bioihbjkbjnl/mcl2 huggingface dataset:
Implementation of Bedside Pediatric Early Warning Systems (PEWS)
Condition: Clinically Deteriorating Paediatric Patients
Study type: Observational

Summary: 
      Timely identification, referral and treatment of children who are clinically deteriorating
      while admitted to hospital wards is a fundamental element of inpatient care. In community
      hospitals, advantages including greater continuity of inpatient-outpatient care, improved
      geographic access for families, and lower healthcare system costs, may be undermined if
      children with evolving critical illness are not recognized and transferred in a timely
      manner. The Bedside Paediatric Early Warning System (Bedside PEWS) is a system of care
      designed to augment existing expertise and to provide a safety net for children who are
      clinically deteriorating while admitted to hospital wards. The Bedside PEWS is comprised of 4
      components; [1] an expert derived, multi-centre validated severity of illness score, [2] an
      inter-professionally developed documentation record into which the severity of illness score
      is embedded, [3] a series of score-matched care recommendations based on the opinions of over
      280 paediatric health care professionals, and [4] an educator-developed
      education-implementation program.
    

Detailed description: 
      We will be performing a prospective observational study of care outcomes, physician workload
      and frontline staff perceptions before and after the implementation of Bedside PEWS in a
      community paediatric hospital. We plan to evaluate the outcomes of patients who were admitted
      to the 22-bed paediatric inpatient unit and were less than 18 years of age at hospital
      admission, and the healthcare professionals caring for them during their inpatient stay.
    

Intervention name(s): Bedside Paediatric Early Warning System (Bedside PEWS)
Intervention type(s): Other
Intervention description(s): The Bedside PEWS is comprised of 4 components; [1] an expert derived, multi-centre validated severity of illness score, [2] an inter-professionally developed documentation record into which the severity of illness score is embedded, [3] a series of score-matched care recommendations based on the opinions of over 280 paediatric health care professionals, and [4] an educator-developed education-implementation program.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to the 22-bed paediatric inpatient unit and were less than 18 years of
        age at hospital admission
      
Keywords: Bedside Pews; Credit Valley Hospital; The Bedside Paediatric Early Warning System; clinically deteriorating
Study to Evaluate the Safety of Rotarix™ in Chinese Children
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy
      children aged 2 to 6 years in China.
    


Intervention name(s): Rotarix ™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Oral, single dose; Oral, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Rotavirus vaccine
Perfetti Method in Upper Extremity of Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The cognitive sensory motor training therapy (Perfetti's technique) might be more
      effectiveness than conventional occupational therapy on upper extremity function recovery
      after acute stroke patients.
    

Detailed description: 
      Globally, stroke is the second leading cause of death above the age of 60 years, and the
      fifth leading cause of death in people aged 15 to 59 years old. Upper extremities problem is
      still faced with poor prognosis for recovery. Cognitive sensory motor training therapy
      (Perfetti's technique) might be better helped for recovery of upper extremity function in
      stroke than conventional therapy.
    

Intervention name(s): cognitive sensory motor training therapy
Intervention type(s): Other
Intervention description(s): training method that emphasis on cognition/ sensation/ and motor movement together train every working day 45 minutes per day for 4 weeks.
Other intervention name(s): Perfetti; Cognitive sensory motor training; Stroke; Upper extremity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; upper extremity; rehabilitation; perfetti
Study of Echinaforce Junior Tablets in Children With Acute Colds
Condition: Respiratory Tract Diseases
MeSH terms: Respiratory Tract Diseases
Study type: Observational

Summary: 
      This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two
      dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children aged 4 - 12 years recruited in pediatrics practice
An Open-label Study That Will Test a Second Treatment Session of RZL-012.
Condition: Submental Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open-label study in which subjects seeking further improvement of their
      SMF will be treated with a second treatment session of RZL-012.

      The second treatment session will be offered to subjects previously treated with RZL-012
      under protocols RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001. Subjects who fully
      completed either of the trials and whose C-CAT score is 2, 3 or 4 will be eligible to
      participate in the new trial.

      For each subject, the study will consist of a screening period, baseline period in which
      subjects will receive a second treatment session of RZL-012 and a follow-up period. RZL-012
      will be administered during a single treatment session via multiple injections into the
      submental area under the chin. Subjects will thereafter be monitored for safety and efficacy
      for at least 84 days.
    

Detailed description: 
      Screening Period:

      Subjects will be eligible to undergo screening after successful completion of (defined as
      completion of the day 84 visit) of either RZL-012-SMF-SWMTG-P2US-001 or RZL-012-SMFC-P2US-001
      studies. Subjects will undergo screening within 28 days prior 2nd RZL session. During the
      screening period, subjects will be assessed for study eligibility by evaluation of subjects'
      SMF using S-CAT, C-CAT, SIQ8, biochemistry blood tests, 2D photography.

      Day 0/Baseline:

      Subjects will receive a second multi-injection treatment of RZL-012 on Day 0. AEs will be
      recorded. Subjects will be asked about their pain levels using VAS.

      Day 1-Day 84 Follow-Up Period Subjects will return to the site for study visits on Days 1, 7,
      28, 56 and 84 for efficacy and safety assessments.

      Safety assessments will include vital signs, labs, AEs severity assessment, and treatment
      area evaluation. Treatment area evaluations will include evaluation of edema, bruising,
      dysphasia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia,
      pruritus, skin ulceration and necrosis, injury to the marginal mandibular nerve, vascular and
      nerve injury, and tissue damage to nearby vulnerable anatomic structures. Swelling severity
      will be assessed as a function of time. Pain will be assessed using the VAS. Concomitant
      medications will be recorded.
    

Intervention name(s): RZL-012
Intervention type(s): Drug
Intervention description(s): Ready to use drug product for injection into the subcutaneous fat
Intervention model: Single Group Assignment
Intervention model description: Second injection session of RZL-012 will be administered to subjects who previously treated with RZL-012 in submental fat
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Dose Ranging Study of Artesunate
Condition: Falciparum Malaria; Uncomplicated Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate
      for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most
      effective treatment regimen as determined by rapidity of parasite clearance by microscopy.
    

Detailed description: 
      To compare the efficacy and tolerability of intravenous artesunate for the initial treatment
      of uncomplicated Plasmodium falciparum malaria at doses that bracket anticipated clinical
      doses (2.4 mg/kg once daily for 3 days; or 2.4 mg/kg initially, at 12 hours on Day 0, and
      then daily on Day 1 and 2) and thereby establish the safest, highly efficacious dosing
      regimen for use in future clinical trials.
    

Intervention name(s): Artesunate for Injection
Intervention type(s): Drug
Intervention MeSH terms: Artesunate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Bronchodilator Properties and Safety in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent large clinical studies have demonstrated the interest of LAMA therapy in the
      management of asthma, when compared to LABA.

      V0162 is a compound with a very long lasting bronchodilator effect when compared to reference
      treatment in non-clinical models and in COPD patients. Secondary properties of V0162
      (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound
      and could bring option in the treatment obstructive lung disease. The objective of the study
      is to assess the bronchodilator properties of V0162 during 8 days in adult patients with
      asthma usually treated with ICS and LABA. The study is a randomised, double-blind,
      placebo-controlled, 3-period crossover, preceded by an open-label active-control period
      before randomisation.
    


Intervention name(s): V0162; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma, COPD, broncodilator, airway, lung, inhalation, antimuscarinic
Pilot Study of Vedic Medicine for Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the feasibility and effectiveness of a
      multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2
      diabetes.
    

Detailed description: 
      Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda,
      into a single, comprehensive, natural approach to health care. The objectives of this phase
      II pilot trial are to determine the feasibility, acceptability, and safety of implementing a
      multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the
      impact of such a protocol on overall glycemic control.
    

Intervention name(s): Vedic Medicine; Vedic Medicine
Intervention type(s): Drug; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2; Vedic medicine; Ayurveda; Transcendental Meditation
A New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems
Condition: Plaque; Gum Disease
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      This 6-month clinical study was designed to investigate clinical efficacy on plaque and
      gingivitis for the Meridol Base Mouthwash containing 0.2% zinc lactate, 0.17% amine fluoride
      and 0.0275% sodium fluoride as compared to a Negative Control Mouthwash containing 0.057%
      sodium fluoride after 3 and 6 months of product use.
    


Intervention name(s): 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash; 0.057% sodium fluoride Mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): mouthwash; mouthwash
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study of Early Nutritional Intervention During Concurrent Chemoradiotherapy for Local Advanced Non-small Cell Lung Cancer
Condition: Local Advanced Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-arm phase II prospective study is to determine the efficacy of early nutritional
      intervention during concurrent chemoradiotherapy for local advanced non-small cell lung
      cancer.
    

Detailed description: 
      This single-arm phase II prospective study is to determine the efficacy of early nutritional
      intervention during concurrent chemoradiotherapy for local advanced non-small cell lung
      cancer.

      Patients in the study group received early nutritional intervention, including individualized
      nutrition counseling and oral nutritional supplements from the initiation of CCRT to 2 weeks
      after its completion. Weekly counseling sessions, conducted by both doctors and nurses, aimed
      to educate patients on regulating their regular dietary intake to meet specific energy,
      protein, and other macronutrient requirements. Dietary advice provided precise instructions
      on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily
      energy intake of approximately 30 kcal/kg. All patients received definitive thoracic
      radiotherapy with total radiation doses of 60-68 Gy, concurrent with weekly docetaxel
      (25mg/㎡) and nedaplatin (25mg/㎡).
    

Intervention name(s): Early Nutrition Intervention from the start of CCRT; Thoracic radiotherapy; Weekly DP chemotherapy concurrent with thoracic radiotherapy
Intervention type(s): Dietary Supplement; Radiation; Drug
Intervention description(s): Nutrition counseling and oral nutritional supplements from the start of radiotherapy; weekly counseling sessions; daily energy intake of approximately 30 kcal/kg.; Definitive thoracic radiotherapy with total radiation doses of 60-68 Gy; Weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡) concurrent with thoracic radiotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Local Advanced Non-small Cell Lung Cancer; Chemoradiotherapy; Early nutritional intervention
Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
Condition: Clostridium Sordellii; Clostridium Perfringens
Study type: Observational

Summary: 
      This primary goals of this study are to: estimate the prevalence of Clostridium sordellii and
      Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive age;
      estimate duration of carriage of the two clostridium species; and estimate the incidence of
      carriage at 2 weeks after a negative test.
    

Detailed description: 
      Since 2000, clostridial pelvic infections have claimed the lives of at least 17 young,
      previously healthy women. The majority of infections detected by molecular methods were among
      women testing positive for Clostridium sordellii only; in 5 cases, deaths were due to
      Clostridium perfringens only; and in 3 cases, the women were positive for both. These deaths
      occurred among both non-pregnant and recently pregnant women. Clostridium has been isolated
      from the vagina in 4-18% of normal, health non-pregnant women, with Clostridium perfringens
      the most common isolate. Most studies do not differentiate the small percentage of other
      clostridia present in the vaginal microenvironment. The vaginal carriage rate for Clostridium
      sordellii remains unknown, but is probably very low, less than 1%.

      The correlates of clostridial carriage are unknown, and data on the etiology and lethality of
      clostridial infection among women of reproductive age are insufficient to guide possible
      courses of safe and effective prevention. In women infected with strains of Clostridium
      perfringens and Clostridium sordellii that produce the lethal toxin, it is not clear whether
      there is an effective treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 5,000 women aged 18 to 45 years in the United States will be enrolled in the
        study. Women will be recruited from approximately 25 clinics and solo or group practices
        providing maternity care (pre- and post-natal), abortion, STI prevention & treatment,
        family planning, and student health services. All women will be recruited, excluding women
        seeking emergency or oncological care.
      
Biospecimen description: 
      Vaginal and rectal swabs
Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series
Condition: Platelets Rich Fibrin, Palatal Donor Tissue
Study type: Interventional
Phase: Phase 4

Summary: 
      Free gingival grafts are important to increase zone of attached gingiva and root coverage.
      This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal
      wound healing. The superior healing observed at the PRF membrane sites supports its use in
      accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious
      approach to protect the raw wound area of a palatal donor site to reduce healing time and
      patient discomfort.
    

Detailed description: 
      Introduction:

      Free gingival grafts are one of the common treatment modalities used to increase the zone of
      keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The
      palatal donor sites had many complications as pain, discomfort and healing by secondary
      intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full
      of growth factors fasten the healing and decrease the pain.

      Materials and methods:

      Ten patients requiring augmentation of KT participated in this case series. The palatal donor
      sites of 7 of these patients were covered with PRF membranes with a new suturing technique
      without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically
      after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed
      during one week in the group with PRF.
    

Intervention name(s): Platelets Rich Fibrin in healing of palatal donor tissue; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain.; the other group is a control group, had no biologic in the palatal wound, only palatal stent
Other intervention name(s): Palatal stent
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Nutrition Education Module for Preschooler Children
Condition: Children Who Registered on the Selected Public Kindergarten and Agree to Follow the Study Assigned by Their Parents and Teacher
Study type: Interventional

Summary: 
      This study evaluates the knowledge of preschooler children before and after intervention of
      nutrition education using nutrition education module for preschooler children. The teachers
      will be given training regarding the module and deliver it in the class during the
      intervention.
    

Detailed description: 
      A nutrition education module for preschooler children had been developed in the previous
      study. The module consists of 3 topics of nutrition (my meal plate, fruits and vegetables,
      healthy snacks). Each topic consists of 4 activities engaging children and teachers. A total
      of 12 activities will be delivered on 4 consecutive school day every week.

      The teacher will deliver the nutrition education which trained prior to the study.
    

Intervention name(s): nutrition education module
Intervention type(s): Behavioral
Intervention description(s): 12 activities of nutrition education module will deliver by the teacher. The activities consists of coloring my meal plate, playing pictures, story telling: Zizi and Ziko, pictures station, fruits and vegetables card, cooking class, planting bean sprouts, field visit to fruits and vegetables garden, making collages, dot to dot, watching video, making healthy snacks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: a quasi-experimental research design with pre-and post-test control group design
Masking: None (Open Label)
Primary purpose: Other
IRT and CBT in Sexual Assault Victims With PTSD
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Sexual assault victims (SAV) have an elevated risk of developing posttraumatic stress
      disorder (PTSD). Trauma-focused cognitive-behavioural therapy (CBT) is an effective
      first-line treatment for this pathology. However, although sleep disturbances are a common
      complaint in SAV with PTSD, trauma-focused CBT does not directly address this symptom.
      Posttraumatic nightmares are widespread among SAV. Trauma-related sleep disturbances are
      associated with significant impairment in general functioning and quality of life (mental and
      physical health), and contribute to the maintenance of PTSD symptoms. This study evaluates
      the efficacy of sequential nightmare therapy (imagery rehearsal therapy; IRT) and
      trauma-focused CBT, in comparison to CBT alone. Forty-two SAV suffering from PTSD and sleep
      difficulties were recruited and randomly assigned to the experimental (IRT+CBT) or control
      condition (waiting period followed by CBT alone). Participants were administered a clinical
      interview and a series of questionnaires assessing PTSD symptoms, general functioning and
      quality of life.
    


Intervention name(s): Cognitive Behavioral Therapy for PTSD; Imagery Rehearsal Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Trauma-focused CBT protocol elaborated by Marchand and Guay from the Trauma Studies Centre at Louis-H. Lafontaine Hospital in Montreal and adapted from Foa, Hembree and Rothbaum (2007); IRT protocol published by Nappi and collaborators (2010)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment