bioihbjkbjnl/mcl2 huggingface dataset:
Building Stronger Allies
Condition: Suicide; Risk Reduction
MeSH terms: Suicide
Study type: Interventional

Summary: 
      BSA is a novel, computerized intervention specifically designed for active military personnel
      with the intent to reduce two risk factors known to be associated with suicide outcomes.
    

Detailed description: 
      The investigators have focused on the identification of malleable risk factors for
      preventative intervention in a number of types of psychopathology including suicidality. In
      the case of Perceived Burdensomeness (PB) and Thwarted Belongingness (TB), theory suggests
      that they may be malleable, though this has received little empirical attention. Taken
      together, the Interpersonal Theory of Suicide and related empirical literature suggest that
      targeting PB/TB should offer a novel and important avenue to reduce suicidality. This
      inspired the investigators' efforts to create and evaluate an intervention - called Building
      Stronger Allies (BSA) - designed to reduce these factors.
    

Intervention name(s): Building Stronger Allies; Health Education Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): BSA was developed to model the educational and behavioral techniques commonly employed in the treatment of individuals with mood psychopathology. The psychoeducation portion uses Cognitive Behavioral Therapy principles to correct problematic ideas and behaviors related to PB/TB. More specifically, the program was designed to correct "myths" regarding PB/TB. The program emphasizes the idea that social interaction is a critical need, just like other basic needs such as the need for food and water. Participants are taught that negative beliefs about being isolated and being a burden are usually inaccurate. Following this, behavioral activation techniques are introduced as a way to decrease isolation and feelings of burdensomeness.; In the HET condition, participants will spend approximately the same amount of time with a program that will present information regarding the importance and benefits of a maintaining a healthy lifestyle and then will provide guidelines to achieve a healthy lifestyle. HET is shown to engage participants with beneficial information while being inert with respect to the risk mechanisms of interest (i.e., PB/TB). The program covers a number of health related topics including: diet, alcohol use, water consumption, exercise, and sleep. The program reviews with the Participants how to monitor their own daily health habits, which will be reinforced by the Smartphone application.
Other intervention name(s): BSA; HET
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 510 participants will be randomly assigned to one of two conditions (1) BSA or (2) HET Control.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Suicide; Prevention; Risk Factor; Intervention; Military
HINCAB-study. Home Based Intervention in Nursing for Coronary Artery Bypass Patients
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      HINCAB-study is a single senter, prospective, randomised controlled trial. The aim of the
      study is to test the effect of a home based intervention program. The hypothesis of the study
      is that a home based intervention will influencing coping strategies in the CABG-patients
      rehabilitation phase, reduce symptoms and improve health related quality of life.
    

Detailed description: 
      Research has shown better quality of life for patients after CABG. At the same point of time
      studies shows that patients experience anxiety and depression years after surgery. Anxiety
      and depression appear frequently at the same time and strengthen each other. Studies
      underline that CABG-patients especially the first month after surgery want follow-up by
      health care provider. Anxiety and depression are assessed as independent risk factors for
      morbidity and death in heart patients.

      203 CABG-patients were randomised into the study. Both patient group, the experimental- and
      control group, answered the same three standardised questionnaires before surgery, 6 weeks
      and 6 months after surgery. The questionnaires are Hospital Anxiety and Depression Scale
      (HADS), Seattle Angina Questionnaire (SAQ) and SF-36.

      The intervention consist of two home visits 2 and 4 weeks after CABG undertaken by project
      leader. The intervention protocol has been approved by The Norwegian Committee for Medical
      Research Ethics.

      Knowledge from this study may generate a basis for clinical guidelines and patient pathways.
      Results from this study will show if the home based intervention in the future will be
      performed for only a risk group of about 20 % that have responded best to the intervention.
      In the future the intervention also may be individualized electronically.
    

Intervention name(s): HINCAB
Intervention type(s): Behavioral
Intervention description(s): Psycho-educative intervention performed 2 and 4 weeks after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Anxiety. Depression. HRQOL. Psycho-educative intervention
A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion
Condition: Absorption; Chemicals
Study type: Interventional

Summary: 
      Think of this section as your research "elevator pitch." Please briefly describe the
      question(s) or issues you are addressing with your research (limited to 100 words). You will
      be able to provide information on specific outcomes, hypothesis, or related analysis in a
      following question.

      Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been
      shown to impact how our body metabolizes fuel. We seek to determine the bioavailability of
      different doses of orally ingested beta-aminoisobutyric acid (BAIBA).
    

Detailed description: 
      Once determined eligible and provided consent, participants will be assigned in a randomized,
      double-blind, placebo-controlled, crossover fashion. Eligible study participants will
      complete one of five testing conditions outlined below. For each testing condition, study
      participants will arrive in the lab after observing an overnight fast. Upon arrival,
      participants will donate the first of seven venous blood samples. Follow-up blood samples
      will be collected at 30, 60, 90, 120, 240, 300 minutes. The first and last collected samples
      will be collected into one 8mL SST and three 4mL EDTA tubes, while the second, third, and
      forth collected samples will be into two 4mL EDTA tubes, and have aliquots of 600 ul of
      plasma isolated and frozen at -80oC. Collected plasma will be analyzed for changes in
      beta-aminoisobutyric acid (BAIBA) and biomarkers commonly assessed by physicians to evaluate
      healthy. Participants will observe a minimum of 48 hours washout between conditions.
    

Intervention name(s): Beta-Aminoisobutyric Acid
Intervention type(s): Dietary Supplement
Intervention description(s): All supplements provided to all research participants containing BAIBA, L-Valine or placebo will be procured and prepared in a similar manner. Briefly, beta-amino isobutyric acid (BAIBA), L-Valine (an amino acid), and a resistant starch commonly consumed in various foods will be used as test agents for this study protcol. All supplements (both BAIBA and Valine) as well as placebo are produced and provided by NNB Nutrition. A certificate of analysis is provided in the attachments for the BAIBA. All supplements (BAIBA, L-Valine, and placebo) will be administered in gelatin capsules and consumed with a specified amount of cold tap water. The same number of capsules will be administered each time. All doses will be capsulated by manufacturer prior to use in the study protocol.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, crossover design
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only])
      plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6
      CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus
      placebo.
    

Detailed description: 
      Eligible patients who are unable to achieve adequate apheresis cell counts may enter an
      Open-Label Rescue Period where they will receive plerixafor, following the same study
      schedule as during the Double-Blind Treatment Period.
    

Intervention name(s): Granulocyte-colony stimulating factor (G-CSF); Plerixafor; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection; 0.24 mg/kg/day subcutaneous injection; 0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection
Other intervention name(s): GRAN®, Filgrastim; Mozobil, AMD3100, GZ316455
Intervention MeSH terms: Plerixafor; Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hematopoietic stem cell transplantation
Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study evaluates the hypothesis that a meal constituted of only glucose produces
      differences in the brain blood flow in people with obesity that are not observed in people
      without obesity. These changes, at least in part, could explain the mechanisms involved in
      maintenance or development of obesity.
    


Intervention name(s): 75 grams of glucose plus water solution; Pure water
Intervention type(s): Other; Other
Intervention description(s): A solution composed by 75 grams of glucose and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
300 mL final volume of the solution.
Time of oral ingestion inferior than 2 minutes.
30 minutes before the radiopharmaceutical injection.
12 hours fasting minimum.; Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
300 mL final volume of the solution.
Time of oral ingestion inferior than 2 minutes.
30 minutes before the radiopharmaceutical injection.
12 hours fasting minimum.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obesity; Single Photon Emission Computed Tomography; Functional Neuroimaging
Near-Infrared Spectroscopy-Guided Exercise Training in Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Background: Patients suffering with atherosclerotic peripheral arterial disease (PAD) have
      limited therapeutic options to improve claudication. Supervised exercise programs are
      generally effective in improving leg pain from walking, but are poorly adhered to because of
      patient discomfort. The benefit of exercise training programs is thought to be mediated in
      part through repeated ischemic stimuli that activate endogenous regenerative mechanisms. In
      preliminary studies, exercise-induced tissue desaturation by near infrared spectroscopy
      (NIRS) precedes the onset of leg pain. This proposal aims to explore a novel strategy of
      exercise training in PAD based on measured tissue hypoxia rather than pain symptoms using
      NIRS to non-invasively characterize muscle oxygen tension.

      Methods: In subjects with symptomatic peripheral arterial disease, the efficacy of a novel
      NIRS-based strategy of thrice-weekly exercise training will be assessed. Enrolled subjects
      will be randomized to NIRS-based training, traditional claudication-based training, or
      self-directed walking. The hypotheses tested include: 1) NIRS-directed exercise improves
      claudication to a similar degree as symptom-directed exercise training and 2) is superior to
      self-directed walking. In the symptom-based group, physical effort will be dictated by
      claudication symptoms, whereas in the hypoxia-based training program, physical effort is
      dictated by NIRS measure of calf oxygen tension. Efficacy in the training programs will be
      evaluated by total walking time on a standard graded treadmill test after 12 weeks. Other
      measures will be claudication onset time, subjective and objective measures of physical
      activity, changes in vascular function. In addition, the hypothesis that hypoxia-directed
      training will result in increased ischemic signaling and increased progenitor cell
      mobilization to a degree similar as in claudication-based training will be tested.

      Conclusions: These experiments will test whether a training strategy based on tissue hypoxia
      (measured by NIRS) is as effective as and more tolerable than traditional symptom-based
      training programs in PAD. In addition, these experiments will characterize mechanistic
      responses to hypoxia that may account for clinical improvements that exercise training
      affords.
    


Intervention name(s): Oxygen guided exercise therapy
Intervention type(s): Other
Intervention description(s): Subjects exercise to a certain intensity based on 15% muscle oxygen desaturation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Objective and Subjective Evaluation of Ophthalmic Lenses With Extra Power
Condition: Asthenopia
MeSH terms: Asthenopia
Study type: Interventional

Summary: 
      To evaluate subjective visual performance and objective visual parameters when wearing
      ophthalmic lenses with extra power (+0.4 D or +0.6 D), and ophthalmic lenses with a selective
      blue cut filter.
    


Intervention name(s): Ophthalmic lens with extra power
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
KEtogenic Diet and Its Multiple EffectS on Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide,
      therefore the study of their pathophysiology is extremely important to find new strategies
      for their treatment. Obesity has a strong impact not only on the metabolism of the patients,
      but also may impact hormonal, inflammatory and immune profile, and profoundly influence the
      daily life of the patients. Weight loss may determine an amelioration of these parameters,
      but the impact of the diet composition aimed to weight loss on them has not been profoundly
      studied yet.

      The aim of our research project is to study the effects of a ketogenic diet in comparison
      with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of
      life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and
      immunological parameters in obese patients.
    


Intervention name(s): Ketogenic diet; Balanced diet
Intervention type(s): Other; Other
Intervention description(s): Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.; Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; metabolism; circadian rhythm; sleep; quality of life; balanced diet; ketogenic diet; immune profile
Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the effect of valsartan on small vessel blood flow in patients with
      mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.
    


Intervention name(s): Atenolol; Hydrochlorothiazide (HCTZ)); Valsartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg tablets orally once a day (od) in the morning.; 12.5 or 25 mg tablets orally once a day (od) in the morning.; 80 mg, 160 mg, or 320 mg tablets orally once a day in the morning
Intervention MeSH terms: Atenolol; Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; valsartan; atenolol; hydrochlorothiazide; microcirculation; arterial compliance; pulse wave analysis
Effects of Increased, Egg-Based Protein Intake on Muscle Composition,
Condition: Muscle Composition; Sarcopenia; Hypertrophy; Inflammation
MeSH terms: Sarcopenia; Inflammation; Hypertrophy
Study type: Observational

Summary: 
      This study is designed to assess the effect of a diet-controlled nutrition program utilizing
      an egg-based higher protein diet on muscle composition and size, and indices of metabolic
      health and markers of systemic inflammation in older men and women who are slightly
      overweight.
    


Intervention name(s): Dietary Protein Intake
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary Protein Intake This is a 12-week randomized,prospective study incorporating a dietary intervention in which subjects will consume either higher protein(HP:1.4g protein•kg-1•d-1) or normal protein diet (NP:.8g protein•kg-1•d-1)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Men and Women between the ages of 65-80
      
Biospecimen description: 
      whole blood, serum, and muscle tissue
    
Keywords: Skeletal muscle lipid content; whole muscle volume; fasting glucose; insulin; blood urea nitrogen
The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single center, prospective randomized double blind, parallel and placebo controlled
      study to evaluate oxidative stress and inflammation before and after treatment with
      linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin sensitizer.
    

Detailed description: 
      This is a single center, prospective randomized double blind, parallel and placebo-controlled
      study to evaluate oxidative stress and inflammation before and after treatment with
      linagliptin for 12 weeks. The study enrolls type 2 patients with diabetes.
    

Intervention name(s): Linagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg daily oral tablets of linagliptin; matching placebo giving orally daily
Other intervention name(s): TRADJENTA
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter
Condition: Cardiac Output, Low; Cardiac Output, High; Congestive Heart Failure
MeSH terms: Heart Failure; Cardiac Output, Low; Cardiac Output, High
Study type: Observational

Summary: 
      Invasive pulmonary capillary wedge pressure measurements using a Swan-Ganz catheter (SGC) is
      considered the gold standard for cardiac output (CO) monitoring. In this prospective study,
      we will compare CO measurements between a PPG-based wearable monitor and a SGC in ambulatory
      CHF patients.
    


Intervention name(s): non-invasive monitoring
Intervention type(s): Device
Intervention description(s): non-invasive measurements of cardiac output
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients from both sexes with CHF arriving for an ambulatory assessment using a
        Swan-Ganz catheter in the Medical Center's Cath-lab.
      
Keywords: Non-Invasive Monitoring; Cardiac Output