bioihbjkbjnl/mcl2 huggingface dataset:
Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease
      in China over three thousand years. Certain TCM have scientifically proved to have
      anti-bacterial property. Patients having orthodontic treatment have higher risks of caries
      and gum diseases. The purpose of this study was to determine whether the use of TCM
      Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic
      patients in maintaining proper oral health.
    

Detailed description: 
      The aim of this study was to investigate the effects of a Traditional Chinese medicine (TCM)
      mouthrinse on gingival health and microbial profiles in orthodontic patients. This six-month
      randomized, single-blinded, parallel controlled clinical trial consists of 90 patients with
      fixed appliance treatment. The subjects were allocated to (1) negative-control group: oral
      hygiene instruction (OHI) alone; (2) positive-control group: OHI plus an EO mouthrinse
      (Listerine®)(3) test group: OHI plus the TCM mouthrinse (5% Fructus mume extract). Clinical
      examinations included Plaque Index (PI), Bleeding Index (BI) and Modified Gingival Index
      (MGI). Salivary microbial quantifications included total aerobic and anaerobic bacteria,
      Streptococci and Lactobacilli counts. Clinical and microbiological examinations were
      conducted at baseline, 3 and 6 months (T1, T2 and T3).
    

Intervention name(s): Listerine mouthrinse; Chinese Medicine mouthrinse
Intervention type(s): Drug; Drug
Intervention description(s): For six months; six months
Other intervention name(s): essential oils mouthrinse; 5% Fructus mume and 2% soudium bicarbonate
Intervention MeSH terms: Listerine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Chinese medicine; gingivitis; cytokine; microbial
Urdu Version Of Cornell Musculoskeletal Discomfort Questionnaire: Reliability And Validity Study
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Observational

Summary: 
      The study aims to translate and adapt Cornell Musculoskeletal Discomfort Questionnaire
      cross-culturally into the Urdu language for the Pakistani population for investigating the
      reliability and validity of Cornell Musculoskeletal Discomfort Questionnaire in the Pakistani
      population and to study the correlation between Nordic Musculoskeletal Questionnaire and the
      Visual Analogue Scale.
    

Detailed description: 
      The English version of the Cornell Musculoskeletal Discomfort Questionnaire will be
      translated into Urdu and culturally adapted, as per a previous recommendation. The Cornell
      Musculoskeletal Discomfort Questionnaire will be given to one hundred and fifty workers of
      Masood Textile Mills, who would be chosen based on convenience sampling and inclusion and
      exclusion criteria. The inter-observer and intra-observer reliability of the Cornell
      Musculoskeletal Discomfort Questionnaire, Nordic Musculoskeletal Questionnaire, and Visual
      Analog Scale will be evaluated in this study. On the same day, the questionnaire will be
      filled out created two times. An Inter - observer assessment will be done with 2 hour break
      between distributions of questionnaires. The initial observer then will gather a third
      assessment over one-week period (intra-observer assessment). For data entry and analysis,
      Statistical Package of Social Sciences Version 24 will be utilized. Internal consistency will
      be checked using the Cronbach alpha value, and test retest reliability will be assessed using
      the Intraclass coefficient.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Population suffering from musculoskeletal discomfort with a working routine of more than 6
        hours both in sitting and standing position.
      
Keywords: Cornell musculoskeletal discomfort questionnaire; factory workers; reliability; validity; Musculoskeletal discomfort
Retrospective Analysis of Outcomes With a Pharmacogenomic Algorithm
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Observational

Summary: 
      Antidepressants are among the most widely prescribed medications, yet only 35-45% of patients
      achieve remission following an initial antidepressant trial. The financial burden of
      treatment failures in direct treatment costs, disability, decreased productivity, and missed
      work may in part derive from a mismatch between optimal, and actual, medications prescribed.
      The present one year retrospective study seeks to evaluate the indirect and direct healthcare
      costs for 96 patients with a DSM-IV-TR depressive or anxiety disorder, in relation to an
      interpretive reporting system designed to predict antidepressant responses based on DNA
      variations in cytochrome P450 genes (CYP2D6, CYP2C19, CYP1A2), the serotonin transporter gene
      (SLC6A4), and the serotonin 2A receptor (5HTR2A) genes.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects under the care of a psychiatrist at Union Health Services, Chicago, IL
      
Biospecimen description: 
      Buccal samples
AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy
Condition: Respiratory Aspiration of Gastric Content
MeSH terms: Respiratory Aspiration of Gastric Contents; Respiratory Aspiration
Study type: Interventional

Summary: 
      The standard procedure used for airway control in general anesthesia for LC (laparoscopic
      cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway
      devices (SADs) used for airway control for certain types of surgeries. The aim of this study
      was to evaluate and compare the performances of new types of SADs with EI regarding their
      insertion times, durations, perioperative complications and effects on hemodynamic parameters
      and peak airway pressures (Paw) in LC as well.
    

Detailed description: 
      The standard procedure used for airway control in general anesthesia for LC (laparoscopic
      cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway
      devices (SADs) used for airway control for certain types of surgeries.Previous studies have
      investigated and/or compared the performance of ProSeal™ LMA (Intavent Orthofix, Maidenhead,
      UK) during LC. But the performances of I-Gel and AuraGain have not been studied well yet. The
      main aim of this study was to evaluate and compare the performances of new types of SADs
      (i.e. AuraGain and I-Gel) with endotracheal intubation regarding their insertion times, ease
      of insertion and perioperative complications. The secondary aim was to observe their effects
      on hemodynamic parameters and peak airway pressures.
    

Intervention name(s): I-gel LMA insertion; AuraGain LMA insertion; ETT insertion
Intervention type(s): Device; Device; Device
Intervention description(s): 'I-gel LMA insertion' was done following anesthesia induction.; 'AuraGain LMA insertion' was done following anesthesia induction.; 'ETT insertion' was done following anesthesia induction.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Other
Keywords: Laringeal masks; Cholecystectomy, Laparascopic; Intubation, intratracheal
Home Versus Hospital Based Action Observation Therapy in Diaplegic Cerebral Palsy
Condition: Diplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Effects of Home Versus Hospital Based Action Observation Therapy on Balance, Mobility and
      Cognition in Diaplegic Cerebral Palsy. It will be a RCT we want to identify the effects of
      action observation therapy on patients coming to the hospital as compared to the patients at
      home. We will also identify the retaining effects of AOT. Our sample size will be 40 diplegic
      patients having no cognitive issues and able to walk with assistive device. We will exclude
      the patient who will suffer with severe comorbidities and visual impairment. We will randomly
      assign the patients into two groups A and B.A will receive Action observation therapy three
      times a day along with stretching exercises .while group B we perform AOT and stretching
      exercises at home with same frequency.
    


Intervention name(s): Action observation at home; Action Observation therapy at hospital
Intervention type(s): Other; Other
Intervention description(s): Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes.
All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.; Exercises included will contain four stages of exercises. Each stage will be followed for 2 weeks i.e. stage 1 for 1st and 2nd week, second stage for 3rd and 4th week, third stage for 5th and 6th week and fourth stage for 7th and 8th week of treatment. Each component of every stage will be played for 1 minute in front of participants, followed by 1 minute rest and then these exercises will be performed for 5 minutes.
All participants will perform AOT 3 times/week for up to 8 weeks along with functional training for the rest of the weeks. Functional training will include stretching and isometric exercises (stretching of hamstring and calf muscle while quads isometric). Assessment will be done by using the tools at baseline and after 8 weeks of intervention. A final reading will be taken after 12 weeks to check the maintenance of training effects.
Other intervention name(s): stretching exercises of lower limb; stretching exercises of lower limb
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Short-term Oxygen During CPET in GUCH
Condition: Grown-up Congenital Heart Disease (GUCH)
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      In a randomized, sham-controlled crossover trial the investigators will test whether
      supplemental oxygen given during cardiopulmonary exercise testing will improve exercise
      performance and physiological parameters in patients with grown-up congenital heart disease.
    


Intervention name(s): Oxygen application; Sham room air
Intervention type(s): Procedure; Procedure
Intervention description(s): Oxygen application Supplemental oxygen via mask; Room air applied via mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
Condition: Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15
      and 30 mg in healthy adult male subjects.
    


Intervention name(s): OPC-41061
Intervention type(s): Drug
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Micrometastases in Axillary Lymph Nodes in Breast Cancer, Post-neoadjuvant Chemotherapy
Condition: Micrometastases; Neoadjuvant Chemotherapy
MeSH terms: Neoplasm Micrometastasis
Study type: Observational

Summary: 
      This study aims to investigate the significance of minimal residual axillary disease
      following NAC, with a particular focus on micrometastases (ypNmi), in comparison to
      pathologic lymph node-negative (ypN0) or macrometastases (ypN+). The investigators will
      further explore the prognostic implications of SLNmi for the prediction of axillary LN status
      and survival outcomes.
    

Detailed description: 
      This study aims to investigate the significance of minimal residual axillary disease
      following NAC, with a particular focus on micrometastases (ypNmi), in comparison to
      pathologic lymph node-negative (ypN0) or macrometastases (ypN+). The investigators will
      further explore the prognostic implications of SLNmi for the prediction of axillary LN status
      and survival outcomes.
    

Intervention name(s): Sentinel lymph node biopsy, axillary lymph node dissection
Intervention type(s): Procedure
Intervention description(s): SLNB was performed using single or dual tracers. For the single tracer technique, Technetium 99, a radioactive substance, was administered periareolarly prior to surgery, and SLNs were identified intraoperatively via a gamma detection system (Neoprobe®). The dual tracer method employed both an isosulfan blue dye and Technetium 99 concurrently. The choice of SLNB technique was contingent upon the surgeon's discretion. SLNs were categorized as one or multiple, and any LN identified by either or both methods was defined as SLN. LNs resected during SLNB without tracer signal were not classified as SLNs.
ALND was characterized by the removal of all LNs in axillary levels I and II. Patients documented to have undergone ALND in surgical records were primarily selected from our registry. Among them, those with fewer than 10 LNs were excluded, based on the assumption that a competent ALND necessitated the removal of 10 or more LNs as defined in previous studies
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We conducted a retrospective review of primary breast cancer patients from the breast
        cancer registries of Gangnam Severance Hospital and Severance Hospital, who underwent
        surgery following NAC between September 2006 and February 2018. These patients were
        clinically diagnosed with stage II or III breast cancer and underwent ALND, with or without
        SLNB. The surgical approach, encompassing either total mastectomy or breast-conserving
        surgery, was dictated by the number and size of the tumors present. Exclusion criteria
        comprised of patients who had initial surgery, underwent only SLNB, or presented with de
        novo stage IV disease.
Study of a Flu Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study tests the safety and effectiveness of a flu vaccine in school children.

      School children are usually the first members of a community to come down with the flu, and
      they often give the flu to their younger siblings, parents, and grandparents. It is hoped
      that giving school children a flu vaccine can help prevent the spread of the flu to other
      members of the community.
    

Detailed description: 
      This is a Phase III trial (an advanced study with a large number of patients). Your child
      will receive a single dose of flu vaccine, which is given by a nasal spray.
    

Intervention name(s): Influenza virus vaccine (CAIV-T)
Intervention type(s): Biological
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Cognitive Behavior Therapy on Quality of Life in Paroxysmal Atrial Fibrillation Patients
Condition: CBT
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Health-Related Quality of Life (HRQoL) was commonly impaired in atrial fibrillation patients.
      Depression, anxiety, and illness perception are psychological correlates of HRQoL. Our
      previous study had shown good effects of CBT on the quality of life in AF patients. This
      study aimed to establish the long-term efficacy of CBT on both psychological distress and
      HRQoL. Method: The study was a prospective, open study, pseudo-randomization with a
      pretest-posttest design and a 6-month follow-up. A total of 102 patients with paroxysmal AF
      were enrolled, and 90 patients were assigned (1:1) to 10 weeks of CBT focused on anxiety
      symptoms or to treat as usual in the end. Item Short Form Health Survey (SF-12), GAD-7,
      PHQ-9, University of Toronto Atrial Fibrillation (AFSS), and Brief Illness Perception
      Questionnaire (BIPQ) were measured as outcomes.
    


Intervention name(s): Cognitive Behaviour Therapy
Intervention type(s): Behavioral
Intervention description(s): The CBT module was adjusted as follows: (1) Health education about paroxysmal atrial fibrillation; (2) Self-awareness training; (3) Exposure training; (4) Habitual reversal training；(5) Correcting cognitive distortion; (6) Behavioral activation (7) Specific training for anxiety; (8) Practice and feedback; (9) Relapse prevention; (10) Review.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
Condition: Streptococcus Pneumoniae; Haemophilus Influenzae
MeSH terms: Influenza, Human; Pneumonia; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2
      formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in
      young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an
      interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third
      dose of the vaccine at Month 6. The protocol posting has been updated following a protocol
      amendment.
    

Detailed description: 
      This Protocol Posting has been updated following amendment of the Protocol, January 2010. The
      sections impacted are: study design and study endpoints.
    

Intervention name(s): GSK2231395A; Engerix-B
Intervention type(s): Biological; Biological
Intervention description(s): Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.; Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Non-typable Haemophilus influenzae; protein vaccine; Streptococcus pneumoniae; young adults
A Practice-nurse Addressed Intervention to Improve Type 2 Diabetes Care
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      A huge challenge in type 2-diabetes care is how to motivate patients towards health behaviour
      changes. In Denmark, the tendency is that nurses in general practice provide a large part of
      type 2 diabetes care.

      Observational studies support Self-determination Theory by finding autonomous motivation and
      perceived competence associated with improved HbA1c-levels in patients with type 2 diabetes.
      Hence, research is needed to develop and test interventions that are autonomy supportive.

      Aim To develop a training course for practice-nurses in autonomy support in patients with
      type 2 diabetes, and to evaluate the effect on patient outcomes.

      Methods The development of the intervention was based on literature research and expert
      meetings. The intervention is evaluated in a cluster randomised controlled trial with 40
      Danish general practices,

        -  where nurses, before enrolment in the study, provided consultations to patients with
           type 2 diabetes,

        -  and about 2500 patients with type 2 diabetes, identified in a Diabetes Database.

      The patients will be followed 15 months from nurse-participation in the course. Data will be
      obtained from registers and patient-questionnaires. The hypothesis is that patients with type
      2 diabetes regardless of education level, age, and gender will benefit from the intervention.
    


Intervention name(s): Training course for practice nurses in autonomy support
Intervention type(s): Behavioral
Intervention description(s): An interactive course consisting of 4X4 hours education in autonomy support over a 6 months period. The main-components in the course are 1) communication skills, 2) introduction to patient work-sheets and 3) a quick up-to-date knowledge about treatment recommendations of type 2 diabetes. Furthermore, the nurses in the intervention-practices receive a half an hour support-visit 4-5 months after the end of the course.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Motivation; patients with type 2 diabetes; practice nurses; general practice; Self-determination Theory
Biomarker and DNA Collection in Subjects Participating in Protocol 22003
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome
Study type: Observational

Summary: 
      The subjects that meet the inclusion and exclusion criteria and consent to participate in
      protocol 22003 will be offered participation in 22003A which will evaluate secreted protein
      before and after treatment with STX209 and placebo to determine if they correlate with
      effectiveness of treatment or susceptibility to treatment with STX209. These same subjects
      will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection.
      The investigators will study the DNA to determine if STX209 works better in people with
      specific gene variations, or to find new gene variations that predict how well STX209 works.
    


Intervention name(s): STX209
Intervention type(s): Drug
Intervention description(s): collection of serum for DNA to elucidate a potential biomarker for patients with ASD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Autism Spectrum Disorder subjects
      
Biospecimen description: 
      DNA from blood, plasma
    
Keywords: fragile X syndrome; biomarkers