bioihbjkbjnl/mcl2 huggingface dataset:
Computer-Based Auditory Rehabilitation
Condition: Presbycusis
MeSH terms: Presbycusis
Study type: Interventional

Summary: 
      Hearing in noisy environments is a perceptual problem that is ubiquitous in modern
      industrialized societies. This particular listening context offers a particular challenge to
      individuals living with hearing impairment (30 million in US alone) even after treatment with
      hearing aids or cochlear implants. The ability of the brain to extract regularities from the
      environment and suppress distracting information can be improved with intensive cognitive
      training. The investigators will test whether the hearing in noise abilities of adults living
      with hearing impairment can be improved with a cognitive training paradigm.
    

Detailed description: 
      Hearing impairment (HI) represents the most common cause of moderate to severe disability in
      the world, with an estimated prevalence of 636 million individuals (30 million in the US
      alone). Amplification devices (i.e., hearing aids) are commonly used to compensate for HI
      stemming from acoustic trauma, ototoxic insult, normal aging or other sources of cochlear
      degeneration. The chief complaint of individuals with HI is hearing in the types of noisy
      environments that characterize most work, educational, and social situations. Unfortunately,
      hearing aids do not completely address the perceptual impairments in these situations. That
      is because the difficulties that individuals with HI have hearing in noise result from the
      reduced salience of cues that are used to sort out auditory scenes. Making sounds louder
      improves audibility, but does not afford adaptation of the brain to the abnormal coding of
      sensory information by the damaged cochlea. The investigators will test whether the hearing
      in noise abilities of adults living with hearing impairment can be improved with a cognitive
      training paradigm.
    

Intervention name(s): Video game based training 1; Video game based training 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 32 one-hour, home-based training sessions over 8 weeks; 32 one-hour, home-based training sessions over 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Presbycusis; Hearing In Noise; Hearing Impairment; Hearing Loss; Aging; Plasticity; Video Games; Perceptual Learning
Changes in Measured Plasma Volume, Glycocalyx and Atrial Natriuretic Peptide During Anaesthesia
Condition: Blood Pressure; Anesthesia
Study type: Interventional

Summary: 
      The arterial blood pressure is thought to affect the ratio between filtration and
      reabsorption of fluids in the circulating blood volume and thereby the plasma volume. During
      induction of anesthesia blood pressure, hemoglobin level and hematocrits decreases and the
      plasma volume increases. The aim of the study is to evaluate weather a maintained blood
      pressure with norepinephrine during anesthesia induction reduces the increase in 125
      iodine-labeled human serum albumine (125I-HSA) measured plasma volume.
    

Detailed description: 
      24 patients scheduled for coronary artery bypass surgery will be included and randomized to
      receive either norepinephrine in the dose needed to maintain pre-anesthesia blood pressure or
      to a control group and receive norepinephrine only if mean arterial pressure decreases below
      60 mmHg. Equal anesthesia in both groups will be monitored. No fluids will be infused.

      Changes in vascular resistance and cardiac output will be measured with thermodilution and
      changes in plasma volume will be measured with 125I-HSA.

      Endothelial cell function will be evaluated by measuring leakage of 125I-HSA and the plasma
      concentration of endothelial cell markers. Hormonal effects will be evaluated by measuring
      the plasma concentration of atrial natriuretic peptide (ANP). Shedding of glycocalyx will be
      evaluated by measuring heparan sulphate. The level of fibrinogen and platelet function will
      be evaluated by thromboelastography/multiplate.
    

Intervention name(s): Norepinephrine; Maintained blood pressure
Intervention type(s): Drug; Procedure
Intervention description(s): Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion; Norepinephrine therapy to maintain preanesthesia blood pressure
Other intervention name(s): Vasopressor
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Anesthesia; Blood pressure; Plasma Volume; Vasopressor agents; Coronary artery bypass; Glycocalyx; ANP; Coagulation
Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp
Condition: Seborrhoeic Dermatitis of the Scalp
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales)
      disorder patterned on the sebum-rich areas of the scalp, face, and trunk.

      The current treatment does not cure the disease permanently. Therefore it must be repeated
      when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the
      mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease,
      but are associated with a high frequency of relapse when treatment is stopped. They are
      reserved for acute flare-ups only as they may precipitate recurrences and dependence. In
      addition, chronic use of corticosteroids is associated with side-effects.

      The scientific rationale for the use of K40 for treatment of SD was based on clinical
      evidence that K40 improves erythema and desquamation with mild adverse reactions in a few
      cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b
      combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and
      desquamation scores at Week 4.
    


Intervention name(s): K40a; K40b; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.; One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.; One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
Other intervention name(s): K301a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: seborrhoeic dermatitis; scalp; K40a; K40b
Lutein Absorption in Healthy Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the absorption of lutein when consumed in different oil blends.
    


Intervention name(s): Study product containing lutein; Study product containing lutein
Intervention type(s): Other; Other
Intervention description(s): delivered in capsule form; delivered in capsule form
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I clinical trial to determine whether orally administered APL A12 at one or
      more doses is superior to placebo in effecting a 25% reduction in interferon (IFN)
      stimulation index in 1(II)-stimulated culture of peripheral blood mononuclear (PBMC) obtained
      from patients with Rheumatoid Arthritis (RA), which will be the primary outcome variable. In
      an effort to learn more about the mechanism of action of APL A12, the investigators will
      assess Th1/Th2/Th3 cytokine production in supernatants from 48h and 144h cultures of PBMC
      stimulated by 1(II) and by APL A12 above. The investigators will assess function of CD4+
      CD25+ T regs to determine whether APL A12 improves their suppressive function. Flow cytometry
      combined with intracellular cytokine staining will be used in an effort to determine which T
      cell subset(s) is/are experiencing shifts in cytokine expression.
    

Detailed description: 
      The study will have 3 treatment arms each with 10 patients who have demonstrated T cell
      immunity to CII and have an in vitro response to APL A12 at the screening visit. Patients
      will be randomized to one of the 3 treatment arms. Each of the 3 treatments will be given for
      16 weeks.

      In keeping with a sequential dose escalation strategy, the originally proposed randomization
      scheme will be modified so that subjects will be randomized to receive either the lowest dose
      (30 mg) or placebo (Block 1), followed by the next dose (50 mg) or placebo (Block 2). We will
      begin with the lowest dose (30 g/day) and enroll 6 to receive 30 g/day APL A12 and 2 to
      receive placebo for 16 weeks. Results will be reported to the Data Monitoring Committee (DMC)
      for a decision to proceed to the next block based on indications of safety. If this dose does
      not cause adverse events or toxicity or worsens RA, we will proceed to enroll patients to
      receive 30 ug, or 50 g/day APL A12 or placebo for 16 weeks. A total of 32 subjects will be
      randomized to obtain 24 subjects who complete the study. Recruitment was difficult. Only 22
      patients were randomized. There were not enough 50mcg patients enrolled so 2 treatment groups
      was analyzed. Arm 1 included 30 and 50 mcg and Arm 2 represents the patients that received
      placebo.
    

Intervention name(s): APLA12; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intervention: Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.; Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ToleroMune House Dust Mite (HDM) Tolerability Study
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and
      fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with
      poorer lung function, greater medication requirements and more asthma symptoms as well as
      chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA
      leads to the development of asthma, in addition to exacerbating pre-existing asthma in
      HDM-sensitised patients.

      ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide
      Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.

      This study to assess the tolerability of ToleroMune House Dust Mite in subjects with
      controlled asthma and house dust mite-induced rhinoconjunctivitis.
    

Detailed description: 
      A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose
      study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with
      controlled asthma and HDM-induced rhinoconjunctivitis.
    

Intervention name(s): ToleroMune HDM; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection 1 x 4 administrations 4 weeks apart; Intradermal injection 1 x 4 administrations 4 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HDM Allergy; Rhinoconjunctivitis; Immunotherapy; ToleroMune HDM
Methylphenidate Treatment of Cancer-Related Fatigue
Condition: Cancer-related Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this randomized controlled clinical trial is to investigate the efficacy and
      safety of methylphenidate in patients with fatigue caused by cancer.
    


Intervention name(s): Methylphenidate hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): sustained release, dosage according to an individual titration schedule; dosage according to an individual titration schedule
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fatigue, Cancer, Methylphenidate,
Clinical Investigation on the Effects of a Vegetable Juice Treatment
Condition: Vegetables; Cardiovascular Disease; Blood Pressure
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the investigators study is to investigate the impact of a commercial vegetable
      juice on dietary vegetable intake and select cardiovascular risk factors in a generally
      healthy population. The study was a 12 week study with 3 groups who received 0, 8 or 16 fluid
      ounces daily of vegetable juice, along with education on the DASH (Dietary Approaches to Stop
      Hypertension) diet. All participants came in for 3 study visits at 0, 6 and 12 weeks into the
      study.
    


Intervention name(s): Vegetable Juice
Intervention type(s): Other
Intervention description(s): Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.
Other intervention name(s): Commercial vegetable juice provided by Campbell Soup Company
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: vegetable juice; cardiovascular; blood pressure
A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus
Condition: Nasal Decolonization of Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the
      safety, tolerability, exploratory efficacy and exposure of LTX-109 administered topically to
      the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible
      S. aureus [MSSA] and/or methicillin-resistant S. aureus [MRSA]).
    

Detailed description: 
      Approximately 60 subjects will be screened to achieve 24 persistent MSSA and/or MRSA carriers
      and 16 randomised and dosed subjects randomized 3:1, active to placebo.

      Eligible subjects will be admitted to the clinic on Day 1 for randomisation and dosing and
      will remain at the clinic until Day 2. Following nasal and perineum swabs and a chlorhexidine
      (Hibiscrub®) shower, the investigational medicinal product (IMP) will be applied topically to
      both nostrils by a qualified health professional 4 times during a six hour period (every two
      hours at 0, 2, 4 and 6 hours) on Day 1.

      Subjects will come back to the research clinic on Day 3, Day 4, Day 8 and Day 15 (Visits 4 to
      7) for safety, tolerability and efficacy assessments and for blood sampling for bioanalysis.
      On Day 5 and Day 6, subjects will take a chlorhexidine shower at home. A final end-of-study
      visit (Visit 8) will take place on Day 22 (±3 days) or after early withdrawal.

      All subjects will be instructed to wash the body and hair with chlorhexidine body wash and
      shampoo at the clinic on Day 1 (prior to the first dose) and on Day 2. Prior to leaving the
      clinic on Day 2, subjects will be provided with chlorhexidine body wash and shampoo for body
      and hair wash at home on Day 3 (prior to Visit 4), on Day 4 (prior to Visit 5) and on Day 5
      and Day 6.

      Each subject is expected to participate in the study for approximately 50 days including a 28
      day screening period
    

Intervention name(s): LTX-109 gel, 3% w/w; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LTX-109 gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.; Placebo gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, Double-blind, Placebo-controlled Randomization 3:1, active to placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation
Condition: Mechanical Ventilation Complication
Study type: Interventional

Summary: 
      One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral
      microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational
      anesthetics can be used during one-lung ventilation. However, there is still a controversy
      which anesthetic would be more appropriate during one-lung ventilation in the perspective of
      oxygenation and microcirculation. The investigators hypothesized that intravenous and
      inhalational anesthetics may affect oxygenation and microcirculation differently during
      one-lung ventilation.
    

Detailed description: 
      Patients undergoing thoracic surgery including one-lung ventilation will be randomized to
      receive intravenous (propofol) or inhalational (desflurane) anesthetic.

      Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial
      blood analysis. Microcirculatory parameters can be obtained from vascular occlusion test.
      Among those parameters, recovery slope during vascular occlusion test is known to reflect
      recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we
      will compare arterial partial pressure of oxygen and recovery slope during one-lung
      ventilation between propofol and desflurane group.
    

Intervention name(s): propofol; desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.; Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
Other intervention name(s): propofol (Fresofol(R)2 MCT 2%, Fresenius Kabi); desflurane (Suprane(R), Baxter Healthcare)
Intervention MeSH terms: Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: oxygenation; microcirculation; one-lung ventilation; thoracic surgery
Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma
Condition: Lymphoma, Non-Hodgkin; Hodgkin Lymphoma; Toxicity, Cardiac
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Cardiotoxicity
Study type: Observational

Summary: 
      Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors,
      particularly at young age, and its early identification is important to prevent clinically
      relevant cardiac events. Complete echocardiographic assessment including 2-dimension global
      longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical
      systolic changes to the cardiac function even when the ejection fraction is preserved. The
      aim of Cardiocare study is to investigate early detection of subclinical chemo and
      radiation-induced changes in left ventricular function using 2D-GLS.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient 19-70 years old with HD or PMBCL or DLBCL requiring treatment with chemotherapy or
        chemotherapy plus mediastinal radiotherapy suitable for a strain-rate echocardiograpy
        evaluation
      
Keywords: strain-rate echocardiography; chemotherapy; radiotherapy, mediastinal; Lymphoma; Hodgkin
The HypoVoice Study
Condition: Diabetes Mellitus; Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The HypoVoice study aims at identifying potential vocal biomarkers associated with
      hypoglycemia to pave the way towards a voice-based hypoglycemia detection approach.
    

Detailed description: 
      While hypoglycemia has been widely studied in medical research, studies assessing vocal
      changes associated with this state are limited. This study aims at collecting a data set
      labelled with the gold standard (blood glucose) to provide a solid basis for the
      identification of vocal biomarkers using machine learning. Additionally, physiological data
      are collected using wearable sensors to assess whether additional integration of vital signs
      (e.g. heart rate) enhances the performance of hypoglycemia detection.
    

Intervention name(s): Controlled hypoglycemic state
Intervention type(s): Other
Intervention description(s): Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).
Intervention MeSH terms: Hypoglycemic Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypoglycemia; Voice; Speech; Detection; Artificial intelligence (AI)