bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents
Condition: Allergic Reactions
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the pharmacokinetic parameters of chlorpheniramine in
      children and adolescents.
    

Detailed description: 
      This is a single-group, single-center, open-label, one period, bioavailability study. This
      study will evaluate the pharmacokinetic (PK) profile of chlorpheniramine in a population of
      children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs. Twelve blood samples (3.0 mL)
      for chlorpheniramine analysis will be drawn at time 0 (pre-dose), and at 0.5, 1, 2, 3, 4, 6,
      8, 12, 24, 48, and 72 hours after dosing. Plasma levels of chlorpheniramine will be
      determined. The following primary, single-dose PK parameters for chlorpheniramine will be
      determined using noncompartmental methods: AUCL, AUCI, and Cmax. The following PK parameters
      will also be determined to provide a complete profile of the drug, as appropriate: oral
      clearance (CL) and volume of distribution (Vd) and adjusted for body weight (per kg); time to
      reach Cmax (tmax), and apparent elimination constant (Kel) and half-life (t1/2). The PK
      parameters will be summarized using descriptive statistics.
    

Intervention name(s): Chlorpheniramine
Intervention type(s): Drug
Intervention MeSH terms: Chlorpheniramine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; children; adolescents; antihistamine
The Effect of Iloprost on Oxygenation During One-lung Ventilation for Lung Surgery
Condition: Lung Cancer
Study type: Interventional

Summary: 
      During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in
      the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial
      oxygenation. This prospective, randomized, double blind study was conducted to evaluate the
      effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt
      fraction during thoracic surgery.
    


Intervention name(s): Inhaled iloprost; Distilled water
Intervention type(s): Drug; Drug
Intervention description(s): Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.; Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Effect of PUR118 on Ozone Induced Airway Inflammation in Healthy Normal Volunteers
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial in healthy subjects will assess PUR118's effect on attenuating ozone induced
      airway inflammation. This trial will establish the tolerability of PUR118 in healthy normal
      volunteers.
    


Intervention name(s): PUR118
Intervention type(s): Drug
Intervention description(s): inhaled PUR118, BID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: inflammation; COPD; respiratory disease; healthy volunteers
A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy
Condition: Seizures; Convulsions; Epilepsy; Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Epilepsy; Seizures
Study type: Observational

Summary: 
      The purpose of this study is to investigate the influence of topiramate monotherapy on the
      bone and mineral metabolism markers, and bone density (the amount of mineral per square
      centimeter of bone ) in female participants with epilepsy (seizure disorder), before
      menopause (time in life when a woman stops having a menstrual period), as compared with
      healthy participants and comparative group received either carbamazepine or valproic acid
      monotherapy for at least last one year.
    

Detailed description: 
      This is a cross-sectional (observations or measurements made at a single point in time,
      usually at participant enrollment), multi-center (conducted in more than one center), and
      comparative study of topiramate monotherapy in female participants with epilepsy. Female
      participants must have received either topiramate, carbamazepine, or valproic acid
      monotherapy for more than one year for the treatment of epilepsy. Blood samples will be
      obtained from fasting participants to investigate the effect of study drug on the bone and
      mineral metabolism markers, and bone density compared to healthy participants and comparative
      group (carbamazepine and valproic acid monotherapy). Bone mineral density will be measured
      from the participants' lumbar spine or femur. A survey of food intake and physical activity
      for the participants will be performed using a standardized validated detailed questionnaire.
      The post-study visit (or follow up phone contact) will be performed for the occurrence of
      serious adverse events (SAE) for safety evaluation. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Topiramate; Carbamazepine; Valproic acid; Normal control
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): This is an observational study. Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.; This is an observational study. Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.; This is an observational study. Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.; This is an observational study. Healthy female participants will be observed in Normal control group.
Intervention MeSH terms: Topiramate; Carbamazepine; Valproic Acid
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Female participants with epilepsy who are receiving topiramate, carbamazepine or valproic
        acid monotherapy for more than one year.
      
Keywords: Topiramate; Carbamazepine; Valproic acid; Epilepsy; Bone mineral density; Monotherapy
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles
      between vildagliptin and glimepiride.
    


Intervention name(s): Vildagliptin; Glimepiride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glimepiride; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type II Diabetes Mellitus; Vildagliptin; Glimepiride; Continuous glucose monitoring
A Trial of Bare Metal Stent - Cobalt Chromium Versus Stent Coating With Sirolimus
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the security issues and efficacy of coronary
      stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with
      coronary artery lesion.
    

Detailed description: 
      Patients will be treated in compliance with the eligibility criteria, with stent study of
      16-19mm. All patients are clinically followed for 60 months after the procedure and will
      undergo a control angiography 6 months. Can be treated multiple lesions, measuring between
      2.5-3.5mm (by visual estimate). Patients enrolled will be randomized in a 1:2 propose in one
      of the groups with or without stent coating, respectively. And a randomized clinical trial,
      prospective study in 5 centers including 60 patients.
    

Intervention name(s): DRUG ELUTING STENT; BARE METAL STENT
Intervention type(s): Device; Device
Intervention description(s): Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.; Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.
Other intervention name(s): Angiography, Stenting
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary artery; thrombosis; stent
The Predictive Role of C-reactive Protein to Albumin Ratio (CAR) in the Treatment of Septic Arthritis in Young Chlidren
Condition: Septic Arthritis
MeSH terms: Arthritis, Infectious; Arthritis
Study type: Observational

Summary: 
      Purpose: C-reactive protein to albumin ratio (CAR) has emerged as a novel marker of
      inflammation. However, almost no research has evaluated the role of CAR in septic arthritis
      (SA). There is currently controversy over the timing of surgery. Our aim is to explore the
      application of the CAR in predicting the treatment choice for SA in children under 4 years of
      age.

      Methods: Retrospective analysis of the clinical data from children under four years of age
      admitted to the Department of Orthopedics at Children's Hospital of Soochow University
      between January 2016 and December 2022 due to SA. Patients were divided into surgery group
      and conservative group based on whether they underwent surgery. The clinical data of the two
      groups were compared. Multivariate logistic regression analysis was performed to determine
      the independent predictors for SA requiring surgical intervention. Receiver operating
      characteristic (ROC) curves were plotted for the independent predictive indicators, and the
      area under curve (AUC) was determined. The cut-off value was determined using Youden index,
      and diagnostic accuracy indicators such as sensitivity (SEN), specificity (SPE), positive
      predictive value (PPV) and negative predictive value (NPV) were calculated.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We reviewed the clinical records of patients under 4 years old with SA who were admitted to
        the Department of Orthopedics at the Children's Hospital of Soochow University for SA
        treatment between January 2016 and December 2022.
Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two
      treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at
      7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days
      post-treatment #2.
    

Detailed description: 
      Subjects will be randomized to one of two study groups:

        -  Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other
           axilla.

        -  Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine
           injection administered to one axillary side.

      Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be
      obtained at all study visits. Patient satisfaction questionnaires will also be obtained at
      30, 60 and 90 days post-treatment #2.
    

Intervention name(s): Ulthera System treatment; Sham treatment
Intervention type(s): Device; Device
Intervention description(s): Ulthera System: Focused ultrasound energy delivered below the surface of the skin.; Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.
Other intervention name(s): Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Underarm sweating
Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu
      AF88434 and the effect of food after swallowing single oral doses
    


Intervention name(s): Lu AF88434; Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434); Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).; Oral solution; Oral solution; Placebo to Lu AF88434 oral solution, single dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Adacel® Vaccine Administered to Persons 10 Years of Age
Condition: Tetanus; Diphtheria; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced
      Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10
      years of age.

      Primary Objectives:

        -  To compare pertussis antibody responses induced by Adacel® in persons 10 to <11 years of
           age to those induced by Adacel in persons 11 to <12 years of age.

        -  To compare the booster responses against pertussis antigens induced by Adacel in persons
           10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.

        -  To compare booster responses against tetanus and diphtheria induced by Adacel in persons
           10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of age.

      Secondary Objective:

        -  To compare seroprotection rates against tetanus and diphtheria induced by Adacel in
           persons 10 to <11 years of age to those induced by Adacel in persons 11 to <12 years of
           age.
    

Detailed description: 
      Study participants will receive a single dose of study vaccine and will then be monitored for
      safety from the day of vaccination for up to 30 days post-vaccination.
    

Intervention name(s): Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed; Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Adacel®; Adacel®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tetanus; Diphtheria; Pertussis; Tdap vaccine; Adacel®
High-dose Antioxidants for Central Serous Chorioretinopathy
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional
Phase: Phase 2

Summary: 
      Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually
      involves the macular area. It is common in patients between 30-50 years old and effects male
      more often than female with the ratio of 5-10. The common risk factors are psychologic
      stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment
      is usually observation especially in the first three-months. The laser or photodynamic
      therapy should be considered when the condition does not improve after that time.
      Nevertheless, the pathogenesis of CSC is still not well understood but the study from
      indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal
      leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins
      or even free oxidative radicals. From this hypothesis, the oxidative process might be
      involved in the pathogenesis of the disease especially in the early stage. This study is to
      determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether
      they can improve the outcomes of the disease.
    


Intervention name(s): antioxidants tablets
Intervention type(s): Drug
Intervention description(s): vitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.
Other intervention name(s): Icaps
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Central serous chorioretinopathy,antioxidants
The Role of Cycling-cognitive Dual-task Training in Early Parkinson's Disease
Condition: Safety and Effectiveness
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of the study will investigate the safety and effectiveness with eight-week
      cycling-cognitive dual-task training for early Parkinson's disease.
    

Detailed description: 
      Background: Parkinson's disease is a neurodegenerative disorder of the basal ganglia in which
      the production of dopamine is reduced, leading to the motor and non-motor impairment and the
      loss of automaticity. Recently, the results across studies have indicated that
      motor-cognitive dual-task deficits in individuals with neurologic disorders appear to be
      amenable to training. Improvement of dual-task ability in individuals with neurologic
      disorders holds potential for improving gait, balance, and cognition. The most recent
      European guideline provides a more graded view, stating that in Hoehn and Yahr stages 2 and 3
      dual-task training may be safe and effective. An overview of current ongoing randomized
      controlled trials focusing on dual-task rehabilitation, gait training or treadmill training
      was the major motor-task. However, cycling augmented by cognitive training has not been
      evaluated. In addition, antioxidant capacity is unclear for Parkinson's disease patients with
      long-term, regular cycling training.

      Study purpose: The purpose of the study will investigate the safety and effectiveness with
      eight-week cycling-cognitive dual-task training for early Parkinson's disease. The
      antioxidant capacity will be assessed as well.

      Methods: Parkinson's disease patients will be assigned to cycling training, cycling-cognitive
      dual task training, and following 8 weeks. All of the subjects will complete 3 assessments at
      pre-training, post-4 weeks, and post-8 weeks. The outcome measures are clinical severity and
      disability, performance of gait-cognitive and cycling-cognitive, cognitive-task performance,
      peripheral-blood oxidative stress, adverse events, etc.

      Significance: In this study, evidence-based practice as the foundation, and perspective to
      design a safe and effective cycling-cognitive dual-task training for early Parkinson's
      disease. It can be verified in the clinical application of these experiments feasibility
      (practice-based evidence).
    

Intervention name(s): Dual-task cognitive-cycling training
Intervention type(s): Other
Intervention description(s): Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training
Other intervention name(s): Single-task cycling training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
    

Detailed description: 
      Fiberoptic bronchoscopy (FOB) is the essential procedures for diagnosis and treatment of
      respiratory diseases。 Fever following FOB has been frequently reported. Fever is usually
      caused by patient discomfort and delay recovery from illness, or even worse. The reported
      frequency of this complication ranges from 1 to 20%. According to previous reports,
      postbronchoscopy fever is associated with advanced age, the presence of abnormal
      bronchoscopic findings,documented endobronchial obstruction, bronchoscopic intervention for
      malignancy, BAL, bronchial brushing, endotoxin contamination during bronchoscopy,
      instillation of topical anesthetic through the bronchoscope, abnormal differential cell
      counts in the BAL fluid (BALF), bacterial growth in the BALF culture,and the severity of
      bleeding. At present, guidelines recommend sedation and analgesia combined with airway
      surface anesthesia for Fiberoptic bronchoscopy. laryngeal spray and cricothyroid anesthesia
      often used in clinical.Cricothyroid local anesthesia has a good effect, but it is an invasive
      operation, this is risk factors for fever after bronchoscopy.Therefore, to compare fever in
      the two kinds of airway anesthesia on Bronchoscopy . So as to provide the local anesthesia
      method with little influence on the patient.
    

Intervention name(s): local surface anesthesia; Laryngeal tube
Intervention type(s): Other; Device
Intervention description(s): Airway anesthesia for Bronchoscopy
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention