bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery
Condition: Nerve Block; Mastectomy
Study type: Interventional

Summary: 
      In this study, the investigators will compare the intraoperative opioid consumption for
      patients undergoing breast cancer surgery. The patients will be divided in two groups, the
      first one will receive a pectoral nerve block right after induction of anesthesia and the
      second one, the control group, will not receive the pectoral block. Our hypothesis is that
      the pectoral nerve block reduces the opioid consumption during the surgery.
    

Detailed description: 
      After induction of general anesthesia with propofol, remifentanil and succinylcholine, the
      patients will be divided either in the pectoral block group or the control group (sham
      block). Both groups will receive the same perioperative and postoperative anesthetic
      protocol. The investigator in charge of the patient will leave the operative room right
      before the completion of the pectoral block (or the sham block) to preserve randomisation and
      the block will be performed by another investigator. The pectoral block is performed under
      ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the
      pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution
      between the pectoralis minor muscle and the serratus anterior muscle at the third rib.
      Anesthesia will be maintained with sevoflurane for a bispectral (BIS) index between 45 and
      60. Analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean
      arterial blood pressure (MAP) in the range of ± 10% of the basal MAP (mean of the last three
      MAPs obtained before surgical incision, under sevoflurane-only anesthesia). The total
      remifentanil consumption will be assessed and compared between the groups. The investigators
      believe that the pectoral nerve block will significantly reduce the intraoperative
      remifentanil consumption.
    

Intervention name(s): Lidocaine 1% with epinephrine 1/400000; sham block
Intervention type(s): Drug; Other
Other intervention name(s): xylocaine with epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesics, opioids; pectoral block
Short-term Effects of Thoracic Manipulation in Shoulder Impingement
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The hypothesis of this study is that thoracic spine manipulation would reduce pain in
      subjects with SIS and cause changes in scapular kinematics and muscle activity in subjects
      with impingement symptoms and in asymptomatic subjects. With this study, the investigators
      want to answer if possible changes in scapular motion and muscle activity following a TSM
      depend on the symptoms or if it is generic to individuals without shoulder dysfunction and
      not specific to subjects with shoulder impingement.
    

Detailed description: 
      Subjects with shoulder impingement signs will be evaluated and will be compared with subjects
      asymptomatic for shoulder symptoms. Both subjects will be randomly assigned to one of two
      intervention groups: thoracic spinal manipulation (TSM) or sham intervention. We want to know
      if possible changes in scapular motion and muscle activity following a TSM depend on the
      symptoms or if it is generic to everyone. Also, we want to know if TSM reduces shoulder pain
      immediately and in a short-therm period.
    

Intervention name(s): Shoulder impingement_TSM; Asymptomatic_TSM; Shoulder impingement_sham; Asymptomatic_sham
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.; A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.; A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.; A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
Other intervention name(s): Spine manipulation; Spinal manipulation; (Spinal) Thrust; Spine manipulation; Spinal manipulation; (Spinal) Thrust; Sham spinal manipulation; Sham spinal manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: manual therapy; rehabilitation; shoulder; spine
Role of Cherry Consumption in Reducing Risk Factors for Chronic Inflammatory Diseases
Condition: Inflammation; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      The goal of this study is to examine if chronic cherry consumption will decrease lipid
      peroxidation and serum concentration of inflammatory markers in human subjects with elevated
      serum C reactive protein (CRP), and to examine the relationship between serum concentrations
      of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce
      serum concentration of inflammatory markers, including CRP, inflammatory cytokines and
      adhesion molecules.
    

Detailed description: 
      The study will last a total of 64 days with three different metabolic periods. First 8 days
      will be period 1, when base line fasting blood samples will be collected on day 1 and 8. For
      the next 28 days (period 2 or intervention period) subjects will supplement their diets with
      280 g/d of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.
      We will prefer that the subjects split the cherries into three equal portions and consume one
      with each meal; however, this will not be mandatory. Subjects will be asked to record all
      foods and drinks consumed for three 24-hr periods during the study. Fasting blood samples
      will be drawn on study days 22 and 36 (14 and 28 day after the start of cherry consumption).
      The third period of 28 days will be post-intervention, when the subjects will return to their
      normal diets without cherries. Post-intervention blood samples will be drawn on study day 64.
      All blood draws will follow a 12-hour fast. Blood samples will be processed within one hour
      of draw and the plasma stored frozen in different aliquots, until analysis.
    

Intervention name(s): Cherry consumption
Intervention type(s): Other
Intervention description(s): Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: anthocyanins; catechins; chlorogenic acid; flavanol glycosides
Determination of Voiding Patterns of Children With Vesicoureteral Reflux
Condition: Vesicoureteral Reflux
MeSH terms: Gastroesophageal Reflux; Vesico-Ureteral Reflux
Study type: Observational [Patient Registry]

Summary: 
      Determine if the pattern of voiding differs in children with vesicoureteral reflux (VUR)
      compared to those who do not have VUR.
    

Detailed description: 
      We hope to determine the statistical difference between the flow rate and volume of urination
      in children with VUR compared to those without.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with history of vesicoureteral reflux, toilet trained, ambulatory, and able to
        void on command. Children scheduled to have procedural correction of vesicoureteral reflux
      
Keywords: voiding patterns; flow rate; ultrasound
Study in Postmenopausal Women to Investigate the Drug-drug Interaction (DDI) Between Itraconazole(ITZ) and Orally Administered Vilaprisan; Absolute Bioavailability Using Intravenous Microtracer Dose of [14C]Vilaprisan
Condition: Clinical Trial, Phase I
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in postmenopausal women to investigate the Drug-drug interaction (DDI)
      between itraconazole(ITZ) and orally administered vilaprisan; absolute bioavailability using
      intravenous microtracer dose of [14C]vilaprisan.
    


Intervention name(s): Vilaprisan (BAY1002670); [14C] Vilaprisan; Itraconazole(ITZ)
Intervention type(s): Drug; Drug; Other
Intervention description(s): single oral doses of 4 mg tablet Vilaprisan, administered once without the comedication of ITZ (period 1) and once with the comedication of ITZ (period 2); an intravenous microtracer dose of [14C]Vilaprisan administered together with the 1st single oral dose of Vilaprisan; Itraconazole(ITZ) 200 mg as solution, once daily for 14 days
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Clinical Trial, Phase I
The Turkish Version of the Inflammatory Arthritis Facilitators and Barriers to Physical Activity
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Arthritis; Spondylarthritis; Axial Spondyloarthritis
Study type: Observational

Summary: 
      Our aim in this study is to translate the Inflammatory Arthritis Facilitators and Barriers to
      Physical Activity (IFAB) Questionnaire which was developed to determine the factors that
      facilitate and prevent individuals for physical activity for patients with inflammatory
      arthritis into Turkish language. Also, our aim is to evaluate the validity and reliability of
      the IFAB Questionnaire in the Turkish population, and to perform a cultural adaptation if
      necessary at the same time. Determining the factors that facilitate and prevent individuals
      for physical activity interventions with rheumatic diseases and then designing physical
      activity programs considering these factors may play an important role in reducing the
      symptoms caused by the disease and increasing their quality of life.
    


Intervention name(s): Determining Barriers and Facilitators of Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Determining Barriers and Facilitators of Physical Activity
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Axial Spondyloarthritis
The Effect of Oxytocin on Placebo Analgesia: an Experimental Study in Healthy Volunteers
Condition: Mechanisms and Modulators of Placebo Analgesia in Healthy Volunteers
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Placebo responses contribute to medical treatment outcome. The purpose of this study is to
      determine whether a single intranasal application of oxytocin can increase the placebo
      response in an experimental model of placebo analgesia in healthy volunteers.
    

Detailed description: 
      Placebo responses contribute to medical treatment outcome. The purpose of this study is to
      determine whether a single intranasal application of oxytocin can increase the placebo
      response in an experimental model of placebo analgesia in healthy volunteers.

      The rationale to study the effects of oxytocin on placebo analgesia is based on previous
      studies showing that oxytocin fosters processes such as empathy, trust and social learning,
      which are key elements of the patient-physician relationship that is pivotal to placebo
      responses. In this experimental mechanisms study we used oxytocin as a tool to modulate these
      factors.

      Placebo analgesia is induced verbal instruction. Therefore two identically looking placebo
      ointments were applied to two sites of the participants' volar forearm. The ointments were
      introduced as a local anesthetic that could reduce or even abolish pain (placebo) and a
      control cream (control), respectively.
    

Intervention name(s): Oxytocin; placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: pain; pain modulation; placebo analgesia
The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer
Condition: Breast Cancer; Aging
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study will look at whether or not participating in a physical activity intervention
      during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a
      large increase after chemotherapy.
    

Detailed description: 
      Our research team has determined that p16INK4a - a biomarker of aging -- increases
      dramatically during chemotherapy and that p16 levels among patients of similar age are lower
      among those who exercise. We hypothesize that engagement in physical activity during
      chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To
      test this hypothesis, we propose to enroll 48 patients age 21-64 with a Stage I-III breast
      cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in a physical
      activity intervention program. Our primary objective is to compare the change in p16 from
      baseline to end of chemotherapy for participants in this study (who are engaged in a physical
      activity intervention) to the mean change in p16 seen in a previous study of similar patients
      who did not participate in a physical activity intervention. As secondary objectives, we
      propose to evaluate (1) changes in treatment-related toxicity, physical function, fatigue,
      and quality of life between baseline, end of chemotherapy and 6 months post-chemotherapy, (2)
      the association of changes in p16 levels with changes in measures of treatment-related
      toxicity, physical function, fatigue, and quality of life, and (3) the association of changes
      in physical activity levels with changes in measures of treatment-related toxicity, physical
      function, fatigue, and quality of life.
    

Intervention name(s): Walk With Ease
Intervention type(s): Behavioral
Intervention description(s): Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.
Other intervention name(s): WWE
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast Cancer Patients age 21-59
      
Biospecimen description: 
      Blood samples will be taken collect p16 levels, CBC + Differential and senescence markers.
    
Keywords: Breast Cancer; Walk With Ease; Physical Activity; Walking; Younger Women; Cancer; p16; Aging; Biomarkers; Biomarkers of Aging; Chemotherapy; Chemotherapy Treatment; Adjuvant Chemotherapy; Neoadjuvant Chemotherapy
Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System
Condition: Fracture
MeSH terms: Fractures, Bone; Wrist Fractures
Study type: Interventional

Summary: 
      Trauma to the extremities such wrist, ankle, limb is very common and affects all population
      groups. It constitutes a significant public health issue. Standard radiography remains the
      basic imaging tool. However, as a 2-dimensional (2D) imaging modality it lacks sensitivity
      and specificity. Misdiagnosis rates are known to be high, especially for non-displaced
      fractures of the scaphoid and talus as well as erosions due to rheumatoid arthritis.
      Misdiagnosis leads to over treatment and unnecessary loss of productivity and quality of life
      including 6-12 weeks in a cast. Missed fractures can result in a chronic, non-healing
      fracture that may require surgical fixation and early arthritis of the joint. From a
      physician perspective, a missed diagnosis can result in a lawsuit and an expensive
      settlement/penalty.

      Computed tomography (CT) offers high resolution and excellent visualization of bone and joint
      morphology, and Magnetic Resonance Imaging (MRI) delivers soft tissue and cartilage
      visibility. However, cost, space and workflow related issues make them prohibitive for small
      orthopedic clinics. Although the radiation dose of a CT scan has been reduced considerably in
      recent years, it is still significantly higher than a regular radiograph. The whole-body
      scanners also have difficulties in imaging patients in portable and weight-bearing
      conditions. Dedicated extremity CT scanners have been commercialized recently in an attempt
      to address the current deficiency. They still suffer from higher cost and at such have a
      limited installation base.
    

Detailed description: 
      The aim of this one-year study is to demonstrate Tomo-E's clinical utility for diagnosis of
      wrist fractures. Tomo-E is a compact and stationary device that utilizes a distributed carbon
      nanotube (CNT) x-ray source array that will be specially designed for extremity imaging to
      collect all the projection views without any mechanical motion.
    

Intervention name(s): Tomo-E scan; Radiograph
Intervention type(s): Device; Device
Intervention description(s): High-resolution limited-angle tomography positioning and examination will vary depending on injury.; Standard of Care radiographic imaging of wrist.
Other intervention name(s): Digital Tomosynthesis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Scaphoid Fracture; Wrist Fracture; Distal Radius Fracture
Nasopharyngeal Streptococcus Pneumoniae Carriage
Condition: Streptococcus Pneumoniae Infections
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Observational

Summary: 
      Primary Objective: Evaluation of the

      - Carriage rate of Streptococcus pneumoniae in the nasopharynx of children

      Secondary Objective:

        -  Carriage rate and distribution of Streptococcus pneumoniae serotypes

        -  Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains

        -  Distribution of Staphylococcus aureus strain

        -  The influence of risk factors in the Streptococcus pneumoniae carriage rate in children
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects aged between 2 months and 5 years attending pediatric clinics in hospitals,
        daycare centers, and kindergartens
      
Keywords: Streptococcus pneumoniae nasopharyngeal carriage
Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation
Condition: Endoscopic Retrograde Cholangiopancreatography
Study type: Interventional

Summary: 
      The purpose of the study is to compare two different techniques (pancreatic sphincterotomy
      (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and
      the success of cannulation in difficult cannulation. For the study, the difficult cannulation
      is de-fined as situation when the common bile duct has not been cannulated in five minutes,
      after five attempts or after two pancreatic guide wire passages or when any of those limits
      is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The
      primary end-point is the risk of PEP .
    


Intervention name(s): Biliary cannulation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Awareness and Attitudes Regarding Prenatal and Preimplantation Genetic Diagnosis for Inherited Breast/Ovarian Cancer Risk
Condition: Breast Cancer; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      We are inviting you to participate in a study of how people who have had genetic counseling
      for breast/ovarian cancer risk feel about certain reproductive technologies, preimplantation
      genetic diagnosis (PGD) and prenatal genetic diagnosis (PND), that may reduce the chances of
      passing increased risk onto one's children. We would also like feedback from patients who
      have been to our clinic in the past on the best ways to talk about PGD and PND during genetic
      counseling sessions. We are seeking both the opinions of people who are interested in these
      technologies and those who are not. It does not matter whether you have heard of PGD or PND
      before - you can still participate. Your past experience with genetic counseling is valuable
      to us in deciding how to communicate this information during sessions.
    


Intervention name(s): questionnaire, interview
Intervention type(s): Behavioral
Intervention description(s): You will be asked to make a one-time visit to MSKCC. At that research visit, you will be asked to complete a short questionnaire about your knowledge of various reproductive technologies relevant to individuals at hereditary risk. Then you will watch a short presentation about these reproductive technologies and complete a second brief questionnaire to assess your understanding of the presentation. Afterwards, you will meet with an interviewer one-on-one for about one hour, during which time you may share your thoughts and feelings about the use of these reproductive technologies.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective participants will be recruited through the MSKCC clinics that serve high-risk
        patients (e.g. Clinical Genetics Service, Special Surveillance Breast Program, etc.)
      
Keywords: Breast; Ovary; Mutation carrier