bioihbjkbjnl/mcl2 huggingface dataset:
Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate effects of soft tissue mobilization versus
      therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical
      sensitivity.
    

Detailed description: 
      To investigate the immediate effects of soft tissue mobilization (STM) versus therapeutic
      ultrasound (US) in patients with neck and arm pain who demonstrate neural mechanical
      sensitivity. Twenty-three patients with neck and arm pain and a positive upper limb
      neurodynamic test (ULNT) were randomly assigned to receive STM or therapeutic US during a
      single session. Outcome measures were collected immediately before and after treatment, and
      at 2-4 day follow-up. Primary outcomes were the Global Rating of Change (GROC), range of
      motion (ROM) during the ULNT, and pain rating during the ULNT. Secondary measures included
      the Neck Disability Index (NDI), Patient-Specific Functional Scale (PSFS), Numeric Pain
      Rating Scale (NPRS), and active range of shoulder abduction motion combined with the wrist
      neutral or wrist extension.
    

Intervention name(s): Soft Tissue Mobilization; Therapeutic Ultrasound
Intervention type(s): Other; Device
Intervention description(s): Patients in the STM group received treatment in supine, with their head resting on one pillow and the involved UE positioned in abduction and external rotation to preload the neural structures of the upper limb. Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner with the intention to improve the mobility of the soft tissues surrounding the pathway of the neural structures of the upper limb as well as any tender or tight tissues. The therapist spent approximately 7 minutes on the neck and scapular region, 4 minutes on the upper arm, and 4 minutes on the forearm and hand. The therapist was allowed to vary the time spent on each region according to his/her assessment of the patient's condition. The procedure lasted a total of 15 minutes.; Patients received therapeutic US applied for a period of 5 minutes to the most painful region of the neck, then a second 5-minute dose at the most painful region of the upper extremity. The US dose was 0.5 w/cm2, with sonation time 50% and frequency 1 MHz.40,52 The patient lay supine with the hand of the involved upper extremity placed on the abdomen and the elbow supported on a pillow. The two US doses and interaction time with the patient lasted a total of 15 minutes in an attempt to have equal patient/therapist contact between the two groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Condition: Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a
      moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine
      in healthy adult subjects.
    


Intervention name(s): Fesoterodine; fesoterodine plus fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single 8 mg oral dose of fesoterodine; On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)
Intervention MeSH terms: Fluconazole; Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Interventions For Neck Pain In Relation to Internet Usage
Condition: Internet Addiction
MeSH terms: Neck Pain; Behavior, Addictive; Internet Addiction Disorder
Study type: Interventional

Summary: 
      After the rapid increase in the use of the Internet in the world, it has brought some
      negativities.People with internet addiction describe all the time they spend without internet
      as worthless and they want to be on the internet with an increasing desire.
    

Detailed description: 
      Under all this information, the exercise program and walking programs that are easily added
      to people's lives in the study; The effects on stress and sleep levels were investigated by
      reducing neck pain symptoms in people with internet addiction.
    

Intervention name(s): postural exercise; aerobic exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The exercises consisted of 4-way neck isometric exercises and stretching exercises for the activation of deep cervical flexors (chin tuck exercise) and combined with this exercise. This protocol consisted of protocols studied in similar studies.; The walking program was carried out daily on a flat surface with a target of 7000 steps. This goal is based on the American College of Sports Medicine reports on the minimum recommended levels of physical activity required to achieve health benefits, which includes several design elements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: addiction; internet
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome
Condition: Sleep Apnea; Metabolic Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic
      dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to
      increase the morbidity associated with metabolic syndrome. This study was designed to
      evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic
      syndrome.
    


Intervention name(s): CPAP (REMstar System One Plus - Philips Medical Systems); Nasal strips
Intervention type(s): Device; Device
Intervention description(s): Standard device for treating obstructive sleep apnea.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Detailed description: 
      A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability,
      pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445
      after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in
      healthy volunteers.
    

Intervention name(s): PRT064445/Enoxaparin; Placebo/Enoxaparin; Placebo
Intervention type(s): Combination Product; Combination Product; Drug
Other intervention name(s): Andexanet
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion
Condition: Skin Irritation
Study type: Interventional

Summary: 
      Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily
      Advance to induce sensitization to the skin
    


Intervention name(s): Cetaphil Moisturizing Lotion Daily Advance
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
Condition: Hypertension
MeSH terms: Hypertension; Systolic Murmurs
Study type: Interventional

Summary: 
      The goal of this pilot study is to effectively treat hypertension in subjects with either
      known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due
      to the unique properties of nebivolol, it is hypothesized that there will be improvements in
      left ventricular (LV) systolic and diastolic function manifesting as increase exercise
      capacity in this patient population with primarily LV diastolic dysfunction. The present
      study was performed to determine the effects of nebivolol on blood pressure, exercise
      tolerance and parameters of left ventricular systolic and diastolic function in a group of
      hypertensive patients with echocardiographic evidence diastolic dysfunction.
    

Detailed description: 
      Prior to the initiation of Nebivolol and after 10 weeks of Nebivolol therapy, subjects
      underwent a resting 2D echocardiogram including routine sampling of mitral valve (MV) inflow
      and LV tissue Doppler imaging as well as a symptom limited exercise treadmill stress test
      with echocardiographic imaging. Primary endpoints were 1) changes in systolic blood pressure
      before and after 10 weeks of treatment and 2) changes in exercise capacity as determined by
      exercise duration and metabolic equivalent (MET) level before and after treatment. Secondary
      endpoints were changes in exercise hemodynamics and Doppler echocardiographic parameters of
      LV systolic and diastolic function and quality of life before and after 10 weeks of nebivolol
      treatment. Subjects completed an EuroQol (EQ-SD) Quality of Life questionnaire which is a
      standardized measure of health status developed by the EuroQol group as a simple general
      measure of health at baseline and at conclusion of the 10 week trial period.
    

Intervention name(s): Nebivolol
Intervention type(s): Drug
Intervention description(s): Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. The dose was titrated by doubling the previous dosage to achieve BP less than or equal to 130/80 mm Hg at 2 weeks and 4 weeks. The mean dose of nebivolol used week 4 through week 10 was 7.8 mg. It should be noted that nebivolol was added to the subject's existing stable antihypertensive regimen which included a mean of 2 other medications.
Intervention MeSH terms: Nebivolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diastolic Function; Nebivolol
Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
Condition: Myopia; Dry Eye
MeSH terms: Dry Eye Syndromes; Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate two different types of contact lenses and their
      effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.
    


Intervention name(s): lotrafilcon A contact lenses; comfilcon A contact lenses; Glasses
Intervention type(s): Device; Device; Other
Intervention description(s): Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.; Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.; Glasses per habitual prescription
Other intervention name(s): Air Optix Night and Day AQUA; Biofinity
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis
Condition: Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study
      to evaluate efficacy and safety of AUR101 (RORgamma inhibitor) in patients with
      moderate-to-severe psoriasis.

      Approximately 90 patients with chronic moderate-to-severe plaque psoriasis will be randomized
      to the 2 dose groups of AUR101 and one group of Placebo. The patients will receive the
      treatment for 12 weeks.
    

Detailed description: 
      This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study
      to evaluate efficacy and safety of two doses of AUR101 in patients with moderate-to-severe
      psoriasis.

      Approximately 90 patients with chronic moderate-to-severe plaque psoriasis (defined as
      Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface Area (BSA) involved ≥10%) will
      be randomized to the 2 dose groups of AUR101 and placebo in the ratio of 1:1:1.

      The patients in each arm will receive AUR101 of 400 mg twice daily or AUR101 600 mg twice
      daily or matching placebo twice daily for 12 weeks in a double blind, double dummy fashion.

      Every patient will receive 12 weeks of treatment. All the patients will be followed up for 14
      ± 2 days of their last dose for safety assessment.

      A subset of approximately 25 patients, who consent, will be asked to come for plasma PK
      assessment in week 4 of dosing.

      Efficacy evaluation will be done by PASI, DLQI and BSA assessment. Safety assessment will be
      done by AEs and regular lab assessment.
    

Intervention name(s): AUR101; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhibitor of RORγ; Drug-Placebo of AUR101 tablet
Other intervention name(s): No other names; No other names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AUR101; Psoriasis
The Effects of Unstable Shoes on Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Some physicians, physiotherapists and nurses use or even suggest unstable shoes in cases of
      low back pain. No studies on the real effects of these shoes on low back pain in health care
      professions have been carried out and therefore as yet there is no real evidence of their
      effectiveness. Thus the investigators assume that wearing unstable shoes over a period of six
      weeks could reduce low back pain and functional disability due to the changes of the gait and
      posture and may increase the quality of life.

      The purposes of this study are:

        1. To evaluate the modifications of pain level, functional capacity and quality of life
           among individuals with moderate level of non-specific chronic low back pain after
           wearing unstable shoes.

        2. To quantify biomechanical modifications of gait and posture.
    


Intervention name(s): Unstable shoes (MBT); Sham intervention (Adidas shoes)
Intervention type(s): Device; Device
Intervention description(s): Wearing unstable (MBT) shoes during 6 weeks; Normal stable shoes (Adidas Bigroar2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back pain; Unstable shoes; Gait; Balance
Virtual Reality After Pediatric Scoliosis Surgery
Condition: Scoliosis Idiopathic; Pain, Postoperative
MeSH terms: Scoliosis; Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery
      in pediatric patients.
    

Detailed description: 
      Purpose: To evaluate postoperative pain scores and postoperative opioid use in pediatric
      idiopathic scoliosis surgical patients using virtual reality (VR) as a method of immersive
      distraction compared with standard electronic use postoperatively.

      Participants: Patients age 11-17 undergoing idiopathic scoliosis surgery on Enhanced Recovery
      After Surgery (ERAS) spine protocol at our institution.

      Procedures (methods): Participants will be randomized to intervention arm (VR) or control arm
      (iPad). Baseline pain and anxiety scores will be assessed. On postoperative day 1, each
      patient will receive a visit by the research assistant who will assess pain scores, PCA use,
      etc. The intervention group will be offered a VR device for up to 30 minutes. The control
      group will be offered an iPad for up to 30 minutes. This visit will be performed twice on
      postoperative day 1. Follow up survey will be conducted at 48-72 hours and 7-10 days
      postoperatively.
    

Intervention name(s): Applied VR; Apple iPad
Intervention type(s): Device; Device
Intervention description(s): The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.; The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Virtual reality; Distraction methods; Idiopathic scoliosis; Postoperative pain; Pediatric surgery
Mantra Meditation in Subjects That Have Chronically Impaired Attention After Stroke
Condition: Stroke Sequelae
MeSH terms: Stroke
Study type: Interventional

Summary: 
      There is an evidence gap on whether meditation may improve behaviorally measured attention
      after stroke, but preliminary research is promising. This study is the first-ever
      investigation of whether mantra meditation may improve chronic, severe impairment in
      attention after stroke.
    

Detailed description: 
      The study is non-concurrent, multiple-baseline, across-subjects, single-case research design
      (SCRD). The central hypothesis is that mantra meditation (independent variable) will be
      associated with improvement on 1 or more tests of behaviorally measured sustained attention
      (dependent variable). The mantra in this study is the syllable "um" and is not assigned any
      spiritual, religious, or affective meaning. The mantra is repeated aloud together by the
      subject and the PI for a duration of 30 minutes in each session. This procedure constitutes
      meditation for the purposes of this study. There are 9 session of meditation (3 times per
      week for 3 weeks). Attention is measured in each of these sessions as well as in 3 separate
      testing sessions that precede the intervention period.
    

Intervention name(s): mantra meditation
Intervention type(s): Behavioral
Intervention description(s): see study description
Intervention model: Sequential Assignment
Intervention model description: single-case research design involving a series of AB designs
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current trial is to establish the bioequivalence of 2 hyoscine
      butylbromide dose forms following oral administration.
    


Intervention name(s): Hyoscine butylbromide; Hyoscine butylbromide
Intervention type(s): Drug; Drug
Intervention description(s): sugar coated tablets for oral administration; drops for oral administration
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW
Condition: Laparoscopic Nephrectomy
Study type: Interventional

Summary: 
      This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and
      tidal volume 10ml/kgBW in laparoscopic nephrectomy patients
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study.
      Non-invasive blood pressure (NIBP) monitor, electrocardiogram (ECG) and pulse-oximeter was
      set on the subjects in the operation room. Anesthesia procedure was epidural regional block.
      After given premedication (midazolam 0.05 mg/kgBW and fentanyl 1-2 ug/kgBW), induced with
      propofol, 1-2 mg/kgbb, endotracheal tube intubation was done facilitated by atracurium 0.5
      mg/kgbb. Mechanical ventilation was set up with volume control mode, (Positive End Expiratory
      Pressure) PEEP 5cmH2O (5 centimeters of water), O2 fraction (FiO2) 30-50%, target
      carbondioxide (CO2) 35-45%. Volume tidal was given according to the group (6 mL/kgBW or 10
      ml/kgBW). Hemodynamic, ventilation parameter, Electrical Impedance Tomography (EIT) parameter
      were recorded. If desaturation happened intraoperatively will be managed by increasing FiO2
      and recruitment maneuver until oxygen saturation (SpO2) >95%. Data was analyzed using
      Statistical Program for Social Sciences (SPSS), for numeric data using unpaired T-test or
      Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Significant
      value is p<0.05.
    

Intervention name(s): Tidal volume 6 ml/kgBW; Tidal volume 10 ml/kgBW
Intervention type(s): Procedure; Procedure
Intervention description(s): Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.; Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Tidal volume; renal transplant; donor; nephrectomy; ventilation; Living renal transplant donor patient