bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to
      characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects
    

Detailed description: 
      This is a phase I dose escalation study. To meet the clinical objectives, we are using a
      two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or
      placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting
      data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of
      DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.
    

Intervention name(s): SR-exenatide
Intervention type(s): Drug
Intervention description(s): Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Other intervention name(s): DA-3091
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SR-Exenatide
Internet and Telephone Counseling for Smoking Cessation
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

Summary: 
      RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop
      smoking. It is not yet known which computer-based smoking cessation program is more effective
      with or without telephone counseling in helping smokers quit smoking.

      PURPOSE: This randomized clinical trial is studying two different computer-based smoking
      cessation programs to compare how well they work with or without telephone counseling in
      helping smokers quit smoking.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of premium internet intervention vs premium internet with telephone
           intervention vs basic internet intervention, as determined by 7-day point prevalence
           abstinence at 12 months, in adult smokers.

        -  Compare the cost-effectiveness of these interventions in promoting smoking cessation.

        -  Determine the effects of internet-based interventions on measured use of the
           intervention (frequency and duration of use, utilization of behavioral coping, expert
           advices, and e-mail) in these patients.

        -  Determine the effects of internet-based interventions on variables important for
           behavior change including mediators (e.g., self-efficacy, use of internet social
           support) and moderators (e.g., gender, baseline motivation) of outcomes in these
           patients.

      OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
      according to gender and baseline motivation level. Patients are randomized to 1 of 3
      intervention arms.

        -  Arm I (basic internet program): Patients are directed to a website of existing QuitNet™
           smoking cessation materials. These materials are not tailored and have no interactive
           features.

        -  Arm II (premium internet program): Patients receive free 6-month access to the QuitNet™
           website including interactive and individualized intervention features.

        -  Arm III (premium internet program plus telephone counseling): Patients receive free
           access to the QuitNet™ website as in arm II. Patients also receive up to 5 telephone
           counseling sessions, scheduled at their convenience.

      All patients are assessed at baseline and then at 3, 6, 12, and 18 months.

      PROJECTED ACCRUAL: A total of 2,205 patients will be accrued for this study.
    

Intervention name(s): Basic Internet; Enhanced Internet; Enhanced Internet + phone
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Basic Internet control intervention; enhanced Internet cessation intervention; enhanced Internet plus proactive telephone counseling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: unspecified adult solid tumor, protocol specific
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
Condition: Stress Urinary Incontinence; Mixed Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      A randomized controlled trial for patients with stress urinary incontinence or
      stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel
      exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health
      system that includes visual biofeedback via smartphone.
    

Detailed description: 
      A randomized controlled trial for patients with stress urinary incontinence or
      stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel
      exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health
      system that includes visual biofeedback via smartphone. Leva subjects will perform guided
      pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform
      kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted
      to continue the exercises or pursue additional therapies as indicated. Subjects randomized to
      the leva digital health system will be further randomized to receive automated reminders for
      the remainder of one year, or no additional reminders.
    

Intervention name(s): Leva; PFDx
Intervention type(s): Device; Device
Intervention description(s): Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.; All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Digital Health; Female
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
Condition: Pregnancy
Study type: Observational

Summary: 
      This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor®
      (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term
      pregnant patients.
    

Detailed description: 
      The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor
      intended to measure uterine activity. It is intended for use on pregnant women, with
      singleton pregnancies, using surface electrodes on the maternal abdomen. The device is
      intended for use by healthcare professionals in a clinical setting.

      This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor®
      (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring
      preterm patients, nonlaboring preterm patients, and nonlaboring term patients.

      This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a
      Gestation Age of greater than 36 at five clinical sites. Each study subject was instrumented
      with two technologies for measuring uterine activity:

        1. Standard tocodynamometer attached to the maternal abdomen,

        2. SureCALL® with a set of abdominal surface electrodes for uterine electromyography
           attached to the maternal abdomen

      Subjects did not recieve any interventions as a part of this study.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with uncomplicated singleton pregnancies
Ramipril - Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      Mean values of systolic and diastolic office blood pressure

      Secondary objectives:

      Total mortality, occurrence of cardio- and cerebrovascular events, change of mean blood
      pressure (ABPM : Ambulatory Blood Pressure Monitoring) during the observation
    


Intervention name(s): Ramipril
Intervention type(s): Drug
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
Condition: Chronic Hepatitis C; CHC; HCV; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of
      VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
    


Intervention name(s): VX-135; Daclatasvir
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of ST266 Versus Saline in Treating Skin Irritation From Radiation
Condition: Radiation-induced Dermatitis
MeSH terms: Dermatitis; Radiodermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety and efficacy of ST266 in treating
      radiation burns of the skin in patients undergoing treatments for breast cancer and to
      compare ST266 treated burns with those treated with saline placebo controls.
    


Intervention name(s): ST266
Intervention type(s): Biological
Intervention description(s): Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy and Safety Profile of Capsaicin 8% Patch Versus 5% Lidocaine Patch in Males With Diabetic Neuropathy
Condition: Diabetic Nerve Problems; Diabetic Neuropathy; Diabetic Complications Neurological
MeSH terms: Diabetic Neuropathies; Diabetes Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to
      8% capsaicin patch in patients with diabetic neuropathy. Assessment of analgesic
      effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS)
      score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral
      neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of
      capsaicin and lidocaine safety and identifying treatment adverse effects were secondary
      endpoints in this study
    

Detailed description: 
      The aim of the present study was to compare the efficacy and tolerability of using lidocaine
      5% patch to 8% capsaicin patch in south Asian male patients with diabetic neuropathy.
      Assessment of analgesic effectiveness was assessed by observing any change in the Numeric
      Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful
      diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC).
      Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were
      secondary endpoints in this study
    

Intervention name(s): Lidocaine 5% patch; Capsaicin 8% Patch, Per 10 Square Centimeters
Intervention type(s): Drug; Drug
Intervention description(s): 5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm; 8% Capsaicin patch [8% w/w] 640 µg/cm² of adhesive, patch area 280 cm2 (20 cm x 14 cm), (Qutenza®; capsaicin 179 mg patch, Astella Pharma Europe Ltd. Chertsey, UK)
Other intervention name(s): Lidocaine patch; Capsaicin patch
Intervention MeSH terms: Lidocaine; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This present study was a double blinded, placebo controlled, parallel group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the effect of food on the relative
      bioavailability of a 50 mg BI 135585 XX tablet.
    


Intervention name(s): BI 135585; BI 135585
Intervention type(s): Drug; Drug
Intervention description(s): one oral single dose per subject; one oral single dose per subject
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and
      progressive disease that can lead to joint destruction and important functional disability.
      Chronic inflammation, with a substantial increase in the amount of pro-inflammatory cytokines
      in synovial joint, is one of the biggest challenges in controlling RA. Resistance exercise
      has been recognized for positively modulate inflammation in healthy subjects. Objective: To
      evaluate the effect of an acute bout of resistance exercise on serum concentrations of tumor
      necrosis factor alpha (TNF-α), interleukin 1 receptor antagonist(IL-1ra), interleukin 1 beta
      (IL-1β), C reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), and
      cartilage oligomeric matrix protein (COMP) in postmenopausal women with RA and women without
      the disease. Methods: 17 volunteers with RA and 17 without the disease, with a mean age of
      54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of
      one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises
      performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples
      were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24
      hours after the exercise session. Serum glucose concentrations prior to exercise were also
      measured. The investigators used the Student's't test, the model of analysis of variance with
      repeated measures and Bonferroni method of multiple comparisons to analyze the data, being
      considered statistically significant levels of p <0.05.
    


Intervention name(s): Resistance training
Intervention type(s): Other
Intervention description(s): 17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Desfluran On Global Dna Methylation
Condition: DNA Damage
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate the molecular effect of desflurane on DNA by
      measuring the global DNA methylation level in patients under going lumbar spinal stenosis
      surgery under general anesthesia.
    

Detailed description: 
      Forty patients scheduled for lumbar spinal surgery will include in the study. Peripheral
      venous blood samples will collect prior to the induction of anesthesia (T1) and after 120
      minutes (T2). Anesthesia will maintaine with 40%-60% O2-air mixture and 6% desflurane. DNA
      will obtain from blood samples with the help of DNA isolation kit and global DNA methylation
      analysis will perform by ELISA method.
    

Intervention name(s): Desflurane
Intervention type(s): Drug
Intervention description(s): Peripheral venous blood samplesof patients will collected at two time points as follows: before the premedication and the induction of anesthesia (T₁): 120 minutes after the beginning of anesthesia (T₂). Anesthesia maintenance will be provided with 40% O₂ and minimum alveolar concentration (MAC) in 60% air with 6% desflurane. DNA will be obtained from blood samples with the help of DNA isolation kit, and global DNA methylation analysis will performed by ELISA method.
Intervention MeSH terms: Desflurane
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with physical status I and II of the American Society of Anesthesiologists (ASA),
        aged between 18-65 and scheduled for lumbar spinal surgery, which will take at least 120
        minutes, will be included in the study
      
Biospecimen description: 
      peripheral venous blood sample
    
Keywords: Desflurane,; DNA methylation; epigenetics; inhalation anesthetics
Under-correction in Refractive Accommodative Esotropia
Condition: Accommodative Esotropia
MeSH terms: Esotropia; Strabismus
Study type: Interventional

Summary: 
      In most clinics, physicians reduce diopter of hyperopic glasses in older patients with
      accommodative esotropia. However, there are risks of decompensation in that practice. The
      authors are going to try measure the change of stability of eye alignment after reducing
      diopter of hyperopic glasses.
    

Detailed description: 
      Inclusion criteria :

      patients with accommodative esotropia

      At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as
      much as the patient can maintain their eye alignment (maximum amount 1.5D).

      Outcome measure :

      Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the
      patients begin wearing under-corrected spectacles. At every visit, symptoms such as
      asthenopia, diplopia, or blurred vision will be documented and ocular examinations, including
      visual acuity and ocular alignment status for distance and near will be performed. Tests of
      fusion and stereoacuity will be performed at the 1-month, 3-month, and 6-month follow-up
      visits.
    

Intervention name(s): Glasses prescription
Intervention type(s): Device
Intervention description(s): At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: accommodative esotropia
Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the continued efficacy of modafinil treatment,
      compared to placebo treatment, in children and adolescents with
      attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment.
    

Detailed description: 
      The primary objective of the study is to evaluate the continued efficacy of modafinil
      treatment, compared to placebo treatment, in children and adolescents with
      attention-deficit/hyperactivity disorder (ADHD) who are responders to modafinil treatment, as
      assessed by the change from baseline (in this current study) in the total score from the ADHD
      Rating Scale, Fourth Edition (ADHD-RS-IV) (Home Version) at endpoint (week 6 or last
      double-blind post-baseline visit).
    

Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Attention-Deficit/Hyper Activity Disorder; ADHD
Telemedicine for Patients With Chronic Respiratory Insufficiency
Condition: Chronic Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM
      programme (supported by continuous availability of a call centre and a pulsed oxygen system)
      is cost/effective saving health care resources.
    

Detailed description: 
      Background: Integrated care and strict follow up have been recommended for frail patients
      with chronic respiratory failure (CRF) discharged at home.

      Objectives: To evaluate impact and costs on health care resources of a telemedicine programme
      (TM) for severe patients discharged at home with oxygen and/or home mechanical ventilation
      (HMV) with a high risk of hospital readmission.

      Design: Prospective randomised controlled trial. Setting: Respiratory Rehabilitation Unit S.
      Maugeri Foundation between May 2004 and March 2007.

      Participants: 240 CRF patients will be randomised into an intervention group (TM) and a
      control Group, which received current usual care (educational plan, 3 months outpatient
      visits).

      Interventions: one year TM with continuous (h 24) on call accessibility to a nurse and/or a
      pulmonologist, a web-based call centre and a pulse oxymetry tracing.

      Main outcome measures: survival, admissions to emergency room (ER), hospitalisations, urgent
      general practitioner (GP) calls, home relapses; probability to remain free from the above
      events will be also compared among groups. TM and health Care System costs as customer
      satisfaction will be also collected.
    

Intervention name(s): telemedicine program
Intervention type(s): Device
Intervention description(s): One year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing will be provided.
Other intervention name(s): home care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COPD; ALS; Telemedicine; mechanical ventilation; Integrated care; strict follow up; impact and costs on health care resources; telemedicine programme; home mechanical ventilation (HMV); frail patients; chronic respiratory failure (CRF)