bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation, Treatment, and Training for Patients With Blood Disorders
Condition: Hematologic Diseases
MeSH terms: Hematologic Diseases
Study type: Observational

Summary: 
      This study is designed to allow the evaluation, follow-up, and medical care of patients with
      blood disorders not currently participating in a research study being conducted by the
      Hematology Branch of the National Heart, Lung and Blood Institute (NHLBI) or not being
      screened for participation in a study.

      The purpose of this study is to allow investigation into the blood disorders of patients in
      order to teach, learn, and gather more information about diseases of the blood.

      In addition, this study allows researchers the opportunity to evaluate patients referred to
      the Hematology Branch of the NHLBI with rare or undiagnosed diseases of the blood. This may
      be potentially beneficial to the patient and at the same time contribute to the development
      of new research ideas.
    

Detailed description: 
      This protocol is designed to allow the evaluation, follow up, and standard medical care of
      patients (and when appropriate, their stem cell donor) with bone marrow failure states,
      cytopenias, metastatic solid tumors, or hematologic malignancies not currently entered on an
      active NHLBI protocol or not being screened for an active NHLBI research protocol. Its
      purpose is to allow investigation into the hematologic problems of these patients for the
      primary purpose of teaching and furthering general hematologic knowledge. The ability to
      evaluate and treat patients with a wide variety of hematologic disease is critical to
      maintaining our accreditation as a hematology fellowship program and training our fellows to
      be competent hematologists, as well as for keeping all staff, including senior staff,
      up-to-date and familiar with the evaluation and treatment of patients with a wide spectrum of
      hematologic disease. It also allows the NHLBI investigators to evaluate patients referred
      with rare or as yet undiagnosed hematologic problems, both potentially benefiting the patient
      and stimulating new research directions for the NHLBI in the future. Periodic follow-up and
      treatment of patients previously entered on NHLBI protocols in order to monitor the long-term
      course of the underlying hematologic state and the consequences of experimental treatments is
      also required for fellowship training, and for maintenance of good referral relationships
      with patients and their physicians.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects age 2 or older and weighing greater than 12 kg, who meet entry criteria will
        be considered for participation on this protocol at the discretion of the Principal or
        Associate Investigator.
      
Keywords: Hematopoiesis; Thrombocytopenia; Anemia; Neutropenia; Dysplasia; Hematologic Malignancies
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics
      and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin
      aspart 70 three times a day in non-obese and obese with type 2 diabetes.
    


Intervention name(s): biphasic insulin aspart
Intervention type(s): Drug
Other intervention name(s): BIASP
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Wearable Monitoring Systems for Swallowing Function and Disorders
Condition: Deglutition Disorders
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation
      services from a distance, facilitating tele-management of many disorders. The proposed
      research will develop and validate a set of mechanically compliant, easy-to-use, and
      inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of
      swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors
      will have equal or better performance than traditional wired sensors used today in clinical
      practice. Factors related to signal quality and patient reported outcomes (e.g.,
      satisfaction/comfort level, adverse effects etc.) will be examined.
    


Intervention name(s): Tele-EaT Sensors; Conventional Sensors
Intervention type(s): Device; Device
Intervention description(s): Several iterations of a wearable surface EMG sensors patch and a wearable intra-oral lingual press device that we will develop, will be tested against commercially available wired devices. The wearable sensor patch will be an ultrathin patch with a honeycomb-inspired design that includes sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. The wearable intra-oral device will integrate a wireless intraoral sensor system that will allow simultaneous recording of lingual pressure and movement during swallows and lingual tasks in a wireless fashion. Participants will perform standardized swallow tasks with both devices.; Conventional sensors will include snap-on wired electrodes and the use of the Iowa Oral Performance Instrument as the control conditions. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Experiments will follow a within-subject randomized cross-over design. The purpose is to develop devices that are optimized for their use. To achieve this goal, for each new iteration of the devices, at least ten new participants will be tested using the current prototypes and the commercially available counterpart sensors in counterbalanced order. Results will be analyzed and discussed in regards to design improvements before the next iteration of development. The plan to recruit a large number of total subjects allows for several pre-clinical experiments to be conducted until the final versions of both devices are optimized.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Scintigraphic Detection of the Biodistribution of Tumor Necrosis Factor With a Radiolabeled Anti-TNFα in Patients With Active Rheumatoid Arthritis and Active Axial and Peripheral Spondyloarthritis
Condition: Axial and Peripheral Spondyloarthritis; Rheumatoid Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Spondylarthritis; Necrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      In this open-label monocentric explorative pilot trial the objective is to show the
      biodistribution of TNFα by administration of radiolabeled anti-TNFα in patients with active
      rheumatoid arthritis and spondylarthropathy. The anti-TNFα used in this trial is certolizumab
      pegol (Cimzia®), a pegylated Fab'-fragment of a monoclonal antibody with high specificity for
      TNFα. Certolizumab pegol will be radiolabeled with 99mTechnetium. The aim of this study is to
      show the TNFα triggered inflammation process in the inflamed joints, especially in patients
      who have very early joint damage where currently other imaging methods such as X-rays are not
      sensitive enough for detection.
    


Intervention name(s): administration of Cimzia®; Immunoscintigraphy with radiolabeled Cimzia®.
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be treated with prefilled syringes containing each 200 mg/ml Cimzia® every 2 weeks which will be administered subcutaneously (The first 3 injections, a dosage of 400mg Cimzia® subcutaneously will be administered).; All 20 patients will undergo an immunoscintigraphy with radiolabeled Cimzia®. Certolizumab pegol (Cimzia®) is an engineered humanized monoclonal antibody Fab' fragment with specificity for human TNF-α, manufactured in E. coli. The antibody fragment is subsequently purified and conjugated with high molecular weight polyethylene glycol (PEG) (40kDa). Lyophilized Cimzia® will be conjugated with S-HYNIC (a bifunctional chelator). The conjugate will be radiolabeled with Tc-99m by adding 0.1 mg Tricine, 0.01 mg SnSO4 and 750 MBq Tc-99m pertechnetate. A dose of 750 MBq Tc-99m Cimzia® will be injected intravenously.
Intervention MeSH terms: Certolizumab Pegol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spondyloarthritis; Rheumatoid arthritis
Spine Quantitative Computed Tomography (QCT)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Osteoporosis; Arthritis, Juvenile
Study type: Observational

Summary: 
      The purpose of this study is to compare healthy children to children who have a chronic
      illness called Juvenile Idiopathic Arthritis (JIA). JIA is a childhood disease that causes
      swollen joints that are often stiff and painful. JIA affects about 1 in 1,000 children age 16
      and younger.
    

Detailed description: 
      Children with chronic illnesses are at risk for bone fragility due to inflammation,
      glucocorticoid therapy, physical activity limitation, malnutrition, and pubertal delay. The
      impact of low bone mass during childhood may be immediate, resulting in childhood fractures,
      or delayed, due to suboptimal peak bone mass attainment.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        200 control patients and 30 study patients
      
Biospecimen description: 
      urine
    
Keywords: Juvenile Idiopathic Arthritis; JIA; Arthritis; Osteoporosis; Osteoporosis in Children
Body-oriented Therapy for Women in SUD Treatment
Condition: Substance Use Disorder
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The long-term objective of this study is to improve women's substance use disorder (SUD)
      treatment. The immediate project goal is to test the efficacy of an innovative mind-body
      intervention, Mindful Awareness in Body-Oriented Therapy (MABT) to reduce substance use
      relapse among women in SUD treatment.

      A novel mind-body approach, MABT combines a hands-on (manual) approach with mind-body
      psycho-education approaches of interoceptive training and mindfulness to develop
      somatically-based self-care skills and to facilitate emotion regulation. A three-group,
      randomized clinical trial using repeated measures, this project will enroll and randomize 225
      women to one of three groups, MABT + Treatment-as-usual (TAU) (n=75), TAU only (n=75), and
      Women's Health Education (WHE) + TAU (to control for time and attention) (n=75). Study
      conditions will be compared at baseline, post-intervention, and at 6 and 12 month follow-up.

      The primary aim is to test the hypothesis that MABT will result in reduced substance use and
      related health outcomes compared to TAU and to WHE+ TAU at 12 month follow-up. The second aim
      is to examine hypothesized underlying mechanisms of MABT. Female outpatients in two diverse
      community treatment facilities, serving racially diverse patients, will be recruited for
      study participation. This study builds on promising preliminary evidence of MABT feasibility
      and acceptability in substance use disorder treatment for women, and addresses the need for
      more clinical research aimed at improving SUD treatment outcomes for women.
    


Intervention name(s): Mindful Awareness in Body-oriented Therapy; Womens Health Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Substance Use Disorders; Complementary Therapies; Women; Mind-Body Therapies; Behavior and Behavior Mechanisms
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of risankizumab versus
      placebo during induction therapy in participants with moderately to severely active Crohn's
      disease (CD).
    


Intervention name(s): placebo for risankizumab; risankizumab IV; risankizumab SC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo for risankizumab administered by intravenous infusion; Risankizumab administered by intravenous infusion; Risankizumab administered by subcutaneous (SC) injection
Other intervention name(s): ABBV-066 BI 655066; SKYRIZI; ABBV-066 BI 655066; SKYRIZI
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease (CD); Risankizumab; ABBV-066; BI 655066
A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy
      Korean volunteers.
    


Intervention name(s): Oseltamivir 75 mg 1 cap
Intervention type(s): Drug
Other intervention name(s): Tamiflu
Intervention MeSH terms: Oseltamivir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
Condition: Sleep Initiation and Maintenance Disorders; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified
      release) compared to zolpidem IR (immediate release) in patients with primary insomnia.
    


Intervention name(s): Zolpidem MR; Zolpidem IR
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Stilnox CR; Ambient CR; Stilnox
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insomnia; zolpidem
Transluminal or Percutaneous Endoscopic Drainage and Debridement of Abcesses After Bariatric Surgery
Condition: Obesity; Sepsis
MeSH terms: Abscess
Study type: Observational

Summary: 
      Patients presenting intra-abdominal abcesses following bariatric surgery complicated by
      fistulae are classically treated by external drainage and endoprosthesis or surgical redo.
      Morbidity and mortality being increased in case of necrotic collections, an endoscopic
      debridement treatment might be proposed in certain cases. This present study aim to review
      the evolution of the patients treated by this method from 2007 to 2011 in the investigators
      institution.
    

Detailed description: 
      This retrospective study in an academic tertiary center will review the files of patients who
      underwent endoscopic drainage and debridement of abdominal abscesses secondary to bariatric
      surgery leaks . The decision for endoscopic treatment was made by the medico-surgical team in
      charge of this type of surgery, who had to weigh the high risk of mortality in case of
      re-intervention, along with endoscopic access to abscesses via the transluminal or
      percutaneous route based on abdominal imaging.

      Data collection will lead to the evaluation of the technical success rate, the clinical
      success and potential complications.
    

Intervention name(s): endoscopic drainage
Intervention type(s): Procedure
Intervention description(s): Endoscopic percutaneous access was obtained through surgical drains or after ultrasound-guided percutaneous drainage with a thin scope , and transluminal procedures with large scopes through the leak hole. All the procedures were performed under general anesthesia and carbon dioxide insufflation. Debridement was done by pus aspiration and irrigation.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the patient treated in an academic tertiary center (Erasme Hospital) who underwent
        endoscopic drainage and debridement of abdominal abscesses secondary to postbariatric
        surgery leaks from october 2007 to April 2011. All other necrosectomies performed for
        pancreatic disorders were excluded from the study
      
Keywords: leaks after bariatric surgery; fistulae after bariatric surgery; abdominal abcesses and bariatric surgery; endoscopic drainage of abcesses; percutaneous drainage of abcesses; gastric bypass; sleeve gastrectomy; necrotic collection and bariatric surgery
Relationship Between Trunk Control and Hand Function and Quality of Life
Condition: Cerebral Palsy; Quality of Life; Hand
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      Increasing quality of life and improving hand functions are very substantial treatment goals
      for physiotherapy and rehabilitation. Trunk control is important for these parameters in
      children with hemiparetic and diparetic Cerebral Palsy.
    

Detailed description: 
      Trunk control, hanf function and quality of life measurements were carried out by a
      physiotherapist using the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric
      Quality of Life Inventory. Participants were informed about the procedure of the tests. The
      evaluation period lasted 30-40 minutes for each child.
    

Intervention name(s): Trunk Control Measurement Scale
Intervention type(s): Other
Intervention description(s): Trunk Control Measurement Scale, easy and simple to use, was used to evaluate trunk control
Other intervention name(s): 9-Hole Peg Test; Pediatric Quality of Life Inventory
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with hemiparetic and diparetic Cerebral Palsy aged 5-18
      
Keywords: Cerebral Palsy; Trunk Control; Hand Function; Quality of Life
Post-traumatic Stress Disease in Health Workers During COVID-19 Pandemia
Condition: COVID; Post Traumatic Stress Disorder
MeSH terms: COVID-19; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The purpose of the questionnaire is to find risk factors for the development of
      post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.
    


Intervention name(s): Maslach Burnout Inventory (MBI)
Intervention type(s): Behavioral
Intervention description(s): The Maslach Burnout Inventory is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population consisted of workers in health services.
      
Keywords: COVID-19
Real-Time fMRI Feedback Effects on Pain Perception
Condition: Cognitive Pain Control
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether real-time functional magnetic resonance
      imaging may be a viable treatment for chronic pain in the future.
    

Detailed description: 
      Twenty-four healthy volunteers will undergo a series of four fMRI scanning sessions wherein
      thermal pain stimuli will be used to elicit activation of the pain neuro-matrix. All
      participants will undergo thermal pain threshold testing before and after fMRI scan.
      Participants will also rate the painfulness and unpleasantness of the thermal stimuli applied
      before fMRI and after fMRI. All participants will be given prompts to apply a set of
      cognitive pain-control strategies. Half of the participants will receive real-time fMRI
      feedback of activity in the Right Anterior Cingulate Cortex (rACC) and the other half will
      receive real-time fMRI feedback of activity in the Prefrontal Cortex (PFC). It is
      hypothesized that those receiving real-time feedback of brain activity thought to be involved
      with analgesic effects will demonstrate greater analgesia associated with the application of
      the cognitive control techniques after fMRI paradigm (decreased pain intensity and
      unpleasantness ratings and increased thermal pain thresholds) than those who are not given
      feedback before fMRI paradigm.
    

Intervention name(s): Attention/Distraction Strategy; Stimulus Quality/Severity Strategy; Control Strategy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body). Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience; One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain. Attempt to perceive the stimulus as low intensity rather than high intensity.; One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to take control of their perception of the painful experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pain; fMRI; real time
Study of Medication and Placebo Response in Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of the research study is to use recordings of brain electrical activity
      (through electroencephalogram, or EEG) and symptom measurements to determine whether patients
      are likely to show a response to medication or placebo treatment during a treatment trial for
      depression.
    


Intervention name(s): sertraline (Zoloft)
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; EEG; QEEG; cordance; Zoloft; sertraline; placebo; electroencephalogram; brain; antidepressants