bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Stabilized Chlorine Dioxide Rinse as a Chemical Adjuvant for Treatment of Per-implant Mucositis
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional
Phase: Phase 4

Summary: 
      A full understanding of etiology and diagnosis of peri-implant diseases is crucial for
      finding effective treatments for these diseases that are more widely accessible to dentists.
      Several treatment protocols for peri-implant diseases have been proposed, but no gold
      standard has been established to date. Thus, the purpose of this study is to analyze efficacy
      of stabilized chlorine dioxide as a chemical adjuvant for treatment of peri-implant mucositis
      in a non-surgical treatment protocol with a 3-month follow-up.
    

Detailed description: 
      Fifty individuals with peri-implant mucositis will be identified to participate in this study
      and randomized into two groups to analyze clinical parameters and results of this study: 1)
      test group (stabilized chlorine dioxide rinse) and 2) control group (placebo). Each group
      will be associated with periodontal basic therapy.

      Treatment Protocol After inclusion of the patients, medical history and initial examination
      are performed, patients will be randomly divided into the following two groups: 1) test
      (stabilized chlorine dioxide rinse associated with periodontal basic therapy); and 2) control
      (placebo associated with periodontal basic therapy).

      Periodontal basic therapy will consist of oral hygiene instruction, motivation, retentive
      factor removal, and an adaptation of the protocol of full-mouth scaling and root planing
      (stabilized chlorine dioxide mouthwash will be used). Plastic currets are used to instrument
      the implants and metal currets to instrument teeth. Immediately after instrumentation,
      chemical solutions of chlorine dioxide or placebo will be dispensed to the subjects.

      The subjects will follow their normal oral-hygiene procedures with the addition of using the
      study rinse toothbrush and toothpaste provided to them.
    

Intervention name(s): Stabilized chlorine dioxide oral rinse; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.; Patients received a rinse containing no active ingredients and periodontal basic therapy.
Intervention MeSH terms: Chlorine dioxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will receive an Oral Hygiene Kit at Visit 1. The MGI, BOP and PI, Pocket depth and radiographs will be measured and all oral tissues examined (baseline examination). Subjects will return for Visit 2 in 14 days ± 3 days to: 1) assess and record changes in indices and oral health and any adverse conditions. Visit 3 (45 days ± 7) will be a compliance visit for study drug utilization. Visit 4 (90 days ± 7) will be a repeat of Visit 1.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Cranial Osteopathy on Visual Function
Condition: Visual Function
Study type: Interventional

Summary: 
      It is the purpose of this study to attempt to determine if there is an immediate, measurable
      change in visual function as a direct result following a session of cranial osteopathic
      manipulation.
    


Intervention name(s): Cranial osteopathic manipulation; Sham/Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): This treatment is performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.; A laying on of hands with no treatment being performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cranial manipulation; Visual function
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)
Condition: Hypercholesterolemia; Atherosclerosis
MeSH terms: Atherosclerosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to obtain data of the coadministration of ezetimibe and
      rosuvastatin to support the concomitant use of these two drugs in patients requiring
      additional cholesterol-lowering management. Treatment is administered for 14 days.
    


Intervention name(s): Ezetimibe + Rosuvastatin; Rosuvastatin; Placebo; Ezetimibe
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablets; rosuvastatin 10 mg + ezetimibe 10 mg, once daily for 14 days; oral tablets; rosuvastatin 10 mg + ezetimibe placebo once daily for 14 days; oral tablets; two ezetimibe placebo once daily for 14 days; oral tablets; ezetimibe 10 mg + ezetimibe placebo once daily for 14 days
Other intervention name(s): Zetia; SCH 58235; Crestor; Crestor; Zetia; SCH 58235
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for
      early intervention as compared against an active control in which Action Based Cognitive
      Remediation (ABCR) will be applied.
    

Detailed description: 
      The proposed project will expand knowledge of the role of compensatory and restorative
      cognitive interventions for early intervention population individuals with schizophrenia. The
      investigators will conduct a two arm randomized trial comparing the impacts of CAT and Action
      Based Cognitive Remediation (ABCR) for individuals with schizophrenia who are under the age
      of 30. The model would mirror the investigators' preliminary work at CAMH (Kidd et al., 2014)
      in which there will be 4 months of specialist-delivered treatment followed by 5 months of
      maintenance by case managers with pre, 4 month, and 9 month evaluations conducted. This study
      will be among the most rigorous examinations of such interventions to date, would be among
      the first to examine integrative approaches, and would make a substantial contribution to the
      early intervention literature.

      The questions for the purposes of this project are:

        1. Is CAT effective among individuals with schizophrenia under the age of 30?

           and

        2. Does integrating cognitive remediation with CAT enhance outcomes as compared with CAT
           alone?
    

Intervention name(s): Cognitive Adaptation Training; Action Based Cognitive Remediation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive Adaptation Training (CAT) is a manual-driven standardized approach that uses environmental supports to improve multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia. Interventions for each functional deficit are based on two dimensions 1) level of impairment in executive functions (determined by neurocognitive tests) and 2) whether the overt behavior of the individual is characterized more by apathy (poverty of speech/movement/inability to initiate and follow through on behavioral sequences), disinhibition (distractibility/behavior which is highly cue-driven) or a combination of these styles (based on the Frontal Lobe Personality Scale (FLOPS).; ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychosis; Psychosis NOS; Schizophrenia; Schizoaffective Disorder; Early Intervention
Functional Magnetic Resonance Imaging Study on the Role of Awareness in Visual Perception in Healthy Adult Subjects.
Condition: Magnetic Resonance
Study type: Observational

Summary: 
      The objective of the study concerns the investigation of the role of awareness in visual
      perception, highlighting the brain systems involved during non-processing Aware of stimuli
      belonging to different semantic categories. Specifically, the theoretical perspective of
      reference is that of the so-called "grounded cognition", according to which the
      representation of the concepts of semantic knowledge is conveyed by information sensorimotor
      and affective, introspective and social states. The main objective is therefore to evaluate
      whether the meaning of the stimulus can be extracted in the absence of awareness,
      investigating the neural response in the brain regions known to be involved in the conscious
      processing of stimuli belonging to the semantic categories in question.

      To this end, two different experimental paradigms were implemented. A first paradigm aimed at
      investigating the unconscious representation of semantic knowledge in the context of
      language, therefore using visual stimuli in lexical mode (words). A second paradigm aimed at
      investigating the same phenomena in the field of visual perception of objects in space, using
      stimuli in iconic mode (images).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Volunteers, enlisted among the students and workers of the San Raffaele Hospital and other
        universities.
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
Condition: Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Coinfection; Hepatitis; Hepatitis, Chronic; Immunologic Deficiency Syndromes; Fibrosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and
      without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV
      GT1- or 4-infected participants with HIV-1 coinfection and to evaluate the percentage of
      subjects achieving HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks
      following treatment.
    


Intervention name(s): ABT-450/r/ABT-267; ABT-333; ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet; tablet; tablet
Other intervention name(s): ombitasvir/paritaprevir/ritonavir; ombitasvir also known as ABT-267; paritaprevir also known as ABT-450; Dasabuvir
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV Genotype 4; Interferon-Free; Hepatitis C Genotype 1; Compensated Cirrhosis; Hepatitis C Genotype 4; HCV / HIV coinfection; Cirrhotic; Hepatitis C; HIV-1; HCV Genotype 1
Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease
Condition: Benign Thyroid Disease
MeSH terms: Thyroid Diseases
Study type: Observational

Summary: 
      New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among
      other things, ultrasound instruments have been used for the dissection, division and
      coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a
      clinically and economically significant reduction in operating time with no increase in the
      complication rate when the Harmonic device has been used. The aim of the present clinical
      trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed
      especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC
      in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the
      surgical site, amount of drainage, and complications, including the incidence of RLN palsy
      and hypoparathyroidism.
    

Detailed description: 
      Thyroidectomy is one of the most frequently performed operations in endocrine surgery.
      Results are generally excellent, and morbidity and mortality are usually negligible. The
      operation requires proper identification of important structures such as the recurrent
      laryngeal nerve (RLN) and the parathyroid glands. Meticulous dissection and exhaustive
      hemostasis are important to ensure a dry field and to avoid inadvertent damage to the
      adjacent structures. The two most common techniques for hemostasis are suture ligatures and
      electrocoagulation. The use of electrocoagulation (EC) to control bleeding has the potential
      risk of injuring the surrounding structures from lateral dispersion of heat. New haemostatic
      techniques have been developed with the advent of laparoscopic surgery. Among other things,
      ultrasound instruments have been used for the dissection, division and coagulation of vessels
      and other tissue. Previous studies in Thyroidectomy observed a clinically and economically
      significant reduction in operating time with no increase in the complication rate when the
      Harmonic device has been used. The aim of the present clinical trial is to evaluate potential
      advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in
      the use of HS in thyroidectomies when compared with EC in terms of operative time, number of
      ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and
      complications, including the incidence of RLN palsy and hypoparathyroidism.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive euthyroid patients with multinodular goiter for whom a total Thyroidectomy
        under general anesthesia is indicated.
      
Keywords: Consecutive euthyroid patients with multinodular goiter for whom a total Thyroidectomy under general anesthesia is indicated
A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat
      people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve
      symptoms in adults with hypoparathyroidism.

      In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A
      placebo looks like the medicine being studied but does not have medicine in it. In this
      study, the placebo will be a standard treatment which is either active Vitamin D, or active
      Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on
      the body. These treatments will be given as a daily injection just under the skin.
      Participants will not know which treatment they received, nor will their study doctors. This
      is to help make sure the results are more reliable. All participants will also take active
      vitamin D and calcium supplements during treatment.

      Participants will record their symptoms in a tool called the hypoparathyroidism symptom
      diary. This tool is used to assess symptoms and their impact and will give an overall score
      for each participant.

      The study doctors will also check for side effects from the study treatments.

      After treatment, researchers will check if there is any difference in the diary scores
      between the 2 treatment groups. A difference in score means there is a difference in symptoms
      and their impact. From this, researchers will learn if symptoms have improved for
      participants treated with rhPTH(1-84) compared with those treated with placebo.
    

Detailed description: 
      24 SEPTEMBER 2020: The temporary enrollment stop of new patients into this study due to the
      COVID-19 pandemic has been lifted in one or more countries, and the study is now again
      enrolling new patients. However, some countries/sites may still have paused the enrollment of
      new patients due to the pandemic.

      20 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19
      situation. The duration of this pause is dependent on the leveling and control of the
      COVID-19 pandemic.
    

Intervention name(s): rhPTH (1-84); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): rhPTH (1-84) SC injection.; Placebo QD SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rhPTH[1-84); Parathyroid hormone; Hypocalcemia; Hypoparathyroidism
Plasma S-adenosylhomocysteine Levels and Endothelial Dysfunction
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and
      endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of
      cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and
      then measaured the plasma levels of methionine metabolites, such as SAH, SAM, and analyze the
      association.
    

Detailed description: 
      To investigate the relationship betweeen plasma S-adenosylhomocysteine (SAH) levels and
      endothelial dysfunction, we plan to enroll approximately 150 patients with high risk of
      cardiovascualr disease,who will be measaured the flow-mediated dilation by B-ultrasound, and
      then use HPLC-MS/MS to measaure the plasma levels of methionine metabolites, such as SAH,
      SAM, and use methylated specifical PCR to detect the promoter DNA methylation of p66shc, and
      use ELISA kits to measure the plasma ROS levels of CVD patients, such as MDA,
      8-iso-prostaglandin F2a, and finally analyze the association between SAH, ROS levels,
      promoter DNA methylation of p66shc, and flow-mediated dilation.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with high cardiovascular risk, or diagnosed as coronary artery disease.
      
Biospecimen description: 
      10mL plasma
    
Keywords: S-adenosylhomocysteine; Endothelial function
Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
Condition: Neck Pain; Pain, Neck
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the
      association of the osteopathic manipulative treatment in individuals with chronic
      non-specific neck pain who receive a exercice program and pain neurocience education.
    

Detailed description: 
      The purpose of this study is to determine whether osteopathic manipulative treatment
      associated exercises and pain neurocience education improves pain and function in individuals
      with chronic non-specific neck pain

      Design: a randomized single blind controlled pragmatic trial will be conducted trial.
      Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic
      manipulative treatment and exercise and and pain neurocience education (n=20) or 2) exercise
      alone and pain neurocience education (n=20). Participants will receive 8 treatments during 4
      weeks. Clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of
      treatment.

      Methods:

      The primary outcome will be pain measured by 11-point numerical pain rating scale. The
      secondary outcome will be disability measured by the Neck Disability Index, range of motion
      measured by Cervical Range of Motion device, Pressure pain threshold measured by electronic
      algometer, global perceived effect, Pain Self-Efficacy Questionnaire and pain catastrophizing
      scale
    

Intervention name(s): Exercises and PNE; Osteopathic manipulative treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Exercise for stretching and strength for neck muscles and pain neuroscience education; Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain
Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a multi-focal contact lens on
      symptomatic patients.
    


Intervention name(s): etafilcon A multifocal contact lens; etafilcon A Contact Lens
Intervention type(s): Device; Device
Intervention description(s): low-add multifocal contact lens; standard sphere contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment