bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Depressive Symptoms in Breast Cancer Patients: Comparison of Cognitive Therapy and Bright Light Therapy
Condition: Treatment of Depressive Symptoms in Cancer Patients
MeSH terms: Depression
Study type: Interventional

Summary: 
      Depressive symptoms are highly frequent among cancer patients. These symptoms significantly
      impair quality of life (e.g., hopelessness, greater risk of suicidal behaviours) and may even
      affect patients' prognosis (e.g., through decreased adherence to cancer treatments).
      Cognitive therapy (CT) is an established treatment for depression in the general population,
      but its efficacy has not yet been investigated in non-metastatic cancer patients.
      Furthermore, because the accessibility to CT is very limited in routine cancer care and
      because many patients are reluctant to use pharmacological treatment, they often turn to
      alternative treatments such as bright light therapy (BLT), but empirical data on its efficacy
      are needed before its use can be recommended. Goal 1: To assess at post-treatment, as
      compared to a waiting-list control condition, the effect of bright light therapy (BLT) and
      cognitive therapy (CT): (1a) in reducing depressive symptoms; and (1b) in improving
      subjective and objective sleep parameters, in reducing fatigue and anxiety and in increasing
      patients' functioning and quality of life. Goal 2: To compare at post-treatment and at 3- and
      6-month follow-ups the effect of BLT and CT : (2a) in reducing depressive symptoms; and (2b)
      in improving subjective and objective parameters of sleep, in reducing fatigue and anxiety
      and in increasing patients' functioning and quality of life. It is hypothesized that, As
      compared to control patients after their waiting period, both BLT and CT groups will have
      significantly greater improvement of all symptoms at post-treatment. However, as compared to
      BLT patients, CT patients will show greater improvements of all symptoms at post-treatment
      and at 3- and 6-month follow-ups. This study will provide empirical data on the efficacy of
      two approaches for treating depressive symptoms in cancer patients in order to better inform
      the scientific community, health care providers, and patients on the most effective
      depression treatments to implement in cancer care.
    


Intervention name(s): Cognitive therapy of depression; Bright light therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive therapy will involve eight individual weekly sessions of 50 minutes with a Ph.D. student in psychology.; Bright light therapy will consist of a 30-min daily morning exposition to a 10 000-lux BLT lamp during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Depression; Anxiety; Fatigue; Sleep; Quality of life; Cognitive therapy; Bright light therapy
Trident® Tritanium™ Acetabular Shell Revision Study
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a hip implant system used when a previous hip
      replacement surgery has failed.
    

Detailed description: 
      Total hip replacement is considered to be a very successful surgical procedure for the
      treatment of degenerative joint disease. Clinical results for cementless acetabular
      components have demonstrated excellent long-term fixation of these devices. However, so
      called 'first generation' cementless acetabular components have not had similar success
      rates. In these cases the acetabular component is often revised due to loosening, wear or
      infection.

      Revision hip arthroplasty also becomes a challenge as patients often present with severe bone
      loss and poor bone quality. This can lead to compromised initial stability, which in turn
      leads to lack of long-term fixation and failure. Acetabular revision with a cementless
      component has shown improved results over cemented fixation.

      Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable
      early to intermediate information that may help predict the long-term success of this new
      system.

      It is the intention of this study to closely follow subjects that have undergone revision hip
      replacement with regard to implant survivorship, signs of radiographic loosening, subjects'
      function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject
      quality of life through SF-36 and adverse events.

      The primary efficacy hypothesis is that the rate of revision or pending revision (as defined
      by radiographic parameters) due to instability or lack of fixation for the Trident®
      Tritanium™ Acetabular Shell will be less than 10% at 5 years.
    

Intervention name(s): Trident® Tritanium™ Acetabular Shell
Intervention type(s): Device
Intervention description(s): Trident® Tritanium™ Acetabular Shell
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Thermogenic and Metabolic Effects of a Whole Food Meal Versus Its Supplemental Equivalent
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      There is limited research on the amount of calories burned and metabolic differences of a
      complete supplemental meal in comparison to a whole food meal. The purpose of this study is
      to analyze the differences in calories burned and metabolic response post-consumption of a
      meal consisting of whole foods compared to its nutritionally engineered equivalent. We
      hypothesize that energy expenditure and satiety will be greater in the whole food meal
      compared to the supplement meal, whereas, there will be no difference in levels of glucose
      between the two conditions.
    

Detailed description: 
      Over 50% of U.S. adults today use some form of dietary supplementation to obtain their
      nutrient intake (Bailey et al., 2011). Previous research has shown that certain nutritional
      supplements may produce varying metabolic and thermogenic (calories burned) responses, when
      compared to other food sources (Acheson et al., 2011). The difference in thermogenic response
      may also suggest that there is a difference between a whole food meal and its supplemental
      equivalent. If there is a difference in thermogenic response, this may indicate that a
      meal-replacing supplement, such as a ready-to-drink-shake and/or food bar may not induce the
      same health benefits as a whole food meal in terms of nutrient digestion, absorption,
      metabolism and storage. There has not been extensive research on the thermic effect and
      metabolic differences of a complete supplemental meal in comparison to a whole food meal. The
      purpose of our study is to analyze the differences in thermogenic and metabolic response
      post-consumption of a meal consisting of whole foods compared to its supplemental, engineered
      equivalent. We hypothesize that energy expenditure and satiety will be greater in the whole
      food meal compared to the supplement meal, whereas, there will be no difference in levels of
      glucose between the two conditions.
    

Intervention name(s): Whole Food Meal; Supplement Food Meal
Intervention type(s): Other; Other
Intervention description(s): Isocaloric/ macronutrient whole food meal; Isocaloric/ macronutrient supplement food meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)
Condition: Healthy
Study type: Interventional

Summary: 
      This cross-over clinical trial is being conducted to evaluate the difference in urinary
      messenger RNA (mRNA) biomarkers of mineralocorticoid receptor activation following a
      low-sodium diet, as compared to a high-sodium diet. The study team will collect urine and
      blood samples from each participant to study mineralocorticoid receptor-regulated mRNA
      biomarkers following the consumption of each diet.

      The study team will instruct the participants to consume 8 days each of high- (300 mmol/day)
      and low- (10 mmol/day) sodium meals. The order in which the participants will eat the two
      study diets will be randomly determined. In between the high- and low-sodium diets, the
      participants will have a wash-out period of 6 days, during which they will be encouraged to
      consume their usual diet. Participants will be asked to provide the study team with 24-hour
      urine samples, random urine samples, and blood samples throughout their participation in this
      clinical trial.
    


Intervention name(s): High-sodium diet 300 mmol sodium/day; Low-sodium diet 10 mmol sodium/day
Intervention type(s): Other; Other
Intervention description(s): Day 7 or day 21 high-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team.; Day 7 or day 21 low-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: low sodium diet; high sodium diet; biomarker; aldosterone; mineralocorticoid; mineralocorticoid receptor
Fast Track Total Hip Arthroplasty vs Standard Care
Condition: Hip Osteoarthritis; Hip Pain Chronic
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Fast-track total hip arthroplasty (THA) is a well-established concept including optimized
      logistics and evidence-based treatment, focusing on minimizing surgical stress and improved
      post-operative recovery. The aim of this protocol is to compare the standard care and fast
      track total hip arthroplasties in terms of functional and subjective outcomes, hospital
      staying, number of transfusions and analgesic consumption.
    

Detailed description: 
      The aim of this protocol is to compare standard care and fast track total hip arthroplasties.
      The fast track care consists of:

        -  preoperative educational lesson in which orthopedic surgeon, anesthesiologist and
           physiotherapist illustrate the operative and post operative path to the patients

        -  antalgic protocol administered only orally

        -  early rehabilitation care. The day of the surgical operation, the physiotherapist helps
           the patient reach the upright position. The standard care consists of usual antalgic and
           physiotherapy post-operative care:

        -  Antalgic protocol consist in intravenous drugs

        -  the first physiotherapy session is the day after surgery
    

Intervention name(s): fast track care protocol; standard care protocol
Intervention type(s): Procedure; Procedure
Intervention description(s): fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.; standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.
Intervention MeSH terms: Cytarabine; Methotrexate; Etoposide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fast track care; Total Hip Arthroplasty
Calibrated Diets and Human Intestinal Microflora
Condition: Bacteria
Study type: Interventional

Summary: 
      The main objective of the study is to realized a collection of feces in order to study the
      modification of the intestinal microflora according to alimentary fibres
    

Detailed description: 
      Human intestinal tract count up to 1014 bacteria. We consider that each bacterial flora is
      composed of more than 500 different species among which only 20% are cultivable. Although
      this flora is well unknown, it is known that it play a major role in the metabolism of the
      eating fibers. Dysfunctions of this flora may be implied in numerous local and general
      pathologies.

      It has been shown that probiotics and prebiotics are able to act upon the intestinal flora.
      On the basis of the personal real-life, it is generally considered acquired that our diet
      modifies this flora. However not many studies have validated this hypothesis with human
      normal diet (not artificially enriched with prebiotics or probiotics). The idea that our diet
      can modified the functioning of our intestinal flora (and so favor certain pathologies or
      activate recovery) is widely hypothetic.

      A best knowledge of the diversity of this flora and to put at disposal tools to study it on a
      large scale could allow to answer this question. The demonstration that some food components
      could modify the composition or the functioning of this flora would have considerable
      consequences in medicine and food processing industry.
    

Intervention name(s): 10 g of fibres per day; 40 g of fibres per day
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 g of fibres per day; 40g of fibres per day
Other intervention name(s): low fibres; high fibres
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: digestive system; Diet
Intervention Study on the Health Impact of Air Filters in Chinese Adults
Condition: Inflammation; Coagulation; Blood Pressure; Pulmonary Function
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study aimed to evaluate whether a short-term indoor air purifier intervention improves
      cardiopulmonary health based on a randomized double-blind crossover trial
    

Detailed description: 
      We conducted a randomized double-blind crossover trial among 35 healthy college students in
      Shanghai, China in 2014. These students lived in dormitories that were randomized into two
      groups and alternated the use of true or sham air purifiers for 48 hours with a 2-week
      wash-out interval.All participants and research staff were blinded to the group assignment.
      We requested all participants to stay in their dormitory room with the windows/doors closed
      throughout each 48-hour intervention period. We delivered foods and drinks to each room
      during the intervention period. All interventions started at 8 a.m. to avoid issues related
      to diurnal variation. We evaluated health endpoints and drew blood immediately after the
      completion of each 48-hour intervention. We measured 14 circulating biomarkers of
      inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and
      fractional exhaled nitric oxide (FeNO).
    

Intervention name(s): Air purifiers
Intervention type(s): Behavioral
Intervention description(s): The 10 dormitory rooms were randomized into two groups of 5 rooms each. One group used an air purifier placed in the center of the room for 48 hours corresponding to one weekend, followed by a 2-week washout period, and another 48 hours of using a sham air purifier under the same conditions. The other group simply reversed the order in which the real and sham air purifiers were used. All rooms used the same qualified air purifiers (model FAP04, 3M Filtrete), with the only difference being removal of the filter gauze in the sham purifiers. The air pollution auto-sensing feature of air purifiers was disabled in both groups. All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period.
Other intervention name(s): Air filtration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: air pollution; air purification; intervention; randomized controlled trial; cardiovascular health; pulmonary health
Trial to Reduce Hospitalizations in Children With Medical Complexity
Condition: Chronic Illness
MeSH terms: Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that an intervention, within an established patient-centered
      medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital
      utilization among medically complex children.
    

Detailed description: 
      The investigators will pilot test an intervention that includes contingency planning and care
      transitions within an established medical home program caring for children with medical
      complexity. Children with medical complexity receiving care within the UCLA Medical Home
      Program will be randomized to the pilot intervention or usual medical home care. The primary
      goal will be to reduce admissions and readmissions in the intervention group.
    

Intervention name(s): Plans of Action and Care Transitions; Routine Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects randomized to the "intervention" will participate in action planning and care transitions (if hospitalized during the study period); Subjects randomized to the "control" group will continue to receive routine care within the medical home program
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Hospitalization; Readmissions; Medical complexity
A Two-part Trial Assessing the Effects of 7α-methyl-19-nortestosterone (MENT) on Blood Pressure in Normal Men: an Open-label Pilot Study Followed by a Randomized, Double-blind, Placebo-controlled Study
Condition: Blood Pressure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part trial assessing the effects of MENT on blood pressure. The first part of
      the trial is an open-label pilot study to verify the MENT gel formulation delivers
      appropriate drug levels. Upon confirming MENT serum levels are within the required range,
      clinical trial material will be produced and labeled. Consequently, the second part of the
      trial, the main study, will proceed approximately two months after the conclusion of the
      pilot study. The main study, is a randomized, double-blind, placebo-controlled study.
    


Intervention name(s): MENT or placebo
Intervention type(s): Drug
Intervention description(s): A dose of 1600µg/d of MENT will be delivered daily using a gel formulation containing 8.0 mg of MENT per 1.0 mL (delivering 800µg/d). Two mLs of gel will be applied daily for four weeks in the pilot study (by 6 men) and for 12 weeks in the main trial (by 62 men).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: male hormonal contraception; Blood pressure, sperm concentration
Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Diagnostic procedures, such as immunoscintigraphy, using a radiolabeled monoclonal
      antibody may help find and diagnose colorectal cancer.

      PURPOSE: This clinical trial is studying how well immunoscintigraphy using a radiolabeled
      monoclonal antibody works in finding tumor cells in patients with colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the ability of iodine I 123 anti-CEA recombinant diabody T84.66 to localize
           to colorectal cancer, as determined by quantitative radioimmunoscintigraphy in patients
           with colorectal cancer.

      Secondary

        -  To evaluate the clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody
           T84.66 clearance in these patients.

        -  To characterize the frequency and titer of the human anti-chimeric response to iodine I
           123 anti-CEA recombinant diabody T84.66 in these patients.

        -  To determine the safety of iodine I 123 anti-CEA recombinant diabody T84.66 in these
           patients.

      OUTLINE: Patients receive an infusion of iodine I 123 anti-CEA recombinant diabody T84.66.
      Patients undergo planar imaging every 5 minutes during the radiolabeled antibody infusion and
      then at 3-6 hrs, 12-24 hours, and, if indicated, 30-48 hours after the radiolabeled antibody
      infusion. Planar spot images of the head, chest, abdomen, and pelvis and whole body images
      (anterior and posterior) are taken. Patients also undergo SPECT scan of the abdomen and
      pelvis at 12 and 24 hours after the radiolabeled antibody infusion.

      Blood samples are collected for pharmacokinetic analysis immediately after the radiolabeled
      antibody infusion and then at 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours after the
      radiolabeled antibody infusion.

      Patients are followed periodically for 6 months.
    

Intervention name(s): pharmacological study; single photon emission computed tomography; iodine I 123 anti-CEA recombinant diabody T84.66
Intervention type(s): Other; Procedure; Radiation
Intervention description(s): Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.; One day post infusion; 10mCi/mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer