bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer
Condition: Venous Insufficiency
MeSH terms: Varicose Ulcer; Venous Insufficiency; Leg Ulcer
Study type: Interventional

Summary: 
      Objective of this study are to compare the interface pressure by applying ordinary elastic
      bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who
      could apply the optimal pressure with OEB and CPG-EB.
    

Detailed description: 
      For treatment of venous ulcer, it was shown that compression bandaging of 35-45 mmHg
      sub-bandage pressure at the ankle was shown in several studies to be safe and effective.The
      efficacy of compression bandage considerably depends on the applied pressure and it is
      therefore largely dependent on the individual applying bandages. The lower pressure leads to
      treatment failure while the higher pressure leads to skin complication.

      The use of objective devices to proof that the bandage is sufficiently applied is not
      available for every patients. To help the patients to apply the bandage with optimal
      pressure, investigators developed the customized pressure guide elastic bandage (CPG-EB) by
      using sub-bandage pressure guidance.

      Objective of this study are to compare the interface pressure by applying ordinary elastic
      bandage (OEB) and CPG-EB. In addition,investigators compared the percentage of inexperienced
      staffs who could apply the optimal pressure with OEB and CPG-EB.
    

Intervention name(s): customized pressure guide bandage; Ordinary elastic bandage
Intervention type(s): Device; Device
Intervention description(s): Investigators developed the customized pressure guide elastic bandage (CPG-EB). The experienced nurse applied the elastic bandages to each patient with sub bandage pressure monitoring. The target pressure was 35-45 mmHg. Measurements of the pressure applied by bandages was performed at point B1 corresponding to the height where the Achilles' tendon turns into the gastrocnemius muscle with Picopress (MicroLAB Elettronica, Ponte S. Nicolo, Italy). If the target pressure 35-45 mmHg was achieved, the circular ink stamp was applied into the entire bandages. The markers in CPG-EB had elliptical shape when they were not stretched. They turned into circular shape when they were stretched.
For the OEB, Bandaging was applied by spiral methods. Three EB were applied with 50 % stretching and 50% overlapping from foot to just below knee level.; Bandaging was applied by spiral methods. Three ordinary elastic bandages were applied with 50 % stretching and 50% overlapping from foot to just below knee level.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Venous insufficiency; Compression; Bandaging
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine paediatric vaccinations in Italy.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; 7 valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.; Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Infants
Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12,
      EU sourced Soliris, and US sourced Soliris in healthy subjects.
    


Intervention name(s): Eculizumab
Intervention type(s): Drug
Intervention description(s): Eculizumab Injection. 300 mg, single dose
Intervention MeSH terms: Eculizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)
Condition: Peripheral Artery Disease; Femoropopliteal Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of
      the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment
      of femoropopliteal artery disease.
    

Detailed description: 
      Although clinically effective, the manufacturing process of first generation PCB coatings
      contributed to inconsistent drug concentrations, particulate formations on the balloon
      surface and their shedding during the interventional procedures. As a consequence
      developments of new PCB coatings have been proposed to address consistency, uniformity, small
      particle drug coverage, which may potentially contribute to improved vessel healing profile
      and improved clinical outcomes. Nevertheless, data on the safety and efficacy of this novel
      coating developments in the clinical setting remain limited. Previously in the experimental
      model, the investigators reported that delivery of paclitaxel via a novel mcPCB resulted in
      low long-term tissue retention of paclitaxel, however displayed reduced neointimal
      proliferation and favorable healing profile. Therefore in current clinical trial the
      investigators will address the feasibility and safety of the mcPCB (PAK, Balton) in the
      treatment of femoropopliteal restenotic disease in a prospective, randomized manner when
      compared to plain balloon angioplasty (PBA). The efficacy analysis will be observational and
      evaluated post-hoc, with no prespecified criteria.
    

Intervention name(s): Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland); Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)
Intervention type(s): Drug; Device
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: paclitaxel coated balloon; restenosis; Femoropopliteal artery disease
Orientation Effects of Breastfeeding for Mothers
Condition: Breastfeeding
Study type: Interventional

Summary: 
      The benefits of breastfeeding are increasingly known of the population and breastfeeding
      rates in the country have been increasing, but still are below satisfactory to the Ministry
      of Health (MH) and the World Health Organization (WHO).

      Simple Strategies to guide and support the mother contributes to increasing knowledge about
      breastfeeding and can have positive impacts on breastfeeding rates.
    

Detailed description: 
      Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the
      first six months of a baby's life.

      110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.

      The first stage was carried out in the maternity - Orientation: Breastfeeding Importance
      Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the
      intervention group held three home visits:

      10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for
      both groups.
    

Intervention name(s): Breastfeeding guidance
Intervention type(s): Other
Intervention description(s): Breastfeeding guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breastfeeding; Orientation
Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interaction (DDI) and Cardiodynamic Evaluation Study To assess the effect of
      multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a
      cytochrome P450 [CYP]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive
      substrate) in healthy adult subjects.
    

Detailed description: 
      This is an open-label, fixed-sequence DDI and cardiodynamic study in healthy adult subjects.

      Twenty-six (26), healthy, adult male and female (non-childbearing potential) subjects will be
      enrolled.

      Screening of subjects will occur within 28 days prior to the first dosing.

      To assess the effect of multiple oral doses of edasalonexent on the single-dose
      pharmacokinetics (PK) of midazolam (a cytochrome P450 [CYP]3A4 sensitive substrate) and of
      deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.

      Visit assessments include Clinical laboratory tests, Safety ECGs and Cardiodynamic ECGs.
      Subjects will be housed on Day -3 of Period 1, until after the 24-hour blood draw and/or
      study procedures are completed on Day 12 of Period 2.
    

Intervention name(s): Edasalonexent 2000 mg TID; Midazolam 2 MG/ML; Deflazacort 36Mg Tab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CAT-1004 capsules; 2 mg/ml syrup; 36 mg tablets
Intervention MeSH terms: Deflazacort; Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Comparing Single-dose Low-volume PEG Plus Bisacodyl vs. Split-dose PEG for Bowel Preparation in Morning Colonoscopy
Condition: Bowel Preparation
Study type: Interventional

Summary: 
      Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed
      that adenoma detection rate positive correlation with good bowel preparation which makes
      bowel preparation an important issue. Hence, investigators conduct a clinical trial about
      adding another laxative agent to morning single dose low-volume PEG. To see if this new
      regimen could have non-inferior efficacy and lower life/sleep impact compared with standard
      regimen.
    

Detailed description: 
      Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has
      come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to
      detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate
      positive correlation with good bowel preparation. That makes bowel preparation an important
      issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and
      safety. However, there are many different adjunctive, dose, timing of administration in PEG
      preparation. Some may decrease patient tolerability due to large fluid volume, and some may
      influence patient's life and sleep quality when performing bowel preparation. Here,
      investigators conduct a clinical trial about adding another laxative agent to morning single
      dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower
      life/sleep impact compared with standard regimen.
    

Intervention name(s): Polyethylene glycol and bisacodyl; Split-dose polyethylene glycol
Intervention type(s): Drug; Drug
Intervention description(s): Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination.; Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day.
Other intervention name(s): Dulcolax®; Klean-prep®; Klean-prep®
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Polyethylene Glycol; Bisacodyl; Colonoscopy; Bowel preparation; Ottawa bowel preparation scale
Ophthalmic Artery Resistance Index After Peribulbar Block in the Presence of Epinephrine
Condition: Ophthalmic Artery; Peribulbar Block
Study type: Interventional

Summary: 
      Evaluate ophthalmic artery flow by echo-Doppler before and after peribulbar block with
      lidocaine in presence or absence of epinephrine.
    

Detailed description: 
      There are controversies regarding the ophthalmic artery (OA) flow after peribulbar block with
      the addition of epinephrine. Therefore, we aimed to evaluate OA flow by echo-Doppler before
      and after peribulbar block with lidocaine in presence or absence of epinephrine.

      Fifty-six patients that were eligible for cataract phacoemulsification surgery were selected.
      Patients were divided into two groups: group 1 - Peribulbar block with lidocaine and
      1/200.000 epinephrine; group 2 - Peribulbar block with lidocaine in the absence of
      epinephrine. The resistance index (RI) of OA was evaluated using echo-Doppler before and 10
      min after the peribulbar block.
    

Intervention name(s): Epinephrine
Intervention type(s): Drug
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Peribulbar anesthesia with 2% lidocaine with epinephrine 1/200,000.
Group 2: Peribulbar anesthesia with 2% lidocaine without epinephrine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ocular flow; cataract surgery; peribulbar block; ocular Doppler
Application of Vibration Wave Therapy to the Children Suffering From Cerebral Palsy and Tongue Spastic Dysarthria
Condition: Cerebral Palsy; Spastic Dysarthria
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy; Dysarthria
Study type: Interventional

Summary: 
      Vibration therapy is the widely used in many neurological disorders for different type of
      problems. Recently, it is being used by researchers for the betterment of motor disorders and
      muscle movements of the cerebral palsy patients and significant results are obtained.
      Investigators are conducting this research to explore that whether this therapy can have some
      effect on the Spastic Tongue Dysarthria of the Cerebral Palsy patients.
    

Detailed description: 
      This study is going to be conducted in collaboration with Shahbaz Khalid Ranjha , Speech
      Language Pathologist, Family Health Hospital Islamabad who is the main person for the idea of
      the study and National University of Science & Technology. This study is funded by Higher
      Education Commission of Pakistan. Recruitment and Intervention Work will be carried out in
      Family Health Hospital. Special device is being designed for transmission of Vibration waves
      in Lab of the university. The device is capable to transmit vibration waves to the patient.
      Urdu language phonological and articulation test(TAAPU) will be used for assessment as it is
      specially designed for Urdu language population which will be the main focus. Investigators
      have defined speech parameters for analysis which will be collected before application of
      intervention, after 3 months and then at the end of the study. Parents assessment will be
      collected and noted through out the intervention.
    

Intervention name(s): Vibro Tactile Gadget
Intervention type(s): Device
Intervention description(s): The concept is to apply vibro tactile gadget to different nerve points which when applied transmit waves to the focused parts of brain which will result in blood flow and activation of dead cells. As a result some disabled part of the body because of those dead cells can show improvement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurorehabilitation; Vibration; Neurotransmission; cerebral palsy; Dysarthria
Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid
Condition: Alzheimer´s Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried out in order to investigate if [11C]AZD2995, compared to [11C]AZD2184,
      is a more suitable PET ligand for in vivo imaging of β amyloid depositions in the human
      brain. In the study the two PET ligands will be examined in both healthy volunteers and
      patients with Alzheimer's Disease.
    


Intervention name(s): Radioligand (11C)AZD2995; Radioligand (11C)AZD2184
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of i.v solution. 1-2 times for AD patients. Once for healthy volunteers.; Single dose of i.v solution. Once for AD patients respective healthy volunteers.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alzheimer´s Disease; amyloid deposits; Positron Emission Tomography; phase I
Mobile Methods for Reducing Obesity Risk in Parents and Children
Condition: Overweight and Obesity; Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of an innovative 6-month
      smartphone-delivered intervention using simplified monitoring of dietary intake compared to a
      smartphone-delivered intervention with standard calorie monitoring among parents with
      overweight or obesity.
    

Detailed description: 
      This is a 6-month randomized controlled trial comparing the efficacy of two smartphone-based
      dietary and weight change interventions among 70 parent-child dyads with at least one child
      between the ages of 2 and 12 (70 adults and 70 children ages 2-12). One intervention group
      (Simple) will use a simplified, low-burden form of dietary tracking in the study smartphone
      application and the other group (Standard) will use standard calorie tracking. Components of
      both interventions include (1) setting personalized goals for weight, dietary intake, and
      daily activity (2) adaptive text message interventions based on behavior change techniques
      such as goal setting and in-the-moment progress feedback several times per week, (3) weekly
      tailored feedback updated in the study smartphone app, and (4) weekly lessons on the
      smartphone app. The primary objective is to promote weight loss in the parents, and the
      secondary objective is to determine if one or both interventions produce a ripple effect of
      parent dietary change onto dietary changes in the child.
    

Intervention name(s): Simple; Standard
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, use a simplified form of tracking only high-calorie, high-fat foods in the study smartphone app, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.; Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, track calorie intake, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prolapse and Pregnancy Assessment
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Pelvic organ prolapse (POP) is one of the most common indications for gynaecological surgery.
      In 1997, more than 225000 inpatient surgical procedures for POP were undertaken in USA (22.7
      per 10000 women) at an estimated cost of more than one billion dollars. In the UK, the
      disorder accounts for 20% of the women on the waiting list for major gynaecological surgery.
      Vaginal birth, advancing age and increasing body mass are the most consistent risk factors.
      Furthermore a racial and congenital predisposition has been reported. The cause of this
      disorder is likely to be multifactorial and attributable to a combination of factors, varying
      from patient to patient.

      Controversy exists as to whether the pregnancy per se rather than the mode of delivery alters
      the risk of POP. Caesarean section appears to protect against the development of prolapse.
      However, when a caesarean section is undertaken during the active stage of labour it may not
      be completely protective. Ideally prospective longitudinal studies are needed to study the
      impact of pregnancy and childbirth on pelvic organ prolapse. Unfortunately, studies to date,
      are small with poor follow-up and have only assessed objective outcome rendering it difficult
      to draw conclusions. The primary objective of our study was to objectively assess the impact
      of pregnancy and childbirth on pelvic organ support using the Pelvic Organ Prolapse
      Quantification (POPQ)System.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women with uncomplicated singleton pregnancy attending the ultrasound scan clinic
        in the second trimester were invited to participate
      
Keywords: Prolapse; Childbirth; Pregnancy
Pharmacokinetic Study Of EPZICOM Tablet
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to explore the drug levels in the blood in Japanese HIV-infected
      patients taking EPZICOM tablet at least for 2 weeks prior to administration of the study
      drug. Pharmacokinetics after administration of EPZICOM tablet will be investigated in a total
      of 8 subjects.
    


Intervention name(s): Lamivudine / Abacavir Sulfate
Intervention type(s): Drug
Intervention MeSH terms: Lamivudine; Abacavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EPZICOM; Lamivudine; Abacavir; pharmacokinetics; Japanese