bioihbjkbjnl/mcl2 huggingface dataset:
The Diabetes Patient Takes Responsibility
Condition: Diabetes Mellitus, Type 1; Patient Reported Outcome; Health Care Economics and Organizations
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit
      procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an
      appointment with a nurse or doctor within defined time intervals via telephone, e-mail or
      apps. Patient-reported outcomes (patient satisfaction and experience, QoL) clinical variables
      (HbA1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet
      physicians) are monitored.
    

Detailed description: 
      This is a 24 month prospective randomized controlled trial. People with Type 1 diabetes (T1D)
      are randomized to two groups: (i) Patients randomized to the control group receive their
      standard diabetes care and are seen in the out-patient clinic with regular intervals
      (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) Patients
      randomized to the intervention group are not called for at fixed time points. They can
      arrange visits in the diabetes clinic whenever they feel the need to do so. The have a
      guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor
      or diet physician within two weeks. Questionnaires (a specific questionnaire focused on
      patient satisfaction developed for the study and AddQoL) are filled in at time 0 and 24
      month. Blood samples for diabetes-related variables (HbA1c, lipid status), blood pressure,
      body weight etc. are likewise recorded at time 0 and 24 month. Economic and time requirements
      are evaluated at 24 month.
    

Intervention name(s): Out-patient clinic on demand (patient-initiated); Scheduled out-patient clinic
Intervention type(s): Other; Other
Intervention description(s): Free use of any resources in the out-patient clinic; Scheduled use of the out-patient clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes; Organization; Out-patient control
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections; Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal
      conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H.
      influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy
      tube placement and outpatient antimicrobial prescriptions in children starting vaccination
      below 18 months of age. These data will be collected from the national registers and will be
      analyzed in combination with data collected for subjects enrolled in a large scale
      cluster-randomized study 111442.

      The study will also assess the immune response to the GSK1024850A vaccine and the impact of
      the vaccine on occurrence of acute otitis media, carriage, safety in children starting
      vaccination below 18 months of age.
    

Detailed description: 
      The protocol posting has been updated with regards to the outcome measures following Protocol
      amendment 4, 12 August 2011.
    

Intervention name(s): Pneumococcal conjugate vaccine Synflorix (GSK1024850A); GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine); GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination; 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.; 2 Intramuscular injections only for children >= 12 months of age at the time of first study vaccination.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Streptococcus pneumoniae; acute otitis media; Pneumococcal conjugate vaccine; nasopharyngeal carriage; Haemophilus influenzae; immunogenicity; invasive disease
Relative Bioavailability of a Single-dose Administration of BIBW 2992 and Multiple-dose Administration of Ritonavir in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate the effect of ritonavir, an inhibitor of P-glycoprotein
      (P-gp) and cytochrome P450 3A4 (CYP3A4), on the pharmacokinetics of BIBW 2992
    


Intervention name(s): BIBW 2992; Ritonavir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ritonavir; Afatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix
Condition: Cervical Intraepithelial Neoplasia; Human Papillomavirus Infection; HPV Infection
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections; Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer.
      HPV testing and risk stratification by genotyping has been recognized as an effective
      cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain
      reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common
      HPV types including all high-risk types. We studied its agreement, sensitivity, and
      specificity compared to DNA sequencing as the gold standard.
    

Detailed description: 
      High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer.
      HPV testing and risk stratification by genotyping has been recognized as an effective
      cervical screening program. HPV detection is also applied for triage of atypical squamous
      cells of undetermined significance and follow-up after treatment for cervical neoplasms. A
      chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV
      Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all
      high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA
      sequencing as the gold standard.

      One-thousand one-hundred and three (1103) subjects were enrolled between December 2012 and
      December 2013 from Linkou Chang Gung Memorial Hospital, Mackay Memorial Hospital, Changhua
      Christian Hospital, and Cathay General Hospital.
    

Intervention name(s): DR. Chip HPV genotyping IVD kit
Intervention type(s): Device
Intervention description(s): HPV typing by gene chip
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Modified Pectoral Nerves Block Versus Serratus Plane Block in Major Breast Cancer Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the analgesic profile of modified pectoral nerves
      block and serratus plane block in patients undergoing mastectomy.
    

Detailed description: 
      This study includes three groups. The first group will receive ultrasound-guided modified
      pectoral nerves block prior to induction of general anesthesia. The second one will receive
      ultrasound-guided serratus plane block prior to induction of general anesthesia. The third
      one will not receive any block preoperatively.
    

Intervention name(s): Bupivacaine 0.25% with epinephrine; Bupivacaine 0.25% with epinephrine
Intervention type(s): Drug; Drug
Other intervention name(s): Markyrene; Markyrene
Intervention MeSH terms: Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Effects of Multiple Doses of Cebranopadol on the Electrical Activity of the Heart in Healthy Subjects
Condition: Prolonged QTc Interval; Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the effects of cebranopadol (GRT6005) on the
      electrical activity of the heart in healthy participants.

      The study consisted of a screening period within 21 days before the first dose of
      investigational medicinal product (IMP) (between Day -25 and Day -4) during which informed
      consent was obtained and the general suitability of the participants for the trial was
      assessed according to the inclusion/exclusion criteria.

      Participants were confined to the trial site from 4 days before first IMP dosing on Day 1 to
      4 days after last IMP dosing on Day 30. During this period, multiple-doses of cebranopadol or
      matching placebo and a single-dose of moxifloxacin or matching placebo were administered.
      Moxifloxacin was used as a positive control. It has consistently shown that it has an effect
      on the heart rhythm. Continuous 12-lead ECGs were recorded at defined time points. Multiple
      blood and urine samples were drawn for pharmacokinetic evaluations and safety laboratory
      monitoring (hematology, chemistry, and urinalysis). Additional safety evaluations included
      recording of adverse events, vital signs (systolic and diastolic blood pressure, pulse rate,
      respiration rate, body temperature, and weight), oxygen saturation, standard 12-lead ECG,
      Clinical Opiate Withdrawal Scale (COWS) assessment, and Columbia-Suicide Severity Rating
      Scale (C-SSRS) assessment.

      An End-of-Trial Visit was performed on Day 34, or within 7 days after the last
      pharmacokinetic sample on Day 34, or at early withdrawal.
    


Intervention name(s): 100 μg cebranopadol; 200 μg cebranopadol; 400 μg cebranopadol; Placebo to cebranopadol encapsulated tablets; 400 mg Moxifloxacin; Placebo to moxifloxacin encapsulated tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Encapsulated 100 μg cebranopadol tablet.; Encapsulated 200 μg cebranopadol tablet.; Encapsulated 400 μg cebranopadol tablet.; Matching placebo to cebranopadol encapsulated tablet.; Encapsulated 400 mg moxifloxacin tablet.; Matching placebo to moxifloxacin (400 mg) encapsulated tablet.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to 1 of 4 treatment groups on Day -3: The study included a nested cross-over design for participants in treatment group 3 (A, B).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: QT/QTc Interval
Use of Chitosan Powder in Loop Electrosurgical Excision Procedure
Condition: Vaginal Bleeding; Loop Electrosurgical Excision
MeSH terms: Uterine Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Early treatment of cervical intraepithelial neoplasia (CIN) II-III gives rise to a decrease
      in the incidence of invasive cervical cancer. Though there is no obvious consensus from
      randomized studies as to the optimal management of CIN II-III, loop electrosurgical excision
      procedure (LEEP) is the most extensively used method because of its technical ease,
      inexpensive, steep learning curve, and low rate of complications.

      In spite of these benefits, current literature suggests that some patients experience some
      complications such as postoperative vaginal bleeding, abnormal vaginal discharge, abdominal
      pain, and infection. These adversely affect the recovery period, increase patient anxiety,
      readmission to the hospital for further treatment and encumber patients' daily life.
      Postoperative vaginal bleeding (PVB) is one of the most common and unpleasant of these
      complications. Its incidence has been reported to vary between 2% to 78%.

      Many different types of treatments have been applied to avert or diminish PVC such as the use
      of vasopressin, tranexamic acid, Monsel's solution, and local hemostats (e.g., TachoSil or
      Tisseel), but these attempts have failed to show precise benefits over routine clinical
      approaches. Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic,
      non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin.
      Due to its molecular characteristics, chitosan has been used for improved hemostasis.
      Furthermore, chitosan has an antimicrobial and wound-healing effect. The current literature
      concerning the influence of using chitosan after the LEEP is limited to only one trial. The
      authors of that study reported that using chitosan after the LEEP can reduce vaginal bleeding
      and enhancing wound healing. However, that study has some limitations. Therefore,
      investigators designed this randomized trial to assess the effect of local chitosan
      implementation on postoperative vaginal bleeding and wound healing in LEEP
    


Intervention name(s): Chitosan
Intervention type(s): Drug
Intervention description(s): Chitosan is a biodegradable, natural polyaminosaccharide with a nontoxic, non-allergenic, positively-charged polysaccharide derived from the deacetylation of chitin. Due to its molecular characteristics, chitosan has been used for improved hemostasis. Furthermore, chitosan has an antimicrobial and wound-healing effect
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety/tolerability and to explore the efficacy
      of MT-1303 in subjects with systemic lupus erythematosus
    


Intervention name(s): MT-1303 Low dose; MT-1303 High dose
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic lupus erythematosus
Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans
Condition: Monoamine Oxidase Inhibitor Activity; Prolactin Levels; Postprandial Blood Glucose
Study type: Interventional

Summary: 
      The current study uses a double-blind, placebo-controlled, randomised cross- over design to
      assess the pharmacodynamics of the platelet MAO-B inhibition, plasma prolactin levels and
      blood glucose levels after consumption of a single serve of 'Blackadder' blackcurrant juice.
    

Detailed description: 
      There is emerging evidence which supports health benefits of consuming blackcurrant fruit,
      including improvements to cognitive performance, modulation of blood flow, regulation of
      blood glucose and inhibition of enzymes underpinning normal cognitive function. Of particular
      relevance is our previous demonstration of inhibition of MAO-A and B after consumption of a
      New Zealand 'Blackadder' blackcurrant juice drink in man.

      In an attempt to establish a "therapeutic window" on which future nutritional interventions
      can be based, the current study will assess the pharmacodynamics of MAO-B inhibition, plasma
      prolactin levels and venous blood glucose profile following consumption of the 'Blackadder'
      blackcurrant juice. The trial will utilise a 500mg dose of the 'Blackadder' juice (equivalent
      to ~100g of fresh fruit) which was shown to have MAO inhibitory effects in our previous
      report and effects will be measured in a cohort of healthy male adults.
    

Intervention name(s): Blackadder Juice; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Phase II Study With ITF2984 in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate in acromegalic patients the effect of different
      doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability of
      three different doses of ITF2984.
    

Detailed description: 
      The study will enroll patients with active acromegaly, de novo or partial responder to
      previous treatment with somatostatin analogues. For patients who had previously received
      medical therapy for acromegaly a washout periods before study entry of 3 months for
      long-acting formulation of somatostatin analogs, 2 weeks for octreotide sc, 2 months for
      pegvisomant and/or cabergoline must be foreseen.

      Each patient will be randomized and wll remain in the study for about 6 months, and they will
      attend a visit every two weeks.

      The patients will be treated for 4 months in a total, in particular every month of treatment
      will be followed by a washout period of 2 weeks.

      At each month of treatment the patients will receive one of the four treatment as reported
      below:

      Octreotide 100 mcg sc three times daily (t.i.d) for 4 weeks, ITF2984 500 mcg sc twice a day
      (b.i.d) for 4 weeks, ITF2984 1000 mcg sc b.i.d for 4 weeks, ITF2984 2000 mcg sc b.i.d for 4
      weeks. Patients will be randomized using a 4 way crossover design to receive ITF2984 or
      octreotide at each treatment month. Each patient will receive all of the four treatments
      overseen in this study.
    

Intervention name(s): Octreotide; ITF2984 500 mcg; ITF2984 1000 mcg; ITF2984 2000 mcg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): octreotide 100 mcg sc t.i.d. for 4 weeks; ITF2984 500 mcg sc b.i.d for 4 weeks; ITF2984 1000 mcg sc b.i.d for 4 weeks; ITF2984 2000 mcg sc b.i.d for 4 weeks
Other intervention name(s): somatostatin analog; somatostatin analog; somatostatin analog; somatostatin analog
Intervention MeSH terms: Octreotide; Somatostatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: de novo or partial responder to somatostatin analogues
Surveillance of Synagis in Korean Pediatric Patients
Condition: Respiratory Syncytial Virus Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Observational

Summary: 
      Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual
      practice according to the approved Korean product label will be registered into this
      observational study. Baseline data will be obtained at enrollment including demographics,
      gestational age, birth weight and underlying diseases and complications especially in regard
      to respiratory disease and cardiovascular disease. At routine visits for Synagis
      administration, which will occur according to usual medical practice, information on Synagis
      prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days
      after the last administration of Synagis.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        General hospital
      
Keywords: Postmarketing Drug Surveillance
Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are
      judged by the Investigator to have had an inadequate response to methylphenidate therapy. The
      study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
    


Intervention name(s): Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Oral 30, 50, or 70mg once-daily for 9 weeks; Oral 10mg to 100mg once-daily for 9 weeks
Other intervention name(s): Vyvanse; Strattera
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
Three-Year Clinical Evaluation of Class II Posterior Composite Restorations
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study was to investigate the clinical effectiveness of direct resin composite
      restorations placed with different placement techniques (incremental or bulk) and with
      different flowable linings (conventional or bulk-fill flowable) used in open-sandwich
      technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in
      a randomized controlled comparison.
    

Detailed description: 
      Forty-seven pairs Class II (mesio-occlusal or disto-occlusal) composite restorations were
      placed in 37 patients. In all cavities, Adper Single Bond 2 was used. In one of the cavities
      of each pair, a conventional flowable composite, Aelite Flo, was applied in approximately 2mm
      thick, and the remaining cavity was restored incrementally with GrandioSO. In the second
      cavity, a bulk-fill flowable composite, x-tra base, was applied in approximately 4 mm thick
      in bulk increments and the remaining 2mm occlusal part of the cavity was restored with
      GrandioSO. All cavities were restored with open-sandwich technique by the same operator. At
      baseline and after 6-month, 1-, 2- and 3-year follow-up visits, restorations were evaluated
      by Modified USPHS criteria.
    

Intervention name(s): Aelite Flo; x-tra base
Intervention type(s): Procedure; Procedure
Intervention description(s): Microhybrid flowable composite; Bulk-fill flowable composite
Other intervention name(s): 1000006652; 1145403
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: composite resin; bulk-fill; teeth endodontically-treated