bioihbjkbjnl/mcl2 huggingface dataset:
Early Dieting in Girls: a Longitudinal Cohort Study
Condition: Eating Behavior; Dietary Habits; Weight, Body
MeSH terms: Body Weight
Study type: Observational

Summary: 
      This longitudinal observational cohort followed the growth and development of non-Hispanic
      white girls from age 5 to 15 years, with a focus on the development of the controls of food
      intake.
    

Detailed description: 
      This longitudinal observational cohort followed the growth and development of non-Hispanic
      white girls from age 5 to 15 years, with a focus on the development of the controls of food
      intake. Data was collected biennially from girls and their mothers and fathers. Measures
      included anthropometrics, questionnaires and laboratory measures of eating behavior, dietary
      recalls, psychosocial characteristics, and parenting measures.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Families in central Pennsylvania with a 5-6 year old daughter.
Effects of Energy Density and Portion Size of Milk in Preschool Children
Condition: Feeding Behaviors
Study type: Interventional

Summary: 
      In this study, the investigators varied both the energy density and portion size of milk
      served with a meal commonly consumed by preschool children. The milk used in this study is
      commercially available and reflects typical variations in energy density. The primary aim of
      the study is to investigate the independent and combined effects of milk energy density and
      portion size on preschool children's intake of the milk and the simultaneously served meal.
      The effect of milk energy density and portion size on children's total energy intake at the
      meal will also be evaluated.
    


Intervention name(s): Low energy density; High energy density; Small portion; Large portion
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Low energy density milk served; High energy density milk served; Small portion of milk served; Large portion of milk served
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Treatment of Iron Deficiency Anemia With Pregnancy
Condition: Iron Deficiency Anemia of Pregnancy
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Iron deficiency anemia is a very common problem accompanying pregnancy. in this study, the
      investigators are going to compare the efficacy and tolerability of two preparations of oral
      iron in treatment of iron deficiency anemia with pregnancy.
    

Detailed description: 
      In this study, the investigators are going to compare two preparations of oral iron in
      treatment of iron deficiency anemia with pregnancy. a total of 300 pregnant women will be
      randomly divided into two equal groups (each containing 150 pregnant woman). one group will
      receive amino acid chelated iron and the other group will receive iron salt (ferrous
      fumarate). All pregnant women attending the obstetrics outpatient clinic of kasr al aini
      hospital at 14-18 weeks gestation will be submitted to complete blood picture and serum
      ferritin. those who prove to have iron deficiency anemia (hemoglobin less than 11g/dl and
      serum ferritin less than 12ug/l) will be included in the study. All eligible women will be
      followed up at 22-23, 29-30 and 36-37 weeks' gestation for the change in hemoglobin level and
      ferritin level. all women will be also enquired about different side effects during treatment
      period.
    

Intervention name(s): amino acid chelated iron; iron salt (ferrous fumarate)
Intervention type(s): Drug; Drug
Intervention description(s): the drug will be given to pregnant women 14-18 weeks' gestation who prove to have iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily. for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.; this drug will be given to pregnant women 14-18 weeks' gestation with iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily, and for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
Other intervention name(s): ferrotron capsules; hemoton capsules
Intervention MeSH terms: Iron; Ferrous fumarate; Iron Chelating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amino acid chelated iron; iron salt; iron deficiency anemia
The Treatment of Depression With Botulinum Type A Toxin
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      A 24-week Randomized, Double-blind study treating people who suffer from depression who also
      have moderate to severe frown lines in forehead region with Botox injections. Subjects
      participating will have their photos taken and complete a questionnaire regarding their
      depression. They will see a psychiatrist at every visit who will assess their depression.
    

Detailed description: 
      Participants will be assigned to receive either placebo or botulinum toxin injections in the
      forehead
    

Intervention name(s): botulinum toxin type A neurotoxin complex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 29-40 U injection; 29-40 U 0.9% NaCl injection
Other intervention name(s): Botox, botulinum toxin type A (BTA); botulinum toxin type A neurotoxin complex matched injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: botox; depression
Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
Condition: Primary Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency; Addison Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement
      dose in conditions of physical or psychological stress to prevent life threatening adrenal
      crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g.
      gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone
      dose is crucial. The study is conducted to offer patients the possibility to perform
      hydrocortisone self administration in emergency situations in a way of administration which
      is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of
      subcutaneous hydrocortisone administration will be studied and compared to intramuscular
      administration.
    


Intervention name(s): Hydrocortisone intramuscular first; Hydrocortisone subcutaneously first
Intervention type(s): Drug; Drug
Intervention description(s): Hydrocortisone intramuscular first; Hydrocortisone subcutaneously first
Other intervention name(s): 100 mg hydrocortisone (Pfizer®) in 2 ml solvent; 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adrenal insufficiency; Addison's disease
Assessing a Wearable Digital Therapy for Youth With ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare three different investigational wearable
      digital interventions to determine if they are helpful for improving symptoms and functioning
      in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
    

Detailed description: 
      The study is a randomized controlled trial of three investigational wearable digital
      therapies. An online screening questionnaire will evaluate eligibility for the study. Parents
      and teachers will complete baseline measures, after which the child will wear the assigned
      device to school Monday-Friday for a four-week period. Parents and teachers will complete the
      measures again at the end of the four-week intervention period. Compliance with wearing the
      device will be monitored remotely.
    

Intervention name(s): FRx-001; FRx-003; FRx-004
Intervention type(s): Device; Device; Device
Intervention description(s): Wearable digital therapy; Wearable digital therapy; Wearable digital therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers
Condition: Nausea and Vomiting, Chemotherapy-Induced
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test
      the extent of the GW679769 affect on Warfarin levels in humans.
    


Intervention name(s): Casopitant (GW679769) oral tablets; Warfarin oral tablets
Intervention type(s): Drug; Drug
Intervention description(s): Casopitant will be available in the dose strength of 20,30 or 50 mg; Warfarin will be available in the dose strength of 5 mg
Other intervention name(s): Casopitant (GW679769) oral tablets
Intervention MeSH terms: Casopitant; Warfarin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: healthy human volunteer; GW679769; warfarin; casopitant
enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars
Condition: Acne Scars - Mixed Atrophic and Hypertrophic
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      The purpose of this pivotal investigation is to evaluate the efficacy and safety of the
      Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser
      and an investigational micro-lens array (MLA) handpiece attachment for improvement of acne
      scars.
    

Detailed description: 
      This is an open-label, prospective, multicenter, pivotal study in up to 45 male or female
      subjects, age 18 to 65 years who desire laser treatment for the improvement of acne scars.
      Subjects will receive up to 6 laser treatments, spaced 6 weeks (± 2 weeks) apart with the
      Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects will be
      contacted by phone 7 days (± 2 days) after their first treatment for follow-up. Subjects will
      return to the site after all study treatments have been delivered for two follow-up visits: 6
      and 12 weeks (± 2 weeks) following their final study treatment.

        1. The Primary Efficacy Endpoint as the correct identification of the 12 weeks post final
           treatment photographs from the baseline by at least two of the three blinded reviewers
           in 75% of the patients and an improvement of one point in the ASAS.

        2. The Secondary Efficacy Endpoints as the:

             -  Efficacy of the Cutera enlighten laser with the Micro-Lens Array handpiece
                attachment treatment as assessed by the investigator starting from the 2nd
                treatment onward, and

             -  Subject satisfaction levels as assessed from the subject questionnaire completed at
                the final follow-up visit 12 weeks post final treatment.

        3. The Safety Endpoint as the safety of the Cutera enlighten laser with Micro-Lens Array
           handpiece attachment as assessed by the frequency and severity of device related adverse
           events,

        4. The Exploratory Analysis as the Efficacy of the Cutera enlighten laser with a Micro-Lens
           Array handpiece attachment for the improvement of skin quality as assessed by the
           investigator and/or blinded evaluators 12-weeks-post final study treatment.
    

Intervention name(s): other
Intervention type(s): Device
Intervention description(s): no arm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage
      colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2)
      postoperatively in patients with high-risk renal cell carcinoma (RCC).
    

Detailed description: 
      Patients with high-risk RCC have a dismal prognosis. To date, no effective adjuvant therapy
      exists for this patients category. We suggest that combination of granulocyte-macrophage
      colony-stimulating factor (GM-CSF), interferon alpha (IFN) and interleukin-2 (IL-2) stimulate
      immune system from dendritic cells till cytotoxic T-lymphocytes step by step and eliminate
      residuary tumor cells.

      This prospective, non-randomized, phase II trial assessed low-dose GM-CSF, IFN and IL-2
      postoperatively in patients with high-risk renal cell carcinoma.
    

Intervention name(s): GM-CSF, IFN alpha and IL-2
Intervention type(s): Drug
Intervention description(s): Treatment during 6 months: GM-CSF, 1 mcg/kg, 3 times per week, subcutaneously, first week of each month; IFN, 10 MIU, 3 times per week, subcutaneously, second week, and IL-2, 1 MIU, 3 tiw, intravenously, third week. Fourth week of each month was free from treatment.
Intervention MeSH terms: Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Cancer; Renal cell carcinoma; High risk; Adjuvant therapy
Role of Leukotriene Receptor Antagonists in Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The adjunctive use of Leukotriene Receptor Antagonist (Montelukast) along with scaling and
      root planing in patients with chronic periodontitis leads to host inflammatory response
      modulation and decrease in serum C reactive protein (CRP) levels. If proven this will open
      new vistas in treatment of chronic periodontitis.
    

Detailed description: 
      A RCT was carried out to check the efficacy of Montelukast as an adjunct to scaling and root
      planing. The patients were randomised to either test group (SRP + Montelukast) and control
      group (SRP). Clinical parameters were assessed at baseline, 3 weeks and 6 weeks. Serum
      C-reactive protein levels were assessed at baseline, 3 weeks and 6 weeks.
    

Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in Montelukast Group were treated with scaling and root planing (SRP) along with Montelukast (Montair 10mg), 1 tablet twice daily for 3 weeks.; Patients in Placebo Group were treated with scaling and root planing (SRP) along with Placebo therapy, 1 tablet twice daily for 3 weeks.
Other intervention name(s): Montair 10 mg (brand name); Leukotriene receptor antagonist.
Intervention MeSH terms: Montelukast; Leukotriene Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Leukotriene receptor antagonist; Chronic periodontitis; Scaling and root planing; C- reactive protein
Multifactor Risk Reduction for Optimal Management of PAD
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      Patients with peripheral arterial disease (PAD) experience significant functional limitations
      due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality
      resulting from untreated cardiovascular disease (CVD) risk factors and aggressive
      atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine
      the synergistic effect of a multifactor risk reduction on walking distance, blood flow and
      quality of life in 300 patients with PAD.

      Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple
      risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T)
      Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as
      assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial
      function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We
      will also explore the association between FMVD and decreased oxidative stress (as measured by
      oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of
      nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide,
      plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic
      GMP).

      Secondary hypotheses examine the association between reducing CVD risk factors, improved
      endothelial function, increased walking distance, improved quality of life and number of
      metabolic syndrome abnormalities in PAD patients.

      Significance. This study will contribute to evidence on the efficacy of multiple risk factor
      reduction on improving physical function and quality of life in the understudied, elderly PAD
      patient. This study will also provide preliminary evidence for the biological basis for the
      efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of
      its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the
      progression of atherosclerosis.
    

Detailed description: 
      closed to recruitment
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): tailored multifactor CVD risk reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Home-based exercise
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: peripheral arterial disease; walking time; lifestyle modification; cardiovascular risk reduction; exercise; diet; claudication
Effects of an Exercise Program on Bone Density
Condition: Bone Density; Body Composition
Study type: Interventional

Summary: 
      Physical inactivity and low adherence to the Mediterranean diet cause alterations in body
      composition, which increases the risk factors for cardiovascular and metabolic diseases. In
      addition, exercise in different surfaces or water could affect the bone density specially in
      women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic
      exercise program in different surfaces on the body composition and bone density of women
      within at work, and to evaluate the quality of the Mediterranean diet and distribution of
      macronutrients in the studied population. Material & Methods: Randomized controlled trial. 63
      women from a randomized work environment (IG, n=34) and a control group (CG, n=29)
      participated in a short-term aerobic exercise programmed (12 weeks), for body composition and
      bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the
      Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for
      macronutrient distribution were used.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Aerobic exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-exudative Age-related Macular Degeneration
Condition: Non-exudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy
Study type: Observational

Summary: 
      Age-related macular degeneration (AMD) is the most prevalent cause of vision loss in
      developed countries and is often discussed in terms of the "dry" and the "wet" forms. The
      "wet" form of AMD is the more advanced form of the disease and is responsible for 80% of the
      legal blindness in AMD. Treatment options include a promising class of biologics called
      anti-vascular endothelial growth factors, as well as photodynamic therapy and laser surgery.
      These therapies can slow further vision loss, but cannot achieve recovery of lost vision. The
      "wet" form of AMD is always preceded by the "dry" form. Therefore, it is reasonable to expect
      that the early detection and treatment of the "dry" form may help reduce vision loss or
      progression to the more damaging "wet" form. Unfortunately, symptoms appear only in advanced
      stages of the "dry" form. As light sensitive cells in the macula breakdown in a process
      called geographic atrophy, the patient may notice blurred central vision.

      OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal
      and choroidal tissue structure in real time. It is analogous to ultrasound B-mode imaging,
      except that OCT measures the intensity of reflected light rather than acoustical waves.

      This study aims is to use OCT technology to compare how the retinal anatomy and blood flow
      differ within three severity groupings of non-exudative age-related macular degeneration
      (NEAMD).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals between the ages of 60 and 85 years of age presenting to the Retina Service
        within the Department of Ophthalmology at the Casey Eye Institute of Oregon Health &
        Science University with signs and symptoms of non-exudative AMD.
      
Keywords: Dry AMD; Age-related macular degeneration; Optical coherenece tomography; Imaging; Blood flow
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to evaluate the effect of several daily doses of
      ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single
      dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and
      tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole
      causes GSK189075 to stay in your bloodstream for a longer period of time. It will also
      examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.
    


Intervention name(s): ketoconazole; GSK189075
Intervention type(s): Drug; Drug
Other intervention name(s): ketoconazole
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ketoconazole,; drug interaction,; pharmacokinetics; T2DM,