bioihbjkbjnl/mcl2 huggingface dataset:
Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
Condition: Chronic Hepatitis B; Late Pregnancy; Transmission; Complication
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of telbivudine and
      lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in
      highly viraemic mothers.
    

Detailed description: 
      This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient
      clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from
      gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL
      and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of
      hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive
      telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no
      treatment as per their preference. All infants will receive standard immunoprophylaxis. Data
      is collected from patient records using data extraction forms. Primary endpoints are vertical
      transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine
      use.
    

Intervention name(s): Telbivudine; Lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): LdT 600mg QD; LAM 100mg QD
Other intervention name(s): LdT; LAM
Intervention MeSH terms: Lamivudine; Telbivudine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Telbivudine; Lamivudine; safety; efficacy; pregnancy
Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate
      efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control
      (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment,
      treatment and follow-up visits. Treatment period is 14 days.
    

Detailed description: 
      The study sample consists of male and female subjects aged between 18 and 60 years-old,
      either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled,
      but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient
      has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole)
      and the other foot will be allocated to active control (Ketoconazole). Randomization will
      determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole.
    

Intervention name(s): Dapaconazole; Ketoconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renal PK Study of LC350189
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the
      effect of renal impairment on the PK and PD of LC350189.
    


Intervention name(s): LC350189 200 mg
Intervention type(s): Drug
Intervention description(s): Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the use of a sonic toothbrush alone is more
      effective than two other toothbrushing protocols on dental plaque elimination in patients
      with fixed orthodontic appliances.
    


Intervention name(s): sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04); manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®); manual toothbrush (elmex® Inter X medium toothbrush); manual toothbrush (elmex® Inter X medium toothbrush)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets; toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets; toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets; toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets
Other intervention name(s): Philips Sonicare® FlexCare; elmex® Inter X medium toothbrush / interdental brush Curaprox®; elmex® Inter X medium toothbrush; elmex® Inter X medium toothbrush
Intervention MeSH terms: Olaflur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: orthodontics; toothbrush; interdental brush; oral hygiene
Digital Impression in Neonates
Condition: Unilateral Complete Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      The goal of this [clinical trial] is to [explore the attitudes of guardians with different
      educational background regarding the technique of impression registration as well as the
      compliance to using feeding appliances ] in [neonates].

      Researchers will compare [conventional impression technique to digital impression]
    


Intervention name(s): Conventional impression; Digital impression
Intervention type(s): Other; Other
Intervention description(s): Palatal impressions obtained using an irreversible hydrocolloid impression material; after obtaining stone models from conventional impression material, stone models were scanned using the I700 (Medit) scanner and Patients were directly scanned intraorally using an intraoral 3D scanner Subsequently, the printed 3D model scan data of the seven patients were then used for standard triangulated language (STL)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Paired design "Same patients receive conventional impression and digital"
Masking: None (Open Label)
Primary purpose: Treatment
PaO2/FiO2*PEEP (P/FP) Ratio and Mortality in Acute Respiratory Distress Syndrome.
Condition: Adult Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      The PaO2/FiO2 (P/F) ratio is same for all the Positive End Expiratory Pressure (PEEP) ≥ to 5.
      This P/F ratio misleads the severity of disease without the knowledge of set PEEP. The
      Oxygenation status is actually worse when the patient is using high PEEP.

      P/F Ratio doesn't include PEEP in the calculation.The P/F ratio doesn't show the severity of
      the disease appropriate for the set PEEP.

      PaO2/(FiO2 X PEEP) P/FP Ratio is a new Formula which addresses this gap to appropriately
      calculate the severity of the disease by including PEEP in the formula.

      This formula is used to predict mortality for different severities of ARDS.
    

Detailed description: 
      The Main aim of this study is to analyse whether this formula can early diagnose the severity
      of the disease appropriate for the set PEEP, so the Rescue measure can be started early which
      can eventually decreases the mortality.

      Increasing the PEEP Value with the same Fio2 gives a different PaO2 and SpO2. The oxygenation
      improves substantially by increasing only the PEEP. So including the PEEP in calculating the
      severity of Oxygenation is better than the current practice.

      The current Definition of ARDS for Oxygenation is P/F Ratio of 300 to 200 is Mild, 200 to 100
      is Moderate and less than 100 is Severe ARDS with PEEP ≥ 5.

      The New P/FP Ratio of 300 to 200 is mild, 200 to 100 is moderate and less than 100 is severe
      Adult Respiratory Distress Syndrome (ARDS) for all the different levels of PEEP values.
    

Intervention name(s): P/FP Ratio
Intervention type(s): Diagnostic Test
Intervention description(s): PaO2/Fio2 X PEEP
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All Intubated Patients admitted to ICU for ARDS and Non ARDS indications.
      
Keywords: P/FP Ratio; ARDS Definition; Severity of Oxygenation in ARDS
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Non-Fasting Conditions
Condition: FED
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's
      test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in
      healthy, adult, human male subjects under non-fasting conditions and to assess the
      bioequivalence.
    

Detailed description: 
      This was an open-label, balanced, randomized, two-treatment, two-period, two-sequence,single
      dose, crossover bioequivalence study in healthy, adult, human, male subjects under
      non-fasting conditions.92 healthy male adults were enrolled.A washout period of 07 days was
      maintained between the successive dosing days.One tablet containing mycophenolate mofetil 500
      mg was administered orally with 240 mL water in sitting posture, after 30 minutes of serving
      of the high fat and high calorie breakfast in each period. This activity was followed by a
      mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the
      first three hours after dosing.
    

Intervention name(s): Mycophenolate Mofetil
Intervention type(s): Drug
Intervention description(s): Mycophenolate Mofetil 500 mg tablets
Other intervention name(s): Cellcept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years
Condition: Measles
MeSH terms: Measles
Study type: Interventional
Phase: Phase 2

Summary: 
      Partially randomized, controlled Phase II study to evaluate safety, immunogenicity and dose
      response of the measles vaccine MVA mBN85B in healthy children aged 6 months to 6 years.
    

Detailed description: 
      Open label study to assess the safety and immunogenicity of MVA-mBN85B in healthy
      vaccine-naive, measles-naive and measles-experienced children. The study is comprised of
      three groups with 30 children each. Two groups will receive two subcutaneous (s.c.)
      immunizations 4 weeks (28±3 days) apart of either either 1 x 10E7 TCID50 (Group A) or 1 x
      10E8 TCID50 (Group B) MVA mBN85B. The control group (Group C) will receive two s.c. doses
      (0.5 ml, 1000 TCID50) of Rouvax® (Sanofi-Pasteur) 24 weeks apart.
    

Intervention name(s): MVA-mBN85B; MVA-mBN85B; Rouvax
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Low Dose arm, 1x 10E7 TCID50; Normal Dose arm, 1x 10E8 TCID50; Standard measles vaccine, approved in South Africa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Measles; Virus Disease; Paediatric Diseases; Paramyoxyviridae
Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The main objective is to develop models for the cortical reorganization of motor areas and
      inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the
      fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to
      correlate the latter with the early phases of motor recovery over the same period, as
      measured by the test Fugl-Meyer.
    

Detailed description: 
      The secondary objectives of this study are:

      A. To evaluate changes in functional outcomes (Box and Blocks Test and NineHolePeg Test from
      Day 0 to Day 60.

      B- To evaluate changes in autonomy (Barthel Index) from Day 0 to Day 60.
    

Intervention name(s): Physiotherapy; Occupational therapy; Functional near-infrared spectroscopy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Physiotherapy regimen (days 0 to 60): orthopedic maintenance, work on trunk balance, sensorimotor techniques for restoration of motor skills, exercises for standing balance and walking. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. They occur as daily sessions during the first two weeks and then two sessions / day.
This is part of routine care.; Occupational Therapy (days 0 to 60): Orthopaedic maintenance, exercises for sitting and standing balance, sensorimotor techniques for the restoration of motor skills, grip exercises. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. 1 session is performed per day.
This is part of routine care.; During the therapy protocol, cortical activation measures using the fNIRS method will be conducted every 15 days (at Day0, Day 15, Day 30, Day 45 and Day 60 for 5 sessions in total) at the technical platform of the Grau du Roi physical therapy centre, during the completion of a standardized motor task (maintaining a level of force) using the healthy upper limb and the paretic upper limb.
Other intervention name(s): fNIRS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunological Characteristics of a Population at Risk of Cholera After Oral Cholera Vaccine (CHOVAXIM)
Condition: Diarrhea Infectious
MeSH terms: Cholera; Dysentery; Diarrhea
Study type: Interventional

Summary: 
      The purpose of the study is to find out if individuals who received first and second dose of
      Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed
      protection against future attacks to cholera. The investigators also want to investigate
      whether vitamin A deficiency and being HIV positive increases the chances of suffering from
      cholera.
    

Detailed description: 
      Cholera is caused by toxigenic strains of Vibrio cholerae O1 and O139 and is characterised by
      sudden onset of acute watery diarrhoea that can lead to severe dehydration and ultimately
      death if not treated. Zambia, has continued to experience cholera outbreaks in several parts
      of the country. In order to curb the disease outbreaks, the World Health Organisation (WHO)
      recommended introducing cholera vaccination as a supplementary cholera control measure
      together with other prevention and control strategies, in endemic areas as well as in other
      places at risk for cholera outbreaks. OCV has recently been introduced to Zambia where a
      large population was vaccinated with 1 dose of Shanchol®, and about 6 months later over 70%
      individuals traced to receive a second dose.

      Considering the annual outbreaks of cholera in Zambia, there is urgent need to determine
      whether Shanchol® is able to elicit a sufficient and specific immunological response in
      individuals who received OCV in Zambia. This study will also help the investigator understand
      whether there are immune response differences based on genetics and may indicate whether some
      people may need more vaccine regimens than others.

      Objective 1: To profile cholera specific antibody status of a population at risk of cholera
      before and after receiving 1st and 2nd dose of shanchol ® oral cholera vaccine (OCV)
      Objective 2: To profile and characterize cholera specific B and T lymphocyte phenotypes among
      the immunized Zambians Objective 3: Develop and evaluate a non-invasive proxy measure of OCV
      immune responses Objective 4: To measure the protective value of immunizing HIV-infected
      individuals through measurement of the neutralization capabilities OCV generated antibodies
      Objective 5: To assess the impact of ABO blood groups on cholera antibody generation
    

Intervention name(s): OCV Vaccine
Intervention type(s): Biological
Intervention description(s): 2 doses of OCV were administered to all enrolled participants 1st dose administered at baseline and second dose administered 28 days post 1st dose.
Intervention model: Single Group Assignment
Intervention model description: A pre/post-vaccine study involving a cohort of individuals receiving an oral cholera vaccine in response to a cholera outbreak in the Lukanga Swamps.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diarrhea; HIV; Vaccines
Sacro-Spinous Ligaments Anterior Apical Anchoring
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here
      to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
    

Detailed description: 
      Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently
      anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS)
      ligaments commonly used for the posterior compartment reconstruction. The SS ligament
      suspension for apical support mesh fixation is thought to yield higher and stronger anchoring
      point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous
      ligament are both, feasible and effective.
    

Intervention name(s): Anterior Sacro-Spinous
Intervention type(s): Procedure
Intervention description(s): Anterior Sacro-Spinous
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients suffering advanced pelvic organ prolapse with anterior predominance and
        apical supportive defect, reffered to mesh reconstruction.
Assessing The Visual Performance Of Hanita Lenses "Intensity SL" Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The Hanita Lenses Intensity SL IOL is intended for implantation in the capsular bag in the
      posterior chamber in order to replace the crystalline lens of the eye to attain visual
      correction of aphakia in adult patients in whom a cataractous lens has been removed, who
      desire improved uncorrected vision, useful near, intermediate and far visual functions, and
      reduced spectacle dependence.
    

Detailed description: 
      Different multifocal intraocular lens (MIOL) designs have been used for more than 25 years1.
      Unlike conventional mono focal intraocular lenses (IOLs), which bend light to a single focus
      point on the retina, MIOLs are designed to help patients to see at varying distances using
      different points of focus2. MIOLs used in clinical practice were either refractive initially,
      or later diffractive in their optical design. Refractive MIOLs incorporate a lens optic with
      different optical powers in different parts of the lens, while diffractive MIOLs use
      diffractive steps on the lens to distribute light rays into two or more principal foci.
      Irrespective of the design type, however, all MIOLs involve some form of optical compromise
      and a process of neuroadaptation for the patient3.

      Intensity SL intraocular lenses (IOLs) represent the latest in premium lens technology.
      Intensity SL lenses provide clear vision at all distances - from near to far - thus offering
      the best chance of true spectacle independence.

      Despite the promising results obtained with the latest generation of MIOLs, many surgeons
      remain reluctant to implant these lenses. Visual symptoms such as glare and haloes, reduced
      contrast sensitivity and night vision problems are all known complications of multifocal
      implants and have served to hamper wider acceptance of these IOLs4.

      Hanita Lenses new Intensity SL IOL has been designed to have very high efficiency of light
      leading to a high MTF, wide focal ranges of far, intermediate and near vision and minimal
      loss of light energy. The main purpose of this study is to evaluate visual acuity and
      contrast sensitivity patients receiving the new Intensity SL IOL.
    

Intervention name(s): "Intensity SL" Intraocular Lens
Intervention type(s): Device
Intervention description(s): Cataract surgery and intraocular lens implantation
Intervention model: Single Group Assignment
Intervention model description: single arm single center, open label study
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels
Condition: Healthy Volunteers; Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested)
      and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which
      one is decided by chance. The study medicine for each person is chosen by a computer. A dummy
      medicine (placebo) looks like the study medicine but has no effect on the body. The dummy
      medicine needs to be used in the study to find out if the study medicine works as expected.
      The dose of the study medicines that participants receive will depend on which group they get
      into. The study has 4 groups of 8-15 participants in each. Each group will get a different
      dose of NNC0385-0434 or placebo. Participants and the study doctor will not know which of the
      study medicine/dose participants will get. However, if a participant's safety is at risk, the
      study doctor will be told in order to decide the future treatment. NNC0385-0434 may help to
      clear cholesterol from the blood. When there is less cholesterol circulating in the blood
      over a long period of time, then there is less risk of arteries (blood vessels) being clogged
      or developing diseases of the heart and blood vessels. Each participant will get one
      injection under the skin and will be in the study for about 4 months.
    


Intervention name(s): NNC0385-0434; Placebo (NNC0385-0434)
Intervention type(s): Drug; Drug
Intervention description(s): Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin); Healthy volunteers will receive one injection s.c.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four (4) cohorts are planned. In 3 cohorts, healthy subjects will be randomised in a 3:1 manner to receive either: 1) NNC0385-0434 or 2) Placebo (NNC0385-0434). Each cohort will last 10 weeks and there will be 3 weeks between cohorts. Following safety observation, a fourth cohort will be initiated with patients with hypercholesterolaemia. Patients will be randomised in a 2:1 manner to receive either: 1) NNC0385-0434 or 2) Placebo (NNC0385-0434).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment