bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Utility of Rapid CT/NG Testing in the ED
Condition: Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to:

        1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae
           (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the
           Emergency Department (ED) for a Sexually Transmitted Infection (STI).

        2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic
           under and over treatment for TV in women evaluated in the ED for an STI

        3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria
           Gonorrhoeae (NG) and TV testing in the Emergency Department setting.

      To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually
      Transmitted Infection diagnosis.
    


Intervention name(s): Rapid Testing
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to evaluate the efficacy of Viltolarsen compared to
      placebo in Duchenne muscular dystrophy (DMD) patients amenable to exon 53 skipping.
    

Detailed description: 
      This is a Phase 3 randomized, double-blind, placebo-controlled, multi-center study to assess
      the efficacy and safety of Viltolarsen in ambulant boys with Duchenne muscular dystrophy.
      Eligible patients with out-of-frame deletion mutations amenable to exon 53 skipping will be
      randomized to receive once weekly intravenous (IV) infusions of 80 mg/kg Viltolarsen or
      placebo for up to 48 weeks.

      The study will enroll approximately 74 patients amenable to exon 53 skipping. Clinical
      efficacy will be assessed at regularly scheduled study visits, including functional tests
      such as Time to Stand Test (TTSTAND), Time to Run/Walk 10 Meters Test (TTRW), Six-minute Walk
      Test (6MWT), North Star Ambulatory Assessment (NSAA), Time to Climb 4 Steps Test (TTCLIMB)
      and Hand-held dynamometer (elbow extension, elbow flexion, knee extension and knee flexion on
      the dominant side only).

      Safety will be assessed through the collection of adverse events (AEs), laboratory tests,
      electrocardiograms (ECGs), vital signs, and physical examinations throughout the study.

      Blood samples will be taken periodically throughout the study to assess the pharmacokinetics
      of study drug.
    

Intervention name(s): Viltolarsen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; IV infusion
Other intervention name(s): NS-065/NCNP-01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Work-Related Fibromyalgia
Condition: Fibromyalgia, Secondary
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational [Patient Registry]

Summary: 
      The research is about fibromyalgia prevalency in working population and searching
      work-related fibromyalgia.
    

Detailed description: 
      4 different job population will be included in the study. Totally 200 people wil be included
      and evaluated. All participants will be women. The investigators will diagnose fibromyalgia
      with 2016 updated diagnostic criteria and evaluate work related musculoskeletal pain with
      nordic musculoskeletal questionnaire.
    

Intervention name(s): working hours
Intervention type(s): Other
Intervention description(s): weekly working hours
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Working woman
      
Keywords: Fibromyalgia; Musculoskeletal Diseases; Work
Fit Moms- an Internet-based Postpartum Weight Loss Program
Condition: Postpartum Weight
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to provide weight loss interventions for Mothers participating
      in the WIC program, using the internet to deliver weight loss materials.
    

Detailed description: 
      Develop recruitment methods and determine feasibility of recruiting WIC postpartum women who
      meet inclusion criteria. We will collect data on number of individuals screened and reasons
      for exclusions. Establish and examine feasibility and effectiveness of protocol for WIC
      counselors reinforcing adherence to web based program. We will assess frequency with which
      WIC counselors adhere to protocol of reinforcing adherence to web-based program and extent to
      which any "treatment contamination" occurs between WIC counselors and Standard Care
      participants.In those randomized to Enhanced WIC + Internet-based postpartum program, examine
      acceptability, burden, ease of use, frequency of technical problems, and adherence to
      web-based program (number of logins, message board postings)Explore whether the Enhanced WIC
      plus Internet postpartum weight loss program will produce significantly greater weight losses
      than Standard WIC at 2 months. Explore whether Enhanced WIC plus Internet postpartum weight
      loss program will result in greater improvements in eating and exercise behaviors (examined
      at 0, and 2 months) and psychosocial parameters (i.e., depression, social support,
      self-efficacy, body image) than standard care.
    

Intervention name(s): Enhanced WIC Program
Intervention type(s): Behavioral
Intervention description(s): Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: WIC; Weight loss; Overweight; Post Partum; Internet based weight loss intervention for Mothers in the WIC program.
3 Days Versus 5 Days Amoxicillin for Chest-indrawing Childhood Pneumonia in Malawi
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in
      children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and
      then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.
    


Intervention name(s): Amoxicillin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily; Placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of [14C]Acp-196 (Acalabrutinib) in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine the absolute bioavailability of oral acalabrutinib and intravenous
      (IV) PK of [14C]ACP-196.
    

Detailed description: 
      This is 2-cohort study. Screening period will be within 28 days before the dose. In the
      treatment period, participants in Cohort 1 will receive a single 100 mg oral capsule dose of
      acalabrutinib and at 58 minutes postdose of acalabrutinib will receive a single microtracer
      (<10 μg; <=1 μCi) [14C]ACP-196 as a 5 mL IV push over 2 minutes; and participants in Cohort 2
      will receive a single 100 mL oral solution of acalabrutinib (1 mg/mL oral solution containing
      a microtracer dose (<10 μg; <=1 μCi) of [14C]ACP-196). Cohort 1 participants will be confined
      continuously from Check-in until Day 5 and Cohort 2 participants will be confined
      continuously from Check-in until Day 8.
    

Intervention name(s): Acalabrutinib; Microtracer [14C]ACP-196
Intervention type(s): Drug; Drug
Intervention description(s): Participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib on Day 1.; Participants in Cohort 1 will receive a single microtracer (<10 μg; ≤1 μCi) IV solution dose of [14C]ACP-196 as a 5-mL IV push over 2 minutes on Day 1. Participants in Cohort 2 will receive a single 100 mL dose of acalabrutinib 1 mg/mL oral solution containing a microtracer dose (<10 μg; ≤1 μCi) of [14C]ACP-196 on Day 1.
Other intervention name(s): ACP-196
Intervention MeSH terms: Acalabrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACP-196; Acalabrutinib; [14C]Acp-196; Healthy participants; Volunteers; Adults; Pharmacokinetics; PK; Bioavailability; Excretion; Metabolism
Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens
Condition: Refractive Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      To evaluate and compare the performance of a new contact lens to a marketed contact lens.
    


Intervention name(s): etafilcon A with print and PVP for dark eyes (EAPVPDE); etafilcon A control lens (EADE)
Intervention type(s): Device; Device
Intervention description(s): A daily disposable contact lens; A marketed daily disposable contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Low Bone Density in Cystic Fibrosis.
Condition: Osteoporosis; Cystic Fibrosis
MeSH terms: Osteoporosis; Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000
      individuals worldwide, including about 3,800 in Italy -- is often associated with low bone
      mineral mass. The current aggressive therapies have ensured a much longer survival of CF
      patients but this has led to a higher frequency of osteoporosis and bone fractures, a serious
      problem which not only affects quality of life, but also hinders further therapeutic
      measures.

      The aim of this study, conducted on a large group of children, adolescents and young adults
      with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment with
      RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility and
      efficacy of alendronate treatment (for another year) in patients not responding to calcium +
      25-OH vitamin D alone.
    

Detailed description: 
      The study included 2 phases.

      Phase 1 (1-year open-label observational study): following baseline evaluation, bone mass
      changes have been studied with a simple therapy of adequate calcium intake and 25-OH vitamin
      D supplements in all eligible subjects (N=171).

      Phase 2 (1-year double-blind, randomized, placebo-controlled, parallel group study): the 128
      subjects showing an insufficient response to calcium + 25-OH vitamin D alone (bone mass
      increase <5%) at the end of Phase 1, were randomized into 2 groups and assigned to
      alendronate treatment (N=65) or placebo (N=63) (in addition to calcium and 25-OH vitamin D as
      during Phase 1).

      The study has been carried out by the Coordinator's Institution (Istituto Auxologico
      Italiano)in collaboration with most Regional Reference Centers for CF in Italy.
    

Intervention name(s): Alendronate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): As active drug, we used Alendros (Abiogen Pharma, Pisa, Italy), distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).; Placebo was distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).
Other intervention name(s): Alendros
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cystic fibrosis; children; adolescents; low bone mass; osteoporosis; alendronate; fractures
CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
Condition: Early-stage Glottic Larynx Cancer
MeSH terms: Laryngeal Neoplasms; Laryngeal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The feasibility of reducing fractions in early-stage laryngeal cancer has not previously been
      prospectively studied, and we will therefore conduct a careful phase I bio-equivalent dose
      fraction reduction study.
    

Detailed description: 
      Patients enrolled at each dose level will undergo routine evaluations to identify potential
      toxicities as well functional voice analyses. Adequate waiting periods will be used to ensure
      that fraction reduction does not proceed prior to observing toxicity. The purpose of the
      study will be either to determine the maximal fraction reduction possible until a dose is
      reached where a dose-limiting toxicity occurs. The initial dose and fractionation will be 50
      Gy in 15 fractions with the goal to reduce number of fractions to a dose of 42.5 Gy in 5
      fractions. The rationale for using 5 fractions is that it is tolerated in centrally located
      lung tumors at a dose of 50 Gy in 5 fractions, and thus, is likely to be tolerated in large
      calliber airways.
    

Intervention name(s): CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
Intervention type(s): Radiation
Intervention description(s): CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Larynx Cancer
Influence of Cooling on the Effect of Strength Training
Condition: Strength Training Effects
Study type: Interventional

Summary: 
      The aim of this study is to investigate if regular cold water immersion after strength
      training has a negative influence on the desired training-induced performance enhancement.
    

Detailed description: 
      Recovery strategies represent a not sufficiently investigated chance in elite training
      control to optimize the complete training process. Coaches and athletes are confronted with
      numerous potentially effective recovery methods, e.g. cooling, warming, active recovery,
      compression, massage or power naps. However, the effectivity of these methods has rarely been
      investigated under controlled scientific conditions. Based on the state of the art,so far
      hardly any definite practical conclusions regarding effective recovery methods can be drawn,
      especially regarding sport-specific strategies and settings. Currently, cold water immersion
      is a particularly popular recovery strategy. However, there are hints that repeated cooling
      interventions after training can impair the training effect. This could potentially be caused
      by a faster reconstitution of homeostasis due to cooling. For fast recovery of performance,
      this effect would be desirable, but at the same time these homeostatic disturbances are the
      basis of signal processes leading to training adaptations.

      The aim of this study is to investigate if regular cold water immersion after strength
      training has a negative influence on the desired training-induced performance enhancement.
    

Intervention name(s): cold water immersion
Intervention type(s): Other
Intervention description(s): 10 min at 12-15°C
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cold water immersion, strength training, training effect
Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH)
Condition: Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Systolic Murmurs
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary: To identify doses of Micardis®(telmisartan) which, administered once daily, are more
      effective than placebo and not inferior to HCTZ in lowering systolic blood pressure (SBP) in
      patients with isolated systolic hypertension (ISH), and to assess the dose response
      relationship of the antihypertensive effect of telmisartan over the dose range of 20 to 80
      mg.

      Secondary: Target fall in SBP, change from baseline in seated DBP. Safety and tolerability of
      Micardis® and HCTZ in patients with ISH as measured by changes in physical examinations,
      heart rate, laboratory parameters and/or 12-lead ECG, as well as the incidence and severity
      of adverse events.
    


Intervention name(s): Low dose of Micardis®; Medium dose of Micardis®; High dose of Micardis®; Hydrochlorothiazide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Intelligibility Assessment for Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The investigators aim at testing the efficacy of an app to measure sentence intelligibility
      in noise in speakers with Parkinson's disease and in healthy controls.
    

Detailed description: 
      Close to 90% of people with Parkinson's disease develop voice problems during the course of
      the disease. These problems lead to reduced intelligibility, which entails a subsequent
      reduction in social participation and overall quality of life. The current study will focus
      on developing and pilot-testing an app to measure the intelligibility of people with PD and
      of healthy controls. In order to test the app's efficacy, speakers will read a set of 50
      sentences that will be embedded in noise for measurement purposes. A group of listeners will
      also transcribe the spoken sentences to correlate their performance to that of the app. The
      ultimate purpose of this investigation is to improve self-monitoring and self-sufficiency in
      people with PD. The study is expected to last 12 months.
    

Intervention name(s): Understand Me For Life
Intervention type(s): Device
Intervention description(s): The aim of the current investigation is to test the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: intelligibility; voice disorders; dysarthria
Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)
Condition: Anterior Wall Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The primary objective of the study is to collect confirmatory data supporting the safety and
      effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI)
      patients who have undergone successful percutaneous coronary intervention (PCI) with stenting
      within six hours of experiencing AMI symptoms.
    

Detailed description: 
      A Multi-Center, Consecutively Enrolled Single-Arm Study to confirm the safety and
      effectiveness of the delivery of supersaturated oxygen (SSO2) Therapy for 60 minutes
      selectively into the left main coronary artery (LMCA) with a commercially available qualified
      SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the
      treatment of qualified patients presenting with anterior acute myocardial infarction in whom
      reperfusion with PCI is successful within six hours after symptom onset.
    

Intervention name(s): SSO2 Therapy
Intervention type(s): Device
Intervention description(s): Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
Other intervention name(s): TherOx DownStream System; TherOx DownStream Cartridge; SSO2 Delivery Catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SSO2 Therapy; Acute myocardial infarction; Anterior myocardial infarction; SuperSaturated oxygen delivery; Left main coronary artery; Myocardial infarction; Heart attack; Percutaneous coronary intervention; Cardiac catheterization laboratory; PCI; Stent; Stenting; Stents; Angioplasty; LMCA; Delivery of supersaturated oxygen (SSO2) therapy for the treatment of anterior acute myocardial infarction
Leflunomide + Methotrexate in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy and safety of the combination of leflunomide and methotrexate for
      treating active rheumatoid arthritis (RA) in an open noncomparative multicenter trial.
    


Intervention name(s): Leflunomide
Intervention type(s): Drug
Intervention description(s): concomitantly leflunomide (no loading dose, 10 mg/day) and methotrexate (starting at 7.5 mg/week and titrating up to 15 mg/week) for 20 weeks.
Other intervention name(s): ARAVA®
Intervention MeSH terms: Leflunomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase
      II "single-arm study". The use of a single dose tumor bed is expected to be very effective in
      terms of tumor control, but it could increase the incidence of radiation induced erythema.
      Therefore, the investigators assumed that a decreased DNA repair capability, as well as a
      reduced detoxification of the damage caused by oxidative stress could explain the increased
      acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the
      investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage
      repair pathways such as GST, XRCC1, XRCC3 and RAD51.

      The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high
      risk, respectively, (groups were identified based on the absence/presence of the above
      polymorphisms alone or in combination), thus the minimum sample size was 56 patients with
      α=0.05, 2-tailed test and a power of the study of 80%.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        breast cancer (BC) patients following single shot partial breast irradiation(SSPBI) after
        breast conservative surgery
      
Keywords: toxicity after single shot partial breast irradiation (SSPBI)