bioihbjkbjnl/mcl2 huggingface dataset:
Contamination Free Bacterial Swap
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      A test of a newly designed device (Contamination free bacterial swab). This device can be
      used to introduce a standard bacterial swab into the nose without direct or indirect contact
      with the nasal vestibule.
    

Detailed description: 
      Aim:

      The investigators want to improved the current method for bacterial culture test in patients
      with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The
      investigators will examine whether significantly fewer Staphylococcus Aureus are detected in
      the middle meatus when applying a new device for bacterial swab introduction. This device is
      designed to prevent bacterial pollution from the nasal vestibule.

      More precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in
      nasal swabs from 10-15 % to 0-5 %.

      The overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients
      with sino-nasal disease.

      Design:

      A comparative study in which patients serve as their own control. A bacterial swab will be
      introduced to both sides of the nose; on the right side using the new device, on the left
      side using the present day technique (visual guidance). 70 participants will be included.

      Statistics:

      A chi-square test will be used for comparison of frequencies.
    

Intervention name(s): Contamination free bacterial swab
Intervention type(s): Device
Intervention description(s): A comparison of the bacteriology in bacterial swabs (Eswab 481CE, Copan Diagnostics, Italy) from the middle meatus. On the RIGHT side using the "Contamination free bacterial swab" introduction device that facilitates the introduction of a bacterial swab into the nose without direct or indirect contact with the nasal vestibule.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: acute rhinosinusitis; staphylococcus aureus; nasal vestibule; contamination
Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Psychosocial factors play an important role in the pathophysiology of acute myocardial
      infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary
      treatment of AMI consisting of medical and interventional therapy.

      The investigators have designed a randomized, controlled study to assess the effects of
      short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an
      emergency percutaneous coronary intervention (PCI) post-AMI.
    


Intervention name(s): Psychotherapy; Medical therapy
Intervention type(s): Behavioral; Drug
Intervention description(s): humanistic-existential psychotherapy conducted in individual and group meetings; Optimal medical therapy after Acute myocardial infarction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril
Condition: Arterial Hypertension; CHD - Coronary Heart Disease
MeSH terms: Hypertension; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      Study objective - to assess the efficacy, tolerability and adherence of
      bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice.

      Type of the program: multicenter, observational, uncontrolled, open program. The program will
      involve 480 general practitioners (GPs) and cardiologists from the primary care
      facilities.Each doctor includes four patients. It is planned to include not less than 1920
      patients in total.
    

Detailed description: 
      Multicenter observational open program. Assessment of the efficacy and tolerability of the
      fixed-dose combination of bisoprolol/perindopril in patients with arterial hypertension and
      stable CAD in daily clinical practice (STYLE)

      Study objectives and purposes:

      Primary endpoints:

        -  efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday
           practice regarding the BP

        -  efficacy of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday
           practice regarding the angina

      Secondary endpoints:

        -  impact on the quality of life of bisoprolol/perindopril FDC in patients with HT and
           stable CAD in everyday practice

        -  adherence to bisoprolol/perindopril FDC therapy in patients with HT and stable CAD in
           everyday practice The program will involve 480 general practitioners (GPs) and
           cardiologists from the primary care facilities. Each doctor includes four patients. It
           is planned to include not less than 1920 patients in total.

      Milestones of the program:

      FSI - November, 2018 LSLV- January, 2019 Database Lock - February, 2019 Statistic Report-
      May, 2019 Clinical Study Report- January, 2020
    

Intervention name(s): bisoprolol/perindopril FDC
Intervention type(s): Drug
Intervention description(s): the first and only single-pill combination of beta-blocker and ACE inhibitor
Intervention MeSH terms: Bisoprolol; Perindopril
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        It is planned to include into the program the patients with HT and concomitant stable CAD.
        It is planned to include not less than 1920 patients in total.

        The patient is included in the program, if the doctor decides to prescribe FDC with
        beta-blocker bisoprolol and ACE inhibitor perindopril in accordance to the instruction for
        use.
Reducing Wrinkles Around the Eyes Using the Ulthera® System
Condition: Periorbital Wrinkles
Study type: Interventional

Summary: 
      The purpose of this prospective, multi-center, single treatment study is to evaluate the
      clinical outcomes associated with the non-invasive treatment to reduce wrinkles around the
      eyes utilizing the Ulthera® System to deliver focused ultrasound energy below the surface of
      the skin.
    

Detailed description: 
      The primary objective of this clinical trial is to demonstrate the effectiveness of the
      Ulthera® System for non-invasive treatment to reduce wrinkles around the eyes.
    

Intervention name(s): Ulthera® System treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin.
Other intervention name(s): Ultherapy
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of once daily vortioxetine
      (Lu AA21004) in adults with major depressive disorder.
    

Detailed description: 
      The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested
      to treat depression in adults who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took vortioxetine.

      The study enrolled 600 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient
      and study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 5 mg

        -  Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but
           had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial was conducted in the United States. The overall time to participate
      in this study was approximately 94 days. Participants made 8 visits to the clinic, and were
      contacted by telephone 1 week, 2 weeks, and 4 weeks after the last dose of study drug for a
      follow-up assessment.
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Encapsulated immediate-release tablets.; Vortioxetine placebo-matching capsules.
Other intervention name(s): Lu AA21004; Brintellix®
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Drug Therapy; Major Depressive Episode
The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE:

      The way in which information about a drug is provided may affect the ability of patients and
      doctors to understand how a drug works and the side effects of the drug.

      PURPOSE:

      This randomized trial is studying how well a drug facts page works compared with a short drug
      summary in helping patients and doctors understand medical information.
    

Detailed description: 
      This is a randomized study. Participants are contacted by phone via random-digit dialing for
      initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible
      participants are then randomized to 1 of 2 intervention arms.

        -  Compare the effect of a prescription drug summary (one-page summary of drug information
           that includes a table with data on drug benefit and side effects) vs standard brief
           summary in direct-to-consumer advertisements on the comparisons of two drugs for the
           same indication, knowledge of drug efficacy and side effects of each drug, perceptions
           of drug efficacy and side effects of each drug

        -  Comprehension of information contained in the drug facts box
    

Intervention name(s): Drug Facts Box; Standard Brief Summary
Intervention type(s): Other; Other
Intervention description(s): Educational intervention of 1 page summary of drug efficacy and side effects; Ads consisted of the standard second page called the brief summary
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: risk communication; probability sample by random digit dialing
Safety and Efficacy Study of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine
Condition: Lip Filler Injections
Study type: Interventional

Summary: 
      A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and
      efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine.
    


Intervention name(s): Emervel Lips Lidocaine; Juvéderma Volbella with Lidocaine
Intervention type(s): Device; Device
Intervention MeSH terms: Lidocaine
Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands
Condition: Cold Hypersensitivity
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The Purpose of this trial is to investigate the efficacy and safety of
      Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity
      in the Hands
    


Intervention name(s): Danggui-Sayuk-Ga-Osuyu-Saenggang-tang; Placebo: corn starch
Intervention type(s): Drug; Drug
Intervention description(s): Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.; Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other intervention name(s): DSGOST; Dangsanin Granule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cold Hypersensitivity in the Hands; Korean medicine; DSGOST
The Volume Effect of Nerve Hydrodissection for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Although many conservative
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a
      short duration. The technique of nerve hydrodissection is now commonly used for peeling the
      nerve from surrounding soft tissue, which may help allow the impulse to pass, and rescue the
      nerve with ischemic damage. However, the exact effect and interval of hydrodissection are
      unknown because of the lack of well-designed studies Hence, investigators design a
      randomized, double- blind, controlled trail to assess the therapeutic effect of
      ultrasound-guided nerve hydrodissection in patients with CTS.
    

Detailed description: 
      After obtaining written informed consent, patients clinically diagnosed with mild-to-moderate
      CTS were inclused and randomized into three groups. Group A, patients received one-session of
      ultrasoung-guided nerve hydrodissection with 10cc normal saline; Group B, patients received
      one-session of ultrasoung-guided nerve hydrodissection with 5cc normal saline; The injection
      syringe was covered to obscure the nature of its contents and patients were asked to turn
      their head away so that they would not see the procedure. As a result, patients were blinded
      to the treatment condition. The primary outcome is Boston Carpal Tunnel Syndrome
      Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS),
      cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the
      median nerve, and global assessment of treatment. The evaluations were performed pretreatment
      as well as on the 2nd week, 1st, 3rd and 6th month after injecton.
    

Intervention name(s): Ultrasound-guided nerve hydrodissection; Ultrasound-guided nerve hydrodissection; Ultrasound; Normal saline
Intervention type(s): Procedure; Procedure; Device; Drug
Intervention description(s): Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.; Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.; The ultrasound was used to measure cross-sectional area and injection guidance; The normal saline was used for injection solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nerve hydrodissection
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent
      graft rejection, can cause renal impairment in some patients. The aims of this study are

        -  To determine the influence of CNI discontinuation on the drug exposure and key
           pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium
           (EC-MPS)

        -  To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen

        -  To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety
           (e.g. rejection rates) and tolerability

        -  To investigate renal function after CsA withdrawal
    


Intervention name(s): enteric-coated mycophenolate sodium; everolimus
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Myfortic; Certican
Intervention MeSH terms: Mycophenolic Acid; Everolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Transplantation; Renal Transplantation; Mycophenolate; Cyclosporine; Everolimus
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
    

Detailed description: 
      This study will be performed to evaluate if the new generic GPO ritonavir product is
      bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.
    

Intervention name(s): GPO ritonavir versus Norvir
Intervention type(s): Drug
Intervention description(s): RTV generic compared to reference drugs (Norvir, Abbott)
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ritonavir generic capsule; Norvir®; Thailand; Determine bioequivalence between Norvir and GPO ritonavir
Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      Over 5 million new cases of skin cancer are diagnosed in the United States each year, more
      than all other cancers combined. Most of these cases are caused by excess exposure to
      ultraviolet radiation from the sun and artificial sources such as indoor tanning. Melanoma,
      approximately 87,000 of the annual skin cancer cases and one of the more deadly skin cancers,
      is on the rise. Previous research on these individuals suggests that while some change how
      much time they spend in the sun and adopt ways to protect themselves when in the sun, many do
      not. In our previous study, we found that 20% of melanoma survivors reported a sunburn in the
      past year and 10% intentionally went outside for a tan, both strong indicators of
      inappropriate sun exposure. Melanoma survivors are at high risk of second melanomas, making
      it critical that they spend less time in the sun or take actions to protect themselves when
      they are in the sun.

      No studies to date have investigated technology-based strategies in melanoma survivors to
      improve sun exposure and protection behaviors. This project will test whether a wearable
      device that tracks sun exposure and provides alerts regarding sun exposure and protection
      behaviors will increase sun protection behaviors in melanoma survivors. The use of wearable
      technology devices (e.g., Fitbit) has grown quickly over the last decade and studies using
      these devices to promote physical activity and weight loss have been promising. We will test
      the technology device versus a similar control device in 368 melanoma survivors and compare
      sun protection behaviors between the two groups.

      This project has the potential to identify a strategy that could significantly lower the
      number of melanoma survivors who go on to have a second melanoma diagnosis. Importantly, this
      easy to use technology could also be utilized by survivors' family members, who are also at
      higher risk for melanoma, and the general population as a means to reduce risk of all forms
      of skin cancer.
    


Intervention name(s): Shade + app with messaging; Shape + app without messaging
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Shade wearable device and application with UV messaging activated; Shade wearable device and application without UV messaging activated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: sun protection; sunburn
Noninvasive Physiologic Sensors to Assess Depression
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      This project aims to use sensors to monitor physiological signals, sleep patterns, vocal
      characteristics, activity, location and phone usage in study patients with depression who are
      receiving standard treatment (compared with healthy controls).
    


Intervention name(s): Physiological Sensors; Sleep Monitoring Device; Vocal Monitoring; Mobile Phone
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Wearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature).; The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.; The participants will be provided with a phone app to leave audio diary recordings.; A mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult outpatients with a current major depressive episode (n=40) and healthy adult controls
        (n=10).
The Effect of Inhalation Agent on the QTc Interval During Liver Transplantation: Sub Study (NCT01886664)
Condition: Anesthesia, General
Study type: Observational

Summary: 
      The purpose of this study is to assess the effects of inhalation agent on corrected QT
      interval duration during liver transplantation.
    


Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sevoflurane; Desflurane
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects who were enrolled prospectively in study (ClinicalTrials.gov Identifier
        NCT01886664)