bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Effects of High-fat Meals With Different Dairy Products on Lipid Metabolism and Inflammation
Condition: Healthy; Overweight; Obesity
MeSH terms: Overweight; Inflammation
Study type: Interventional

Summary: 
      The aim of this project is to elucidate how high-fat meals with different kinds of dairy
      products affect postprandial responses of lipid metabolism and inflammatory markers in
      healthy and obese subjects.
    


Intervention name(s): Butter; Cheese; Whipped cream; Sour cream
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Butter with jam and three slices of bread; Cheese with jam and three slices of bread; Whipped cream with jam and three slices of bread; Sour cream with jam and three slices of bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy Volunteers; Obese Volunteers
Adoptive Immunotherapy, Aldesleukin, and Zoledronate in Treating Patients With Stage IV Kidney Cancer and Lung Metastases
Condition: Kidney Cancer; Metastatic Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated
      in the laboratory to stimulate the immune system in different ways and stop tumor cells from
      growing. Aldesleukin may help the laboratory-treated white blood cells stay in the body
      longer. Drugs used in chemotherapy, such as zoledronic acid, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving cellular adoptive immunotherapy together with interleukin-2 and zoledronic acid may
      kill more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects of giving cellular adoptive
      immunotherapy together with aldesleukin and zoledronic acid and to see how well it works in
      treating patients with stage IV kidney cancer and lung metastases.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety of adoptive immunotherapy comprising
           2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta (gd) T cells, zoledronate, and
           IL-2 after nephrectomy, especially with regard to the incidence and frequency of adverse
           events.

        -  Determine the duration of in vivo persistence of the transferred gd T cells in patients.

        -  Determine the doubling time of tumor growth before and after adoptive immunotherapy.

        -  Determine the tumor-size reducing effect of adoptive immunotherapy based on the Best
           Overall Response Chart.

      OUTLINE: Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells
      (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and aldesleukin for 11
      days. Patients then receive the expanded Gamma Delta T cells, aldesleukin, and zoledronic
      acid once a month for 6 months.

      After completion of study treatment, patients are followed for up to 1 month.
    

Intervention name(s): aldesleukin; therapeutic autologous lymphocytes; zoledronic acid
Intervention type(s): Biological; Biological; Drug
Intervention MeSH terms: Zoledronic Acid; Aldesleukin
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent renal cell cancer; stage IV renal cell cancer; clear cell renal cell carcinoma; lung metastases
Intensive Psychotherapy for Chronic Depression
Condition: Chronic Depression; Persistent Depressive Disorder; Recurrent Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The study evaluates whether Intensive psychotherapy show superior effect on chronic
      depression over TAU
    

Detailed description: 
      Background: Accumulating evidence indicates that intensive psychotherapy (i.e., greater
      number of treatment sessions per time unit) improves outcomes for patients with mental health
      problems. However, few studies have investigated whether patients with chronic depression
      (CD) benefit from treatment with higher intensity. The main purpose of this study is to
      investigate if intensive psychotherapy could improve treatment for patients with chronic
      depression (CD). The primary research question is whether two intensive psychodynamic
      inpatient treatments, affect phobia therapy (APT) and VITA, are superior to low intensity
      treatment (TAU) at completion of treatment. To indicate if a potential difference between
      intensive treatment and TAU is due to the intensity of the therapy, the study contrasts two
      therapies with similar intensity, but different theoretical rationales. Methods: 280 patients
      with CD are included in a naturalistic study. Patients are assessed at four time points;
      assessment, start of therapy, end of therapy and 1-year follow-up. Three comparisons are
      performed with patients matched across groups; Intensive treatment (APT + VITA) vs TAU during
      treatment, APT vs VITA during treatment and APT vs VITA during follow-up. The outcome measure
      is the BDI-II.
    

Intervention name(s): Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Intensive psychotherapy (i.e., greater number of treatment sessions per time unit)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
Condition: Kidney Disease, Chronic; Ischemic Heart Disease
MeSH terms: Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      There is a pressing need to find effective strategies for the prevention of contrast induced
      nephropathy in patients with advanced renal dysfunction. The current study was designed to
      assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients
      with advanced renal dysfunction undergoing coronary interventions
    


Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19
Condition: COVID-19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, and immunogenicity of
      booster dose of vaccine in participants who are generally healthy or with stable pre-existing
      health conditions. Study details include:

        -  The study duration per participant will be approximately 209 days (28 days screening, 1
           day vaccination, and 180 days follow-up).

        -  The treatment will include 1 booster dose only.

        -  The visit frequency will be 6 on-site visits and 1 phone visit.
    

Detailed description: 
      This is a Phase II, prospective, randomized, observer-blinded, multi-center study, to
      evaluate the safety, tolerability, and immunogenicity of a booster vaccination with AZD1222,
      mRNA-1273, or MVC-COV1901 vaccine. Approximately 960 participants aged 18 ~ < 80 years, who
      received homologous two doses of vaccines 150 ~ 365 days ago, will be enrolled and divided
      into three groups. Each group will consist of 320 eligible subjects, and for each group the
      randomization will be stratified according to study site and age to four treatments (AZD1222,
      half dose of mRNA-1273, full dose or half dose of MVC-COV1901 in 1:1:1:1 ratio). Therefore,
      within a group, for either age stratum, there will be at least 30 participants for each
      treatment.
    

Intervention name(s): Half dose of MVC-COV1901; Full dose of MVC-COV1901; AZD1222; Half dose of mRNA-1273
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Approximately 240 participants will receive 1 doses of half of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.; Approximately 240 participants will receive 1 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.; Approximately 240 participants will receive 1 doses of AZD1222 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.; Approximately 240 participants will receive 1 doses half of mRNA-1273 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19 Vaccine
Short Clinical Outcome of Microscope Assisted Discectomy: Results of 90 Cases in Iraq
Condition: To Evaluate the Effectiveness if Microscope in Discectomy
Study type: Interventional

Summary: 
      A total of (90) patients involved in this study a randomized sampling use. The adult patient
      between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and
      neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy
      (life style modification, NSAIDs, and physiotherapy). They are operated by Microscopic
      assisted discectomy and were followed by ODI and VAS for back pain and leg pain for 4 months
      after surgery
    

Detailed description: 
      A total of (90) patients involved in this study a randomized sampling use. The adult patient
      between (17) and (50) years of age complaining of lower back pain; and or radiculopathy and
      neurological symptoms, whom failed to respond to a (6-8) weeks period of conservative therapy
      (life style modification, NSAIDs, and physiotherapy). The diagnosis carried out using
      history, physical examination, MRI done for the patient to confirm the diagnosis and the
      level of disc herniation and know the direction and extend of disc herniation.Population
      excluded from study were the age group above or less the ones whom involved in the study, any
      other type of disc herniation apart from L3-L4, L4-L5, L5-S1, multilevel pathology, patients
      with spondylolisthesis, spondylolysis, patients with scoliosis and kyphosis, patients with
      cauda equina syndrome, patients with previous back surgery, and with no local infection.All
      the patients discharged on the same day of operation or a day after, mobilized soon as they
      were ready. Patient were reviewed in intervals of (2) weeks (2) months and (4) months after
      surgery using VAS for low back pain and leg pain and Oswestry disability index.
    

Intervention name(s): Microscope assisted discectomy
Intervention type(s): Procedure
Intervention description(s): Microdiscectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: short-term clinical outcome; microscopic assisted discectomy; lumbar disc herniation
The Effect of Health Literacy Based Practices
Condition: Health Literacy Level
Study type: Interventional

Summary: 
      It is important to adopt healthy lifestyle behaviors such as nutrition and physical activity
      in adolescence. Health literacy, which is the competence of adolescents to participate in
      their own health decisions and takes responsibility for health, needs to be developed.
      Developing healthy nutrition and physical activity behaviors with a focus on health literacy
      is important in terms of maintaining the desired behavior in adulthood. This study aims to
      examine the effects of health literacy-based motivational interviewing and health education
      on nutrition and exercise behaviors of adolescents. The research will be conducted with a
      single-blind randomized controlled experimental design. The population of the research
      consists of ninth-grade students. It is planned to include 72 people in the research sample
      according to the power analysis calculation. The research will be carried out with two
      intervention groups as motivational interview and health education and a control group.
    


Intervention name(s): Health literacy based motivaonal interview; Health literacy based health education
Intervention type(s): Other; Other
Intervention description(s): Motivational interviewing technique was used based on health literacy.; Health education based on health literacy was used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: health literacy; motivational interview; health education; nutrition; physical activity; adolescent
Bevacizumab and Vasoconstriction
Condition: Hypertension; Cancer
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Rationale: The introduction of angiogenesis inhibitors has remarkably improved treatment of
      patients with several types of cancer. One of the most common side effects of angiogenesis
      inhibitors is hypertension. In patients treated with bevacizumab hypertension had an overall
      incidence up to 32%. The etiology of hypertension caused by treatment with angiogenesis
      inhibitors is unclear.

      Objective: To study if arterial bevacizumab infusion causes acute vasoconstriction using
      plethysmography in healthy volunteers.
    


Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): Intra-arterial infusion during 6 minutes
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Desflurane Versus Propofol in the Sitting Position
Condition: Cerebral Ischemia
MeSH terms: Brain Ischemia; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The investigators hypothesized that both propofol and desflurane would decrease the regional
      oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when
      patients are raised to the sitting position.
    

Detailed description: 
      The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but
      propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the
      sitting position. Therefore, the purpose of this study was to investigate the effect of
      desflurane and propofol on rSO2 values during the beach chair position for shoulder
      arthroscopy.
    

Intervention name(s): propofol; Desflurane; alfentanil; Rocuronium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.; anaesthesia was maintained by desflurane 4-7vol%; administration of alfentanil 10 μg kg-1 for anesthetic induction; administration of rocuronium 0.6 mg kg-1 for anesthetic induction
Other intervention name(s): Des; alf; roc
Intervention MeSH terms: Alfentanil; Propofol; Desflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: propofol; desflurane; cerebrovascular circulation; sitting
A Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
Condition: Critical Illness; Adult; Sepsis; Systemic Inflammatory Response Syndrome
MeSH terms: Critical Illness; Systemic Inflammatory Response Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to assess the efficacy and tolerability of the low-volume supplement.
      The investigators randomized critically ill patients to receive Intestamin plus Fresubin or
      Fresubin alone.
    

Detailed description: 
      To compare early supplementation with antioxidants and glutamine using an enteral
      pharmaconutrition supplement (Intestamin®) to an energy adjusted standard elementary diet and
      to investigate its affect on clinical efficacy and tolerability in critically ill patients
      with sepsis/SIRS.

      Methods: This was a prospective controlled randomized study in 58 critically ill patients.
      They received either Intestamin or a diluted Fresubin solution. After 10 or 14 days
      inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.
    

Intervention name(s): Fresubin Original; Intestamin plus Fresubin Original
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: critically ill; sepsis; antioxidants; enteral nutrition; SIRS (APACHE score 10-30); enteral feeding within 48 h of admission
The Effects of Exercise Training in Vascular Function of Patients Living With HIV
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus
      (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear
      that the aerobic exercise training induces improvements in autonomic control and vascular
      function, through increases in vasodilator agents and blood vessels number. However, the
      investigators could not find previous works that studied the microvascular function in
      response to exercise training in HIV patients.

      Objectives: To study the impact of aerobic exercise training in endothelial function of HIV
      patients. In addition, the investigators will verify the association of the physical fitness
      to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.

      Methods: The study subjects will be composed by HIV patients, that will be randomly divided
      in two different groups: exercised and sedentary. The subjects will be tested before and
      after training in regards to endothelial function, nitric oxide bioavailability, physical
      fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary
      exercise test, and biochemical tests; respectively. The exercise training will be performed
      in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.

      Expected Results: The investigators expect to achieve markers that will help in understanding
      the interaction of HIV with several factors that contribute to an increased endothelial
      function after exercise training.
    

Detailed description: 
      HIV-infection triggers a massive oxygen reactive species production, increasing oxidative
      stress and vascular complications. Despite the importance of therapeutic strategies in
      reducing the cardiovascular risk among HIV-infected patients (HIVP), exercise-related effects
      upon macro-and-microvascular endothelial function and oxidative stress in HIVP have not been
      previously reported.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vascular function; Physical training; Laser Speckle Contrast Imaging
Gait Evaluation in Haemophiliac Patients
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Observational

Summary: 
      Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the
      commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability
      and mobility, axial deviation, deterioration and decreased function are the most frequent
      complains in patients with severe haemophilic arthropathy In this context, the purpose of our
      study is to examine and analyse specific changes in gait in patients suffering from
      haemophilic arthropathy and determine the impact on health-related quality of life in terms
      of conceptual components of pain and stiffness, psychosocial stress, disability, and activity
      limitations as recommended by the International Classification of Function (ICF) recently
      published by the World Health Organization.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        haemophilia A or B, mild, moderate or severe.
      
Keywords: gait; haemophilia; arthropathy
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study to evaluate the safety, tolerability and anti-viral activity of
      GS-9669 in patients with Hepatitis C infection.
    


Intervention name(s): GS-9669 tablets; Placebo to Match GS-9669 tablet
Intervention type(s): Drug; Drug
Other intervention name(s): Cohort 1 (N = 10, genotype 1a): 100 mg GS-9669 or placebo BID with; food [total daily dose (TDD) = 200 mg] for 3 days;; Cohort 2 (N = 10, genotype 1a): 400 mg GS-9669 or placebo BID with; food (TDD = 800 mg) for 3 days;; Cohorts 1 and 2 may be conducted in parallel. Additional adaptive BID; and/or QD cohorts (Cohorts 3-5) in genotype 1a subjects may be; conducted depending on the safety, virology, and available; pharmacokinetics from the first two cohorts. Cohorts 3 -5 may be; conducted in parallel if the total daily dose is lower than the highest total; daily dose previously tested and determined to be safe and well tolerated.; Cohort 3 (N = 10, genotype 1a): up to 400 mg GS-9669 or placebo BID; with food (TDD = up to 800 mg) for 3 days;; Cohort 4 (N = 10, genotype 1a): up to 400 mg GS-9669 or placebo BID; Cohort 5 (N=10, genotype 1a): up to 800 mg GS-9669 or placebo QD in; the morning with food (TDD = up to 800 mg) for 3 days;; Based on the results of Cohorts 1 to 5, one or more regimens will be; selected for an evaluation in genotype 1b subjects to enable comparison; between genotypes. Cohorts 6 and 7 may proceed in parallel with other; Cohorts if the total daily dose is the same or lower than the highest total; Cohort 6 (N = 10, genotype 1b): up to 400 mg GS-9669 or placebo BID; with food (TDD = up to 800 mg) for 3 days; Cohort 7 (N = 10, genotype 1b): up to 800 mg GS-9669 or placebo QD in; the morning with food (TDD = up to 800 mg) for 3 days.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: HCV RNA; Polymerase inhibitor; Treatment naïve and Treatment experienced; GS-9669; Hepatitis C; HCV