bioihbjkbjnl/mcl2 huggingface dataset:
Preparedness Study - HPV Vaccine
Condition: Sexual Transmission of Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      Moffitt Cancer Center is the Coordinating Center for this study.

      The purpose of this study is to develop and test the infrastructure to conduct a future Phase
      III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus
      (HPV) genotype distribution, data needed to design a Phase III trial. The investigators
      propose to conduct a Preparedness study among women ages 16-24 years of age residing in a
      region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.

      The specific aims of this study are to:

        1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm,
           400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18
           [Gardasil]) or placebo vaccine.

        2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical
           lesion prevalence among young females ages 16-24 years at high risk for HIV infection.

        3. Assess the rate of compliance through the 3-dose vaccination series
    

Detailed description: 
      The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6.
      Both HPV and placebo vaccines will be in identical bottles, and all treatment codes will be
      kept under lock and key. All vaccines will be injected intramuscularly into the deltoid
      muscle by a member of the clinical staff. Each participant will be monitored for systemic and
      local reactions for 30 minutes postvaccination after each study vaccination for any adverse
      effects, including allergic reactions. Vaccine adverse events will continue to be monitored
      throughout the duration of the study period. Vaccine will be shipped to a central pharmacy at
      Stellenbosch University and stored in a refrigerator monitored and maintained at 2-8 C prior
      to distribution and local storage at participating clinical centers.
    

Intervention name(s): Gardasil Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.; The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
Other intervention name(s): Gardasil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vaccine; Placebo; sexually transmitted infection (STI); HIV; Human Immunodeficiency; Gardasil; HPV; human papillomavirus
Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health
Condition: Overweight/Obesity; Anemia; Mental Development
MeSH terms: Overweight
Study type: Observational

Summary: 
      The follow-up study was based on our previous nutritional intervention trial entitled "Impact
      of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up
      all livebirths born to women of the trial to measure their height, weight, and hemoglobin and
      to implement a questionaire survey (including developmental milestones, disease history,
      breast feeding, passive smoking, et al). We selected a sub-sample of infants to assess their
      IQ, emotional and behavioral problem, and language development status. The outcomes of
      interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness,
      anemia, developmental milestones, IQ, emotional and behavioral disorder, language
      developmental status, and disease history. Other interesting exposure includes breast
      feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an
      impact on offspring's physical, mental, and language development. We also hypothesize that
      cesarean delivery including CDMR has an impact on offspring's these outcomes.
    

Detailed description: 
      The follow-up study was based on our previous nutritional intervention trial entitled "Impact
      of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up
      all livebirths born to women of the trial to measure their height, weight, and hemoglobin and
      to implement a questionaire survey (including developmental milestones, disease history,
      breast feeding, passive smoking, et al). We selected 1200 <30 months infants to assess their
      IQ with Bayley scale, emotional and behavioral problem with CBCL scale, and language
      development status with LDS scale. We also selected 1500 >30 months children to measure their
      emotional and behavioral problem with CBCL scale. The exposure groups include intrauterine
      nutritional exposure and cesarean delivery exposure as well as CDMR. The outcomes of interest
      include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia,
      developmental milestones, IQ, emotional and behavioral disorder, language developmental
      status, and disease history. Other interesting exposure includes breast feeding, passive
      smoking, et al. We hypothesize that intrauterine nutritional exposure has an impact on
      offspring's physical, mental, and language development. We also hypothesize that cesarean
      delivery including CDMR has an impact on offspring's these outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all livebirths born to women of our previous trial (NCT00133744) who were from Laoting,
        Fengrun, Xianghe, Mancheng, and Yuanshi counties of China.
Vapocoolant (Pain Ease Medium Stream) for Intravenous Lines in Emergency Department Patients
Condition: Pain
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy and safety of vapocoolant stream (Pain Ease Medium Stream ) in
      decreasing the pain of intravenous cannulation.

      To compare vapocoolant stream (Pain Ease medium Stream) with control (e.g. sterile water)
      stream.
    

Detailed description: 
      Vapocoolant sprays have been used to decrease the pain associated with painful medical
      procedures such as immunizations, needle aspirations, injections, venipuncture and
      intravenous cannulation. In general, vapocoolant sprays , have been found to be effective in
      decreasing the pain of various medical procedures. Moreover, the use of vapocoolant sprays
      ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a
      painful injection and does affect the success rate of the procedure including intravenous
      cannulation and may even increase the success rate of the intravenous cannulation.
    

Intervention name(s): Vapocoolant; Sterile water
Intervention type(s): Device; Device
Intervention description(s): Topical stream of 4 to 10 seconds duration to skin; Topical intervention of sterile water stream 4 to 10 seconds to skin.
Other intervention name(s): Pain Ease stream; Nature's Tears by Bio-Logic Aqua Technologies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Vapocoolant
Short Term Weight Loss With Liraglutide and Metformin in Infertile Obese PCOS Patients
Condition: Obesity; PCOS
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate the impact of short-term weight reduction achieved with
      12-week intervention with metformin alone or in combination with liraglutide on oocyte
      maturity and embryo quality in infertile obese PCOS population.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in
      particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with
      impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective
      study was to investigate the effect of the antiobesity medical therapy (combination of
      metformin and liraglutide (COMBI)) on short time weight loss in the specific infertile obese
      PCOS population. Additionally, we analyzed eventual impact of the short term weight loss 5%
      or more before IVF on oocyte maturity and embryo quality in infertile obese PCOS population.
    

Intervention name(s): Metformin; Liraglutide + metformin
Intervention type(s): Drug; Drug
Intervention description(s): In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg twice per day per os for 12 weeks; In the COMBI group the initial dose of metformin was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg twice per day. Liraglutide 1.2 mg once per day s.c. was added after first two weeks of monotherapy with metformin.
Other intervention name(s): Glucophage tablets; Victoza 6 mg/ml solution and Glucophage tablets
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; PCOS; Infertility; Liraglutide; Metformin; IVF
OP-1 Putty for Posterolateral Fusions
Condition: Degenerative Lumbar Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Interventional

Summary: 
      The trial was designed to demonstrate the comparability of the overall success rate in the
      OP-1 Putty treatment group to the autograft treatment group.
    

Detailed description: 
      A controlled, open- label, blinded radiographic assessment, randomized, prospective,
      multicenter, multinational pivotal study in which patients with single level (L3-S1)
      degenerative lumbar spondylolisthesis (Grade 1 or 2) with spinal stenosis underwent
      decompression and spinal fusion and received OP-1 Putty or autograft. This study was a
      one-sided, non- inferiority trial comparing the overall success between the OP-1 Putty group
      and the control autograft group.
    

Intervention name(s): Spinal fusion
Intervention type(s): Procedure
Intervention description(s): Surgical procedure for lumbar spinal posterior decompression with concomitant posterolateral intertransverse process arthrodesis
Other intervention name(s): Lumbar Spinal Fusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative Disc Disease
Blood Compatibility Characteristics of Baxter Xenium+, Fresenius FX and Gambro Polyflux Dialyzers
Condition: End Stage Renal Failure on Dialysis
MeSH terms: Kidney Failure, Chronic
Study type: Observational

Summary: 
      The aim of the dialyzer evaluation is to compare performance characteristics and
      haemocompatibility of the Baxter Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux
      dialyzers
    

Detailed description: 
      The Xenium+ is a new high flux dialyzer made from Polynephron membrane designed and
      manufactured by the Nipro Company in Japan. This dialyzer has been subjected to in-vitro
      testing, and all legally required biological safety tests have been conducted and CE-mark was
      granted in June 2010. Xenium+ has the same Polynephron membrane as the Xenium family of
      dialyzers which has been available commercially globally for approximately three years.
      Clinical evaluations have been completed with the Polynephron membrane within the last three
      years. The improvement in the Xenium+ line is that the casing is now made from polypropylene.

      The aim of the dialyzer evaluation is to compare performance characteristics and
      hemocompatibility of the Xenium+ (Polynephron), Fresenius FX and Gambro Polyflux dialyzers.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        8 patients will undergo 1 treatment each with the 4 high-flux dialyzer types using a
        bloodflow of 300 ml/min, dialysate flow 500 ml/min and the dialysis machine Fresenius 5008
      
Keywords: hemodialysis; high-flux-dialyzer; performance; blood compatibility
The Effects of Oxytocin in Obese Adults
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, placebo-controlled study of the effects of intranasal
      oxytocin in obese adults, ages 18-45 years old. Subjects will be randomized to receive of
      intranasal oxytocin or placebo (3 sprays per nostril, 4 times per day) for 8 weeks. Study
      visits include screening to determine eligibility, a 2-part baseline visit, and visits every
      2 weeks thereafter until week 14, with a safety follow-up visit 6 weeks after the last dose
      of study drug. Study procedures include behavioral, metabolic, neuroimaging, and endocrine
      assessments.
    


Intervention name(s): oxytocin nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oxytocin intranasal spray; Placebo nasal spray
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: weight loss; body mass index; oxytocin; magnetic resonance imaging
Evaluating Yoga for Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study will compare the effectiveness of yoga classes, exercise classes, and a self-care
      book in the management of pain and function for people with low back pain.
    

Detailed description: 
      Back problems are among the most prevalent conditions affecting adults and are a leading
      reason for using complementary or alternative medical (CAM) therapies. Despite the common use
      of CAM therapies for back pain, little is known about how they compare with conventional
      treatments. This study will lay the groundwork for a full-scale trial that compares yoga with
      conventional exercise and usual care for chronic low back pain.

      This study will randomize 30 people with chronic low back pain to each of the following
      groups: yoga, a conventional therapeutic exercise program, and usual care. There will be 12
      weeks of weekly treatment and follow-up assessments via phone at 6, 12, and 26 weeks to
      measure each treatment's impact on symptoms, function, quality of life, and utilization and
      costs of back pain related care.
    

Intervention name(s): Yoga; Exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution
Condition: Colorectal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      This study investigates the safety and feasibility of performing laparoscopic surgery for
      colorectal and gastric cancer inside versus outside the primary registered medical
      institution under multi-sites practice (MSP) policy. This is a single practitioner,
      retrospective comparative study. The endpoints are peri-operative outcomes, pathological
      results, and medical costs.
    


Intervention name(s): surgery inside the primary institution; surgery outside the primary institution
Intervention type(s): Other; Other
Intervention description(s): to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution; to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        colorectal cancer and gastric cancer
Evaluation of a Tracheostomy Tube That Enables Communication
Condition: Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life
Study type: Interventional

Summary: 
      Verbal communication is vital to critically ill mechanically ventilated patient's quality of
      life (Hess, 2005). Patients who have a tracheostomy tube may be able to communicate using a
      speaking valve, however, some patients may not be able to tolerate cuff deflation for use of
      speaking valve. There are talking tracheostomy tubes that do not require cuff deflation to
      facilitate speech in this population. Unfortunately, not all candidates are offered these
      options due to lack of awareness. Recently, at our institution, there has been an increase in
      the use of these tubes to facilitate speech. One of the talking tracheotomy tubes that has
      proven to be effective is the Portex Blueline Ultra Suctionaid (BLUSA).

      In 2010, we conducted a retrospective review of 4 cases and found that BLUSA tracheostomy
      helped facilitate communication in this unique population (IRB #: NA_00041547). We would now
      like to formally conduct a prospective pilot study to evaluate the feasibility of measuring
      outcomes of patients with a BLUSA using a pretest-posttest research design.

      Communication empowers patients and allows healthcare staff to obtain a more accurate
      assessment of patients' condition and tailor care accordingly. Identifying the predictors of
      speech intelligibility and the impact of BLUSA on quality of life will promote communication
      between patients and healthcare providers.

      Study Hypothesis: Determine the impact of a talking tracheostomy tube on quality of life in
      patients requiring prolonged mechanical ventilation in the hospital.
    


Intervention name(s): Portex Blueline Ultra Suctionaid Tracheostomy Tube
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of Life; Talking Tracheostomy Tube; Speech; Mechanically ventilated patients
Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.
Condition: Idiopathic Thrombocytopenic Purpura (ITP)
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete
      the entire study. The study will consist of a pre-treatment phase and a treatment phase. The
      pre-treatment phase will include screening and baseline period 1. The treatment phase
      consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral
      dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose;
      Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant
      administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each
      treatment period. The screening period will be up to 13 days in duration. After fulfilling
      screening requirements, subjects will check into the clinic on Day -1 for baseline
      assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment
      Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient
      visits. They will be domiciled in the clinical testing facility for at least 14 days for
      Treatment Period 2 and will return intermittently for study procedures for 7 outpatient
      visits.
    


Intervention name(s): E5501
Intervention type(s): Drug
Intervention description(s): 20 mg oral dose of E5501; 240 mg once daily oral dose of sustained release verapamil; 400 mg oral dose of cyclosporine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
Condition: Myelodysplastic Syndrome (MDS); Aplastic Anaemia (AA); Myelofibrosis (MF); Thalassemia Intermedia
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Thrombocytopenia; Thalassemia; Anemia, Aplastic; beta-Thalassemia; Leukopenia; Hematologic Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on
      anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS),
      aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did
      not respond to available treatment options.
    


Intervention name(s): Chinese herbal concoction twice a day for 6 months
Intervention type(s): Drug
Intervention description(s): Definition of each TCM syndrome is based on TCM theory. Formulation composition is based on each defined TCM syndrome with addition or removal of herbs as indicated by the patient's manifestation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chronic cytopenic haematological diseases; Chinese herbal concoction; Supportive management
Combination of Remifentanil and Flurbiprofen in Sedation and Analgesia for ESWL of Pancreatic Stone
Condition: Pancreatic Stone Disease
MeSH terms: Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      Extracorporeal shock wave lithotripsy (ESWL) of pancreatic stones has been described as an
      effective approach for stone drainage and pain relief, and general or epidural anesthesia has
      been reported for such procedure. Single infusion of remifentanil has been described in ESWL
      of urinary stones, but it has never been described in ESWL of pancreatic stones. Moreover,
      single infusion of remifentanil might induce several complications, such as postoperative
      nausea and vomiting. The investigators attended to investigated whether combination of
      flurbiprofen with remifentanil reduced remifentanil dose and attenuated the complications.
    


Intervention name(s): Remifentanil; Flurbiprofen and remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.; Patients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method.
Intervention MeSH terms: Flurbiprofen; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extracorporeal shock wave lithotripsy; remifentanil; flurbiprofen; pancreatic stone