bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women
Condition: Cytochrome P450 Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor
      itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
    


Intervention name(s): Lu AF35700; Itraconazole (200 mg); Itraconazole (300 mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg; 100 mg Capsules for oral use, 200 mg/day. In a fed state; 100mg Capsules for oral use, 300 mg/day. In a fasted state.
Intervention MeSH terms: Itraconazole; Hydroxyitraconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deep Brain Stimulation for Parkinson's Disease Trial
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the effect of deep brain stimulation in the the
      globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and
      psychiatric function, and quality of life in patients with Parkinson's disease.
    

Detailed description: 
      Medical therapy is the mainstay of treatment for patients with Parkinson's disease (PD).
      After several years of drug therapy, however, a large proportion of patients experience
      worsening of their parkinsonism and develop incapacitating motor fluctuations and
      dyskinesias. To deal with this, attention has been directed to surgical procedures, such as
      deep brain stimulation (DBS). Recently, stimulating the areas of the brain that control
      movement, the globus pallidus (Gpi) and subthalamic nucleus (STN), has been proposed as a
      therapy for treating many of the disabling symptoms associated with PD and drug-induced side
      effects.

      The major aim of this 5-year study is to carry out a prospective, double blinded, randomized,
      clinical trial of DBS for medically intractable PD. The study will evaluate the effect of DBS
      in the Gpi and STN on motor, neuropsychological and psychiatric function, and quality of life
      in patients with PD. The study also will address two key issues: 1) whether there are
      differences between unilateral Gpi-DBS and STN-DBS and 2) which patients are the best
      candidates for bilateral DBS.
    

Intervention name(s): deep brain stimulation
Intervention type(s): Procedure
Intervention description(s): Deep brain stimulation (DBS) is a surgical intervention used to treat movement disorders such as Parkinson's disease (PD). Target sites of stimulation may differ among patients. The Gpi and STN are two commonly targeted sites within the brain for treatment of PD, yet differences in outcomes between stimulation at the Gpi vs the STN (unilateral and bilateral) are not currently well understood.
Other intervention name(s): DBS
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; PD; deep brain stimulation; DBS
Nutritious Eating With Soul at Rare Variety Cafe
Condition: Obesity
Study type: Interventional

Summary: 
      To date, few dissemination and implementation (D&I) studies exist of successful healthy
      eating interventions delivered through restaurant settings. Therefore, the proposed study
      will investigate the following aims:

      Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention
      delivered through a train-the-trainer approach in a soul food vegan restaurant.

      Aim 2: Assess resource use and cost associated with a train-the-trainer D&I approach in a
      restaurant setting.

      Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight
      loss, and quality of life from baseline to follow-up (3-months) and at maintenance
      (9-months).

      Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.
    


Intervention name(s): Vegan diet
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Rate of Anterior Segment Retraction Using Two Types of Mechanics
Condition: Bimaxillary Protrusion
Study type: Interventional

Summary: 
      The rate of anterior segment retraction in bi-maxillary protrusion cases was evaluated
      comparing the friction and friction-less mechanics. since, there has been a lack of clear cut
      guidelines for clinicians for the optimum method for retraction, this randomized clinical
      trial was done.
    

Detailed description: 
      Thirty bi-maxillary protrusion female patients were randomly allocated into either
      intervention groups. In the Friction group, retraction was accomplished using elastomeric
      power chains extending from crimpable hooks distal to the lateral incisors, on
      0.017x0.025-inch Stainless Steel wires, to the mini-screws . While in the friction-less group
      with retraction done using T- loop springs made of 0.017x0.025-inch titanium molybdenum
      wires. Retraction force was set to 160g per side in both intervention groups. Activation was
      done every four weeks. Rate of anterior segment retraction was evaluated via digital models.
    

Intervention name(s): Friction Mechanics; Frictionless Mechanics
Intervention type(s): Other; Other
Intervention description(s): anterior segment retraction using elastomeric power chains; anterior segment retraction using closing loops
Other intervention name(s): sliding mechanics; segmented mechanics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: T loops; Friction; Frictionless; power chains; digital models; anterior segment retraction
The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures
Condition: Burst Thoracic Spine Fractures
MeSH terms: Fractures, Bone; Spinal Fractures
Study type: Observational

Summary: 
      The purpose of this study is to analyse the anatomic influence of the ribs related to the
      incidence and severity of burst spine fractures.
    

Detailed description: 
      To analyse the anatomic influence of the ribs related to the incidence and severity of burst
      spine fractures, with the measurements of kyphosis, vertebral collapse and vertebral canal
      narrowing
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with burst fractures of the thoracic spine treated by the Hospital Ortopedico de
        Passo Fundo
      
Keywords: spinal fractures; Thoracic vertebrae; spinal canal; kyphosis
Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient
Condition: Pediatric Urologic Surgeries
Study type: Interventional

Summary: 
      The purpose of this study is to compare peak airway pressure and gastric insufflation in
      Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric
      patient
    


Intervention name(s): Pressure-controlled ventilation; Volume-controlled ventilation
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Gastric insufflation; I-gel; Peak airway pressure; Pressure-controlled ventilation; Volume-Controlled Ventilation; pediatric patient
Acetaminophen Before Vaccines for Infants Study (AVIS)
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol)
      for routine infant vaccinations is helpful in preventing fever or other symptoms.
    

Detailed description: 
      Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended
      childhood vaccinations. Although serious events are rare, post-vaccination fever causes
      discomfort for the child, can lead to medical utilization, can rarely result in febrile
      seizure, and can cause a working parent to miss time from their job to care for a febrile
      infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants
      receiving current vaccinations, in terms of reduction of discomfort for the child,
      improvement of quality-of-life indicators for the parent, or reduction of medical
      utilization, have not been measured. This randomized, blinded, placebo-controlled trial will
      assess the efficacy of prophylaxis with acetaminophen in prevention of fever following
      routine childhood immunizations.
    

Intervention name(s): Acetaminophen; placebo
Intervention type(s): Drug; Other
Intervention description(s): Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.; Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Acetaminophen; Vaccination; Immunization
Cognitive Characteristics of PTSD Patients With OCD
Condition: Post-Traumatic Stress Disorders; Obsessive-Compulsive Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      Cognitive profile of patients who suffer both from PTSD and OCD, as compared to those who
      suffer from PTSD or OCD without other comorbidity.
    

Detailed description: 
      Demographic data and cognitive data will be compared on PTSD, PTSD-OCD and OCD patients using
      a battery of computerized cognitive tests
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible patients from each group were invited to participate in the study from the
        inpatient, outpatient and public clinic populations of the Chaim Sheba Medical Center
        Psychiatric Division
Age-related Correlates of Treatment for Late-acquired Sounds
Condition: Speech Sound Disorder; Phonology Disorder; Phonology Impairment; Phonological Disorder; Articulation Disorders in Children; Developmental Phonological Disorder; Speech Disorders; Speech Delay; Articulation Disorders, Developmental
MeSH terms: Speech Disorders; Articulation Disorders; Language Development Disorders; Speech Sound Disorder
Study type: Interventional

Summary: 
      Late-acquired sounds, such as /r/ are difficult to learn and many children experience
      persistent errors on these sounds. The purpose of the present study is to determine whether
      treating these sounds earlier in the child's life may result in better outcomes.
    

Detailed description: 
      Late-acquired sounds, such as /r/ are difficult to learn and many children experience
      persistent errors on these sounds. However, these sounds are often treated later in a child's
      life because they are not expected to be fully acquired until quite late--age 7-8 for some
      sounds. This practice places treatment in a time of the child's development in which they
      struggle to learn new sounds.The purpose of the present study is to determine whether
      treating these sounds earlier in the child's life may result in better outcomes, and to
      examine treatment efficacy and efficiency for two methods of treatment.
    

Intervention name(s): articulation therapy; phonologic treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): children receive instruction in producing new sounds at the isolation, syllable and word level.; children receive instruction in producing new sounds at the word level
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Young children (age 4-5) and Old children (age 7-8) will be enrolled in either a Motoric behavioral treatment arm or phonological treatment arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment; efficacy; efficiency; late-acquired sounds
Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Esophageal and Gastric Varices; Fibrosis
Study type: Interventional

Summary: 
      Background and Aims: The efficacy of portal pressure reduction by beta blockers for the
      management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The
      present randomized controlled trial aims to address these issues. The investigators also
      assessed the utility of serial HVPG measurements in these patients.

      Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history
      of variceal bleed, were randomized to receive propranolol or placebo. These patients were
      further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement.
      Propranolol was titrated to reduce heart-rate to 55/min.
    


Intervention name(s): Propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.; Placebo tablets given two times daily.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Chocolate for Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Chocolate is a widely appreciated foodstuff with historical appreciation as food from the
      gods. It is a rich source of (poly)phenolics, which have several proposed salutogenic
      effects, including neuroprotective anti-inflammatory, antioxidant, and cardioprotective
      properties.

      This study will evaluate the potential salutogenic contribution of chocolate intake, to
      mitigate inflammatory and oxidative burden in chronic kidney disease patients.
    

Detailed description: 
      This study is evaluating patients with CKD on a regular HD program randomized in the
      chocolate group and control group. The chocolate group is receiving 40g of dark chocolate per
      day for 2 months and the control group is not receiving any intervention. Peripheral blood
      mononuclear cells (PBMC) are being isolated for expression of Nrf2, NF-kB, and NADPH quinone
      oxidoreductase 1 (NQO1) by a quantitative real-time polymerase chain reaction. Antioxidant
      enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive
      protein (hs-CRP) will be assessed using an enzyme-linked immunosorbent assay (ELISA).
    

Intervention name(s): Dark Chocolate
Intervention type(s): Dietary Supplement
Intervention description(s): The patients will receive 40g per day of dark chocolate for 2 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Chocolate group Control Group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of AZD6140 and its active
      metabolite, safety, tolerability of AZD6140 following single administration in healthy male
      Japanese volunteers.
    

Detailed description: 
      A Phase I, Single Centre, Open Study to Assess the Pharmacokinetics of oral AZD6140 after
      Single Dose in Healthy Japanese Male Volunteers
    

Intervention name(s): AZD6140
Intervention type(s): Drug
Intervention description(s): tablet
Intervention MeSH terms: Ticagrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteer; Japanese males; PK study
A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013)
Condition: Gram-Positive Bacterial Infections
MeSH terms: Infections; Bacterial Infections; Gram-Positive Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the pharmacokinetics (PK) of tedizolid phosphate and its active
      metabolite, tedizolid, and the safety of tedizolid phosphate following administration of a
      single IV (Part A) or oral suspension (Part B) administration to hospitalized participants
      ages 6 to <12 years (Groups 1 and 3, respectively), and 2 to <6 years (Groups 2 and 4,
      respectively).
    

Detailed description: 
      Part A (IV):

        -  Group 1 (Cohort 1 and Cohort 2) (6 to <12 years)

        -  Group 2 (Cohort 1 and Cohort 2) (2 to <6 years)

      Part B (Oral Suspension):

        -  Group 3 (6 to <12 years)

        -  Group 4 (2 to <6 years)

      In Cohort 1 of Group 1 (IV) participants received a single administration of tedizolid
      phosphate at 5 mg/kg of total body weight. After all participants in Cohort 1 of Group 1
      received study drug, a preliminary analysis of the safety and PK data was performed and
      results were used to select 4 mg/kg as the appropriate dose for Cohort 2 of Group 1 and Group
      3, and to select 6 mg/kg as the starting dose for the younger participants, Cohort 1 of Group
      2. After all participants in Cohort 1 of Group 2 receive study drug, another preliminary
      analysis of the safety and PK data will be performed and results will be used to confirm 6
      mg/kg as the appropriate dose for Cohort 2 of Group 2. Similarly, the Group 4 dose will be
      confirmed after data review of Group 3 results.
    

Intervention name(s): Tedizolid Phosphate (IV); Tedizolid Phosphate (oral suspension)
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg/vial powder for injection; Powder for oral suspension 20 mg/mL following reconstitution
Other intervention name(s): Sivextro; TR-701 FA; MK-1986; Sivextro; TR-701 FA; MK-1986
Intervention MeSH terms: Tedizolid phosphate; Tedizolid; Oxazolidinones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Smoking Cessation Study for Patients With Schizophrenia or Schizoaffective Disorder
Condition: Smoking Cessation
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Study will determine whether patients with schizophrenia or schizoaffective disorder can be
      helped to quit smoking safely while using varenicline and receiving smoking cessation
      counseling.
    

Detailed description: 
      This is a safety study.
    

Intervention name(s): placebo; varenicline (CP-526,555)
Intervention type(s): Drug; Drug
Intervention description(s): Randomization 2:1 treatment to placebo; One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid
Other intervention name(s): Chantix, Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study seeks to evaluate a novel treatment approach for performing continuous real-time
      glucose sensing and insulin delivery at the same subcutaneous tissue site.
    

Detailed description: 
      The treatment of type 1 diabetes usually comprises the measurement of glucose in blood
      obtained by finger pricking and the administration of insulin via subcutaneous bolus
      injection or continuous subcutaneous infusion.

      This study seeks to test a new treatment approach where glucose sensing and insulin
      administration are combined and performed at a single subcutaneous tissue site (single-port
      treatment approach). A single-port device consisting of a continuous glucose sensor and an
      insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes
      patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period.
      The performance of the single-port device is assessed by comparing the obtained glucose
      readings with those of a blood glucose meter and an additionally worn control sensor.
    

Intervention name(s): insulin delivery; glucose sensing
Intervention type(s): Drug; Device
Intervention description(s): Subcutaneous insulin (100 U/ml, NovoRapid®; Novo Nordisk, Bagsvaerd, Denmark) delivery with an insulin pump (Vibe-TM; Animas Corp., West Chester, PA, USA) and an insulin infusion cannula (SOF-SET MICRO QR 6mm; Medtronic MiniMed, USA) placed at the same site as the continuous glucose sensor.; Glucose sensing with a continuous glucose sensor (Dexcom G4 Platinum Sensor; Dexcom Inc., San Diego, USA) placed at the site of subcutaneous insulin delivery.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: continuous glucose sensor; subcutaneous insulin infusion; closed-loop glucose control; type 1 diabetes
Intraseasonal Short-time Up-dosing With Alutard SQ Grasses
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing
    


Intervention name(s): Allergy vaccination (Alutard SQ)
Intervention type(s): Biological
Intervention description(s): Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment