bioihbjkbjnl/mcl2 huggingface dataset:
Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation
Condition: Patients Undergoing Liver Transplantation
Study type: Observational [Patient Registry]

Summary: 
      Although the negative impacts of colloid solutions with high molecular weight on renal
      functions, combination of lower molecular weight colloid varieties with crystalloid solutions
      and its use during intraoperative period have been subject to current research. Since the
      first liver transplantation, pre-or post-transplantation renal problems are still among the
      main causes of mortality and morbidity. The aim of the study was to evaluate the effects of
      fluid replacement solutions used intraoperatively on renal functions in elective living-donor
      liver transplantation.This study was approved by the Ethics Committee of Hospital and all
      patients were informed and gave written consent. Participants were patients scheduled for
      elective living-donor liver transplantation. Patients with normal renal function were
      randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group).
      Blood samples were obtained before induction of anesthesia (baseline), at the end of the
      operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD,
      CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.
    


Intervention name(s): %6 HES and %4 Gelofusine
Intervention type(s): Drug
Intervention MeSH terms: Polygeline
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing living donor liver transplantation
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on
      endogenous hormone levels associated with breast cancer among sedentary postmenopausal women
      and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone
      levels.
    

Detailed description: 
      Physical activity has been associated with a decreased risk for breast cancer. The biological
      mechanism(s) underlying the association between physical activity and breast cancer is not
      clear. Most prominent hypothesis is that physical activity may protect against breast cancer
      through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical
      activity prevents overweight and abdominal adiposity.

      In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are
      randomly allocated to an intervention or a control group. The intervention consists of an
      1-year moderate-to-vigorous intensity aerobic and strength training exercise programme.
      Participants allocated to the control group are requested to retain their habitual exercise
      pattern. Primary study parameters measured at baseline, at four months and at 12 months are:
      serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding
      globulin and insulin. Other study parameters include: amount of total and abdominal fat,
      weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.

      This study will contribute to the body of evidence relating physical activity and breast
      cancer risk and will provide insight into possible mechanisms through which physical activity
      might be associated with reduced risk of breast cancer in postmenopausal women.
    

Intervention name(s): Physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Physical activity; Sex steroid hormones; Breast cancer risk; Intervention study; Postmenopausal women
Respiratory Problems and Caries in Children With Bruxism
Condition: Bruxism; Dental Caries
MeSH terms: Dental Caries; Bruxism
Study type: Observational

Summary: 
      The aim of the present study are to determine whether there is an association between
      respiratory problems and dental caries in children who exhibit the habit of bruxism.
    

Detailed description: 
      Objectives: The aim of the present study was to determine whether there is an association
      between respiratory problems and dental caries in children who exhibit the habit of bruxism.

      Method: Patient histories were taken and clinical exams were performed on 90 children for
      selection and allocation to one of two groups. For the determination of bruxism, a
      questionnaire was administered to parents/guardians and an oral clinical exam was performed
      based on the criteria of the American Academy of Sleep Medicine. Thirty-three male and female
      children between four and seven years of age participated in the present study - 14 children
      with bruxism and 19 children without bruxism. The data were statistically analyzed using the
      chi-square test, with level of significance set at 5% (p < 0.05).
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with either the complete primary or mixed dentition who were not in dental
        treatment were included in the study and divided into two groups: those with bruxism and
        those without bruxism. For the diagnosis of bruxism, a questionnaire was administered to
        determine the occurrence of teeth clenching/grinding and a physical exam was performed for
        the determination of dental wear based on the criteria of the American Academy of Sleep
        Medicine. Dental caries were determined based on the criteria of the World Health
        Organization
      
Keywords: bruxism; children; oral breathing; dental caries
Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with
      placebo in Japanese patients with Type 2 Diabetes Mellitus.
    

Detailed description: 
      The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75
      mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients
      with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design.
      The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline.
      The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.
    

Intervention name(s): 10mg DS-8500a tablet; 75mg DS-8500a tablet; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Firuglipel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus
Indole-3-Carbinol in Preventing Cancer in Healthy Participants
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
      or coming back. The use of indole-3-carbinol may prevent cancer.

      PURPOSE: This randomized phase I trial is studying the side effects and best dose of
      indole-3-carbinol and to see how well it works compared to placebo in preventing cancer in
      healthy participants.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of indole-3-carbinol in healthy participants.

        -  Determine the safety and tolerability of this drug in these participants.

        -  Determine the pharmacokinetics of this drug in these participants.

      Secondary

        -  Determine the effects of this drug on selected markers of sexual function in these
           participants.

        -  Determine the effects of this drug on markers of susceptibility to cancer in these
           participants.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study.
      Participants at each dose level are randomized to 1 of 2 treatment arms.

        -  Arm I: Participants receive a single dose of oral indole-3-carbinol on day 1.

        -  Arm II: Participants receive a single dose of oral placebo on day 1. Cohorts of 3
           participants receive escalating doses of indole-3-carbinol until the maximum tolerated
           dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3
           participants experiences dose-limiting toxicity. An additional cohort of 3 participants
           is treated at the MTD.

      Participants are followed on days 2, 3, and 6.

      PROJECTED ACCRUAL: A total of 24 participants (18 in arm I and 6 in arm II) will be accrued
      for this study.
    

Intervention name(s): indole-3-carbinol
Intervention type(s): Drug
Intervention MeSH terms: Indole-3-carbinol
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: unspecified adult solid tumor, protocol specific
Development of a Blended Lifestyle Intervention to Promote Physical Activity, Diet, and Health in Hong Kong Older Adults
Condition: Health Behavior; Physical Activity; Healthy Diet
Study type: Interventional

Summary: 
      This pilot study will provide a theory-based low-cost and easy-to-operate program in the area
      of healthy lifestyle promotion among community dwelling older adults. The blended
      intervention product will be helpful for health professionals, social workers and
      practitioners working in the elderly centers and health centers to promote older adults' PA,
      healthy diet and wellness. Furthermore, this study would initiate advocacy for policymakers
      to disseminate cost-saving, time-efficient and effective healthy lifestyle programs to the
      communities for healthy aging promotion.
    

Detailed description: 
      Project Objectives

        1. To review and meta-analyze lifestyle interventions for promotion of physical activity,
           diet and health among older adults.

        2. To assess the feasibility of the pilot study.

        3. To assess acceptability of the pilot study.

        4. To examine between-group differences in changes of physical activity (min/week), diet
           (portion/day), physical health-related outcomes (physical fitness, blood pressure,
           fasting blood sugar, and blood lipids), mental health-related outcomes (depression,
           loneliness) and health-related quality of life (QoL) among the sample.

      A series of generalized linear mixed models (GLMM) will be applied to evaluate the
      intervention effects on outcome measures at T2, with time, groups, and their interaction as
      fixed effects. Per-protocol analyses will be used for primary analyses, while
      intention-to-treat approach will be used for sensitivity tests.
    

Intervention name(s): Blended intervention group
Intervention type(s): Behavioral
Intervention description(s): Face-to-face workshops will be delivered in the neighborhood elderly center every week. Each workshop will consist of two sections (a) a 60-minute PA session, including a Health talk (20 minutes), and a physical exercise training (40 minutes); and (b) a 60-minute healthy diet promotion, including group discussion and sharing (30 minutes), and knowledge of diet and nutrition (30 minutes).
In addition, a 15-minute online psychological session will be implemented following the PA and diet session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: face-to-face intervention; eHealth intervention; health behavior change; old adults
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to
      assess the safety and efficacy of orally administered DS102 capsules versus placebo in the
      treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): DS102; Placebo
Intervention type(s): Drug; Other
Intervention description(s): DS102; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
K1-70 - A Study in Subjects With Graves' Disease
Condition: Graves' Disease
MeSH terms: Graves Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first time that K1-70 will be administered to humans. The principal aim of
      this study is to obtain safety and tolerability data when K1-70 is administered as an IM
      injection or as an IV infusion to subjects with Graves' disease.

      Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction
      of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium
      antagonists may be used to control some of the symptoms of hyperthyroidism.

      K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo
      diagnostic and therapeutic tools for the management of patients with Graves' disease,
      patients with thyroid cancer and patients who would benefit from controlling receptor
      activity.
    

Detailed description: 
      Graves' disease is one of the most common overt autoimmune disorders. Patients with Graves'
      disease have thyroid over activity and hyperthyroidism. Symptoms of hyperthyroidism include
      goitre, fatigue, heat intolerance, sweating, weight loss despite good appetite, shakiness,
      inappropriate anxiety, palpitations of the heart, shortness of breath, tetchiness and
      agitation, poor sleep, thirst, nausea and increased frequency of defaecation.

      The rationale of this study is to obtain safety and tolerability data when K1-70 is
      administered as an intramuscular injection or as an IV infusion to subjects with Graves'
      disease.

      This information, together with the pharmacokinetic data, will help establish the doses and
      dosage regimen suitable for repeat administration to patients.

      This is an open-label study. The expected duration of each subject's participation in the
      study is approximately 18 weeks (including a screening period of up to 4 weeks).
    

Intervention name(s): K1-70 intramuscular or K1-70 intravenous
Intervention type(s): Drug
Intervention description(s): Each subject will receive one dose of K1-70 by IM injection or one dose of K1-70 by IV infusion on the morning of Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetic performance of film-coated tablet and granule
      formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized,
      four-period, four-treatment crossover design is used. In each period, each volunteer will
      receive a single oral dose of the tablet or granule formulation either with or without food.
    


Intervention name(s): RG1662 granules; RG1662 tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, oral administration of RG1662 immediate release granules; Single dose, oral administration of film-coated RG1662 immediate release tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
Condition: Cerebral Palsy, Spastic
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is
      affected by various causes in the prenatal, perinatal or postnatal period. Damage to the
      central nervous system in children with CP causes motor problems, balance and postural
      disorders. It is reported in the literature that the effects of balance and the effects of
      balance exercises in children with CP, similarly respiratory effects were also investigated.
      Balance and balance responses are especially important in children with ambulatory SP and
      balance problems are seen in most CP children. Insufficient control of respiratory muscles
      affects pulmonary ventilation negatively in children with CP. However, it seems that CP has
      limited articles in which respiratory muscle strength is investigated, and also limited
      studies involving inspiratory muscle training. Inspiratory muscle training is shown to
      improve pulmonary function and diaphragm (which is one of the core muscles) strength and have
      an effect on balance. Studies showed that respiratory muscle strength in children with CP is
      lower than in children with normal development. Nevertheless, there was no study showing the
      effects of respiratory muscle training on functional capacity and balance in children with
      CP. The aim of this study is to investigate the effects of balance training and inspiratory
      muscle training on functional capacity, balance, respiratory function and respiratory muscle
      strength in children with CP.
    


Intervention name(s): Conventional physiotherapy including balance exercises; Inspiratory muscle training
Intervention type(s): Other; Other
Intervention description(s): Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System. Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.; Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Balance; Inspiratory Muscle Training; 6-Minute Walk Test; Pulmonary Function Test; Postural Stability
Biomarkers in Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors identify and learn more about biomarkers related to cancer. It may also help doctors
      predict how well patients will respond to treatment.

      PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell
      lymphoma treated with combination chemotherapy with or without rituximab.
    

Detailed description: 
      OBJECTIVES:

        -  To identify genes predictive of clinical outcome (failure-free survival and overall
           survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP
           induction on ECOG-E4494 using the nuclease protection assay for measuring gene
           expression in paraffin-embedded tissue.

        -  To identify genes that change their prognostic profile with the addition of rituximab to
           CHOP chemotherapy.

      OUTLINE: This is a multicenter study.

      Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via
      nuclease protection assay.
    

Intervention name(s): gene expression analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E4402 from whom samples were submitted for research
      
Keywords: contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; recurrent adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once
      daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40
      consecutive weeks in participants who completed a phase 2 dose-ranging study.
    

Detailed description: 
      Both insulin hyposecretion and insulin-resistance are considered to be involved in the
      development of type 2 diabetes mellitus.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2
      peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of DPP-IV will improve glycemic control in patients with type 2 diabetes.

      To evaluate the long-term safety and efficacy of alogliptin, this extension study was
      administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2
      dose-ranging study) to participants who had completed the phase 2 dose-ranging study
      SYR-322/CCT-001 (NCT01263470).
    

Intervention name(s): Alogliptin; Alogliptin; Alogliptin; Alogliptin; Voglibose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.; Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.; Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.; Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.; Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Other intervention name(s): SYR-322; SYR-322; SYR-322; SYR-322; Voglib; BASEN®
Intervention MeSH terms: Alogliptin; Voglibose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy