bioihbjkbjnl/mcl2 huggingface dataset:
Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
Condition: Lung Cancer; Precancerous Condition
MeSH terms: Lung Neoplasms; Precancerous Conditions
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Inositol may be effective in preventing the development
      of lung cancer in patients with bronchial epithelial dysplasia.

      PURPOSE: This phase I trial is studying the side effects and best dose of inositol in
      preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety of inositol for the prevention of lung cancer in patients with
           bronchial epithelial dysplasia who are current or former smokers.

        -  Determine the potential efficacy of this drug in regression of existing dysplastic
           lesions or prevention of appearance of new dysplastic lesions in these patients.

        -  Determine whether intake of this drug can facilitate smoking cessation in patients who
           are current smokers.

      OUTLINE: This is a dose-escalation study.

      Patients receive oral inositol twice daily. Treatment continues for 1 or 3 months in the
      absence of disease progression or unacceptable toxicity.

      Cohorts of 3-12 patients receive escalating doses of inositol until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 12
      patients experience dose-limiting toxicity.

      Once the MTD is determined, 10 patients are treated with inositol twice daily at the MTD for
      3 months in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 1 month.

      PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.
    

Intervention name(s): inositol
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Inositol
Primary purpose: Prevention
Keywords: non-small cell lung cancer; small cell lung cancer; precancerous condition
Testing TRUST Depression Management Intervention
Condition: Depressive Symptoms; Quality of Life
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of a novel depression self-management intervention in
      adolescents with depression.
    

Detailed description: 
      Half of participants will receive a traditional depression self-management intervention,
      while the other half will receive the novel depression self-management intervention. In an
      exploratory, pilot 2-group randomized controlled trial (RCT), 16 adolescents were followed
      over 6 months. Data were collected at baseline, 3 months, and 6 months.
    

Intervention name(s): Trust-building Self-management Together; Depression Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Trust building plus depression self-management; Traditional depression self-management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescent; parent
Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction
Condition: Rupture of Anterior Cruciate Ligament; Infiltration; Regional Anesthesia Morbidity
MeSH terms: Rupture
Study type: Interventional
Phase: Phase 4

Summary: 
      Early rehabilitation after anterior cruciate ligament reconstruction is of paramount
      importance and requires optimal pain control based on a multimodal concept, including
      injection of local anaesthetics. Regarding this latter, different options have emerged
      recently such as the adductor canal block, performed before the surgery by the
      anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of
      the intervention. No trial has compared these two approaches. As practice of medicine should
      be based on evidence, we decided to undertake this randomised controlled trial where we
      compared the adductor canal block with the local infiltration analgesia technique in terms of
      pain and functional outcomes
    

Detailed description: 
      Patients scheduled to undergo anterior cruciate ligament reconstruction under general
      anaesthesia will be randomly allocated to two groups: local infiltration analgesia or
      adductor canal block.

      The local infiltration analgesia will be performed by the surgeon at the end of surgery with
      20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the
      anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient,
      using the same solution (20 mLs ropivacaine 0.5%)

      Postoperative analgesia will include intravenous patient-controlled analgesia of morphine
      (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen
      (4x1000 mg).

      A research assistant and a physiotherapist, both blinded to the group allocation, will
      collect pain and rehabilitation data, respectively.
    

Intervention name(s): Ropivacaine 0.5% 20 mLs
Intervention type(s): Drug
Intervention description(s): Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.
Other intervention name(s): Naropine, Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks
Condition: Mental Health Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The validity and the sensitivity of different measures implemented in the web application
      StayOk are investigated. The measures are used primarily for the assessment and the early
      identification of psychosocial risks. Secondarily, the results of the assessment are applied
      to generate health-promoting advices for the user of the web application.
    


Intervention name(s): StayOk web application
Intervention type(s): Device
Intervention description(s): Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices
Intervention model: Single Group Assignment
Intervention model description: Patients are examined at two time points: baseline and 12 weeks after the Intervention.
The Intervention consists of health-promoting advices provided by the software algorithm. The effect of this intervention is evaluated 12 weeks after.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: mental health; assessment; health promotion; case management; health insurance
Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Condition: Xerophthalmia; Blepharitis
MeSH terms: Blepharitis; Xerophthalmia
Study type: Interventional
Phase: Phase 3

Summary: 
      Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry
      Eyes
    

Detailed description: 
      Comparison of efficacy of Systane Ultra and Refresh Tears
    

Intervention name(s): Systane Ultra eyedrops; Refresh eye drops
Intervention type(s): Drug; Drug
Intervention description(s): Four times a day; Four times a day
Other intervention name(s): Systane Ultra, Alcon; Refresh, Allergan
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine
      (EXforge®) with nifedipine, as well as vascular function index.
    


Intervention name(s): Valsartan/Amlodipine; Nifedipine
Intervention type(s): Drug; Drug
Intervention description(s): Valsartan/Amlodipine 80/5mg single pill combination (SPC); Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg
Other intervention name(s): Exforge®; Adalat
Intervention MeSH terms: Amlodipine; Valsartan; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Valsartan Amlodipine single pill combination; BP control; ABPM; Hypertensive patients not adequately controlled by mono antihypertensive drugs
Medical Yoga for Patients With Stress-related Symptoms
Condition: Stress-related Illness/Anxiety
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to
      conventional treatment provided by a physical therapist, for people with perceived
      stress-related symptoms.

      Forty people are to be randomized to either:

        1. Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week,
           with the guidance of a physical therapist.

           or

        2. Control - treatment as usual (TAU) in physical therapy.
    


Intervention name(s): Medical Yoga; Treatment as Usual (physical therapy)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of this safety and feasibility study is to assess whether the endocardial
      creation of electrically nonconductive lesions via PEF catheter ablation applied using the
      FARAPULSE Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and
      associated AFL
    

Detailed description: 
      This is a prospective, multi-center safety and feasibility study in subjects with persistent
      AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as
      cavotricuspid isthmus interruption and other left atrial ablations at the investigator's
      discretion. Subjects will then be followed at 30 days, 60 ± 15 days, 6 months and 12 months
      for adverse events, recurrence of arrhythmia after a 90 day blanking period and other
      relevant outcome measures.
    

Intervention name(s): Ablation
Intervention type(s): Device
Intervention description(s): Ablation using the FARAPULSE™ Cardiac Ablation System Plus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Acupuncture for Insomnia in Breast Cancer Patients Undergoing Chemotherapy
Condition: Insomnia, Secondary; Breast Cancer Female; Chemotherapy
MeSH terms: Breast Neoplasms; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This pilot study is designed to determine whether acupuncture is a feasible, effective and
      safe method for alleviating insomnia among breast cancer patients undergoing chemotherapy as
      compared with a wait-list control.
    

Detailed description: 
      Hypothesis:

      Acupuncture is a feasible, effective and safe method for alleviation of insomnia symptoms in
      breast cancer patients undergoing chemotherapy as compared with a wait-list control.

      Objective:

      To determine whether the insomnia condition in the acupuncture group is significantly
      improved when compared to the wait-list control group.

      Design and strategy:

      This is a randomized, wait-list controlled, assessor-blinded trial. 30 subjects will be
      recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or wait-list
      control. All patients in the 2 groups will receive routine Western medical care for symptom
      management.

      Study instrument:

      Insomnia Severity Index (ISI) will be employed as a primary outcome assessment.

      Intervention:

      In the treatment group, 12 sessions acupuncture treatment (electroacupuncture & auricular
      acupressure) will be given twice a week for 6 weeks after randomization. In the wait-list
      control group, no treatment except routine care will be given at the first 6 weeks, followed
      by 12 sessions treatment as treatment group.

      Main outcome measures:

      Primary outcome: ISI scores will be measured at week 0, 3, 6, 10, 14.

      Secondary outcomes:

      Pittsburgh Sleep Quality Index, Sleep diary, Actiwatch, Functional Assessment of Cancer
      Therapy-Breast Cancer, and adverse events will be documented and compared between groups.

      Data analysis: The primary endpoint will be the continuous ISI score. For the primary
      analysis, if normality of the ISI or its transformation can be achieved, a two-sample t-test
      on the average ISI score will be performed to access the significance of the treatment
      effects; otherwise, a nonparametric approach will be taken.

      Expected outcome: ISI score of the acupuncture group is expected to be significantly lower
      than wait-list control group after 6 weeks of treatment.
    

Intervention name(s): Acupuncture
Intervention type(s): Device
Intervention description(s): Electroacupuncture (EA) and Auricular Acupuncture (AA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Insomnia; Breast cancer; Chemotherapy
The Effect of Clinical Pilates Training on Balance and Postural Control of People With Parkinson's Disease.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Many studies showed that clinical pilates exercises has positive effects on static and
      dynamic balance of different populations. It was suggested that this type of exercise reduce
      the risk of falls and physical damage. It also helps prevention of kyphotic posture.
      Parkinson's patients have both balance and postural problems but no study investigated the
      effect of clinical pilates exercises for this population. The aim of this study is to
      investigate the effects of clinical pilates exercise program on postural control and balance
      in individuals with Parkinson's disease.
    

Detailed description: 
      The patients will be randomly assigned into two groups: Clinical Pilates (CP) Group and
      Classic Physiotherapy (CF) Group. Both groups will be treated for 8 weeks. The evaluation of
      the patients will be done before the beginning of exercise program and will be repeated at
      the end. Static balance of patients will be evaluated with Single Leg Stance Test and Tandem
      Stance Test, dynamic balance with Functional Reach Test (FRT) and 30 second Chair Stand Test.
      Postural control and balance will also be evaluated with Berg Balance Scale and functional
      capacity by Timed Up and Go Test. Symptom severity and treatment complications of the
      patients will be evaluated with United Parkinson's Disease Rating Scale.
    

Intervention name(s): Clinical Pilates; Classic Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): This exercise model focus on the awareness of the neutral position of the spine and strengthen the deep postural muscles of the spine. Training of trunk muscles is emphasized and trunk stabilization is achieved and more difficult activities are initiated and thus, body awareness is improved. There are general principles to be followed during exercises. These; The principle of concentration is respiration, central focus, control, stability and isolation. These principles are achieved by simultaneous muscle activation of muscles responsible for trunk stabilization (multifidus, diaphragm, transversus abdominis and pelvic floor muscles). In order for an exercise to become a clinical pilates exercise, trunk stabilization must be ensured and breath control should be established in each exercise.; This exercise program will include strengthening, stretching, posture exercises, balance and gait exercises. Aim is to improve muscle strength and prevent shortness of muscles. Also, balance and gait exercise aim to improve walking capacity.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups will receive different exercise program for 8 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
Condition: GERD; Proton Pump Inhibitor
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved
      drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1.
      Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet
      needs that may accompany traditional proton pump inhibitors, with two separate pH-depended
      release phases, the first in the proximal duodenum and the second in the more distal small
      intestine. This dual release system extends the plasma concentration and pharmacodynamics
      effects beyond those of single-release PPIs, allowing for dosing at any time of the day
      without regard to meals 1. A study conducted by Fass et al. has shown that the use of
      dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective
      than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and
      consequently improving work productivity, sleep quality and quality of life 2.

      Because of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove
      beneficial in optimizing the management of GERD and the associated burdens that often surface
      after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep
      quality.
    

Detailed description: 
      To investigate the efficacy and quality of life improvement of Dexlansoprazole 60mg taken
      once daily at Iftar time in patients with known symptomatic heartburn exacerbated in Ramadan
      and who are not on daily treatment.
    

Intervention name(s): Dexlansoprazole 60 MG
Intervention type(s): Drug
Intervention description(s): This drug will be given to 34 random patients during the 2nd, 3rd, and 4th weeks of the month of Ramadan to assess its ability to relieve GERD symptoms
Other intervention name(s): Dexilant 60 MG
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validating NIAAA Screen Guide in YCMC
Condition: Alcohol Related Disorders
MeSH terms: Alcohol-Related Disorders
Study type: Observational

Summary: 
      Alcohol use is a serious health threat to the 26% youth in the US with chronic medical
      conditions. While alcohol use can significantly impact an underlying illness and its
      safe/effective management, medical specialists rarely screen their adolescent patients for
      alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18
      year old youth with chronic medical conditions. Comprehensive assessment information will be
      collected and analyzed to describe relationships between youth alcohol use, other substance
      use, and chronic disease outcomes and findings integrated into the validated screen as
      actionable clinician guidance and health advice.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or
        gastroenterologic conditions
      
Keywords: Alcohol related disorders
Intrathecal Morphine for Unilateral Total Knee Arthroplasty
Condition: Primary Osteoarthritis of Knee Nos
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study evaluates postoperative numerical pain score and systemic opioid requirement
      within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of
      intrathecal morphine; 0,50, 100 ug with multimodal analgesia.
    

Detailed description: 
      Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity
      surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness.
      Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral
      analgesic drugs, adductor canal block and local analgesia infiltration.

      This study evaluates whether intrathecal opioid should be added in the role of multimodal
      analgesia in total knee arthroplasty.
    

Intervention name(s): 50 ug IT morphine; 100 ug IT morphine; No IT morphine; Morphine; Bupivacaine
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug
Intervention description(s): Spinal block with bupivacaine and intrathecal morphine 50 ug; Spinal block with bupivacaine and intrathecal morphine 100 ug; Spinal block with bupivacaine and intrathecal morphine 0 ug; intrathecal morphine; 0.5 isobaric bupivacaine
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intrathecal morphine, total knee arthroplasty