bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects
Condition: Healthy Subjects; Cardiac Repolarization
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of EVP-6124 at therapeutic and
      supratherapeutic concentrations on cardiac repolarization in healthy subjects.
    

Detailed description: 
      Subjects will be randomized to six treatment sequences of 10 subjects each. Subjects will be
      admitted to the clinic on Day -1 before dosing. Each of the EVP-6124 and placebo treatment
      periods (blinded) will include a 10-day/9-night confinement to the Clinical Pharmacology Unit
      (CPU) with study drugs being administered on Day 1 and Day 2. The moxifloxacin treatment
      period (open-label) will include a 3-day/2-night confinement to the CPU with moxifloxacin
      administration on Day 1.

      The study will include 2 washout periods in which each washout starts from the time of the
      last dose of the preceding treatment period to the first dose of the next treatment period.
      The washouts following the EVP-6124 or placebo treatments will be 30 days while the washout
      following the moxifloxacin treatment will be 7 days. Follow-up visit (5 to 10 days following
      discharge from the CPU).
    

Intervention name(s): EVP-6124; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral low dose of EVP-6124 in cranberry juice (180 mL) administered on Day 1 and a high dose of EVP-6124 in cranberry juice (180 mL) administered on Day 2.; Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2.; A moxifloxacin 400 mg tablet administered orally on Day 1
Other intervention name(s): Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Thorough QT (TQT); EVP-6124
Assessment of Visual Acuity in Refugee Population
Condition: Visual Acuity; Refractive Errors; Low Vision; Vision Disorders
MeSH terms: Vision, Low; Vision Disorders; Refractive Errors
Study type: Observational [Patient Registry]

Summary: 
      The present research process is a prospective clinical study that will be conducted under the
      auspices of the Democritus University of Thrace (DUTH) in the open accommodation structure
      for refugees and immigrants of Kavala, Kavala, Greece, and the Pre-Removal Detention Center
      (PROKEKA) for Foreigners of Kos, Kos, Greece. The study aims to assess the basic
      ophthalmological condition of the refugee/immigrant population and is developed in two main
      areas:

        1. The recording of the ophthalmological care that the refugee/immigrant has received until
           his/her inclusion in the study through a structured questionnaire (eg previous
           examinations, spectacle utilization, pharmaceutical or other interventions, etc.)

        2. The measurement of monocular best-spectacle corrected visual acuity in both eyes using a
           web-based visual acuity chart.

      Adult participants living in the two aforementioned centers will be recruited in a
      consecutive-if-eligible basis. All age groups will be proportionally represented
      (proportional age distribution).
    

Detailed description: 
      Study protocol will adheres to the tenets of the Helsinki Declaration and written informed
      consent translated in the language of each examinee will be obtained by all participants.
      Subsequently, participants will complete a questionnaire about demographic and general
      clinical information.

      Then, the best spectacle-corrected distance visual acuity of each participant's both eyes
      will be evaluated monocularly via a web-based digital chart in a high-resolution screen. The
      same environmental lighting conditions and the same screen brightness will be applied. The
      examination will be performed at the same predetermined viewing distance.

      Finally, according to each participant's visual acuity, appropriate instructions will be
      given for the improvement of his/her eye care.
    

Intervention name(s): Distance Visual Acuity Examination
Intervention type(s): Diagnostic Test
Intervention description(s): Best spectacle-corrected distance visual acuity of refugees/immigrants will be examined via a web-based digital visual acuity chart
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normal- and low-vision adult refugees or immigrants living in accommodation structures
      
Keywords: distance visual acuity; refugee; immigrant
Rosacea Prevalence in General Population - Pilot Study
Condition: Rosacea
MeSH terms: Rosacea
Study type: Observational

Summary: 
      The purpose of this study is to test and refine, a subject questionnaire aimed to be used in
      a general population rosacea prevalence study.
    

Detailed description: 
      The study will test the subject questionnaire aimed to be used in a full general population
      prevalence study to screen potential subjects with rosacea.

      Questionnaire will be self-administrated to Dermatology outpatients.

      Testing will be performed at the practice of 2 Dermatologists experts in rosacea who will
      evaluate subjects' answers and propose fine-tuning of the questionnaire content, if needed.
    

Intervention name(s): Questionnaire testing
Intervention type(s): Other
Intervention description(s): Questionnaire testing on rosacea and non-rosacea dermatology outpatients
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Rosacea and non-rosacea patients
Lactobacillus Reuteri DSM17938 in C-Section Infants
Condition: C-section
Study type: Interventional

Summary: 
      RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut
      microbiota in children delivered by C-section
    

Detailed description: 
      RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to
      newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary
      Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The
      gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut
      bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938
      compared to the gut bacterial composition in infants born vaginally and the salivary
      concentration of IgA at 48h ±3h after birth and at Day 30.
    

Intervention name(s): Lactobacillus reuteri DSM17038; Placebo for Probiotics
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Oil drops of L. reuteri containing 1x10>8 CFU; Oil drops mimicking in consistency and flavor to experimental product
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT two arms to evaluate the safety and efficacy of L. reuteri vs. placebo to modulate the microbiome gut profile in newborn babies delivered by C-section
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON
      2 Capsule Endoscopy System (CCE) procedures in average risk patients.

      Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam
      CCE.
    

Detailed description: 
      This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects
      undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1
      to receive one of two bowel preparation regimens prior to PillCam CCE.

      Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the
      eligibility criteria will be screened for study participation at a baseline visit and will be
      evaluated on the procedure day or until capsule excretion. A telephone follow-up will be
      conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient
      well-being, and capture any adverse events.
    

Intervention name(s): PillCam® COLON 2 procedure-CONTROL; Senna tablets; PEG; Metoclopramide; Erythromycin; SUPREP oral sulfate solution; Bisacodyl; SUPREP oral sulfate solution with Gastrografin
Intervention type(s): Device; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Metoclopramide; Bisacodyl; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Polyps; Capsule endoscopy; Bowel preparation regimen; Average risk patients for colorectal cancer screening
Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin
Condition: Hematoma Absorption and Neurological Function Recovery
MeSH terms: Intracranial Hemorrhage, Hypertensive; Hemorrhage; Hematoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether panax notoginseng saponins are effective in
      the treatment of Hypertensive Intracerebral Hemorrhage Patients.
    

Detailed description: 
      Patients with HICH were randomly assigned to receive either PNS integrated with conventional
      therapy. Patients were treated with conventional therapy for 3 days, then plus PNS for 14
      days. Patients in the control group received conventional therapy for 17days. Hematoma volume
      measured by CT scanning, National Institutes of Health Stroke Scale (NIHSS) scores, Barthel
      index (BI), all the three were used to evaluate the therapeutic effect for both groups after
      two weeks of intervention.
    

Intervention name(s): Panax Notoginseng Saponins
Intervention type(s): Drug
Intervention description(s): Panax Notoginseng Saponins integrated with conventional therapy
Other intervention name(s): XUESAITONG Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: panax notoginseng saponins; hypertensive intracerebral hemorrhage; hematoma; neurological function
Safety of Spine Radiofrequency Procedures
Condition: Radiofrequency Ablation in Patients With Spinal Hardware
Study type: Interventional

Summary: 
      The goal of the study was to determine if patients undergoing radiofrequency neurotomy (RFN)
      of lumbar facet joints that are adjacent to previously placed pedicle screws from a fusion,
      would lead to an increase in the temperature of the pedicle screws.
    

Detailed description: 
      This study was a prospective clinical trial, examining outcomes related to temperature
      increases in pedicle screws. It was not possible to blind the investigators or the patient.
      Outcomes related temperature differences were collected at each pedicle screw adjacent to a
      zygapophyseal joint being treated.

      A conventional 18-gauge, 1-cm curved active tip radiofrequency cannula was placed under
      fluoroscopic guidance to the area to be treated (the junction of the transverse process and
      the superior articulating process of the facet joint). This position placed the tip of the
      radiofrequency cannula immediately adjacent to, but not in direct contact with, the pedicle
      screws. The radiofrequency cannula was connected to a radiofrequency generator, and the
      conventional settings for clinical medial branch neurotomy was used, heating the tissue to
      80°C for 90 seconds. The procedure described up to this point is the normal procedure and
      protocol for RFN performed at the Mayo Clinic.

      The experimental portion of the procedure is as follows: A separate 22 gauge radiofrequency
      cannula was intentionally placed in direct contact with the dorsal surface of the pedicle
      screws and was connected to a radiofrequency generator solely for the purpose of measuring
      temperature, as the RF cannula are dual purpose probes capable of both conducting energy for
      the radiofrequency lesion and monitoring tissue temperature. In other words, this small gauge
      needle was placed for the sole purpose of acting as a thermistor probe/temperature monitor.
      This process was repeated for each level necessary for treatment.
    

Intervention name(s): Radiofrequency cannula
Intervention type(s): Device
Intervention description(s): Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: radiofrequency ablation
Effectiveness of Two Exercise Programs on the Neck.
Condition: Subjects With Deep Cervical Muscle Strength Deficit
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical results in lower cervical range of
      motion, size deep muscles, endurance, craniovertebral angle and cervical propioception by a
      training protocol with the new device for cervical treatment (CDAT) and the conventional
      training protocol (CT) versus a control group (C) in subjects with cervical deep muscle
      strength deficit.
    

Detailed description: 
      Neck pain is one of the major public health problems, which has a great impact on people's
      lives, with high prevalence and recurrence rate. Cervical vertebral column is heavily
      dependent on the muscles for its physical support and activities. There are increasing
      evidences to support that cervical muscles may impair in patients with neck disorders.
      Training protocols can help to improve pain, cervical function, posture and cross-sectional
      area. However, there are no training protocols in subjects with strength deficit of deep
      cervical muscles, including deep neck extensor and flexor muscles. The cervical device
      treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and
      comfortable way.
    

Intervention name(s): Training protocol with the cervical device for treatment (CDAT).; Conventional training protocol
Intervention type(s): Other; Other
Intervention description(s): Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.; Endurance training program of deep cervical flexors and deep cervical extensors with conventional training protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a randomized controlled trial with 3 different groups
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck muscles; neck pain; exercise therapy; telerehabilitation; muscle weakness
Early Range of Motion Following Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether there is a difference in the quality of
      life, ability to return to functioning (back to everyday life), the amount of experienced
      pain in patients who immediately move their shoulder versus patient who delay moving their
      shoulder after arthroscopic rotator cuff repair. We are also interested in whether there is a
      difference in the healing rates between these two groups.
    


Intervention name(s): Early motion; Standard motion
Intervention type(s): Other; Other
Intervention description(s): Early referral to physical therapy for range of motion (2 days post); Standard referral to physical therapy for range of motion (4 weeks post)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: rotator cuff; rehabilitation; range of motion
A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To provide access to a telaprevir-based treatment to subjects of the Control Group of Study
      VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who
      stopped treatment due to inadequate response to treatment. Safety, tolerability, and
      Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
    


Intervention name(s): Telaprevir; Ribavirin; Pegylated interferon alfa 2a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Solution for Injection
Other intervention name(s): VX-950
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 1
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
Condition: Cystic Fibrosis; Mucociliary Clearance; Airway Hydration
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating doses of
      GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore
      airway hydration and mucociliary clearance in the lung.
    

Detailed description: 
      GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary
      clearance in patients with cystic fibrosis. This study is evaluating the safety and
      tolerability of 4 dose levels of GS-9411 as an inhaled product, compared to a matched
      placebo.
    

Intervention name(s): GS-9411; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled GS-9411 dissolved in sterile saline; Inhaled placebo in sterile saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; CF; Mucociliary Clearance; Epithelial Sodium Channel Inhibitor; ENaC Inhibitor; Airway Hydration; Amiloride
Skin to Skin and Heart Rate Variability
Condition: Heart Rate Variability; Preterm Infant
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The objective of this study is to monitor heart rate variability in preterm infants receiving
      respiratory support, including conventional mechanical ventilation, during skin-to-skin care.
      We hypothesize that skin to skin care will be associated with a more mature pattern of
      parasympathetic activity as measured by various domains of heart rate variability.
      Specifically, the standard deviation of the normal-to-normal interval (SDNN), the root mean
      squared of successive differences of normal-to-normal intervals (RMSDD), and the standard
      deviation of deceleration (SDDec) will decrease in infants that are receiving skin-to-skin
      care across all types of respiratory support compared to infants who are lying in their
      isolette.
    

Detailed description: 
      This will be a prospective crossover study, with each infant serving as their own control.
      Any infant for whom the parent has consented to participate in the study will have heart rate
      variability leads applied and be monitored before, during and after a skin-to-skin session
      with the infant's parent. Due to the nature of the study, blinding is not feasible. Infants
      will remain on the hospital cardiac monitor during the study to maintain standard of care,
      and data obtained in this study will not be used for clinical care. All sessions will occur
      during the infant's NICU admission.

      Infants will be screened for eligibility by reviewing the Newborn Intensive Care Unit (NICU)
      census daily. Consent will be obtained after an infant has delivered. No pregnant women will
      be approached for consent.

      Any infant who has been consented for participation and completes at least 1 skin to skin
      session will be included in the final study sample. As skin to skin is part of standard of
      care, and information, aside from gender, will not be obtained from the parent, consent will
      be obtained for the infant to participate in the study.
    

Intervention name(s): Skin to Skin
Intervention type(s): Other
Intervention description(s): During routine Skin-to-skin sessions, the heart rate variability of the infant will be measured.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants born preterm are eligible for study inclusion if they meet the above criteria.
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the induction effect of multiple oral
      doses of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.
    


Intervention name(s): BI 1015550; Nintedanib; Pirfenidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 1015550; Soft capsules; Film-coated tablets
Other intervention name(s): Ofev®; Esbriet®
Intervention MeSH terms: Pirfenidone; Nintedanib
Intervention model: Crossover Assignment
Intervention model description: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of PRI-724 for Hepatitis C or B Virus Derived Liver Cirrhosis
Condition: Hepatitis C; Hepatitis B; Liver Cirrhoses
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis.
    

Detailed description: 
      【Phase I Phase】 To evaluate safety and pharmacokinetics when PRI-724 is administered to
      patients with HCV or HBV liver cirrhosis , and determine the recommended dose of PRI-724.

      【Phase IIa phase】 To evaluate the efficacy and safety of the recommended dose of PRI-724
      administered to patients with HCV or HBV liver cirrhosis.
    

Intervention name(s): PRI-724
Intervention type(s): Drug
Intervention description(s): twice a week for 4 hours continuous intravenous administration of PRI-724
Other intervention name(s): CBP-b-catenin inhibitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C virus; Hepatitis B virus; liver Cirrhosis