bioihbjkbjnl/mcl2 huggingface dataset:
Methadone in Pediatric Anesthesiology II
Condition: Pain
Study type: Interventional

Summary: 
      Three arm randomized controlled trial to evaluate the efficacy of a single dose of
      intraoperative methadone in reducing post-operative pain and opioid consumption in
      adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the
      pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).
    

Detailed description: 
      Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring
      for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care
      are not altered for study purposes. All patients are induced by propofol and muscle
      relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either
      control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4
      mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized
      1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body
      weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction
      of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of
      intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be
      treated at the discretion of the anesthesiologist with fentanyl. In the control groups,
      intraoperative opioid administration will be left at the discretion of the anesthesia
      providers. Patient controlled analgesia as prescribed by the clinical team, using
      hydromorphone or morphine, will be used to treat postoperative pain relief.
    

Intervention name(s): 0.3mg/kg IV methadone HCl; 0.4mg/kg IV methadon HCl; control no methadone
Intervention type(s): Drug; Drug; Other
Intervention description(s): Group I will receive 0.3mg/kg IV methadone HCl; Group II will receive 0.4mg/kg IV methadone HCl.; The control group will not receive methadone.
Other intervention name(s): methadone HCl, dolophine; methadone HCl, dolophine
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal surgery; Methadone
Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal
      Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to
      SevereScalp Psoriasis
    

Detailed description: 
      -  Evaluate the potential of DSXS topical product to suppress HPA axis function in patients
           with moderate to severe scalp psoriasis.

        -  Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product
           administered to patients with moderate to severe scalp psoriasis.
    

Intervention name(s): DSXS topical product
Intervention type(s): Drug
Intervention description(s): treatment daily for 28 days
Other intervention name(s): Active
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Hemodynamic Response in Cardiopulmonary Bypass Graft After Cardiopulmonary Bypass Using Transesophegeal Echocardiography
Condition: Cardiopulmonary Bypass Graft
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double blind randomization study, assessing hemodynamic response in patients who
      underwent a cardiopulmonary bypass graft (CABG) with cardiopulmonary bypass (CPB) using
      intraoperative trasnesophageal echocardiography (TEE) to know what inotropic drug will be
      batter to improve the heart function. Epinephrine, milrinone, dobutamine and levosimendan
      will be assessment.
    


Intervention name(s): epinephrine and levosimendan
Intervention type(s): Drug
Intervention description(s): epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)
Intervention MeSH terms: Simendan; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CABG; Echocardiography; Heart Failure; Heart Function
Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical
      system following one, two, or three topical system applications and compare to the
      pharmacokinetics of ZTlido.
    


Intervention name(s): SP-103; ZTlido
Intervention type(s): Drug; Drug
Intervention description(s): lidocaine topical system 5.4%; lidocaine topical system 1.8%
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.
Condition: Incretin Action; Obesity
Study type: Observational

Summary: 
      Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in
      response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon
      are all known to regulate parameters such as appetite, food intake and induce weight loss.

      Therefore we want to investigate mechanistic relations between the three hormones.
    


Intervention name(s): GLP-1 infusion; Glucagon infusion; Oxyntomodulin infusion; GLP-1 and glucagon infusion; Placebo
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 1 pmol/kg/min; 3ng/kg/min; 3 pmol/kg/min; 1 pmol/kg/min 3 ng/kg/min; NaCl 9 g/L infusion
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Sampling method: Non-Probability Sample
Study population: 
        Healthy young males
      
Biospecimen description: 
      blood samples
    
Keywords: Incretin hormones; Glucagon; Satiety; Hunger; Energy expenditure
Auto-injector Real Life Handling in Patients
Condition: RA
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the real-life patient handling experience with the use of an autoinjector in
      patients with moderate to severe active Rheumatoid Arthritis (RA) who self-inject AVT02
      subcutaneously (SC).
    

Detailed description: 
      This is an autoinjector handling study to assess the ability of patients to self-inject AVT02
      with the proposed autoinjector in the normal standard of care setting, and to assess the
      reliability of the proposed autoinjector for AVT02.

      On Week 0 (Day 0) eligible patients will be trained by qualified study site personnel
      (Investigator-led trained injection) following the first injection. The patient will return
      to the clinic on Week 2 (Day 14) and will be asked to selfinject the second dose (trained
      self-injection). The injection will be observed by the study personnel and the patient
      provided any assistance necessary to complete an acceptable injection.

      On Week 4 (Day 28), Week 6 (Day 42), and Week 8 (Day 56), the patient will return to clinic
      and will be asked to self-inject the dose without assistance but under observation of
      qualified trial staff (observed self-injection).

      Observations of autoinjector handling events are recorded independently by both trial site
      staff and patients using standardized questionnaires.

      Any failures to inject will be investigated to determine if they are mechanical failures of
      the device or due to use error of the patient.

      All failures will be further investigated to determine the root cause, and where necessary,
      appropriate mitigation will be developed and implemented.

      In the Extension period (Weeks 9 to 56), AVT02 40 mg will be administered every other week
      via prefilled syringe (PFS) starting from Week 10 and ending at week 54. The final efficacy
      evaluation is expected at Week 56.

      The clinical study report (CSR) will include the data from the 8week active period. The
      extension phase CSR will include the data from the 48-week extension period (Weeks 9 to 56).
    

Intervention name(s): Adalimumab
Intervention type(s): Combination Product
Intervention description(s): Combined product as Drug is delivered through an autoinjector pen on which real-life patient handling experience is assessed.
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: auto injector pen in RA patients
The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is
      used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair
      the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the
      dual hormone treatment in preventing hypoglycaemia.

      The purpose of this study is to determine, whether ethanol influences the glucose response to
      subcutaneous glucagon during mild hypoglycaemia.

      The investigators hypothesize that prior evening ethanol consumption does not reduce the
      effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol
      consumption.

      The study aims:

        1. To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to
           restore plasma glucose after an episode of mild hypoglycemia.

        2. To determine the late effects of ethanol on the counter-regulatory hormones and
           hypoglycaemia awareness during mild hypoglycaemia

      A double-blinded placebo-controlled study will be conducted. Participants will serve as their
      own controls. Eligible participants will after an informed consent complete two study visits,
      one with and one without ethanol consumption, in a random order. On each study visit,
      participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with
      or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100
      mcg glucagon is administered. Two hours later a second bolus is administered.
    


Intervention name(s): Alcohol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Cocktail; Mocktail
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glucagon; Ethanol
Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of catheter ablation for atrial
      fibrillation between contact force-guided and impedance-guided annotation using automated
      annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly
      assigned in the same number to two groups with impedance guided ablation and contact force
      guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter,
      Biosense Webster, Inc., Diamond Bar, CA).
    

Detailed description: 
      During atrial fibrillation ablation, the location where ablation is conducted is displayed
      through annotation tags using 3D system to recognize energy delivery is done at the area.
      However this annotation method was unable to identify how effectively the ablation is done.
      To remedy this disadvantage, automated annotation system (VisiTag™ module, Biosense Webster,
      Inc., Diamond Bar, CA) was recently developed to make an automatic annotation when all
      pre-defined criteria are satisfied. But study on the clinical effects of this system is
      insufficient.

      The purpose of this study is to compare the efficacy of catheter ablation for atrial
      fibrillation between contact force-guided and impedance-guided annotation using automated
      annotation system.
    

Intervention name(s): Ablation
Intervention type(s): Device
Intervention description(s): Catheter ablation for atrial fibrillation
Other intervention name(s): THERMOCOOL® SMARTTOUCH™ catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Catheter ablation
Pharmacokinetic Effects of Oral DMAA
Condition: Outcomes of Single Oral Dose
Study type: Interventional

Summary: 
      1,3-dimethylamylamine (DMAA) has become increasingly popular as a component of dietary
      supplements. It is also used within "party pills," often in conjunction with alcohol and
      other drugs, and has been associated with untoward effects when abused at high dosages. To
      our knowledge, no studies have been conducted to determine the combined pharmacokinetic
      profile and physiologic responses of DMAA. To conclude on the safety profile of DMAA based
      solely on case reports would be problematic, in particular when accepting testimony from
      patients in uncontrolled environment, potentially under the influence of alcohol and other
      drugs. This is especially true in light of the fact that no prospective studies have shown
      these effects. Hence, the intent of the present study was to determine the pharmacokinetic
      profile of a single 25mg oral dosage of DMAA alone through 24 hours post-ingestion. This
      represents a typical dosage within one serving of many popular dietary supplements containing
      DMAA.
    


Intervention name(s): DMAA
Intervention type(s): Dietary Supplement
Intervention description(s): no placebo
Other intervention name(s): 1,3-dimethylamylamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: 1,3-dimethylamylamine
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Condition: Papillomavirus Infections; Warts; Condylomata Acuminata; Epidermodysplasia Verruciformis
MeSH terms: Warts; Papillomavirus Infections; Epidermodysplasia Verruciformis
Study type: Interventional

Summary: 
      The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to
      treat warts located on the hands.
    

Detailed description: 
      -  At least 5, but not more than 20 participants will be enrolled in the study.

        -  Each wart is randomly assigned a test product prior to the start of the study

        -  Warts are equally distributed between products so that an equal number of warts treated
           on each person. One (1) product will be assigned to each hand to minimize treatment
           confusion for the participants

        -  The test product will be applied to a wooden applicator and gently rubbed into the wart,
           then covered with a latex free adhesive bandage.

        -  Subjects will log date and time of application and anything notable (such as changes in
           wart appearance or missed dose) in a log book.

        -  Measurement of wart (longest diameter) and photos taken at each visit by trained office
           medical assistants, LPNs, PA-C or MD.

        -  Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
    

Intervention name(s): PURELL VF481; Placebo Solution
Intervention type(s): Other; Other
Intervention description(s): One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed; One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed
Other intervention name(s): PURELL VF481 alcohol based hand gel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study is about asthma and how the environment affects asthma. Scientists know that air
      pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms
      worse. This research is being done to study how the health of a person with asthma responds
      to an air cleaner. The investigator hypothesize that an air cleaner will improve the health
      of persons with asthma.
    

Detailed description: 
      The investigators seek to determine the effect of placing air cleaner devices in the homes of
      adults with asthma on the adults' asthma health. To this end, the investigators aim to study
      40 adults with asthma that are 18-50 years of age and live in Baltimore. Participants will
      receive either true air cleaners or sham cleaners in a blinded, randomized manner for one
      month, and then, after a washout period, participants will cross over and receive the other
      intervention (sham or true cleaner). All participants will have environmental monitoring
      (personal and in-home) to determine participants' particulate matter exposure, and be
      followed repeatedly during the 3 month study period for markers of asthma disease, including
      respiratory symptoms, medication and health care utilization, pulmonary function, systemic
      markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell
      dysfunction.
    

Intervention name(s): High Efficiency Particulate Air Cleaner; Sham air cleaner
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: asthma; HEPA; air pollutants; lung function; home environment; respiratory symptoms
Think Health! A Personal Weight Management Program
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Think Health! A Personal Weight Management Program, or "¡Vive Saludable! Un programa
      personalizado de control de peso" aims to improve the treatment of obesity in adults in the
      general population, by conducting research with men and women recruited from primary care
      medical practices. The study has a particular focus on African Americans and Latino. The
      design is randomized trial of the effectiveness of two versions of a lifestyle weight loss
      program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical
      practice sites to their own patients. The two versions of the lifestyle weight loss program
      are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same
      PCP counseling plus additional counseling by specially trained ancillary practice staff
      acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month
      for up to 2 years).
    


Intervention name(s): Think Health! program; Basic Plus program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief 10-15 minute counseling with Primary Care Provider for weight management, Participant binder with eating, physical activity and stress management educational materials, adapted from the Diabetes Prevention Program (DPP)(Knowler et al, 2002; DPP Research Group, 2002), physical activity resource guide, and telephonic health related messages (year 2).; 15 minute counseling sessions with lifestyle coach, in addition to the Basic Think Health! program intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Management in adults; Reducing Health Disparities
Stria Gravidarum and Olive Oil for Pregnancy Women
Condition: Striae Gravidarum; Pregnancy Related
MeSH terms: Striae Distensae
Study type: Interventional

Summary: 
      The aim of this study was to investigate the clinical efficacy of olive oil on the severity
      and progression of striae gravidarum. This randomized controlled clinical trial included 156
      primipara women who were early third trimester. They were randomly allocated into two groups:
      an experimental group and a control group. Women in the experimental group applied olive oil
      to their abdomen twice a day in the morning and evening. The control group had no
      intervention.
    

Detailed description: 
      The development of striae is one of the most common skin changes in pregnancy. The aim of
      this study was to investigate the clinical efficacy of olive oil on the severity and
      progression of striae gravidarum.

      This randomized controlled clinical trial included 156 primipara women who were early third
      trimester. They were randomly allocated into two groups: an experimental group and a control
      group. Women in the experimental group applied olive oil to their abdomen twice a day in the
      morning and evening. The control group had no intervention.Data were collected using maternal
      information form, Fitzpatrick Skin Type Scale and Davey's Severity Score.
    

Intervention name(s): Olive oil
Intervention type(s): Other
Intervention description(s): To apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Striae Gravidarum; primipara women; pregnancy; Olive oil
Assessing the Surgical Skills of Trainees in Learning the LDG
Condition: Gastrostomy; Surgical Procedure, Unspecified; Assessment, Self
Study type: Interventional

Summary: 
      Laparoscopic distal gastrectomy (LDG) is a common surgery in the surgical trainees. However,
      there is no assessment system to measuring the surgical skill of surgical trainees. The novel
      surgical assessment system, which called Japanese Operative Rating Scale for Laparoscopic
      Distal Gastrectomy (JORS-LDG) by the task analysis and the Delphi method have been developed.
      This study describes assessing the development of surgical skill by JORS-LDG in the initial
      experience of LDG.
    


Intervention name(s): Laparoscopic distal gastrectomy
Intervention type(s): Procedure
Intervention description(s): Longitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other