bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease
Condition: Peripheral Arterial Diseases
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare the performance of the CYPHER SELECTTM +
      Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon
      angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or
      posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized
      clinical study.
    

Detailed description: 
      This is a multicenter, prospective, randomized study to be conducted in 18 centers in Europe.
      A total of 200 subjects will be entered into the study and will be randomized on a 1:1 basis
      to either balloon angioplasty or the CYPHER SELECTTM + Coronary and Infrapopliteal Stent for
      infrapopliteal use in subjects with symptomatic peripheral artery disease (Rutherford 3, 4,
      or 5).

      All subjects will undergo a repeat angiography at 12 months to assess the primary endpoint of
      In-Segment Binary Restenosis. Follow-up visits are scheduled at 6 weeks, 6 and 12 months.
    

Intervention name(s): balloon angioplasty; drug eluting stent
Intervention type(s): Device; Device
Intervention description(s): balloon angioplasty; Cypher Select+ Coronary or Infrapopliteal Stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Partial Lacrimal Punctual Occlusion
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The purpose of this study is to describe a case series of patients with chronic dry eye
      submitted to partial punctual occlusion.
    


Intervention name(s): Partial Lacrimal Punctual Occlusion
Intervention type(s): Procedure
Intervention description(s): Cauterization of the edge of all lacrimal punctum was carried out in all patients
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cornea; Dry eye; lacrimal punctual occlusion; lacrimal film; ocular surface
Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain
Condition: Gynecological Disorder
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      Temporal summation of pain, which is defined as the perception of increasingly greater pain
      evoked by repetitive painful stimuli, is highly variable between individuals. This study
      aimed to determine the impact of the timing of rocuronium after induction with propofol on
      temporal summation of pain in gynecologic laparoscopic surgery.
    


Intervention name(s): The difference of the timing of rocuronium administration after propofol injection
Intervention type(s): Other
Intervention description(s): The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.
Intervention MeSH terms: Propofol; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One hundred patients, between 18-60 years of age were randomly assigned to one of the two groups; group PRi received immediate injection of rocuronium after propofol administration, and group PRd received rocuronium injection when bispectral index score became below 60 after propofol administration
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pain, Propofol, Rocuronium, Temporal summation.
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the serum IgA response of three dose levels of the
      oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high
      dose in an infant schedule.
    

Detailed description: 
      The primary objective of this study is to assess the cumulative anti-rotavirus serum IgA
      response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB
      administered in a neonatal schedule at a High, Mid or low vaccine titre. In addition the
      cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4
      weeks after 3 doses of RV3-BB administered in an infant schedule at a high dose of vaccine
      will be assessed along with cumulative vaccine take and components of vaccine take after 3
      doses of RV3-BB administered in a neonatal or infant schedule.

      The safety and tolerability of RV3-BB when administered as an infant or as a neonatal
      schedule will be described.
    

Intervention name(s): RV3-BB; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase II, randomised, double-blind, placebo-controlled, four-arm parallel group study of two different dosing schedules of oral RV3-BB
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dose ranging; Neonatal vaccine; RV3-BB vaccine
Translating Biometric Data Into Blood Glucose Levels
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study is designed to assist with the development of a first, truly non-invasive
      technology for blood glucose monitoring, which will have the potential to eliminate the need
      for painful finger pricking or expensive continuous blood glucose monitor use. The purpose of
      this study is to collect biometric data, such as bioimpedance (how well the body impedes
      electric current flow), from participants who are living with type 2 diabetes. A
      proof-of-concept prototype (non-invasive continuous glucose monitor; NI-CGM) will be used to
      collect this biometric data. The data will then be used to develop and refine a computer
      model that can be used to predict blood glucose levels (BGLs). Individuals with diabetes
      experience a great range of blood BGLs throughout their daily life and activities, therefore
      it is essential to gather biometric data corresponding to this large range to build a
      computer model, to ensure model reliability.
    

Detailed description: 
      The study will be conducted over a two-week period where the participants are required to
      wear the prototype, that will continuously collect the biometric data. Participants are
      required to use this device together with two existing commercially available blood glucose
      meters that are considered management routine for diabetes (an Abbott FreeStyle Libre and an
      Accu-Chek® Mobile), throughout the duration of the study. The majority of the study is
      carried out independently, by the participants, where they wear the prototype throughout
      their daily life and activities. The data collected from the non-invasive custom-built device
      and the existing blood glucose meters will be used to develop a computer model that will
      allow for blood glucose levels to be predicted, over time.

      The study will not interfere with any of the participants' diabetes management plans provided
      to them, by their regular doctor, under regular care, such as medications, diet and current
      use of blood glucose monitoring.

      It is hypothesised that the bioimoedance data collected using the non-invasive prototype
      device, in conjunction with existing devices used in diabetes management, will enable the
      development of a computer model that allows for blood glucose levels to be predicted in
      people with type 2 diabetes.
    

Intervention name(s): Opuz NICGM
Intervention type(s): Device
Intervention description(s): A wearable and non-invasive prototype device that allows for measurement of bioimpedance data with the aim to help develop a mathematical model to predict blood glucose levels.
Other intervention name(s): Opuz Device; Opuz Ring
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Non-invasive; Blood Glucose Levels; Monitoring
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Study type: Interventional
Phase: Phase 3

Summary: 
      The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a
      control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00345579).

      No new recruitment will take place during this booster phase of the study. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis
      serogroups C and Y-tetanus toxoid conjugate vaccine.

      The study will be conducted in a single blind manner up to 30 days after administration of
      the booster dose; the extended safety follow-up after the booster dose will be conducted in
      an unblinded manner.

      All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially
      co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.

      Note: This protocol posting deals with the objectives & outcome measures for the booster
      phase of the study. The objectives & outcome measures for the primary phase are presented in
      a separate protocol posting (NCT00345579)
    

Intervention name(s): GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014); PedvaxHIB; Prevnar; M-M-R II; Varivax
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Booster dose by intramuscular injection; Booster dose by intramuscular injection; Booster dose by intramuscular injection; Single dose by subcutaneous injection; Single dose by subcutaneous injection
Other intervention name(s): Monovalent Hib conjugate vaccine.; Measles; mumps and rubella vaccine.; Varicella vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: H. influenzae type B vaccine; Infants; Neisseria meningitidis; Vaccines, conjugate; Meningococcal vaccines; Prophylaxis; Comparative study; Safety; Humans
Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The aim of this study is to investigate the visceral fat reduction versus total body fat
      reduction on stress urinary incontinence in obese females.
    

Detailed description: 
      compare the effect of visceral fat reduction versus total body fat reduction on stress
      urinary incontinence in obese females.

      control group: consist of 20 obese women. They will receive Kegel exercises only 3 session/
      week for 12 weeks.

      Diet group: consist of 20 obese women. They will receive low caloric diet and Kegel exercises
      3 session/week for 12 weeks.

      Ultrasound cavitation group: consist of 20 obese women. They will receive Kegel exercises 3
      session/week and ultrasound cavitation two sessions per week.
    

Intervention name(s): low caloric diet, ultrasound cavitation,Kegel exercises
Intervention type(s): Behavioral
Intervention description(s): low caloric diet (800-1200) calories/day,). According to each patient, diet contained (carbohydrate protein, fats, minerals, vitamins). 50 to 55% of total calories are carbohydrates, 10 to 15% of total calories protein. Fat limited to less than about 28% of daily total calories .Women took 1200 calories in the first month, 1000 calories in the second month, and 800 calories in the third month. Every week, each woman allowed to change the types of food to avoid boarding.
ultrasound cavitation emits low-frequency ultrasound 40 khz for 30 minutes on abdomen twice/ week with 3 days apart for 12 weeks.
kegel exercise: Each woman in the study took the same Kegel exercise program performed the Kegel exercise for 12 weeks (3 sessions per week)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Visceral fat reduction vs total body fat reduction on obese female with stress urinary incontinence
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Visceral fat; total body fat; obese female; stress urinary incontinence
A Study to Assess the Systemic Pharmacokinetics, Metabolism and Excretion Routes of YM178 in Man, After Administration of Radio-labeled YM178
Condition: Metabolic Processes
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to assess the routes and the extent of metabolism and excretion of YM178 after
      a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male
      volunteers.
    

Detailed description: 
      Four subjects are studied in one group. Each subject stays in the clinic for 6 days, and
      receives a single oral dose of 14C-labeled YM178. Blood, plasma, urine, feces and expired air
      are collected for 96h after dosing.

      If 14C-radioactivity quick counts show that radioactivity in urine or feces is above
      acceptable limits (ie. > 50 dpm/ml in urine; >75 dpm in 400 mg feces) on day 5, subjects are
      requested to stay in the clinic until the levels decrease. If, after 3 days, radioactivity is
      still > 50 dpm/ml in urine and/or >75 dpm in 400 mg feces, urine and/or feces is collected at
      home, until the amount of radioactivity decreases.
    

Intervention name(s): 14C-labeled YM178
Intervention type(s): Drug
Intervention description(s): oral solution (1.85 MBq)
Other intervention name(s): mirabegron; Myrebtriq
Intervention MeSH terms: Mirabegron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radioactivity; Excretion rate; Human subjects; Pharmacokinetics; YM178; Radio-labeled; Phase 1
Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The use of the renal resistive index in pediatric patient with idiopathic nephrotic syndrome
      to detect steroid resistance and to use it as a prognostic instrument of the progression of
      the disease.
    

Detailed description: 
      Renal Doppler will be done for all children in supine and lateral positions using Toshiba
      Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity-
      end diastolic velocity/ peak systolic velocity) at diagnosis, after one month, 3 months and
      6months, in which these values will be obtained by the ultrasound machine based on the
      computer algorithm. Also the kidneys will be scanned firstly for length, width, cortical
      thickness and echogenicity.
    

Intervention name(s): renal doppler
Intervention type(s): Device
Intervention description(s): Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        60 children and adolescents with nephrotic syndrome who will be diagnosed and followed at
        our nephrology Unit and Clinic at TUH during the period of the study.
      
Keywords: renal doppler; nephrotic syndrome; steroid resistance
The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy
Condition: Ottawa Scale <6
Study type: Interventional
Phase: Phase 3

Summary: 
      Effective bowel preparation is important for examination of the entire colon adequately and
      for identifying colonic lesions during colonoscopy. However, it is well known that bowel
      preparation of inpatients is much poorer than that of outpatients. Our goal is to improve
      bowel preparations with reinforcement of nurse education that explains the steps required for
      bowel preparation for inpatients undergoing colonoscopies. The education will focus on
      explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the
      pre-colonoscopy diet, and the instructions for completing the laxative. Patients in the
      control group will receive the standard written bowel preparation instructions, while
      patients in the intervention group will receive standard written instructions plus a
      explanation from reinforcement-educated nurse. The investigators hypothesize that patients
      received a explanation from reinforcement-educated nurses will lead to improved patient
      compliance and a better bowel preparation. In addition, the investigators hypothesize that a
      better quality bowel preparation will improve detection of colonic polyps and patients'
      satisfaction for colonoscopy.
    


Intervention name(s): Reinforcement Nurse Education
Intervention type(s): Other
Intervention description(s): The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions from reinforcement educated nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bowel preparation
Accuracy of Conventional and Digital Impression Techniques Used for Maxillary Hybrid Prosthesis
Condition: Prosthesis Durability
MeSH terms: Prosthesis Failure
Study type: Interventional

Summary: 
      evaluation and comparison of the accuracy of conventional and digital impression for full
      arch screw retained prosthesis for edentulous maxilla.
    

Detailed description: 
      Each patient received 6 implants in the maxillary ridge (widely distributed across the arch)
      in the following positions: central incisors, canines/first premolar teeth and first molar
      teeth aided by surgical stent. then each patient received 2 types of impression techniques
      Technique 1 :conventional impression conventional open tray impression technique with
      splinted transfers using vinylpolysiloxane and Technique2 : Digital impression taken using
      original scan bodies torqued to the implants .three dimensional accuracy of impression
      techniques was evaluated using linear measurements and 3D deviation between the two
      techniques was measured.
    

Intervention name(s): impression techniques for implant used for maxillary screw retained hybrid prosthesis
Intervention type(s): Other
Intervention description(s): conventional splinted open tray impression technique was done for maxillary implants to fabricate screw retained hybrid prosthesis and digital intra oral impression was done for the same patients after screwing scan bodies to the implants intra orally.
evaluation of accuracy and 3D deviation between the two techniques was done
Other intervention name(s): digital and conventional impression techniques
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: the conventional open tray splinted impression technique and the digital intraoral impression technique were done for each patient
Masking: None (Open Label)
Primary purpose: Other
Keywords: digital impression, conventional impression
Serotonin 1A Agonists and Cognition in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who
      have been treated with antipsychotic medications. Patients will be assigned to take active
      medication (Buspar)or placebo along with their prescribed antipsychotic medication for six
      weeks. Patients' memory and problem-solving ability will be tested before and after
      medication.
    

Detailed description: 
      Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who
      have been treated with olanzapine or risperidone for at least three months randomized to
      receive adjunctive treatment with a 5-HT1A agonist (buspirone, 15-30 mg/day)or placebo.
    

Intervention name(s): adjunctive treatment with buspirone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): buspirone 15-30 mg qd; placebo
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to
      5 Years.
    


Intervention name(s): montelukast; placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks; Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks
Other intervention name(s): MK0476; SINGULAIR ®
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment