bioihbjkbjnl/mcl2 huggingface dataset:
Hearing Aid Transmitter Performance Study - SRF-366
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Sonova Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Sonova Hearing
      Systems undergo a final quality control in terms of clinical trials. This is a confirmatory
      study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical
      investigation which will be conducted mono centric at National Acoustic Laboratories a well
      known institution with exceptional experience (Australia).
    

Detailed description: 
      In this study a comparison with two Phonak Receiver in Canal (RIC) devices is done. The
      experimental device with a modified hearing aid loudspeaker concept and the active comparator
      with the existing technology will be compared regarding speech intelligibility, listening
      effort and sound quality in speech in noise, quiet situations for people with mild to
      moderate hearing losses.
    

Intervention name(s): New hearing aid loudspeaker; Standard hearing aid loudspeaker
Intervention type(s): Device; Device
Intervention description(s): The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.; The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acoustical Coupling
Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium
Condition: Hypopituitarism
MeSH terms: Hypopituitarism
Study type: Interventional
Phase: Phase 4

Summary: 
      The effects of acute administration of non-steroidal anti-inflammatory drugs (NSAIDs) on the
      neuroendocrine regulation of hydro-electrolytic metabolism are not precisely known to date.

      Although the mechanism by which NSAIDs favor the antidiuretic action of vasopressin (AVP) in
      the kidney has been partially elucidated, their influence on the mechanisms responsible for
      regulating its secretion are less known. The interactions between NSAIDs and natriuretic
      peptides are also not entirely certain.

      The present pharmacological research study therefore aims to investigate, in a cohort of
      healthy subjects, the acute effects of intravenous infusion of diclofenac sodium on the
      neuroendocrine regulation systems of water and salt balance (i.e. the antidiuretic axis and
      the system of natriuretic peptides).
    


Intervention name(s): Intravenous Infusion of Diclofenac Sodium; Intravenous Infusion of Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Infusion of Diclofenac Sodium is administered at the dose of 75 mg, diluted in 100 ml of isotonic saline, over 15 minutes.; Intravenous Infusion of Placebo (represented by 100 ml of isotonic saline) is administered over 15 minutes.
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      The goals of this study are to describe the safety, reactogenicity and immunogenicity of
      MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected.

      This study was originally performed by MedImmune. However, GSK is now responsible for the
      clinical development of the HPV vaccine.
    

Detailed description: 
      This is a Phase II, double-blind, randomized, comparative trial of three formulations of
      MEDI-517 given at 0, 30, and 180 days by intramuscular injection. The volunteers in this
      study will be healthy females 18 through 30 years of age. The study collects safety,
      reactogenicity and immunogenicity data of MEDI-517 with and without adjuvant. Extended
      follow-up will provide long-term immune response data.
    

Intervention name(s): MEDI-517 HPV-16/18 VLP AS04 vaccine; MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3; MEDI-517 HPV-16/18 VLP vaccine without adjuvant
Intervention type(s): Biological; Biological; Biological
Intervention description(s): IM injection; IM injection; IM injection
Other intervention name(s): MEDI-517 HPV-16/18 VLP AS04 vaccine; MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HPV, Vaccine
Non Invasive Multicenter Italian Study for Coronary Artery Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine if 16-64 slice multidetector CT (MDCT) can replace the invasive procedure in
      patients scheduled for coronary angiography in order to exclude the presence of CAD
    

Detailed description: 
      Because coronary artery disease (CAD) is the most frequent cause of death in industrialized
      nations and its onset is currently unpredictable, there is a need for new methods of
      screening apparently healthy individuals to identify those at increased risk.

      Several imaging techniques are in use to visualize coronary arteries. These include both
      invasive procedure as x-ray coronary angiography and those non invasive like computed
      tomography (CT) and magnetic resonance imaging (MRI). Among these imaging modalities,
      selective cardiac catheterization and x-ray angiography is the current gold standard for
      visualization of coronaries and detection of their stenoses, providing for optimal spatial
      resolution, a general "road map" of the coronary tree for interventions. The replacement of
      even a fraction of these procedures with non-invasive modalities would constitute an
      important advance in the care of patients with suspected coronary artery disease Preliminary
      results reported in literature addressing the study of coronary arteries by multidetector-CT
      (MDCT) appear to be interesting. Several studies have been performed firstly using Electron
      beam CT (EBCT).EBCT provides high temporal resolution and enables quantitative assessment of
      the coronary artery calcium, but because of limited spatial resolution as a result of limited
      z axis resolution, it does not permit direct visualisation in multi-reformation of the whole
      coronary artery system.

      With the introduction of 4-row MDCT there have now been several studies aimed to compare the
      MDCT with a standard invasive angiography. Data published for over 200 subjects from 4
      studies demonstrated that patient compliance at breath-hold, heart rate and rhythm are
      crucial limitation to this procedure. In the Nieman and Achembach papers not all the coronary
      segments were assessable because of the limited temporal resolution of 4-slice MDCT. With
      this machine it is mandatory to select patients carefully, considering only those with
      baseline hearth rate < 65 bpm (also obtained by pre-treatment with β-blockers in order to
      slow hearth rate).
    

Intervention name(s): MDCT and Coronary Angiography
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Comparison study between MDCT and coronary angiography
Repeat Injection of Cingal® for Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety of an injection of Cingal® in subjects
      with Osteoarthritis (OA) of the knee who participated in Cingal 13-01, and who received
      either a Cingal, Monovisc, or saline injection in the 13-01 study. The safety evaluation will
      be done by a through examination of the incidence of adverse events and physical examination
      of the knee.
    

Detailed description: 
      The Cingal 13-02 study is a follow-on study to the recently completed clinical trial Cingal
      13-01 [NCT01891396]. Cingal 13-01 was a multi-center, randomized, double-blind, Phase III
      study that enrolled 368 subjects at up to 20 sites in Canada and Europe. The Cingal 13-01
      study objective was to assess the safety and effectiveness of a single injection of Cingal®
      for relief of joint pain and symptoms in patients with osteoarthritis (OA) of the knee. The
      study had three arms: the Cingal® investigational arm, an active comparator arm (Monovisc®)
      and a control arm (saline). Cingal 13-02 is designed to evaluate the safety of an open-label
      injection of Cingal® in subjects who received a study injection in the Cingal 13-01 trial.
      Sites that enrolled 5 or more subjects in the Cingal 13-01 study were eligible to participate
      in the Cingal 13-02 study. All subjects at these sites who met enrollment criteria had the
      option to participate in the follow-on study.
    

Intervention name(s): Cingal; Cingal; Cingal
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Injection into the knee; Injection into the knee; Injection into the knee
Other intervention name(s): Hyaluronic Acid with Triamcinolone Hexacetonide; Hyaluronic Acid with Triamcinolone Hexacetonide; Hyaluronic Acid with Triamcinolone Hexacetonide
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hyaluronic Acid; Triamcinolone diacetate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects enrolled into the Cingal 3-02 follow-on study received an intra-articular injection of Cingal. The three 'arms' of the study were for subjects who received a Cingal, Monovisc, or saline initial injection in the Cingal 13-01 study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Intra-articular Injection; Hyaluronic Acid; Triamcinolone Hexacetonide
A Phase III Trial of e-TNS for the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The main objective of this study is to have Phase III evidences of the efficacy of the
      Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This
      randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine
      using the Cefaly® Abortive Program device.
    

Detailed description: 
      The main objective of this study is to have Phase III evidences of the efficacy of the
      Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as
      triptans are generally used. That is to say having randomized, double-blind, sham-controlled
      data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive
      treatment of acute migraine as measured by 2-hour pain freedom, pain relief and
      migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after
      the beginning of the treatment session.
    

Intervention name(s): Verum Cefaly® Abortive Program device; Sham Cefaly® Abortive Program device
Intervention type(s): Device; Device
Intervention description(s): The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.; The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Magnetic Resonance Imaging at Different Levels of Magnetic Intensity
Condition: Cardiovascular Disease; Healthy
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the
      human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields
      to create images of the body and organs. Occasionally, researchers will give patients
      undergoing a MRI an injection of a substance called gadolinium. Gadolinium works by
      brightening areas of the magnetic resonance image, thereby improving the contrast.

      In this study researchers will use magnetic resonance imaging and contrast substances, like
      gadolinium, on normal volunteers in order to evaluate different aspects of its performance.
      Information gathered from this study may be used to develop more specific research studies
      involving MRI.
    

Detailed description: 
      Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on
      normal volunteers. These studies will be conducted in the MRI systems located at the NIH.
      These studies may involve the intravenous administration of commercially available MR
      contrast media and exercise. The results will be used to evaluate the performance of various
      pulse sequences, gradient coils, and RF coils on human subjects and will provide essential
      ground work for specific patient protocols.
    

Keywords: Imaging; Spectroscopy; MRI; Cardiovascular; Technical Development; Heart; Safety; Toxicity; Gadolinium; Adverse Events; Normal Volunteer
Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins
      during atrial fibrillation ablation, however, the methodology has not been validated either
      in terms of the reproducibility of the adenosine response or the effect on clinical outcomes,
      namely whether using pulmonary vein reconnection to guide additional ablation lowers rate
      recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response
      to adenosine used in this manner is reproducible over time.
    

Detailed description: 
      Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be
      randomized to treatment and control groups. Treatment group subjects will received 12 mg IV
      adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is
      documented. If electrical reconnection is not observed at 5 minutes, a second dose of
      adenosine will be administered, monitoring again for electrical reconnection. Control
      patients will be observed for 10 minutes post initial electrical isolation of the pulmonary
      vein for spontaneous electrical reconnection. If reconnection is observed, veins will be
      re-isolated per standard clinical practice. This procedure will be repeated for each of a
      patient's pulmonary veins. Patients will be followed up at clinical visits to examine for
      adverse effects of procedure and/or adenosine administration as well as atrial fibrillation
      recurrence.
    

Intervention name(s): Adenosine arm
Intervention type(s): Drug
Intervention description(s): In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: atrial fibrillation; ablation; pulmonary veins; adenosine
Thoracic Fluid Content and Acute Lung Injury
Condition: Acute Lung Injury
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Observational

Summary: 
      To study the association of the thoracic fluid content and acute lung injury during liver
      transplantation.
    

Detailed description: 
      Acute lung injury is not uncommon after liver transplantation. A new monitor non-invasive
      cardiac output monitor (NICOM) is designed to measure thoracic fluid content. The
      investigators attempt to use the parameter thoracic fluid content to investigate its
      relationship with acute lung injury in liver transplant recipients.
    

Intervention name(s): NICOM
Intervention type(s): Device
Intervention description(s): NICOM monitoring thoracic fluid content at baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        end stage liver disease patients scheduled for liver transplantation in National Taiwan
        University Hospital were enrolled.
Cocaine Use Disorder and Cortical Dopamine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this study is to use [C-11]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure
      cortical dopamine transmission in cocaine dependent individuals and healthy controls
    

Detailed description: 
      This study seeks to examine dopamine (DA) transmission in vivo, using positron emission
      tomography (PET) with [C-11]FLB 457, in cortical regions of interest in subjects who have a
      history of cocaine dependence. We hypothesize that cocaine dependence is associated with
      decreases in dopamine in the prefrontal cortical regions compared to controls. This may
      explain the impulsivity and cognitive deficits that underlie relapse in this disorder.
    

Intervention name(s): d-amphetamine; [C-11]FLB 457
Intervention type(s): Drug; Radiation
Intervention description(s): oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain; PET radiotracer
Intervention MeSH terms: Amphetamine; Dextroamphetamine; FLB 457
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: [C-11]FLB 457 d-amphetamine
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison Among the Effects of Blood Flow Restriction Training and Conventional Exercise in Knee Osteoarthritis.
Condition: Osteoarthritis, Knee; Hypertrophy
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hypertrophy
Study type: Interventional

Summary: 
      The main objective of the study is to compare the effects of Blood flow Restriction training
      vs. traditional exercises on knee pain , knee functional disability and on quadriceps
      strength in patient with knee osteoarthritis.
    

Detailed description: 
      Osteoarthritis is a degenerative disease affecting the most commonly weight bearing joint.The
      common form of arthritis is osteoarthritis (OA) causing structural changes in the joint. Age
      is a common factor affecting the strength and muscle mass.Worldwide there is a drastic
      increase of osteoarthritis in the older population. In the past 20 years the prevalence of
      knee pain increased and reached up to 50% in the older population. The most common OA
      affecting lower extremity is in the knee Joint.Majority of the people affected by knee OA are
      the older population. Knee Joints being the most weight bearing joint affected in OA causing
      pain , limiting function and mobility.Mobility and function may be affected in osteoarthritic
      population usually experience pain and stiffness.

      The main objective of this study is to compare the Effects of blood Flow restriction training
      vs conventional treatment exercises on knee pain, functional disability and quadriceps
      strengthening.

      The main purpose of this study is to improve the muscular strength of lower limbs which are
      being affected in a disease osteoarthritis in the adult population.
    

Intervention name(s): Blood flow Restriction/Resistance Training; Conventional Therapy Group
Intervention type(s): Other; Other
Intervention description(s): During each exercise, only blood flow in the involved leg was restricted using an aneroid sphygmomanometer. Prior to exercise the cuff was placed on the most proximal portion of the limb and limb occlusion pressure (LOP) was calculated in the body position that the Blood flow Restriction (BFR) stimulus would be applied. Blood Flow Restriction BFR pressure was set at 50% occlusion. Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. Participants will perform exercises 2 sets with 15 repetitions through 0 to 90 degrees.; Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally.participants will perform 2 sets with 15 repetitions in (0 to 90 degree.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Blood Flow Restriction; Quadriceps; Resistance Training