bioihbjkbjnl/mcl2 huggingface dataset:
Knowledge and Attitude About HPV Vaccines
Condition: Knowledge; Attitude; Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to analyze the knowledge and attitude about HPV vaccines among
      Brazilian women after an educative intervention. The knowledge was measured on sexual
      behavior and HPV infection. The attitude was measured on acceptance of vaccines.
    

Detailed description: 
      Two hundred Brazilian women were selected ranged 18 to 30 years old. They were randomized on
      two groups: 1) One hundred received a brief educative intervention about HPV infection and
      vaccines and answered a questionaire about sexual behavior, HPV infection and vaccines and
      2)one hundred not received anything and answered the same questionaire.
    

Intervention name(s): educative folder
Intervention type(s): Behavioral
Intervention description(s): folder about HPV infection and vaccines
Other intervention name(s): HPV vaccines information
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: HPV; vaccines; knowledge; attitude
Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of the current study is to investigate the effects of a novel breathing training,
      called inspiratory muscle strength training (IMST), on sleep patterns, breathing and blood
      pressure for patients diagnosed with mild, moderate and severe sleep apnea.
    

Detailed description: 
      Aims of the study:

        1. To determine the influence of IMST on resting blood pressure and baroreceptor
           sensitivity.

        2. To determine the effect of IMST on sympathetic nervous system by measuring plasma
           cathecholamines and nerve recording (MSNA).

      Population:

      30 subjects aged 30-75 years, who have previously been diagnosed with obstructive sleep
      apnea, as defined by the National Institutes of Health (National Heart Lung, and Blood
      Institute) will be included in this study.

      Study Protocol:

        -  Pre-training assessment and overnight sleep study

        -  5-10 minutes each day breathing training (IMST) at home using a hand-held device for 6
           weeks

        -  Once weekly laboratory visit

        -  Post-training assessment and overnight sleep study

      Pre- and post-training assessment include blood pressure measurement, body weight, neck
      circumference, cardiorespiratory monitoring, nerve recording, blood draw and sleep surveys.
    

Intervention name(s): Inspiratory muscle strength training; Placebo
Intervention type(s): Other; Other
Intervention description(s): Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing.
Other intervention name(s): IMST
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the subjects were randomly allocated to either the sham training group or the inspiratory muscle training group using randomization lists for 4 strata (male/female X young/old)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Inspiratory Muscle Strength Training; Baroreceptor Sensitivity; Blood Pressure
Halitosis and Mouth Breathing in Children
Condition: Mouth Breathing; Halitosis
MeSH terms: Respiratory Aspiration; Mouth Breathing; Halitosis
Study type: Observational

Summary: 
      Objective: determine whether there is a correlation between halitosis and mouth breathing in
      children. Study design: Fifty-five children between three and 14 years of age were divided
      into two groups (nasal and mouth breathing) for the assessment of halitosis. Descriptive
      analysis was carried out regarding the degree of halitosis in each group. The chi-square test
      was used for the comparison between groups, with 5% level of significance.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All children registered at the clinic of the specialization course in pediatric dentistry
        of the ABCD/SP in 2008 were included in the study.

        The children were divided into two groups based on breathing pattern (nasal and mouth) for
        the evaluation of halitosis. Breathing pattern was determined by a clinical evaluation and
        specific tests (mirror test and water-in-mouth test) and confirmed by the evaluation of an
        otolaryngologist.
      
Keywords: halitosis; pediatric dentistry; mouth breathing
Exercise Intensity for Down Syndrome Children
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      The current study aimed to determine the appropriate exercise intensity for the
      rehabilitation of children with down syndrome.
    

Detailed description: 
      Two groups of down syndrome children were recruited. one group received mild-intensity
      treadmill training while the other received moderate-intensity treadmill training. Eccentric
      knee extensors and ankle plantar flexors peak torques were assessed before and after the
      intervention. Also, functional mobility was assessed for both groups before and after the
      intervention. The within and between-subjects effect was used to analyze the obtained data
      before and after the intervention. isokinetic dynamometer and the time up and go test were
      used for evaluation.
    

Intervention name(s): treadmill exercise (mild); treadmill exercise (moderate)
Intervention type(s): Other; Other
Intervention description(s): mild intensity treadmill training.; moderate-intensity treadmill training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Identification of Respiratory Profiles From Nasal Pressure Signals
Condition: Healthy
Study type: Interventional

Summary: 
      Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by
      smoking and associated with significant morbidity due to recurrent exacerbations or even
      hospitalizations. It is one of the leading causes of death in rich countries.

      Early detection of exacerbations of the disease is thus an economic and public health issue
      in the world. Finding tools for automatic and early detection of an exacerbation is the
      subject of the study. A continuous analysis of the frequency and shape of the patients'
      breathing will be used.

      As a first step in this study, investigators want to measure the frequency and shape of
      breathing in healthy subjects as they execute standard activities. These activities include
      resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and
      recuperation.
    


Intervention name(s): Oxygen therapy simulation
Intervention type(s): Other
Intervention description(s): The intervention consists of reproducing oxygen therapy situations in healthy individuals by replacing oxygen bottles with bottles of air. A TeleOx® device will be placed on the circuit between the source and the nasal cannula for respiratory signals recording.
The intervention will last 30 minutes, containing the following activities in the given order:
rest (9 minutes);
drinking water (1 minute);
rest (1 minute);
coughing (1 minute);
rest (1 minute);
reading aloud (1 minute);
rest (1 minute);
breathing by the mouth (1 minute);
rest (1 minute);
exercising (running) (3 minutes) and
rest (10 minutes)
Recordings will be retrieved after each test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Development of a Skin Test for the Na-ASP-2 Hookworm Antigen
Condition: Hookworm Infection; Allergy
MeSH terms: Hookworm Infections; Ancylostomiasis
Study type: Interventional

Summary: 
      Na-ASP-2 is a protein expressed during the larval stage of the N. americanus hookworm life
      cycle. In a clinical study in previously hookworm-infected adults in Brazil, this protein
      induced urticarial reactions (rash) in a subset of volunteers. This study will evaluate
      solutions of varying concentrations of the protein in both a skin prick-puncture and
      intradermal test that will eventually be used to screen volunteers living in hookworm endemic
      areas who are being considered as potential participants in vaccine trials, to reduce the
      potential of inducing allergic reactions in those vaccinated with the Na-ASP-2 Hookworm
      Vaccine.
    

Detailed description: 
      -  Study site: George Washington University Medical Center

        -  Number of participants: up to 15

        -  Study duration: up to 3 months; each participant will undergo a minimum of one screening
           visit and one study visit.

        -  Each participant will have both skin prick-puncture and intradermal skin tests applied
           on the same study day. The prick-puncture and intradermal tests will be applied
           sequentially to the volar aspects of the participant's forearms:

             1. Skin prick-puncture: four different concentrations of Na-ASP-2 solution (1, 10,
                100, and 1000 μg/mL) will be applied simultaneously in duplicate, to the left
                forearm.

             2. Intradermal: three different concentrations of Na-ASP-2 (10, 100, and 1000 μg/mL)
                will be injected simultaneously, in duplicate, to the right forearm.

             3. Allergen diluent and histamine solutions will be utilized as the negative and
                positive controls, respectively, for both the skin prick-puncture and intradermal
                tests.

             4. Participants will be observed in the study clinic for at least 30 minutes following
                application of the skin tests, and will be contacted via telephone 2 days following
                skin testing.

             5. Sizes of the wheal and erythema reactions for each application will be recorded and
                graded in comparison to the histamine positive control reaction.

        -  Each participant will have blood collected via venipuncture (a maximum of 25 mL)
           immediately prior to application of the skin tests, in order to measure antibodies
           (particularly IgG and IgE) to Na-ASP-2 using an ELISA procedure.
    

Intervention name(s): Na-ASP-2 Skin Test Reagent
Intervention type(s): Biological
Intervention description(s): Na-ASP-2 Hookworm Skin Test Reagent, 1-1000 mcg/mL solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hookworm; Allergy; Vaccine; Skin test
Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this clinical study is to investigate the effect of drinking a sugar-sweetened
      beverage along with a meal on insulin concentrations and, glucose and lipid metabolism, in
      overweight and obese subjects, during a 10-hour visit.
    


Intervention name(s): Control product E; Test product A; Test product B; Test product C; Test product D; Comparative product F
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Plain water; Beverage with no sugar but sweetener; Beverage with 22 g/L sugar and sweetener; Beverage with 33 g/L sugar and sweetener; Beverage with 47 g/L sugar and sweetener; Beverage with 98 g/L sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sugar-sweetened beverage; Overweight; Obese; Sugar; Water
Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children
Condition: Caries Arrest
Study type: Interventional
Phase: Phase 4

Summary: 
      Testing 3 different caries arresting techniques and the quality of life of a group of
      preschool children in Mansoura city, Egypt.
    

Detailed description: 
      135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate
      caries arrestment. The first group received 38% silver diamine fluoride, the second received
      conventional Atraumatic restorative technique and the third group received ultra consevative
      treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity
      according to the ICDAS.

      The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to
      assess oral health related quality of life.
    

Intervention name(s): 38 % silver diamine fluoride; Atraumatic restorative technique; Ultra conservative dentistry
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Application of 38% SDF on carious dentine lesions.; Hand excavation of carious dentine followed by application of Glass ionomer; Removal of soft dentine and enlarging of cavity to control bio film
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 equal groups receiving 3 different protocols
Masking: None (Open Label)
Primary purpose: Prevention
Low Implanted Second Trimester Placenta and Placenta Previa
Condition: Placenta Previa
MeSH terms: Placenta Previa
Study type: Observational

Summary: 
      Placenta Previa is defined as a placenta implanted in the lower segment of the uterus,
      presenting ahead of the leading pole of the fetus (over or near the internal os). The
      prevalence of placenta previa has been estimated to be approximately 0.5% of all pregnancies,
      and this increase correlates to the elevated cesarean section rate . In Egypt, the prevalence
      of placenta previa is around 1.3% in Sohag Governorate and 1.5% in Aswan region according to.

      Although various studies have tried to address risk factors associated with Placenta Previa
      development, the etiology of placenta previa still remains obscure. Several risk actors have
      been identified as strong contributors to placenta previa development. It is also a
      significant contributor to severe postpartum hemorrhage.Risk factors include; history of
      previous cesarean section, advanced maternal age, history of previous abortions, high parity
      and substance abuse during pregnancy (cigarette smoking), placental size (multiple
      pregnancy), endometrial damage (previous dilatation and curettage), uterine scars and
      pathology (previous myomectomy or endometritis), placental pathology (marginal cord
      insertions and succenturiate lobes), previous placental Previa, and curiously.
    


Intervention name(s): ultrasound
Intervention type(s): Radiation
Intervention description(s): to detect the placental site
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        low implanted placenta women
PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the relative bioavailability and pharmacokinetic characteristics of a newly single
      pill combination of finasteride and tamsulosin with a conventional combination of finasteride
      and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence
      -2period crossover study.
    

Detailed description: 
      This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence,
      crossover study was conducted to compare the relative bioavailability and pharmacokinetic
      characteristics of a newly developed formulation with a conventional formulation in healthy
      subjects.

      For this, a single-center, randomized, single-dose, open-label, 2-period and 2-sequence
      crossover study with a 14-day washout period was conducted in 26 healthy volunteers. Plasma
      samples for the analysis of finasteride/tamsulosin were collected up to 48 h after drug
      administration. Participants received either reference (in combination of of 0.2mg tamsulosin
      and 5mg finasteride) or test drug formulation (single pill combination of 0.2mg tamsulosin
      and 5mg finasteride) in the first period and the alternative formulation in the second
      period. Plasma concentrations of both tamsulosin and finasteride were determined by validated
      high-performance liquid chromatography coupled to tandem mass spectrometry detection.
      Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental
      analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC,
      and the mean ratios and their 90% confidence intervals (CI) were calculated. According to
      regulatory requirements set forth by Korea and the US Food and Drug Administration, products
      meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are
      within the range of 0.80 to 1.25.
    

Intervention name(s): In combination of 0.2mg finasteride and 5mg tamsulosin; GL2701 capsule
Intervention type(s): Drug; Drug
Intervention description(s): oral medication with 240 mL water; oral medication with 240 mL water
Other intervention name(s): GL2701 capsule; Harunal-D (tamsulosin 0.2mg); Prosca (Finasteride 5 mg)
Intervention MeSH terms: Tamsulosin; Finasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Benign Prostatic Hyperplasia (BPH); pharmacokinetics; bioequivalence; finasteirde; tamsulosin
The Effect of Eprosartan on Hormones and Kidney Function in Healthy Humans.
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan
      reduces the activity of the sympathetic nervous system in healthy individuals - during
      baseline conditions and after activation of the sympathetic nervous system.
    


Intervention name(s): Eprosartan
Intervention type(s): Drug
Intervention MeSH terms: Eprosartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Critical Treatment of Coronary Artery Disease
Condition: Coronary Artery Disease; Coronary Artery Disease Progression
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Disease Progression
Study type: Interventional

Summary: 
      Identifying the critical lesion of coronary artery disease and determining the interventional
      plan are significant for reducing adverse cardiovascular adverse events. The assessment of
      critical lesion requires the consideration of plaque morphology, tissue composition, and
      endometrial stress which leading to rupture. In summary, accurate assessment of critical
      lesions has high application value. In this study, patients with critical coronary artery
      disease were divided into two groups: an accurate assessment group and a simple assessment
      group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis,
      potential cardiovascular risk, possible "excessive" intervention.
    


Intervention name(s): Stent implantation
Intervention type(s): Device
Intervention description(s): Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Coronary Artery Disease; Critical lesion
A Study of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent (NTD) Beta-Thalassemia
Condition: Beta-Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof-of-mechanism study is being performed to investigate the safety, tolerability,
      efficacy, pharmacokinetics, and pharmacodynamics of multiple oral doses of bitopertin in
      adults with NTD beta-thalassemia.

      This study consists of two parts:

      Part 1 - The main study - 16 weeks in total: Participants will undergo a 6-week
      dose-escalation period followed by 10 weeks of treatment at the attained target dose.

      Part 2 - Open Label Extension (OLE) - up to an additional 12 months. Participants will be
      given the option to enroll into the OLE once the 16-week treatment of Part 1 has been
      completed. Participants who decide not to enroll in the OLE, at the end of Part 1 will enter
      a 6-week follow-up period.
    


Intervention name(s): Bitopertin
Intervention type(s): Drug
Intervention description(s): Bitopertin will be administered orally once daily at doses up to 120 milligrams (mg).
Other intervention name(s): RO4917838
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment