bioihbjkbjnl/mcl2 huggingface dataset:
Promotion of Family Planning Methods Through an Interactive Platform Offered in Growth and Development Control Services
Condition: Women
Study type: Interventional

Summary: 
      Family planning and the use of contraceptive methods are of the main strategies to reduce
      maternal and perinatal morbidity and mortality, because they can prevent unplanned
      pregnancies, teenage pregnancies and abortions in dangerous conditions. It is also a tool
      that contributes to development as it improves children's health, improves access to early
      childhood education, empowers women and contributes to reducing poverty as it improves
      economic conditions.

      Currently the use of modern contraceptive methods has increased worldwide, in Latin America
      and the Caribbean the use of modern contraceptive methods has remained at 66.07% from 2008 to
      2015. However, the number of women who do not want to get pregnant and that do not use a
      contraceptive method is still high - 214 million women of childbearing age in developed
      countries.

      In our country according to the ENDES 2016 survey, the number of women who used a
      contraceptive method decreased by 0.7 percent compared to 2012, of which 54.3 percent used
      some modern contraceptive method and 21.9 percent some method traditional.

      The unmet demand for family planning in 2016 was 6.0%, affecting mainly women from the lowest
      poverty quintile (7.4%) and those living in rural areas (6.8%).

      Of the women who were surveyed and did not use a contraceptive method, 80.6% did not talk
      about family planning either at home or in a health facility in the last 12 months. Only
      16.3% of non-users were women who attended a health facility and received information on
      family planning.

      Through this study the investigators propose the design and evaluation of an interactive
      platform to promote modern contraceptive methods.
    

Detailed description: 
      Sample Size: Sample size of 176 participants (interventional group=88, control group=88), it
      is possible to detect minimum differences of 5% to 20%.

      Statistical analysis plan: The data collected will be entered into a database in Microsoft
      Excel, to be analyzed by the Epi Info statistical program. The qualitative variables will be
      analyzed by frequencies and percentages, the quantitative variables by relative risk.
    

Intervention name(s): Interactive Platform
Intervention type(s): Device
Intervention description(s): The participants will see the interactive platform.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Quasi - experimental study design.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: interactive platform; family planning; contraception
Effects of WBV Associated With IMT on Functionality
Condition: Frail Elderly Syndrome
Study type: Interventional

Summary: 
      The pre-frail elderly are a population more vulnerable to diminished functionality and future
      disabilities. Thus, interventions focused on the prevention of sarcopenia are indicated to
      prevent dysfunction in this population. This study aims to evaluate the effects of whole body
      vibration training associated with inspiratory muscle training on functional outcomes,
      balance and muscle metabolism in pre-frail elderly women.
    


Intervention name(s): WBV + IMT; WBV + IMTsham; WBVsham + IMTsham
Intervention type(s): Other; Other; Other
Intervention description(s): The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance.; The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance.; Whole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aging; functional capacity; muscle metabolism
Return To Sport Activities in Patients Surgically Treated For Flat Foot in Paeditric Age
Condition: Flat Feet; Surgery; Sports Physical Therapy
MeSH terms: Flatfoot
Study type: Observational [Patient Registry]

Summary: 
      The SURGERY of arthrosis of the subtalar joint, carried out between 9 and 12 years of age,
      the aim is to restore and maintain the physiological alignment between the talus and the
      calcaneus during bone maturation.

      There are few articles in the literature that talk about the return to sport of pediatric
      patients after surgery. The aim of the study is to review patients operated on remotely kick
      heel and describe how they return in their sports (resilience, type of activities carried
      out, recovery times). The aim of this study is to evaluate the clinical and functional
      results of patients of age Pediatric treated in the investigator's SC Orthopedics Pediatric
      Traumatology department for flat feet with "calcaneostop" surgery. The study aims to describe
      the method of resuming sports activities, analyzing the timing and difficulties declared by
      patients after surgery, with the help of specific questionnaires.
    


Intervention name(s): calcaneo-stop: arthrosis of the subtalar joint
Intervention type(s): Procedure
Intervention description(s): arthrosis of the subtalar joint with a screw in the talus bone to stop pathological pronation of the heel
Other intervention name(s): arthrosis of the subtalar joint
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The analysis will be performed on pediatric patients undergoing surgical treatment for
        correction of idiopathic flatfoot in the Orthopedics Pediatric department of the IRCCS
        Rizzoli Orthopedic Institute in the years 2016-2017.
Etanercept in New Onset Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators hypothesized that the administration of Etanercept to children newly
      diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study
      is to evaluate the feasibility and safety of Etanercept administration to pediatric patients
      recently diagnosed with type 1 DM.
    

Detailed description: 
      This is a double-blind randomized 24-week placebo-controlled feasibility and safety study.
      Subjects received study drug for a 24- week period, followed by 4 and 12-week wash out
      periods.
    

Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly; administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 1 diabetes, Etanercept, honeymoon period
Regulatory T Cells in Type 1 Diabetes Patients Treated With IL-2
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Type 1 diabetes is the most common severe chronic autoimmune disease worldwide and is caused
      by the autoimmune (loss of self tolerance) mediated destruction of the insulin producing
      pancreatic beta cells thus leading to insulin deficiency and development of hyperglycaemia.
      Currently, medical management of type 1 diabetes focuses on intensive insulin replacement
      therapy to limit complications (retinopathy, nephropathy, neuropathy); nevertheless clinical
      outcomes remain sub optimal. There are intensive efforts to design novel immunotherapies that
      can arrest the autoimmune process and thereby preserve residual insulin production leading to
      fewer complications and better clinical outcomes.

      The vast majority of genes that contribute to susceptibility to type 1 diabetes have been
      found to encode proteins involved in immune regulation and function. In particular, several
      susceptibility proteins are involved in the interleukin 2 (IL-2) pathway that regulates T
      cell activation and tolerance to self antigens. Aldesleukin is a human recombinant IL-2
      product produced by recombinant DNA technology using genetically engineered E. coli stain
      containing an analog of the human interleukin-2 gene. There is substantial nonclinical,
      preclinical and clinical data that ultra low dose IL-2 (aldesleukin) therapy can arrest the
      autoimmune mediated destruction of pancreatic beta cells by induction of functional T
      regulatory cells. However, prior to embarking on large proof of concept trials in type 1
      diabetes it is essential that the optimum dose of IL-2 (aldesleukin) is determined. The
      objective of this study is to establish in patients with type 1 diabetes the optimal dose of
      IL-2 (aldesleukin) to administer in order to increase T regulatory cell response.
    


Intervention name(s): Aldesleukin (Proleukin)
Intervention type(s): Drug
Intervention description(s): A single, subcutaneous dose will be given administered with the maximum dose allowed 1.5 X 106 IU/M2.
Intervention MeSH terms: Aldesleukin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Interleukin 2; Type 1 diabetes; T regulatory cells; Adaptive trial
Psychiatric Disorders in Children With Psychogenic Cough
Condition: Psychogenic Cough
MeSH terms: Cough; Mental Disorders; Problem Behavior
Study type: Observational

Summary: 
      The study aims to evaluate psychiatric disorders and clinical features of children with
      psychogenic cough. Psychiatric disorders are assessed via a semi-structured interview (Kiddie
      Schedule for Affective Disorders and Schizophrenia) and clinical features are investigated
      via sociodemographic form, which was developped by researchers. Investigator planned to
      compare psychiatric diagnoses, specifically anxiety and depression, with children referred to
      pediatric clinics.
    


Intervention name(s): Kiddie Schedule for Affective Disorders and Schizophrenia
Intervention type(s): Diagnostic Test
Intervention description(s): Both of the clinical and control group will be evaluated via Psychiatric semi-structured interview
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who were diagnosed as having psychogenic cough between 2015 and 2018 years. Age
        and gender matched control who don't have any chronical health problems.
      
Keywords: psychiatry, children, habit cough
Health Effects of Oat and Oat Bioactive in Human
Condition: Postprandial Glucose Regulation
Study type: Interventional

Summary: 
      Aim of the study is to investigate health effects of oats and oat derived components, in
      human intervention studies, with the purpose to build new knowledge for development of
      cardiometabolic protective foods
    

Detailed description: 
      The overall goal is to increase the knowledge which can be used for the development of food
      products with anti-diabetic properties, with the purpose to facilitate healthier food choices
      for people. More specifically the primary purpose of this project is to evaluate effects in
      healthy humans on cardiometabolic test markers of oat and oat based product. The new
      knowledge will form a base for the development of oat based food products with added health
      values.
    

Intervention name(s): Effects of Oat and Oat Components on Cardiometabolic risk variables
Intervention type(s): Combination Product
Intervention description(s): Oat and oat bioactive components consumed as breakfast meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The primary purpose of this study is to describe the tolerability of canagliflozin and any
      sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms
      of the percentage of patients with at least one episode of hypoglycaemia, in patients with
      T2DM who fast during Ramadan.
    

Detailed description: 
      This is non-randomized, parallel-cohort, prospective, multicenter (when more than one
      hospital works on a medical research study), observational study to describe the treatment of
      T2DM with canagliflozin during the Holy Month of Ramadan. Observed participants will be
      participants with T2DM (at the time of enrollment) who are being treated with either
      canagliflozin or any sulphonylurea, each administered on a background therapy of metformin
      with or without a DPP-4 inhibitor within clinical practice, and who intend to fast during the
      Ramadan period. On enrollment, patients will enter one of two parallel treatment cohorts
      based on their ongoing T2DM therapy: canagliflozin and metformin with or without a DPP-4
      inhibitor will be the treatment of interest, while any sulphonylurea and metformin with or
      without a DPP-4 inhibitor will serve as the reference standard treatment. Safety will be
      monitored throughout the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with a confirmed diagnosis of type 2 diabetes and has been treated with
        canagliflozin or any sulphonylurea, each on a background therapy of metformin with or
        without a DPP-4 inhibitor, will be enrolled in this study.
      
Keywords: Canagliflozin; Metformin; Diabetes Mellitus, Type 2; INVOKANA; Sulfonylurea
Postprandial Differences After Herring and Beef
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      While observational studies often find that diets rich in fish reduce the risk of disease,
      and that diets including a high intake of red meat are associated with increased risk of
      cardiovascular disease and cancer, the difference in health effects between red meat and fish
      are rarely researched in intervention studies.

      The investigators hypothesise that the post-prandial plasma response of lipids and markers of
      cardiovascular disease risk will be more favourable after intake of herring compared to beef.

      In addition, while pickling herring in a brine/sugar solution is a common form of
      preparation, little is known if there is a difference in potential health effects based on
      the preparation of herring. The investigators will compare baked and pickled herring to
      understand if preparation is potentially an important factor to be considered when looking at
      intake of fish and health.
    


Intervention name(s): Baked beef; Baked herring; Pickled herring
Intervention type(s): Other; Other; Other
Intervention description(s): A meal based on baked beef; A meal based on baked herring; A meal based on pickled herring
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Fish; Herring; Meat; Beef
Length of Adaptation and Threonine Requirement
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to determine if the body's needs for threonine (an amino acid which is an
      essential building block for protein) is different when assessed after 1, 3 or 6 days of
      adaptation to the level of threonine intake being studied.
    

Detailed description: 
      Our method, the Indicator Amino Acid Oxidation (IAAO) method has been used before to look at
      amino acid requirements. Over the years, we have changed our method to make our studies on
      amino acid requirements safer to use in specific vulnerable populations like babies or older
      adults. For example, we have shown that we only need to collect breath and urine samples
      instead of collecting blood.

      Another feature of our method is that we require subjects to consume personalized diets for 3
      days at a time, repeated for up to 7 times. These personalized diets are important as they
      allow us to study the amount of amino acids needed by the body. The body's metabolism changes
      with different intakes of amino acids. We measure this change in metabolism by collecting
      breath and urine samples on the 3rd day of each diet period. However, we do not know if this
      specific length of time for the personalized diets (i.e. 3 days) is sufficient or whether
      more time is needed for the body to adjust to the amount of amino acids provided. There is a
      possibility that 3 days is not enough time and our results (i.e. our estimates of amino acid
      needs) may be different if we allow more time.

      The purpose of this study is to find out if the threonine requirement determined using IAAO
      in adult men changes if the length of time on the personalized diets increases from 3 days to
      5 and 9 days.
    

Intervention name(s): Dietary Intakes
Intervention type(s): Other
Intervention description(s): 6 levels of threonine intake will be provided by the protein liquid drink
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy; Adult; Men; Threonine; Dietary Requirement
Examining Relationships Between Family Mealtime and Feeding Outcomes in Young Children With Sensory Food Aversions
Condition: Feeding Disorder of Infancy or Early Childhood
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This study will examine the feasibility and preliminary effects of the Mealtime PREP
      (Promoting Routines of Exploration and Play) intervention package for young children with
      Sensory Food Aversions and their parents.
    

Detailed description: 
      This pilot study will collect rich data from twenty participants on the feasibility and
      effects of a novel intervention, the Mealtime PREP, which has a dyadic focus on both the
      young child and the parent participants. The investigators will collect video recorded child
      meals in the home during a baseline period (under normal circumstances), during
      parent-training (while parents are practicing skills learned), and following parent training
      (when therapist support is withdrawn). This in depth examination of child meals will provide
      valuable information to guide the optimization of this intervention approach for future
      trials.
    

Intervention name(s): Mealtime PREP (Promoting Routines of Exploration and Play)
Intervention type(s): Behavioral
Intervention model: Sequential Assignment
Intervention model description: Single-Case Experimental Design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sensory Food Aversions
A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of GSK2330672 compared to sitagliptin when administered with metformin for
      14 days to subjects with type 2 diabetes mellitus (T2DM). Approximately 72 male and female
      subjects aged 30-64 years with T2DM and currently taking metformin will be recruited for this
      study. Eligible subjects will begin a run-in period of 13-15 days to stabilize on metformin
      850 milligram (mg) twice a day (BID). Subjects will then be randomized to GSK2330672 10 mg,
      20 mg, 30 mg, 90 mg, matching placebo or open-label sitagliptin 50 mg for 14 days BID.
      Subjects will return for a follow-up visit 7-10 days after discharge.
    


Intervention name(s): GSK2330672; Placebo; Sitagliptin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed; Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed; Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days; Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetic; intestinal bile acid transporter inhibitor; metformin; sitagliptin; GSK2330672; pharmacodynamic