bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Infraclavicular and Interscalen Block on Oxygenitaon of the Forearm
Condition: Upper Extremity Fracture
Study type: Interventional

Summary: 
      to research the oxygenitaon effects of infraclavicular and interscalene blocks on the
      forearm.
    

Detailed description: 
      To research the oxygenation effects of infraclavicular and interscalen blocks on the forearm
      by comparing the blood flow (BF) values using the USG, Perfusion index (PI) and Near infrared
      spectroscopy (NIRS) values using the massimo device.
    

Intervention name(s): Infraclavicular Block; Interscalen Block
Intervention type(s): Procedure; Procedure
Intervention description(s): USI and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.; USI and neurostimulator guided interscalen block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be a two-arm parallel assignment. One group will receive infraclavicular block and the other will receive interscalen block
Masking: Single (Participant)
Primary purpose: Treatment
Safety & Prevention Outcomes Study
Condition: Drug Overdose; Opioid-Related Disorders
MeSH terms: Drug Overdose; Opioid-Related Disorders
Study type: Interventional

Summary: 
      Unintentional poisoning is a developing public health problem in the U.S. Unintentional
      poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. There
      were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related
      overdoses, particularly prescription opioid overdoses, have accounted for much of this
      increase. There have been parallel increases in sales of opioids (with a 6 fold increase
      between 1997 and 2007), as well as both medical and non-medical use of prescription opioids.
      Prescription opioids are now among the most common of drugs used non-medically in the U.S.

      The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription
      opioid overdose prevention intervention. We will examine therapeutic alliance, perceived
      satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on
      precursors of overdose risk behavioral change immediately post-intervention. We will compare
      intervention and control participants on knowledge, self-efficacy, readiness to change, and
      behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects
      on overdose risk behaviors six months post-intervention. We will compare intervention and
      control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in
      combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and
      sedatives); and, 3) route of administration.
    


Intervention name(s): TBI - Cohort 1; TBI - Cohort 2
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of the study is to assess the safety and immune response after vaccination with
      different doses and vaccination schedules of virosomal influenza vaccine.
    

Detailed description: 
      Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose.
      The aim of this study is to evaluate the safety and immunogenicity of different doses and
      vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized
      (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at
      Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a
      standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at
      Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be
      documented. To assess the subjects' humoral and cellular immune response against homologous
      and heterologous virus strains, blood will be drawn from each participant at baseline (Day
      1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.
    

Intervention name(s): Virosomal influenza vaccine
Intervention type(s): Biological
Intervention description(s): Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
15 μg HA antigen of A/California/7/2009 (H1N1)-like virus
15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
15 μg HA antigen of B/Brisbane/60/2008-like virus
Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
Other intervention name(s): Inflexal V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Vaccination; Virosomal influenza vaccine
Bioavailability of Magnesium Supplements
Condition: Healthy; Magnesium Deficiency
MeSH terms: Magnesium Deficiency
Study type: Interventional

Summary: 
      The primary objective of this clinical trial is to demonstrate the superiority of Natural
      Calm magnesium powder with respect to absorption when compared to three marketed forms of
      magnesium (two magnesium bisglycinate powders and magnesium citrate capsules). The primary
      endpoints were serum magnesium AUC (0-8h) and urine magnesium AUC (0-8h) after a single dose
      of 150 mg elemental magnesium.
    


Intervention name(s): Magnesium; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150mg elemental magnesium; Rice flour
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Five period crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Endometrial Gene Expression Profile in Controlled Ovarian Stimulation Cycles With Premature Luteinization
Condition: Premature Luteinization
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Previous studies have suggested that premature luteinization (PL)during controlled ovarian
      stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium
      receptivity. This study aims to describe the impact on endometrial gene expression of PL in
      GnRH antagonist and GnRH agonist cycles.
    


Intervention name(s): endometrial biopsy
Intervention type(s): Procedure
Effects of Medical and Surgical Weight Loss on Metabolism
Condition: Type 2 Diabetes; Obesity
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      This study will follow ,morbidly obese subjects as they undertake weight loss before and
      after laparoscopic gastric banding, examining markers of glucose and lipid metabolism,
      adipokines and measures of body fat.
    


Intervention name(s): laparoscopic gastric banding
Intervention type(s): Procedure
Intervention description(s): standard surgical procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        morbidly obese subjects with type 2 diabetes or metabolic syndrome
      
Biospecimen description: 
      serum, tissue
The Impact of Prenatal Short Messages (SMS) on Maternal and Newborn Health
Condition: Short Message Service; Text Messaging
Study type: Interventional

Summary: 
      It is hypothesized that delivering short messages (SMS) to pregnant women can improve
      maternal and newborn health outcomes. This pilot offers mothers-to-be in rural China free
      daily short messages (SMS) via cell phone. The aim is to advise them on (a) good household
      prenatal practices (GHPP) and (b) care seeking (CS) in order to improve the quality of life
      for mothers and newborns.
    

Detailed description: 
      Factorial quasi-randomization is utilized to compare two groups of interventions (i.e., GHPP
      and CS) as well as to compare these individual interventions with a combination of the
      interventions. It is also possible that distinct treatments have interaction effects, and we
      plan to test for this. Policymakers are interested in using different strategies to enhance
      neonatal health. For example, the bank of SMS developed by our team is a combination of
      several components: reminders for regular checkups, information on GHPP, and information on
      CS. From a policy perspective, the evaluation of the full bank of SMS may be sufficient for
      the government to decide whether or not to scale up the full bank of SMS. However, to
      understand maternal behavior and, for policy purposes, to understand which components in the
      bank of SMS should be scaled up, it is important to disentangle which component contributes
      most to final neonatal health. Taken together, are all the components of the bank of SMS
      effective in changing maternal behavior and enhancing neonatal health? Which mechanisms are
      at play, good household prenatal care, care seeking in pregnancy, or both?
    

Intervention name(s): Good household prenatal practice; Care seeking; Full bank of SMS
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression; Danger-sign recognition
Reminders for government projects; Danger-sign recognition
Reminders for government projects
Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Keywords: Short Message Service; newborn health; maternal behavior; good household pregnancy practice; care seeking
Using Bluetooth Beacon Technology to Reduce Distracted Pedestrian Behavior
Condition: Health Behavior
Study type: Interventional

Summary: 
      Over 4,800 American pedestrians die annually, a figure that is current increasing. One
      hypothesized reason for the increasing trend in pedestrian injuries and deaths is the role of
      mobile technology in distracting both pedestrians and drivers. The investigators propose to
      develop and then evaluate Bluetooth beacon technology as a means to alert and warn
      pedestrians when they are approaching dangerous intersections, reminding them to attend to
      the traffic environment and cross the street safely rather than engaging with mobile
      technology. One aspect of the research will involve a crossover research trial to evaluate
      efficacy of the program.

      Bluetooth beacons are very small (about the size of a dime) and inexpensive (~$20 range)
      devices that broadcast information unidirectionally (beacon to smartphone) within a closed
      proximal network. The investigators propose placing beacons at intersection corners (e.g., on
      signposts) frequently trafficked by urban college students. The beacons will transmit to an
      app installed on users' smartphones, signaling users to attend to their environment and cross
      the street safely. The app will be developed to be flexible based on user preferences; for
      research purposes, the app also will download data concerning the users' behavior while
      crossing the street. The crossover trial will evaluate the app with a sample of about 411
      young adults whose behavior is monitored for: (a) 3 weeks without the app being activated,
      (b) 3 weeks with the app activated, and then (c) 6 weeks without the app activated to assess
      retention of behavior. Throughout the 12 week period, the investigators will monitor user
      behavior at multiple intersections around campus, along with gathering self-report
      questionnaire perceptions and behavior at baseline and 12-week post-intervention assessments.
    


Intervention name(s): beacon alerts; no alerts retention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection; no alerts will appear, but we will measure retention of behavior learned during the active intervention stage
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Reactions to Disease Risk Information
Condition: Cancer
Study type: Interventional

Summary: 
      This study is part of an effort to learn about interactions between doctors and patients. The
      study will use virtual reality technology to examine how patients and doctors interact when
      they discuss disease risks.

      Men and women between the ages of 25 and 40 who have access to the Internet and were born and
      raised in the United States may be eligible for this study. Participants will be recruited
      from the Washington D.C. area.

      Participants undergo the following procedures:

        -  Complete an online questionnaire about their health-related background, family health
           history, cancer risk perceptions, and demographic information (e.g., age, marital
           status, education, etc.).

        -  Participate in activities in a virtual reality environment in which they interact with a
           virtual doctor in a virtual clinical scenario. For this experiment, participants wear a
           head-mounted display that allows them to see the virtual world images.

        -  Fill out a second questionnaire after completing the virtual reality activities. This
           questionnaire includes information on the participants virtual reality experience, the
           information provided in the experience, and questions about themselves and their
           background.
    

Detailed description: 
      This study will investigate interactions between doctors and patients regarding risks of
      common, complex diseases using virtual reality technology.

      Men and women between the ages of 25 and 40 who have access to the Internet and were born and
      raised in the United States may be eligible for this study. Participants will be recruited
      from the Washington D.C. area.

      Study subjects complete two phases. The first phase is to complete an online questionnaire
      about their heath-related background, family health history, cancer risk perceptions, and
      demographic information using a secure survey website. The second phase involves interacting
      with a virtual doctor in a virtual environment clinical scenario, followed by completion of a
      second questionnaire. While in the virtual environment, participants wear a head-mounted
      video unit that allows them to see elements of the environment. The activities in the virtual
      environment take about 15 minutes. The total time for the study is about 60 minutes.
    

Intervention name(s): A; B
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention; Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Virtual Reality Technology; Communication; Doctor-Patient Communication
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
Condition: Acne
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and bioequivalence of Perrigo's product to
      an FDA approved product for the treatment acne vulgaris.
    


Intervention name(s): Adapalene and Benzoyl Peroxide Gel; Adapalene and Benzoyl Peroxide Gel (Reference); Placebo gel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer Subjects
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.
    


Intervention name(s): ALN-TTR02; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Dose levels between 0.01 and 0.5 mg/kg by intravenous (IV) infusion; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ATTR
Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The aim of the current study was to investigate the effect of a chitosan brush on the
      treatment of residual pockets in patients already treated for periodontal disease. Thirty-six
      patients with chronic periodontitis (Stage ΙΙΙ, ΙV) that had already completed causative
      therapy and exhibited at least two residual periodontal pockets ≥ 5mm that bled on probing,
      were randomly assigned to two groups. In the test group debridement of residual pockets was
      performed with ultrasonic scaler and the chitosan brush, whereas in the control group only
      ultrasonic scalers were used.
    


Intervention name(s): chitosan brush; ultrasonic scaler
Intervention type(s): Device; Device
Intervention description(s): debridement of periodontal pockets with ultrasonic scaler first and after with chitosan brush for 2 minutes; debridement of periodontal pockets only with ultrasonic scaler
Other intervention name(s): Labrida BioClean
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized parallel arm clinical trial
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: residual pockets; chitosan; treatment of periodontitis
Intra-Articular Injection in Moderate Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      AqueousJoint is a new intra-articular (IA) injectable joint lubricant for patients suffering
      from knee Osteoarthritis developed by Liposphere LTD.

      AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and
      protects it from further damage and degradation. The product goal is restoring cartilage its
      natural bio-lubrication properties.

      AqueousJoint is a surface lubricant that does not change the synovial fluid mechanical
      characterization but provides hydration protection from cartilage degradation and wear.
    


Intervention name(s): AqueousJoint
Intervention type(s): Device
Intervention description(s): AqueousJoint is a liposomal boundary lubricant, which coats the cartilage surface and protects it from further damage and degradation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children who have
      refractory or progressive solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan in
           children with refractory or progressive solid tumors.

        -  Determine the pharmacokinetics of this drug and its metabolites (SN-38, SN-38G, and APC)
           administered with and without concurrent anticonvulsants in this patient population.

        -  Determine the benefit this drug offers this patient population.

      OUTLINE: This is a dose-escalation, multicenter study. Patients are accrued into stratum 1
      initially and into stratum 2 if stratum 1 closes due to dose-limiting toxicity of
      myelosuppression or diarrhea. Patients on anticonvulsants will be accrued into stratum 3 and
      must meet the eligibility criteria for the stratum that is open (stratum 1 or stratum 2).
      (Stratum 1 closed as of 2002-09-15).

      Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6
      weeks in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
      dose (MTD) with and without anticonvulsants is determined. The MTD is defined as the dose
      preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      Patients are followed every 6 months for 4 years and then annually thereafter.

      PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.
    

Intervention name(s): irinotecan hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific