bioihbjkbjnl/mcl2 huggingface dataset:
Sleep Disorder and Oral Habits in Children
Condition: Sleep Disorder; Malocclusion
MeSH terms: Malocclusion; Sleep Wake Disorders; Parasomnias
Study type: Observational

Summary: 
      Sleep is a vital physiological function for the maintenance of health and quality of life.
      Harmful, non-nutritive and parafunctional oral habits are believed to have a negative effect
      on adequate rest at night. The aim of the present study was to determine associations between
      quality of sleep and harmful oral habits among children aged three to six years. Fifty
      children from a private school in São Paulo (Brazil) were evaluated using two questionnaires
      on sleep quality and harmful oral habits. The data were submitted to descriptive analysis.
      The chi-square test was employed for the categorical variables and analysis of variance
      (ANOVA) was carried out to compare mean values. The Student's t-test was used for all
      analyses, with the significance level set at 5%. The SPSS 12.0 program for Windows was used
      to analyze the results.
    

Detailed description: 
      An observational cross-sectional study was carried out with the aim of determining
      associations between quality of sleep and harmful oral habits among children aged three to
      six years. This study was conducted in compliance with the Brazilian National Health
      Council/Ministry of Health guidelines contained in Resolution 196/96 and received approval
      from the Human Research Ethics Committee of the Universidade Metropolitana de Santos (Brazil)
      under process number 026/2010. Parents/guardians of all participants were properly informed
      regarding the objectives of the study and signed a statement of informed consent.

      Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo were
      evaluated by means of two questionnaires administered to parents/guardians: The "Undesirable
      Habits Questionnaire", composed of 15 investigative questions on harmful oral habits as well
      as dietary and psychological factors, and the Sleep Habits Questionnaire.6 The data were
      submitted to descriptive analysis. The chi-square test was employed for the categorical
      variables and analysis of variance (ANOVA) was carried out to compare mean values. The
      Student's t-test was used for all analyses, with the significance level set at 5%. The SPSS
      12.0 program for Windows was used to analyze the results.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo
      
Keywords: sleep disorder; malocclusion; children
Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Observational

Summary: 
      Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even
      nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal
      motility impairement.
    

Detailed description: 
      The aim of this study is therefore to measure antro-pyloro-duodenal motor activity in
      patients with idiopathic gastroparesis.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Idiopathic gastroparesis and healthy volunteers
      
Keywords: gastroparesis; gastric emptying; antro-duodenal manometry
Additional Manual Therapy Over Inspiratory Muscle Training in COPD
Condition: Chronic Obstructive Pulmonary Disease Severe; Muscle Weakness
MeSH terms: Muscle Weakness; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional

Summary: 
      The benefits of inspiratory muscle training(IMT) in patients with chronic obstructive
      pulmonary disease(COPD) were reported.But in severe COPD patients, benefit from IMT may be
      limited.There is need for further research in new and complementary modalities to improve IMT
      efficiency in severe COPD patients.Manual therapy(MT) additional over IMT may be such a new
      approach that has not yet been investigated in COPD.

      Aims: To investigate effects of MT additional over IMT on functional capacity,respiratory
      muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe COPD
      patients.

      Methods: It was a prospective single-blind randomized trial. 40 patients with COPD in Global
      Initiative for Chronic Obstructive Lung Disease(GOLD) stage III-IV were included. Patients
      were randomly assigned to receive either MT additional over IMT at 40% of maximal inspiratory
      pressure(MIP)(n= 20) or only IMT(n= 20) for 12 weeks. MT group received MT during 12 weeks
      for 40 minutes additional to IMT. Pulmonary function using spirometry, respiratory muscle
      strength using mouth pressure device, functional capacity using six minute walk test, dyspnea
      using Modified Medical Research Council(MMRC) dyspnea scale, fatigue using fatigue severity
      scale and quality of life using St. George's Respiratory Questionnaire(SGRQ) were evaluated.
    


Intervention name(s): Manual therapy technics; Inspiratory Muscle Training
Intervention type(s): Other; Other
Intervention description(s): Manual therapy technics; Inspiratory Muscle Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: copd; manual therapy; inspiratory muscle therapy
Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The study is designed to evaluate the clinical changes in gingival health by measuring the
      reduction of gingival bleeding and inflammation over 4 weeks. Additionally plaque removal
      will be evaluated after a single use and over 4 weeks.
    

Detailed description: 
      Data will be analyzed and reported as mean. The target population is approximately 70 healthy
      adult volunteers. There will be two groups with a total of 35 subjects per group. Subjects
      will be randomized using a simple random sample. A computer-generated randomization schedule
      will be prepared by the study statistician. Based on the randomization schedule, patients
      will be randomly assigned in a 1:1 ratio to receive either:

      With 35 subjects per group, the study will have 90% power to detect an average reduction in
      the percent of sites with BOP of 25%.

      The primary outcome will be the reduction in the percentage of sites with bleeding on probing
      (BOP) after 4 weeks.

      Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the
      MGI after 2 (+/- 2 days) and 4 weeks. Reduction in RMNPI Pre & post, 2 weeks and 4 weeks (=/-
      2 days)

      Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all
      indices. Intraoral examination will be performed and any adverse events will be reported and
      followed up.

      Subjects will complete a questionnaire at the completion of the study.
    

Intervention name(s): Electric toothbrush; Control
Intervention type(s): Device; Device
Intervention description(s): Electric toothbrush and power interdental device; Oscillating-rotating
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)
Condition: Coronary Artery Disease; Distal Radial Artery; Radial Artery Occlusion
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arterial Occlusive Diseases
Study type: Interventional

Summary: 
      Randomized-controlled trial to comparison of the long-term radial artery occlusion in
      coronary diagnosis and intervention via distal vs conventional radial approach
    

Detailed description: 
      Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This
      study aims to explore the long-term radial artery occlusion after coronary diagnosis and
      intervention via distal radial artery at 3 months after procedure using portable
      high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time
      of puncture, duration of hemostasis, radial artery trauma, etc.
    

Intervention name(s): distal radial approach; conventional radial access
Intervention type(s): Procedure; Procedure
Intervention description(s): coronary diagnosis and intervention via distal vs conventional radial approach; conventional radial access
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center parallel randomized controlled study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: coronary artery disease; distal radial artery; conventional radial artery; radial artery occlusion
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the potential of Topicort® (desoximetasone)
      Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary
      objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event
      profile.
    

Detailed description: 
      An open label, post marketing safety study to assess the potential of a TOPICORT®
      (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily
      dosing for 28 days.
    

Intervention name(s): Topicort® (desoximetasone) Topical Spray, 0.25%
Intervention type(s): Drug
Intervention description(s): Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Other intervention name(s): desoximetasone
Intervention MeSH terms: Desoximetasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ischemia Reperfusion: Prostaglandins and Antioxidants
Condition: Ischemic Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      The purposes of this study are two-fold. The first purpose is to determine the effect of
      taking vitamins on the recovery of an artery (blood vessel) following an induced temporary
      injury. The second purpose is to determine whether a specific vasodilator is less abundant
      after the injury and whether this contributes to increased constriction or after the injury.
      Finally, does vitamin consumption have an effect on the recovery from the injury if one of
      the substances in the blood that causes vessels to enlarge (dilate) is stopped?
    


Intervention name(s): Antioxidant; Prostaglandin inhibitor (Ibuprophen)
Intervention type(s): Dietary Supplement; Drug
Other intervention name(s): ibuprofen
Intervention MeSH terms: Ibuprofen; Antioxidants; Prostaglandin Antagonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Genetic Epidemiology of Responses to Antihypertensives
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To determine whether measured variation in genes coding for components of vasoconstriction
      and volume regulating systems predict interindividual differences in blood pressure response
      to therapy with a thiazide diuretic, hydrochlorothiazide, or an angiotensin II receptor
      blocker, candesartan, in hypertensive African-Americans (N=300 treated with each drug) and in
      hypertensive European Americans (N=300 treated with each drug).
    

Detailed description: 
      BACKGROUND:

      Essential hypertension is a common disorder that contributes to morbidity, mortality, and
      cost of health care, especially among African-Americans. Although a single-drug therapy is
      commonly prescribed for treatment of hypertension, blood pressure levels are controlled in
      some individuals but not in others. The study has the potential to identify genes
      contributing to the etiology of interindividual differences in blood pressure response to
      diuretic therapy in African-Americans and European Americans.

      DESIGN NARRATIVE:

      Hypertensive adults were treated with the diuretic hydrochlorothiazide, 25 mg/day, for four
      weeks; or with the angiotensin II receptor blocker candesartan, 16 mg/day for 2 weeks
      followed by 32 mg/day for 4 weeks. Interindividual variations in blood pressure responses and
      in candidate genes coding for components of systems regulating vasoconstriction and volume
      were measured. In addition, a panel of 500,000 single nucleotide polymorphisms genome-wide
      was measured in subsets of the most extreme responders and nonresponders to each drug for
      genome-wide association of analyses.
    

Intervention name(s): Hydrochlorothiazide; Candesartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Candesartan; Candesartan cilexetil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult African American men and women with previously diagnosed primary hypertension were
        recruited from Atlanta, Georgia; and adult European American man and women with previously
        diagnosed primary hypertension were recruited from Rochester, Minnesota.
      
Biospecimen description: 
      Serum, plasma, buffy coat, urine.
    
Keywords: Hypertension; Pharmacogenetics; Hydrochlorothiazide; Candesartan
Trial of the Safety and Immunogenicity of an Oral, Replicating Ad26 Vectored HIV-1 Vaccine
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose escalation study to test the safety and immunogenicity of an oral HIV-1
      vaccine.
    

Detailed description: 
      This study is a phase I dose-escalation randomized, double blind, placebo-controlled study
      designed to evaluate the safety and immunogenicity of rcAd26.MOS1.HIV-Env, an oral
      replicating adenovirus 26 vector vaccine in healthy HIV-1 uninfected adults. The vaccine will
      be administered orally at a single time point (Day 0) at one of four dose levels depending on
      study group: 1 x 10^8 virus particles (vp), 1 x 10^9 vp, 1 x 10^10 vp and 1 x 10^11 vp.
      Volunteers will be randomized to vaccine: placebo in a 5:1 ratio in each group.

      Volunteers will be screened up to 56 days before vaccination and will be followed for 12
      months after vaccination.

      Because the vaccine is replication competent, volunteers will be housed in an isolation unit
      from day -2 through day 9. Household contacts will also be enrolled and tested for possible
      transmission.
    

Intervention name(s): rcAd26.MOS1.HIV-Env 1x10^8 vp; rcAd26.MOS1.HIV-Env 1x10^9 vp; rcAd26.MOS1.HIV-Env 1x10^10 vp; rcAd26.MOS1.HIV-Env 1x10^11 vp
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 1 oral capsule, 1x10^8 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo; 10 oral capsules, 1x10^8 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo; 1 oral capsule, 1x10^10 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo; 10 oral capsules, 1x10^10 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; HIV Prevention; HIV Vaccine; Healthy
Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury
Condition: Brain Concussion
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      The purpose of this study is to see whether providing education and counseling after a mild
      traumatic brain injury will help in preventing symptoms from becoming chronic over the first
      six months after injury.
    

Detailed description: 
      This study examines the effect of scheduled telephone calls on the outcome after mild
      traumatic brain injury (MTBI) or concussion. These calls offer subjects information, focused
      counseling, and referrals. MTBI is extremely common in the United States, numbering well over
      a million cases per year. Although recovery for most is quite good, 10-20% of persons have
      persisting symptoms that affect employment, quality of life, and health care expenses. We are
      examining one means to decrease persisting symptoms by offering early, consistent
      intervention before symptoms become persistent.

      The subjects are enrolled in the emergency departments (ED) of the hospital and receive the
      baseline assessment while still in the ED. Subjects are randomly assigned to two groups:
      Group 1 standard care and Group 2 standard care, toll-free telephone number, and scheduled
      telephone calls for follow-up at 1-2 days, 2, 4, 8, and 12 weeks after injury. All subjects
      are contacted again at 6 months for an outcome assessment that is done over the telephone.

      On the telephone, subjects are asked about current problems, and are given both information
      about recovery from MTBI and some counseling on dealing with symptoms or other complaints.
      They are also given community resources to obtain assistance if needed. Telephone call are
      reviewed by supervisors (physician and psychologist) for adherence to protocol and for
      training purposes.
    

Intervention name(s): Scheduled telephone follow-up
Intervention type(s): Behavioral
Intervention description(s): Persons in the experimental group (group 1) received scheduled telephone counseling calls focused on symptom management and self-management skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Brain injuries; Directive counseling
A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl
      Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel
    

Detailed description: 
      The objectives of this study are to evaluate the therapeutic equivalence and safety of
      Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin®
      (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) in the treatment of
      acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference
      products over the placebo control
    

Intervention name(s): Clindamycin and Benzoyl Peroxide Gel 1%5%; BenzaClin® Topical Gel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.); BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.); Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
Other intervention name(s): Active; Active; Vehicle
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)
Condition: Anesthesia, General; Neuromuscular Blockade
Study type: Interventional
Phase: Phase 3

Summary: 
      The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in
      Chinese and Caucasian subjects for registration purposes in China.
    


Intervention name(s): Sugammadex
Intervention type(s): Drug
Intervention description(s): After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.
Other intervention name(s): Org 25969, Bridion®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
Condition: HIV Infections; HIV Seronegativity
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who
      are at risk from becoming infected with HIV. Patients who become infected despite
      immunization will be studied to see if receiving the vaccine before becoming infected will
      help keep HIV levels (viral load) low.
    

Detailed description: 
      Volunteers receive 7 blinded, intramuscular vaccinations (at Months 0, 1, 6, 12, 18, 24, 30)
      containing either the AIDSVAX B/B vaccine or a placebo (aluminum adjuvant only). Volunteers
      are randomized in a 2 to 1 vaccine-to-placebo ratio. HIV-uninfected persons are followed for
      a total of 16 visits beginning at screening and continuing until Month 36. Patients who
      become HIV infected during study are followed every 4 months for at least 24 months.
    

Intervention name(s): MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: HIV-1; Dose-Response Relationship, Drug; Acquired Immunodeficiency Syndrome; AIDS Vaccines; Sexually Transmitted Diseases; Risk Factors; HIV Seronegativity; Antigens, Viral; Alum Compounds
DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the potential of DFD01 spray to suppress the HPA
      (hypothalamic-pituitary-adrenal) axis as compared to Comp01 lotion when applied twice daily
      for 15 days.
    


Intervention name(s): DFD01 Spray; Comp01 Lotion
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment