bioihbjkbjnl/mcl2 huggingface dataset:
An Egg Based Breakfast Maintains Flexibility in Older Adults
Condition: Diabetes; Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      Aging is associated with an increased risk for metabolic diseases, such as type 2 diabetes
      and cardiovascular disease. There is reason to believe that the time of day when specific
      food groups are eaten affects this risk. The investigators propose that eating foods made up
      of fat and protein (such as eggs) in the morning for breakfast, rather than foods made up of
      carbohydrates (such as white-bread toast or sugary cereal) may promote a healthier
      metabolism. This is because the body is designed to burn fat during times of fasting, such as
      overnight, during sleep. Thus, the body is not prepared to burn sugar early in the morning,
      when most people eat breakfast. Studies with mice have shown that a sugary breakfast meal
      inhibits the ability of the body to burn fat for the entire day. In contrast, a breakfast
      meal with more fat enabled the animals to burn fat as well as other fuels throughout the day.
      The ability to burn fat is thought to minimize risk for obesity, as well as related diseases
      such as type 2 diabetes and heart disease. The purpose of this study is to determine if, in
      older adult humans, consumption of a lower-carbohydrate breakfast meal (relative to a
      higher-carbohydrate meal) is associated with a healthier metabolism.
    


Intervention name(s): High fat breakfast; Higher carbohydrate breakfast
Intervention type(s): Other; Other
Intervention description(s): High fat breakfast; Higher carbohydrate breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this study is to compare the subjective performance of the comfilcon A contact
      lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.
    

Detailed description: 
      This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study
      comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens
      pair.
    

Intervention name(s): comfilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.
Condition: Sepsis; Bacteremia; Fungemia
MeSH terms: Sepsis; Toxemia; Bacteremia; Fungemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the consumption of antimicrobial therapy in
      patients comparing a rapid molecular test (PCR in Real-Time Multiplex) with blood cultures to
      identify the etiological agents of sepsis.
    

Detailed description: 
      Patients staying more than 48 hours in hospital with clinical suspicion of sepsis could be
      included in the study. Blood samples for cultures and multiplex PCR will be collected
      immediately prior to initiation of antibiotic therapy. Patients will be randomly selected
      into two groups. In Group I, the PCR results will be immediately reported to the medical
      researcher (6-12 hours), which will change the antimicrobial regimen (De-escalation). In
      Group II, the Multiplex PCR results will not be informed, being focused care as a result of
      blood culture (at least after 72 hours). The initial empirical antimicrobial therapy will be
      the same in both groups, according to the standardization of the institution.
    

Intervention name(s): Antibiotic regimen
Intervention type(s): Other
Intervention description(s): The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h).
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Sepsis; Real time PCR; Blood culture; Bacteremia diagnosis; Fungemia diagnosis
Plasma Endostatin Predicts Outcome of Septic AKI
Condition: Acute Kidney Injury Due to Sepsis
MeSH terms: Sepsis; Acute Kidney Injury
Study type: Observational

Summary: 
      Introduction: Acute kidney injury (AKI) occurs up to 50% of patients admitted to intensive
      care unit. Plasma Endostatin, released from basement membrane of Bowman's capsule, rises
      early during AKI.

      Aim of Work: To investigate the role of the plasma endostatin in the outcome prediction
      (renal recovery, ICU stay, mortality) of acute kidney injury in patients with sepsis.

      Methods: a prospective, observational single center study on 40 patients with Sepsis at the
      Critical Care Department, Cairo University hospitals between March 2019 and November 2019.
      Serum plasma endostatin was measured at the day of admission & every 48hrs (3 samples).
      APACHE II, SOFA scores were calculated. Forced diuresis was used if indicated.
    

Detailed description: 
      The study was conducted on 40 patients with sepsis who admitted in the Critical Care
      department of Cairo University.

      The sepsis is identified according to surviving sepsis campaign guidelines with use of SOFA
      score to establish the diagnosis.

      The patients divided into 2 groups the first group included 25 patients who developed AKI as
      defined by KDIGO guidelines and the other group included 15 patients as a control group.

      The Plasma Endostatin level is sampled in the first 24 hours of diagnosis of AKI, the
      estimation of plasma Endostatin level done by ELISA technique.

      The results were presented in form of: descriptive, analytical and comparative data between
      the groups of study.

      It was found that the patients with higher levels of plasma endostatin had a higher incidence
      of recovery from AKI and higher incidence of 28 days survival, while the patients with lower
      levels of plasma Endostatin below the determined Cut-off value have increased incidence of
      RRT .

      Also that the patients with higher levels of plasma Endostatin levels were less labile to
      mechanical ventilation and had a higher incidence of weaning of vasopressors in comparison of
      the other group of lower levels of plasma Endostatin.

      Plasma Endostatin levels have no difference between the AKI group and sepsis group which may
      need further investigations to determine its role in sepsis.

      so that, the plasma Endostatin can be used as a marker of recovery from AKI.
    

Intervention name(s): measuring plasma Endostatin level
Intervention type(s): Diagnostic Test
Intervention description(s): measuring plasma Endostatin level at the time of admission then after 48hrs and 96 hours
Intervention MeSH terms: Endostatins
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Age: 18- 80 years .

        - No gender preference
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, single-dose, double-blinded, 4-period, crossover study to
      evaluate the pharmacokinetics, safety, and tolerability of mitapivat in healthy adult
      participants under fasted and fed (high-fat meal) conditions. Secondary objectives include
      evaluating the effect of mitapivat on electrocardiogram (ECG) parameters, including
      concentration-QT interval corrected for heart rate (C-QTc) analysis under fasted conditions.
      The study will include a 28-day screening period, four 7-day treatment periods. Participants
      will receive a follow-up telephone call within 28 (±1) days after the last dose of study
      drug.
    


Intervention name(s): Placebo for Treatment A; Mitapivat 100 mg; Placebo for Treatment B; Mitapivat 300 mg; Placebo for Treatment C
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 6 tablets matched to mitapivat tablet; Two 50-mg tablets; 4 tablets matched to mitapivat tablet; Six 50-mg tablets; 4 tablets matched to mitapivat tablet
Other intervention name(s): AG-348; AG-348
Intervention MeSH terms: Mitapivat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study was to investigate the safety and tolerability of
      BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and
      10 mg over 12 days in male patients with type 2 diabetes.
    


Intervention name(s): BI 1356 BS - single rising dose; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Relationship Between Quality of Life, Life Satisfaction and Anxiety Levels of Wheelchair Basketball Players
Condition: Quality of Life; Life Satisfaction; Anxiety Levels
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Today, there are many studies on wheelchair basketball players. However, these studies do not
      indicate the relationship between the quality of life, life satisfaction and anxiety levels
      of wheelchair basketball players, in the extent of the knowledge. As a result of this study,
      it is aimed to obtain information about the quality of life, life satisfaction and anxiety
      levels of wheelchair basketball players.
    

Detailed description: 
      The study aimed to examine the relationship between the quality of life, life satisfaction
      and anxiety levels of wheelchair basketball players. This study was carried out with
      wheelchair basketball players in Istanbul between March 2022 and May 2022. Twenty-three
      wheelchair basketball players were included in the study. The scope of the study was
      explained to the wheelchair basketball players who participated in the study during the
      face-to-face interview, and the consent forms prepared by the researcher were distributed.
      The participants, who approved the consent form and agreed to participate in the study, had
      to fill out the sociodemographic form. The quality of life of the participants was determined
      by the SF-12 Quality of Life Scale; Satisfaction with life was evaluated with the
      Satisfaction with Life Scale, and anxiety levels were evaluated with the Beck Anxiety Scale.
      Statistics were performed using SPSS Version 22.0 program.
    

Intervention name(s): relationship between quality of life, life satisfaction and anxiety levels of wheelchair basketball players
Intervention type(s): Other
Intervention description(s): relationship between quality of life, life satisfaction and anxiety levels of wheelchair basketball players
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        wheelchair basketball players
Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the effect of high fiber multigrain
      supplementation on the level of clinical disease severity measures, blood inflammatory
      molecules, and nutritional status changes in RA patients.
    

Detailed description: 
      Rheumatoid Arthritis (RA) is a chronic inflammatory, autoimmune rheumatic disease, resulting
      in progressive joint inflammation and destruction. At present, there is no known cure for
      this disease. As a consequence of the potential side effects, many RA patients turn to other
      alternative remedies such as specialised diets and/or dietary supplements in a bid to relieve
      their symptoms. Therefore, the current study aims to examine the effectiveness of high fiber
      multigrain supplementation on the level of clinical disease severity measures, blood
      inflammatory molecules, together with the nutritional status changes in RA patients, as
      compare with conventional drug treatments.
    

Intervention name(s): Multigrain powder (S)
Intervention type(s): Dietary Supplement
Intervention description(s): A twice daily high fiber multigrain powder supplementation for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rheumatoid Arthritis; Fiber; Multigrain
Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer
Condition: Progression Free Survival
MeSH terms: Carcinoma, Non-Small-Cell Lung; Disease Progression
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic
      change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in
      non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the
      treatment of first generation EGFR TKI, half of patients will get disease progression.For
      patients progression after treated with first line EGFR TKI and second line double bullets
      chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical
      important for benefit patients' survival. We conducted this study was aimed to compare the
      efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy
      in patients with local advanced or metastatic non-squamous cell lung cancer.
    


Intervention name(s): Osimertinib; docetaxel, bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg oral daily; until disease progression, intolerable toxicities, or patient death.; Docetaxel and bevacizumab are common used in third line therapy in non-small cell lung cancer if not used before. Docetaxel (75 mg/m2) intravenous infusion on day 1 and bevacizumab (7.5 mg/kg) on day 1 every 21days a cycle, until disease progression, intolerable toxicities, or patient death.
Intervention MeSH terms: Bevacizumab; Docetaxel; Osimertinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osimertinib; EGFR T790M Resistant Mutation; Docetaxel; Bevacizumab; Non Small Cell Lung
A Study of LY2140023 in Healthy Males and Females
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the effect of different particle size of LY2140023. The study
      involves 4 single doses of 80 milligrams (mg) LY2140023 taken as 1 tablet by mouth with a
      washout period of at least 3 days between doses. This study will last approximately 60 days
      not including screening. Screening is required within 30 days prior to study entry.
    


Intervention name(s): LY2140023 Reference form; LY2140023 Test-Low; LY2140023 Test-Medium; LY2140023 Test-High
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 80-mg tablet administered orally; 80-mg tablet administered orally; 80-mg tablet administered orally; 80-mg tablet administered orally
Other intervention name(s): LY2140023 Monohydrate (Reference); LY2140023 Monohydrate (Test - Low); LY2140023 Monohydrate (Test - Medium); LY2140023 Monohydrate (Test - High)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of phase 1 of this study is to establish the recommended phase II dose
      (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy
      of bendamustine at the recommended pediatric dose for the treatment of pediatric patients
      with relapsed or refractory acute leukemia.
    


Intervention name(s): Bendamustine
Intervention type(s): Drug
Intervention MeSH terms: Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D and Omega-3 Inhibit Metabolic Syndrome
Condition: Type 2 Diabetes Mellitus; Hypertension; Hyperlipidemia; Obesity
MeSH terms: Diabetes Mellitus, Type 2; Metabolic Syndrome; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will test the hypothesis that supplementing the diet of subjects with Metabolic
      Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will
      facilitate weight loss, improve body composition and reduce metabolic and biochemical risk
      factors associated with type II diabetes and cardiovascular disease. Adult men and women who
      meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled
      and embark on a 16 week diet and exercise intervention using a low glycemic index diet with
      or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and
      blood collected at weeks 0 and 16.
    


Intervention name(s): low glycemic diet; vitamin D omega-3
Intervention type(s): Other; Dietary Supplement
Intervention description(s): a low glycemic diet, calorie restricted with exercise sessions 3 times per week; 2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss; overweight; body composition; visceral obesity; insulin; glucose tolerance; cholesterol; hypertriglyceridemia
Long-Term Effects of Iodine I Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Condition: Lymphoma; Quality of Life
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Observational

Summary: 
      RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help
      improve the ability to plan effective treatment and follow-up care.

      PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab
      and autologous bone marrow or stem cell transplantation in patients with relapsed or
      refractory non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the progression-free survival and overall survival of patients with relapsed
           or refractory B-cell non-Hodgkin's lymphoma previously treated with iodine I^131
           tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC
           protocols 296, 521, 792, or 915.

        -  Determine the long-term toxic effects of this regimen in these patients.

        -  Determine the quality of life of patients treated with this regimen.

      OUTLINE: This is a long-term, follow-up study.

      Patients undergo testing for human anti-mouse antibody at 1, 3 and 12 months. Patients
      undergo physical examinations, blood tests, and immune system assessments every 3 months for
      1 year and then annually thereafter. Thyroid, pulmonary, and cardiac function are assessed at
      1 year and then annually as needed. Patients also undergo CT scans and bone marrow biopsy (if
      clinically indicated) annually for up to 10 years.

      Quality of life is assessed annually.

      PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients previously treated with myeloablative doses of iodine I^131 tositumomab and
        autologous bone marrow or stem cell transplantation on 1 of the following phase I or II
        protocols:

          -  FHCRC-296

          -  FHCRC-521

          -  FHCRC-792

          -  FHCRC-915
      
Keywords: quality of life; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent small lymphocytic lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; Waldenstrom macroglobulinemia; recurrent adult grade III lymphomatoid granulomatosis; splenic marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma