bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of PTSD III: Neurocognitive Training of Emotional Regulation
Condition: Post Traumatic Stress Disorder; Major Depression; Anxiety Disorders
MeSH terms: Depression; Stress Disorders, Traumatic; Anxiety Disorders; Stress Disorders, Post-Traumatic; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The proposed work will evaluate the ability of neurocognitive retraining of executive
      functions and emotional regulation to reduce neurocognitive dysfunctions that follow trauma
      exposure and thereby prevent PTSD. The scientific rationale for this work is the hypothesis
      that impaired emotional regulation interferes with the expected recovery from the early
      responses to traumatic events, leading into a chronic disorder. In an initial phase the
      investigators will recruit 20 recently traumatized participants among trauma survivors
      admitted to a general hospital emergency room and test the planned intervention's acceptance
      and right 'dosing'. In the second phase the investigators will enroll 80 recent survivors
      into a randomized controlled study of the new intervention. The intervention will consist of
      web-based neurobehavioral training interventions that instill an emotional bias toward
      positive stimuli, improve emotion recognition and labeling, reduce resistance to emotional
      distraction, and enhance executive functioning. Control participants will complete web-based
      video games that do not have emotion-regulatory benefits. Outcome measures will include
      improvement in neurocognitive functioning and in PTSD symptoms.
    


Intervention name(s): Neurocognitive retraining Web Based Intervention; Control, web-based tasks
Intervention type(s): Procedure; Other
Intervention description(s): Neurobehavioral training will be delivered through the web, with prompting for training tasks accomplished through daily emails that include a single integrated log-in system using a customized implementation with OneLogin. All training tasks have "game-like" features making them visually engaging, and motivating. The training tasks provide immediate feedback about performance, and are specifically designed to target circuitry critical for executive functioning (EF) and emotional reactivity.; No training modules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Post Traumatic Stress Disorder (PTSD); Major Depression; Secondary Prevention; Neurocognitive Retraining; Randomized Controlled Trial
Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because
      the body's immune system has attacked and destroyed the beta cells. It is thought that
      exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby
      protective immune cells are stimulated and these then counteract the "bad" immune cells that
      damage the beta cells. This study aims to determine if intranasal insulin can protect beta
      cells and stop progression to diabetes in individuals who are at risk.
    

Detailed description: 
      Autoimmune diseases are the outcome of dysregulated immune responses to self-antigens. Type 1
      diabetes (T1D), previously known as insulin-dependent or juvenile diabetes, is an autoimmune
      disease in which the body's immune system reacts against and destroys the insulin-producing β
      cells in the islets of the pancreas. T1D classically affects children and young adults.
      Approximately 15% of people with diabetes have this form of the disease and no treatment is
      currently available to prevent it. Asymptomatic individuals in the pre-clinical stage of T1D
      can be identified by the presence of circulating antibodies to the islet autoantigens
      (pro)insulin, glutamic acid decarboxylase (GAD) and tyrosine phosphatase-like insulinoma
      antigen 2 (IA2). (Pro)insulin is the only autoantigen that is specific for β cells and
      several lines of evidence demonstrate that it plays a key role in driving autoimmune β-cell
      destruction.

      The ability to use self-antigens as tools to induce protective immunity, free from the side
      effects of conventional non-specific immunosuppression, is the 'Holy Grail' of autoimmune
      disease therapy. Animal models provide proof-of-concept for such antigen-specific therapy.
      For example, in the non-obese diabetic (NOD) mouse, a model of spontaneous T1D, transgenic
      over-expression of proinsulin in antigen-presenting cells in the immune system during
      development or in transferred bone marrow stem cells completely prevented diabetes. On a more
      practical and translatable level, immune tolerance to an antigen can be achieved by
      administering antigen to the mucosal immune system. Thus, immune responses to antigen are
      suppressed by feeding antigen ('oral tolerance') or by administering antigen to the
      naso-respiratory mucosa .
    

Intervention name(s): Intranasal insulin; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 440IU Insulin; Placebo insulin carrier solution containing benzalkonium chloride and glycerol
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Type 1 diabetes
Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot
Condition: Focus of Study: Carotenoid Absorption
Study type: Interventional

Summary: 
      The goal of this study is to determine if papaya fruits are an exceptionally good food source
      for carotenoids in humans, particularly when compared more common carotenoid sources like
      carrots and tomatoes. This objective will be accomplished by quantitation of the immediate
      post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from
      subjects who consumed a meal containing fresh papaya, tomato, and carrot.
    

Detailed description: 
      The main purpose of this study is comparing bioavailability of papaya carotenoids versus
      carrot and tomato carotenoids. Previously, vitamin A deposition in rat livers was studied,
      showing that carotenoid bioavailability from papaya is higher than from spinach, parsley and
      carrots. Detailed knowledge about human carotenoid absorption and conversion from papaya
      fruit compared to other food sources is still lacking.
    

Intervention name(s): Papaya; Carrot; Tomato
Intervention type(s): Other; Other; Other
Intervention description(s): Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Papaya; Carrot; Tomato; Carotenoids; Lycopene; Beta-carotene; Beta-cryptoxanthin
RDS MultiSense® SpO2 Validation Study
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of
      the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100%
      arterial oxygen saturation (SaO2) as compared to arterial blood samples assessed by measuring
      carbon monoxide (CO) bound to hemoglobin by CO-Oximetry. Additionally, data will be collected
      for heart rate accuracy as compared to reference ECG. The end goal is to provide supporting
      documentation for the SpO2 and heart rate accuracy validation for RDS MultiSense® Pulse
      Oximetry.

      A minimum of 10 healthy adult male and female participants, ranging in age and pigmentation
      from light to dark, will be enrolled in the study to meet the study design requirements
      defined by International Organization for Standardization ISO 80601-2-61:2017: corrected
      version 2018-02 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The
      participants will have an arterial catheter placed in the radial artery to allow for
      simultaneous blood samples during stable plateaus of induced hypoxic levels.

      The investigational device will be placed on the placed on the thorax of the participants
      (patch on the upper back and external electrode on the right pectoral) per the instructions
      for use. Simultaneous data collection will be set up for the system under test and control
      oximeter.
    


Intervention name(s): Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
Intervention type(s): Device
Intervention description(s): Measurement of physiological parameters
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypoxia; Pulse Oximetry; SpO2; Remote Monitoring; Connected device; Real-time monitoring
Obesity and Psychotherapy as an Alternative to Treatment
Condition: Obesity; Therapy
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Adherence to obesity treatment programs has been a limiting factor to good results in loosing
      weight. This study aimed to verify if obese subjects submitted to a physical exercise program
      and group psychotherapy would have a greater adherence, than obese people exercising only.
    

Detailed description: 
      The sample was forty people, both genders, mean age: 42,2 ± 10,7 years old. Physical exercise
      consisted of walking and stretching three times a week, during 50 minutes, with intensity
      verified by the Borg Scale, during three months. One of the days were supervised by the
      authors while two were freely chosen by the participant, without supervision. The verified
      variables were: total body mass, height, body mass index, physical activity level, caloric
      expenditure, waist circumference and fat percentile. Half of the sample participated of group
      psychotherapy once weekly.
    

Intervention name(s): Group Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): Group psychotherapy once a week, under a psychiatrist supervision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Exercise; Psychotherapy
A Study of GWP42003 as Adjunctive Therapy in the First Line Treatment of Schizophrenia or Related Psychotic Disorder
Condition: Schizophrenia; Schizophrenia-related Psychotic Disorder
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to compare the change in symptom severity in participants with schizophrenia or
      related psychotic disorder when treated with GWP42003 or placebo in conjunction with existing
      anti-psychotic therapy over a period of six weeks.
    

Detailed description: 
      This eight-week (six-week treatment period and two-week follow-up), multi-centre,
      double-blind, randomized, placebo-controlled, parallel group study aimed to determine the
      efficacy, safety and tolerability of GWP42003 in participants with schizophrenia or a related
      psychotic disorder.

      Eligible participants entered the study at a Screening and Randomization Visit (Day 1), where
      eligibility was established. Once all inclusion and exclusion criteria were reviewed,
      participants were randomized to receive either GWP42003 or placebo in conjunction with their
      prescribed anti-psychotic medications and began treatment on Day 1 as instructed. Assessments
      were performed on Days 8, 22, and 43. A safety follow-up visit was conducted on Day 57.
    

Intervention name(s): Placebo; GWP42003
Intervention type(s): Drug; Drug
Intervention description(s): Placebo oral solution (0 milligrams [mg]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring.; GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.
Other intervention name(s): Placebo control; Cannabidiol
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GWP42003; Cannabinoids; Schizophrenia; CBD; Cannabidiol
Acromegaly Treatment Quality of Life Study
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Observational

Summary: 
      The investigators hypothesize that treatment of acromegaly will be associated with an
      improvement in quality of life compared to active acromegaly. At the same time, they will
      also be studying the effects of different acromegaly treatments on the quality of life.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There will be 3 groups/cohorts: 1) Patients with active acromegaly (n=35), 2) patients
        receiving pegvisomant monotherapy to treat acromegaly (n=31), and 3) patients receiving
        somatostatin analog monotherapy to treat acromegaly (n=60)
      
Biospecimen description: 
      Plasma and blood serum
The Development of an Eating Laboratory for Overweight Adolescents
Condition: Adolescent Obesity
MeSH terms: Overweight; Pediatric Obesity
Study type: Observational

Summary: 
      The purpose of the study is to develop methods to evaluate the eating behavior of
      adolescents, including overweight, normal weight, and candidates for adolescent bariatric
      surgery.
    

Detailed description: 
      The purpose of this study is to examine the eating behavior, meal-related perceptions and
      meal-related hormones in overweight adolescents, normal weight adolescents and overweight
      adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a
      single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a
      luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing
      subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will
      be taken before, during, and after the meal to assess hormonal responses to the meal. The
      multiple-item meal will permit an assessment of total caloric consumption, food and
      macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery
      will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their
      surgery. Some bariatric surgery patients will only be studied after their after their
      surgery.

      The data gathered from these pilot subjects will be used to further develop and refine our
      future studies on assessing eating behavior in overweight adolescents.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      10 cc (2 teaspoons) of blood will be drawn during the screening assessment to screen for
      medical illness.

      60 cc (12 teaspoons) of blood will be drawn from an indwelling IV catheter during the
      single-item meal to assay for meal-related hormones (ghrelin, leptin,cholecystokinin,
      insulin, peptideY). Bariatric surgery participants may have an additional 20 cc of blood
      taken to measure glucose responses to the meal.
    
Keywords: adolescent; obesity; bariatric surgery; eating
Radiotherapy for Solid Tumor Spine Metastases
Condition: Solid Tumor Spine Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Although it is being increasingly used off protocol, there is minimal data regarding the
      efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of
      metastatic lesions to the spine. The primary objective of this study is to evaluate
      radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared
      to the expected rate following conventional radiation therapy.
    

Detailed description: 
      This is a phase II trial evaluating the rate radiographic local recurrence following
      post-operative stereotactic radiosurgery boost in patients with metastatic solid malignancies
      with spine metastases status post resection. Patients will be treated with 600 cGy x 5
      fractions to the tumor bed and then followed both clinically and radiographically to
      determine if local recurrence following this treatment is better than might be expected for
      conventional radiation therapy.
    

Intervention name(s): Post-operative, Stereotactic Body Radiation Therapy (SBRT)
Intervention type(s): Radiation
Intervention description(s): All participants received SBRT at 600 cGy x 5 fractions
Intervention model: Single Group Assignment
Intervention model description: Post-Operative Stereotactic Radiosurgery
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stereotactic radiotherapy; SRS
Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children
Condition: Treatment Side Effects
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional
Phase: Phase 1

Summary: 
      A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the
      pain and discomfort. It provides local analgesia by blocking the initiation and transmission
      of impulses. Lidocaine topical anesthetic gel allows the use of high concentrations of the
      anesthetic bases without concern about local irritation, uneven absorption or systemic
      toxicity (Argoff, 2000 ). So, the aim of this study is to compare between the effect of
      lidocaine phonophoresis and pulsed ultrasound in myofascial pain syndrome in swimmers
      children.
    

Detailed description: 
      Fourty five children (athletic swimmers) participated in this study, and were classified into
      three groups ; First control group A : this group consisted of fifteen children were
      receiving traditional physical therapy program. Second study group B: this group consisted of
      fifteen children were receiving pulsed ultrasound in addition to traditional physical therapy
      program as the same as in group A. Third study group C: this group consisted of fifteen
      children were receiving lidocaine phonophoresis in addition to traditional physical therapy
      program as the same as in group A. Treatment program in the three groups applied three times
      a week for three successive months. The study was done in the outpatient clinic of Ismailiy
      Sporting Club, Ismailia, Egypt.
    

Intervention name(s): Lidocaine; pulsed ultrasound; especially designed physical therapy program
Intervention type(s): Drug; Device; Other
Intervention description(s): transmission of the drug molecules to the underlying muscles; using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain; by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius
Other intervention name(s): lidocaine topical
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: myofascial pain syndrome, pain quality
Immediate Effect of Tai Chi Exercise in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Tai Chi has been widely practiced as a Chinese martial art that focuses on slow sequential
      movements, providing a smooth, continuous and low intensity activity. It has been promoted to
      improve balance and strength and to reduce falls in the elderly, especially those 'at risk'.
      The potential benefits in healthy younger age cohorts and for wider aspects of health have
      received less attention.

      The present study documented prospective changes in balance and vascular responses for a
      community sample of adults.
    


Intervention name(s): Tai Chi
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: Volunteers
Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if a naturally-occurring hormone called erythropoietin
      changes the action of platelets in the blood. Patients with heart attacks are treated with
      medicines to reduce the clotting action of platelets. This study is trying to determine
      whether erythropoietin alters the clotting action of platelets in patients receiving
      anti-platelet medicines. It is important to understand the effects of erythropoietin on
      platelets since preliminary studies in animals suggest that erythropoietin may protect the
      heart from damage during a heart attack.
    

Detailed description: 
      Anti-apoptotic effects of erythropoietin in experimental myocardial infarction (MI) and
      ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute
      MI. Before the therapeutic potential of recombinant human erythropoietin (rHuEpo) in acute MI
      can be tested in large clinical trials, more information on the effects of short-term rHuEpo
      on platelet function are needed. Accordingly, the current proposal aims to determine the
      effects of rHuEpo (at a dose previously shown not to inhibit the anti-platelet effects of
      aspirin and clopidogrel in healthy subjects) on platelet function and other safety measures
      and measure of infarct size in patients with acute coronary syndromes receiving
      clinically-indicated standard anti-platelet therapy with aspirin, clopidogrel and
      glycoprotein Iib-IIIa inhibitors.

      Specific Aim 1: To determine the effects of intravenous rHuEpo 400 U/kg daily for 3 days vs.
      placebo on in vivo and in vitro platelet function in patients with acute MI undergoing
      percutaneous revascularization.

      Specific Aim 2: To obtain pilot data to estimate the effects of administration of rHuEpo 400
      U/kg daily for 3 days vs. placebo on biochemical markers of myocardial infarction size and
      left ventricular ejection fraction in patients with acute MI undergoing percutaneous
      revascularization
    

Intervention name(s): Recombinant human erythropoietin alfa (drug); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 U/kg IV daily for 3 days vs. matched volume of normal saline IV daily for 3 days; Normal saline to match active drug (rHuEpo)
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet function tests; Erythropoietin; Myocardial infarction