      and insulin sensitivity
    
Keywords: Cystic Fibrosis; Healthy Controls; Diabetes; Cystic Fibrosis Related Diabetes (CFRD); CFRD
The Leeds Women's Wellbeing (LWW) Study
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this parallel design study is to assess the relative effects of two 12-week
      healthy eating dietary interventions: general healthy eating (Diet A) and general healthy
      eating combined with advice to increase fibre intake (Diet B) to at least 25g/day (with a
      large proportion of the fibre intake derived from cereal or wheat bran), in overweight
      low-fibre consuming premenopausal female adults on body weight change (kg). It is
      hypothesized that adding fibre to a healthy eating diet (Diet B) would lead to greater weight
      loss and/or weight loss maintenance than following a healthy eating diet alone (Diet A).
    

Detailed description: 
      In this randomised, single blind, parallel design study participants were randomly assigned
      to one of two 12-week healthy eating dietary interventions: Diet A: general healthy eating OR
      Diet B: general healthy eating combined with advice to increase fibre intake to at least
      25g/day (with a large proportion of the fibre intake derived from cereal or wheat bran.
    

Intervention name(s): Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day
Intervention type(s): Other
Intervention description(s): Participants were randomly assigned to one of two parallel arms:
Diet A:healthy eating without extra advice to increase fibre intake or Diet B: healthy eating with extra advice to increase fibre intake to a minimum of 25g/d. Healthy eating advice was based on the British Heart Foundation booklet: "Food Should Be Fun And Healthy". Participants following Diet A were encouraged to eat breakfast cereals and were provided with complementary cereals and snacks low in fibre. Participants following Diet B were encouraged to eat high fibre breakfast cereals and to incorporate wheat bran fibre in other meals. Complementary high fibre cereals and snacks were provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dietary intervention; dietary fibre; weight loss; weight maintenance
Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe
      hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing
      elective surgical or other invasive procedures.
    


Intervention name(s): PEGylated Recombinant factor VIII (rFVIII)
Intervention type(s): Biological
Intervention description(s): Lyophilized powder and solvent for solution for injection
Other intervention name(s): BAX 855; ADYNOVATE
Intervention MeSH terms: Factor VIII; BAX 855
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)
Condition: Type 2 Diabetes Mellitus; Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 10-week study is to compare the reduction in cholesterol following
      treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and
      hypercholesterolemia.
    


Intervention name(s): MK0653A, ezetimibe (+) simvastatin; Duration of Treatment: 4 wk placebo run in then 6 wk active; Comparator: atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Krill Oil as Supplementation to Healthy Young Adults.
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change
      the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the
      total fatty acids) in the membrane in red blood cells. We investigate this at two different
      doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil
      intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid
      composition, as well as product tolerance in healthy, young individuals.
    


Intervention name(s): Krill oil low dose; Krill oil high dose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 capsules krill oil per day; 9 capsules krill oil per day
Other intervention name(s): Rimfrost Sublime krill oil; Rimfrost Sublime krill oil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: krill oil; omega-3 index; plasma lipid profile; tolerance; young adults
Effect of Smartphone Addiction on Manual Coordination, Strength and Hand Pain in Normal Teenage Students
Condition: Smart Phone Addiction, Manual Coordination, Hand Grip Strength, Pinch Strength, Teenage Students
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Observational

Summary: 
      Statement of the problem:

      • Does addiction of smart phone affect upper limb coordination, manual dexterity, hand grip
      and pinch strength?

      Null Hypotheses:

      • Addiction of smart phone does not affect upper limb coordination, manual dexterity, hand
      grip and pinch strength in normal teenage students.
    

Detailed description: 
      Subjects:

      The survey targets the normal teenage students from both sexes. Sample size estimation will
      be carried out to determine the recruited number of students, selected randomly from both
      governmental and private preparatory and secondary schools at Ashmoon educational
      administration, Menofia Governorate to participate in this study.

      Study design:

      Cross sectional observational study. Sample design will be a cluster sample,

      A. Inclusion criteria:

        1. The students' age will range from 12 to 18 years.

        2. Normal students including both boys and girls.

        3. Participants have a range score from 31 to 60 points for boys and from 33 to 60 points
           for girls on smartphone addiction scale according to Kwon et al (2013).

        4. Their body mass index will be within the normal range according to WHO indices .

        5. Cooperative students who wish to participate in the current study.

        6. The students will represent different socioeconomic levels.

      B. Exclusion criteria:

      The students will be excluded from the study if they have one of the following:

        1. Congenital abnormalities or medical conditions, which may affect the study.

        2. Musculoskeletal problems such as previous or recent orthopedic surgery, fractures,
           prostheses, inflammation of the fingers, arms, or shoulder.

        3. Visual or hearing defects.

        4. Motor, behavioral, or neurologic disorders and learning disabilities. • Participants
           have a range score from 31 to 60 points for boys and from 33 to 60 points for girls on
           smartphone addiction scale, then participants will be divided into 2 levels of
           addiction.

      Assessment of manual dexterity and upper extremity coordination will be carried out by using
      The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Bruininks and
      Bruininks, 2005). Hand grip strength and pinch strength will be assessed by hand dynamometer
      and pinch meter.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        community sample
CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to compare the safety, efficacy, and tolerability of two
      different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for
      the treatment of the signs and symptoms of Dry Eye Disease (DED).
    

Detailed description: 
      This phase 2 study explored the safety, efficacy and tolerability of two CyclASol
      concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked
      vehicle control arm, an open-label comparator arm consisting of Restasis was included.

      The study explored a range of signs and symptoms of DED to gain an understanding of the
      possible treatment effects in comparison to vehicle and estimation of effect sizes. In line
      with current treatment guidelines, the proposed phase 2 population consisted of patients
      suffering from moderate to severe DED.

      The primary treatment comparisons in this study were between the two CyclASol concentrations
      versus vehicle for the sign variable total corneal fluorescein staining and the symptom
      variable dryness severity visual analogue scale at day 113. All other comparisons between
      treatments groups were considered secondary analyses.
    

Intervention name(s): Cyclosporine A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topical ocular, eye drops; topical ocular, eye drops
Other intervention name(s): Ciclosporin, CsA; Excipient
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Olmesartan Medoxomil in Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Cardiovascular Disease; Kidney Disease
MeSH terms: Kidney Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study in diabetic patients with at least one additional cardiovascular risk factor
      and normoalbuminuria prior to randomization.
    


Intervention name(s): Olmesartan medoxomil; Placebo Tablets
Intervention type(s): Drug; Drug
Intervention description(s): tablets; Tablets
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Microalbuminuria
Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment
Condition: Polycystic Ovary Syndrome; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of Time restricted eating in patients
      diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.
    

Detailed description: 
      After being informed about the study and potential risks, all patients were given a written
      informed consent. Patients were recruited through social media and digital questionnaires, to
      make sure they met the criteria. There was a semi aleatory distribution of the patients into
      three different groups, one group underwent time restricted eating with no hormonal treatment
      (TRE group), the second group received hormonal treatment combined with time restricted
      eating (combined group) and the last group received only hormonal treatment (HT). PCOS was
      diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood
      samples and self reported menstrual cycle.

      Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal
      status, including insulin and glucose.

      Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin
      resistance, as well as metabolic disfunction.

      After data collection, statistical analyses was done to determine the effect of the different
      approaches.
    

Intervention name(s): Time restricted eating
Intervention type(s): Behavioral
Intervention description(s): Only eating windows were determined to an 6 hour period, starting at 12:00hrs and ending at 18:00hrs. After that, patients in group 1 and 2 were indicated not to consume any calories. The composition of their diet was not modified, it was assessed by performing a 24-hour recall to make sure there were no significant changes in diet composition throughout the study.
Other intervention name(s): time restricted eating with hormonal treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: group 1: time restricted eating with NO hormonal treatment group 2: time restricted eating with hormonal treatment group 3: hormonal treatment with NO time restricted eating
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of Testosterone on Experimental Pain Perception
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This trial examined how the administration of exogenous testosterone would influence pain
      tolerance and other endogenous steroids (i.e. estradiol and progesterone).
    


Intervention name(s): Testosterone; Placebo Syrup
Intervention type(s): Drug; Other
Intervention description(s): Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.; Oil-based sublingual product.
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: testosterone; pain tolerance; estradiol; progesterone
Immunogenicity, Safety, and Tolerability of an MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus
Condition: H1N1 Influenza Virus; Chronic Pulmonary Disease; Chronic Heart Disease; Diabetes Mellitus
MeSH terms: Influenza, Human; Lung Diseases; Heart Diseases; Diabetes Mellitus; Chronic Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, randomized, controlled, open label study with two vaccine regimens. The
      study will assess the relative safety and immunogenicity of vaccine regimens comparing
      adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine
      in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and
      to compare safety and immunogenicity data with a contemporaneously enrolled control group of
      age-comparable, healthy subjects.

      Because certain individuals may be hypo-responsive to influenza vaccination, additional
      studies with high-risk groups are warranted in order to determine the optimal vaccine
      formulation and dosing schedule for prevention of novel H1N1 virus infection.
    


Intervention name(s): Focetria®; Fluad®; Begrivac®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 7.5 ug of HA antigen; adjuvanted; monovalent; 15 ug of HA antigen; adjuvanted; trivalent; 15 ug of antigen; non-adjuvanted; trivalent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H1N1; Pulmonary Disease; Heart Disease; Diabetes; Influenza; immunogenicity; safety; tolerability
Exercise Habit & MPAC
Condition: Public Health
Study type: Interventional

Summary: 
      The limitations of applying social cognitive models to understand physical activity (PA) have
      led to the emergence of several new PA models within the past decade. The Multi-Process
      Action Control (M-PAC) is a comprehensive PA model that proposes intention is established
      from outcome expectations, perceived capability, and opportunity, then the success of
      translating this to behavior depends on affective judgments and behavioral-regulation. Over
      time, M-PAC proposes that behavior is can become maintained through the formation of identity
      and habit. The purpose of this study was to investigate the trajectory of change of these
      M-PAC constructs across time in a randomized controlled trial. Participants (n=85) were
      inactive new gym members and were randomized into a control (n=41) or intervention (n=44)
      group. The intervention group attended a workshop and received a booster phone call follow-up
      at week four. Measures for both groups included accelerometry and M-PAC at baseline and eight
      week follow-up.
    


Intervention name(s): Facilitating an Exercise Habit and Identity via the Multi-Process Action Control Model- A Randomized-Controlled Trial
Intervention type(s): Behavioral
Intervention description(s): Participants attended a workshop which consisted of a presentation and an exercise planning exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of this study is to measure the effectiveness of topical gentamicin to prevent
      post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is,
      if it is effective as a prophylactic agent, to compare it's effect with intra venous single
      dose cefazolin sodium prophylaxis.
    

Detailed description: 
      This study is a single blind prospective randomized trial. To measure and compare the
      effectiveness intra-operative topical gentamicin application in tension-free inguinal hernia
      repair in contrast to intravenous peri-operative prophylactic cefazolin sodium and
      combination of gentamicin and cephazolin this study is designed.

      The patients are grouped randomly in to two groups:

        -  Group1;intravenous cefazolin sodium

        -  Group2;topical gentamicin

        -  Group3:topical gentamicin and intravenous cefazolin sodium

      As a control group we decided to use the data of control groups ( without any prophylactic
      agent usage ) of previous studies done in our clinic and medical data base reviews.
    

Intervention name(s): Gentamicin and cefazolin; Cefazolin; Gentamicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation; 1000 mg cefazolin application intravenously 1 hour before operation; 80 mg gentamicin application intraoperatively
Other intervention name(s): Drug: Cefazolin; Other names:; Cezol; Eqizolin; Drug: Gentamicin; Gensif; Gentamed; Cezal; Eqizolin; Gensif; Gentamed
Intervention MeSH terms: Gentamicins; Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: inguinal hernia; infection prophylaxis; topical gentamicin