bioihbjkbjnl/mcl2 huggingface dataset:
Scooter Board Activities in Diplegic Cerebral Palsy
Condition: Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor
      coordination and deficits in postural control. These changes, individually or collectively,
      affect psychomotor function. As a result, activities that are performed quickly and readily
      by healthy children may be difficult and time-consuming for children with CP.
    

Detailed description: 
      Similar vestibular stimulation can be provided with ascooter-board which requires more active
      participation on the part of the child. A scooter-board is simply a wooden board mounted on
      four castors so that it can roll freely and spin in any direction, it should be big enough to
      support the middle part of the body while the head, upper chest and legs hang off the ends.
    

Intervention name(s): Physical therapy program; scooter board activities
Intervention type(s): Other; Other
Intervention description(s): Stretching exercises
Strength Training Kneeling exercises
Standing exercises
Gait Training; Scooter board bear walk.
Scooter board crab walk.
Sitting on scooter board, use it to move forward and backward, move the pool rings from one end to another.
Cross sitting on scooter board, pulls along the rope using his/her hands
Sit with knees pulled into the chest (like a bug pose) and move around with arms only.
Prone over scooter board, pulling rope to move forward. Pull self along an anchored rope to retrieve items
Scooter rolls outs. Place knees on floor and hands holding the edge of the front scooter board. Push board out a few inches then pull back, the further you roll, the harder it gets.
Kneeling, Push self forward and backward with the use of a therapy ball (lots of Motor Planning).
Supine flexion on scooter board, Clip clothespins to a rope hanging above.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The selected subjects will be divided into two groups of equal numbers (control and study).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diplegia; cerebral palsy; core stability; trunk control
Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)
Condition: Type 2 Diabetes (T2D)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and tolerability of omarigliptin. It is hypothesized that
      administration of once-weekly omarigliptin in obese but otherwise healthy participants, and
      in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated
      to permit continued clinical investigation.
    


Intervention name(s): Omarigliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-weekly 50 mg capsule; Once-weekly placebo capsule
Other intervention name(s): MK-3102
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes (T2D)
Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Condition: Lipid Metabolism Disorders; Sterols; Diet, High-Fat; Cholesterol; Fatty Acids; Hyperlipidemias
MeSH terms: Hyperlipidemias; Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The objective of the study is to assess the effect of two diets with different fat
      composition on cholesterol metabolism. The study was a randomized cross-over trial where
      volunteers follow two study periods with different types of meat (lean and fat red meat)
      separately by a ten days wash-out period. At the beginning of the study and after the study
      periods the following parameters are determined: anthropometric (weight, waist, circumference
      and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise
      assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL
      cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid,
      glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol,
      campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols
      (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by
      High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout
      along the study in order to demonstrate the effect of different red meat on the hepatic
      metabolism of cholesterol.
    


Intervention name(s): Changes in cholesterol metabolism; Lean red meat diet; Fat red meat diet
Intervention type(s): Behavioral; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Lipids; Non Cholesterol Sterols; Oxysterols; Cholesterol Metabolism
SAD Study of IA-14069
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics, food
      effect, and pharmacodynamics following a single oral dose of IA-14069 in healthy male
      subjects.
    


Intervention name(s): IA-14069; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects received IA-14069 tablet orally on Day 1.; Subjects received matching placebo tablet orally on Day 1.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      The investigators aimed to determine the predictive values of fetal pancreas size and
      maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP)
      for gestational diabetes mellitus (GDM).
    

Detailed description: 
      The investigators aimed to determine the predictive values of fetal pancreas size and
      maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP)
      for gestational diabetes mellitus (GDM).In this prospective observational study including 109
      pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were
      measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28
      weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance
      test (OGTT) and the fetal pancreas size was measured in all the participants again.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        With a design of prospective observational study, this research was carried out in the
        Perinatology Clinic of Haseki Hospital, affiliated with the University of Health Sciences,
        in Istanbul, between September 2021 and April 2022, following the approval of the local
        ethics committee (date: February 09, 2022, Registry No: 05-2022) and the valid Helsinki
        Declaration. After all the objectives of this work and context of all the procedures that
        could be undertaken were properly explained to each pregnant woman, the participant was
        requested to sign an informed written consent form.
Clopidogrel Efficacy and Acute Coronary Syndromes
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The purpose of this study is to compare clopidogrel effectiveness between severe
      hemodynamically unstable versus stable patients with acute myocardial infarction.
    

Detailed description: 
      Clopidogrel exists in oral form only. As a prodrug, it has to be metabolized to the active
      form by cytochrome system in the liver. Both facts could lead to lower efficacy of the drug
      in hemodynamically unstable patients, where splanchnic and liver hypoperfusion is present. We
      hypothesised that clopidogrel efficacy is insufficient in patients with acute myocardial
      infarction and severe hemodynamic instability. Therefore we would like to compare the effect
      of clopidogrel in unstable STEMI patients on mechanical ventilation with stable STEMI
      patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Population of 40 consecutive patients is planned, all of them with acute myocardial
        infarction with ST-segment elevation.
      
Biospecimen description: 
      Whole blood
    
Keywords: platelet; VASP; clopidogrel; cardiogenic shock; myocardial infarction; percutaneous coronary intervention
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Condition: Type I Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed pilot study is to determine whether glucose control can be improved
      with Bydureon treatment in patients with type I diabetes (T1D)
    

Detailed description: 
      This is a multi-site randomized placebo controlled trial of Bydureon in patients with type I
      diabetes (T1D) of at least 2 years duration who may or may not still have detectable levels
      of C-peptide during a mixed meal tolerance test (MMTT). Bydureon is a recently approved long
      acting form of Exenatide. Because of the lack of safety data for Bydureon in children, we
      propose to conduct the trial in adults (>18 yrs.).

      Both the subject and the study personnel will be blinded to treatment assignment. The
      randomization will be done, 1;1, by the coordinating site (at Yale). As a secondary analysis,
      we propose to determine whether the presence of residual insulin production modifies the drug
      effect. To do this, we plan to stratify patients for randomization on the basis of detectable
      C-peptide levels. We will therefore wait for the results of the C-peptide levels from the
      enrollment MMTT prior to randomization. The study investigators will not be told in which
      stratum the patient is being randomized and will be blinded to the C-peptide results of the
      MMTT until the conclusion of the study.

      Note: The primary and study completion dates were changed 4/2016 to reflect an extension of
      the recruitment and accrual periods.
    

Intervention name(s): Exenatide (Bydureon®); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Neulasta in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to find out if giving a 12 week course of Neulasta
      (Pegylated granulocyte colony stimulating factor (GCSF)) to people with type 1 diabetes (T1D)
      is safe. The secondary purpose of this research study is to determin if giving GCSF to
      patients with T1D changes the immune system or preserves insulin production.
    

Detailed description: 
      As a participant in this study the following will happen:

      Blood test, Mixed meal Tolerance Test (MMT) to find out how much C-peptide is being produced,
      Human Leukocyte Antigen (HLA) test, Hemoglobin A1C (HbA1c) test for overall blood sugar
      control, and randomized to either receive the 12 week course of Neulasta (Pegylated
      granulocyte colony stimulating factor (GCSF)) or a placebo (no medication).
    

Intervention name(s): Neulasta (Pegylated); Placebo; Mixed Meal Tolerance Test (MMTT); Blood test; DNA Test
Intervention type(s): Drug; Drug; Dietary Supplement; Other; Other
Intervention description(s): Subjects will receive 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.; Placebo injections will be given in identical volumes in identical syringes in the identical subcutaneous manner. 6mg/dose given every 2 weeks for 12 weeks. Subjects less than 45kg will receive 100mcg/kg/dose every 2 weeks for 12 weeks.; This is a 2 hour test to find out how much C-peptide is being produced. C-peptide is used to measure the insulin being made by the cells of the pancreas. Both groups will have this test performed.; HbA1c is a blood test that measures the average blood sugar control and will be performed in both groups.; The HLA test looks at the different chromosomes (DNA) for diabetes and will be performed in both groups.
Other intervention name(s): Pegylated granulocyte colony stimulating factor (GCSF); Saline; Hemoglobin A1C (HbA1c); Human Leukocyte Antigen (HLA)
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Physiological Variables During Blood Donation
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The investigators have developed a system based on a pulse oximeter, a tablet, and an
      algorithm running on the tablet that analyzes the pulse oximeter waveform.

      The algorithm that runs on this system should be able to accurately keep track of blood loss
      during blood donation. The investigators will compare the algorithm with the blood loss
      tracked by a device called a flow meter.

      The algorithm that runs on this system should be able to accurately keep track of stroke
      volume changes. The investigators will compare the algorithm with the stroke volume changes
      tracked by a device called a CCNexfin.

      The algorithm that runs on this system should work whether it's in place for the whole blood
      donation, or if it's placed after the blood donation has started. The investigators will use
      two pulse oximeters for the system on each hand and compare one that is used for the whole
      blood donation versus one that is not used for the whole blood donation.
    

Detailed description: 
      Hypothesis: p-values for testing the hypothesis of no correlation against the alternative
      that there is a nonzero correlation for each subject will be calculated. The minimum average
      power correlation, alpha = 0.05, will be used. Correlation will be made (CRI trend during
      550ml blood volume removal) using pre and post blood draw data.

      Specific Aims: These data will be submitted to the FDA with the following claims: The CRI
      algorithm

        1. Is intended for use by clinicians and medically qualified personnel to noninvasively
           display the trend of intravascular volume changes (hemorrhage)

        2. Is intended for use by clinicians and medically qualified personnel to noninvasively
           display the trend of stroke volume changes and

        3. The CRI trend value is not relative to an initial CRI reading, instead it is an actual
           CRI trend value that does
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers donating blood
A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The aim of this research is to determine if the biological fluids (blood/saliva) from chronic
      brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein
      markers. To accomplish this two populations of chronic TBI patients who are receiving
      treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and
      non-penetrating TBI will be studied. Using multiple proteomic approaches including mass
      spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the
      investigators aim to identify biomarkers in the blood/saliva of patients suffering from
      chronic TBI and to determine the similarities/differences between the blast and
      non-penetrating injury groups. Identification of these biochemical changes will give insight
      into the long-lasting changes associated with head injury, and may identify new targets for
      treating the associated pathologies.
    


Intervention name(s): Blood/saliva sampling
Intervention type(s): Other
Intervention description(s): one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        TIRR Clinics
      
Biospecimen description: 
      Saliva sample Blood sample (plasma)
    
Keywords: TBI; Brain Injury
GSK2018682 FTIH in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol describes the first administration of GSK2018682 to humans. The study will
      evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending
      doses of GSK2018682. The study will also provide preliminary evidence of the potential
      therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte
      counts.
    

Detailed description: 
      This protocol describes the first administration of GSK2018682 to humans. The study will
      evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending
      doses of GSK2018682. The study will also provide preliminary evidence of the potential
      therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte
      counts.
    

Intervention name(s): GSK2018682; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2018682; Matched Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GSK2018682; First Time in Human; Healthy Volunteer
Interventions for Patients With a Shortened Dental Arch
Condition: Anomaly of Dental Arch
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Dental services for large sectors of the population of the Western Cape (WC) Province of
      South Africa (SA) has been, and continues to be, limited to low-cost treatment options and
      emergency services, such as extractions at public health clinics. Replacement of missing
      teeth for the disadvantaged majority of the population is provided almost exclusively at the
      dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result
      of disease and the lack of restorative care and then having these replaced by a removable
      partial denture, if the patient can afford it Null Hypothesis: The daily functional needs and
      quality of life of partially dentate adult patients with a reduced posterior dental arch and
      /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the
      posterior teeth with a removable prosthesis.
    

Detailed description: 
      The aim of this research is to determine whether the daily functional needs and the quality
      of life of partially dentate adult patients with a reduced posterior dental arch will be
      satisfied and improved without having the posterior teeth replaced with a removable
      prosthesis, as compared to having the use of such prosthesis.

      Objectives: To conduct a randomized controlled trial amongst partially dentate adult patients
      with a reduced posterior dental arch (3-5 pairs of posterior occluding pairs of teeth) and
      where these patients will be randomly assigned to one of two groups: one group would be
      provided with a metal- based removable partial denture (RPDP) to replace the posterior teeth,
      the other will receive no treatment.

      Daily functioning ability and patient satisfaction between the groups (with/without RPDP)
      would then be compared.
    

Intervention name(s): Removable partial denture (Chrome Cobalt Distal extension); A reduced posterior dental arch
Intervention type(s): Device; Other
Intervention description(s): For Group A: a distal extension removable denture will be constructed for patients with a reduced posterior dental arch; For Group B: Patients with a reduced posterior dental arch will not be provided with a removable denture and will be compared to patients in Group A
Other intervention name(s): Chrome Cobalt Distal extension denture for Group A patients; No intervention for Group B patients
Intervention MeSH terms: Cobalt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized controlled trial; intervention; posterior reduced dental arch; patient satisfaction; sequential sampling