bioihbjkbjnl/mcl2 huggingface dataset:
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of a booster dose of
      diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b
      vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and
      reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal
      vaccine (ACW) at 24 to 30 m in primed subjects.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      This open study will have two parallel groups based on the vaccination received in the
      primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed
      Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a
      booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK
      Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30
      months of age. Blood sampling will be done prior to (pre) and one month after (post) the
      Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum
      7 to maximum 16 months per subject.

      Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an
      inconsistency in the earlier version of the protocol posting and to reflect the actual
      situation.
    

Intervention name(s): Tritanrix™- HepB; Hiberix™; Mencevax™ ACW
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months; One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months; One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal serogroups A and C diseases; tetanus; hepatitis B; pertussis; Haemophilus influenzae type b; meningococcal vaccine; Prophylaxis diphtheria
Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neoplasm, Residual
Study type: Observational

Summary: 
      RATIONALE: Testing for minimal residual disease in cell samples from patients with acute
      lymphoblastic leukemia may help doctors plan better treatment.

      PURPOSE: This research trial studies a genetic test in identifying previously undetectable
      minimal residual disease in cell samples from younger patients with acute lymphoblastic
      leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  To identify and characterize changes in clonal populations of B cells in children with
           acute lymphoblastic leukemia (ALL) at diagnosis and Day 29 of induction.

        -  To define the ability of this technology to reclassify patients as minimal residual
           disease (MRD) positive at Day 29 of induction.

        -  To determine whether more sensitive detection of MRD at Day 29 would have clinical
           prognostic value in children with ALL.

      OUTLINE: DNA extracted from diagnostic cells are analyzed for immunoglobulin heavy chain
      variable region by next-generation sequencing.
    

Intervention name(s): cytogenetic analysis; nucleic acid sequencing; diagnostic laboratory biomarker analysis; laboratory biomarker analysis; medical chart review
Intervention type(s): Genetic; Genetic; Other; Other; Other
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients With Acute Lymphoblastic Leukemia
      
Biospecimen description: 
      cell samples
    
Keywords: childhood acute lymphoblastic leukemia in remission; recurrent childhood acute lymphoblastic leukemia; B-cell childhood acute lymphoblastic leukemia
The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
Condition: Analgesia, Patient-Controlled; Analgesia, Postoperative
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine
      mixture for intravenous patient-controlled analgesia (PCA).
    

Detailed description: 
      Patient-controlled analgesia (PCA) is a widely accepted method to control postoperative pain.
      Morphine is the commonest opioid for PCA, however its side effects are troublesome.
      Morphine-related side effects include pruritus, nausea, vomiting, constipation, urinary
      retention, respiratory depression, and sedation. Many studies had been conducted to reduce
      the side effect of morphine. The current trend of reducing morphine side effect is direct
      combination of other drugs and morphine in PCA. The advantages of this method are convenient
      in clinical use and preventive for side effects. Dexmedetomidine is a highly selec¬tive
      α2-adrenergic receptor agonist that has been reported to cause sedative effects and reduce
      opioid requirements in the perioperative period. The main advantage of this drug is that it
      does not cause serious respiratory side effects. The analgesic, sedative/hypnotic and
      anxiolytic prop¬erties of dexmedetomidine make this drug potentially useful for postoperative
      sedation and analgesia. No previous study had investigated the effect of direct combination
      of dexmedetomidine and morphine in PCA. The goal of this study is to investigate the
      combination effect of dexmedetomidine and morphine in postoperative patient-controlled
      analgesia.
    

Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Implementation of Optical Diagnosis of Diminutive Colorectal Polyps: DISCARD3 Study (Incorporating AI-DETECT)
Condition: Colonic Polyp
MeSH terms: Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      This is a prospective feasibility study. The aim of this work is to assess the acceptability
      and feasibility of optical diagnosis-led care in bowel cancer screening patients undergoing
      colonoscopy. This study will determine whether bowel cancer screening colonoscopists are able
      to consistently record and diagnose diminutive adenomas suitable for a resect and discard
      strategy allowing assignment of surveillance intervals according to Preservation and
      Incorporation of Valuable Endoscopic Innovations (PIVI) criteria. A practical quality
      assurance program around optical diagnosis will be introduced. The use of a CAD
      polyp-detection system will also be evaluated (AI-DETECT).
    


Intervention name(s): CAD polyp-detection system
Intervention type(s): Diagnostic Test
Intervention description(s): Software will be used during the procedure to aid the detection of polyps during the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Colonoscopy lists will be randomised for the use of a CAD polyp-detection system to be used as an adjunct to optical diagnosis. 50% of colonoscopy lists will be randomly assigned to use the CAD system and 50% of colonoscopy lists will not use the CAD system.
Masking: None (Open Label)
Primary purpose: Diagnostic
Waiting Room's Environment and Children Anxiety Prior Dental Treatment
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The amount of time the patient has spent awaiting treatment and the nature of the waiting
      room environment influence the anxiety level prior treatment. The objective of the present
      study is to compare the effect of waiting room's environment on the levels of anxiety
      experienced by children, in sensory adapted dental environment (SADE) and traditional waiting
      rooms. A parallel randomized trial. The participants will be randomly assigned to one type of
      waiting room. The participants will be asked to answer Venham Picture Test (VPT) scale while
      waiting in the waiting room just before entering the clinic.
    

Detailed description: 
      The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. All
      ceiling fluorescent lighting is removed. The adapted lighting consisted of slow-moving,
      repetitive visual color effects created by a projector, and a lighting column that children
      can touch and climb on. Auditory stimuli include rhythmic music, which is heard via
      loudspeakers. The traditional waiting room: a waiting area outside the clinic with ten seats
      in one row faces the reception desk in an area of 15 square meters. The area is
      air-conditioned, moderately well-lit, without posters or paintings on the walls, and no
      reading material.

      •Dental anxiety scale- Venham Picture Test (VPT) is widely used and easily administered. In
      this test, children are presented with eight cards, with two figures on each card, one
      'anxious' figure and one 'nonanxious' figure. They are asked to choose the figure from each
      pair that describes how they feel at that particular time. All cards are shown in their
      numbered order. If an anxious figure is chosen, a score of one is recorded. If a nonanxious
      cartoon is chosen, a score of zero is recorded. A measure of anxiety is obtained by totaling
      the number of times the child picks the cartoons depicting the anxious state (minimum score,
      0; maximum score, 8). The participants will be asked to answer while waiting in the waiting
      room just before entering the clinic.

      Study design- The study is a parallel randomized trial. The participants will be randomly
      assigned to one type of waiting room.

      Additional data- gender, age, the lengths of waiting, the purpose of the visit (examination
      or treatment with/without sedation), dental experience, type of waiting room, child escort.
    

Intervention name(s): sensory adapted waiting room
Intervention type(s): Other
Intervention description(s): The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. A lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Modified Connective Tissue Graft Wall With Wing Technique for Posterior Teeth
Condition: Recession
Study type: Interventional

Summary: 
      The investigators reported here the application of usage modified connective tissue graft
      wall technique for posterior teeth. The treatment outcomes suggested the efficacy of the used
      technique in treating recession defects accompanied by infrabony defects in molars.
    

Detailed description: 
      Gingival recession is defined as the apical migration of the gingival margin leaving the root
      surface denuded. Treatment of Class III and IV defects and achievement good of results seems
      to be quite difficult due to the advanced loss of the soft and hard tissues supporting the
      affected teeth. Furthermore, partial to total loss of the interproximal papilla is one of the
      main challenges that contribute for achieving higher levels of esthetics especially in
      anterior zone. In such a case, conventional techniques of root coverage results usually in
      poor prognosis.
    

Intervention name(s): Modified connective tissue graft wall with wing technique
Intervention type(s): Procedure
Intervention description(s): the usage of bone graft and collagen barrier to treat recession defects accompanied vertical bony defcets in posterior teeth
Other intervention name(s): bone graft and collagen barrier
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: connective tissue wall technique; modified connective tissue wall technique with a wing; recession defects in posterior teeth; recession defects with infrabony defects
Treatment With the Evoke System for Facial and Submental Laxity
Condition: Laxity; Skin
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction
      after Evoke treatment for face and submental area
    

Detailed description: 
      The aim of the study is to evaluate the efficacy, patient comfort, and patient satisfaction
      after Evoke treatment for face and submental area Prospective, open label clinical study.
    

Intervention name(s): Evoke radiofrequency device
Intervention type(s): Device
Intervention description(s): Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Role of Cytokines in Hepatitis E Virus Infection During Pregnancy
Condition: Hepatitis; Cytokines; Pregnancy
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis E; Hepatitis
Study type: Observational

Summary: 
      Hepatitis E virus is a public health problem in several countries of the world where safe
      drinking water is a problem. HEV is an exclusive cause of epidemic hepatitis in general
      population. HEV infection occurs most frequently in rainy season. The disease affects mainly
      young adults in the age of 15-40 years.HEV viral infection is of particular concern in
      pregnancy. It is a potential disaster for mother and child. HEV infection during pregnancy is
      fulminant and fatal especially if it occurs in third trimester. The mortality in the second
      trimester is around 20% and reaches upto 45% in the third trimester.
    

Detailed description: 
      The study will include pregnant women with acute viral hepatitis and fulminant hepatic
      failure (jaundice). The women with FHF will be recruited from the medical wards and antenatal
      wards as all such patients are routinely admitted in the hospital.

      The pregnant women with acute viral hepatitis will be recruited either from antenatal clinic
      and medical outpatient, or from the medical and antenatal wards because pregnant women with
      AVH are admitted if they have serum bilirubin levels > 15- 20 mg / dl, persistently high
      bilirubin levels for more than 2-3 weeks, abnormal prothrombin time, evidence of progression
      of the disease, need parenteral therapy (because of excessive vomiting).

      The enrolled subjects will be evaluated on the basis of a pre-designed and pre-tested
      proforma with respect to history and clinical examination, obstetrics examination and
      ultrasonography. Ten ml venous blood sample will be drawn from the patient at the time of
      enrollment detection of hepatotropic viruses (Various serological markers of hepatitis will
      be done which includes: IgM anti-HAV, HBsAg, IgM anti-HBc, HBeAg, anti-HCV Ab and IgM
      anti-HEV would be done using commercially available ELISA kits and Extraction of HEV-RNA from
      serum will be done) & levels of cytokines (IL-6, TGF-beta, IFN-g and TNF-α). All the subjects
      will be followed- up till delivery. The promoter region of cytokine gene will be amplified by
      PCR in appropriate reaction conditions using suitable sets of primers. PCR product will be
      used for studying the polymorphisms by restriction fragment length polymorphism.

      The control group would comprise of age and POG matched healthy asymptomatic pregnant women

      Follow up

      All participants will be followed up till delivery for obstetrical complications, medical
      complications and pregnancy outcome.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women of 18-40 years with jaundice and Healthy pregnant women as controls
      
Keywords: Hepatitis E Virus; Cytokines; Pregnancy
Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability
      and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched
      non-Hispanic healthy adult Caucasian subjects.
    


Intervention name(s): Lanadelumab
Intervention type(s): Drug
Intervention description(s): SC injection of 300mg in 2mL (150 mg/mL) solution of lanadelumab will be administered as a single dose injection in the abdomen.
Other intervention name(s): SHP643
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lanadelumab
Comparison of Gene Mutations in Matched Samples in Advanced Nonsquamous NSCLC Using NGS
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The objective of the study was to compare the gene mutation status among the primary tumor,
      matched metastatic lymph node (LN) and peripheral blood in advanced nonsquamous non-small
      cell lung cancer (NSCLC) using next-generation sequencing (NGS).
    

Detailed description: 
      Many gene mutations have been detected in lung cancer, which might differ between the primary
      tumor and the metastases in a same patient. One may cause by the heterogenicity of the tumor,
      another may cause by the sensitivity of the detection technique. So we determine to use NGS,
      which is a more sensitive technique, to detect the different gene mutations among the primary
      tumor, metastatic LN and peripheral blood in advanced nonsquamous NSCLC.

      The study was designed as a prospective and single center study. Thirty five patients will be
      enrolled into the study and the clinical data of the patients, including his smoke history,
      cancer history, occupation exposure and so on, will be collected and recorded in a case
      report form. For the patients recruited in the study, the primary tumor and metastatic lymph
      nodes will be obtained by interventional pulmonology technology. And about 10ml peripheral
      blood will be collected at the same time. The tissue will be sent to Pathology Department of
      Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed
      with nonsquamous NSCLC, the rest tissue will be extracted with DNA and performed NGS for the
      qualified DNA sample using Illumina Nextseq500 sequencer.The matched peripheral blood will
      also be extract with DNA and performed NGS using Illumina Nextseq500 sequencer.
    

Intervention name(s): Nextseq500 sequencer
Intervention type(s): Device
Intervention description(s): The sequencer will be used to detect the gene mutations of the primary tumor, metastatic LN and peripheral blood samples obtained from patients.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gene testing; Next-generation sequecing; Primary tumor; Metastatic lymph node; Peripheral blood
Altrazeal™ Versus Aquacel® Ag for Partial Thickness Skin Donor Sites
Condition: Partial-thickness Skin Donor Sites
Study type: Interventional

Summary: 
      The primary objective of the study is to evaluate the time to wound healing in skin graft
      donor sites with a new treatment (Altrazeal dressing) compared to standard of care treatment
      (Aquacel Ag- Carboxymethylcellulose dressing) in partial thickness skin graft donor sites.
    

Detailed description: 
      This is a single center, randomized, therapeutic exploratory study to monitor wound healing
      with the new AltrazealTM flexible hydrogel nanoparticle dressing compared to the existing
      treatment standard (Aquacel ® AG sodium carboxymethylcellulose dressing) in patients with at
      least two skin graft donor sites. 40 patients with at least 2 skin graft donor sites, ranging
      in age from 3 and 85 years, will be enrolled. Children (age 3 to 16 inclusive) will be
      included in the patient population if possible, but should not exceed 50% of all patient
      enrolled. Researchers will first identify the skin donor sites (A and B) for each patient and
      take baseline digital images and measurements immediately following surgery (Day 1). Trained
      personnel will apply the dressings provided by the Sponsor for and labeled as A or B by the
      Sponsor in a random fashion. Typical meticulous wound care and adequate analgesic medical
      coverage will be provided for the duration of the study. Both the patient and medical staff
      will be trained on instructions for use of each dressing. The patients will be monitored
      daily as part of standard procedure while they are in the in-patient setting. If and when
      patients move to the out-patient setting, they will continue to be monitored at least
      every-other-day at the study center. On each day (in-patient) or every-other-day
      (outpatient), the physician will determine whether each skin graft donor site has healed per
      standard care guidelines (i.e. > 95% re-epithelization), and pain and adverse events will be
      monitored. The last study visit will be on Day 24 or on the day when both wounds have been
      assessed as "healed", whichever comes first.
    

Intervention name(s): Altrazeal; Aquacel Ag
Intervention type(s): Device; Device
Intervention description(s): Sterile, odorless, crystalline white powder consisting of flakes of freeze dried HEMA and HPMA polymers. For application, the powder is distributed to the surface of the wound or burn where it forms a moist, flexible film and adheres to the surface of the wound.; Textile fiber made from sodium carboxy-methylcellulose containing 1.2% silver in ionic form.
Intervention MeSH terms: Carboxymethylcellulose Sodium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin Graft donor sites