bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Health Information Needs of Brain Cancer Patients
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      The purpose of this research is to explore the factors involved in brain cancer health care
      literacy needs.
    

Detailed description: 
      A mere subset of the reasons behind unmet health care literacy needs include the health care
      systems' increasing complexity, increased time constraints, profound treatment decision
      making requirements, decreased financial resources, fracturing social networks and
      diversifying educational and cultural needs.

      This project will use focus groups to explore the factors involved in brain cancer health
      care literacy from the perspectives of patients and those involved in their care. Hypothesis
      generated from this project will be directly applied toward future projects. The overarching
      goals are improved access and adequacy of health care literacy information through the
      eventual development of validated, useful, reliable health care literacy information tools
      for brain cancer patients and those involved in their care.
    

Intervention name(s): Focus Group
Intervention type(s): Other
Intervention description(s): A single focus group will be held until a "saturation" of themes has been identified.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited during routine interactions with the investigators.
      
Keywords: Brain Tumor; Brain Neoplasm
The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
Condition: Healthy
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of our graduate student research study is to observe the effects of ginger on
      hsCRP, IL-6, and TNF-α levels in exercising individuals based on their level of activity.
    

Detailed description: 
      Participants will fill out a demographic questionnaire and a quality of life survey, (SF-36).
      Take a 3g supplement of ginger in powder form with meals once/day (preferably in the morning)
      for 8 weeks. By end of week 4 (halfway through the study), subjects will do another blood
      test for mid-intervention CRP, IL-6, and TNF-α values. By end of week 8, participants will do
      a final blood test for CRP values and fill out the SF-36 survey for post-intervention levels.
    

Intervention name(s): Ginger
Intervention type(s): Dietary Supplement
Intervention description(s): 3g ginger powder supplement once a day with meals (preferably in the morning) for a duration of 8 weeks. Powder can be mixed with juice or water.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to evaluate whether tacrolimus dose reduction in de novo renal
      recipients receiving everolimus can preserve renal function while maintaining efficacy.
    


Intervention name(s): Everolimus (RAD001); Tacrolimus; Basiliximab; Corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Everolimus; Tacrolimus; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to estimate the treatment effect of PDA001 (evaluating
      3 different PDA001 dosings) versus placebo in subjects with moderate-to-severe Crohn's
      Disease. The secondary objective of the study is to assess the safety and tolerability of
      PDA001 versus placebo in the above-mentioned patient population.
    


Intervention name(s): Human Placenta-Derived Cells PDA001 Intravenous Infusion; Vehice Control
Intervention type(s): Biological; Drug
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Placenta-Derived Cells for the Treatment of Moderate-to-Severe Crohn's Disease
Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

      PURPOSE: This research study is studying biomarkers in blood samples from patients with
      refractory non-small cell lung cancer previously treated with sorafenib tosylate.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell
           lung cancer treated with sorafenib tosylate on protocol ECOG-2501.

        -  To determine the association between BRAF, KRAS, or EGFR mutation status and clinical
           benefits in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.
    

Intervention name(s): DNA analysis; mutation analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients enrolled on E2501
      
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Therapeutic Exploratory Study of CWP-0403
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate
      optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks
      to type 2 diabetes patients who are insufficiently controlled by diet and exercise in
      comparison to placebo.
    


Intervention name(s): CWP-0403 100mg; placebo; CWP-0403 50mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks; Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.
Twice a day, 1 tablet at a time for 12 weeks; 50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Family Psychoeducation for Children With Mood Disorders
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation
      Group for the families of children with mood disorders.
    

Detailed description: 
      Mood disorders among youth are a major health concern. Existing mood disorder studies focus
      on adults, and studies that focus on effective intervention strategies for youth with mood
      disorders are needed. This 8-session study is an adjunct to ongoing medication management and
      individual and family psychotherapy for children with mood disorders.

      In this study, parents learn about mood disorders, their treatments, and how to work
      effectively with mental health and school systems. Parents also practice problem-solving and
      communication skills for symptom management. Children learn about mood disorders and their
      treatments, including basic cognitive-behavioral principles. Children also learn and practice
      anger management, problem-solving, and communication skills.

      Patients and their families are randomly assigned to 1 of 2 groups. The first group receives
      8 sessions of psychoeducation plus treatment as usual (TAU). The second group is a wait-list
      control in which participants receive only TAU. Patients and caregivers undergo a variety of
      interviews, tests, and behavioral observations throughout the study. Anxiety, depression,
      psychosocial stressors, manic symptoms, and children's experiences with psychotropic
      medications and with treatment or service providers are assessed. Caregivers, teachers, and
      family friends undergo interviews and make observations of the patient's level of support,
      general appearance and behavior, and overall functional capacity. The extent to which
      caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood
      disorders is also assessed. Assessments occur at 3, 6, 12, 15, and 18 months after study
      enrollment. A comprehensive assessment is conducted at study entry and 1 year later.
    

Intervention name(s): Multifamily Psychoeducation Group (MFPG); Treatment as usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MFPG will include 8 weekly 90-minute group therapy sessions.; Participants will receive standard care for mood disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Randomized Controlled Trial of Shang Ring Male Children Circumcision: Comparison Between Flip and No Flip Technique
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This is a prospect, randomized control trial to evaluate merits between flip and no flip
      technique in Shang Ring children circumcision.
    

Detailed description: 
      The boys between 7 and 12 years old seeking for circumcision in The Affiliated Hospital of
      Medicine School of Ningbo University will be evaluated. Those who match the inclusion
      criteria and without exclusion criteria will be recruited.

      The investigators will perform randomization preoperatively. participants were distributed
      into No Flip Group and Flip Group correspondingly according to a table of random number.

      All of the procedures will be performed by a specific study surgeon in the hospital operation
      room. An assistant will take the pictures and recorder the parameters needed. In both groups,
      participants will be measured twice by a scale plate of holes, the diameter of penis with the
      foreskin noneverted and the diameter of exposed glans. Local anesthesia will be administered
      to the dorsal penile nerve using 2% lidocaine. The operation will not begin until the
      anesthesia is satisfied. The proper ring will be chosen according to different strategies of
      two groups. Participants will stay in hospital for 24 hours after operation. Pain during
      operation, half a hour post-operation and 24 hours will be evaluated, adverse events at
      hospital will be recorded carefully as well.

      Participants will be advised to return usually at 7th, 14th, 21st, 28th and 90th
      post-operative days. However, if the wound does not heal completely 28 days post-operatively,
      the participant will be asked come to visit weekly until complete healing. All of the
      assessments will be performed and recorded by the lead investigator.
    

Intervention name(s): No flip technique of Shang Ring circumcision; Flip technique of Shang Ring circumcision
Intervention type(s): Device; Device
Intervention description(s): Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the glands, inner ring is placed into foreskin cavity, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Ring is detached spontaneously.; Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the penis, inner ring is placed around the penis, flip foreskin over the inner ring, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Remove the ring 7days postoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Circumcision, Male; Shang Ring; Children; Foreskin
Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
Condition: Rhinitis; Rhinoconjunctivitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, non-controlled, non-randomised, prospective safety study in patients
      with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically
      relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.
    

Detailed description: 
      The objective is to evaluate the safety and tolerability of the administration of two
      allergen extracts of dust mite mixtures at 200 DPP/ml (DP/MG/14-1 Dermatophagoides
      pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus /
      Lepidoglyphus destructor) using a rush build-up phase in patients with allergic rhinitis or
      rhinoconjunctivitis, with controlled asthma.
    

Intervention name(s): DP/MG/14-1; DP/MG/14-2
Intervention type(s): Biological; Biological
Intervention description(s): The administration regimen will consist of a rush build-up régimen and a follow up period; The administration regimen will consist of a rush build-up régimen and a follow up period
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Weight Reduction on Inflammatory Markers and Genes Expression in Obese Individuals
Condition: Obesity; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      To investigate whether weight reduction by life style modification for 12 weeks will improve
      circulating inflammatory markers, adipocytokines as well as gene expression of
      proinflammatory protein obtained from circulating monocytes from obese individuals.
    


Intervention name(s): Lifestyle modification
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Obesity; Inflammation
Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength
Condition: Lumbar Spine Fusion
Study type: Interventional

Summary: 
      To analyze safety and the effects of early initiation of the rehabilitation. Including the
      objective measurement outcomes after lumbar spine fusion, based on the principles of strength
      training.
    

Detailed description: 
      The 27 patients were recruited for the study, aged 45 to 70 years, who had undergone lumbar
      spine fusion. The patients were randomized in to two groups. The strength training group
      started rehabilitation 3 weeks after surgery. The patients exercised two times per week, over
      9 weeks. The focus was on muscle activation of lumbopelvic muscles stabilization. The control
      group followed a standard postoperative protocol, where no exercises were performed at the
      rehabilitation stage. The functional outcomes and the plain radiographs were evaluated after
      3 weeks and subsequently after 3 and 18 months after the surgery.
    

Intervention name(s): The training group
Intervention type(s): Behavioral
Intervention description(s): The training group performed rehabilitation program twice per week over 9 weeks. The group commenced rehabilitation 3 weeks after the surgery. During the phase one training (week 1 to week 5), the isometric exercises were preformed on the trunk extension, flexion and lateral flexion muscles. During the phase 2 (week 6 to week 9), the exercises were performed on the strength machines and duration of the exercises were maintained and prolonged to 30 seconds. The leg adduction and hip extension exercises were added. The patients were instructed to perform abdominal bracing (IAP) and maintain the neutral position of their lumbar spine before and during the exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rehabilitation; randomized controlled trial; strength training; early initiation; intra-abdominal pressure
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder
      in healthy subjects.
    

Detailed description: 
      The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
      Study with a washout period of 7 days. During each session, the subjects will receive a
      subcutaneous single dose of rE-4 (rE-4 Injection 10µg or rE-4 Freeze-dried Powder 10µg)
      administered 30min prior to the start time of a standard breakfast.
    

Intervention name(s): rE-4 Injection; rE-4 Freeze-dried Powder
Intervention type(s): Drug; Drug
Intervention description(s): During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Injection 10µg administered 30 minutes prior to the start time of a standard breakfast.; During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Freeze-dried Powder 10µg administered 30 minutes prior to the start time of a standard breakfast.
Other intervention name(s): Recombinant Exendin-4 Injection; Recombinant Exendin-4 Freeze-dried Powder
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CRTd Responders Optimization
Condition: Heart Failure; Heart Failure With Reduced Ejection Fraction; Cardiac Death
MeSH terms: Heart Failure; Death
Study type: Observational

Summary: 
      Suboptimal optimization of atrio-ventricular (AV) and inter-ventricular (VV) timings could
      affect the clinical response of CRTd in T2DM patients. Thus, authors hypothesize that
      automatic sensor guided CRTd optimization could ameliorate clinical outcomes in patients with
      T2DM. However, authors will evaluate the effects of cardiac resynchronization therapy (CRTd)
      in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs.
      echocardiographic guided approach.Authors will conduct a prospective, multicenter study to
      recruit, from October 2016 to June 2019, patients with T2DM and heart failure (HF) candidate
      to receive a CRTd. After CRTd the patients will be optimized via automatic vs.
      echocardiographic guided approach.
    


Intervention name(s): echocardiographic optimization of CRTd
Intervention type(s): Other
Intervention description(s): the patients after the implant of CRTd and during the follow-up will receive an echocardiography to optimize the atrio-ventricular and inter-ventricular delay, and to improve the effects of CRTd.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged more than 18 and less than 75 affected by chronic heart failure in NYHA class
        II/III with reduced cardiac pump and indication to receive a CRTd.
A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study seeks to evaluate the safety, tolerability, pharmacokinetics (PK) and
      immunogenicity of ABT-555 in participants with relapsing forms of multiple sclerosis (RFMS).
    


Intervention name(s): ABT-555; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intravenous Infusion; Intravenous Infusion
Other intervention name(s): Elezanumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Relapsing-remitting; Secondary progressive; Relapsing forms