bioihbjkbjnl/mcl2 huggingface dataset:
Prevelance of Frailty and Its Associated Factors in Patients With Axial Spondyloarthritis
Condition: Frailty; Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Frailty
Study type: Observational

Summary: 
      Axial Spondyloarthritis is an inflammatory arthritis disease and its main symptoms are
      chronic pain and stiffness, causing structural damage to the spinal vertebrae. Axial
      Spondyloarthritis leads to physical disability and a decrease in the level of physical
      activity.

      Frailty is a syndrome characterized by decline in physiological reserve and loss of muscle
      strength. Frailty can lead to vulnerability of individuals to possible injuries and a
      decrease in independence, and ultimately an increase in mortality. Although frailty is
      associated with older adults, it has been reported that it can be detected in patients with
      cancer, diabetes and rheumatological diseases and it is not related with age. Frailty has
      been reported to be a reversible and a treatable condition.

      The aim of our study was to investigate the prevalence of frailty and the relationship
      between frailty and disease activity, physical functional level, quality of life and other
      associated factors in individuals with Axial Spondyloarthritis.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with Axial Spondyloarthritis in a tertiary research and training
        hospital
Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling
Condition: Cardiopulmonar Artery Bypass Grafting
Study type: Observational

Summary: 
      The currently available data are insufficient to develop a model that achieves optimum
      morphine dose individualization at the postoperative period of coronary artery bypass
      grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could
      justify morphine consumption, drug plasma concentration and pain intensity during the
      postoperative period after CABG and evaluate the post operative pain.
    

Detailed description: 
      The protocol was a prospective, open-label study, approved by the institutional ethical
      committee of the hospital where the study was performed. Patients were randomly assigned to
      receive general anesthesia plus intrathecal morphine at a dosage of 400 mcg (morphine group)
      or general anesthesia alone (control group) according to a simple computer-generated list.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with coronary artery disease, eligible to cardiopulmonary artery bypass grafting
        surgery
      
Biospecimen description: 
      For pharmacokinetic analysis, a serial of blood samples of patients was collected
      postoperatively after the extubation from a venous catheter (5mL each) into an EDTA tube (BD,
      Sao Paulo/Brazil) in the periods as follows: 0, 0.08, 0.25, 0.5, 1, 3, 6, 12, 18, 24 and 36
      hrs. Blood samples were centrifuged at 2800 g for 20 minutes, plasma was transferred to
      labeled polyethylene vials and frozen at -80ºC until drug plasma assay.
    
Keywords: pharmacokinetic/pharmacodynamic modeling; intrathecal morphine; postoperative analgesia; patient-controlled analgesia device
Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      An impairment of endothelial function plays the central role in the pathogenesis of
      cardiovascular diseases and their complications. Most of cardiovascular risk factors are
      known to impair endothelial function and the established disease further aggravates
      endothelial dysfunction.

      The aim of the present study is to investigate the effects of nebivolol or metoprolol
      succinate on endothelial function and large artery stiffness.
    

Detailed description: 
      The aim of this study was to compare the effects between the vasodilating β-blocker nebivolol
      and the cardioselective β-blocker metoprolol succinate on aortic blood pressure and left
      ventricular wall thickness. We conducted a randomized, double-blind study in 80 hypertensive
      patients. Patients received either nebivolol 5 mg or metoprolol succinate 50-100 mg daily for
      one year. Their heart rate, central and brachial blood pressure, mean arterial pressure,
      augmentation index, carotid-femoral pulse wave velocity and left ventricular wall thickness
      were measured at baseline and at the end of the study.
    

Intervention name(s): metoprolol succinate; Nebivolol
Intervention type(s): Drug; Drug
Intervention description(s): once daily 50 or 100 mg for one year; once daily 5 mg capsule for one year
Other intervention name(s): Corvitol; Nebilet
Intervention MeSH terms: Metoprolol; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of an Oral Nicotine Product in Smokeless Tobacco Users
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this research study is to find out how three different nicotine pouches and
      participant's own brand of smokeless tobacco affect blood nicotine levels and how
      participants feel.
    


Intervention name(s): oral nicotine pouch - 2 mg; oral nicotine pouch - 4 mg; oral nicotine pouch - 8 mg; Smokeless tobacco
Intervention type(s): Other; Other; Other; Other
Intervention description(s): "On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor; "On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor; "On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor; Participant's typical brand of smokeless tobacco
Intervention MeSH terms: Lobeline; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 in Healthy Volunteers
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy
      volunteers.
    


Intervention name(s): KVD900; Placebo to KVD900
Intervention type(s): Drug; Drug
Intervention description(s): Active; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Acute-phase Response & Periodontal Treatment in Diabetes Affected Patients
Condition: Periodontitis; Diabetes
MeSH terms: Periodontitis; Diabetes Mellitus; Acute-Phase Reaction
Study type: Interventional

Summary: 
      Thirty-eight periodontitis- and diabetes-affected subjects will be randomly allocated to non
      surgical periodontal treatment with either Full-Mouth Approach (FM-SRP) or Quadrant approach
      (Q-SRP).

      Patients will be seen one day and three months (study completion) after treatment. The 24
      hours appointment will be occurring after the entire completion of the FM-SRP or the first
      quadrant of the Q-SRP. In the latter group other sessions of treatment will be performed
      within the following 3 weeks.

      At baseline, 24 hours and three months, anthropometric, inflammatory and endothelial
      parameters will be collected. Periodontal parameters will be checked at baseline and at three
      months.

      Main outcome of the study is the level of C-reactive protein 24 hours after treatment.
    


Intervention name(s): FM-SRP; Q-SRP
Intervention type(s): Procedure; Procedure
Intervention description(s): Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.; Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-centre randomized controlled clinical trial with a 3- month follow-up
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease.
Condition: Gaucher Disease Type I; Cerebroside Lipidosis Syndrome; Clucocerebrosidase Deficiency Disease; Glucosylceramide Beta-Glucosidase Deficiency Disease; Gaucher Disease, Non-Neuronopathic Form
MeSH terms: Gaucher Disease; Lipidoses; Deficiency Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating
      patients with skeletal manifestations secondary to Type I Gaucher disease.

      The study objective is to evaluate and quantify skeletal responses as compared to baseline in
      Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional
      objectives were to assess the usefulness of various skeletal parameters, such as bone pain,
      bone crises, bone mineral density, and serum and urine bone markers, as indicative of
      treatment response and may be useful in dose management.
    


Intervention name(s): Cerezyme (imiglucerase for injection)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I Gaucher disease; Glucocerebrosidase Deficiency Disease
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the
      efficacy of liraglutide to induce body weight loss and the purpose of the extension is to
      evaluate the long term safety and tolerability of liraglutide.

      Trial has the following trial periods: A 20-week randomised, double-blind,
      placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open
      label orlistat comparator arm followed by an 84 week extension period.
    


Intervention name(s): liraglutide; orlistat; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injected s.c. (under the skin) once daily; 120 mg capsule. Administered thrice daily; Injected s.c. (under the skin) once daily
Intervention MeSH terms: Liraglutide; Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Concurrent Training and Prediabetes Control
Condition: Metabolic Disturbance
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide
      inter-individual variability after exercise training explored mainly in adults but not in
      adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the
      concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e.,
      percentage of subjects who experienced a non-change/worsened response after training in some
      metabolic outcomes).
    


Intervention name(s): Endurance training plus resistant training
Intervention type(s): Behavioral
Intervention description(s): CT in women with prediabetes and co-morbidities associated. Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 2 groups proposed. All sessions will be supervised by an exercise physiologist during 20-weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Behavioral
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Metabolic syndrome; Obesity
Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia
Condition: Postoperative Nausea
MeSH terms: Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if intravenous fosaprepitant can interfere with
      nervous system monitoring signals in patients having surgery under general anesthesia. This
      medication has numerous effects on the sensory nerve transmission which can theoretically
      have effects on the ability to accurately measure somatosensory evoked potentials.
    

Detailed description: 
      The purpose of this study is to determine if intravenous fosaprepitant can interfere with
      nervous system monitoring signals in patients having surgery under general anesthesia.
      Fosaprepitant is a drug commonly used to prevent post-operative nausea and vomiting, and
      works by inhibiting "substance P", which is found in the brain and spinal cord.
      Theoretically, fosaprepitant could interfere with nervous system recordings because of its
      effect on substance P,but it is not known if this actually occurs. The drug will be given
      after the patient has been anesthetized but before surgical incision so that if there are any
      changes on the intraoperative neuromonitoring signals they can only be attributed to
      fosaprepitant.

      If fosaprepitant alters intraoperative neuromonitoring signals during surgical procedures
      under general anesthesia, it would be important because anesthesiologist's who administer
      this drug would want to give it at the beginning of surgery when changes in intraoperative
      neuromonitoring signals would be unlikely to mean that these changes were due to surgical
      damage to the nervous system.
    

Intervention name(s): Fosaprepitant 150 mg
Intervention type(s): Drug
Intervention description(s): Antiemetic used to prevent nausea and vomiting after general anesthesia.
Intervention MeSH terms: Fosaprepitant; Aprepitant
Intervention model: Single Group Assignment
Intervention model description: A single group of up to 50 patients will be administered a standard dose of fosaprepitant 150 mg IV after induction of anesthesia. A standard neuromonitoring setup utilizing motor evoked potentials, and somatosensory evoked potentials will be used as indicated for the type of surgery. After baseline neuromonitoring measurements have been made, but prior to surgery starting, we will administer the fosaprepitant to determine if there are any effects on the motor evoked potentials or somatosensory evoked potentials measurements.
Masking: None (Open Label)
Primary purpose: Treatment
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
    

Detailed description: 
      A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848
      administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS
      followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission
    

Intervention name(s): ZP1848
Intervention type(s): Drug
Intervention description(s): sc. bolus
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD
Condition: Anxiety Disorders; Obsessive-Compulsive Disorder
MeSH terms: Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of parent coached exposure therapy
      (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety
      disorders and obsessive compulsive disorder (OCD).
    

Detailed description: 
      The purpose of this study is to examine the effectiveness of parent coached exposure therapy
      (PCET) through baseline comparisons, to compare effectiveness of individual PCET and
      individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual
      PCET and individual standard CBT, to compare effectiveness of group intensive PCET,
      individual PCET, and individual standard CBT, and acceptability.
    

Intervention name(s): Parent Coached Exposure Therapy - Individualized; Cognitive Behavior Therapy; Parent Coached Exposure Therapy - Group (removed from study)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subject and parent begin by working with a therapist to create an individualized fear hierarchy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety.; Subjects will work with a therapist using anxiety management strategies to address thoughts, feelings, and behaviors.; Subjects and parents will work in a group setting to receive exposure therapy consisting of situations and stimuli that produce anxiety for the child, gradually progressing from less anxiety to more anxiety.
Other intervention name(s): PCET-I; CBT; PCET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Observational

Summary: 
      With advancing age testosterone levels decline in men. Low testosterone levels plus certain
      symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to
      testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease
      in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH.
      Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement
      (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the
      additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist
      circumference) in patients, who are on a diet and exercise program.
    


Intervention name(s): Testosterone Undeconate (Nebido-R, BAY86-5037)
Intervention type(s): Drug
Intervention description(s): Male patients > 35yrs in medical practices fulfilling all criteria for documentation.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients in medical practices > 35yrs fulfilling all criteria for documentation.
      
Keywords: Hypogonadism; Abdominal obesity; Physical exercise; Testosterone
Development of an Ergonomic Wheelchair Pushrim
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effectiveness of newly designed ergonomic manual
      wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard
      handrim. It is our hope that the new design of the handrims will help reduce upper extremity
      pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim
      was designed to directly address the shortcomings of standard handrims and to improve the
      standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed
      for individuals who have limited hand function, making it difficult to grasp standard
      handrims.
    

Detailed description: 
      This research will have three parts.

      The first part will include completing propulsion and braking tasks with the subject's
      original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new
      standard handrim) will be installed on the subject's wheelchair and subjects will again be
      asked to complete another set of propulsion and braking tasks. Subjects will also be asked to
      complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the
      condition of the palm of their hand.

      For the second part of the study, subjects will be asked to participate in a 4-month trial
      use period of the new handrims on their wheelchair.

      In the third part of the study, subjects will complete the final set of propulsion and
      braking tasks and complete a follow-up questionnaire.
    

Intervention name(s): Natural-Fit; PalmRim; Handrim Control Group
Intervention type(s): Device; Device; Device
Intervention description(s): Ergonomic handrim for wheelchairs; Ergonomic handrim for wheelchair; Participants were given a new standard handrim to test. This intervention group is the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Wheelchair; Handrims; Rehabilitation; Upper extremity
Sensitive Periods in Human Flavor Learning
Condition: Development
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The goals of the proposed research are to specify the timing and consequences of the
      sensitive period for flavor learning in infants who are being breastfed or formula fed. The
      investigators will conduct a randomized within- and between-subject study of women and their
      infants during a 15-month window.
    

Detailed description: 
      This is a randomized clinical trial on both breastfeeding and formula feeding infants to
      determine the effects of the timing of flavor experiences on subsequent food acceptance in
      both members of the dyad.
    

Intervention name(s): Timing of Diet and Flavor Experience
Intervention type(s): Other
Intervention description(s): Groups differ in the timing and duration of exposure to flavored food experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Breastfeeding; Flavor learning; Mother; Moms; Infants; Babies; Baby; Food Habits; Fruits; Vegetables