bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
Condition: Hyperlipidemia; Endothelial Dysfunction
MeSH terms: Hyperlipidemias
Study type: Observational

Summary: 
      Some nutraceuticals are often advised for their lipid lowering effects. Although many
      clinical trials have been conducted to assess their efficacy many doubts remain whether they
      could be considered an effective alternative to statins therapy.

      The aim of this study was to evaluate the lipid lowering effects and the improvement of
      endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product
      (Armolipid Plus)
    


Intervention name(s): Mixture of Berberine, Policosanol, Red Yeast, Placebo
Intervention type(s): Dietary Supplement
Intervention description(s): A tablet one a day for 6 weeks
Other intervention name(s): Armolipid Plus
Intervention MeSH terms: Policosanol
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        males and females aged between 18 and 70 with hypercholesterolemya
The Influence of Dietary Variety and Course Sequence on Fruit Intake in Preschool-Aged Children
Condition: Caloric Intake
Study type: Interventional

Summary: 
      The purpose of this study is to determine the extent to which manipulation of dietary variety
      and course sequence affects fruit intake and overall energy intake in preschool-aged
      children.
    

Detailed description: 
      In the past two decades overweight and obesity rates in children (ages 2-19) have risen from
      5% to 17%, with toddlers (ages 2-5) at 10%. Among children and adolescents the consumption of
      low-energy-dense foods, such as fruit and vegetables (F&Vs), remain below current
      recommendations. Therefore, strategies to increase low-energy-dense F&V intake and decrease
      high-energy-dense food intake aimed at young children are essential. Antecedents, or cues,
      can trigger eating. Therefore, manipulating food presentation can be utilized to produce
      certain behaviors. Dietary variety and course sequence are two examples of this relationship.
      It has been well established that high dietary variety leads to greater consumption patterns
      compared to low DV diets in adults. High DV has only been tested with problematic foods, and
      not with the goal of increasing F&V intake. Additionally, serving a first course meal can act
      as a preload to decrease intake of the second course entrée. Dietary variety and course
      sequence manipulations have been experimentally tested with caloric intake goals but never
      with the goal of increasing F&V intake. Therefore, the purpose of this study is to determine
      the extent to which manipulation of dietary variety and course sequence affects fruit intake
      and overall energy intake in preschool-aged children.
    

Intervention name(s): Variety; Non-Variety
Intervention type(s): Behavioral; Behavioral
Intervention description(s): These conditions will have snack served with an increase of fruit variety.; These conditions will receive a snack without a variety of fruit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dietary variety; course sequence; preschool; child feeding
A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug
      interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two
      drugs are administered in combination in healthy participants.
    


Intervention name(s): IDX320; IDX184; IDX184 placebo; IDX320 placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IDX320 400 mg in tablets (8x50 mg) administered orally once daily; IDX184 100 mg in capsules (2x50 mg) administered orally once daily; IDX184 matching placebo in capsules administered orally once daily; IDX320 matching placebo in tablets administered orally once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HCV; Hepatitis C
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in
      participants with Atopic Dermatitis.
    


Intervention name(s): ruxolitinib cream
Intervention type(s): Drug
Intervention description(s): ruxolitinib cream 1.5% will be applied twice daily as a thin film
Other intervention name(s): INCB018424
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ruxolitinib; Itch; Chronic Pruritus
Inulin-type Fructans-rich Vegetables, Obesity, Gut Microbiota
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study was to evaluate the effect of a diet based on ITF-rich vegetables in
      combination with purified ITF supplementation on weight management, metabolic alteration and
      gut microbiota composition. Obese patients were treated for 3 months and several parameters
      were measured before and after the study period.
    


Intervention name(s): Inulin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patient receive inulin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of inulin-rich vegetables; Patient receive maltodextrin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of vegetables poor in inulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Shape Up! Kids Study
Condition: Healthy
Study type: Observational

Summary: 
      Identify the unique associations of body shape to body composition and bone density indices
      in a pediatric population that represents the variance of sex, age, BMI-Z, and ethnicity
      found in the US population.

      Describe the precision and accuracy of optical scans to monitor change in body composition,
      bone density and metabolic health interventions.

      Estimate the level of association of optical to common health indicators including metabolic
      risk factors (glucose, triglycerides, HDL-cholesterol, blood pressure, VAT, WC and strength)
      by gender, race, age, and BMI-Z.

      Investigate holistic, high-resolution descriptors of 3D body shape as direct predictors of
      body composition and metabolic risk using statistical shape models and Latent Class Analysis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigator will recruit a stratified sample of 720 participants, approximately 360
        from each site, using the following equally-weighed stratifications: sex, age (5-10, 11-14,
        15-17 years), BMI-Z score (less than -2, -2 to 1, 1 to 2, and greater than 2) and ethnicity
        (White, Black, Mexican-American, Asian and Native Hawaiian or Other Pacific Islander).

        Within this sample, the investigator will include up to 36 participants with very low and
        high BMI by special recruitments from the facilities. The remainder of the participants
        will be recruited as a sample of convenience using local advertisements around the
        specified facilities.
Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow
Condition: Headache Disorders
MeSH terms: Headache Disorders; Headache
Study type: Interventional

Summary: 
      Studying Carbon monoxide effects on brain vessels in healthy volunteers with magnetic
      resonance imaging.
    

Detailed description: 
      In this study we will systematically investigate the headache-releasing properties of carbon
      monoxide as well as measure the effect of carbon monoxide on mean blood flow rate in the
      brain's large vessel with magnetic resonance imaging. These studies are important for
      understanding and further investigating the carbon monoxide's headache-releasing effect in
      healthy subjects.
    

Intervention name(s): Carbon monoxide
Intervention type(s): Other
Intervention description(s): Carbon monoxide inhalation
Intervention MeSH terms: Carbon Monoxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Pain Due to Peripheral Intravenous Catheter Insertion
Condition: Pain
Study type: Interventional

Summary: 
      This study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in
      reducing pain associated with peripheral intravenous catheters (PIVCs) insertion.

      Study Hypothesis:

      H0-1. The application of rose oil aromatherapy during the PIVC insertion procedure does not
      reduce the pain associated with the procedure.

      H0-2. During the PIVC insertion procedure, the patient's family holding the patient's hand
      does not reduce the pain associated with the procedure.
    


Intervention name(s): rose oil aromatherapy
Intervention type(s): Other
Intervention description(s): Aromatherapy refers to the medicinal or therapeutic use of essential oils absorbed through the skin or the olfactory system. The positive effects of social support, such as hand-holding, on anxiety and pain have been described
Other intervention name(s): handholding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess and describe the pain
      in relation to subcutaneous (under the skin) injection of different combinations of injection
      speed and volume with respect to acceptance of the injection pain and backflow.
    


Intervention name(s): 19 injections; sodium chloride 0.9% solution
Intervention type(s): Other; Drug
Intervention description(s): Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).; Solution for injection.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effect of a family and interdisciplinary approach
      on individual and family insulin resistance and insulin secretion in patients with
      prediabetes.
    

Detailed description: 
      This a randomized clinical trial designed to evaluate the efficacy of the following
      treatments:

        1. Family and interdisciplinary approach that includes nutritional, physical activity and
           psychological counseling + metformin 850mg twice at day for 12 months

        2. Individual approach that includes nutritional and physical activity counseling +
           metformin 850mg twice at day for 12 months

      To improve individual and family insulin resistance and insulin secretion in patients with
      prediabetes.

      Patients will have a follow-up visit every month in the Metabolic Research Laboratory at the
      University of Guanajuato, Mexico, and will have a fasting measurement of lipids, glucose and
      insulin every 3 months, as well as 2h oral glucose tolerance test (OGTT) at basal, 6 and 12
      months.
    

Intervention name(s): Family and interdisciplinary approach; individual approach
Intervention type(s): Other; Other
Intervention description(s): Family and interdisciplinary approach that includes:
nutritional counseling,
physical activity counseling,
psychological counseling,
metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.; individual approach that includes:
nutritional and physical activity counseling in individual appointments,
metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the feasibility and efficacy of using the
      demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients
      with high risk myelodysplastic syndrome (MDS).
    

Detailed description: 
      The study drug, 5-azacytidine, is given daily intravenously for 7 days. After every 2 cycles
      study participants will have a bone marrow test to evaluate the effect of the 5-azacytidine
      on the Myelodysplastic Syndrome (MDS). Participants continue to get cycles of 5-Azacytidine
      until 2 bone marrow tests show the MDS has stopped responding to the treatment. At that time
      they will undergo a transplant if a donor is available.
    

Intervention name(s): 5-azacytidine
Intervention type(s): Drug
Intervention description(s): The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously or intravenously, daily for 7 days.
Other intervention name(s): Mylosar; Vidaza; 5-AC; 5-AZC; U-18496
Intervention MeSH terms: Azacitidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myelodysplastic Syndrome; 5-azacytidine; allogeneic stem cell transplantation
Relationship Between Gastroesophageal Reflux Disease and Dental Erosion
Condition: Gastroesophageal Reflux Disease; Tooth Wear
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Tooth Wear; Tooth Erosion
Study type: Observational

Summary: 
      This study aimed to investigate the relationship between gastroesophageal reflux disease
      (GERD) and dental erosion and the alterations in oral tissues. This was a case-control study.
      The GERD group consisted of 50 individuals with endoscopic esophagitis who had
      gastroesophageal reflux symptoms, and the control group consisted of 50 healthy individuals.
      The prevalence of teeth wear and caries was evaluated using the Smith and Knight tooth wear
      index (TWI) and the decayed, missing, and filled teeth index (DMFT), respectively.
      Inflammatory mouth sensitivity, tongue sensitivity, nonspecific itching and burning,
      halitosis, dry mouth, teeth sensitivity, and the erythema of the soft and hard palatal mucosa
      and uvula were also evaluated. Stimulated saliva samples were collected, and the salivary
      flow rate, pH, and buffering capacity values were measured.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This case-control study was conducted in Ankara University Faculty of Dentistry, Department
        of Restorative Dentistry Polyclinics and Ankara University Faculty of Medicine, Department
        of Gastroenterology Polyclinics with a total of 100 participants (49 females and 51 males
        between the ages of 16-65) of whom 50 were in the GERD group, and 50 were in the control
        group. Among the patients who were admitted to the clinics, those with a diagnosis of GERD
        were included in the patient group and those without GERD were included in the control
        group. Ethical approval of the study protocol was granted by the Ankara University Faculty
        of Dentistry Research Ethics Committee (No:131/2 Date:10.06.2008).
      
Keywords: Dental erosion; DMFT; Gastroesophageal Reflux Disease; Saliva
Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)
Condition: Measles; Mumps; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of
      age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as
      immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates
      to measles, mumps and rubella at 42 days following the vaccination.

      AND/OR

      To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of
      age using separate injection sites, a single dose of VARIVAX® administered by IM route is as
      immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate
      to varicella at 42 days following the vaccination

      Secondary objectives:

        -  To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days
           following the vaccination in children immunised with M-M-R™II and VARIVAX® administered
           concomitantly at two separate injection sites by the same route IM or SC,

        -  To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at
           two separate injection sites by the same route IM or SC.
    


Intervention name(s): M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Prevention of : Measles, Mumps, Rubella and Varicella diseases
Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Twelve health organizations from around the US were selected to participate in a chart review
      Hypertension and Diabetes Initiative with the goal of improving blood pressure control in
      persons with diabetes.

      Hypothesis:

      A three-phase quality improvement initiative facilitated and monitored through the
      International Diabetes Center (IDC) will result in improved population-mean systolic blood
      pressure in the aggregate data pool of patients from all 12 participating sites at
      geographically distinct health systems.
    

Detailed description: 
      Phase 1 - Preparation: Each participating site begins to organize itself for the project.
      Baseline data will be collected and will be used to benchmark where each site is relative to
      blood pressure control/management of persons with diabetes prior to the implementation of the
      training programs.

      Phase 2 - Implementation: Sites begin to address the gaps they have identified that affect
      blood pressure outcomes of patients with diabetes. IDC provides two on-site training programs
      for providers and support staff.

      Phase 3 - Follow-up: IDC provides on-going support to each site via individual and
      collaborative conference calls and resources on the project Web site. Patient and visit data
      (audit form) will be collected six and 12 months after training. This data will be compared
      to the site's pre-training data.
    

Intervention name(s): quality improvement
Intervention type(s): Other
Intervention description(s): 3-phase quality improvement intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Keywords: hypertension; diabetes; quality improvement; blood pressure