bioihbjkbjnl/mcl2 huggingface dataset:
Menthol for PDT Pain Relief
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Topical photodynamic therapy (PDT) is widely used to treat superficial non-melanoma skin
      cancer (NMSC) and dysplasia, notably actinic keratosis and may also be effective in a range
      of other dermatological conditions. A major limitation of PDT is pain during irradiation. A
      lack of knowledge of the mechanism of PDT-induced pain has limited the development of
      effective approaches for prevention or relief of this adverse effect. The investigators have
      investigated the possible efficacy of menthol for PDT pain ex vivo and will now study this in
      a clinical trial. This proposal describes the prospective randomised double blind, placebo
      controlled clinical trial that will be undertaken to investigate the use of topical menthol
      for PDT-induced pain relief in patients with actinic keratosis of the face and scalp who will
      be attending general dermatology and PDT outpatient clinics at Ninewells Hospital, Dundee.
    

Detailed description: 
      This proposal describes the prospective randomised double blind, placebo controlled clinical
      trial that will be undertaken to investigate the use of topical menthol for PDT-induced pain
      relief in patients with actinic keratosis of the face and scalp who will be attending general
      dermatology and PDT outpatient clinics at Ninewells Hospital, Dundee.

      This will be undertaken by comparison of 5% menthol in aqueous cream with aqueous cream as
      placebo and the primary outcome measures will be pain recorded on a visual analogue scale
      (VAS) during and up to 24 h after PDT. Secondary outcomes are phototoxicity, assessed by a
      semi-quantitative scoring system immediately after PDT, fluorescence assessed routinely after
      cream application and before irradiation and outcome based on clinical assessment three
      months after PDT and patient evaluation. Patients will be involved in the study from the
      first visit for PDT until the three-month assessment visit after PDT. Data analysis will be
      undertaken using within-subject paired analyses as patients act as their own control.
      Information from this study will inform investigators as to whether topical menthol should be
      routinely incorporated into PDT treatment regimens in order to reduce pain and increase
      tolerance of treatment. The information will also provide additional information as to the
      mechanisms of PDT-induced pain and its possible prevention and/or relief.
    

Intervention name(s): Menthol; Aqueous Cream
Intervention type(s): Drug; Drug
Intervention description(s): Topical menthol in aqueous cream; placebo
Other intervention name(s): 5% menthol in aqueous cream; placebo
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Kegel Exercise Device in Strengthening Pelvic Floor and Treating Urinary Incontinence (UI)
Condition: Stress Urinary Incontinence; Sexual Dysfunction
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This study will assess the effectiveness of a new pelvic floor exercise device in
      strengthening pelvic floor muscles and treating urinary incontinence among women who are
      experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks and
      results will be collected through self-assessment questionnaires and clinical pelvic
      examination. Effectiveness outcomes will be tracked over the duration of the trial and
      measured against historical symptoms.
    

Detailed description: 
      The objective of the study is to test the device with women who are experiencing symptoms of
      pelvic floor weakness, namely urinary incontinence, vaginal laxity and sexual sensation
      problems, to assess the changes in pelvic floor muscle strength, before and after the
      intervention.

      The study device is a pelvic floor exercise device that provides biofeedback and exercise
      guidance.

      Women who meet the inclusion criteria will be recruited from the regular patients at the
      investigation site and given the device to use at home daily for 12 weeks. Subjects will
      submit information regarding their experience with the device and self-assessed improvements
      in their symptoms. A pelvic examination will be conducted at the start and conclusion of the
      study to measure a pelvic floor muscle strength reading.

      The research hypothesis is that strength level, subjective assessment of vaginal tightness
      and sexual sensations will be greater at the end of the study than at the baseline and the
      mean value of frequency and volume of bladder leaks will be less than at the baseline.
    

Intervention name(s): Pelvic floor exerciser
Intervention type(s): Device
Intervention description(s): Daily exercise using the study device
Other intervention name(s): KegelSmart pelvic floor trainer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Effect Site Concentration of Remifentanil for Preventing Cough During Emergence Between Male and Female Patients With Thyroidectomy
Condition: Patients Undergoing Thyroidectomy
Study type: Interventional

Summary: 
      The clinical studies demonstrate more powerful analgesic effect among female to both μ- and
      κ-opioid agonist (Fillingim et al. 2004). The antitussive effect of opioid is mediated
      predominantly by μ-, κ-opioid receptors (Kamei J. 1996). Therefore, the investigators
      hypothesized that there are sex differences in the antitussive responses to opioid.

      It has been reported that target-controlled infusion (TCI) of remifentanil can reduce cough
      against endotracheal tube during emergence from general anesthesia. Some studies, reporting
      the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in
      different sex and surgeries (B. Lee et al. 2009, E.M.Choi et al. 2012), showed differences in
      EC50 and EC95.

      The purpose of this study was to find out EC50 and EC95 of remifentanil in effect-site TCI
      for preventing cough during emergence in each sex and to evaluate whether there were sex
      differences in EC50 and EC95 of remifentanil in effect-site TCI or not.
    


Intervention name(s): up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence
Intervention type(s): Drug
Intervention description(s): Targeted effect-site TCI remifentanil for preventing cough effectively during emergence from general anesthesia. For effect-site TCI of remifentanil, a TCI pump was used and pump operation was based on Minto and colleagues' pharmacokinetic model. By Dixon's up-and-down method, the predetermined effect-site concentration(Ce) of remifentanil was determined according to the cough response of the previous patient. The initial target Ce of remifentanil for the first patient was 2.0 ng/ml. If the patients did not cough throughout the peri-extubation period, the predetermined Ce of remifentanil for the subsequent patient was decreased by 0.4 ng/ml. If the patient coughed anytime around extubation, the predetermined Ce for the subsequent patient was increased by 0.4 ng/ml. The stopping rule, as well as for the requirement of at least six turning points in the same direction of the sequential allocation response graph, required the recruitment of more than 20 patients.
Other intervention name(s): remifentanil Ce, Ultiva Ce
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Trial of Aspirin and Arginine Restriction in Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to understand the effects of oral aspirin taken daily
      with an arginine-restricted diet on certain colorectal cancer biomarkers in treated
      colorectal cancer patients. Patients with colorectal cancer are at high risk for recurrence
      and for development of secondary colorectal cancers in the future. Specific chemicals
      (polyamines, prostaglandins) in the body referred to as biomarkers can be measured to help
      understand a person's risk for developing colorectal cancer. Specific biomarkers associated
      with colorectal cancer have been identified in prior laboratory studies. By measuring these
      predefined biomarkers before and after the study intervention, we can assess how they are
      affected by the intervention, and gain knowledge about their usefulness in colorectal cancer
      patients on clinical trial.

      This study is a Phase IIa clinical biomarker study, using oral aspirin 325 mg taken daily
      with an arginine-restricted diet designed to reduce arginine intake by at least 30% during
      the 12-week study period. The biomarkers will be obtained from patient by performing
      endoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy
      (taking samples of tissue), phlebotomy (drawing blood), and urine collection. Biopsies are
      done to evaluate changes in tissue content that may relate to early events in colon cancer
      formation. This was the procedure used to diagnose your condition initially. There will be 24
      patients enrolled into this study performed through University of California Irvine Medical
      Center.
    


Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): 325 mg taken daily with an arginine-restricted diet
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Colorectal cancer; aspirin
Optimizing the Use of Morphine in Pre-Term Neonates
Condition: Premature Neonates
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to improve the dosing of morphine in critically ill premature
      neonates.
    

Detailed description: 
      The investigators hypothesize that identifying co-variates predictive of variability in
      morphine disposition and/or response will provide the scientific basis for rationale and
      individualized morphine dosing schemes in neonates and young infants.

      60 preterm neonates ranging in gestational age from 22 to 32 weeks will be recruited from the
      NICU. Stratification by gestational age will be done to ensure broad representation. The
      decision to initiate morphine therapy will be based solely on clinical indications. Prior to
      morphine dosing, a biochemical assessment of hepatic and renal function will be obtained. A
      0.05 mg/kg loading dose of morphine will be given by an intravenous infusion over 30-minutes
      in preterm neonates with a gestational age of less than 29 weeks, followed by a continuous
      infusion of 0.005 mg/kg/h, whereas a loading dose of 0.1 mg/kg will be given in preterm
      neonates with a gestational age of 29 weeks or more followed by a continuous infusion of 0.01
      mg/kg/h. Pain assessment will be performed at baseline (prior to study medication
      administration) and at .5, 1, 2, 4, 8, 12 and 24 hours after the dose. At each of these time
      points infants will be videotaped for two minutes with two cameras. Videotapes will be scored
      afterward using standard validated pain assessment tools for preterm infants.
    

Intervention name(s): Morphine; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Gestational Age< 29 weeks: A loading dose of 0.05 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.005 mg/kg/h.; Gestational Age>= 29 weeks: A loading dose of 0.1 mg/kg I.V. morphine over 30-minutes, followed by a continuous infusion of 0.01 mg/kg/h.
Other intervention name(s): inulin; Inulin
Intervention MeSH terms: Morphine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preterm Neonates; Morphine; Critically ill
Building Closer Friendships in Social Anxiety Disorder
Condition: Social Anxiety
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      This study assesses whether a 4-week computerized intervention can be used to decrease fear
      of intimacy, and loneliness and improve perceived social support in people with Social
      Anxiety Disorder.
    

Detailed description: 
      This study hopes to assess whether a month long computerized intervention aimed at giving
      people skills to form closer friendships. Participants will be randomized into an active
      treatment condition or a wait list control. We hypothesize that 1) participants in the
      treatment condition will have lower fear of intimacy at post treatment than those in the
      waitlist condition 2) participants in the treatment condition will have lower levels of
      loneliness than those in the waitlist condition 3) participants in the treatment condition
      will have higher perceived social support than those in the waitlist condition.
    

Intervention name(s): Building Closer Friendships
Intervention type(s): Behavioral
Intervention description(s): Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into active treatment or waitlist control.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety Study of Dexmedetomidine in Elderly Under General Anesthesia
Condition: Hip Fractures; Hip Disease
MeSH terms: Hip Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out appropriate dose range of dexmedetomidine to provide
      the elderly patients satisfactory sedation and analgesia with stable hemodynamics during
      perioperative period of hip replacement under general anesthesia.
    

Detailed description: 
      All patients will be screened to determine eligibility for study entry, and the patients who
      meet the eligibility requirements will be informed about the study and potential risks. After
      giving written informed consent, the patients will be randomized into different doses of
      dexmedetomidine groups and the comparative groups in a same ratio.
    

Intervention name(s): Dexmedetomidine; Normal saline; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In dexmedetomidine groups, patients will be pumped 0.1ml/kg of dexmedetomidine (contained dexmedetomidine 0.25/0.5/0.75µg/kg in Group D0.25/D0.5/D0.75) for 15min before anesthesia induction, following continuous infusion at the rate of 0.125ml/kg/h until the end of operation.; normal saline; midazolam
Other intervention name(s): Dex; physiological saline; Dormicum
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dexmedetomidine; Elderly; Hemodynamics; Hip replacement; General anesthesia
A Local Register Study For Major Depression Of Paroxetine Controlled Release
Condition: Depressive Disorder, Major; Major Depressive Disorder (MDD)
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to
      Paroxetine Immediate Release, as well as the drug tolerability profile when treated on
      patients with Major Depression.
    


Intervention name(s): Paroxetine CR; Paroxetine IR
Intervention type(s): Drug; Drug
Other intervention name(s): Paroxetine CR
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major Depression; paroxetine controlled release (CR); paroxetine immediate release (IR)
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
Condition: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This clinical study will involve performing a series of medical imaging procedures of the
      abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed
      with Nonalcoholic Fatty Liver Disease (NAFLD). The primary objective of this clinical study
      is to evaluate the clinical feasibility of an investigational ultrasound technique for
      quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat
      percentage obtained from MRI Proton Density Fat Fraction (MRI-PDFF) measurements. All
      subjects enrolled in this study will undergo one investigational abdominal ultrasound
      examination using the Philips EPIQ Ultrasound System and one MRI PDFF examination according
      to the clinical standard of care.
    


Intervention name(s): Investigational Liver Fat Quantification Software
Intervention type(s): Device
Intervention description(s): All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Liver Fat Quantification; Ultrasound; Liver Disease; Digestive System Disease
Microbicides Acceptability Among Sexually Active Young Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      ATN 062 is designed to gain scientific knowledge of microbicide-use adherence, acceptability,
      and attitudes among sexually active young women
    

Detailed description: 
      ATN 062 will take place in parallel to another study, MTN 004, "Phase I Study of the Safety
      and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young
      Women." ATN 062 will use quantitative and qualitative research methods. The quantitative
      method will consist of a computerized diary used by participants during the 14 days of the
      gel trial of MTN 004. The qualitative methods will include email messages sent by
      participants to a research assistant as a supplement to the diaries, as well as in-depth
      interviews through teleconferences to contextualize the recorded events. All study activities
      will be timed to coincide with those of MTN 004
    

Intervention name(s): Automated diary system; Automated diary system; Automated diary system
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.; Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.; Participants will use a computerized phone diary to describe their experiences with the study product during the 14 days of the trial. They will have three teleconferences with "Juliana" to discuss the product and the technology used in the study. They will also have the opportunity to send emails to "Juliana" during the course of the study.
Other intervention name(s): VivaGel™; 3% w/w SPL7013 Gel; VivaGel™ Placebo; HEC Placebo Gel; HEC Gel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-negative women ages 18 to 24 years old who are non-pregnant, sexually active and
        enrolled in MTN 004 will be offered the option to enroll in ATN 062. Approximately half of
        the participants will be recruited in San Juan, PR, and the other half in Tampa, FL.
      
Keywords: HIV; Microbicide Gel; HIV Seronegativity
Dose-ranging Study of Tranexamic Acid in Valve Surgery
Condition: Hemorrhage; Valvular Heart Surgery
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic
      acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and
      transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently
      multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown
      that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized
      study focus on TA in primary valve surgery. The aim of this prospective, double-blinded,
      randomized trial is to compare two dosing regimens of TA during primary valve surgery on
      perioperative blood loss and allogeneic blood transfusion.
    


Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): High and low dosage. Loading dose followed by continuous infusion in operation.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Alkaline Phosphatase on Renal Function in Septic Patients
Condition: Severe; Septic; Shock
MeSH terms: Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      Septic shock is the most common cause of death in patients requiring intensive care. The
      kidney is one of the first organs to fail, stressing the importance to search for clinical
      interventions that may protect the kidneys during sepsis.

      Alkaline phosphatase functions as a host defence molecule and is present in many cells and
      organs (e.g. intestine, placenta, liver, kidney and bone). Alkaline phosphatase has a dual
      mode of action. First, it binds to and, subsequently, dephosphorylates lipopolysaccharide
      (LPS). Second, the enzymatic reaction product monophosphoryl-LPS is a non-toxic substance for
      mammals which acts as a partial antagonist on the LPS receptor complex. In several animal
      studies, administration of alkaline phosphatase attenuates the inflammatory response and
      reduces mortality.

      It is unknown whether these results can be extrapolated to septic patients . We studied the
      effects of alkaline phosphatse administration on kidney damage and function in patients with
      severe sepsis or septic shock.
    


Intervention name(s): bolus injection, followed by a continuous infusion ( 24 h) (Alkaline phosphatase)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: alkaline phosphatase; sepsis; kidney function