bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Chronic Intake of Cannabis on Contrast Sensitivity
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      Rates of driving under the influence of cannabis have risen in recent years. Cannabis is
      involved in 1/3 of motor vehicle collisions. The chronic use of cannabis is known to affect
      dopaminergic regulation and may thus impair contrast sensitivity. In turn, contrast
      sensitivity disorders could originate difficulties to anticipate and avoid collision with
      objects, especially when objects are in movement. The investigators goal is to examine the
      effects of a chronic intake of cannabis on contrast sensitivity. The observed values will be
      compared to standard references. In addition, since smoking cannabis is always associated
      with tobacco, the investigators will control the effects of tobacco on contrast sensitivity.

      In this study, the investigators will include 36 cannabis addicts, 36 tobacco addicts and 36
      no smokers. The investigators will present gratings with different spatial frequencies and
      the investigators will determine contrast thresholds for static and dynamic (moving)
      gratings. The investigators predict that cannabis addicts will present abnormal contrast
      sensitivity especially in case of dynamic presentation of gradings.
    


Intervention name(s): electroretinogram; contrast sensitivity tests
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
Condition: Chronic Low-back Pain; Lumbal Disc Herniation; Imbalance
MeSH terms: Intervertebral Disc Displacement; Back Pain; Low Back Pain; Hernia
Study type: Interventional

Summary: 
      This study was aimed to investigate the effectiveness of mulligan mobilization technique on
      balance, pain and functionality in patients with chronic low back pain and to compare it with
      exercise.37 patients aged between 18-65 who applied to Fındıkzade Medipol Hospital were
      included in the study. The individuals participating in the study were divided into two
      groups, 18 control and 19 mulligan groups, according to the randomization table. The
      intervention was performed 3 times a week for 4 weeks. Conventional physiotherapy and
      exercise program accompanied by a physiotherapist were applied to the control group, and
      conventional physiotherapy and mulligan mobilization technique were applied to the mulligan
      group. Conventional physiotherapy methods included ultrasound (US), Transcutaneous Electrical
      Nerve Stimulation (TENS), and hotpack. The patients were evaluated with TecnoBody Static
      Balance Device, algometer, electrogoniometer, visual analog scale, Oswestry Low Back Pain
      Disability Questionnaire before and after the treatment.
    


Intervention name(s): Mulligan Technique; Exercise Therapy
Intervention type(s): Other; Other
Intervention description(s): Mulligan suggested that injuries or sprains can cause a minor positional error in a joint, thereby causing limitations in physiological movement. Unique to this concept is mobilization of the spine while weight bearing and directing the mobilization parallel to the spinal facet planes. Although it includes various mobilization techniques, one of the most important techniques, motion co-mobilization, is the SNAG's technique, which includes the application of accessory passive gliding to the lumbar vertebra while the patient performs active movement simultaneously.; Exercise is recommended by physical therapists for most chronic low back pain patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balance; Chronic Low Back Pain; Exercise; Lumbal Disc Herniation; Manual Therapy; Mulligan Mobilization
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with
      acute low back pain
    


Intervention name(s): Diclofenac; Celecoxib
Intervention type(s): Drug; Drug
Intervention description(s): 75 mg oral capsule twice daily for 7 days; 400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
Intervention MeSH terms: Celecoxib; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Novel Virtual Reality for Burn Wound Care Pain in Adolescents
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Burn wounds cause intense, complex pain, and subsequent burn wound care causes further
      intense, episodic pain that is often unrelieved by opioid and non-opioid medications,
      resulting in under-treatment of pain. Further, opioid analgesics can have untoward side
      effects including respiratory depression, nausea, constipation, pruritus, drowsiness,
      lethargy, dependence, and induced hyperalgesia. As one of the most severe types of pain, burn
      wound care pain adds to the trauma pediatric patients already experience from the burn itself
      impacting quality of life with subsequent behavioral and maladaptive responses, such as
      agitation, anger, anxiety, hyperactivity, uncooperativeness, aggression, and dissociation.
      Lack of control over the procedure, pain memory, anxiety in anticipation of the repeated
      painful nature of the procedure, and transmission of clinician distress associated with
      inflicting procedural pain on the child contribute to the pain perceived.

      Virtual reality (VR) shows great promise as an engaging, interactive, effective
      non-pharmacologic intervention for various painful healthcare procedures, including burn
      wound care, therapies, and chronic pain conditions, despite equivocal findings, perhaps due
      to methodological issues. Designs of many studies of VR during burn wound care have been case
      studies or carefully controlled within-subject designs; sample sizes have been small.
      Recommendations for ongoing research include conducting more rigorous studies including
      randomized controlled trials (RCTs), repeat design studies, testing VR throughout the
      healthcare procedure, comparing VR to other distraction interventions; and using larger
      sample sizes.

      Primary Aim 1: Compare the effectiveness of age-appropriate, consumer available, high
      technology, interactive VR with standard care (SC) on adolescents' acute procedural pain
      intensity perception during burn wound care treatment in the ambulatory outpatient clinic
      setting.
    


Intervention name(s): Virtual Reality Distraction
Intervention type(s): Behavioral
Intervention description(s): Patient will utilize a virtual reality device during wound care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia
Condition: Combined Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, double blind, prospective, longitudinal, randomized, 12-week study
      with a 52-week open-label follow-up to evaluate the safety and efficacy of daily
      administration of Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen (the combination of
      both Pravastatin and Fenofibrate 40/160 mg) in the treatment of combined hyperlipidemia.
      There will be an open-label, 8-week, Selection Phase prior to randomization in which all
      patients will be stabilized on Pravastatin 40 mg/day. Following the Selection Phase, and if
      the patients meet all inclusion/exclusion criteria, they will be randomized to a three arm,
      double blind, 12-week Efficacy Phase during which they would receive either Pravastatin 40 mg
      or Fenofibrate 160 mg or Pravafen (the combination of Pravastatin and Fenofibrate 40/160 mg).
      The 12-week Efficacy Phase will be followed by an open-label, 52-week, Safety Phase in which
      all patients will receive Pravafen.

      After the 8-week Selection Phase, patients that still meet the inclusion/exclusion criteria
      will be randomized on a 1:1:2 ratio to Pravastatin 40 mg or Fenofibrate 160 mg or Pravafen
      (the combination of both Pravastatin and Fenofibrate 40/160 mg) for 12 weeks. After the
      completion of the 12-week double-blind phase of the study, all patients that haven't had
      changes in their well being, will be allowed to roll-over into the 52-week, open-label,
      follow-up portion of the study. During the 52 week, open label, Safety Phase of the study,
      all patients will receive Pravafen (the combination of Pravastatin and Fenofibrate 40/160
      mg).

      Patients will be evaluated at baseline and every three weeks thereafter throughout the
      initial 12-week Efficacy Phase of the study. Patients that roll-over into the 52-week,
      open-label, follow-up Safety Phase will be evaluated at 12, 24, 36 and 52 weeks.

      Participation in the study can be up to 72 weeks.
    


Intervention name(s): Pravafen; Pravastatin; Fenofibrate
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Combination of Pravastatin 40 mg and Fenofibrate 160 mg; Pravachol
Intervention MeSH terms: Fenofibrate; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiovascular Disease; Fenofibrate; LDL cholesterol; HDL cholesterol; Hyperlipidemia; Pravastatin; Triglycerides
Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma
Condition: Leukemia; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to explore the effect of music imagery on patients receiving
      intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma.
    

Detailed description: 
      Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes
      intensive chemotherapy that typically requires a 4-week hospital stay in protective
      isolation. Patients treated in isolation units may experience elevated levels of
      psychological distress. Both guided imagery and music therapy have been effective in
      improving the moods of cancer patients, but studies have not been conducted in acute leukemia
      and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on
      these patients.

      Participants in this study will be randomly assigned to receive either standard care plus
      music imagery or standard care alone. Participants assigned to the standard care plus music
      imagery group will receive a 45-minute weekly music imagery session with a music therapist.
      All participants will complete questionnaires and self-reports regarding their general
      anxiety, affect, and fatigue.
    

Intervention name(s): Music Imagery
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Music Therapy; Anxiety; Depression
Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population
Condition: Monosymptomatic Nocturnal Enuresis
MeSH terms: Enuresis; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are
      all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment
      resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot
      study performed at our department showed a correlation between weight and plasma
      concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to
      the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics
      (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old.
      Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary
      concentration testing will be evaluated
    


Intervention name(s): desmopressin
Intervention type(s): Drug
Intervention description(s): One time dosing of desmopressin oral lyophilisate formulation. The dose is age-dependant: >6 months and < 2years: 60µg; ≥2 years and <4 years: 120µg PO and ≥4 years and <8 years: 240 µg PO. There will be blood sampling and urine sampling for PK and PD/safety
Other intervention name(s): dDAVP
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Desmopressin; Paediatrics; urinary concentration test
A Study to Treat Patients Whose Chronic Angina Symptoms Are Not Relieved by Medication and Have an Area of the Heart That Cannot be Treated by Standard Therapies
Condition: Moderate to Severe Angina Pectoris
MeSH terms: Angina Pectoris
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine whether treatment with an experimental gene
      therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of
      new blood vessels. This will be measured by testing whether participants are able to exercise
      longer without experiencing angina after treatment, as compared to before treatment.

      Additionally, this study will collect information about any side effects that might be
      related to the treatment with the experimental therapy.
    


Intervention name(s): BioBypass®
Intervention type(s): Genetic
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Quality Control of CE-Certified Phonak Hearing Aids - 2017_13
Condition: Hearing Loss, Bilateral Sensorineural, Progressive
MeSH terms: Hearing Loss; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted
      on hard of participants with a hearing loss to grant quality control prior to product launch.
      The aim of the investigation series is to ensure usability, zero-defect overall performance
      of the new hearing systems as well as maximum benefit for the participant with the devices in
      comparison to previously outstanding Phonak Hearing Systems.
    

Detailed description: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials in the way as planned for
      this study ("phase of final inspection"). This will be a controlled, single blinded and
      randomised active comparator clinical evaluation which will be conducted mono centric at
      Sonova AG Headquarters based in Stäfa (Switzerland).
    

Intervention name(s): Line extension of the Phonak Audéo B product family; Phonak Audéo B
Intervention type(s): Device; Device
Intervention description(s): The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.; Phonak Audéo B will be fitted to the participants individual hearing loss.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Phonak Audéo B and a line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Masking: Single (Participant)
Primary purpose: Treatment
Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The etiology of immune-mediated diabetes mellitus (IMD) remains unclear. However, previous
      studies indicate that autoimmunity may be a result of dysfunction of natural killer T cells
      (NK-T cells). Newly diagnoses patients with IMD have been shown in our laboratory to have
      significantly lower NK-T cells than normal controls. Other studies have shown that oral
      administration of lactobacillus can boost NK-T cell activity in children with HIV without
      side effects. Our objective is to evaluate the effect of lactobacillus administration on NK-T
      cell activity in patients with IMD
    


Intervention name(s): Oral lactobacillus administration
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Immune-mediated diabetes mellitus
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Condition: Japanese Patients With ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic
      Lateral Sclerosis Patients with gastrostomy
    


Intervention name(s): MT-1186
Intervention type(s): Drug
Intervention description(s): Suspension
Other intervention name(s): Edaravone
Intervention MeSH terms: Edaravone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Hepatitis A Vaccine Dosing Regimens Among Pediatric Patients on Immunosuppressive Therapy
Condition: Autoimmune Rheumatologic Disease
MeSH terms: Hepatitis A; Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      The study is a prospective, single centre, double-blinded randomized controlled trial whose
      goal is to compare the immune response of a population of immunosuppressed pediatric
      rheumatology patients on immunosuppressive medications to two different doses of Hepatitis A
      vaccine. The objectives are (a) to confirm that adolescents, like their adult counterparts,
      have a reduced immune response to hepatitis A vaccine, and (b) to compare the immunogenicity
      of two different dosing options of vaccine for this age group after one and two doses. A
      total of 60 adolescents aged 12 - 15 years with confirmed chronic rheumatologic conditions
      for which they are being treated with an immunosuppressive therapy will be recruited from the
      Rheumatology Clinic at Alberta Children's Hospital (ACH). Those found to have no immunity to
      hepatitis A will be enrolled. Informed, written consent will be obtained from the parent or
      guardian of subject, with assent obtained from the study subjects. Subjects will be randomly
      assigned to two doses of either Avaxim Pediatric® or Avaxim ® (adult) vaccine (Sanofi Pasteur
      Canada), six months apart, with hepatitis A titres done at baseline and one month after each
      dose. Both formulations are licensed for this age group.
    

Detailed description: 
      This is a prospective, single centre, randomized, controlled trial comparing immune responses
      to two doses of a licensed Hepatitis A vaccine in children. Subjects will receive 2 doses
      (0.5 mL each) of the assigned study vaccine (Avaxim Pediatric® or Avaxim ® (adult) vaccine).
      One lot of each vaccine formulation will be studied. All subjects will provide safety
      observations using a diary and sequential blood samples will be obtained to measure
      serologic/immunologic responses.

      The study population will include 60 subjects with confirmed rheumatologic condition on
      immunosuppressive medication, males and females, in the age range 12 - 15 years. The maximum
      age at enrollment is 15 years and 5 months, to allow for up to 7 months in which to complete
      2 doses of vaccine before age 16 years.Both vaccine formulations used in this trial has been
      licensed for use in Canada in the age range of the subjects being studied.
    

Intervention name(s): Avaxim Pediatric®; Avaxim ® (adult)
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine.; 2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
MK-0616 (Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020)
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to compare the plasma pharmacokinetics (PK) of MK-0616
      following a single 20 mg dose in participants on a background of statin therapy with varying
      degrees of renal impairment (moderate, severe, end stage renal disease [ESRD]) to those of
      healthy mean matched control participants on a background of statin therapy. There is no
      formal hypothesis.
    


Intervention name(s): MK-0616
Intervention type(s): Drug
Intervention description(s): Single oral dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Weight Loss in Obese Difficult-to-treat Asthmatics
Condition: Asthma; Obesity; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      Sixty percent of patients with difficult to control asthma seen in our outpatient clinic are
      obese. The impact of weight reduction in this subpopulation of asthmatics has not been
      studied. Our aim is to evaluate the impact of weight reduction on asthma control of these
      patients.
    

Detailed description: 
      Study design: interventional, open label, randomized

      Patients selection

      Thirty-three difficult to control obese asthmatic patients, aged between 18 to 65 years old
      will be recruited from the outpatient clinics of the Pulmonary Division of the University of
      Sao Paulo Hospital.

      Difficult to control asthma will be defined as patients who do not achieve asthma control
      (according to GINA) despite best treatment regimen and checked adherence after at least three
      months of treatment.

      Intervention: Patients will be divided in two groups: asthma treatment plus weight loss
      program or asthma treatment alone for 6 months without drug dose changing.

      Procedures (baseline and after 6 months) - quality of life questionnaire, asthma control
      questionnaire, lung function tests, serum and sputum inflammatory markers.
    

Intervention name(s): Low caloric diet plus orlistat and sibutramine
Intervention type(s): Behavioral
Intervention description(s): All subjetcs
Intervention MeSH terms: Orlistat; Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Obesity; weight loss