bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Seven Day Prucalopride Administration in Healthy Volunteers
Condition: Molecular Mechanisms of Pharmacological Action; Depression; Depressive Disorder; Mood Disorders; Mental Disorders; Antidepressive Agents; Cognition
MeSH terms: Depressive Disorder; Mental Disorders; Mood Disorders
Study type: Interventional

Summary: 
      This study will investigate whether seven days administration of the serotonin receptor
      subtype 4 (5-HT4) partial agonist prucalopride has effects on emotional processing and neural
      activity in healthy volunteers, compared to placebo administration. Using an experimental
      medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant
      action will be characterised. In a double-blind design, participants will be randomised to
      receive seven days administration of either prucalopride (1mg daily) or placebo. All
      participants will come for a Screening visit, Research Visit One (including an MRI scan) and
      Research Visit Two (including measures of emotional processing and non-emotional cognition).
      The primary study hypothesis is that seven-day prucalopride administration will have positive
      effects on emotional processing and reward sensitivity. A secondary hypothesis is that
      seven-day prucalopride administration will alter non-emotional cognition. Finally, the study
      will test the hypothesis that seven day prucalopride administration will alter neural
      activity during an emotional faces task and a memory task.
    


Intervention name(s): Prucalopride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1mg prucalopride capsule, once daily for seven days; Lactose placebo capsule, once daily for seven days
Other intervention name(s): Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly allocated to one of two groups (prucalopride or placebo). Participants in the prucalopride group will receive 1mg once daily for seven days. Participants in the placebo group will receive a lactose placebo once daily for seven days. Note that the study is not assessing the safety or efficacy of prucalopride, rather it is using prucalopride to assess the behavioural and neural effects of 5-HT4 partial agonists.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: 5-HT4; Prucalopride; Resolor; Functional Magnetic Resonance Imaging (fMRI); Emotional Processing; Healthy Volunteers
A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis
Condition: Ankylosing Spondylitis; Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis
Study type: Interventional

Summary: 
      This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of
      spinal movement in a group of patients with axial spondyloarthritis.
    

Detailed description: 
      One of the most important goals of therapy in axial spondyloarthritis is to improve and/or
      preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible
      but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for
      spinal mobility using tape measures are inaccurate and do not capture many aspects of
      kinematics such as spinal rotation or speed of movement. There is also a need for wearable
      sensors to give patients feedback and encourage more regular exercise.

      The investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40
      patients with axial spondyloarthritis. The investigators will be testing aspects of
      inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the
      traditional tape measure test (BASMI).
    

Intervention name(s): ViMove Spinal Sensor
Intervention type(s): Device
Intervention description(s): Sensors will be used to measure spinal movement
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia
Condition: General Anesthesia; Children; MRI; Sevoflurane; Propofol/Remifentanil
Study type: Observational

Summary: 
      Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing
      MRI in general anesthesia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        120 children ASA 1-2 aged 1 to 10 yrs. scheduled for MRI in general anesthesia
A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and
      tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus
      inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin
      combination therapy. After an initial screening period, patients will be randomized to one of
      3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4
      weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of
      pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target
      sample size is 500+ individuals.
    


Intervention name(s): pioglitazone; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30mg po once daily for 4 weeks, followed by 45mg once daily; 10mg sc once weekly; 10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly
Intervention MeSH terms: Pioglitazone; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
HOBSCOTCH Phase II
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and efficacy of the home-based
      cognitive self-management program "HOBSCOTCH" delivered at four New England medical centers.
      It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be
      delivered from a distance utilizing e-health tools for parts of the program.
    

Detailed description: 
      HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) is a home-based
      self-management program to treat cognitive symptoms and improve quality of life, while
      minimizing the barriers of access to care. The program is based on Problem Solving Therapy
      (PST) and teaches problem solving strategies and compensatory mechanisms to help manage
      cognitive dysfunction and enhance quality of life.

      HOBSCOTCH Phase II is a replication study of the original HOBSCOTCH study, designed to
      translate the findings of HOBSCOTCH into a real world setting. This is a multi-center study,
      with the HOBSCOTCH intervention being implemented at four epilepsy clinics in New England.
    

Intervention name(s): Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
Intervention type(s): Behavioral
Intervention description(s): HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Epilepsy Memory Problems; Self-Management
Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      The objective of this study was to assess the safety and appropriateness of a sunscreen
      product for use on sport users, under supervised outdoor-use conditions. The study was
      conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated
      swimming pool facility.
    


Intervention name(s): BAY 987519, SPF 50, Y51-002; BAY 987519, SPF 50, P04-147
Intervention type(s): Drug; Drug
Intervention description(s): Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.; Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Reader Study of DeltaView™ Chest Radiograph Software
Condition: Lung Neoplasm
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      A new software product takes two chest radiographs, aligns them, and then subtracts one image
      from the other. The resulting image represents an image showing any differences between them.
      The study is to determine whether radiologists using this new software perform better with it
      than when they do not use it.
    


Sampling method: Non-Probability Sample
Study population: 
        Radiologists in community practice of radiology chest radiographs of individuals with or
        without a lung nodule
      
Keywords: lung neoplasm nodule image processing computer-assisted
Safety Assessment of Potential Interactions Between IV Methamphetamine and Osmotic-Release Methylphenidate (OROS-MPH)
Condition: Methamphetamine Dependence; Methamphetamine Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a human inpatient clinical pharmacology study to assess potential interactions
      between intravenous (i.v.) methamphetamine infusion and oral osmotic release methylphenidate
      (OROS-MPH). The primary objective of this study is to determine the safety of the OROS-MPH
      concurrent with i.v. d-methamphetamine infusions of 15 mg and 30 mg. Safety outcome measures
      include cardiovascular responses [heart rate (HR), blood pressure (BP), and
      electrocardiograph (ECG) measurements], oral temperature, adverse events (AEs), and clinical
      laboratory analyses.
    


Intervention name(s): OROS-MPH; OROS-MPH; OROS-MPH
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 18 mg bid on days 1 and 2; 27mg bid on days 3 and 4; 35 mg bid on days 5-9
Other intervention name(s): Concerta; Concerta; Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Methamphetamine
Efficacy of "Tailored Physical Activity" in Health Care Workers
Condition: Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the effect of "Tailored Physical Activity" on the number
      of sick-days.

      The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days.
    

Detailed description: 
      Health care workers have high prevalence of musculoskeletal pain. Pain in the back and neck
      and other musculoskeletal disorders are the leading cause for long-term sick leave.

      This study test the effect of "Tailored Physical Activity" on self-reported days on sick
      leave and parameters regarding pain, function and quality of life respectively on the body
      function and participation level of health care workers which have experienced
      musculoskeletal pain related to the back or upper body.

      A minimum of 44 health care workers in DK-Sønderborg Municipality will be randomized for
      "Tailored Physical Activity" or a reference group.

      Primary endpoint is 3 months and 12 months follow-up.
    

Intervention name(s): Tailored Physical Activity; Health Counselling
Intervention type(s): Other; Behavioral
Intervention description(s): Tailored Physical Activity (3*50 min/week in 10 weeks); Health guidance (1,5h)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: health care workers; tailored physical activity; prevention; spine; upper body; pain related to Spine or Upper body
Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the safety and efficacy of early corticosteroid discontinuation in liver
      transplant recipients more than 90 days post transplant, utilizing a combination of two drugs
      (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.
    

Detailed description: 
      To determine the safety and efficacy of early corticosteroid discontinuation in liver
      transplant recipients more than 90 days post transplant, utilizing a combination of two drugs
      (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.
    

Intervention name(s): tacrolimus; mycophenolate mofetil; Prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.; Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.; Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Other intervention name(s): Prograf, FK506; MMF, CellCept; corticosteriods
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver; Transplant; Corticosteroid withdrawal; Tacrolimus; CellCept; MMF; Mycophenolate mofetil
The Influence of Multi-domain Cognitive Training on Large-scale Structural and Functional Brain Networks in MCI
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to integrate advanced computational techniques and multimodal
      neuroimaging methods to examine the potential effects of long-term, multi-domain, online,
      computerized cognitive training on large-scale structural and functional brain networks in
      older adults with mild cognitive impairment (MCI).
    

Detailed description: 
      This multilevel study will be comprised of a placebo controlled randomized controlled trial
      to test the effect of long-term (6 months), multi-domain, computerized cognitive training on
      large-scale structural and functional brain networks in individuals with MCI (age >= 65
      years). Neuroimaging and neuropsychological data before and after intervention will be
      evaluated within and between groups to elucidate the trajectory of neuronal network
      improvements associated with training compared to typical MCI development. We will compare
      the outcomes between participants with MCI who receive structured cognitive training
      (treatment group: TG) with those who receive nonspecific computerized training activities
      (active controls: AC). The duration of intervention is 6 months. The focus of the study will
      be on individuals with amnestic MCI (single- or multi- domain). The study includes 30 MCI
      subjects in a treatment group (TG) and 30 matched MCI subjects in active control (AC) group.
      TG and AC participants will be evaluated at two time points: 1) baseline and 2) 6-month
      (post-training).
    

Intervention name(s): Multi-domain cognitive training; Cross-word puzzle training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The cognitive exercises are designed to train executive functions and memory.; The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
The HPV Self-test as a Test of Cure in Madagascar
Condition: Human Papilloma Virus Infection; Cervical Intraepithelial Neoplasia Grade 2/3
MeSH terms: Papillomavirus Infections; Papilloma; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether Self-HPV may be an accurate method for the
      follow-up of women with a history of HPV infection.
    

Detailed description: 
      The efficacy and the availability of cold coagulation render it a valuable technique for the
      treatment of precancerous lesions in low-resource settings. The Human Papillomavirus (HPV)
      test performed by women themselves (HPV self-test) could be an efficient method to assess the
      long-term risk of recurrent/persistent disease in women with a history of HPV infection and
      cervical intra-epithelial lesions grade 2 or higher (CIN2+).

      A total of 443 HPV-positive women, aged 30-65 years, have been selected through a screening
      campaign conducted in Ambanja, Madagascar, between 2013 and 2015. Of these, 260 have been
      treated by cold coagulation, conisation or electrocauterization. A follow-up visit at 1-3
      years after primary screening will be organized for all HPV-positive women detected at
      primary screening. Participants will perform an HPV self-test. A sample for cytology and HPV
      testing will also be collected by the physician. The goal of the study will be the
      histological search for CIN2+ lesions at one to three years after primary screening.

      The investigators expect to see that Self-HPV may be an accurate method for the follow-up of
      women with a history of HPV infection.
    

Intervention name(s): HPV test
Intervention type(s): Device
Intervention description(s): Women will perform the HPV self-test and will also undergo a physician-performed HPV test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Fetal Hemoglobin Induction Treatment Metformin
Condition: Sickle Cell Anemia; Sickle Cell Disease; Hemoglobin Disorder
MeSH terms: Anemia, Sickle Cell; Hemoglobinopathies
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether metformin is effective in the treatment for
      sickle cell anemia (SCA).
    

Detailed description: 
      This is a dose escalation, pilot study for subjects with sickle cell anemia (SCA) disease to
      determine if metformin has a beneficial effect on the treatment and quality of life of SCA
      patients.
    

Intervention name(s): Metformin; Questionnaires
Intervention type(s): Drug; Behavioral
Intervention description(s): Metfomin will be taken daily. The metformin dose will be increased during two time points per subject if protocol dose escalation criteria is met.; Questionnaires will be completed to assess the impact quality of life
Other intervention name(s): Glucophage; Riomet,
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; Sickle Cell Anemia; Sickle Cell Disease; Hemoglobinopathies; Hemoglobin Disorder; Blood Disease; Hemoglobin Disease
GLP-1 Response and Effect in Individuals With Obesity Causing Genetic Mutations
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The obesity epidemic is attributable to dietary and behavioral trends acting on a person's
      genetic makeup to determine body mass and susceptibility to obesity-related diseases.
      Furthermore, common forms of obesity have a strong hereditary component and many genetic
      pathways that contribute to obesity have already ben identified.

      Glucagon-like peptide-1 (GLP-1) is an incretin hormone that potentiates glucose-stimulated
      insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the
      appetite center in the hypothalamus. Today, GLP-1 receptor agonists are available for the
      treatment of type 2 diabetes, and their treatment potential in obesity is an area of active
      research.

      The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in
      people diagnosed with obesity causing genetic disorders and to investigate the physiological
      role of GLP-1 on food intake and appetite regulation in this group.
    

Detailed description: 
      -  Exploration of the physiological role of GLP-1 concerning food intake and appetite
           regulation in obese adults diagnosed with obesity related genetic disorders.

        -  Assessment of the effect of GLP-1 on body composition, bone mineral density, energy
           expenditure, cardiac function, glucose tolerance, insulin sensitivity, lipid
           concentrations and neuroendocrine function.

        -  Assessment of the impact of the leptin induced adaptive thermogenesis response in the
           weight reduced study participants.

        -  Investigating the alteration of the composition of gut bacteria as well as subjective
           ratings of satiety and hunger before after supplement with GLP-1.
    

Intervention name(s): Liraglutide
Intervention type(s): Drug
Intervention description(s): S.c. liraglutide 3.0mg once daily
Other intervention name(s): Victoza, Novo Nordisk A/S in DK-2880 Bagsvaerd; Serial number:76477425; International code name: 005; US Class Codes: 006, 018, 044, 046, 051, 052
Intervention MeSH terms: Liraglutide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Obesity Genetics; GLP-1; GLP-1 Receptor Agonists