bioihbjkbjnl/mcl2 huggingface dataset:
Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop
      tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as
      bevacizumab, can block cancer growth in different ways. Some block the ability of cancer
      cells to grow and spread. Others find cancer cells and help kill them or deliver
      cancer-killing substances to them. It is not yet known whether paclitaxel works better with
      or without bevacizumab in treating breast cancer.

      PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without
      bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the time to treatment failure in patients with locally recurrent or metastatic
           breast cancer treated with paclitaxel with or without bevacizumab.

        -  Compare the objective response rate, duration of response, overall survival, and time to
           progression in patients treated with these regimens.

        -  Compare the toxicity of these regimens in these patients.

        -  Compare the quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to disease-free interval (no more than 24 months vs more than 24 months), number of
      metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy (yes
      vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are
      randomized to one of two treatment arms.

        -  Arm I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 followed by
           bevacizumab IV over 30-90 minutes on days 1 and 15.

        -  Arm II: Patients receive paclitaxel as in arm I. In both arms, courses repeat every 4
           weeks in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline and on day 1 of weeks 17 and 33.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued
      for this study within 31 months.
    

Intervention name(s): bevacizumab; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle; 90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest
Other intervention name(s): Avastin
Intervention MeSH terms: Paclitaxel; Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; male breast cancer
A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.
Condition: Cystic Fibrosis-related Diabetes; Diabetes Mellitus; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Diabetes Mellitus; Fibrosis
Study type: Observational

Summary: 
      Cystic fibrosis (CF) is autosomal recessive, genetic disorder cause of cystic fibrosis
      transmembrane regulatory (CFTR) gene mutation. CF often is observed in caucasian population.
      CFTR protein in cell apical membrane is canal responsible of transport sodium and clorid
      ions. Impaired sodium ion transport causes production viscous mucus. Disease include problems
      such as mucus, breathlessness and coughing. Blood glucose levels fluctuation are observed.
      This study aims comparison between lung function, functional capacity, muscle strength,
      physical activity, physical fitness and activities of daily living activities in cystic
      fibrosis with and without abnormal glucose tolerance
    

Detailed description: 
      The study aimed that comparison of clinical parameters in children with and without abnormal
      glucose tolerance in Cystic fibrosis.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        cystic fibrosis with (impaired glucose tolerance, cystic fibrosis related diabetes) and
        without abnormal glucose tolerance
      
Keywords: Glucose; Cystic fibrosis; Muscle strength; Physical fitness
The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
Condition: Pain; Needle Phobia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares the efficacy of the Synera patch with Eutectic Mixture of Local
      Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
    

Detailed description: 
      Venipunctures are common and necessary components of pediatric health care. Unfortunately,
      many children have "needle phobia" and even a simple procedure, such as a venipuncture, can
      cause significant stress and anxiety to the patient and the parents involved. Studies have
      shown that needles are the worst part of hospital/healthcare related visits for children.

      The Synera patch uses a controlled heating system to transcutaneously deliver a
      lidocaine/tetracaine mixture for analgesic effect. No published studies compare the efficacy
      of the Synera patch with other topical anesthetics in children. The objective of this study
      is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of
      EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children.

      Patients, 4-12 years old children requiring venipunctures in clinics, were randomized to
      receive Synera for 20 minutes or EMLA for 60 minutes. A blinded observer recorded pain scores
      using a numerical rating scale (NRS). Child and parent assessed pain with the Wong-Baker
      FACES Scale and the NRS, respectively. The primary outcome was the number of subjects
      reporting "no pain". Secondary outcomes were parent and observer measures of the child's pain
      and the presence of skin reactions.
    

Intervention name(s): EMLA Cream; Synera Patch
Intervention type(s): Drug; Combination Product
Intervention description(s): 60 minutes x1; 20 minutes x1
Other intervention name(s): Lidocaine/prilocaine cream; Lidocaine/tetracaine patch
Intervention MeSH terms: Lidocaine; Tetracaine; Prilocaine; Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: EMLA; venipuncture; children; Synera patch; pediatric; Lidocaine/prilocaine
A Study to Assess the Safety and Tolerability of E2511 in Healthy Adult and Elderly Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety, tolerability, and plasma
      pharmacokinetic (PK) of E2511 following multiple oral doses in healthy adult participants.
    


Intervention name(s): E2511; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2511 tablets.; E2511 matched placebo tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: E2511; Healthy Participants; Elderly Participants
Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical study is to determine the safety of intravenous MN-221
      compared to placebo when administered in subjects diagnosed with stable moderate to severe
      COPD.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multi-center dose escalation study in
      subjects diagnosed with stable moderate to severe COPD. The study will be conducted in
      approximately 6 Clinical Research Units (CRUs).

      Subjects with a diagnosis of stable moderate to severe COPD will be screened and must
      demonstrate an improvement in FEV1 after bronchodilator treatment of at least 12% at Screen
      Visit 1. The subject's degree of dyspnea will be captured on the British Medical Research
      Council (MRC) questionnaire, and severity will be determined by the Global Initiative for
      Chronic Obstructive Lung Disease (GOLD) spirometric criteria. Subjects meeting entry criteria
      at Screen Visit 1 will be asked to return to the CRU for Screen Visit 2 within 14 days of
      Visit 1. Subjects confirming entry criteria including degree of COPD severity by spirometry
      at Screen Visit 2 will be randomized to receive either MN-221 or placebo. Serial spirometry
      will be performed over the 8 hour treatment period after initiation of study drug
      administration. Subjects will be discharged from the CRU after completing the Hour 8 study
      procedures and asked to return approximately 24 hours after initiation of study drug for
      follow up safety assessments including spirometry. A study diary will be provided to each
      subject upon discharge from the CRU to complete as instructed and return it to the site at
      the 24 hour Follow-up Visit.

      There will be three dose levels and each will include approximately 16 subjects randomized to
      receive either MN-221 or placebo in 3:1 ratio (12 subjects receive MN-221:4 subjects receive
      placebo). A risk/benefit evaluation will be performed by the study's Safety Review Committee
      at completion of each dose level prior to escalating to the next dose level.

      Safety and efficacy will be monitored throughout the treatment period. Blood samples for PK
      parameters and metabolite identification will be obtained.
    

Intervention name(s): MN-221 (Dose Group 1); MN-221 (Dose Group 2); MN-221 (Dose Group 3)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour; i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour; i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
Condition: Borderline Personality Disorder; Oxytocin
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Observational

Summary: 
      This study aims to determine the feasibility and preliminary data on the interaction between
      oxytocin and cortisol during stress in borderline personnality disorder.
    

Detailed description: 
      The investigators will recruit 10 female patients with borderline personnality disorder and
      10 controls with no psychiatric diagnosis, aged between 18 and 25 years old.

      salivary cortisol daily curve ( 6 measures during the day) will be measured in participant's
      naturalistic environnement, together with salivary oxytocin. In addition, salivary oxytocin
      and cortisol will be measured during a psychosocial stress task and recovery.
    

Intervention name(s): stress test
Intervention type(s): Other
Intervention description(s): TSST- psychosocial stress test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young patients with and without borderline personality disorder
      
Keywords: cortisol; tsst; borderline personnality; stress
Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Observational

Summary: 
      Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular
      compressions (NVC) on the patients with idiopathic trigeminal neuralgia (ITN). However, due
      to lack of stereoscopic vision, this traditional method sometimes cannot meet the requirement
      on identifying the existence and details of NVC, especially when the aberrant vessels turn
      out to be delicate veins. The three-dimensional analytic techniques, such as curved planar
      reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be helpful to
      improve the sensitivity and specificity on the demonstration of NVC with stereo and dynamic
      views, so as to assist to design the surgical plan.

      Furthermore, the frequent finding of NVC on MRI studies of asymptomatic patients incited the
      creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross
      perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the
      root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve
      may correlate with the severity of facial pain due to atrophy of the nerve in most cases of
      ITN, and is likely secondary to the micro-structural abnormalities, such as axonal loss,
      demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume
      (V) of the cisternal trigeminal nerve will be assessed to determine whether it can be a
      useful biomarker for predicting the degree of ITN.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Chronic trigeminal neuralgia patients prior to the surgery of microvascular decompression
        (MVD) or Gamma Knife radiofrequency ablation (GKRFA)
      
Keywords: MRI; Virtual Endoscopy; Pain Measurement
Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop
Condition: Foot Drop
MeSH terms: Peroneal Neuropathies
Study type: Interventional

Summary: 
      The objective of this research is to compare the new ankle foot orthosis (AFO) with prior
      support developed by Turbomed, with the AFO with posterior support from Turbomed as well as
      two competing AFOs currently on the market.

      With this research, we seek to answer the following questions:

        -  Is the new AFO as biomechanically efficient as the AFOs currently on the market?

        -  Is the new AFO more comfortable than the AFO currently on the market?

        -  Is the new AFO easier to put on and attach than the AFOs currently on the market?
    


Intervention name(s): New ankle foot orthosis with anterior support; Ankle foot orthosis with anterior support; Ankle foot orthosis from competitor 1; Ankle foot orthosis from competitor 2
Intervention type(s): Device; Device; Device; Device
Intervention description(s): New ankle foot orthosis with anterior support developed by Turbomed; Ankle foot orthosis with anterior support from Turbomed; Ankle foot orthosis with posterior support from competitor 1; Ankle foot orthosis with posterior support from competitor 2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
Condition: UTI; Stone, Kidney
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional

Summary: 
      This study is designed to provide an evaluation of currently available disposable flexible
      ureteroscopes in real-world conditions. Due to high re-processing costs associated with
      re-usable flexible ureteroscopes, there has been a demand for Urologic device manufacturers
      to provide single-use flexible ureteroscopes.
    

Detailed description: 
      Patients randomized to the experimental group will receive flexible ureteroscopy with the
      Storz Flex-XC1 disposable flexible ureteroscope.

      Data will be collected and stored electronically in REDCap. Quality assurance steps will
      include testing of the database, including any potential data calculated by command functions
      within REDCap

      Scope performance survey will be administered with REDcap.
    

Intervention name(s): Storz Flex-XC1 Disposable Flexible Ureteroscope; Storz Flexible Digital Ureteroscope
Intervention type(s): Device; Device
Intervention description(s): Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.; Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
ICT-based Monitoring for Arrhythmia Detection After AF Ablation
Condition: Arrhythmias, Cardiac; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring
      system against the efficacy and stability of an existing outpatient-based electrocardiogram
      (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation
      ablation, and to test whether such continuous monitoring can better detect arrhythmia that is
      undetectable by existing methods and how this may affect treatment outcomes
    

Detailed description: 
      This clinical trial is a prospective, randomized, controlled, multicenter study in patients
      who are capable of using and consent to use a smartphone-based ECG monitoring after ablation
      for atrial fibrillation. The patients will be randomly assigned to either the Holter
      monitoring or ICT-based centralized clinical trial monitoring system group in a 1:1 ratio and
      will undergo monitoring from immediately after the procedure to 12 months after discharge.
    

Intervention name(s): ICT-based ECG monitoring; Holter monitoring
Intervention type(s): Device; Device
Intervention description(s): Continuous monitoring will begin from the time of participation in the trial in the ICT-based centralized monitoring group. 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in this group, as in the Holter monitoring group. If heart rate drops below 40 beats/min or increases above 120 beats/min on ECG during ICT-based ECG home monitoring, the participant will be notified first through an alarm function.; 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Arrhythmias, Atrial Fibrillation
Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The experience of trauma not only impacts the way an individual thinks and feels, but can
      also produce changes in the way someone remembers their personal past. It is not only
      memories of the trauma that are affected- avoidance of trauma memories can also lead to
      memories of other events becoming vague, and in particular, memories of positive experiences
      can seem out of reach. This memory difficulty promotes posttraumatic stress disorder (PTSD).
      This study will explore an intervention that aims to improve memory difficulties, which
      should then flow on to improve PTSD. The study will be completed with individuals who have
      experienced a single incident trauma. Twenty five participants will complete MemFlex straight
      away, and 25 will go on a waiting list. Once this first group has finished MemFlex, the
      researchers will compare the two groups to see if the programme produced a larger reduction
      in PTSD symptoms. MemFlex is workbook-based, and as such, if it is successful it may offer an
      easy, cheap, and accessible way to offer psychological treatment to PTSD sufferers around the
      world.
    


Intervention name(s): Memory Flexibility training (MemFlex)
Intervention type(s): Behavioral
Intervention description(s): MemFlex is a primarily self-guided, paper workbook-based program which aims to reduce overgeneral memory bias and improve recall of positive, specific event memories. Prior to completing one month of self-guided, workbook-based intervention, the participant will attend one 45 minute face-to-face session in which the facilitator outlines the importance of autobiographical memory in everyday life, discusses the impact of trauma on autobiographical memory, and provides information on the different types of autobiographical memories (e.g., specific, general) and their potential everyday functions. The session also introduces the cued-recall tasks which were used to train the memory skills throughout the workbook, and provides facilitator-assisted practice with the tasks. Once participants are comfortable with the training exercises, they set a schedule for completion of the eight-session workbook over the following four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind, randomized controlled trial comparing active intervention to waitlist control
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
Condition: Acute Ischaemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the
      efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for
      patients with acute ischaemic stroke in 4.5 hours after stroke onset.
    


Intervention name(s): Recombinant human urokinase; Alteplase
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.; Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.
Other intervention name(s): rhPro-UK; rt-PA
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability after ocular administration
    


Intervention name(s): 0.02 mcg tiotropium solution; 0.04 mcg tiotropium solution; 0.08 mcg tiotropium solution; 0.16 mcg tiotropium solution; 0.28 mcg tiotropium solution; 0.40 mcg tiotropium solution; Placebo solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment