bioihbjkbjnl/mcl2 huggingface dataset:
Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The purpose of this study is to determine the relative performance of a new daily disposable
      toric soft contact lens against a daily disposable toric contact lens currently available in
      market, specifically with regards to the comfort and vision with the lens.
    


Intervention name(s): Etafilcon A toric contact lens; Nelfilcon A toric contact lens
Intervention type(s): Device; Device
Intervention description(s): contact lens to correct astigmatism; contact lens to correct astigmatism
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Aerobic or Resistance Exercise on the Endothelial Response in Post-acute Myocardial Infarction Patients Submitted to Angioplasty
Condition: Cardiac Rehabilitation; Aerobic Exercise; Resistance Exercise
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Cardiac Rehabilitation, as art and acting science multiprofessional, is based on the training
      with exercises that provides the post-infarct patients to satisfactorily re-establish the
      patient's clinical condition and that improve the functional capacity of these individuals.

      Evidence shows that aerobic exercise training provides improvements in the endothelial
      function of this population. However, we do not yet have strong evidence of other modalities
      of exercise in these parameters in post-infarction patients treated with angioplasty.
    


Intervention name(s): Resistance exercise session
Intervention type(s): Other
Intervention description(s): Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.
Other intervention name(s): Aerobic exercise session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Erythrocytes and Skeletal-muscle Fatty Acids Are Positively Correlated After Caloric Restriction and Exercise
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The aim is compare and correlate skeletal muscle and erythrocytes fatty acids (FAs) profiles
      in adult healthy human after caloric restriction and acute exercise in order to validate
      erythrocyte FAs profile as marker of changes in muscle fatty acid composition.
    

Detailed description: 
      The study was performed with 11 healthy sportsmen participating in a caloric restriction
      trial for 1 month. The participants follow a caloric restriction, 30-40% respect to the usual
      diet of each participant, three alternate days weekly along 4 weeks. After the caloric
      restriction period the participants realized an exercise stress test. For each participant
      one blood sample and muscular biopsy were obtained after acute exercise and caloric
      restriction intervention. All the participants were informed of the purpose and demands of
      the study before giving their written consent to participate. The study protocol was in
      accordance with the Declaration of Helsinki for research on human participants and was
      approved by the local Ethics Committee of the Consell Català de l'Esport.
    

Intervention name(s): Caloric restriction
Intervention type(s): Other
Intervention description(s): three alternate days weekly along 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Earol Madrid Study
Condition: Cerumen Impaction of Both Ears
Study type: Interventional

Summary: 
      Accumulation of ear wax in the external ear canal is a common pathology. The presence of ear
      wax not only interferes with the clinician's view of the tympanic membrane, but may also
      result in hearing loss and vertigo, and may predispose to ear infections.

      Removal of ear wax is facilitated using a variety of cerumenolytics, or ear wax solvents. The
      current study is designed to evaluate the safety and the cerumenolytic effects of the Earol
      product, when dosed into the auditory canal prior to the dewaxing and ear cleaning procedure.
      This study is designed to be conducted in the primary care setting as a prospective clinical
      trial.

      A detailed literature review has been conducted to provide a background summary of relevant
      information on the disease/pathology, other available treatment options and the pre-clinical
      testing and clinical research that has been conducted to date on the intended population or
      related populations and/or the device.

      The aim for conducting this clinical investigation is to perform a PMCF to evaluate the
      safety and performance of Earol. Although there are alternative methods for ear wax removal,
      Earol represents a simple method based on natural ingredients (olive oil) which aids the
      removal of ear wax as well as prevents appearance of clinical symptoms in the ear canal (E.g.
      reducing itching and irritation).
    


Intervention name(s): Earol
Intervention type(s): Device
Intervention description(s): Treated with Earol on both ears and subsequent removal after 6 days of application
Other intervention name(s): Ear Wax removal
Intervention MeSH terms: Carbamide Peroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ear Wax Removal; Ear Wax; Earol; Olive oil; Cerumen; Impaction
Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
Condition: Snoring
MeSH terms: Snoring
Study type: Interventional

Summary: 
      Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in
      the treatment of habitual snoring. The decision making process in the management of habitual
      snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to
      investigate the correlation of systematic clinical pretreatment oropharyngeal examination
      scores with the efficacy of interstitial RF surgery of SP in a multi-center study
    

Detailed description: 
      TABLE 1. The inclusion and exclusion criterion used for the multicenter study.

      Criteria Inclusion Exclusion _____________

      Age (years) 18-65 < 18, > 65

      Habitual snoring yes no Excessive daytime sleepiness no yes

      BMI (kg/m2) < 28 > 28

      AHI (events/hour) < 15 > 15

      Overjet (mm) < 5 > 5 Clinical suspicion of obstruction no yes at base of tongue

      Size of palatine tonsils (grade) 0-II III-IV

      Nose breathing problems no yes

      Pharyngeal tonsil hypertrophy no yes

      A bed partner to assess snoring yes no

      _____________

      Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.
    

Intervention name(s): Interstitial soft palate surgery
Intervention type(s): Procedure
Intervention description(s): Soft palate RF surgery in local anaesthesia
Other intervention name(s): RFA; RFTA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Condition: Refractory Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to evaluate the efficacy of zanubrutinib in
      participants with centrally confirmed relapsed or refractory MCL.
    


Intervention name(s): Zanubrutinib
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm.
Other intervention name(s): BGB-3111
Intervention MeSH terms: Zanubrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate
      the efficacy and long-term safety of SAL067 in T2DM patients uncontrolled by metformin,
      comprising 24 weeks of double-blind treatment period followed by an open-label treatment
      period, making up a total of 52 weeks.
    

Detailed description: 
      All eligible subjects would enter the 24 weeks of double-blind treatment period and were
      randomized into the SAL067 group (12 mg once daily) or placebo group at a 2:1:1 ratio. After
      24 weeks of double-blind treatment, subjects would enter the extended open-label treatment
      period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily)
      treatment, while patients in the SAL067 groups continued the same treatment until the end of
      the whole 52 weeks.
    

Intervention name(s): SAL067; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAL067 6mg(2 tablet) and Metformin ≥1500mg; Placebo (2 tablet) and Metformin ≥1500mg
Other intervention name(s): SAL067 Group; Placebo Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Additional Axial Load on Cervical Motor Control
Condition: Healthy
Study type: Observational

Summary: 
      he objective of this study is to examine the influence of additional axial load abd body
      position on cervical motor control in young healthy adults.
    

Detailed description: 
      Motor control of the cervical spine is impotent for responsible for maintaining balance
      during daily living activities and to withstand external loads. Stabilization-aspects of the
      cervical spine is very complex, passive (ligaments, joint capsule and the skin and active
      (muscles), and neurological subsystems are involved. Mostly proprioceptive testing and
      exercises like head and neck position sense testing and re-training have been an integral
      part of rehabilitation. Another method to evaluate spinal motor control is the assessment of
      spinal stiffness. The main objective of this study is to explore the effects of additional
      axial loading on motion control in healthy individuals. Does the motor control of the
      cervical spine in healthy subjects change with additional axial load or body position? A
      better understanding of spinal stiffness and neck position sense leads to novel insights into
      spinal cervical stabilization mechanisms.
    

Intervention name(s): axial load
Intervention type(s): Other
Intervention description(s): With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young healthy adults
      
Keywords: cervical spine
Bortezomib and Doxil for the Treatment of Patients With Acute Myelogenous Leukemia
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether bortezomib in combination with
      doxil/lipodox is effective in the treatment of Acute Myeloid Leukemia.
    

Detailed description: 
      Acute myeloid leukemia (AML) remains largely incurable despite advances that have been made
      in recent years into increasing the complete response (CR) rates. In elderly patients (over
      the age of 60), CR rates are lower, 40 to 50%, and long term disease-free and overall
      survival is less than 10%. The therapeutic options for relapsed/refractory AML are
      significantly limited. Bortezomib has shown promising activity in patients with advanced
      hematologic malignancies, including those with leukemia and non-Hodgkin's lymphoma.

      Given the available data suggesting efficacy of bortezomib in combination with doxil in
      patients with relapsed multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and Non
      Hodgkin's lymphoma (NHL) as well as the known sensitivity of AML to anthracyclines and in
      vitro data demonstrating the sensitivity of multiply resistant AML cells to bortezomib, we
      are proposing the use of this combination in patients with relapsed/refractory AML or elderly
      patients who are not candidates for standard induction therapy.

      Using the subcutaneous formulation of bortezomib would provide patients with reduced
      neurotoxicity and easier schedule due to decreased time in the infusion room and it would
      decrease overall cost of care.
    

Intervention name(s): Bortezomib; Doxil
Intervention type(s): Drug; Drug
Intervention description(s): Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.; Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
Other intervention name(s): Velcade; LipoDox; pegylated liposomal doxorubicin
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bortezomib; Doxil
Relative Bioavailability (rBA) of Evobrutinib Intended Commercial and Clinical Tablets, and Effect of Food on Intended Commercial Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the relative bioavailability (rBA) of the intended commercial tablet
      formulation (Test Treatment, TF2) of Evobrutinib compared to the clinical tablet formulation
      (Reference Treatment, TF1) of Evobrutinib and to assess the effect of food on the
      bioavailability of the intended commercial tablet formulation of Evobrutinib.
    


Intervention name(s): Evobrutinib
Intervention type(s): Drug
Intervention description(s): Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A and Treatment B), or under fed conditions that is within 30 minutes after start of high-fat meal (Treatment C) in period 1, 2 and 3.
Other intervention name(s): M2951
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Evobrutinib; Pharmacokinetics; Relative Bioavailability; Crossover
A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy
      adults.
    

Detailed description: 
      Each subject participates in all four treatment periods separated by washout periods.

      In order to maintain the blind between arms, all subjects will receive the same number of
      tablets per day in each period of either active drug or placebo.
    

Intervention name(s): YM443; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Other intervention name(s): Z-338; acotiamide hydrochloride; Avelox
Intervention MeSH terms: Moxifloxacin; Z 338
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: QT interval; Cardiac Repolarization; Cardiac Conduction; Healthy Subjects; YM443 (Z-338, acotiamide hydrochloride); Evaluation of QT Interval
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo
      and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and
      supratherapeutic doses of icosabutate in healthy male and female subjects.
    


Intervention name(s): NST-4016 600mg; Placebo oral capsule; Moxifloxacin 400mg; NST-4016 2000mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Likely maximum therapeutic dose of NST-4016; Placebo for comparison with moxifloxacin and potential NST-4016 effects; Active comparator with known effect on QT interval; Supratherapeutic dose of NST-4016
Other intervention name(s): Icosabutate; Icosabutate
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Metabonomics to Investigate Effects of Healthy Diets on Blood Pressure: the OmniHeart Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To compare the urinary metabolomes on individuals undergone three different healthy diets--a
      carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.
    

Detailed description: 
      BACKGROUND:

      This study based on the OmniHeart dietary intervention study, a randomized, three period
      cross-over feeding study that compared the effects on blood pressure and plasma lipids of
      three DASH-like diets: a carbohydrate-rich (CARB) diet pattern, a rich in protein (PROT) and
      a rich in unsaturated (MUFA) fat, predominantly monounsaturated fat diet (see full details of
      OmniHeart dietary intervention https://clinicaltrials.gov/ct2/show/record/NCT00051350).

      This metabonomic study aims to evaluate the feasibility of identifying individuals showing
      variation in clinical response to three different healthy diets, with the purpose of reducing
      cardiovascular disease (CVD) risk, using proton nuclear magnetic resonance (NMR) based
      metabolic phenotyping approach.
    

Intervention name(s): CARB rich diet; MUFA rich diet; PROT rich diet
Intervention type(s): Other; Other; Other
Intervention description(s): Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention; Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention; Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension
Cell Selection for Bone Marrow Transplants to Prevent Graft-Versus-Host-Disease
Condition: Graft vs Host Disease; Hematologic Neoplasm
MeSH terms: Hematologic Neoplasms; Graft vs Host Disease
Study type: Observational

Summary: 
      Blood contains different kinds of cells, white blood cells, red blood cells, and platelets.
      In order to treat certain diseases, specific cell types can be removed from blood and
      transplanted into patients. The process of removing white blood cells for the treatment of
      leukemia is called apheresis.

      This study will make available blood cell collections from volunteers genetically matched to
      various degrees with recipients in order to test and, if necessary, refine the process of
      removing white blood cell T-lymphocytes....
    

Detailed description: 
      This protocol has been written to make available apheresis collections from volunteers
      matched to various degrees with recipients in order to test and, if necessary refine, the
      selective immunodepletion procedure prior to introducing it in a clinical trial.
    

Time perspective: Prospective
Keywords: Volunteer; Leukocyte Donors; Family Members; Leukocyte Collection; No Reimbursement
BDNF Promoter Methylation: Effects on Cognition, Stress and Anxiety and Depression Symptom in Healthy Women.
Condition: BDNF; Memory Impairment; Stress; Well-being; Methylation
MeSH terms: Depression
Study type: Observational

Summary: 
      The purpose of this study is to explore the association between BDNF methylation and
      neurocognitive performance, perceived stress, and well-being in healthy women.
    


Intervention name(s): Healthy women active teachers
Intervention type(s): Other
Intervention description(s): The neuropsychological testing data, psychometric measure, demographic, clinical and lifestyle information and blood samples were collected at similar time points. This group not received any intervention.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female participants will be recruited from public schools linked to the "Diretoria Regional
        de Educação de Santo Amaro - DRESA" - a southern section of the São Paulo City Hall public
        education secretaryship.
      
Biospecimen description: 
      blood
    
Keywords: BDNF methylation; Memory; women; Stress
A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of clobetasol
      propionate 0.05% (Clobex®) spray compared to clobetasol propionate 0.05% (Olux®) foam.
    

Detailed description: 
      Same as above.
    

Intervention name(s): Clobetasol Propionate 0.05% Spray; Clobetasol Propionate 0.05% Foam
Intervention type(s): Drug; Drug
Intervention description(s): Apply to affected areas twice daily; Apply to affected areas twice daily
Other intervention name(s): Clobex® Spray; Olux® Foam
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Pilot Observational Clinical Survey: Impacts of Tahitian Noni Juice on the Quality of Life of Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Tahitian Noni Juice (TNJ) made from Morinda citrifolia (noni) fruits may provide a safe
      adjunctive treatment for osteoarthritis (OA) due to its anti-inflammatory and analgesic
      properties. In this study the investigators examined whether TNJ was able to improve the
      symptoms and quality of life (QOL) of OA patients. The investigators also sought to evaluate
      the tolerability and safety of TNJ.

      This was an open label three-month intervention pilot study. Data were collected by pre and
      post intervention survey as well as laboratory testing. Inclusion criteria were: adults of
      both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care
      physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a
      day.
    


Intervention name(s): Noni Juice
Intervention type(s): Dietary Supplement
Intervention description(s): This was an open label three-month intervention pilot study. Data were collected by pre and post intervention survey as well as laboratory testing. Inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a day
Intervention model: Single Group Assignment
Keywords: Osteoarthritis