bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis
Condition: Recurrent Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative
      treatment available to date. The challenge remains in patients that do develop drug
      resistance and/or secondary infection, although topical corticosteroids and antimicrobials
      are the first therapeutic choice. The aim of the study was to evaluate the efficacy and
      safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative
      therapy for minor RAS.

      Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule
      form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic
      function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally
      applied on RAS among Chinese population.

      In this study, a randomized, double-blind, placebo-controlled clinical trial (from March 2010
      to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing
      Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days.
      An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day 3 and Day 5.
      Any noted adverse reactions were recorded.
    


Intervention name(s): Yunnan Baiyao toothpaste; Placebo toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): The patients were instructed to brush the teeth twice daily for 5 days, using 1 gram of Yunnan Baiyao toothpaste (equivocal to approximately 6-7 lines on a standard toothbrush) for 3 minutes. 6.5 milligrams of Yunnan Baiyao active extract were contained in 1 gram of the toothpaste.; One gram of the placebo toothpaste was used twice daily by the control group patients. Except for the active Yunnan Baiyao extract, all ingredients contained in the placebo-toothpaste were the same as that in the experimental toothpaste.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Yunnan Baiyao; recurrent aphthous stomatitis; clinical trial
Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of pelvic floor muscle training in the
      treatment of urinary incontinence after radical prostatectomy.
    

Detailed description: 
      Urinary incontinence is a well known side effect of radical prostatectomy. The prevalence
      differs according to time period after the operation and the definition of incontinence used.
      However, a prevalence of 10-20% have been reported one year after the operation. Pelvic floor
      muscle training has been suggested as a treatment of urinary incontinence. The aim of this
      study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary
      incontinence after radical prostatectomy.We conduct a randomized clinical trial, comparing
      one group(n=40) following a pelvic floor muscle training program after prostatectomy and one
      group (n=40) receiving only standard information.Primary outcome variable is self
      registration of urinary incontinence.
    

Intervention name(s): Strength training of the pelvic floor muscles; strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group A followed a pelvic floor muscle exercise course consisting of intensive pelvic floor muscle training with follow up instructions (training group or DVD instructions)by a physiotherapist;3 x 10 contractions daily.
Group B were instructed to train the pelvic floor muscles 3 x 10 contractions daily without follow up instructions by a physiotherapist.
Other intervention name(s): Physiotherapy, pelvic floor muscle training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: urinary incontinence; pelvic floor muscle training; radical prostatectomy; physiotherapy
Remegal Different Doses in Patients With Refractory Partial Seizures
Condition: Drug Safety; Normal Drug Tolerance; Self Efficacy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine weather different doses of Remegal are
      effective,safety and tolerant in Additional Therapy for Patients With Refractory Partial
      Seizures and pharmacokinetics definition
    

Detailed description: 
      Phase II
    

Intervention name(s): Remegal
Intervention type(s): Drug
Intervention description(s): Drug/ placebo
Other intervention name(s): Remegal (beprodone)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Point-of-Choice Prompts to Reduce Prolonged Sitting Time at Work
Condition: Adult Office Workers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether an on-screen prompt put on the work
      computer every 30 minutes is effective in getting office workers to reduce prolonged periods
      of sitting at work.
    

Detailed description: 
      Prolonged bouts of uninterrupted time spent sitting is associated with indicators of poor
      health, independent of how physically active a person is. Many occupations are now sedentary,
      and are characterised by long periods spent sitting at a desk. Brief education on the
      benefits of standing regularly and breaking up prolonged sitting will be provided to
      participants, working at a Scottish University. One intervention group will additionally have
      software installed on their work computer which placed a prompt window in the centre of their
      screen for 1 minute every 30 minutes. The prompt will remind participants to stand-up and
      take a break, and the window cannot be removed or minimised.
    

Intervention name(s): MyRestBreak 1.0; education talk and leaflet
Intervention type(s): Device; Behavioral
Intervention description(s): Prompting software (MyRestBreak 1.0 copyright Vikram Sharma) will be installed on the work computer. A prompt with the message "stand up, take a break" is placed on the screen of the work computer for 1 minutes every 30 minutes, from the time the computer is switched on in the morning. The prompt is contained in a window 11x9 cm in the centre of the screen. The prompt cannot be removed or minimised, but work can continue in any windows visible around the prompt. The prompt is on the computer for 5 days.; A short educational talk, read from a script, regarding the health risks of prolonged sitting, stating that standing every 30 minutes could be beneficial. A short information leaflet stating with the same message is also provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: occupation; work; sitting; sedentary behaviour; office worker; adult; education; point-of-choice prompt
Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion
Condition: Anesthesia, Spinal
Study type: Interventional

Summary: 
      Intravenous infusion of dexmedetomidine during procedure was known to be associated prolonged
      duration of spinal anesthesia. In patients receiving dexmedetomidine infusion during
      procedure, it has been not evaluated whether use of adjuvant intrathecal fentanyl had
      additional prolonging effect on duration of spinal anesthesia or not. Therefore, the
      investigators planned this trial to compare clinical outcomes in patients receiving spinal
      anesthesia with heavy bupivacaine only and heavy bupivacaine plus fentanyl adjuvant.
    


Intervention name(s): fentanyl; bupivacaine only
Intervention type(s): Drug; Drug
Intervention description(s): intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation; heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation
Other intervention name(s): Hana Pharmacy; AstraZeneca
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fentanyl; dexmedetomidine
Comparison of Two Strategies to Realize Apnea Test for the Diagnostic of Brain Death in Potential Organ Donors (CPAPNEE STUDY)
Condition: Alternative Method of Apnea Test
MeSH terms: Apnea
Study type: Interventional

Summary: 
      Clinical diagnostic of brain death requires a non-reactive coma, absence of brain stem
      reflex, and absence of spontaneous breathing. The confirmation of absence of spontaneous
      breathing is established the apnea test (according to the American Academy of Neurology's
      Guidelines). However this test may lead to complications (acute hypoxemia, ventilatory and
      cardiocirculatory disorders) and reduces significantly the number of lung transplants. Some
      data suggest modifying the apnea test : replace the ventilator switching off with continuous
      positive airway pressure (CPAP) use. These studies showed that this alternative method (CPAP)
      increased the level of lung harvest but they were not sufficient because these studies were
      monocentric, non randomized and with little patients,. That why the aim of the present study
      is to compare the standard strategy and CPAP strategy with a prospective, multicenter,
      randomized study.
    


Intervention name(s): Apnea test - control; Apnea test - CPAP
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Phase I/II Study of SRP-4053 in DMD Patients
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability,
      efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with
      deletions amenable to exon 53 skipping.
    

Detailed description: 
      Part 1: Randomized, placebo-controlled dose-titration to assess safety, tolerability and
      pharmacokinetics of 4 dose levels of SRP-4053 in genotypically-confirmed DMD patients with
      deletions amenable to exon 53 skipping.

      Part 2: Open-label evaluation of SRP-4053 in patients from Part 1, along with newly enrolled
      DMD patients with deletions amenable to exon 53 skipping and an untreated group of DMD
      patients with deletions not amenable to exon 53 skipping.

      Safety, including adverse event monitoring and routine laboratory assessments, will be
      followed on an ongoing basis for all patients.

      Clinical efficacy, including functional tests such as the six-minute walk test (6MWT), will
      be assessed at regularly scheduled study visits. Patients in the treated groups will undergo
      one baseline and one follow-up muscle biopsy. Patients in the untreated group will not
      undergo biopsies and will follow an abbreviated schedule of study assessments.
    

Intervention name(s): Placebo; SRP-4053
Intervention type(s): Drug; Drug
Intervention description(s): SRP-4053 placebo-matching solution for IV infusion.; SRP-4053 (golodirsen) solution for IV infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; Exon Skipping; DMD; Exon 53; Ambulatory; Pediatric
Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery
Condition: Gynecologic Disease
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative
      analgesic effect for abdominal surgery with midline incision. Laparoscopic gynecologic
      surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage
      the pain.The purpose of this study is to investigate the analgesic effect of
      ultrasound-guided RSB to multi-port laparoscopic gynecologic surgery which has incision site
      at umbilical area. Patients will randomly assigned to two groups, RSB group and Control
      group. Each patients will assessed for time to first rescue analgesia, verbal numerical
      rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by
      IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.
    

Detailed description: 
      Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of
      general anesthesia. The procedure will be performed bilaterally and 15 ml on each side, total
      30 ml of 0.25% ropivacaine will be injected. After the procedure, a surgery scheduled will be
      proceeded. Patient of Control group will be proceeded the surgery after induction of
      anesthesia. All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl with
      150 mg of ketorolac for 48 hours postoperatively. If a patient complains pain more intense
      than VNRS 4 or demands an analgesic drug, a rescue analgesic would be allowed.
    

Intervention name(s): Rectus sheath block; Ropivacaine; Bandage; IV-PCA containing Fentanyl and Ketorolac
Intervention type(s): Procedure; Drug; Other; Drug
Intervention description(s): Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine; Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine; After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.; All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.
Other intervention name(s): RSB; Naropin; Intravenous patient controlled analgesia
Intervention MeSH terms: Ketorolac; Fentanyl; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study of ABT-869 in Subjects With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of
      ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was
      determined in a previous the M04-710 study.
    


Intervention name(s): ABT-869
Intervention type(s): Drug
Intervention description(s): 2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maternal Vitamin D for Acute Respiratory Infections in Infancy
Condition: Upper Respiratory Tract Infections; Lower Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      There is a growing body of data suggesting that vitamin D modulates the host's immune
      response to acute respiratory infection (ARI). The primary aim of this study is to determine
      whether maternal vitamin D3 supplementation versus placebo decreases the incidence rate of
      microbiologically confirmed viral-associated ARI among infants in Dhaka, Bangladesh.
      Secondary outcomes include: A) incidence of ARI associated with specific major pathogens, B)
      incidence of clinical ARI (without the need for positive microbiology), and C) quantitative
      density of pneumococcal carriage. Infants will be followed from birth until 6 months of life.
      Among infants who meet at least one of the specific case definitions for ARI (see 'Detailed
      Description' section), nasal swab specimens will be collected. Respiratory samples will be
      analyzed by real-time polymerase chain reaction (qPCR) to identify a 7-virus panel (influenza
      A and B, respiratory syncytial virus, human metapneumovirus, adenovirus, and parainfluenza
      types 1, 2, and 3) plus quantitative density of S. pneumonia.
    

Detailed description: 
      In this study, an acute respiratory infection (URTI and/or LRTI) has been clinically defined
      as:

      A) Upper respiratory tract infection (URTI)

      A new-onset illness consisting of at least two of the following clinical criteria at any time
      during a surveillance week:

        -  Caregiver-reported cough;

        -  Caregiver-reported rhinorrhea;

        -  Caregiver-reported nasal congestion; and,

        -  Measured axillary temperature greater than or equal to 37.5°C.

      B) Lower respiratory tract infection (LRTI)

        1. New onset clinically-diagnosed LRTI:

             -  Caregiver-reported cough AND/OR difficulty breathing during a surveillance week;
                AND,

             -  Observed lower chest wall indrawing AND/OR elevated respiratory rate (60 breaths
                per minute or greater for infant up to 59 days of age, or 50 breaths per minute or
                greater for infant 60 days of age or older)

        2. Hospitalized LRTI

             -  Hospitalization with physician diagnosis of pneumonia or bronchiolitis
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bangladesh; Vitamin D; Acute Respiratory Infections; Infancy; Pregnancy
A Pilot Study to Measure Blood Levels of Desflurane in Children
Condition: Desflurane Levels
Study type: Interventional

Summary: 
      In this feasibility study we will collect blood from indwelling arterial catheters in up to
      20 patients undergoing non-emergent surgery with desflurane anesthesia at Children's Hospital
      of Philadelphia. Desflurane levels will be determined by high pressure liquid chromatography
      (HPLC).

      Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during
      fetal surgery. We propose a pilot study to assess the ability of our assay to measure
      desflurane in human blood.
    

Detailed description: 
      Fetal surgery is an evolving field. Some previously fatal diseases can be surgically
      corrected before birth. Animal models of the procedures have been carefully translated to
      humans, but less is known about anesthetic techniques. In children, inadequate anesthesia
      results in greater stress responses as shown by cardiovascular, neuro-endocrine, and
      metabolic changes. These stress responses have been associated with poorer outcomes. One of
      the major goals of anesthesia for these procedures is to attenuate this stress response.
      Fetuses get intramuscular opioids before their incision, and the mother is given high doses
      of volatile anesthetic (desflurane) with the assumption that whatever amount of desflurane
      crosses the placenta adequately anesthetizes the fetus. No studies have quantified the fetal
      levels of desflurane.

      High pressure liquid chromatography (HPLC) has been used to measure levels of volatile
      anesthetic in various tissues. Measurement of desflurane has been challenging because of its
      higher boiling point (23.5 °C at one atmosphere pressure) when compared to older volatile
      anesthetics such as sevoflurane (boiling point 58.6 °C) and isoflurane (boiling point 48.5
      °C). With techniques in cold rooms and using ice for sample transport, investigators have
      successfully measured desflurane levels in blood and brain tissue of mice.

      Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during
      fetal surgery, but we first propose a pilot study to assess and refine the ability of our
      assay to measure desflurane in human blood.
    

Intervention name(s): Desflurane Levels
Intervention type(s): Other
Intervention description(s): The subject's participation will take place over one surgical procedure. It will begin with the first blood collection and end with either the second blood draw or the end of the procedure.
Intervention MeSH terms: Desflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: arterial line; end-expiratory desflurane
Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee
Condition: Osteo Arthritis Knee
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Evaluating the safety and efficacy of a single injection of autologous adipose tissue for
      treatment of osteoarthritis of the knee.
    

Detailed description: 
      This clinical trial is a single site, double blinded, paired within groups, controlled
      clinical study to investigate the safety and efficacy in the use of adult autologous adipose
      tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is
      that the treatment will be safe and the proposed clinical outcome measures of reduced pain
      resulting from the treatment of OA of the knee joint with autologous adipose tissue will be
      superior to a placebo control treatment.
    

Intervention name(s): Injection of Autologous Adipose Tissue; Injection of lactated ringers
Intervention type(s): Other; Other
Intervention description(s): Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis; Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind parallel groups assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Osteo Arthritis Knee; Autologous Adipose Tissue