bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness
Condition: Unilateral Deafness
MeSH terms: Deafness; Hearing Loss; Hearing Loss, Unilateral
Study type: Observational

Summary: 
      The purpose of this 3-year prospective investigation is to examine the short-term and
      long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single
      sided deafness
    

Detailed description: 
      Limited studies have been done on the BAHA in adults with single sided (sensorineural)
      deafness, and these studies have evaluated only short-term efficacy at one month post
      implantation. The findings of the limited number of studies to date on the BAHA with single
      sided deafness demonstrate that the BAHA improves understanding in noisy or group situations
      and understanding conversation when addressed by a speaker on the side of the bad ear and
      most users have judged the BAHA to have at least satisfactory benefit. But conflicting
      findings have been obtained regarding whether the BAHA improves the ability to locate the
      source of a sound. Additionally, no studies have been done to see whether the magnitudes of
      the improvements seen at one month post implantation increase over time because of learning
      effects or brain plasticity.

      This investigation will show whether the previously reported BAHA benefits at one month post
      BAHA sound processor fitting, related to speech recognition in noise and subjective
      satisfaction, persist at one year, and whether learning effects increase the magnitudes of
      these benefits from one month to one year post BAHA sound processor fitting. This long-term
      investigation also attempts to resolve the conflicting findings pertaining to the BAHA effect
      on localization abilities.

      Subjects with hearing impairment will comprise 20 adults with single sided deafness who
      consent to remediation with the BAHA.In order to see how the adults with unilateral hearing
      loss will differ from the normal-hearing subjects over time, a control group of 20
      normal-hearing individuals also will be evaluated over time, to see how closely the results
      of the unilateral deafness group approximate the results of the normal individuals.
    

Intervention name(s): Bone-anchored hearing aid
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Prospective
Keywords: Unilateral hearing loss; Unilateral deafness; Bone anchored hearing aid
"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"
Condition: Malocclusion, Angle Class II
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      The goal of this controlled clinical trial is to compare the effects of two distalization
      methods supported by inter-radicular mini-screw for maxillary molars distalization in 20
      adult patients with skeletal class I or moderate skeletal class II malocclusion, dental class
      II molar relationship, and full permanent dentition. The participants were randomly selected
      according to inclusion / exclusion criteria from the outpatient clinic of the Department of
      Orthodontics and Dentofacial Orthopedics, Faculty of dentistry, Ain Shams University, Cairo,
      Egypt. Selectees age was ranging from 18 to 25 years old.

      An informed consent has been signed by each patient before his / her enrollment in this
      study, where the aim , methodology, and possible complications were been clearly described in
      details. This research has been thoroughly reviewed by the Research Ethics Committee of the
      Faculty of dentistry, Ain Shams University.
    

Detailed description: 
      This study is a two-arm, parallel group, prospective randomized clinical trial with the
      allocation ratio of 1:1. The Consolidated Standards of Reporting Trials (CONSORT statement)
      were used as a guide for this study.

      After reviewing the study protocol, the ethical committee at the Faculty of Dentistry,
      Ain-Shams University approved the study.

      Before treatment was carried out, a detailed written Arabic consent was signed by all the
      subjects of both groups after full explanation of the aim of the study and the procedures.

      This prospective clinical study was conducted on a total of 24 maxillary first molars.

      No financial competing interests: This study was part of a Masters' degree in Orthodontics,
      Faculty of Dentistry, Ain-Shams University.

      No financial conflicts of interest were declared. The study was self- funded by the principal
      investigator.

      A sample size of 24 distalizing sites was selected and divided into two groups twelve each:

      Group 1: Single coil spring. Group 2: Double coil spring.
    

Intervention name(s): Maxillary molars distalization
Intervention type(s): Device
Intervention description(s): Maxillary molars distalization by using a nickel titanium open coil spring as an posterior displacement device.
Other intervention name(s): Posterior displacement of maxillary molars
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A sample size of 24 maxillary dental distalizing sites were selected and divided into two groups twelve in each:
Group 1: Single coil spring. Group 2: Double coil spring.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental malocclusion
Bioequivalence Study of Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the relative bioavailability of one 15 mg
      Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam)
      Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fasting conditions.
    

Detailed description: 
      Twenty eight (twenty six study subjects + two alternate subjects)healthy male and/or female
      subjects participated in an open label, two-period, two-sequence, two- treatment,single dose,
      two-way crossover study with at least 14 days washout between doses conducted under fasting
      conditions.
    

Intervention name(s): Meloxicam
Intervention type(s): Drug
Intervention description(s): Meloxicam Tablets 15 mg
Other intervention name(s): Mobic Tablets 15 mg
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
Condition: Lung Cancer; Lung Diseases
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in
      predicting fluid responsiveness in patients undergoing one-lung ventilation.
    

Detailed description: 
      Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation.
      Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters
      (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic
      patients. The aim of the present study is to evaluate the mechanically ventilating patients
      under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid
      responsiveness.

      The investigators hypothesized that applying PEEP in one-lung ventilating patients can also
      change dynamic parameters and the magnitude of the change of stroke volume variation, pulse
      pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in
      one-lung ventilating patients and observed the dynamic parameters including stroke volume
      variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid
      challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid
      challenge.
    

Intervention name(s): PEEP challenge
Intervention type(s): Procedure
Intervention description(s): apply PEEP 10 mmHg in one-lung ventilating patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Day-night Rhythm in Muscle Metabolism of Prediabetics
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism
      in prediabetic subjects. Subjects will stay at the research facility for 44 hours with a
      standardized living protocol during which several measurements of skeletal muscle and whole
      body energy metabolism will be performed.
    

Detailed description: 
      Recent evidence from both observational and experimental studies indicates that disobedience
      of a normal day-night rhythm negatively influences metabolic and cardiovascular health,
      possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of
      obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent
      research indicates that also skeletal muscle mitochondrial function is under the influence of
      a day-night rhythm. In this study, the presence of a day-night rhythm in skeletal muscle
      energy metabolism (in particular mitochondrial function) of overweight prediabetic
      participants will be investigated. During this study, subjects will stay at the research unit
      for 44 hours, with standardized meals and sleeping time. Five muscle biopsies (v. lateralis)
      and frequent blood draws will be taken. In addition, indirect calorimetry measurements will
      be performed.
    

Intervention name(s): Standardized living protocol
Intervention type(s): Other
Intervention description(s): Subjects stay at the research facility for 44 hours and adhere to a standard sleeping, eating and activity protocol. During this protocol, multiple measurements will be performed including skeletal muscle biopsies (m. vastus lateralis), blood draws, indirect calorimetry and MRS measurements.
Intervention model: Single Group Assignment
Intervention model description: Standardized living protocol
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Circadian Rhythm
Regulatory T-cells After Subcutaneous Immunotherapy
Condition: Grass Pollen Allergy; Specific Immunotherapy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      The primary endpoint was the induction of T-regulatory cells under s specific subcutaneous
      immunotherapy (SCIT). Patients suffering from grass pollen allergy (relevant clinical
      symptomes during the pollen season, Skin Prick test diamter >4mm or RAST class II or higher)
      were included. The patients were allocated to three study groups:

      Group 1: during and directly after SCIT (after completion the 2nd or 3rd year of treatment)
      Group 2: completed SCIT more then three years ago Group 3: Patients with clinically relevant
      grass pollen allergy without SCIT.

      The investigators analyzed the lung function parameters, exhaled NO (eNO) and asked the
      patients to record symptoms during the adjacent pollen season. A blood sample was drawn to
      analyze the amount of TH1 and TH2 and regulatory T-cells, inflammatory markers(IL-2, IL-5,
      IL-10, IL-12/23, TNF-alpha, IFN-gamma) and blocking antibodies (IgG, IgG4).
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 7-28 years of age with house grass pollen allergy
      
Biospecimen description: 
      serum
    
Keywords: T-regulatory cells; TH1, TH2 cells; specific IgE; specific IgG; specific IgG4; IL2; IL5; IL10; IL12/23; Y-IFN; TNF-a
IRESSA in Combination With Cisplatin & Radiotherapy in Patients With Advanced Head & Neck Carcinoma
Condition: Cancer of Head and Neck
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      · To evaluate the disease free survival rate at 2 years of patients with advanced head and
      neck carcinoma treated with ZD1839 250 mg administered once daily in combination with
      cisplatin and a standard course of radiotherapy.
    


Intervention name(s): Gefitinib, Cisplatin and Radiotherapy
Intervention type(s): Drug
Intervention MeSH terms: Gefitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck Cancer Disease; Head Cancer; Neck Cancer; Cancer of Head; Cancer of Neck; Cancer of the Head; Cancer of the Head and Neck; Cancer of the Neck; Neoplasms, Head and Neck
A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study. Part I is designed to test single doses of GSK678586A in healthy
      volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients
      with mild asthma. Both parts are designed to investigate the safety, tolerability and the way
      the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).
    


Intervention name(s): GSK679586; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug; Saline
Other intervention name(s): Saline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: melbourne,; healthy; antibody,; male,; Safety and pharmacokinetic study,; mild asthmatic patients,; australia; monoclonal; female,; volunteers,
Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 10 subjects will be enrolled. All subjects will receive an increased density
      UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face
      and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be
      obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
    

Detailed description: 
      This is a prospective, single-site, non-randomized clinical trial efficacy of an additional
      Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous
      Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction
      questionnaires will be obtained.
    

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: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Clinical Evaluation of Therapeutic Meibomian Gland Expression
Condition: Visual Acuity; Meibomian Gland
Study type: Observational

Summary: 
      This will be a single centre pilot study to evaluate appearance of the Meibomian glands.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited and enrolled based on Inclusion/Exclusion criteria
HPV DNA Testing Through Mobile Mammography Unit
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Invasive cervical cancer incidence and mortality can be dramatically reduced through early
      detection and treatment, but many women do not complete screening at recommended intervals.
      Many low-income women in Virginia remain uninsured and are at significant risk of being
      medically underserved and failing to complete regular cervical cancer screening.
      Self-collection of specimens for HPV testing is an innovative approach that may increase
      access to cervical cancer screening in populations that do not participate in traditional
      clinic-based screening. Innovative delivery models are needed to reach at-risk populations.
      This study seeks to explore the acceptability and feasibility of pairing self-collection of
      HPV samples for DNA testing with mobile mammography in women living in rural Virginia.
    

Detailed description: 
      The proposed study aims to determine whether offering self-collection for HPV testing through
      the mobile mammography unit is an acceptable and feasible method to increase access to
      cervical cancer screening for under-screened women in rural Virginia. The procedures will be
      recruitment of under-screened women in rural Virginia to complete HPV testing using
      self-collection kits distributed through the mobile mammography unit. Regardless of HPV
      positivity, all women will be provided with information about cervical cancer screening
      (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.
    

Intervention name(s): HPV self collection
Intervention type(s): Device
Intervention description(s): The proposed community based participatory study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in Southwest Virginia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and
      immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy
      subjects.
    


Intervention name(s): SB5; EU sourced Humira®; US sourced Humira®
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Study in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the most safe and effective dose of the
      investigational drug in comparison with a control drug and placebo.
    


Intervention name(s): Formoterol Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Formoterol; Fumarate
SSP-002358 Drug Interaction Study With Omeprazole
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug interaction study evaluating whether blood plasma concentrations of
      SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.
    


Intervention name(s): SSP-002358; SSP-002358 + omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg, oral, once; SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2
      diabetic patients.
    


Intervention name(s): CVX-096
Intervention type(s): Biological
Intervention description(s): Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1 Type 2 diabetes CVX-096 diabetes mellitus; adult-onset diabetes mellitus; non-insulin dependent
A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in
      children during the flu season. Children who would benefit from influenza prophylaxis when
      influenza is circulating in the community will receive treatment with Tamiflu syrup (or
      capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and
      influenza symptoms will be recorded throughout the study. The anticipated time on study
      treatment is <3 months, and the target sample size is <100 individuals.
    


Intervention name(s): oseltamivir [Tamiflu]
Intervention type(s): Drug
Intervention description(s): 30-75mg po daily for 6 weeks
Intervention MeSH terms: Oseltamivir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioavailability of Levoketoconazole and Ketoconazole Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover
      study in healthy male and female subjects to evaluate the relative oral bioavailability of
      levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug
      product).
    

Detailed description: 
      This is a phase 1, randomized, open-label, single-dose, two-period, two-sequence crossover
      study in healthy male and female subjects to evaluate the relative oral bioavailability of
      levoketoconazole tablets (the test drug) and ketoconazole tablets (the reference drug
      product). Subjects will be randomized to receive a single oral dose of 150 mg
      levoketoconazole (Study Drug A) or a single oral dose of 200 mg ketoconazole (Study Drug B)
      in each period.
    

Intervention name(s): Levoketoconazole; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Levoketoconazole tablet; Ketoconazole tablet
Other intervention name(s): COR-003
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other