bioihbjkbjnl/mcl2 huggingface dataset:
Targeted Video Messaging About Emergency Contraception
Condition: Contraception
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      This research study will assess the real-world effectiveness of Facebook advertising as a
      strategy to reach women of reproductive age who are at risk of unintended pregnancy with a
      brief educational intervention about emergency contraception (EC).
    

Detailed description: 
      This research study will assess the real-world effectiveness of Facebook advertising as a
      strategy to reach women of reproductive age who are at risk of unintended pregnancy with a
      brief educational intervention about emergency contraception (EC). The investigators will
      assess whether a video or website link has superior reach, engagement, and return on
      investment (measured as cost per click) through a Facebook ad campaign. The investigators
      will also ensure that both modalities of consumer engagement (website and video) are
      efficacious at ensuring adequate and improved knowledge of emergency contraception through a
      laboratory-environment trial.
    

Intervention name(s): Emergency contraception website; Emergency contraception video
Intervention type(s): Other; Other
Intervention description(s): Existing website with factual information about emergency contraception; Existing video with factual information about emergency contraception
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Photobiomodulation for Plantar Fasciitis
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot,
      results in pain-related disability in Service Members and beneficiaries and contributes to
      decreased physical activity and excessive healthcare costs. Even if effective, current
      treatment protocols may require 6-12 months of therapy to return individuals to pain-free
      activity. Photobiomodulation (PBM), or low level laser therapy, uses non-ionizing light to
      elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence
      supports use of PBM for other degenerative connective tissue conditions, such as Achilles
      tendinopathy and epicondylitis. Unfortunately, previous studies of PBM for treatment of
      plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on
      its clinical effectiveness.

      SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in
      conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the
      clinical effectiveness of photobiomodulation in conjunction with and compared to usual care
      to improve function and decrease pain and in patients. 3. Assess the difference between two
      photobiomodulation dose parameters in conjunction with and compared to usual care for plantar
      fasciitis treatment.

      DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims
      of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be
      randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus
      PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6
      month) follow-up, measures of foot function and pain will be collected for analysis. The
      proposed methods will allow the study team to establish if PBM accelerates recovery compared
      to usual care, as well as determining the optimal dose for future trials comparing PBM to
      other, more invasive, therapies for plantar fasciitis.
    


Intervention name(s): Stretching; Cryotherapy; Photobiomodulation Low Power; Photobiomodulation High Power
Intervention type(s): Other; Other; Device; Device
Intervention description(s): Daily foot and ankle stretching protocol; Daily cryotherapy in conjunction with stretching; Photobiomodulation treatment with 10W power output; Photobiomodulation treatment with 25W power output
Other intervention name(s): Ice; Low Level Laser therapy; low level light therapy; Low level laser therapy; low level light therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: photobiomodulation; plantar fasciitis
The Prevalence Of Sacroiliac Joint Dysfunction In Patients With Lumbar Disc Hernia
Condition: Lumbar Disc Herniation; Sacroiliac Joint Dysfunction
MeSH terms: Intervertebral Disc Displacement; Joint Diseases; Hernia
Study type: Observational

Summary: 
      In this study evaluated the prevalence of sacroiliac joint dysfunction in patients with
      lumbar disc hernia and examined the variations in clinical parameters cause by this
      combination.
    

Detailed description: 
      Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in
      the study. During the evaluation, sacroiliac joint dysfunction was investigated using
      specific tests, pain levels with a Visual Analog Scale, and the presence of neuropathic pain
      using the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. Other clinical
      assessments were performed using the Beck Depression Inventory, Health Assessment
      Questionnaire, and Tampa Kinesiophobia Scale. Positivity in three out of six provocation
      tests was adopted as a criterion for sacroiliac joint dysfunction.

      Sample Size A power analysis using the formula n= t2pq / d2 was performed to determine the
      sample size. Based on those data the investigators concluded that a minimum of 174 and a
      maximum of 322 patients would be required to achieve significant results, and 234 patients
      were enrolled.

      Statistical Analysis The study data were expressed as mean plus standard deviation (SD) for
      constant variables values and as number and percentage for categoric variables. The
      chi-square test was used to analyze categoric variables. Results were evaluated at a 95%
      confidence interval at a significance level of p˂0.05. The analysis was performed on
      Statistical Package for the Social Sciences (SPSS) for Windows 16.0 software.

      The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline
      has been implemented in this manuscript.
    

Intervention name(s): Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation
Intervention type(s): Other
Other intervention name(s): Pain level; Presence of neuropathic pain; Functional capacity; Quality of life; Presence of depression; Presence of kinesiophobia
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in
        the study. 63.2% of patients were female and 36.8% were male. Mean age was 46.72 ± 11.14
        years.
      
Keywords: Disc hernia; Dysfunction; Lumbar; Sacroiliac joint
A Phase 1 Study Evaluating Eliglustat's Effects on Pharmacokinetics, Safety & Tolerability of Digoxin in Healthy Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the effect of repeat oral doses of
      eliglustat 150 mg twice daily (BID) (or 100 mg BID for CYP2D6 poor metabolizers) on the
      pharmacokinetics (PK) of orally administered digoxin 0.25 mg in healthy adult subjects. This
      will be a single-site, open-label study in 2 staggered cohorts of healthy adult subjects. The
      study will comprise a screening period (between Day -45 and Day -2), treatment period 1 (Day
      -1 to Day 4), treatment period 2 (Day 11 to Day 18), and a safety follow-up visit (Day 24 ±
      1). There will be a 10-day washout between dosing of study drug in Period 1 and Period 2. The
      duration of each subject's participation in the study, inclusive of the screening and
      follow-up visits, will be approximately 10 weeks.
    

Detailed description: 
      Cohort 1 will comprise 10 subjects and Cohort 2 will comprise 18 subjects. Initiation of
      treatment in Cohort 1 will occur at least 6 days prior to the start of treatment for Cohort
      2. In each cohort, eligible subjects will be admitted to the clinical facility on Day -1, the
      day prior to the start of dosing in Period 1, and will remain in the clinic until completion
      of study procedures on Day 18, the last day of Period 2 (an approximately 18-night inpatient
      stay). In Period 1, all subjects will receive a single oral dose of digoxin 0.25 mg on Day 1.
      In Period 2, subjects will receive repeat oral doses of eliglustat 150 mg BID (or 100 mg BID
      if a CYP2D6 poor metabolizer) from Day 11 to Day 17 and a single oral dose of digoxin 0AA mg
      on Day 15. For Cohort 2, co-administration of digoxin and eliglustat on Day 15 will occur
      only after review of safety data (including telemetry data) through at least Day 16 for all
      subjects in Cohort 1. The decision to proceed with concomitant dosing of subjects in Cohort 2
      will be at the discretion of the Investigator, with consultation of the Sponsor, as
      appropriate.
    

Intervention name(s): eliglustat; digoxin; digoxin
Intervention type(s): Drug; Drug
Intervention description(s): repeat oral doses of 150 mg BID (or 100 mg BID if a CYP2D6 poor metabolizer) eliglustat (Day 11 to Day 17) plus singe dose of digoxin 0.25mg on Day 15; oral 0.25mg dose of digoxin (single dose) on Day 1
Other intervention name(s): Genz-112638
Intervention MeSH terms: Digoxin; Eliglustat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Genz-112638; digoxin
Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:To investigate if BI 10773 affects the pharmacokinetics of ramipril and if
      ramipril affects the pharmacokinetics of BI 10773.
    


Intervention name(s): BI 10773; Ramipril; BI 10773; Ramipril; Ramipril; Ramipril
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): medium dose, oral administration; Medium dose oral administration on day 2-5; medium dose oral administration; Low dose oral administration on day 1; Low dose oral administration on day 1; Medium dose oral administration on day 2-5
Intervention MeSH terms: Empagliflozin; Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Autologous Bronchial Basal Cell Transplantation for Treatment of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor
      airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even
      death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by
      recent clinical methods so far. This study intends to carry out a single-centered and
      non-randomized phase I/II clinical trial with concurrent controls to investigate whether
      bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial
      basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful
      characterization, expanded cells will be transplanted autologously into the lesion by
      fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by
      measuring the key clinical indicators.
    


Intervention name(s): Bronchial basal cells
Intervention type(s): Biological
Intervention description(s): Transplantation of autologous bronchial basal cells
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study
Condition: Upper Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This is a multi-center, prospective, non-randomized, open-label, exploratory clinical
      investigation performed to evaluate safety and effectiveness of the PillSense System when
      used for detection of blood in the stomach of patients suspected to have an Upper
      Gastrointestinal Bleed (UGIB).
    

Detailed description: 
      The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and
      disposable capsule and PillSense Receiver, an external real-time monitor for results display.
      The PillSense Capsule is a non-invasive, single use device designed to detect blood in the
      stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is
      a handheld device which displays real-time information gathered from the capsule and clearly
      displays results, "Blood Detected" or "No Blood Detected".

      All enrolled participants were admitted for suspected UGIB and were required to ingest a
      PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense
      Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule
      evaluation and results were compared with the PillSense System result, i.e., "Blood Detected"
      or "No Blood Detected".

      The study was also designed to confirm transit of the PillSense Capsule through the GI tract
      and patient tolerability of the PillSense Capsule.
    

Intervention name(s): PillSense System
Intervention type(s): Device
Intervention description(s): The PillSense capsule is a diagnostic capsule equipped with a sensor for in vivo detection of liquid blood and a paired PillSense receiver for result display.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Yoga for Treatment of Hot Flashes
Condition: Menopause-related Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      The Yoga for Treatment of Hot Flashes and Menopausal Symptoms is an uncontrolled pilot
      clinical trial to determine the feasibility of recruitment and of evaluating yoga for the
      relief of menopausal hot flashes in 12 peri- or postmenopausal women. Participants will
      attend an Introductory Yoga Workshop, 8 yoga training sessions in 8 weeks, be assessed
      clinically before, during, and after training and contacted by telephone 3 months later.
    

Detailed description: 
      This is an uncontrolled pilot trial of yoga among 12 healthy peri- or postmenopausal women
      experiencing at least 4 hot flashes per day or 30 hot flashes per week. Participants will
      complete a Screening and Baseline Visit, and then be taught yoga during weekly sessions that
      will be held in the evening at the Laurel Heights Conference Center. The yoga postures and
      breathing techniques will be taught by a qualified and certified yoga instructor using the
      standardized protocol determined by a Yoga Expert Panel. Each group yoga session will take
      approximately 90 minutes. Participants will also be required to practice yoga at home at
      least 3 times per week, and be given yoga materials (mat, blocks, straps), and an instruction
      manual for their use at home. They will be asked to keep a calendar log of the dates/times
      that they practiced yoga at home. Outcomes will be assessed midway through the yoga training
      and at a Final Visit.

      The main efficacy outcomes are change in number of hot flashes per week and change in
      severity of hot flashes from baseline to post-training reported on a 7-day diary. We will
      also measure changes in sleep and quality of life.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menopausal Symptoms; Hot Flashes; Yoga
Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      A high energy and low protein renal formula tailored for the specific needs of pre-dialysis
      CKD patients.
    

Detailed description: 
      Previous studies indicated that low-protein formula nutritional supplements may improve
      compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients

      This study will evaluate the suitability of the disease-specific enteral formula Fresubin®
      renal in predialysis chronic kidney disease patients.
    

Intervention name(s): Low protein diet with Fresubin® renal; Low protein diet with normal food
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Low protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight.; All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic kidney disease; Oral nutrition supplement
Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy
Condition: Prostate Cancer; Magnetic Resonance Imaging; Target Lesion; Fusion Biopsy; Clinically Significant Prostate Cancer; Transperineal
MeSH terms: Prostatic Neoplasms; Erythema Multiforme
Study type: Interventional

Summary: 
      Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many
      biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With
      multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of
      increasing the detection of detecting clinically significant prostate cancer (csPCa) while
      decreasing the detection of non-significant PCa.
    

Detailed description: 
      In men with previously negative prostate biopsy and persistent elevated prostate-specific
      antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate
      for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound
      fusion-guided biopsy improves the detection rates of clinically significant prostate cancers
      (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.

      Patients who fulfill all eligibility criteria and have provided written consent will be
      randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B).
      Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization
      procedure according to a computer-generated randomization list. The primary end point will be
      the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined
      according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for
      targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for
      SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral
      cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa
      and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm
      A mpMRI+ and arm B.
    

Intervention name(s): MRI/ultrasound transperineal prostate biopsy; transrectal ultrasound-guided prostate biopsy
Intervention type(s): Device; Device
Intervention description(s): 3-6 targeted biopsy cores from each prostate region of interest; 12 systematic biopsy cores
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: prostate cancer; magnetic resonance imaging; transperineal biopsy; target lesion; fusion biopsy