bioihbjkbjnl/mcl2 huggingface dataset:
Exploring the Impact of " ACP Board Game for Life" on Death Preparation and Anxiety in Patients With Stage 4 and 5 Chronic Kidney Diseases: A Pilot Study
Condition: Chronic Kidney Disease; Chronic Renal Failure; Chronic Renal Insufficiency; End of Life Care; Advance Care Planning; Death Anxiety
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Death; Anxiety Disorders
Study type: Interventional

Summary: 
      This study was to explore the impacts of participating in "ACP board game for life" on death
      preparation, death anxiety, end-of-life care preferences, and intervention perception in
      stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center.
    

Detailed description: 
      This study was to explore the impacts of participating in "ACP board game for life" on death
      preparation, death anxiety, end-of-life care preferences, and intervention perception in
      stage 4-5 CKD patients with advanced chronic kidney diseases in a medical center. A
      nonrandomized two-arm pretest and posttest quasi-experimental design was used. Patients in
      the control group received routine care while patients in the experimental group received
      routine care and ACP board game for life. The ACP board game, death preparation subscale,
      Chinese Likert death anxiety scale, self-created questionnaires and brief interview were used
      for data collection.
    

Intervention name(s): ACP board game for life
Intervention type(s): Other
Intervention description(s): The research subjects will be assigned to the experimental group or the control group according to their wishes. Those who are willing to participate the ACP board game will be assigned to the experimental group. The intervention time for each board game is around 2 hours. There are 60 cards in this ACP board game; the focus of the game is to know the participants' thoughts on the card options. Questionnaires need to be filled in before and after intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Chronic Kidney Disease; Death Preparation; Death Anxiety; Advance Care Planning; Board Game
Evaluation of the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program
Condition: Obesity; Obesity, Morbid; Obesity, Visceral; Central Obesity; Metabolic Disease; Hypertension; Dyslipidemias; Type 2 Diabetes; Visceral Obesity
MeSH terms: Obesity; Dyslipidemias; Metabolic Diseases; Obesity, Morbid; Obesity, Abdominal
Study type: Observational

Summary: 
      A retrospective review of body composition outcomes of participants of a comprehensive
      visceral-fat focused anti-obesity program. Data from approximately 2000-2500 participants are
      expected to be included in the study.
    

Detailed description: 
      This is a retrospective, multi-center clinical study to evaluate the efficacy of the
      20Lighter comprehensive anti-obesity program in reducing body composition measures including
      body weight, body fat, visceral adiposity, intracellular fluid, and other metrics of
      interest. Anecdotal evidence on reductions of prescription medication, chronic health issues,
      and improvements in quality of life will be gauged via review of patient assessment forms and
      surveys.
    

Intervention name(s): 20Lighter anti-obesity program
Intervention type(s): Other
Intervention description(s): A customized expert supervised 3-phase program including non-invasive proprietary nutritional, behavioral, and physiological components.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults over the age of 18 with overweight or obesity, and may have other comoribid
        conditions including hypertension, type 2 diabetes, dyslipidemia, cardiovascular disease
        (CVD), nonalcoholic fatty liver disease, sleep apnea, and other related health issues.
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
Condition: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-cohort, open-label study in previously untreated participants with chronic
      lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), excluding those with the 17p
      deletion, to evaluate a debulking strategy that would enable all participants to receive
      subsequent venetoclax as outpatients, with lower risk of tumor lysis syndrome.
    

Detailed description: 
      Safety and efficacy data through 13 October 2021 are included in the interim analysis, which
      was conducted after all participants completed the post-treatment Week 65 visit or
      discontinued from the study.
    

Intervention name(s): Obinutuzumab; Bendamustine; Venetoclax
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered via intravenous infusion; Administered via intravenous infusion; The venetoclax dose was administered according to a weekly ramp-up schedule over 5 weeks to the recommended daily dose of 400 mg. Participants were instructed to take venetoclax tablets with a meal and water at approximately the same time each day. Venetoclax tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing.
Other intervention name(s): Gazyva; Bendeka; Venclexta; ABT-199; GDC-0199
Intervention MeSH terms: Venetoclax; Bendamustine Hydrochloride; Obinutuzumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Chronic Lymphocytic Leukemia; 17p Deletion; Debulking; Obinutuzumab; Bendamustine; Tumor lysis syndrome; Venetoclax; Small Lymphocytic Lymphoma
A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome
Condition: Sickle Cell Disease
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from
      sickling of red blood cells, that can lead to pain or organ complications such as acute chest
      syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound
      important for dilating the blood vessel wall. Citrulline is a substance that is known to
      increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of
      continuous IV citrulline that can be given to individuals with sickle cell disease
      experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side
      effects.
    


Intervention name(s): Intravenous citrulline
Intervention type(s): Drug
Intervention description(s): Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sickle cell disease; citrulline
Efficacy and Safety of ATL-962 in Obese Diabetics
Condition: Non-Insulin-Dependent Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether ATL-962 induces weight loss in diabetic
      patients and whether its safety and tolerability profile is superior to that of orlistat in
      such patients
    

Detailed description: 
      Obesity is a significant and increasing clinical problem. There is a need for effective
      therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could
      reduce the amount of fat absorbed from a person's diet, leading to weight reduction.

      In this study patients with Type II diabetes who are clinically obese will receive ATL-962 at
      one of three dose levels, or placebo, or orlistat (another lipase inhibitor). The study will
      investigate the amount of weight lost after 12 weeks' treatment and will compare the safety
      and tolerability profile of ATL-962 and orlistat.
    

Intervention name(s): ATL-962; Orlistat
Intervention type(s): Drug; Drug
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Non-insulin-dependent diabetes mellitus; NIDDM; Type II diabetes; Obesity; Lipase inhibitor
Influence of the Proton Pump Inhibitor Omeprazole on the Anti-Platelet of P2Y12 Antagonists in Subjects With Coronary and Peripheral Artery Disease
Condition: Coronary Artery Disease; Peripheral Artery Disease
MeSH terms: Coronary Artery Disease; Peripheral Arterial Disease
Study type: Observational

Summary: 
      To determine if prasugrel is superior to clopidogrel in providing adequate antiplatelet
      effect in a high risk population that requires concomitant use of a Proton Pump Inhibitor
      (PPI).
    

Detailed description: 
      To evaluate if simultaneous treatment with the PPI omeprazole and a P2Y12 receptor antagonist
      will influence the effect of either clopidogrel and/or prasugrel on platelet reactivity in
      patients with Coronary Artery Disease (CAD) or Peripheral Arterial Disease (PAD).
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Coronary or Peripheral Artery Disease
      
Biospecimen description: 
      Blood specimens for platelet activity and genotyping
Cognitive Training for Mood and Anxiety Disorders
Condition: Major Depressive Disorder; Depression; Bipolar Disorder; Post-traumatic Stress Disorder; Generalized Anxiety Disorder; Social Phobia
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders; Depressive Disorder, Major; Stress Disorders, Traumatic; Bipolar Disorder; Stress Disorders, Post-Traumatic; Phobia, Social
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a computerized cognitive training
      program (an attention and memory exercise performed on a computer) on thinking and memory in
      individuals with mood and anxiety disorders, and to begin to test whether this training
      affects symptoms of depression or anxiety.
    

Detailed description: 
      The objective of this research protocol is to collect feasibility and pilot data
      investigating the efficacy of a computerized cognitive training paradigm. The training
      paradigm aims to enhance cognitive control for emotional information-processing and reduce
      the negative affective biases observed among those experiencing mood and anxiety symptoms and
      disorders. This protocol will also investigate whether improvements in cognitive control and
      affective bias are associated with changes in mood and anxiety symptoms. Participants will
      undergo 6 weeks of cognitive training sessions, with three sessions per week.
    

Intervention name(s): emotional memory training exercise; memory training exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive training; depression; bipolar depression; anxiety; ptsd; generalized anxiety; social phobia
Efficacy of Flywheel Inertial Resistance Training in the Architecture and Function of the Hamstring
Condition: Hamstring Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Investigate the efficacy of the inercial Flywheel training protocol in modifying the
      architecture and function of the hamstrings in patients with a history of structural muscle
      injury vs conventional training.

      The researchers hypothesize that inercial Flywheel training protocol will be a useful
      strategy in the modification of the architecture and function of the hamstring in patients
      with a history of indirect structural muscle injury and decrease the recurrence.
    

Detailed description: 
      Randomized controlled intervention study
    

Intervention name(s): Exercises program for hamstring architecture and function
Intervention type(s): Behavioral
Intervention description(s): To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hamstring Injury; Flywheel Inertial Resistance; Hamstring architecture; Ultrasound; Eccentric
Effect of Gastric Bypass on Patients With Type 2 Diabetes and/or Dyslipidemia
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Observational

Summary: 
      This is a retrospective review of patients who have undergone bariatric surgery at VUMC and
      who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that
      gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators
      are interested in looking at the longer term results after surgery.
    

Detailed description: 
      Review and record changes in the subject's medication. subjects vitals: weight, blood
      pressure, and fasting blood values, which include:

        -  HbA1c

        -  Fasting blood glucose

        -  Fasting Insulin

        -  Lipid Panel ( total cholesterol, LDL, HDL and triglycerides) were obtained.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Type 2 diabetes with a BMI over 35kg/m2
      
Keywords: Gastric by-pass on patients with T2DM
A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The primary aim of this study is to compare, in a group of at-risk individuals, the role of
      three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended
      Korean pattern; b) the typical American diet, based on national dietary intake surveys; and
      c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on
      intestinal microbiota and on inflammatory biomarkers.
    


Intervention name(s): Controlled Feeding Dietary Intervention
Intervention type(s): Other
Intervention description(s): All meals will be provided during each 4-week intervention period. Participants must consume all foods provided and must not consume any outside foods during each intervention period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary Objective:

      To describe the safety of the 2004-2005 pediatric formulation of the inactivated,
      split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the
      package insert for vaccine-naïve young children) to the investigational and control groups.

      Observational Objective:

      To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers
      (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the
      investigational and control groups.
    

Detailed description: 
      This is an observational and descriptive study that will provide preliminary comparative
      information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to
      12 weeks (the investigational group, also referred to as the 2-month-old group) versus
      children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group).
      The study is not designed to achieve any preset statistical power, and no hypotheses will be
      tested.
    

Intervention name(s): Influenza virus vaccine (2004-2005 Formulation); Influenza virus vaccine (2004-2005 Formulation)
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular; 0.25 mL, Intramuscular
Other intervention name(s): Fluzone® Preservative-free; Fluzone® Preservative-free
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza vaccine
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
Condition: Myopia; Hyperopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare subjective ratings of lens handling at insertion for
      a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
    

Detailed description: 
      This is a non-dispensing, randomized, double-masked, crossover study. Participants will wear
      2 different contact lenses bilaterally over 4 study visits, all conducted on the same day.
      Estimated duration of involvement for each participant is 4 hours.
    

Intervention name(s): Control Contact Lens; Test Contact Lens
Intervention type(s): Device; Device
Intervention description(s): Daily disposable contact lens for 90 minutes; Monthly replacement contact lens for 90 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Refractive Errors; Eye Diseases
Pharmacokinetics and Safety in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish
      pharmacokinetic similarity of BI 695501 to adalimumab.
    


Intervention name(s): BI 695501; adalimumab-EU source; adalimumab-US source
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 695501 single s.c. injection; adalimumab-EU source single s.c. injection; adalimumab-US source single s.c. injection.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Community-based Hepatitis B Interventions for Hmong Adults
Condition: Liver Cancer
MeSH terms: Hepatitis B; Liver Neoplasms; Hepatitis
Study type: Interventional

Summary: 
      The purpose of this study is to design an intervention to increase hepatitis B (HBV)
      screening among Hmong Americans.
    

Detailed description: 
      The investigators will design an intervention to measure the baseline proportion of Hmong
      adults (ages 18-64) that have been serologically tested for Hepatitis B. Investigators will
      work with lay health workers to promote serologically testing for Hepatitis B and increase
      knowledge of Hepatitis B among Hmong adults. The effectiveness of the lay health worker
      intervention will be evaluated by conducting a randomized, controlled trial among Hmong
      adults aged 18-64 not previously tested for hepatitis B.

      The primary hypothesis is that the proportion of Hmong adults, ages 18-64 reporting
      serologically testing for Hepatitis B at post-test will be significantly greater in the
      intervention group than in the control group.

      Secondary hypotheses are:

      There will be greater increases in knowledge of Hepatitis B and liver cancer in the
      intervention group than in the control group.

      Participants with greater knowledge of hepatitis B and liver cancer at post-test will be more
      likely to be serologically tested for hepatitis B.
    

Intervention name(s): HBV Screening - Small group educational session; Nutrition - Small group educational session
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Small group HBV focused discussion with HBV screening resources.; Small group session with diet & nutrition focused, topic related resources provided.
Other intervention name(s): Hepatitis B screening in Hmong population; Nutritional education for the Hmong population.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Asian American Health; Cancer; Hepatitis; Hepatitis B; Liver Cancer
Normobaric Hyperoxia Combined With Reperfusion for Acute Ischemic Stroke
Condition: Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke; Hyperoxia
Study type: Interventional

Summary: 
      NBO is a nonpharmacological measure of neuroprotection. The purpose of our study is to
      evaluate the safety and efficiency of NBO（Normobaric hyperoxia) in the acute ischemic stroke
      patients who received endovascular treatment. Looking for more clinical evidence for the
      ischemic stroke patients who will be treated with NBO in the future.
    


Intervention name(s): Normobaric oxygen therapy
Intervention type(s): Drug
Intervention description(s): In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Normobaric hyperoxia;; Acute ischemic stroke;; vascular recanalization;; Endovascular treatment;; reperfusion therapy