bioihbjkbjnl/mcl2 huggingface dataset:
Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK
      Biologicals' pneumococcal conjugate vaccine GSK1024850A.

      Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib
      and OPV vaccines.
    

Detailed description: 
      This protocol posting has been updated according to Protocol Amendment 2, September 2010. The
      impacted sections are arms and inclusion criteria.
    

Intervention name(s): GSK1024850A (Synflorix); Tritanrix-HepB/Hib; Polio Sabin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2, 3 or 4 intramuscular injection; Intramuscular injection, 4 doses; 4 oral doses
Other intervention name(s): DTPw-HBV/Hib; OPV
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Booster vaccination; Catch-up vaccination; Pneumococcal vaccine; Pneumococcal disease; Sickle cell disease; Safety
Subcuticular Skin Closure at Cesarean Delivery
Condition: Cesarean Section; Infection
Study type: Interventional

Summary: 
      Subcuticular skin closure with suture after cesarean has been shown to result in lower rates
      of wound complications than with staple closure. However, the optimal choice of suture
      material for subcuticular skin closure is unclear. Vicryl vs Prolen suture materials will be
      used for subcuticular closure of transverse skin incisions after cesarean section. Patients
      will be controlled for superficial surgical site infections 1 week after the cesarean
      section.
    

Detailed description: 
      Cesarean section is the most common abdominal surgery worldwide. Subcuticular skin closure
      with suture after cesarean has been shown to result in lower rates of wound complications
      than with staple closure. However, the optimal choice of suture material for subcuticular
      skin closure is unclear. Vicryl vs Prolen suture materials will be used for subcuticular
      closure of transverse skin incisions after cesarean section. Patients will be controlled for
      superficial surgical site infections 1 week after the cesarean section.
    

Intervention name(s): Cesarean Section with Vicryl; Cesarean Section with Prolen
Intervention type(s): Procedure; Procedure
Intervention description(s): Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with Vicryl.; Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with prolen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cesarean Section; Complications; suture material
RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion
Condition: Spinal Deformity; Spinal Instability; Instrumented Spinal Fusion
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the non-inferiority of AttraX® Putty as a bone
      graft substitute for autograft in instrumented posterolateral fusion of the thoracolumbar
      spine, in terms of efficacy and safety.
    

Detailed description: 
      Spinal fusion, a surgical procedure frequently used for many spinal conditions requiring
      stabilization of the vertebral column, is currently performed by using large amounts of
      autologous bone graft or autograft. A substitute for this patient own bone would eliminate
      the graft harvesting morbidity that is currently one of the main disadvantages. Recently, a
      promising synthetic graft substitute has been developed that has shown favorable results in
      pre-clinical studies. This product is AttraX® Putty (CE-557130), a bioresorbable tricalcium
      phosphate (TCP), mixed with a fast resorbing polymer carrier to improve surgical handling.
      The aim of the current study is to clinically investigate AttraX® Putty as an alternative to
      autologous bone graft in adult patients qualified for instrumented posterolateral fusion of
      the thoracolumbar spine (T10-S1).

      The study design is a patient and observer blinded, controlled, randomized, multi-center
      clinical trial with intra-patient comparisons. This means that each patient is it owns
      control. According to a randomization scheme, one side of the spine will be grafted with
      AttraX® Putty the other side receives bone harvest from the iliac crest, which is currently
      the gold standard.

      The primary outcomes of this study are the posterior spinal fusion rate after one year (based
      on CT-scans), and potential serious adverse events related with AttraX® Putty. Secondary
      outcomes are the resorption characteristics during the first year, volume of bridging bone
      mass after one year, evaluation of iliac crest pain, correlation of the posterior fusion rate
      to the presence of interbody fusion after one year and the posterior spinal fusion rate after
      two years.
    

Intervention name(s): AttraX® Putty; Autologous bone graft
Intervention type(s): Device; Other
Intervention description(s): Synthetic bone graft comprised of calcium phosphate granules and hydroxyapatite with an advanced biodissolvable polymer carrier that allows for better handling of the granules in putty form.; Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bone graft; Ceramic; Spinal fusion; RCT; Thoracolumbar region
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Condition: Pain; Depression; Substance Use
MeSH terms: Chronic Pain; Substance-Related Disorders; Depression
Study type: Interventional

Summary: 
      Individuals will be recruited by posted advertisements in the waiting rooms of the PCP
      offices and by physician referral. After an initial phone screen, research staff will meet
      with interested individuals in their PCP offices for informed consent, baseline interview and
      randomization. Participants will be randomized into a Health Education study arm, and receive
      7 individual sessions on general health education, or an Intervention study arm, and receive
      7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention.
    


Intervention name(s): Treating Opioid Patients' Pain and Sadness (TOPPS); Health Education
Intervention type(s): Behavioral; Behavioral
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain; depression; substance use
GSK1349572 Mass Balance Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Mass balance study to determine the recovery of a single radiolabelled dose of GSK1349572
      from urine and feces
    


Intervention name(s): [14c}-GSK1349572
Intervention type(s): Drug
Intervention description(s): HIV-Integrase inhibitor labelled with a carbon 14 marker
Intervention MeSH terms: Dolutegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteer; radiolabelled
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the relative bioavailability of ABI-H2158 tablets (Test
      Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the
      pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting
      conditions.
    


Intervention name(s): ABI-H2158 Reference Formulation; ABI-H2158 Test Formulation
Intervention type(s): Drug; Drug
Intervention description(s): ABI-H2158 tablets Reference Formulation; ABI-H2158 tablets Test Formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome
Condition: Neonatal Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hyaline Membrane Disease; Syndrome
Study type: Observational

Summary: 
      Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption
      through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing
      evidence has demonstrated that these lung disorders might be an important cause of neonatal
      respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function,
      particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might
      predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of
      SCNN1A are associated with NRDS, we conducted a case-control study to investigate the
      NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A
      gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Newborns with RDS are consecutively recruited for this study from the neonatal intensive
        care unit (NICU) at Daping Hospital, Third Military Medical University, Chongqing, China, a
        tertiary care facility. The control blood samples, which are collected from healthy
        neonatal umbilical cord blood, are obtained from the maternity ward of 80 hospitals in
        Chongqing and nearby areas.
      
Keywords: Lung fluid absorption disorders; Neonatal respiratory distress syndrome; Single nucleotide polymorphism; SCNN1A
A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to compare the pharmacokinetics (i.e. the course of the blood
      concentrations of the administered trial drug) of faster-acting insulin aspart (faster
      aspart), and the currently marketed formulation of insulin aspart (NovoRapid®) when given as
      a bolus using an insulin pump in people with type 1 diabetes. The pharmacodynamic response
      (i.e. the course of the blood sugar lowering effect of the administered trial drug) and the
      safety and tolerability of faster aspart and NovoRapid® will also be assessed.

      The participants will be in the study for approx. 21 days. Each participant will have 5
      visits to the clinic, with an overnight stay at both dosing visits. Participants will have a
      number of tests, and they will have to give blood and urine samples.
    


Intervention name(s): Faster-acting insulin aspart; Insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate; In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Noninvasive Ventilation on Chronic Obstructive Pulmonary Disease (COPD) Patient Functionality
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      On the following tests, there would be a greater increase in the functionality of COPD
      patients who underwent combined therapy than in those who only exercised: a set of activities
      of daily living (ADLs), the six-minute walk test (6MWT), an incremental symptom-limited
      cardiopulmonary test (CPT), and the physical functioning scale of the Short-Form 36 quality
      of life questionnaire (SF-36).
    

Detailed description: 
      Impact of aerobic exercise plus noninvasive ventilation (NIV) on the functionality of
      patients with COPD. Thirty patients (70.5 - 8.5 years) with COPD (forced expiratory volume in
      the first second 48.5 - 15.4% of predicted) were randomized into either a physical training
      group involving aerobic treadmill exercise (PTG, n=12) or an exercise plus bilevel
      ventilation group (PTGNIV, n=11) with sessions three times a week for six weeks.
    

Intervention name(s): physical training
Intervention type(s): Other
Intervention description(s): For both groups, the approximately hour-long sessions occurred three times a week on alternate days for six consecutive weeks (18 sessions). Each session began with five minutes of stretching that included the cervical muscles and the upper and lower limbs, which was followed by five minutes of warm-up on a treadmill at 2Km/h and 30 minutes of aerobic physical training at a constant 3% incline.
Other intervention name(s): TFG: physical training group; PTGNIV: exercise plus bilevel ventilation group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aerobic exercise; noninvasive ventilation; functionality
Titanium-Prepared Platelet Rich Fibrin in the Sinus Lifting Procedure
Condition: Maxillary Sinus
Study type: Interventional

Summary: 
      This study evaluates the radiographic, histological and clinical comparisons of the
      completely autologous T-PRF or allograft effectiveness at the maxillary sinus elevation
      procedure.
    

Detailed description: 
      Participants randomly divided into 2 groups and the test group had a Schneiderian membrane
      elevation with using balloon lifting technique and after that sinus was filled with T-PRF
      produced from the patients' blood and 4 months waiting period has been entered. At the end of
      the 4th month, the bone samples were received from the implant slots and sent to histological
      evaluation. After 3 months, implant stability was measured and recorded. In the control
      group, the same procedures were followed and sinus was filled with only allograft. Waiting
      period was changed to 6 months for this group.
    

Intervention name(s): Titanium-Prepared Platelet Rich Fibrin; Allograft (CTBA Allograft)
Intervention type(s): Other; Other
Intervention description(s): Blood samples were collected from the each participant's arm in the test group by 20 ml syringe and then was transferred into 10ml grade IV titanium tube without anticoagulant. After centrifugation of blood samples (2800 rpm, 12 minutes) at room temperature, the T-PRF clot was removed from the tubes with sterile tweezers. 6 blood tubes were collected for a sinus floor elevation/lifting operation and 6 T-PRFs were prepared for each participant.; After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maxillar sinus; Titanium-Prepared Platelet Rich Fibrin; Allograft; implant
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MabThera in patients with active
      rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha
      inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous
      inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated
      with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate
      therapy. The anticipated time on study treatment is 2+ years, and the target sample size is
      100-500 individuals.
    


Intervention name(s): rituximab [MabThera]
Intervention type(s): Drug
Intervention description(s): 1 g was given by intravenous infusion on Days 1 and 15
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation Of A New Medication (GW642444) In Asthmatic Patients
Condition: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and
      pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre,
      double-blind, placebo controlled, dose ascending, four way cross-over study in approximately
      28 mild to moderate asthmatic subjects.

      Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will
      be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical
      laboratory tests, collection of adverse events (AE) information and blood samples.
    


Intervention name(s): GW642444; Placebo; salmeterol 50mcg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): drug; placebo; salmeterol
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GW642444 asthmatic subjects safety tolerability PD and PK
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
Condition: Colorectal Cancer; Non Resectable Metastasis; Reference Lesion; Biopsy; Thymidylate Synthase Quantitation
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study was to evaluate the feasibility of TS determination in a multicenter
      trial setting using a central facility for measurement and confirm its role as predictive
      factor for 5-FU treatment in MCRC.
    

Detailed description: 
      Eligible were patients with non-resectable metastasized or recurrent histologically proven
      CRC with the presence of a reference lesion two-dimensional measurable and accessible for a
      biopsy.The biopsy was taken from the reference lesion either by surgery during primary tumor
      resection, by trans-cutaneous true-cut needle biopsy or by trans-anal approach. Intratumoral
      relative TS mRNA expression levels were determined using samples shipped in RNA-preserving
      solution or as glass slides after microdissection of tumor cells. An independent company
      stratified the patients according to ther relative TS mRNA expression level in TS low and TS
      high followed by randomization to receive either FUFA of Folfiri. Response to chemotherapy
      was evaluated and documented according to the RECIST criteria after every therapy cycle.
    

Intervention name(s): FUFA; systemic chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 2600/500 mg/m2 i.v. 24 h via port, 1 time weekly for six weeks, than have a break for 2 weeks (=8 weeks for 1 cycle); CPT-11, 80 mg/m2 for 90 minutes and 5 FU/FA 2000/500 mg/m2 iv. 24h via port; 1 time weekly for six weeks, than have a break for 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colorectal Cancer; non resectable metastasis; reference lesion; biopsy; thymidylate synthase quantitation
Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate
Condition: Whole Body Energy Metabolism
Study type: Interventional

Summary: 
      Fatty acids are the main components of the cell membranes. It has been demonstrated that diet
      can alter the characteristics and function of many membranes in the body, which has an effect
      on cardiovascular and metabolic health. Over the last two decades there has been a
      substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on
      bodily function. There are two fatty acids that are of particular interest to researchers,
      eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique
      unsaturated structures, and their incorporation into biological membranes seems to generate
      important and positive physiological effects. The body is unable to synthesize these fatty
      acids in high concentrations to elicit significant effects, so they must be obtained through
      diet in food or via supplementation.

      It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR)
      in humans, in part by increasing the use of fat as a fuel during rest. There are a limited
      number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an
      increase in RMR while others have found no change. These studies have some limitations, as
      that they have either used a small sample size, a low omega fatty acid dose and/or short
      supplementation periods. Due to the variable results, the investigators will improve the
      reliability of the RMR measurements by making measures on each subject during two consecutive
      days at each time point that it is measured (0, 6 and 12 weeks).

      Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3
      supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The
      researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR
      and fat oxidation in some subjects and not in others. The duplicate RMR measures will
      determine the prevalence and magnitude of the omega 3 supplementation.
    


Intervention name(s): Omega-3 Complete; Placebo Pill
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Omega-3; Resting metabolic rate; Eicosapentaenoic acid; Docosahexaenoic acid