bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers
Condition: Diphtheria
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of GSK's combined
      diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus
      influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV's
      DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12
      weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age
      vaccination schedule.
    


Intervention name(s): DTPa-HBV-IPV/Hib; DTaP5-HBV-IPV-Hib; Pneumococcal 13-valent conjugate vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 doses (1 each at 2, 4 and 12 months of age) of DTPa-HBV-IPV/Hib vaccine administered by intramuscular injection into the right thigh; 3 doses (1 each at 2, 4 and 12 months of age) of DTaP5-HBV-IPV-Hib vaccine administered by intramuscular injection into the right thigh; 3 doses (1 each at 2, 4 and 12 months of age) of pneumococcal 13-valent conjugate vaccine administered by intramuscular injection into the left thigh
Other intervention name(s): Infanrix hexa; Vaxelis; Prevenar 13
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Primary immunization; Immunogenicity; Safety; Diphtheria; Tetanus; Acellular pertussis; Hepatitis B; Inactivated poliovirus; Haemophilus influenzae type b
Can High Ventilation Provide Higher Success Rates in Retrograde Intrarenal Surgery?
Condition: Kidney; Mobile
Study type: Interventional

Summary: 
      RIRS (Retrograde Intrarenal Surgery) has been accepted as a first-line treatment option for
      urinary stones smaller than 2 cm and is generally performed under general anesthesia to
      manipulate respirator-related renal mobility. Many surgeons prefer general anesthesia during
      RIRS to minimize respiration-related renal mobility. Standard mechanical ventilation settings
      were still inadequate to limit renal mobility and the surgeons tried to find the most
      effective ventilation mode to minimize renal mobility.
    

Detailed description: 
      A standard general anesthesia protocol is given to all patients by the same anesthesiologist.
      A Drager Primus (Germany) mechanic ventilator (MV) is preferred for general anesthesia. The
      MV will determine the tidal volume and respiration frequency according to the patient's age
      and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode is 8-10 mL/kg
      tidal volume and 10-15 respirations/min. During HV mode, the tidal volume will decrease to
      6-8 mL/kg and the frequency will increase to 15-18 respirations/min. No changes are made in
      the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP)
      parameters. The ventilation mode of the mechanic ventilator (SV or HV) is determined via
      randomization software before the surgery. According to randomization, the anesthesiologist
      is informed about the ventilation mode but the surgeons are absolutely blind. A high
      ventilation mode is formed by increasing the respiration frequency and decreasing the study's
      tidal volume. The aim of the study was to evaluate the effect of this mode on the efficacy
      and safety of RIRS.
    

Intervention name(s): Changing mechanic ventilatation parameters
Intervention type(s): Procedure
Intervention description(s): The tidal volume and respiration frequency were determined by the MV according to patient's age and weight with end-tidal CO2 levels of 30-35 mmHg. Standard ventilation mode was defined as 8-10 mL/kg tidal volume and 10-15 respirations/min. During HV mode, the tidal volume was decreased to 6-8 mL/kg and the frequency was increased to 15-18 respirations/min. No changes were made in the inspiratory expiratory ratio (1:2), FiO2, and positive end-expiratory pressure (PEEP) parameters.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be divided randomly by a computer-generated randomization table into two equal groups.
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: renal mobility; urinary stone; mechanic ventilation; success status
A Study Assessing GW870086's Potential to Cause Skin Thinning
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to
      explore the potential for skin thinning in healthy adult volunteers after 42±2 days of
      treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086
      2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or
      clobetasol propionate 0.05% cream.
    

Detailed description: 
      This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to
      explore the potential for skin thinning in healthy adult volunteers after 42±2 days of
      treatment. The primary objective of this study is to assess the thickness of the skin using
      ultrasound. The secondary objectives are to assess skin thinning using a visual scale for
      skin atrophy and telangiectasia, safety and tolerability of GW870086 and to assess the
      pharmacokinetics of GW870086 administered as a cream for 42±2 days.

      Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream.
      They will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol
      propionate 0.05% cream. Subjects will apply all 3 treatments once daily during the 42±2 day
      treatment period. However subjects who are randomised to receive the unblinded clobetasol
      propionate will only apply this once daily for a maximum of 21±2 days but will continue to
      dose with the other 2 treatments. If significant evidence of skin thinning is observed in any
      of the treatment arms (25% reduction in skin thickness measured using ultrasound) then
      application of this treatment will be discontinued. Three areas of approximately 5 x 5 cm on
      the arm will be identified and each treatment will be applied to the same area throughout the
      42±2 day treatment period.
    

Intervention name(s): GW870086 0.2%; GW870086 2%; Clobetasol Propionate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): White to slightly coloured opaque cream; White to slightly coloured opaque cream; White cream; White to slightly coloured opaque cream
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effect of Aspergillus Niger Prolyl Endoprotease (AN-PEP) Enzyme on the Effects of Gluten Ingestion in Patients With Coeliac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Oral supplementation with enzymes that can cut gluten has been suggested as a potential
      treatment modality for coeliac disease. In the present study the investigators wish to
      determine if co-administration of such an enzyme, a prolyl endoprotease derived from the food
      grade organism Aspergillis niger (AN-PEP), is capable of detoxifying 8 grams of gluten in a
      commercial food product.
    

Detailed description: 
      The objective of the study is to determine whether AN-PEP enzyme is effective in mitigating
      the effects of 8 g wheat protein ingestion in patients with celiac disease.

      Fourteen patients with coeliac disease, 18-70 years old are recruited. During the first
      period, patients consume once daily a gluten-containing food product with the AN-PEP enzyme
      for 2 weeks. After a 2-week washout period (second period), patients enter the third period
      of this study, and are randomized to one of two groups and consume the same gluten-containing
      food product with AN-PEP or placebo.

      Period 1: Patients are given a food product containing 8 g of wheat protein, to which AN-PEP
      is added, once daily for 14 d.

      Period 2: Wash-out period of 14 d. During this period, patients will consume a gluten-free
      diet.

      Period 3: Patients who are negative for coeliac disease symptoms during the 1st period will
      be randomized across two groups. Both groups receive a food product containing 8 g of wheat
      protein once daily for 14 d. One group receives additional AN-PEP with the gluten meal
      whereas the other group receives the placebo.

      Patients will visit the outpatient clinic five times; one visit before the start of the
      study, a visit during and at the end of the first period, and a visit during and at the end
      of the third period. During three of the visits, spike-biopsies are taken from the duodenum
      by oesophago-gastro-duodenoscopy. Blood samples are taken during all of the five visits.
      Patients will also fill in a quality of life questionnaire at the start and the end of the
      first and third period.
    

Intervention name(s): Aspergillus niger prolyl endoprotease; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 160 PPU daily for 2 weeks; Placebo
Other intervention name(s): AN-PEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Celiac disease; Coeliac disease; treatment; AN-PEP; prolyl endoprotease; gluten
The Effect of Premedication With Melatonin on Postoperative Recovery From Bariatric Surgery
Condition: Recovery From Bariatric Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Melatonin has sedative, hypnotic and analgesic properties that make it a good premedication
      agent before anesthesia and surgery.

      In this study the investigators intend to randomise 60 patients undergoing bariatric surgery
      into two groups. The participants will receive either melatonin or placebo on the evening
      prior to the surgery, and the same agent two hours before the surgery.

      The patients recovery from the surgery and anesthesia will be assessed using the Q0R15
      questionnaire. The patients will be asked to take the questionnaire once in the pre-operative
      clinic, again after the second melatonin or placebo pill before entering the operating room,
      and once more on the first post-operative day.
    

Detailed description: 
      Melatonin has sedative, hypnotic, analgesic, antiinflammatory, and chronobiologic properties
      that make it a good premedication agent before anesthesia and surgery. Patients undergoing
      surgery in our establishment usually receive benzodiazepines as premedicants to reduce
      anxiety before the surgery. For bariatric patients benzodiazepines are usually avoided due to
      side effects which could be deleterious in obese patients.

      In this study the investigators intend to randomise 60 patients undergoing bariatric surgery
      into two groups. The participants will receive either melatonin or placebo on the evening
      prior to the surgery, and the same agent two hours before the surgery.

      The patients recovery from the surgery and anesthesia will be assessed using the Q0R15
      questionnaire. The patients will be asked to take the questionnaire once in the pre-operative
      clinic, again after the second melatonin or placebo pill before entering the operating room,
      and once more on the first post-operative day.
    

Intervention name(s): Melatonin; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: melatonin's; quality of recovery
Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
Condition: Pregnancy Complication
MeSH terms: Pregnancy Complications
Study type: Interventional

Summary: 
      To detect the effect of sildenafil citrate on Doppler parameters in fetuses suffering from
      growth restriction to support its use later as prolonged therapy in those pregnancies at
      higher risk for such complication.
    

Detailed description: 
      Participants were randomized in 1:1 ratio into one of the following drug regime:

      Group (I): "sildenafil citrate group" This group consisted of 22 women who received single
      oral dose of 50 mg sildenafil citrate.

      Group (II): "placebo group" This group consisted of 22 women who received single oral dose of
      placebo. All participants were evaluated by ultrasound once they admitted and again after
      2-hours following administration of either of the treatment tablets. One sonographer was
      allocated to evaluate all mothers included in the study.
    

Intervention name(s): sildenafil citrate; placebo
Intervention type(s): Drug; Other
Intervention description(s): single oral dose of 50 mg; single oral dose of placebo tablet
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Histoacryl™ vs. Suture for Mesh Fixation in Lichtenstein Hernioplasty: A Randomized Prospective Double-Blinded Study
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This is a prospective, randomized double-blinded study to find out if mesh fixation with
      n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures
      in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is
      that glue fixation is safe, simple and fast method compared to conventional Lichtenstein
      technique.
    

Detailed description: 
      Hypothesis:

        1. To use glue (instead of sutures) for mesh fixation during open hernioplasty causes a
           lower immediate postoperative pain.

        2. The use of Histoacryl is associated to a lower postoperative complications rate.

        3. The use of Histoacryl is not associated to a higher hernia recurrence rate.

      Methods:

      350 patients with inguinal hernia undergone Lichtenstein operation in day-case surgery
      setting. Mesh fixation is performed using 2 methods: cyanoacrylate glue: Histoacryl™ (n=175:
      Group H), and non-absorbable sutures: polypropylene 2/0 (n=175: Group S). Operative time and
      pain scores, immediate postoperative outcome are followed 1, 7, 30 days and 1 and 5 years
      postoperatively.

      Surgeon doesn't know previously which fixation method will be used in each patient. This
      method (glue or sutures) is decided intraoperatively, when mesh is placed, using a blind
      randomization code (www.randomizer.org) Patients are discharged (day-case surgery) if
      adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after
      examination by the surgeon in order to discard immediate complications. Postoperative oral
      treatment is prescribed to patients of both groups: dexketoprofen 25 mg/8 h + paracetamol 1
      gr/8.

      Follow-up is performed at the medical office by a blind observer (third surgeon) who didn't
      participate in the surgical procedure, at 1 day, 7 days, 30 days, 1 year and annually
      thereafter. Pain is measured using a VAS scale (0-10).

      Operative data (including operating time, complications, hospital stay, etc.), early and late
      complications, acute and chronic pain and recurrence rate will be recorded.
    

Intervention name(s): Lichtenstein Hernioplasty with Histoacryl; Lichtenstein Hernioplasty with Sutures
Intervention type(s): Procedure; Procedure
Intervention description(s): Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl:
0.5 ml of cyanoacrylate glue is used for mesh fixation; Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inguinal hernia; mesh fixation; glue; cyanoacrylate; Lichtenstein; ambulatory surgery
Lifestyle Intervention's Impact on Health Care Costs
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of
      life outcomes of a nutrition intervention involving lifestyle case management and medical
      nutrition therapy by a registered dietitian compared to usual medical care in obese persons
      with type 2 diabetes. The intervention is aimed at moderate weight loss (> 5-10%),
      improvement in diet quality and an increase in physical activity.
    


Intervention name(s): Usual medical care; Lifestyle Case management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Health Behavior; Lifestyle; health care costs; quality of life
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting
      serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary
      objectives were to investigate the safety and tolerability and effect of Omacor on lipid
      parameters after 12 weeks treatment.
    

Detailed description: 
      This was a multicenter, randomized, double-blind, parallel-group study of twice daily
      treatment of Omacor or matching placebo in subjects with moderate or severe HTG.
    

Intervention name(s): Omega-3-acid ethyl ester or Placebo
Intervention type(s): Drug
Intervention description(s): Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Drug Exposures Of Two Formulations of PF-02341066
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over,
      single-dose study employing administration of two PF-02341066 formulations in the fasted
      state to healthy adult volunteers.
    


Intervention name(s): PF-02341066; PF-02341066
Intervention type(s): Drug; Drug
Intervention description(s): A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Powder-in-Capsule and 2 x 100-mg Powder-in-Capsules; A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Immediate Release Tablet and 2 x 100-mg Immediate Release Tablets
Intervention MeSH terms: Crizotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability, capsule, tablet, healthy volunteer
Children Education and Cardiovascular Risk Reduction in Their Parents
Condition: Risk Reduction
Study type: Interventional

Summary: 
      This study aims to evaluate if a multidisciplinary educational program in primary
      cardiovascular prevention for children could improve the Framingham Score index of their
      parents after one year.
    

Detailed description: 
      Students aging 6 to 10 years old were exposed to two different approaches in the city of Sao
      Paulo, Brazil. For the students of the morning period (control group) we delivered written
      educational material for their parents in the beginning and middle of the year 2010 about
      healthy lifestyle (nutrition, exercise and smoke quitting). The students of the afternoon
      period (intervention group) received the same educational material for their parents and the
      children were exposed to a weekly educational program in cardiovascular prevention with a
      multidisciplinary heath team during the year 2010. This intervention tried to teach to these
      children, in different manners appropriate for their age, concepts of healthy nutrition,
      avoidance of tobacco and physical activity. Both at the inclusion in the study and one year
      later we collect data of parents and their children of the two groups, in a single weekend,
      including nutritional and exercise survey, measures of weigh, height, waist circumference,
      arterial blood pressure, and laboratorial exams.
    

Intervention name(s): Educational program in cardiovascular prevention; Lifestyle counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.; The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Primary Prevention; Cardiovascular disease; Child; Behavior modification; Activities, Educational
A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose
      study of PF-06865571 in healthy male participants to characterize the ADME properties of
      [14C]PF-06865571 following oral administration; and to evaluate the absolute oral
      bioavailability (F) and fraction absorbed (Fa) of PF-06865571 following oral administration
      of unlabeled PF-06865571 and IV administration of [14C]PF-06865571.
    


Intervention name(s): Oral [14C]PF-06865571; Oral PF-06865571; IV [14C]PF-06865571
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral radiolabeled PF-06865571; Oral PF-06865571; IV radiolabeled PF-06865571
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ADME