bioihbjkbjnl/mcl2 huggingface dataset:
Proactive Automatized Lifestyle Intervention
Condition: Health Risk Behaviors
Study type: Interventional

Summary: 
      Background: The co-occurrence of health risk behaviors (HRBs), namely of tobacco smoking,
      insufficient physical activity, unhealthy diet and at-risk alcohol use, more than doubles the
      risk of cancer, other chronic diseases and mortality; and applies to more than half of adult
      general populations. However, preventive measures that target all four HRBs and that reach
      the majority of the target populations and particularly those persons most in need and hard
      to reach (e.g. with low socio-economic status), are scarce. Electronic interventions may help
      to efficiently address multiple HRBs in whole populations, such as health care patients. The
      aim is to investigate the acceptance of a proactive and brief electronic multiple behavior
      change intervention among general hospital patients with regards to reach, retention, equity
      in reach and retention, satisfaction and subsequent trajectories of behavior change
      motivation, HRBs and health.

      Methods: A pre-post-intervention study with four time points will be conducted at a general
      hospital in Germany. Patients admitted to participating medical departments (internal
      medicine, general surgery, trauma surgery, ear-nose-throat medicine) and aged 18-64 years
      will be systematically approached and invited to participate, irrespective of reason for
      admission and HRB profile. Based on HRB profile and on psychological behavior change theory,
      participants (n=175) will receive individualized computer-generated feedback concerning all
      four HRBs and motivation-enhancing feedback for up to two HRBs; directly on the ward and 1
      and 3 months later. Intervention reach and retention will be determined by the proportion of
      participants among eligible patients and participants, respectively. Equity in reach and
      retention will be measured with regards to school education and other socio-demographics. To
      investigate satisfaction with the intervention and trajectories of motivational measures,
      HRBs and health measures, a 6-month follow-up will be conducted. Descriptive statistics,
      multivariate regressions and latent growth modelling will be applied.

      Discussion: This study will be the first to investigate the acceptance of a proactive,
      electronic and brief multiple behavior change intervention among general hospital patients.
      If reach is high and efficacy established by a randomized controlled trial, the intervention
      has potential for public health impact in terms of primary and secondary prevention of
      diseases.
    


Intervention name(s): Proactive Automatized Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dietary Intake and Circulating Levels of Branched Chain Amino Acids
Condition: Dietary Intake of Branched Chain Amino Acids
Study type: Interventional

Summary: 
      The investigators are conducting this research study to find out if eating low or high levels
      of specific amino acids changes the levels of these same amino acids in the blood. Amino
      acids are the building blocks of protein that are normally found in food. The amino acids the
      investigators are studying are called branched chain amino acids. The investigators will look
      at the levels (amount) of branched chain amino acids in blood before and after consumption of
      specially prepared meals. The investigators hypothesize that circulating branch chain amino
      acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high
      BCAA-content diet.
    


Intervention name(s): Diet high in amino acid levels; Diet low in amino acid levels
Intervention type(s): Other; Other
Intervention description(s): Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.; Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.
Other intervention name(s): Amino Acid supplements to be used in prepared meals:; Vitaflo MSUD express; l-isoleucine; l-leucine; l-valine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nutrition
Evaluating Barriers to Stroke Screening and Prevention in Children With Sickle Cell Disease
Condition: Stroke Ischemic; Sickle Cell Disease
MeSH terms: Stroke; Ischemic Stroke; Anemia, Sickle Cell
Study type: Observational

Summary: 
      DISPLACE is a three part, multi-center U.S. based study to evaluate the barriers to stroke
      screening and prevention in children with sickle cell anemia (SCA). In the United States, TCD
      (Transcranial Doppler ultrasound) is a proven method of screening children with SCA for
      stroke. However, many children are not getting the screening they need. This study will
      examine the issues that hinder and help children get the screening at 28 different hospitals
      and sickle cell centers to improve care for all children with sickle cell anemia. The
      investigators will then plan a study (part 3) aimed to improve stroke screening and
      prevention in sickle cell anemia.
    

Detailed description: 
      DISPLACE (Dissemination and Implementation of Stroke Prevention: Looking At the Care
      Environment) is a multi-center, national NHLBI-funded grant to evaluate the real world
      implementation of the STOP protocol in which transcranial Doppler (TCD), a measure of
      cerebral blood vessel velocity, is used to screen for stroke risk in children ages 2-16 with
      sickle cell anemia (SCA). Based on the STOP (Stroke Prevention Trial in Sickle Cell Anemia)
      protocol, children identified as high risk of stroke by TCD are initiated on chronic red cell
      transfusion therapy (CRCT) for stroke prevention. Children with normal TCD are screened
      annually from the age of 2 until they are 16 years of age.

      This will be a THREE-part study beginning with Part 1 - a retrospective case record review
      followed by Part 2 - a multi-level qualitative assessment of barriers and enablers to TCD
      screening and initiation of chronic red blood cell transfusions and later adding Part 3 - a
      multi-center implementation clinical trial.The investigators will compare two implementation
      interventions to improve TCD screening.

      There are three aims of the grant and each aim is equivalent to the respective parts of the
      grant (i.e. Part 1 covers 1 aim). There are a total 28 consortium sites. The Medical
      University of South Carolina is the lead institution for this study.
    

Intervention name(s): Questionnaire/Interview
Intervention type(s): Other
Intervention description(s): A convenience sample of patients/parents and stakeholders will be asked to participate in a survey and/or interview to evaluate barriers to care in sickle cell.
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children with sickle cell anemia who were between 2-16 years of age from 2012-2016.
      
Keywords: sickle cell anemia; TCD; screening; dissemination; implementation
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Condition: Scoliosis; Pain
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Acute pain management following major surgical procedures in pediatric patients continues to
      be a challenge, especially after extensive posterior spine fusions.

      Spine surgery is particularly traumatic, initiating pain in both peripheral and central
      pathways. While the standard management of post-surgical pain involves a multimodal approach,
      opioids provide the predominant benefit. However, opioid use is associated with many adverse
      effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease
      total opioid consumption and adverse effects as well as improve satisfaction with pain
      management after scoliosis repair.
    

Detailed description: 
      This study is a double blind comparison, evaluating the benefits of intraoperative methadone
      in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg
      will be given to the treatment group. Postoperative evaluation for narcotic use, pain
      control, and adverse effects will be compared to a standard treatment approach used at
      Children's Hospital of Wisconsin.
    

Intervention name(s): Methadone; Normal Saline; Morphine
Intervention type(s): Drug; Other; Drug
Intervention description(s): Perioperative IV methadone to be given; control arm; Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Other intervention name(s): generic methadone; salt water; Duramorph
Intervention MeSH terms: Morphine; Methadone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methadone; Gabapentin; Postoperative Pain; Posterior Spinal Fusion; Pediatric
MyoSure Hysteroscopic Tissue Removal System Registry Study
Condition: Uterine Fibroids; Polyps
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate the safety and effectiveness of community
      gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the
      MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.
    

Detailed description: 
      Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study.
      Approximately 100 of these cases will be completed in an office setting, with the remaining
      400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will
      undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal
      fibroids.
    

Intervention name(s): MyoSure Tissue Removal System
Intervention type(s): Device
Intervention description(s): The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.
Other intervention name(s): Myomectomy procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: morcellator; hysteroscope; myomectomy; polypectomy; uterine fibroids; uterine polyps
Neuromodulation for Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The investigators propose to use a clinical trial to test Trigeminal Nerve Stimulation (TNS)
      to examine the efficacy of TNS as a new treatment for Post Traumatic Stress Disorder (PTSD)
      in veterans. Recruitment will take place at the PTSD Outpatient Clinic at the Veterans Affair
      Greater Los Angeles (VA GLA). Study participants will be asked to complete, at most, 9
      assessments/questionnaires regarding their PTSD symptoms and quality of life, use the TNS
      device every night for 8 hours, log their use of the device, and attend weekly visits to
      monitor safety and complete assessments. Each subject will be asked to attend 8 visits over
      the course of 8 weeks. Subjects who receives the sham-controlled treatment will have an
      additional follow-up phone visit 4 weeks after the week 8 endpoint to examine symptom
      improvements.

      Enrollment and subject-related procedures are projected to take approximately 36 months.
      Preparations for clinical trial, clinical trial/study procedures and data analysis will
      occupy a 6 month period, a 36 month period, and a 6 month period, respectively. The duration
      of this project is approximately 4 years.
    


Intervention name(s): Trigeminal Nerve Stimulation; Placebo
Intervention type(s): Device; Device
Intervention description(s): Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.; Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
Other intervention name(s): TNS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trigeminal Nerve Stimulation; Post-Traumatic Stress Disorder
Depression and Dopamine Transporter Function Study Using C-11 Altropane
Condition: Major Depressive Disorder; Anhedonia
MeSH terms: Anhedonia; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      Major depressive disorder (MDD) is often characterized by anhedonia and impaired ability to
      modulate behavior as a function of rewards. However, the neurobiology of anhedonia and
      reduced reward responsiveness remains largely unknown. Because dopamine (DA) plays a critical
      role in goal-directed behavior and reinforcement learning, DA dysregulation might play an
      important role. In fact, several lines of evidence suggest that down-regulation of DA
      transmission might characterize depression vulnerability and the emergence of depressive
      symptoms. The current study seeks to elucidate the role of DA dysfunction in MDD. We
      hypothesize that MDD subjects will show reduced DAT binding potential, reduced reward
      learning in the probabilistic reward task, and abnormal functional magnetic resonance imaging
      (fMRI) activation in dorsal and ventral striatal regions during an instrumental learning
      task.

      This study will include three sessions.

      The first will take place at Massachusetts General Hospital or at McLean Hospital's Center
      for Depression, Anxiety and Stress Research. The aims of this session will be to (a) explain
      the study; (b) collect written informed consent, and (c) assess the subject's eligibility.

      Following this, another session (either second or third in order) will take place at the MGH
      PET Imaging Laboratory. Participants will complete a PET scan and a probabilistic reward task
      designed to measure reward learning and sensitivity to reward. The radioactive tracer
      utilized is 11C-altropane.

      Another session (either second or third in order) will take place at the McLean Hospital
      Neuroimaging Center. Participants will complete an instrumental learning task while in the
      fMRI, followed by a social reinforcement learning task and an implicit learning serial
      reaction time task upon completion of the scan. In the instrumental learning task,
      participants have the opportunity to earn money but need to learn, by trial and error,
      stimulus-outcome associations. The social reinforcement learning task is designed to
      investigate whether learning deficits in MDD are specific to learning from monetary
      incentives or whether the learning deficits are more global and are affected when learning
      from social rewards and punishments. Participants will also complete an implicit learning
      serial reaction time task, designed to exclude the possibility of global learning deficits in
      MDD.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Positron Emission Tomography (PET); Magnetic resonance imaging (MRI); reward; stress; learning; Major Depressive Disorder; Anhedonia
Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational [Patient Registry]

Summary: 
      50 pregnant females were divided in two groups, twenty five as a control group and twenty
      five as high risk group; they were subjected to uterine artery Doppler, measurement of
      maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14
      weeks of gestation, all pregnancies were followed until 40 weeks for development of
      pre-eclampsia
    

Detailed description: 
      50 pregnant females were divided in two groups, twenty five as a control group and twenty
      five as high risk group; they were subjected to uterine artery Doppler, measurement of
      maternal serum (pp-13) and detection of (MTHFR) gene polymorphisms in first trimester at 11
      to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of
      pre-eclampsia
    

Intervention name(s): ultrasound monitoring
Intervention type(s): Other
Intervention description(s): Uterine artery Doppler assessment
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pregnant women at 11 to 14 weeks of gestation
      
Keywords: Preeclampsia; placental protein 13; Uterine artery doppler
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to
      severe Crohn's disease who completed the double-blind induction treatment in Study A3921083
      and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
    


Intervention name(s): Placebo; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablets twice daily; oral tablets twice daily; oral tablets twice daily
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tofacitinib; Xeljanz; CP-690,550; maintenance therapy
Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, multicentre, randomised, 2-cohort, sequential and crossover study to assess
      the relative oral bioavailability of MT-7117 higher content tablets versus MT-7117 lower
      content tablets and the pharmacokinetics of MT-7117 under various gastric conditions (fed and
      fasted, and following administration of a proton pump inhibitor and an acidic beverage) in
      healthy subjects
    


Intervention name(s): MT-7117; PPI; Acidic beverage
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): MT-7117; Proton pump inhibitor; Acidic beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Other
Keywords: Relative Bioavailability and DDI study with MT-7117 and a proton pump inhibitor
The PRISM Pilot Trial for Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      A Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and Effectiveness of
      Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to Standard of Care, in
      Subjects with Post-Traumatic Stress Disorder (PTSD)
    

Detailed description: 
      Prism is a software device intended for neurofeedback (NF) training (i.e. operant condition
      based on EEG signals, also known as EEG-biofeedback), to be used in combination with a
      standard computer and supported EEG hardware. For purposes of this training, information for
      feedback is derived and processed from several EEG channels. Prism provides visual and/or
      auditory signals that correspond to the patient's computed EEG signal, which serves as a
      surrogate indicator of achieving a state of reduced amygdala activity.

      The study is a Prospective, Single-Arm, Open-Label Pilot Trial, to Assess Safety and
      Effectiveness of Process-Instructed Self neuro-Modulation ("Prism"), as an Adjunct to
      Standard of Care, in Subjects with Post-Traumatic Stress Disorder (PTSD).

      The study population will include subjects diagnosed with Post-Traumatic Stress Disorder
      (PTSD) from 1 year to 20 years after index trauma. The total expected enrollment is up to 100
      subjects in one or more sites.

      The study's primary objective is to assess the safety and effectiveness of fifteen (15)
      EEG-NF training sessions using the Prism software in reducing PTSD-related symptoms.
    

Intervention name(s): PRISM
Intervention type(s): Device
Intervention description(s): Subjects will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks.
Intervention model: Single Group Assignment
Intervention model description: single-arm, open-label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD