bioihbjkbjnl/mcl2 huggingface dataset:
Magnetic Field Modulation Pillow for Insomnia Clinical Trial
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This interventional study was designed to explore the clinical effect of magnetic field
      modulation system on insomnia patients and provide a new solution for insomnia treatment.
    

Detailed description: 
      Patients with insomnia receiving this sleep pillow with magnetic system or not would be
      observed in months.The effect of sleep pillow with magnetic system for insomnia would
      evaluated.
    

Intervention name(s): magnetic field modulation device; placebo device
Intervention type(s): Device; Device
Intervention description(s): use the device with magnetic field modulation to treat insomnia; use the sleep pillow without magnetic field modulation treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Treatment; magnetic field modulation
Effectiveness of Circular Muscle Exercise (Paula Method) Versus Kegel Exercise for Urinary Stress Incontinence
Condition: Urinary Stress Incontinence (SI)
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized controlled trial comparing two methods of exercise for the treatment of
      stress incontinence ( loss of urine after physical exertion) in women. We are comparing the
      Paula method of circular muscle exercise, in which circular muscles controlling sphincters of
      the body (such as the eyes, mouth and rectum) are exercised, with pelvic floor training
      (Kegel exercises) in women in the community. The study hypothesis is that the effectiveness
      of circular muscle exercises is equivalent to pelvic floor training among women with this
      disorder.
    

Detailed description: 
      Background: Urinary stress incontinence(SI) is defined as involuntary urinary loss which
      appears during increased intra-abdominal pressure which can be measured objectively. It is an
      important social and hygienic problem. Its prevalence varies fron 12-55% depending on age,
      and geography. The economic costs of this condition were estimated to reach 24 billion
      dollars in the US in 1995. The objectives of this study are to evaluate two non-invasive
      methods of treatment of stress incontinence.

      Methods: 200 women who chosen from the community and suffering from SI will enter the study
      and will be randomized to one of two arms. The first arm is the Paula method of circular
      muscle exercises: these women will receive private lessons from a registered Paula
      instructor. The system is based on activating circular muscles in the body. The second arm
      will receive instruction in pelvic floor muscle training by a physiotherapist.

      The clinical trial will compare the efficacy of the methods for the treatment of SI. The
      candidates for inclusion in the trial will undergo a gynecological exam and a "Pad Test". The
      efficacy will be measured in terms of changes in the Pad test (quantity of urinary leakage)
      and subjective reports of the participants on leakage, quality of life and sexual function.
    

Intervention name(s): circular muscle exercises versus pelvic floor exercises
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Urinary stress incontinence; Randomized trial; circular muscle training; pelvic floor training; bioequivalence
Whole-body Vibration With or Without Localized Radiofrequency and Body Composition in Obese Female
Condition: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of whole-body vibration in the presence or
      absence of localized radiofrequency on body composition in obese female subjects. Moreover,
      strength tests will be performed. The study hypothesis is that whole-body vibration induces
      positive changes in body composition i.e., reduction of fat mass and increase of lean mass
      with associated increase in performance. The possible additive role of radiofrequency will
      also be assessed.
    

Detailed description: 
      -  recruitment of female obese subjects

        -  baseline assessment (body composition with dual energy x-ray absorptiometry (DXA) and
           strength tests)

        -  2-mo whole body vibration training (2 sessions a week, 30 min per session) with or
           without local delivery of radiofrequency (two randomly selected groups)

        -  final assessment (body composition with DXA and strength tests)

        -  data collation and analysis
    

Intervention name(s): vibrating platform (Bioplate RF)
Intervention type(s): Device
Intervention description(s): whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
Other intervention name(s): Bioplate RF vibrating platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: whole-body vibration; radiofrequency; muscular strength; exercise; body composition
Facilitating Needle Alignment With Aiming Method
Condition: Central Venous Catheters
Study type: Interventional

Summary: 
      Although ultrasound-guided catheterization of the subclavian vein is becoming standard
      procedure in anesthetic practice, failure to align the needle and the transducer still can
      lead to possibly complications. In this study, we proposed a new alignment method, namely
      Aiming Method. The purpose of this study is to investigate whether the use of this aiming
      method improved resident volunteers' performance of ultrasound-guided SC insertion in real
      patients. Specifically, residents were asked to perform three different methods: landmark
      techniques, ultrasound-guided with aiming method and ultrasound-guided plus needle guide
      techniques.
    


Intervention name(s): subclavian vein catheterization; landmark techniques; Ultrasound-guided plus needle guide techniques
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Here we introduced a new freehand method, named as Aiming Method, which facilitated the alignment of injection needles with ultrasound beams. During this aiming method, patient is still positioned in Tredelenburg with the arm abducted to 90° and no needle guidance will be used.; The patient is positioned in Tredelenburg with the arm abducted to 90°. Venipuncture should occur 1 cm lateral to the curvature of the middle third of the clavicle with the needle pointing horizontally directed at the sternal notch. If subclavian vein is missing at the first try, withdraw the needle and direct horizontally at the cricoid cartilage at the second try.; Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. The patient is positioned in Tredelenburg with the arm abducted to 90°. During the needle insertion, the needle is secured in the needle guidance device which keeps the alignment of needle and ultrasonic beam.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Infections and Pregnancy Loss: Correlation Between Abortion and Silent Infections.
Condition: Pregnancy Loss
MeSH terms: Abortion, Spontaneous; Fetal Death
Study type: Observational

Summary: 
      Correlation between the presence of intracellular viruses/bacteria and the incidence of
      miscarriage during the first trimester of pregnancy.
    

Detailed description: 
      In this study we will analyse chorionic villi derived from abortion during the first
      trimester of pregnancy (spontaneous abortion vs voluntary pregnancy interruption), in order
      to correlate the presence of infective viruses/bacteria and the incidence of miscarriage.

      The first objective of this project will be to find the viral DNA of HPV, BK and JC
      polyomaviruses and bacterial DNA of Chlamydia trachomatis, Ureaplasma parvum, Ureaplasma
      urealyticum, Mycoplasma hominis in the aborted tissues collected from spontaneous abortions,
      and to compare the prevalence of these DNAs to those derived from elective specimens.

      Acronyms:

      DNA: deoxyribonucleic acid HPV: human papillomavirus PCR: polymerase chain reaction HPyV:
      human polyomavirus PBMC: peripheral blood mononucleated cell BKV: BK polyomavirus JCV: JC
      polyomavirus
    

Intervention name(s): Spontaneous miscarriage; Voluntary pregnancy interruption
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Viral DNA and RNA analysis of HPyV and HPV, BKV and JCV. Bacterial DNA and RNA analysis of Chlamydia trachomatis, Ureaplasma parvum, U. urealyticum, Mycoplasma hominis.; Viral DNA and RNA analysis of HPyV and HPV, BKV and JCV. Bacterial DNA and RNA analysis of Chlamydia trachomatis, Ureaplasma parvum, U. urealyticum, Mycoplasma hominis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who underwent revision of uterine cavity for spontaneous abortion or voluntary
        termination of pregnancy
      
Biospecimen description: 
      All samples, both spontaneous (spontaneous miscarriage) and elective (voluntary interruption
      of pregnancy), will be obtained after uterine cavity curettage.

      All women underwent PBMC extraction from peripheral whole blood.
DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)
Condition: Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis B; Hepatitis C, Chronic; Coinfection; Hepatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a prospective study to determine the incidence, morbidity, mortality and predisposing
      factors for the reactivation of hepatitis B virus replication during direct anti-HCV
      treatment of HCV/HBV co-infection patients.
    

Detailed description: 
      Patients who receive direct-acting anti-HCV treatment will be prospectively studied during
      2-year period. All patients have HCV/HBV co-infection.

      The inclusion/exclusion criteria and the follow up plan will be listed in following part.
    

Intervention name(s): Ledipasvir/Sofosbuvir; Sofosbuvir and Daclatasvir; Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir; Entecavir; Tenofovir disoproxil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.; TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.; VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.; Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.; VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
Other intervention name(s): Harvoni®; GS-7977; GS-5885; Sovaldi®, GS-7977; Daklinza®,BMS-790052; VIEKIRA PAK™; BARACLUDE®; VIREAD®
Intervention MeSH terms: Ritonavir; Tenofovir; Sofosbuvir; Entecavir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Imaging the HIV Reservoir
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      Radiolabelling broadly neutralizing anti-HIV antibody 3BNC117 with a Copper-64 radio isotope
      for infusion into people with HIV followed by MRI/PET scanning to detect HIV in vivo.
    

Detailed description: 
      This study aims to develop a method to accurately image the size and location of HIV
      persistence in HIV-infected individuals. The project aims to combine the broadly neutralizing
      anti-HIV antibody 3BNC117 with a Copper-64 radio isotope for use in a clinical trial.

      The clinical trial has three different stages. The first stage is to recruit two HIV
      uninfected individuals and determine the safety of 3 mg/kg of 3BNC117 combined with Copper-64
      and MRI/PET scanning at 1, 24 and 48 hours post infusion. The second stage is to examine the
      distribution on MRI/PET of the 3BNC117-Copper-64 combination in four HIV-infected individuals
      with viremia who are not receiving antiretroviral therapy. The final stage is to perform the
      same intervention in aviremic people with HIV receiving antiretroviral therapy.
    

Intervention name(s): 3BNC117-Copper-64
Intervention type(s): Drug
Intervention description(s): 3 mg/kg 3BNC117 combined with radio-isotope Copper-64
Intervention MeSH terms: Copper
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Conscious Sedation for Cataract Operations Under Topical Anaesthesia
Condition: Conscious Sedation
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 2

Summary: 
      Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of
      local anaesthetic injection in the peribulbar or retrobulbar block so that patient
      comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required
      to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the
      present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine
      versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative,
      postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as
      secondary outcomes
    

Detailed description: 
      In both groups, the patients will receive i.v. nalbuphine 50 μg/kg. Patients in group D, will
      receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance
      infusion of 0.5 μg/kg/h. Patients in group P, will receive a bolus i.v. dose of propofol 0.5
      mg/kg followed by an infusion started at 0.025 mg/kg/min .If sedation score was <3, rescue
      sedation with boluses of midazolam 0.01 mg/kg will be given. If the patient complained of
      pain (Numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be
      given as an intra-operative rescue analgesic and the surgeon will be instructed to use
      additional topical local anaesthetic eye drops if appropriate. After the completion of
      surgery, all infusions will be stopped, and the patients will be shifted to the
      postanaesthetic care unit (PACU) to be monitored for 2 hours before discharge.
    

Intervention name(s): Nalbuphine; Propofol; Dexmedetomidine; Benoxinate Hydrochloride 0.4% Eye Drops
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): i.v. nalbuphine bolus of 50 μg/kg.; A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min; i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h.; Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
Other intervention name(s): Nalbuphine bolus; propofol infusion; Dexmedetomidine infusion; Topical anaesthesia of the eye
Intervention MeSH terms: Dexmedetomidine; Nalbuphine; Propofol; Benoxinate; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The Study Hypothesis:

      Aggressive, upfront, dual therapy for treatment-naïve NYHA I/II/III PAH is superior to a
      traditional "step-up" approach.

      The study will evaluate:

        1. Impact of dual, upfront, therapy on cardiovascular parameters in PAH as gauged by
           cardiac magnetic resonance imaging (cMRI) at 24 weeks and event free survival at outcome
           at 48 weeks.

        2. Value of novel biomarkers (NT-pro BNP, Mts1/S100A4, and insulin resistance) and
           cutting-edge imaging technologies (cardiac MRI) as newer endpoints for clinical trials
           in PAH.

        3. Utility of longer clinical trial design with the use of combined clinical events as time
           to clinical worsening surrogate
    

Detailed description: 
      This is a 48 week interventional study evaluating the effect of Dual therapy ( Treprostinil
      inhalations and Tadalafil) versus Mono therapy (Tadalafil). The impact of the therapy on
      cardiovascular parameters in PAH measured at 24 weeks and event free survival outcome at 48
      weeks.
    

Intervention name(s): treprostinil inhalations; tadalafil
Intervention type(s): Drug; Drug
Intervention description(s): Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.; tadalafil 20mg QD PO increasing to 40mg QD as tolerated
Other intervention name(s): Tyvaso; Adcirca
Intervention MeSH terms: Treprostinil; Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Diode Laser Therapy As An Adjunct To Scaling And Root Planing
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Laser therapy has been proposed as a novel treatment option in controlling subgingival
      microorganisms. This randomized controlled clinical trial evaluates the effect of 980nm diode
      laser as an adjunct to scaling and root planing (SRP) in the management of chronic
      periodontitis (CP).
    

Detailed description: 
      Conventional mechanical debridement can achieve a temporary decrease in the subgingival
      levels of Pg along with other pathogens. However, mechanical therapy alone may fail to
      eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root
      concavities, furcation areas etc. In search of more efficient and less traumatic techniques
      to improve periodontal healing, researchers proposed the use of lasers in periodontal
      therapy.

      The adjunctive use of lasers with conventional tools may facilitate treatment and have the
      potential to improve healing. The diode laser is highly absorbed in hemoglobin and other
      pigments and is excellent for use in soft tissue surgical procedures.Laser application in
      improving clinical outcome in periodontal therapy, needs to be further investigated with well
      designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser
      as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with
      quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR)
      assay.
    

Intervention name(s): Ultrasonic Scaling and root planing; 980 nm diode laser irradiation
Intervention type(s): Procedure; Procedure
Intervention description(s): Procedure of scaling and root planing at day 0 and at 1 week; Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Biomarkers of Mild and Moderate Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to assess if putative brain injury biomarkers have utility as
      blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be
      accomplished by examining the relationships between potential serum-based TBI biomarkers and
      clinical measures of injury severity, occurrence of complications, and outcome, in subjects
      with mild or moderate TBI. The assay will be evaluated in a sample population of subjects
      over the age of 18 who have been referred to the health care provider for closed head injury
      evaluation.
    


Intervention name(s): Head CT scan and blood draw
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who present to the health care facility with Traumatic Brain Injury (GCS 9-15)
        within 4 hours of injury.
      
Biospecimen description: 
      Whole blood, serum, plasma
Influence of Non-steroidal Anti-inflammatory Drugs (NSAID) on Muscle Regeneration
Condition: Muscle Damage
Study type: Interventional

Summary: 
      The purpose of this study is to determine the influence of non-steroidal anti-inflammatory
      drugs (NSAIDs) on muscle regeneration.

      The investigators' hypothesis is that ingestion of NSAID will delay or impair muscle
      regeneration.
    

Detailed description: 
      The model employed to induce muscle damage is electrical stimulation. Muscle biopsies will be
      examined to follow the response of satellite cells and muscle regeneration. Study
      participants will be randomly assigned to a placebo or NSAID group in a double-blinded
      manner.
    

Intervention name(s): NSAID; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Effect of NSAID ingestion on muscle regeneration; receive placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Muscle regeneration; Satellite cells; electrical stimulation; eccentric contractions; myogenic precursor cells