bioihbjkbjnl/mcl2 huggingface dataset:
Cat-PAD Exposure Chamber Study
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with
      allergic rhinoconjunctivitis and/or asthma. Cat-PAD is a novel, synthetic, allergen-derived
      peptide desensitising vaccine, currently being developed for the treatment of cat allergy.

      This study will look at the efficacy, safety and tolerability of two doses of Cat-PAD in cat
      allergic subjects following challenge to cat allergen in an EEC.
    

Detailed description: 
      This study is designed as a randomised, double-blind, placebo-controlled, parallel group
      study to evaluate the safety and tolerability of Cat-PAD in cat allergic subjects with
      allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of
      Cat-PAD will be explored in subjects using an(Environmental Exposure Chamber)EEC.

      The study will consist of 3 study periods. In Period 1, Screening will be performed up to a
      maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic,
      at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at
      least 3 days before randomisation.

      In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be
      randomised to one of three groups and will receive treatment every 2 weeks (±2 days) for 14
      weeks.

      In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after
      the first administration in the treatment period and assessments will be performed identical
      to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.
    

Intervention name(s): Placebo; Cat-PAD; Cat-PAD
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intradermal injection 1x8 administrations 2 weeks apart; Intradermal injection 1x8 administrations 2 weeks apart; Intradermal injection, 1x8 administrations 2 weeks apart, alternating active and placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cat allergy; Rhinoconjunctivitis; Exposure chamber; Immunotherapy; Cat-PAD
Hemodynamic Changes During One Lung Ventilation in Non-intubated Vedio-assisted Thoracoscopic Operations
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Non-intubated thoracoscopic surgery has been proved as an adequate alternative for management
      of many lung conditions such as pneumothorax , lung volume reduction, pulmonary
      metastasectomy, removal of lung nodules, segmentectomy and lobectomy. However, the
      hemodynamic changes during one lung ventilation have not been fully investigated. The goals
      of this study are to compare the changes of hemodynamics (including blood pressure, heart
      rate, cardiac output, pulse pressure variation, fluid responsiveness) during one lung
      ventilation between conventional intubated and non-intubated vedio-assisted thoracoscopic
      (VATS) operations.
    

Detailed description: 
      Non-intubated vedio-assisted thoracoscopic (VATS) is proved safely performed as well as
      traditional intubated VATS. However, the differences of hemodynamic changes and fluid
      responsiveness during one lung ventilation(OLV) between these two groups were rarely
      reported. For complete lung collapse, spontaneous negative pressure respiration must be well
      maintained on non-intubated VATS. In comparison, positive pressure ventilation on dependent
      lung was applied during OLV in intubated VATS. This study planned to compared the changes of
      hemodynamics (including blood pressure, heart rate, cardiac output) during OLV between
      groups. As functional hemodynamic monitoring (FloTrac system) was mostly utilized with
      positive pressure ventilation, the applicability of FloTrac in non- intubated VATS was also
      testified. In this study, we also measure the fluid responsiveness by FloTrac system with
      rapid infusion (within 10 minutes) of 10 mL/kg crystalloid fluid. We planned to compare the
      changes on cardiac output and the fluid responsiveness during OLV between these two groups.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients scheduled to receive video-assisted thoracoscopic (VATS) operations with one lung
        ventilation(OLV)

        Inclusion criteria:

          1. age over 20 y/o, less than 70 y/o

          2. scheduled to receive VATS operations with OLV

        Exclusion:

          1. previous thoracic surgery

          2. cardiac disease ( including arrhythmias, congestive heart failure, coronary cardiac
             disease, etc.)

          3. pulmonary disease
      
Keywords: one lung ventilation,; cardiac output; fluid responsiveness
Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment
Condition: Anaemia; Schistosomiasis Infection; Malaria; Iron Deficiency
MeSH terms: Malaria; Schistosomiasis; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Observational

Summary: 
      The purpose of this study is to determine the extend and the nature of anemia in school
      children and the correlation between anemia and schistosomiasis infections, malaria
      infections and/or malnutrition (iron deficiency).
    

Detailed description: 
      The study will be carried out in an area around Lake Victoria in Kenya where the prevalence
      of schistosomiasis and malaria are highest in the areas nearest to the Lake. Depending on the
      prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in
      the study. The children who will be in the age between 9 to 12 year, will have their stool
      and urine examined for schistosomiasis and intestinal worms and a blood sample will be
      examined for malaria parasites and the hemoglobin level. Children will also be weight,
      measured and examined by a doctor and register their food intake over one week, to determine
      their nutritional status. Children who are found to be infected with schistosomiasis,
      intestinal worms or malaria will be offered treatment. Children who are found to have anemia
      will be offered a course of iron supplementation, children with severe anemia will be
      referred to the nearest health facility for treatment. 12 months after the initial
      examinations and treatment all children will have a re-examination of their stool, urine and
      blood.
    

Intervention name(s): praziquantl, iron, ACT
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children 9-12 years of age
      
Keywords: schistosomiasis; anaemia; malaria; iron deficiency
Interpersonal Psychotherapy in Youth With Severe Mood Dysregulation-Pilot
Condition: Severe Mood Dysregulation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and acceptability of an utilizing
      an adapted form (IPT-SMD)of a psychosocial intervention, Interpersonal Psychotherapy for
      Depressed Adolescents, for youth with severe mood dysregulation (SMD).

      The investigators hypothesize that retention rates will be >80%,satisfaction scores will
      average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT-SMD
      intervention will have overall improvement in SMD symptoms.
    


Intervention name(s): Interpersonal Psychotherapy for youth with SMD (IPT-SMD)
Intervention type(s): Behavioral
Intervention description(s): Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interpersonal psychotherapy; severe mood dysregulation
Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15
      schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive
      functioning, and metabolic parameters.

      Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or
      Massachusetts General Hospital. A total of 15 subjects will be enrolled.
    

Detailed description: 
      The specific aims include:

      Primary aims:

        1. Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms
           as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for
           Assessment of Negative Symptoms (SANS).

        2. Examine the efficacy of salsalate in improving cognition as measured by the Measurement
           and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.

      Secondary aims:

      1. Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive
      protein (hs-CRP), TNF-α and IL-6.
    

Intervention name(s): salsalate
Intervention type(s): Drug
Intervention description(s): open-label trial of salsalate 3g/day for 12 weeks.
Intervention MeSH terms: Salicylsalicylic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; Metabolism; Antipsychotics; Psychopathology
Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and PK of MK-8892 in participants with
      pulmonary arterial hypertension. The primary hypothesis is that the geometric mean of MK-8892
      area under the concentration time-curve from Hour 0 to 24 hours (AUC0-24hr) in participants
      with PAH, will be equal to or greater than the efficacious exposure in humans of 0.6 μM•hr.
    


Intervention name(s): MK-8892; Placebo for MK-8892
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to further investigate rituximab in the treatment of rheumatoid
      arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to
      improve the evaluation of treatments.
    

Detailed description: 
      Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin's
      B cell lymphoma (a type of cancer) and for certain patients with rheumatoid arthritis (RA) by
      the Food and Drug Administration (FDA). To date, more than 1000 subjects with rheumatoid
      arthritis have received rituximab in clinical studies.

      Magnetic resonance imaging (MRI) is a modern and sensitive method of looking at joints in
      people with rheumatoid arthritis. It uses a magnetic field to create an image. The MRI takes
      an image in 3 dimensions and this provides a better picture for a physician to see more
      details.

      There are two treatment groups in this study with equal numbers of patients assigned to each
      group. All the patients will receive their baseline Methotrexate and two intravenous
      infusions 2 weeks apart of one of the following:

        -  1000 mg rituximab or

        -  placebo. Patients outcomes will be compared between the 2 groups. After week 24 (open
           label phase), the patients will receive rituximab if rheumatoid arthritis remains
           active.

      All the patients will have MRI of their dominant hand and wrist with and without gadolinium
      performed at baseline, 12, 24 and 48 weeks on 1.5 Tesla MRI . Some patients will also have
      additional MRI of the same hand and wrist without gadolinium at the same time points on 0.2
      Tesla MRI. Comparison of the images from the two machines will be performed.

      Various blood biomarkers will also be examined, compared between the 2 treatment groups and
      correlated with the MRI results.
    

Intervention name(s): Rituximab
Intervention type(s): Biological
Intervention description(s): At Week 24 or any time up to Week 48 if the Patient DAS 28 > 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magnetic Resonance Imaging; Rituximab; Low Field MRI; Biomarkers
Study of Cerebral Function in Patients With Chronic Hepatitis C Infection (HCV/CNS)
Condition: Hepatitis C, Chronic; Cognition Disorders; Fatigue Syndrome, Chronic; Major Depressive Disorder
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Fatigue Syndrome, Chronic; Hepatitis; Hepatitis, Chronic; Depressive Disorder; Depression; Depressive Disorder, Major; Cognition Disorders
Study type: Interventional

Summary: 
      Patients with HCV infection often suffer from chronic fatigue, depression and reduced
      cognition, even before evolving severe liver fibrosis, liver cirrhosis and hepatic
      encephalopathy.

      It is currently unclear to what extent the symptoms er due to a direct pathological effects
      of the virus itself, or due to pre-existing psychiatric disease. There is a complex
      relationship between prior or existing drug abuse, psychiatric disease and HCV infection,
      that makes it difficult to establish cause-effect relationships.

      A biological mechanism has been suggested to contribute to development of cerebral
      dysfunction in the patients. According to the prevailing Trojan Horses hypothesis circulating
      lymphocytes cross the blood brain barrier carrying HCV to the central nervous system and
      virus is subsequently replicated in the macrophages and the microglia in brain as a separate
      compartment. As part of the immunological response to viral replication, neurodegenerative
      processes takes place with a harmful effect on the neural circuit and cerebral function.
      Identification of HCV RNA negative strand, a replication product, in brain tissue from HCV
      patients, as part of autopsy studies, supports the hypothesis. Moreover, HCV patients have
      also been observed with abnormal metabolic concentrations in the frontal white substance and
      the basal ganglia by MRI spectroscopy compared to control groups.

      The overall study objective is to assess cerebral function with particular emphasis on
      cognitive functions in HCV patients (genotypes 1,2,3 and 4) by use of a neuropsychiatric test
      battery. Furthermore, the patients will be examined by MRI, including magnetization transfer,
      diffusion tensor and contrast perfusion, in order to perform measurements of cerebral
      volumetric and microstructure. Finally, HCV analysis, including viral sequences and cytokine
      profiles, in serum and cerebrospinal fluid will be carried out in the study population.
    


Intervention name(s): Interferon and ribavirin
Intervention type(s): Drug
Intervention description(s): Interferon 180 microgram weekly s.c. and ribavirin (800/100/1200 mg daily) p.o.
Other intervention name(s): Pegasys (ATC Code: L03AB11) and Copegus (ATC Code: J05AB04)
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Chronic Hepatitis C; cognitive dysfunction; MRI; MR spectroscopy; interferon; ribavirin; sustained virologic response, major depressive disorder
SIA - Internet-administered CBT for Adolescents With Low Self-esteem
Condition: Self Esteem
Study type: Interventional

Summary: 
      The study will investigate a novel CBT based treatment approach for low self-esteem among
      adolescents.
    


Intervention name(s): Cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): Internet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive behavior therapy
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of an association with one
      anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory
      plus caffeine in the treatment of osteomuscular pain in adults.
    

Detailed description: 
      -  Double-blind,randomized, multicenter

        -  Maximal experiment duration: 9 days

        -  02 or 03 visits and a phone contact

        -  Evaluate the efficacy of an association with one anti-inflammatory and one muscle
           relaxant agent with caffeine compared to the one muscle relaxant agent plus caffeine in
           the treatment of osteomuscular pain in adults.

        -  Adverse events evaluation
    

Intervention name(s): ketoprofen and cyclobenzaprine association with caffeine; Cyclobenzaprine with caffeine
Intervention type(s): Drug; Drug
Intervention description(s): The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h; The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h
Other intervention name(s): EMS association; Miosan Caf®
Intervention MeSH terms: Ketoprofen; Amitriptyline; Cyclobenzaprine; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Airway Resistance Measurement in Children 3 to 6 Years of Age
Condition: Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Interventional

Summary: 
      In preschool aged children, the most suitable techniques to assess airway obstruction is
      debit interruption technic (Rint) and plethysmographic measure of specific airway resistance
      (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung
      tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to
      be better for discriminating airway obstruction. These two techniques will be compared in
      terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.
    


Intervention name(s): airway resistance measurement
Intervention type(s): Other
Intervention description(s): assessment of airway resistance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance
Condition: Augmented Renal Clearance (ARC); Systemic Inflammatory Response Syndrome (SIRS)
MeSH terms: Systemic Inflammatory Response Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with
      augmented renal clearance (ARC).
    

Detailed description: 
      To evaluate the single-dose pharmacokinetic (PK) profiles of ceftaroline and avibactam
      following intravenous (IV) administration of ceftaroline fosamil/avibactam ("CXL") in adults
      with augmented renal clearance (ARC).
    

Intervention name(s): Ceftaroline fosamil/Avibactam (CXL)
Intervention type(s): Drug
Intervention description(s): IV infusion of CXL (combination of ceftaroline fosamil [600 mg] plus avibactam [600 mg]) infused over 60 (± 5) minutes.
Intervention MeSH terms: Ceftaroline fosamil; Avibactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of Physical Activity Monitoring and Distance Counseling in an Occupational Health Setting
Condition: Physical Inactivity
Study type: Interventional

Summary: 
      The CoAct study is investigating a novel lifestyle intervention, aimed at the working
      population, with daily activity monitoring and distance counseling via telephone and secure
      web messages. The main purpose of this study is to evaluate the effectiveness of lifestyle
      counseling on the level of physical activity in an occupational health setting. The purposes
      include also analyzing the potential effects of changes in physical activity on productivity
      at work and sickness absence, and health care costs.
    

Detailed description: 
      CoAct is a randomized controlled trial with two arms: a control group and intervention group
      with daily activity monitoring and distance counseling. The intervention focuses on lifestyle
      modification and takes 12 months. The study population consists of those volunteering from
      1100 eligible employees from a Finnish insurance company. The primary outcomes are change in
      physical activity measured in MET hours per week, work productivity and sickness absence, and
      health care utilization. Secondary outcomes include various physiological measures.
      Cost-effectiveness analysis will also be performed. The outcomes will be measured by
      questionnaires at baseline, after 6, 12, and 24 months, and sickness absence will be obtained
      from the employer's registers.
    

Intervention name(s): Activity monitoring and distance counseling
Intervention type(s): Behavioral
Intervention description(s): The physical activity monitoring and distance counseling concept combines the use of a personal activity monitor with web-based tailored physical activity advice. Users can interactively plan and evaluate their own activity advice based on their actual PA scores and their PA preferences and goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Physical activity; health behaviour; lifestyle; productivity; outcomes
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult
      volunteers and participants with hepatitis B virus (HBV).
    


Intervention name(s): ARO-HBV Injection; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Other
Intervention description(s): Single or multiple doses of ARO-HBV Injection by subcutaneous (sc) injection; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment