bioihbjkbjnl/mcl2 huggingface dataset:
The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct
      topical application to prescription medication when administered daily over the course of
      four weeks, in moderate to severe rosacea in comparison to the control regimen (CR).
    


Intervention name(s): Burt's Bees Skin Care Regimen; Control Regimen
Intervention type(s): Other; Other
Intervention description(s): Burt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime); Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Comparison of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery
Condition: Postoperative Pain; Soft Tissue Bleeding; Wound Heal
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The study evaluates postoperative pain, intraoperative bleeding and wound healing after
      second stage implant surgery. Submerged implants were exposed with diode laser in Group 1
      (n=20) and by using Er,Cr:YSGG laser in Group 2 (n=20).
    


Intervention name(s): 940 nm Gallium Aluminum Arsenide Diode Laser; 2780 nm Er,Cr:YSGG Laser
Intervention type(s): Device; Device
Intervention description(s): Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with diode laser for placing the healing abutment.; Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diode Laser; Erbium Laser; Second-stage Implant Surgery
Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology
Condition: Patient Monitoring
Study type: Interventional

Summary: 
      This trial is multi-center prospective study to develop Patient Transfer Monitoring system
      using mobile lot network and the Risk Factor Detection System and apply to real In-Hospital
      Patients and verify the efficacy.
    

Detailed description: 
      Hospitalized patients who need transfer for a diagnostic examination or rehabilitation
      therapy during hospitalization, and have a risk of hypoxemia during transfer will be enrolled
      in this trial. The subjects will be provided with a portable oximeter and a smart-phone which
      application for monitoring is installed, and oxygen saturation and pulse rate will be checked
      in real time during transfer. The collected data will be transferred to cloud system via Iot
      network, and the transmitted data will be monitored in real time via monitoring equipment in
      the (Patient-hospitalized) ward. If there is a risk, the alarm system is activated so that
      the medical team is able to check risk factor and manage it immediately.

      All the risk factors and severity will be collected during transfer, also these are checked
      whether the monitoring system and the data transmission system work properly or not, the time
      from detecting risk factor to medical response, the composition of medical staffs who
      responding to alarmed risk factors and improvement of the subjects.

      Pilot study will be conducted with 20 subjects in Asan medical center. In pilot study,
      monitoring machines (HR, SpO2 monitor) commonly used in wards or hospitals will be used to
      verify the stability of oximeter used in this study and the developed risk detection system.
    

Intervention name(s): Patient Transfer Monitoring System
Intervention type(s): Other
Intervention description(s): The subjects will be provided with portable oximeter and smart-phone which application for monitoring is installed, and the transmitted data will be monitored in real time via monitoring equipment in the (Patient-hospitalized) ward.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: mobile IoT technology; Patient Transfer Monitoring System
Clinical Study on the Efficacy and Safety of BAT5906 Injection
Condition: Wet Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-center, open, and phase II clinical study to evaluate the efficacy and
      safety of BAT5906 injection in patients with wet age-related macular degeneration. The
      results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher
      doses (2.5 mg and 4 mg) may be substituted for the duration of maintenance efficacy; drugs
      with the same target (such as brolucizumab and Abecip) have also been found in clinical
      studies High doses can extend the interval and reduce the frequency of administration.
      Therefore, in this study, two doses with better safety and efficacy were selected, once every
      4 weeks, followed by 3 consecutive injections for treatment as needed, and preliminary
      exploration of the best clinical effective dose and replacement frequency
    


Intervention name(s): 2.5mg of BAT5906; 4mg of BAT5906
Intervention type(s): Drug; Drug
Intervention description(s): Specification: 2.5mg of BAT5906; Specification: 4mg of BAT5906
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Foxiga Korea Local Phase 4 Study
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect of dapagliflozin on body composition in Korean T2DM subjects.12-month,
      randomised, open-label, parallel-group, multi-centre phase IV study.
    

Detailed description: 
      This is a 52 weeks, randomized, open-label, parallel-group, multi-centres phase IV study.

      Participants will be randomized 1:1 to receive dapagliflozin 10 mg qd or glimepiride 1~2 mgqd
      in an open-label manner for 12 months as add-on to metformin 1000 mg.

      Parallel group study design was chosen. In order maintain the practicality of the phase IV
      study, open label design of study drug delivery was chosen. The reading of the DXA scans will
      be conducted by one expert in blinded manner. Glimepiride is the most frequently used SUs in
      Korea and therefore this was chosen as comparator.Dapagliflozin treatment will be associated
      with reduction of total body FM, BW, abdominal VAT and SAT volume compared with glimepiride.
    

Intervention name(s): Dapagliflozin; Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment; Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment
Intervention MeSH terms: Dapagliflozin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DM
Effect of Physical Activity Through Interactive Video Games in Overweight Children
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of interactive video game in management
      of overweight in children. The investigators will evaluate the effect of product versus
      standard physical activity.
    

Detailed description: 
      Background. Child Overweight and obesity are a world public health problem, in low income
      countries is more. One difficulty in the management is the poor adherence to physical
      activity, some studies show that active video games could improve this.

      Objective: Establish the effect of the introduction of active video game (Nintendo Wii) on
      fitness, anthropometry and adherence to treatment, as part of an intervention program for the
      management of childhood obesity in children over 5 years of age with obesity Methodology: A
      clinical trial, randomized and controlled. children between 5-10 years with a diagnosis of
      overweight or obese, were divided into two groups. (Wii group), received 3 weekly sessions of
      one hour of physical activity by an active video game, the other group (control group)
      received 3 weekly sessions of one hour of physical activity by static exercises.
    

Intervention name(s): Nintendo Wii
Intervention type(s): Other
Intervention description(s): Tennis, box and bowling on Nintendo Wii, 3 hours per week.
Other intervention name(s): active video games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMI; Obesity; overweight; child; Physical activity
Early Detection of Lung Cancer in a High-Risk Population Defined by PFT, Biomarkers, and CT Scanning
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Lung cancer is the number one cancer killer in Kentucky and has a very high incidence within
      the 5th Congressional District of Kentucky (110.8 cases per 100,000 in period 1996-2000).
      Surgical removal provides the best chance for cure. Unfortunately, the majority of lung
      cancer cases are detected in an advanced stage, when surgical resection is impossible. This
      leads to shorter survival rates and increased mortality rates for lung cancer, increased
      patient suffering, and greater cost to the healthcare system. Methods that favor earlier
      detection are therefore crucial for successful treatment. One such method, low-dose spiral
      computed tomography (CT) is being studied to determine whether its use as a screening method
      will lead to earlier detection and earlier intervention, perhaps impacting survival and
      mortality in lung cancer. This method has a modest sensitivity to detect lung cancer, but low
      specificity, which leads to many false positives and a low negative predictive value. The
      present study is designed to address both of these limitations by: 1) identifying individuals
      in the population at highest risk for developing lung cancer (due to smoking habits and
      decreased pulmonary function) for subsequent CT screening, and 2) performing biomarker
      testing in conjunction with the CT scan to improve the ability to discern individuals with
      benign lung nodules from those with malignant tumors. The 5th Congressional District of
      Kentucky has one of the highest rates of lung cancer in the nation and is an ideal location
      to test the validity (sensitivity and specificity), feasibility (negative and positive
      predictive value), and efficacy (stage distribution shift to earlier stage disease, increased
      survival, and decreased cancer-specific mortality) of these strategies to enhance early
      detection.
    


Intervention name(s): CT
Intervention type(s): Other
Intervention description(s): Screening CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Lung cancer; screening
A Study of Balapiravir in Patients With Dengue Virus Infection
Condition: Dengue
MeSH terms: Virus Diseases; Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the
      safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue
      virus infection whose symptoms began within the 48 hours preceding the first administration
      of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally
      twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an
      out-patient follow-up to week 12. Target sample size is <200
    


Intervention name(s): balapiravir [RO4588161]; placebo
Intervention type(s): Drug; Drug
Intervention description(s): sequential cohorts receiving doses orally twice daily for 5 days; orally twice daily for 5 days
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Photobiomodulation Laser Therapy for COVID-19 Positive Patients With Pulmonary Disease
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment
      for pulmonary complications due to COVID-19 infection.
    

Detailed description: 
      Participants will be randomized into treatment vs. control group. Both groups will receive
      regular inpatient medical treatment. Participants in the experimental arm will receive laser
      treatments once daily for 4 days. Treatments will be delivered to the patients in a prone
      position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard
      nursing protocols would be used to identify participant's pulmonary status throughout
      treatment.
    

Intervention name(s): MLS Laser; Regular Inpatient Medical Care
Intervention type(s): Device; Other
Intervention description(s): Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.; Regular inpatient medical care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will utilize a randomized parallel assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID; Laser; Pulmonary
Cerebrospinal Fluid Rhinorrhea After Functional Endoscopic Sinus Surgery
Condition: Cerebrospinal Fluid Leakage
MeSH terms: Cerebrospinal Fluid Leak
Study type: Observational

Summary: 
      Sinus surgery is a common procedure. A potential complication is injuring the membranes of
      the brain. This can lead to leakage of brain fluid through the nose. We would like to
      estimate the incident rates of that complication. At the end of the operation, a thin gauze
      is inserted into the nose on both sides in addition to the usual tampon. This gauze will be
      analyzed at the laboratory for beta-2-transferrin, which is a biomarker for brain liquid.
    

Detailed description: 
      Sinus surgery is a common procedure in rhinology for the treatment of chronic inflammation,
      tumors and other pathologies. These procedures are performed in the immediate vicinity of the
      skull base. The risk of injuring the membranes covering the brain in a way that requires
      further treatment is less than 1% [ 1]. Such Injuries to the skull base could lead to the
      loss of cerebrospinal fluid (CSF). The destruction of the natural barrier raises the
      potential risk of ascending infections of the membranes and the brain itself from the nose.
      Leakage of cerebrospinal fluid in the usually bloody surgical field of view is not always
      distinguishable and is sometimes only noticed postoperatively. The spontaneous closure of a
      leaky membrane of the brain without further surgical treatment is known. This is why small
      traumata in the skull base often remain undetected.

      At the end of the operation, a thin gauze is inserted into the nose on both sides in addition
      to the usual tampon. The tampon and the additional gauze are removed the day after the
      operation and will be sent with a tube of venous blood to the laboratory. The gauze and the
      venous blood will be checked for beta-2-transferrin, which is a biomarker for cerebrospinal
      fluid.

      During further clinical standard controls will the patient be asked about symptoms of fluid
      leak through the nose.

      If positive, regardless to this study, the patient must have an additional CT scan of the
      sinuses and another blood sample checking for beta-2-transferrin.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with indication to a sinus intervention without planned opening of the skull base
      
Biospecimen description: 
      RNA Samples
Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine that the efficacy of the sustained release (SR)
      formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR)
      formulation.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Seroquel SR
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia
Spine Quantitative Computed Tomography (QCT) for the Assessment of Osteoporosis on Children
Condition: Systemic Lupus Erythematosus
MeSH terms: Osteoporosis; Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      The purpose of this study is to compare healthy children to children who have systemic lupus
      erythematosus (SLE). SLE is a childhood disease that has high risk for low bone mass and
      vertebral compression fractures.
    

Detailed description: 
      The purpose of this research study is to measure bone mass in children with SLE using
      different measurement techniques. Children with chronic illnesses are at risk of bone
      fragility. This is important because bone fragility can result in childhood fractures
      especially children with SLE. Therefore better diagnosis technique can lead to better
      management of bone health.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        200 control patients (124 controls participated in unique protocol ID: 2007-10-5528 data
        will be used for this study, we will be trying to recruit about 76 control patients for
        this study) and 30 study patients with SLE
      
Biospecimen description: 
      urine
    
Keywords: Systemic Lupus Erythematosus; SLE; Lupus; children with SLE
Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors
Condition: Quality of Life
Study type: Interventional

Summary: 
      This study aimed to evaluate the effects of a biopsychosocial-spiritual (BPS-S) Group
      intervention on quality of life among seniors with disabilities in long-term care residential
      settings.
    

Detailed description: 
      Background: Traditionally, biomedical care approach has been insufficient to meet the complex
      needs of older people living with multi-morbidity. Promoting whole-person wellness and better
      quality of life becomes a key goal of care in residential long-term care facilities. The
      integrative approaches composed of physio-psycho-social and spiritual components might be a
      viable strategy to assist older adults accept uncontrollable life changes and enhance
      holistic wellness.

      Purpose: The study purpose was to develop and evaluate the effects of 8-week
      biopsychosocial-spiritual (BPS-S) group intervention versus usual care on self-perception of
      quality of life (QoL) and meaning in life among seniors with disability in residential care
      home at mid- and post-intervention, and at a 1-month follow up.

      Methods: This single-blind randomized controlled trail with repeated measures design was
      conducted in residential long-term care facilities. Both the experimental groups (EG) and the
      control group (CG) received routing group activities based on their institution's schedule.
      Additionally, the EG received 8 sessions of weekly BPS-S group therapy for 80 minutes each.
      The baseline characteristics of residents with disabilities (including demographic
      information, length of stay in the institution and medical conditions) were collected using a
      data sheet, and activities of daily living of these residents were measured using the Barthel
      Index. To evaluate the effectiveness of the BPS-S group therapy, the primary outcomes
      including "participants' overall QOL" and the secondary outcome "meaning in life" were
      assessed at four time points: before, mid- and post- intervention and at a 1-month follow up.
      Quality of Life Index (QLI)-Part I and Purpose in Life (PIL) test were used to measure these
      outcome variables, respectively.
    

Intervention name(s): the Biopsychosocial-Spiritual Group Intervention
Intervention type(s): Behavioral
Intervention description(s): The Experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Quality of Life; Institutionalized seniors; Disabilities; Meaning in life; Biopsychosocial-Spiritual group intervention
A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of the study is to test the effectiveness of a community pharmacist-led
      intervention to increase adherence to lipid lowering treatment.
    

Detailed description: 
      Medication non-adherence represents an important threat to the health of the Western people.
      A large number of pharmacy records based studies demonstrated that adherence to lipid
      lowering treatment in daily practice is substantially worse compared to adherence observed in
      the controlled setting of randomized controlled trials. In addition, the relationship between
      non-adherence with statin-treatment assessed with pharmacy records and cardiovascular
      outcomes has been convincingly demonstrated. This implies that pharmacy records can and
      should be used to identify non-adherent patients and thus patients at risk for major
      cardiovascular events. Using this data, community pharmacists can play a more substantive
      role in developing the concept of pharmaceutical care. The objective of the study is to test
      the effectiveness of a community pharmacist-led intervention to increase adherence to lipid
      lowering treatment.
    

Intervention name(s): advanced adherence counseling+reminder; Compliance Card
Intervention type(s): Behavioral; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Adherence; Compliance; Statins; Intervention; Hypercholesterolemia