bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.
Condition: Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability and pharmacokinetics of ABT-614 in subjects with type 2
      diabetes and chronic kidney disease with albuminuria and to determine whether ABT-614 reduces
      glomerular filtration rate.
    

Detailed description: 
      This Phase 1b, single-site, double-blind, randomized, placebo-controlled study will be
      conducted in three Periods; Baseline, Dosing and Outpatient. Eligible adult male and female
      subjects with type 2 diabetes and CKD (chronic kidney disease) with albuminuria will be
      selected to participate.

      Eighteen subjects will be selected to participate in the Baseline Period to ensure that 16
      subjects are enrolled in the Dosing Period. Subjects who are eligible from Screening will be
      confined to the study site beginning on Day -2 (the day before the Baseline Period infusion).
      On Day -1, subjects will be administered an iothalamate infusion to measure baseline GFR
      (glomerular filtration rate). Subjects who continue to be eligible on Day 1 will be
      randomized in a 1:1 ratio to receive either a 10 mg dose of ABT-614 or matching placebo
      daily, for 15 days.

      On Day 15 subjects will be administered a second iothalamate infusion. Plasma and urine
      samples for ABT-614 and iothalamate will be collected. Subjects will be released from
      confinement on Day 20 after the completion of all study procedures including the 120-hour
      blood sample collection. Thereafter, subjects will return for outpatient visits on Days 25
      and 30 as well as 30 days after the last dose of study drug. A ± 2 day window will be
      permitted on the 30-day Follow-up Visit to accommodate subject scheduling.
    

Intervention name(s): ABT-614; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Active; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Type 2 diabetes; Kidney disease
Lancet Blood Volume Comparison Study
Condition: Diabetes
Study type: Observational

Summary: 
      The primary objective of the study examines the success rate of various OneTouch Delica
      lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is
      based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4
      times with two lancet sizes at a single depth setting. There will be 120 paired lancing
      events for each lancet size within the group.

      Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of
      1.0μL for the 28g lancet across all depth settings.

      Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for
      the 28g lancet across all depth settings is less than 90%.
    


Intervention name(s): Delica Device
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with diabetes from the surrounding communitu
Appetite Regulation in Older-Aged Obese Individuals
Condition: Obesity; Aging
Study type: Interventional

Summary: 
      This study plans to learn more about how age and weight impact appetite and food intake.
      Specifically, this study is being done to see whether age and obesity impact appetite and the
      brain's response to food. In this study the investigators will be evaluating how participants
      brains respond to food images as well as your food-related behaviors and hormones. The
      investigators will be comparing older individuals aged 65 to 85 years who are normal weight
      compared to those who are obese. The Investigators will then compare older aged individuals
      to younger adults aged 21 to 45 years.
    

Detailed description: 
      In a cross sectional design participants will be studied on one occasion after a 3-day diet
      run-in. On the study day they will present in the fasting state, have an intravenous catheter
      placed for blood draws and have baseline blood samples taken and appetite measures performed.
      Participants will then undergo functional magnetic resonance imaging (fMRI). This will be
      followed by a breakfast meal. Blood and appetite measures will be performed every half hour
      for 3 hours. Repeat fMRI will be performed 30 minutes after the meal. After three hours
      participants will be offered a buffet style lunch and then will be done with the study visit.
    

Intervention name(s): 3-day diet Run-in; fMRI; Intravenous catheter placed for blood draws
Intervention type(s): Dietary Supplement; Procedure; Procedure
Intervention description(s): Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.; After a 3-day diet run-in, participants will undergo a functional magnetic resonance imaging procedure (fMRI). Repeat fMRI will be performed 30 minutes after the meal.; On the study day participants will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken. Blood and appetite measures will be performed every half hour for 3 hours.
Other intervention name(s): Functional Magnetic Resonance Imaging; IV catheter
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study compares the performance of respiration rate from pleth measured prospectively
      with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived
      from the manual scoring of the capnography waveform in healthy adult subjects.
    


Intervention name(s): INVSENSOR00032 and INVSENSOR00033
Intervention type(s): Device
Intervention description(s): Investigational pulse oximeter device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
Condition: Cerebral Palsy, Spastic
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Gait abnormalities, which occur in Cerebral Palsy (CP), are characterized usually by a
      toe-to-floor or a plantar-to-floor initial contact (equinus gait), followed by an early
      braking of the tibia's forward progression (during ankle dorsiflexion). This causes
      consequently a trunk deceleration. Moreover, children with CP have difficulties to stabilize
      the trunk and the head in the space, and that could have impact on gait. If equinus gait is
      often attributed to the triceps surae spasticity, recent works suggest rather that this early
      braking of the dorsiflexion could be a motor adaptation to axial postural control
      difficulties. This thesis project aims firstly to attest that locomotor disorders are related
      to these difficulties in the stabilization of the axial body segments in children with CP
      and, secondly, to show that improving the trunk and head postural control with a specific
      rehabilitation protocol could reduce the early braking of the dorsiflexion and, consequently,
      the gait abnormalities observed in CP.
    


Intervention name(s): Rehabilitation involving strongly the trunk
Intervention type(s): Other
Intervention description(s): The Rehabilitation involving strongly the trunk (RIST) leaded by a physiotherapist was based on exercises in different postures performed by the child each day that strongly involve the trunk to cope with balance.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trunk control; Postural Control; Cerebral Palsy; Rehabilitation; Axial segments
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational
      drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus.
      Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment
      with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.
    


Intervention name(s): Placebo to Ertugliflozin; Ertugliflozin 1 mg; Ertugliflozin 5 mg; Ertugliflozin 25 mg; Sitagliptin 100 mg; Placebo to Sitagliptin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days; Tablet, 1 mg, once daily for 84 days; Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days; Tablet, 25 mg, once daily for 84 days; Tablet, 100 mg, once daily for 84 days; Tablet, matching placebo to 100 mg, once daily for 84 days; Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Other intervention name(s): Januvia®, Tesavel®, Xelevia®, Ristaben®; Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Ertugliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 2; safety and efficacy study with ertugliflozin (PF-04971729, MK-8835); Type 2 diabetes mellitus
Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been
      shown to prevent the transmission of several strains of HPV in young women. Women with
      inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to
      having IBD or due to immunosuppressants used to control IBD. This study will test how well
      women with IBD respond to the Gardasil vaccine.
    

Detailed description: 
      Although guidelines exist for immunization of patients with inflammatory bowel disease, few
      studies exist demonstrating vaccine efficacy in this population. In patients with
      inflammatory bowel disease, lower than normal humoral responses have been shown with the
      tetanus toxoid booster, oral cholera, and influenza vaccinations. It is currently uncertain
      whether women with inflammatory bowel disease (IBD) have an increased risk of cervical
      dysplasia and cancer. Gardasil, a vaccine against human papilloma viruses (HPV) 6, 11, 16,
      and 18, has been approved for the prevention of cervical dysplasias and cancers in women ages
      9-26 years. However, its immune response in immunocompromised or immunosuppressed patients is
      unknown.

      Young women with inflammatory bowel disease who have not received the HPV vaccine will
      receive the vaccine. The vaccine is given in 3 doses over 6 months. Response to the vaccine
      will be measured 6 months after completing the vaccine series.
    

Intervention name(s): Human Papillomavirus Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5mL intramuscular for 3 doses at 0, 2, and 6 months
Other intervention name(s): Gardasil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inflammatory bowel disease; Crohn disease; ulcerative colitis; Papillomavirus vaccines
Thromboelastography-Guided Fluid Management in Spinal Surgery
Condition: Spinal Fusion
Study type: Observational

Summary: 
      The Researchers are trying to evaluate whether using a blood test called thromboelastogram
      (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce
      complications after surgery compared with the standard practices.
    

Detailed description: 
      Multi-level instrumented spinal fusions represent an important treatment modality for
      degenerative scoliosis and sagittal malalignment. These surgeries remain a significant
      physiologic burden with high blood loss and long operative times. Thromboelastography
      provides a quantitative measure for blood product transfusion surrounding procedures. We aim
      to utilize thromboelastography to guide transfusions for multi-level spinal instrumentation.
      This two-arm, randomized, non-blinded prospective analysis will clarify reduced transfusion
      requirements for TEG-arm compared to non-TEG arm. We will also evaluate postoperative
      outcomes at the 1 year time-point.
    

Intervention name(s): Intervention; Control Group
Intervention type(s): Procedure; Other
Intervention description(s): We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion; Laboratory analysis to guide transfusion
Other intervention name(s): Thromboelastography; Point of care testing
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of Mayo Clinic receiving a multi-level spinal fusion surgery.
Interest of a 30 Minutes' Intermittent Work Exercise Test in Patients With Chronic Obstructive Pulmonary Disease: Cardiac and Pulmonary Functions
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of the study is to observe the ventilatory and cardiac function (included the
      pulmonary arterial pressure) during an intermittent work exercise test with high density work
      load.
    


Intervention name(s): EFR
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pulmonary arterial pressure; COPD; Cardiac output; pulmonary and cardiac functions; pulmonary arterial pressure measurements
The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
Condition: Muscle Damage; Muscle Inflammation
MeSH terms: Myalgia; Myositis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of fish oil supplementation (Lovaza,
      GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.
    

Detailed description: 
      When a person exercises at a high intensity or starts a new exercise program, muscle soreness
      will develop. Muscle soreness that peaks between 24-72 hours after exercise and diminishes in
      5-7 days is characterized as delayed onset muscle soreness (DOMS). DOMS is associated with
      the eccentric phase of exercise, where the muscle is actively creating force while
      lengthening. The onset of muscle soreness is part of an inflammatory response due to the
      muscular damage caused by the exercise.

      Research has shown that fish oils have anti-inflammatory properties. Direct intake of various
      polyunsaturated fatty acids (PUFA) alters the cell membrane fatty acid composition, which, in
      turn modulates cell/tissue response to infection, injury and inflammatory events. These
      properties may be beneficial to relieve muscle soreness.

      Therefore, the purpose of this study is to determine the effects of fish oil supplementation
      (Lovaza, GlaxoSmithKline, 3 grams per day for 65 days) on muscle strength, muscle soreness
      and inflammation following exercise.

      Participants will be randomly assigned to one of two groups: Lovaza (3 grams/day) or placebo.
      Participants will consume either the Lovaza or the placebo for 65 consecutive days. On Day
      60, participants will have baseline measurements of muscle strength, muscle soreness,
      creatine kinase activity, and muscle inflammatory marker assessed. Participants will then
      perform eccentric exercise on an isokinetic dynamometer using the quadriceps muscles in order
      to induce muscle soreness. On each of Days 61-65, muscle strength, muscle soreness, creatine
      kinase activity, and muscle inflammatory markers will again be assessed.
    

Intervention name(s): Lovaza (omega-3-acid ethyl esters); Wheat Germ Oil
Intervention type(s): Drug; Drug
Intervention description(s): Lovaza, 3 grams per day for 65 days; Wheat germ oil, 3 grams/day for 65 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Assess Relative Bioavailability and Safety of AZD5718 in Healthy Volunteers
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover
      study in healthy subjects The study will be performed at a single study centre in the United
      Kingdom.
    

Detailed description: 
      The study will comprise:

        -  A screening period of maximum 28 days;

        -  3 treatment periods during which subjects will be resident at the Clinical Unit from the
           day before dosing with AZD5718 (Day -1) until at least 48 hours after dosing (Day 3),
           with discharge on the morning of Day 3 of each treatment period; and

        -  A final visit within 5 to 7 days after the last administration of AZD5718.

      Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days
      washout, under fasted and fed conditions. Two different formulations (Test Formulation and
      Reference Formulation) will be given in a randomised order:

        -  Treatment A (Test Formulation): AZD5718 Dose A, fasted

        -  Treatment B (Test Formulation): AZD5718 Dose A, fed

        -  Treatment C (Reference Formulation): AZD5718 Dose A, fasted
    

Intervention name(s): AZD5718
Intervention type(s): Drug
Intervention description(s): Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AZD5718; Bioavailability; 5-lipoxygenase activating protein (FLAP) inhibitor; Safety and tolerability
Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain
Condition: Low Back Pain, Mechanical; Low Back Pain; Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an
      active treatment for pain control in individuals with at least moderate acute mechanical low
      back pain.
    


Intervention name(s): S (+) - Ibuprofen; Ibuflex®
Intervention type(s): Drug; Drug
Intervention description(s): S (+) - Ibuprofen + placebo of Ibuflex®; Ibuflex® + placebo of S (+) - Ibuprofen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain control; Low back pain; Pain relief; Ibuprofen; Inflammation; Anti-inflammatory
Cortisol Levels on Menopausal Symptoms - Ancillary (Addendum) Study to Protocol 16997
Condition: Menopause
Study type: Observational

Summary: 
      This is an ancillary study to Protocol 16997 to examine the stress hormone level in women
      with menopausal symptoms. This ancillary project will collect additional data from the 45
      subjects enrolled in Protocol 16997 (no subjects have enrolled in Protocol 16997 so far).
      This study protocol differs from the main protocol (16997) because it will include an ACTH
      (Hormone) Stimulation Test which will assess the functioning of stress response in the
      subjects at entry and exit.

      Subjects will undergo the ACTH test for this ancillary protocol in the morning when they
      complete 24-hour urine collection for Protocol 16997. The ACTH (Hormone) Stimulation Test
      will not be done in the main protocol 16997. During the ACTH test an IV will be placed in
      subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at
      -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected
      intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That
      is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the
      subjects during the ACTH (Hormone) Stimulation Test.

      The 24 hour cortisol data collected in the main protocol 16997 will be used for this study
      analysis.

      When subjects are consented for Protocol 16997, they will also be consented for this
      ancillary study. In addition to the consent visit, subjects will have two study specific
      visits (entry and exit) for this ancillary study. The PI will schedule the specific visits
      for this study to be in conjunction with those scheduled for Protocol 16997.

      There is no collaborations with other sites in the ancillary study.
    


Intervention name(s): ACTH
Intervention type(s): Procedure
Intervention description(s): During the ACTH test an IV will be placed in subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the subjects during the ACTH (Hormone) Stimulation Test.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Menopausal women
      
Keywords: Menopause; Cortisol; ACTH
A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, observer-blinded, placebo-controlled study will assess the safety,
      tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers.
      Subjects will be randomized in cohorts to receive single ascending intravenous or
      subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4,
      with a safety follow-up of 15 weeks after dosing.
    


Intervention name(s): RO5469754; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses, iv or sc; Single doses, iv or sc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)