bioihbjkbjnl/mcl2 huggingface dataset:
Ibuprofen and Renal Function in Premature Infants
Condition: Premature Infants; Patent Ductus Arteriosus
MeSH terms: Premature Birth; Ductus Arteriosus, Patent
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose of the study:

        1. To evaluate renal function maturation within the first month of life in very premature
           infants.

        2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter
           renal function maturation at short term and up to 28 days of life.
    

Detailed description: 
      Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several
      studies showed that Ibuprofen has significantly less side effects than Indomethacin that was
      used for this indication. However, experimental studies and few clinical observations
      suggested that side effects on renal function could occur in very premature infants.

      Purpose of the study:

        1. To evaluate renal function maturation within the first month of life in very premature
           infants.

        2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter
           renal function maturation at short term and up to 28 days of life.

      Population:

      At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to
      demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording
      of mother and child history, and associated therapies prone to alter renal function should
      allow to improve the use of this treatment.
    

Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Premature Infants; Patent ductus arteriosus; Renal function; Ibuprofen
Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to compare the antihypertensive effect and tolerability of
      S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate
      hypertension.
    


Intervention name(s): S-amlodipine gentisate; Amlodipine besylate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hypertension
Heidelberg Edge Perimetry (HEP) Detecting Glaucomatous Visual Field Defects
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The purpose of this study is to compare standard automated perimetry (SAP) using the
      Heidelberg Edge Perimeter (HEP) to the Octopus Visual Field (OVF) analyzer and determine
      test-retest reliability of both parameters in detecting glaucomatous visual field losses.
      This study will also investigate novel imaging parameters of the optic nerve head and new
      automated structure-function reports.
    

Detailed description: 
      Each participant undergo the following tests:

        1. Standard ophthalmic examination (usual care): Best-corrected visual acuity,
           biomicroscopy (look at front of eye), intraocular pressure (IOP) using Goldman
           applanation tonometry, central corneal thickness measurement and fundoscopy (look at
           back of eye).

        2. Octopus Visual Field (OVF) Analyzer using G-top strategy recording mean deviation (MD)
           and pattern standard deviation (PSD).

        3. Heidelberg Edge Perimeter (HEP) standard automated perimetry (SAP) using advanced
           staircase thresholding algorithm (ASTA).

        4. Spectralis optical coherence tomography (OCT) using glaucoma module premium edition
           (GMPE) software to measure minimum rim width (MRW) and retinal nerve fiber layer (RNFL)
           thickness in 6 sectors (superior nasal, superior temporal, inferior nasal, inferior
           temporal, nasal and temporal) in the retina.

      Order of HEP SAP III and OVF, and order of the eye tested (right vs. left) if both eyes of
      patients meet inclusion criteria will be randomized. Patients with glaucoma will be randomly
      chosen and asked to return in 3 to 6 months for repeat HEP and OVF testing.
    

Intervention name(s): Heidelberg Edge Perimeter; Octopus Visual Field; Optical Coherence Tomography
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): HEP measures peripheral vision; OVF measures peripheral vision; OCT measures retinal nerve fiber layer thickness
Other intervention name(s): HEP; OVF; OCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a
      frequent and often severely disabling symptom of different disorders of the auditory system.
      There are currently no causal treatments. Using repetitive transcranial magnetic stimulation
      (rTMS), we have previously demonstrated that the temporoparietal cortex is critically
      involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these
      cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment
      strategy against tinnitus. At this stage, small pilot studies indicate some effect on
      tinnitus impairment but the reduction is predominantly reported to be transient, with high
      interindividual variability, and questionable clinical relevance. Moreover, the optimal
      stimulation area is unclear.

      Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation
      of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of
      daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Procedure
Intervention description(s): Bilateral Theta Burst Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tinnitus; transcranial magnetic stimulation; treatment; cortex
Smartphone Use and Neck Flexion Angle
Condition: Neck Disorder
Study type: Observational

Summary: 
      Excessive smartphone use can disrupt your sleep, which can have a serious impact on your
      overall mental health. It can impact your memory, affect your ability to think clearly, and
      reduce your cognitive and learning skills. Encouraging self-absorption.
    

Detailed description: 
      Persistent failed attempts to use cell phone less often. Preoccupation with smartphone use.
      Turns to cell phone when experiencing unwanted feelings such as anxiety or depression.
      Excessive use characterized by loss of sense of time.

      Nomophobia-an abbreviation of "no-mobile-phone-phobia"-is also called "cell phone addiction."
      Symptoms include: Experiencing anxiety or panic over losing your phone. Obsessively checking
      for missed calls, emails, and texts.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy volunteers using smartphone less or more than 4 hours per day have not any signes
        of musculoskeletal problems
      
Keywords: smartphone; neck flexion
Lipid-lowering Effect of Plant Stanol Yogurt
Condition: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias
Study type: Interventional

Summary: 
      To determine the effect of investigational products on serum LDL cholesterol.
    

Detailed description: 
      Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented.
      LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well
      known.

      Study was monitored by Foodfiles
    

Intervention name(s): Yogurt that contains plant stanol esters; Placebo yogurt
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)
Condition: Healthy; Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of
      60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in
      two successive cohorts of subjects, healthy volunteers and patients with allergic asthma
      without prior exposure to omalizumab, according to a skin test protocol, consisting of a
      prick skin test and/or intradermal test.
    


Intervention name(s): Cohort I; Cohort 2
Intervention type(s): Drug; Drug
Intervention description(s): In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
Dilutions of omalizumab and its excipients were in SWFI.; In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation.
For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration.
Dilutions of omalizumab and its excipients were made in saline.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Xolair; Asthma; Skin Tests
Vulvar Paget Disease
Condition: Vulvar Paget's Disease
Study type: Observational

Summary: 
      In this study only women with vulvar paget disease will be included and will be analysed
      retrospectively. Vulvar paget disease patients are frequently treated with surgical resection
      of the affected tissue. During a surgical treatment surgical margins are frequently positive.
      Recidives are seen frequently after surgical treatment or the development of other
      pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease
      will be analysed and compared between the participants. It's primary goal is to create a
      better view on the outcome and the prognosis to prevent e.g. complications in the future.
    

Detailed description: 
      In this study only women with vulvar paget disease will be included and will be analysed
      retrospectively. Vulvar paget disease patients are frequently treated with surgical resection
      of the affected tissue. During a surgical treatment surgical margins are frequently positive.
      Recidives are seen frequently after surgical treatment or the development of other
      pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease
      will be analysed and compared between the participants. It's primary goal is to create a
      better view on the outcome and the prognosis to prevent e.g. complications in the future.

      All the information of the patients will be gathered retrospectively from their medical file
      , after they gave their consent.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with vulvar paget disease
TIPS With 8- OR 10-mm Covered Stent for Preventing Variceal Rebleeding
Condition: Decompensated Cirrhosis; Portal Hypertension; Bleeding Varices
MeSH terms: Hypertension, Portal; Hemorrhage; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether transjugular intrahepatic portosystemic
      shunt (TIPS) with 10-mm covered stent is associated with lower shunt dysfunction in comparing
      TIPS with 8-mm covered stent in cirrhotic patients with at least one episode of variceal
      bleeding.
    


Intervention name(s): 8-mm covered stent group; 10-mm covered stent group
Intervention type(s): Device; Device
Intervention description(s): Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.; Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transjugular intrahepatic portosystemic shunt; TIPS; liver cirrhosis; variceal bleeding; 8- or 10-mm covered stent
OnabotulinumtoxinA in the Management of Psychogenic Dystonia
Condition: Torticollis, Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to evaluate if patients with psychogenic dystonia
      treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and
      disability at one month and at three months than those having received placebo injections
    

Detailed description: 
      Specific Aim 1: To investigate the effect of BoNT on PsyD severity and disability.

      We will measure the changes in severity, duration, and incapacitation scores of the Rating
      Scale for Psychogenic Movement Disorders (RSPMD)10 in adult patients with clinically definite
      PsyD one month after intramuscular injections with onabotulinumtoxinA in selected muscles of
      the affected limb(s).

      H1: PsyD patients treated with onabotulinumtoxinA injections will demonstrate lower severity
      and disability at one month than those having received placebo injections.

      Specific Aim 2: To investigate the effect of CBT on PsyD severity and disability with and
      without BoNT pretreatment.

      We will examine the extent to which any changes in severity and disability of PsyD, as
      measured by the RSPMD, after 12 weekly CBT sessions, can be influenced by pre-CBT injections
      with onabotulinumtoxinA.
    

Intervention name(s): CBT
Intervention type(s): Behavioral
Intervention description(s): All participating subjects will start a 12-week CBT treatment program. These consist of weekly 1-hour CBT sessions led by a cognitive therapist. Assessments will be repeated at week 16. All PsyD subjects will undergo a 15-minute, structured diagnostic interview (Mini International Neuropsychiatric Interview (MINI)) developed to screen for axis I DSM-IV and ICD-10 psychiatric disorders. We will also use two clinician-rated instruments to assess comorbid psychopathology in PsyD patients, the 17-item Hamilton Depression Rating Scale (HAM-D), to evaluate for depressed mood, vegetative and cognitive symptoms of depression; and the 14-item Hamilton Anxiety Rating Scale (HAM-A) to evaluate psychic and somatic anxiety. These scales will be administered as part of a structured interview.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pragmatic Impact of Proteomic Risk Stratification in Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Single-center, prospective, 2:1 randomized controlled parallel-group study, with an open
      label extension to evaluate SomaSignal Informed Medical Management (informed) versus Standard
      of Care (uninformed).
    

Detailed description: 
      Primary Aim: To determine whether risk stratification from SomaLogic's Cardiovascular Risk in
      Type 2 Diabetes (CVD-T2D) test leads to riskconcordant changes in prescriptions and/or
      medical management in patients with diabetes.

      Secondary Aims:

      Secondary Aim 1: To evaluate the perspectives of healthcare providers on the impact of
      SomaLogic's Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test risk calculator in clinical
      practice.

      Secondary Aim 2: To enable future health economic analyses of the impact of precision
      risk-stratified treatment.

      Secondary Aim 3: In an open-label extension, to determine the impact of additional Metabolic
      Factor test results (beyond the SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D))
      on medical management of the previously uninformed group at the end of the study.
    

Intervention name(s): SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) Test and SomaSignal Metabolic Factors test
Intervention type(s): Other
Intervention description(s): The SomaSignal Cardiovascular Risk in Type 2 Diabetes (CVD-T2D) test is used to predict the four-year likelihood of myocardial infarction, stroke, hospitalization for heart failure or death. It will be provided to the participant's ordering provider.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
SlimShape Device for Abdominal Fat and Circumference Reduction
Condition: Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape
      device for non-invasive abdominal fat and circumference reduction.

      Study subjects will undergo SlimShape treatments on the abdominal area.
    

Detailed description: 
      The objective of this trial is to evaluate the safety and efficacy of the SlimShape device
      utilizing the SlimShape Applicator Belt for abdominal non-invasive fat and circumference
      reduction. Eligible subjects will receive up to 3 bi-weekly treatments (2 weeks interval)
      with the SlimShape device utilizing the SlimShape Applicator Belt according to the study
      protocol.

      The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and
      12 weeks (12wk FU) after the last treatment.

      Each subject will be enrolled for total expected study duration of up to 16 weeks.
    

Intervention name(s): SlimShape
Intervention type(s): Device
Intervention description(s): SlimShape radiofrequency treatment to the abdomen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lipolysis; fat reduction; circumference reduction
Multiple-Dose Study of Effect of Bardoxolone Methyl on QT/QTC Interval Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, multiple-dose, randomized, double-blind, double-dummy,
      placebo-controlled, active-comparator, parallel study in healthy volunteers.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Bardoxolone Methyl 20mg; Bardoxolone Methyl 80mg; Bardoxolone Methyl Placebo; Moxifloxacin 400mg; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral; Oral; Oral
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Subsymptom Threshold Exercise Protocol Following Mild TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The study will monitor outcomes of two interventions to develop a best practice in the
      treatment of mild Traumatic Brain Injury (mTBI).
    

Detailed description: 
      The proposed pilot randomized controlled clinical trial (RCCT) will provide preliminary data
      to examine the effect of a novel intervention to promote brain health after mild Traumatic
      Brain Injury (mTBI). The study will implement a randomized controlled clinical trial of a 6
      week exercise intervention (STEP) for participants with persistent mTBI symptoms, comparing
      STEP to standard of care practice in the controls. We will demonstrate the feasibility and
      acceptability of the STEP intervention. We hypothesize that STEP will lead to meaningful
      improvement on objective measures of self-reported mTBI symptoms, formal neuropsychological
      performance, and postural stability.
    

Intervention name(s): STEP; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical therapists guide participants through novel set of assigned exercises; Participants self-guide through standard exercises
Other intervention name(s): Subsymptom Threshold Exercise Protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: concussion; sports concussion; exercise therapy