bioihbjkbjnl/mcl2 huggingface dataset:
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Study type: Observational

Summary: 
      This observational study will evaluate the use in clinical practice and efficacy of Mircera
      (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients
      not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible
      patients will be followed for 24 weeks.
    


Intervention name(s): C.E.R.A.
Intervention type(s): Drug
Intervention description(s): Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with stage III-IV chronic kidney disease not on dialysis receiving treatment with
        Mircera for chronic renal anemia
An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast
Condition: Breast Enhancement
Study type: Observational

Summary: 
      The study evaluates degradation of NASHA in breast 4 and 6 years post treatment, long term
      safety and evaluation if a satisfactory breast cancer screening can be performed in subjects
      treated with NASHA-gel in breast. An independent evaluation of the aesthetic changes is also
      performed.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects treated in study 31GB0607
Paricalcitol in Treating Patients With Myelodysplastic Syndrome
Condition: Leukemia; Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop
      into normal bone marrow cells.

      PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who
      have myelodysplastic syndrome.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the clinical effects of paricalcitol in patients with myelodysplastic
           syndromes.

        -  Determine whether this drug can improve RBC, WBC, or platelet counts in these patients.

        -  Determine whether this drug can decrease the risk of development of leukemia without
           causing undue toxicity in these patients.

      OUTLINE: Patients receive oral paricalcitol daily for 4 months in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed at 1 month.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 8 months.
    

Intervention name(s): paricalcitol
Intervention type(s): Drug
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; refractory anemia with ringed sideroblasts; refractory anemia; chronic myelomonocytic leukemia
Safety and Efficacy of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Selected Advanced Solid Tumors
Condition: Advanced Solid Tumors; Melanoma
MeSH terms: Neoplasms; Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A multicenter, open-label, phase 1b/2 study to evaluate the safety and efficacy of AK104, a
      PD-1 and CTLA-4 bispecific antibody, in selected advanced solid tumors.
    


Intervention name(s): AK104
Intervention type(s): Biological
Intervention description(s): AK104, 6mg/kg, Q2W
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bispecific; PD1/CTLA4; PD-1/PD-L1 relapsed/refractory tumors
Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the possible effects of daily intake of yogurt drink
      fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic,
      metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).
    

Detailed description: 
      ninety diabetic patients will be selected. Patients who are receiving vitamin D, calcium or
      omega-3 supplements within the last three months will be excluded. Patients will be assigned
      randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin
      D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will
      consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first
      and last visits, dietary and laboratory assessments will be performed for all patients.
      Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary
      outcome is prevention of long-term diabetic complications.
    

Intervention name(s): plain yogurt drink; vitamin D fortified yogurt drink; vitamin D-calcium yogurt drink
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): daily intake of two bottle of plain yogurt drink; daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL; daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package
Other intervention name(s): PY; DY; DCY
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: vitamin D fortification; yogurt drink; type 2 diabetes; efficacy
LEO 27847 - A Study in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-man trial is to determine the safety and tolerability of
      ascending single and multiple doses of LEO 27847 in healthy male subjects. The trial will be
      performed in two parts. In Part 1, single doses of LEO 27847 will be administered to healthy
      male subjects. In Part 2, multiple doses of LEO 27847 will be administered to healthy male
      subjects.
    


Intervention name(s): LEO 27847
Intervention type(s): Drug
Intervention description(s): First in man
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety and tolerability of LEO 27847
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated
      interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid
      virologic response rates at least 35% greater than those with placebo.
    


Intervention name(s): Daclatasvir; Daclatasvir; Placebo; peg-interferon alfa-2a; ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response; Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response; Tablets, oral, 0 mg, once daily, 24 weeks; Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response; Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Other intervention name(s): Pegasys; Copegus
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Absorption of Insulin Following Subcutaneous Bolus Administration With Different Bolus Durations
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      To cover meal-related insulin requirements, insulin pumps allow insulin to be delivered at
      high rates over a short period of time (bolus delivery). The length of this period (bolus
      duration) usually depends on the chosen bolus size and on the used insulin pump model. This
      study will evaluate the impact of different bolus durations (i.e., durations commonly
      employed in commercially available insulin pumps: 2 and 40 seconds for delivering 1 Unit of
      insulin) on the pharmacokinetic and pharmacodynamic properties of an rapid-acting insulin
      analogue.

      Objective: To evaluate in type 1 diabetic patients the pharmacodynamics and pharmacokinetics
      of rapid-acting insulin (insulin lispro) administered as subcutaneous boluses with different
      bolus durations.

      Study design: Single-center, randomized, controlled, two-arm cross-over intervention study

      Population: Twenty type 1 diabetic subjects

      Intervention: The investigational treatment is the subcutaneous administration of insulin
      lispro either as one bolus of 15 IU over a period of 30s or as one bolus of 15 IU over a
      period of 10 min. Plasma samples to assess pharmacodynamic and pharmacokinetic properties
      will be taken during an 8-hour clamp experiment. Patients will undergo both investigational
      treatments in a randomized order; between the two clamp visits there will be a wash-out
      period of 5-21 days.

      Main study endpoint: Time to maximum glucose infusion rate
    


Intervention name(s): Insulin LISPRO
Intervention type(s): Drug
Intervention description(s): Administration of 15 IU of insulin lispro over a period of 30 seconds
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin pump therapy; insulin bolus; rapid acting insulin; insulin lispro; pharmacodynamics; pharmacokinetics; glucose clamp
Letting Children Listen to Music During Computed Tomography
Condition: Fear; Computed Tomography
Study type: Interventional

Summary: 
      This study examines the effect of music during computed tomography in children. This study,
      conducted on a total of 60 children, was divided into two groups: the music group and the
      control group. According to the research results; showed that music reduces fear and anxiety
      levels in children and stabilizes vital signs (pulse and respiratory rate) during a
      tomography scan.
    

Detailed description: 
      Aim: This research was conducted to determine the effect of music played during computerized
      tomography (CT) imaging in children on fear, anxiety and vital signs.

      Method: This randomized, double-blind controlled trial was conducted with Consolidated
      Standards of Reporting Studies (CONSORT) guidelines. The sample includes children aged 5-10
      years who had CT scans in the emergency department of a public hospital in eastern Turkey
      between April 18 and May 20, 2023 and met the inclusion criteria for the study. The research
      was completed with a total of 60 children, divided evenly into one of two groups. The nursing
      intervention of the research is to listen to music. Data were collected through face-to-face
      interviews using the Child and Family Information Form, the Child Fear Scale, the State
      Anxiety Scale for Children, and the Vital Signs Monitoring Form (pulse, blood pressure, and
      oxygen saturation). Ethical principles were followed in the research.
    

Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Children were played music during computerized tomography.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: They were divided into two groups: control group and experimental group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Child; Music; Anxiety; Fear
Study on the Effect of Fish Oil and Appetite
Condition: Obesity; Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of
      0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they
      were given a standard breakfast and asked to report their appetite on visual analogue scales
      (VAS) immediately before and after the meal. The results were analyzed in accordance with the
      paired design under consideration of both supplement sequence and gender.
    

Detailed description: 
      In a randomized cross-over design, 20 normal-weight healthy subjects (10 males, 10 females)
      were given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of
      each period they were given a standard breakfast and asked to report their appetite on visual
      analogue scales (VAS) immediately before and after the meal. The results were analyzed in
      accordance with the paired design under consideration of both supplement sequence and gender.
    

Intervention name(s): Fish oil
Intervention type(s): Dietary Supplement
Intervention description(s): For 3 weeks 5 g/d in 10 capsules, providing 3.5 g long-chain n-3 fatty acids in the fish oil period. Cross-over between arms with 1 week of wash out
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Appetite; Fish oil; Long-chain n-3 fatty acids
Extension Study of the Family Spirit Program
Condition: Parenting
Study type: Interventional

Summary: 
      The aim of the proposed research is to implement and evaluate a follow-up study of the impact
      of the Family Spirit family strengthening program among a high-risk sample of Apache mothers
      and their children. The Family Spirit intervention is a 52-session home-visiting curriculum
      administered by American Indian paraprofessionals to young mothers from 28 weeks gestation
      through the child's first 3 years of life. In a series of pilot studies and a recently
      completed randomized controlled trial, the Family Spirit intervention has been found to
      positively impact several maternal, parenting and child outcomes up through three years
      postpartum. In the proposed study, the investigators will implement the Family Spirit
      intervention to young mothers (12-20 years at conception), with revisions to several
      assessment measures and to the curriculum such that the substance abuse prevention curriculum
      modules will be taught earlier than in the original study.
    

Detailed description: 
      This is a single group pre-post study designed to evaluate the impact of a home visiting
      intervention in improving parenting self-efficacy and a number of other maternal and child
      health and behavioral outcomes among a sample of young mothers, including maternal substance
      use. The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration)
      delivered during a 39-month intervention phase. All sessions are designed to be taught at the
      participant's home, but they may also occur at another location chosen by the participant
      (e.g. study office, vehicle). Outcome data will be collected at Baseline and at 2 months, 6
      months, 12 months, 24 months and 36 months postpartum.
    

Intervention name(s): Family Spirit
Intervention type(s): Behavioral
Intervention description(s): The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Home visiting interventions; American Indian; Community based participatory research
Safety and Efficacy Study of Allogeneic Adipose-derived Stem Cells for Treatment of Lateral Epicondylitis
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of allogeneic
      adipose-derived stem cells (ALLO-ASC) in patients with lateral epicondylitis.
    


Intervention name(s): ALLO-ASC-TI; Placebo
Intervention type(s): Biological; Drug
Other intervention name(s): Allogenic adipose-derived stem cell; 0.9% Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Epicondylitis
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
Condition: Therapeutic Equivalency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a test
      formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after
      a single oral dose administered under fasting conditions.
    

Detailed description: 
      The purpose of this study is to evaluate and compare the relative bioavailability of a test
      formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after
      a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese,
      healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in
      a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7
      day washout period between dosing periods. On the morning of Day 1, after an overnight fast
      of at least 10 hours, subjects will receive either a single oral dose of the test
      formulation, cilostazol (1 x 100 mg tablet), or a single oral dose of the reference
      formulation, Pletal® (1 x 100 mg tablet). After a 7 day washout period on the morning of Day
      8, following an overnight fast of at least 10 hours, subjects will receive the alternate
      regimen. Blood samples will be drawn from all participants before dosing and for 24 hours
      post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics
      of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours
      post-dose. A further goal of this study is to evaluate the safety and tolerability of this
      regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion
      of the study for adverse reactions to the study drug and/or procedures. Blood pressure and
      pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events
      whether elicited by query, spontaneously reported, or observed by clinic staff will be
      evaluated by the investigator and reported in the subject's case report form.
    

Intervention name(s): Cilostazol 100 mg Tablets; Cilostazol (Pletal®) 100 mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Cilostazol (1 x 100 mg tablet) administered after an overnight fast of at least 10 hours; Cilostazol (Pletal® 1 x 100mg tablet) administered after an overnight fast of at least 10 hours.
Other intervention name(s): Pletal®
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of the Canabrava/s Pupil Expansion Device in Cataract Surgery With Small Pupils: The First 30 Cases
Condition: Small Pupil; Cataract
MeSH terms: Miosis; Cataract
Study type: Interventional

Summary: 
      To evaluate the intraoperative stability, safety and overall efficacy of the Canabrava Ring
      (AJL - SPAIN) when used to expand pupils with less diameter than 5 mm and pupils with
      sphincter synechiae.
    

Detailed description: 
      In this consecutive case series, 30 eyes of 29 patients underwent cataract surgery using a
      new disposable small-pupil expansion device, Canabrava's Ring (AJL Ophthalmic, Spain). It is
      the first iris expansion ring produced with indents that do not align with each other in the
      superior and inferior regions, resulting in a small vertical length (0.4mm) that minimizes
      risk of endothelial contact. All eyes had poorly preoperatively dilated pupils of less than
      5mm. Fifteen eyes had significant infective or traumatic pathology preoperatively. Vertical
      and horizontal pupil diameters were evaluated pre-, intra- and 1 month postoperatively, and
      were used to calculate pupil circumference. Intraoperative and postoperative pupil
      circumference comprised the primary outcomes of interest.
    

Intervention name(s): Cana's Ring
Intervention type(s): Device
Intervention description(s): The device is used during cataract surgery to help dilate small pupils (under 5mm)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Small pupil
Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics
      (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative
      colitis (UC).
    

Detailed description: 
      At the end of the study, eligible participants could enroll and receive treatment and
      follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004
      were followed by telephone contact at 6-month intervals for 2 years after the last
      administration of study treatment to collect reports of adverse events, including colectomy,
      severe infections [including progressive multifocal leukoencephalopathy (PML)], and
      dysplasia/cancer.
    

Intervention name(s): Vedolizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vedolizumab for intravenous infusion; Placebo intravenous infusion
Other intervention name(s): Entyvio; MLN0002; MLN02; LDP-02
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment