bioihbjkbjnl/mcl2 huggingface dataset:
iPhone App Compared to Standard Riva-Rocci (RR)-Measurement During Stress Testing
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the
      photoplethysmography signal of the inbuilt camera can measure blood pressure (BP)
      fluctuations with sufficient correlation compared to the goldstandard oscillometric BP
      measurements. Investigators will recruit patients who are scheduled for a routine treadmill
      stress test and assess their blood pressure before and right after the test with the
      smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced
      BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR
      DELTA BP Study is the correlation of the absolute difference of subsequent measurements
      between both techniques. If the relative chances of BP fluctuations are sufficiently assessed
      with this new device, BP fluctuations could be monitored continuously after calibration.
    


Intervention name(s): cuff device; iphone
Intervention type(s): Device; Device
Intervention description(s): Measurement of blood pressure during stress testing with cuff device; Measurement of blood pressure during stress testing with iPhone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Blood pressure; smartphone App; Hypertension; Stress testing; Prevention; Cardiovascular risk factors
Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance
Condition: Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional

Summary: 
      The purpose of this study is to examine and compare the effect of pituitary adenylate
      cyclase-activating polypeptide-38 (PACAP38) and vasoactive intestinal polypeptide (VIP) on
      intracranial arteries and neuronal activity in patients with migraine without aura using a
      high resolution magnetic resonance imaging (MRI), including MR angiography (MRA) and
      functional MRI (fMRI).

      MRA will be used to detect changes in intracranial artery circumferences before and after
      PACAP38 and VIP.

      fMRI will be used oo detect changes in blood-oxygenation-level-dependent-signal
      (BOLD-signal).

      PACAP38 but not VIP induces migraine like attacks in migraine patients. The migraine specific
      drug sumatriptan will be given to relieve pain and the effect will also be registered using
      MRA and fMRI.
    


Intervention name(s): Pituitary Adenylate Cyclase-Activating Polypeptide-38; Vasoactive Intestinal Peptide
Intervention type(s): Drug; Drug
Intervention description(s): 10 pmol/kg/min over 20 mins; 8 pmol/kg/min over 20 mins
Intervention MeSH terms: Vasoactive Intestinal Peptide; Pituitary Adenylate Cyclase-Activating Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: PACAP38; MMA; migraine; angiography; VIP; vasodilatation
Analgesic Efficacy of Ultrasound Guided Quadratus Lumborum Block During ESWL
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Extracorporeal shockwave lithotripsy (ESWL) is widely used for the treatment of urinary tract
      calculi; however, the vast majority of patients do not tolerate the procedure without
      analgesia and sedation.

      Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs,
      opioids, alpha 2 agonists, transversus abdominis plane block with long-acting local
      anesthetics, paravertebral block, local anesthetics infiltration, lidocaine/prilocaine
      cream).

      The quadratus lumborum block was first described by Blanco. QL block is performed as one of
      the perioperative pain management procedures for abdominal surgery. QL block provides
      anesthesia and analgesia on the anterior and lateral wall of the abdomen.
    


Intervention name(s): Bupivacaine; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 10 ml %0.5 bupivacaine; 10 ml %2 lidocaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Extracorporeal Shockwave Lithotripsy; Quadratus Lumborum Block; bupivacaine; lidocaine
Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers
Condition: Flu
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is of this study is to assess the safety and tolerability of three dose levels of
      H3N2 M2SR influenza vaccine versus placebo delivered intranasally to healthy adult subjects.
    

Detailed description: 
      Healthy adult subjects will be screened with the objective to randomize 96 subjects with the
      lowest levels of H3 hemagglutination inhibition (HAI) titers that meet all
      inclusion/exclusion criteria and have signed an informed consent. Subjects will be rank
      ordered from low to high based on their HAI titer. Subjects will then be assigned treatment
      based on a randomization to either active vaccine or placebo. The first two subjects dosed in
      each dose cohort will serve as sentinels and will receive active IP (not randomized).

      Subjects will receive a single dose inoculation of the H3N2 M2SR seasonal monovalent
      influenza vaccine administered intranasally as a liquid formulation, or placebo (saline). The
      sentinel subjects will be vaccinated in dose cohort 1 and a safety monitoring committee (SMC)
      will conduct a review of safety data, tolerability, reactogenicity, and clearance of
      infectious virus prior to dosing the remaining subjects of the cohort with active or placebo.

      After the last subject in the cohort has been followed for at least 7 days the SMC will
      conduct another review of safety data prior to proceeding to the next higher dose level:
      Cohort 2. The same processes of sentinel subject dosing and SMC review will be conducted for
      Cohorts 2 and 3.
    

Intervention name(s): the H3N2 M2SR monovalent influenza vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The H3N2 Bris10 M2SR influenza vaccine candidate (Bris10 M2SR) is formulated to contain different levels of an M2-deleted non-replicating influenza virus expressing the HA and NA genes of influenza strain A/Brisbane/10/2007.; saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
Condition: Nail Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the proposed study is to evaluate the efficacy and safety of Enstilar Foam
      (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.
    

Detailed description: 
      Eligible subjects will be provided twice daily. Enstilar Foam (calcipotriene and
      betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail
      plate, around the nail plate and under the nail plate. The patient will be instructed to
      apply one application at night immediately before bed and not wash their hands before
      morning. All subjects who completed the 6-month treatment will be followed for 1 month after
      discontinuation.
    

Intervention name(s): Enstilar Foam
Intervention type(s): Drug
Intervention description(s): Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.
Other intervention name(s): calcipotriene and betamethasone dipropionate
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enstilar Foam
Adenotonsillectomy and Obstructive Sleep Apnea Study
Condition: Adenotonsillectomy
Study type: Observational

Summary: 
      Adenotonsillectomies are one of the most common childhood surgeries and are first-line
      treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study
      comparing patients with and without OSA looking at the length of stay following
      adenotonsillectomy and the factors affecting length of stay.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing adenotonsillectomy only with no concurrent surgery
High-Intensity Interval Training and Fat Mass Losses
Condition: Overweight and Obesity; Men
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The aims of this study was to compare two isoenergetic HIIT (High-intensity Interval
      training) programs (cycling vs. running) on body composition, substrate oxidation at rest and
      during a moderate exercise, muscle functionality, glycaemic control, lipid profile,
      inflammation, maximal aerobic capacity (VO2max) and gut microbiota composition in men with
      overweight or obesity.

      The investigators hypothesized that both programs could decrease total, abdominal and
      visceral fat mass but due to differences in muscle solicitation, metabolism adaptation and
      blood flow, and that running could favors greater fat mass losses.
    

Detailed description: 
      The first aim of this study was to compare two isoenergetic HIIT programs (cycling vs.
      running) on body composition in men with overweight or obesity.

      20 men with overweight or obesity should completed HIIT program three times a week during
      twelve weeks.

      i) High intensity interval training - BIKE (HIIE BIKE) 10 cycles of speeding up for 45 s at
      80-thPHR followed by pedaling slowly (40% thPHR) for 1m30s (37min30s) ii) High intensity
      interval training - RUN (HIIE RUN) 9 cycles of speeding up for 45 s at 80-thPHR followed by
      pedaling slowly (40% thPHR) for 1m30s (35min15s)

      Body composition will be measured before and after HIIT program by Dual-energy X-ray
      absorptiometry (DXA).
    

Intervention name(s): Physical activity
Intervention type(s): Other
Intervention description(s): Comparison of HIIT mode (running vs cycling)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups : running vs cycling
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cycling; running; high-intensity interval training; fat mass; visceral tissue; health
To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or
      Nintedanib in healthy volunteers
    


Intervention name(s): HEC585; Pirfenidone; Nintedanib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mulltiple doses of HEC585 for up to 10 days; Mulltiple doses of Pirfenidone for up to 3 days; Mulltiple doses of Nintedanib for up to 7 days
Intervention MeSH terms: Pirfenidone; Nintedanib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction
      (SWISS-AMI).

      Study population: Patients with acute myocardial infarction, treated with primary PCI.

      Objective: To determine whether intracoronary infusion of BMCs improves recovery of left
      ventricular function after acute myocardial infarction treated by PCI

      Design: Multi-center, randomized, controlled clinical trial with central core lab analysis
      for MRI.

      Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4
      weeks after successful primary PCI

      Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months
      relative to baseline measured by quantitative MRI.

      Secondary Endpoints:

        -  Change in LVEF at MRI at 12 months

        -  Change in regional left ventricular wall motion and thickness at 4 and 12 months.

        -  Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique
           by MRI

        -  Analysis of the myocardial infarct size and transmurality, time to PCI and coronary flow
           characteristics after PCI as predictor of LV remodeling and change after cell therapy

        -  Change in myocardial perfusion at 4 and 12 months

        -  Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)

        -  Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI,
           stroke, hospitalization for cardiac reasons) at 12 months

      Interventions:

        -  Aspiration of 50 ml bone marrow (<24 hours) prior to administration

        -  Intracoronary balloon-based infusion of 10 ml BMCs

        -  Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months

      Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized
      infarct related vessel at day 5-7 or day 21-28.

      Control group: Management according to the "state of the art" medical therapy after
      successful primary PCI.

      Safety: A study independent "safety committee" will analyze the clinical results after the
      first 60 patients.
    


Intervention name(s): intracoronary bone marrow cells infusion
Intervention type(s): Procedure
Intervention description(s): intracoronary bone marrow cell infusion via a OTW balloon; "Stop-flow-technique" as previously described
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute myocardial infarction; MRI; bone marrow cells; stem cells; remodeling
Analysis of Sleep Study Data to Assess Depressive Burden
Condition: Sleep Disorder; Depressive; Behavioral Disorder; Mood Disorders
MeSH terms: Sleep Wake Disorders; Mood Disorders
Study type: Observational

Summary: 
      This study evaluates the effectiveness of the MEB-001 device in assessing physiological
      parameters that provide a clinically significant depressive burden screener. This study uses
      objective physiological markers from MEB-001 to estimate the clinically significant
      depressive burden as subjectively reported by the subject with the Beck Depression Inventory
      - II (BDI-II).
    

Detailed description: 
      This study evaluates the effectiveness of the MEB-001 device in assessing physiological
      parameters that provide a clinically significant depressive burden screener. This study uses
      objective physiological markers from MEB-001 to estimate the clinically significant
      depressive burden as subjectively reported by the subject with the BDI-II.

      This is a two (2)-phase, non-significant risk, cross-sectional, naturalistic, single-arm,
      multi-center study conducted under a common protocol and designed to:

      Phase 1: MEB-001 algorithm development (software medical device). Phase 2: Evaluate the
      effectiveness of the MEB-001 device in assessing physiological parameters that provide
      clinically significant depressive burden screener.
    

Intervention name(s): MEB-001
Intervention type(s): Device
Intervention description(s): Software medical device used to aid in the screening of patients with potential depressive burden symptoms.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are at least 18 years old but not older than 75 years old, who have been
        referred to a sleep clinic for sleep disturbances and sign an informed consent form (ICF)
        will be eligible to participate in this study.
Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole
      (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed
      Release Tablets ), in subjects who continue to require acid-suppressive therapy following a
      course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).
    


Intervention name(s): Esomeprazole; pantoprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Effect of Synching Prescription Refills on Adherence
Condition: Hypertension; Hypercholesterolemia; Diabetes; Medication Adherence
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      To determine the effect of synchronizing a patient's prescription refill schedule on
      medication adherence. The targeted population is Humana members who are currently taking 2 or
      more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current
      customers of RightSource. Participants will be randomized to one of two groups. Group one
      will be usual care and group two will be the Rx synchronization group.
    


Intervention name(s): Refill synch
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy
      male subjects.
    


Intervention name(s): NN9924 (oral); placebo; NN9924 (oral); placebo; NN9924 (s.c.); NN9924 (i.v.)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation.; Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.; Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.; Subjects will be randomized to receive a single dose of placebo.; As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit; As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Dose-ranging, 12-week Randomized, Double-blind, Placebo controlled, Parallel-group
      Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol
      Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal
      Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy.

      Vulvovaginal atrophy is a natural consequence of the progressive estrogen deficiency that
      occurs in menopause. Epidemiological data have indicated that about 50% of otherwise healthy
      women over 60 years of age experience symptoms related to urogenital atrophy such as vaginal
      dryness, dyspareunia, burning, itching, as well as urinary complaints or infections of the
      lower urinary tract. As these alterations frequently affect the quality of life of
      postmenopausal women, it is important for doctors to detect their presence and offer
      treatment options. Estrogen therapy is the most effective treatment of moderate to severe
      symptoms of vulvar and vaginal atrophy. One advantage of local treatment with estrogen is
      avoidance of first-pass liver metabolism, making it possible to use lower doses of estrogen
      compared with oral therapy; the local route also minimize systemic adverse effects. The
      search for therapeutic alternatives which may present improvements in relation to the current
      products has been encouraged.
    


Intervention name(s): Estriol; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment