bioihbjkbjnl/mcl2 huggingface dataset:
Patient Reported Outcomes With LASIK: PROWL-2
Condition: Laser in Situ Keratomileusis
Study type: Observational

Summary: 
      This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related
      quality of life (QoL) of 300 civilian participants prior to and three months following
      state-of-the-art laser in situ keratomileusis (LASIK).
    

Detailed description: 
      The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among
      the FDA's Center for Devices and Radiological Health (CDRH), the Department of Defense, and
      the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs)
      following LASIK surgery. This three-phased project is part of FDA's ongoing effort to better
      monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-2 is
      the third phase of the larger LQOLCP project. The primary objective of PROWL-2 is to explore
      the psychometric properties of a computer-based questionnaire assessing the patient-reported
      outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3
      months following LASIK. This questionnaire initially developed and examined in PROWL-1 (a
      military population) will be examined psychometrically in a civilian population. PROWL-2 is a
      prospective, multi-center, observational study in which a participant's pre-operative status
      will serve as the baseline for one-month and three-month post-surgical comparisons. Three
      hundred (300) participants planning to undergo refractive surgery using LASIK for myopia,
      hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across
      the United States. Additionally, routine clinical data will be collected pre- and
      post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront
      aberrometry, conreal topography, and other clinical assessments) and questionnaires will be
      independently administered pre-operatively and at the one-month and three-month
      post-operative visits.
    

Intervention name(s): LASIK
Intervention type(s): Procedure
Intervention description(s): Laser eye surgery
Other intervention name(s): Refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals age of 21 to 84 years planning to undergo refractive surgery using LASIK for
        myopia, hyperopia, or astigmatism
      
Keywords: Myopia; Hyperopia; Astigmatism; Patient-reported outcomes; Patient satisfaction; Refractive Error; Emmetropia; Dry eyes; Glare; Halos; Patient expectations
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if a manual blood loss can be detected using the non-invasive blood monitor.
    


Intervention name(s): CM1500
Intervention type(s): Device
Intervention description(s): blood volume monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: blood loss, hemorrhage, hemorrhagic shcok
An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
Condition: Crohn's Disease; Rheumatoid Arthritis; Psoriasis
MeSH terms: Arthritis; Crohn Disease; Psoriasis
Study type: Observational

Summary: 
      For public health purposes disability is becoming increasingly important as an outcome
      measure. Despite this, there are few data on the effectiveness of adalimumab on disability
      outcomes in patients with immune-mediated inflammatory diseases (IMIDs), particularly in the
      Phase IV setting. There are even less data available in New Zealand, which did not have the
      opportunity to participate to a major extent in large, multinational, Phase III pivotal
      studies of adalimumab in IMIDs.

      The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple,
      validated, free and easy-to-use generic assessment instrument for health and disability. It
      is applicable across cultures, in all adult populations. It is a responsive measure that can
      show what difference a treatment makes.

      Results from study of effect of adalimumab on WHODAS scores and other patient-reported
      outcomes (PROs) of work activity and well-being will be of interest to a variety of
      stakeholders in the healthcare system including patients, healthcare practitioners and
      payers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will be males and/or females who are attending a routine clinical visit and meet
        all of the inclusion criteria and none of the exclusion criteria.
      
Keywords: Crohn Disease; Arthritis, Rheumatoid; Psoriasis; Patient Outcome Assessment; Adalimumab; Global Health; Quality of Life
Blood, Hair and Lung Concentrations of Metals and Metalloids in Patients With Lung Cancer or Chronic Obstructive Pulmonary Disease
Condition: Lung Cancer; Chronic Obstructive Pulmonary Disease; Emphysema; Lung Surgery
MeSH terms: Lung Neoplasms; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Interventional

Summary: 
      Prospective research to study the relationship between concentrations of metals/metalloids in
      blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive
      pulmonary disease.
    


Intervention name(s): Lung surgery
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metals; Metalloids; Blood; Hair; Lung; Lung cancer; Chronic obstructive pulmonary disease
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
Condition: Advanced Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to
      treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected
      chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic
      efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However,
      docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate
      the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with
      advanced ovarian cancer.
    


Intervention name(s): Neoadjuvant chemotherapy; Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles; Carboplatin AUC 5, q 3 weeks, 3 cycles
Intervention MeSH terms: Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adriamycin, Vinblastine, DTIC and Revlimid in Elderly Hodgkin Lymphoma Patients
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine within the scope of the trial what the maximum
      tolerated dose (MTD) of lenalidomide in combination with AVD should be.
    


Intervention name(s): Doxorubicine; DTIC; Lenalidomide; Vinblastine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50mg/m2 day 1 + 15; 375mg/m2 day 1 + 15; day 1 - 21; 6mg/m2 day 1 + 15
Intervention MeSH terms: Doxorubicin; Lenalidomide; Vinblastine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Massage Therapy on Sleep After Heart Surgery
Condition: Coronary Artery Bypass Graft Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of Massage Therapy for improving the
      quality of sleep in patients on postoperative period of coronary artery bypass graft surgery
      (CABG).
    

Detailed description: 
      Patients We evaluated patients admitted to the ward waiting for elective CABG surgery.

      Preoperative evaluation The preoperative clinical assessment consisted of obtaining
      information regarding demographics and personal characteristics.

      Postoperative protocol and evaluation After discharge from the intensive care unit to the
      ward during the postoperative period, the patients were randomized to 3 nights of sitting for
      10 minutes, with no intervention (Control) or to MT. Briefly, MT consisted of massage of the
      neck, shoulders, and back. The massage was initiated with light manual compression and
      progressed to deep compression. The compression was performed with the inner region of the
      fingers, hand-shaped clamp, and friction (digital compression with the thumb) on trigger
      points, cervical traction, and mobilization in all planes (front, back, and sides). The
      massage was finished with light manual compression. During the study period, all patients
      completed a sleep diary containing the time they went to sleep, woke up, and took daytime
      naps. The patients completed a VAS for pain and fatigue (similar to the preoperative
      evaluation described previously) as well as a VAS for sleep on days 1, 2, and 3,
      corresponding to the morning following the intervention that was performed on the previous
      night.
    

Intervention name(s): Massage Therapy; Control
Intervention type(s): Other; Other
Intervention description(s): After discharge from the intensive care unit to the ward during the postoperative period, patients which were randomized for 3 nights to receive intervention (Massage Therapy)which were consisted of massage of the neck, shoulders, and back. The massage was initiated with light manual compression and progressed to deep compression. The compression was performed with the inner region of the fingers, hand-shaped clamp, and friction (digital compression with the thumb) on trigger points, cervical traction, and mobilization in all planes (front, back, and sides); no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: massage therapy; sleep quality; coronary artery bypass grafting surgery; Patients after Coronary Artery Bypass Graft Surgery
Conditions of Realization of the Echocardiography in Newborns
Condition: Premature Newborn
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery
      vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus
      screening may generate this hemodynamic response and whether postural support would be able
      to modulate it.

      Study design

      Prospective, single center, randomized study in less than 29 weeks of gestation neonates,
      with a post natal age < 48 hours, and requiring invasive mechanical ventilation.

      Crossover design with order of echocardiographies determined by computer randomization: in
      one group ultrasounds are performed with postural support, than standard conditions, in the
      other, ultrasounds are performed in standard conditions than with postural support.

      The objective of the study is to assess the ratio of the acceleration time/ejection time of
      pulmonary arterial flow.

      The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus
      shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right
      and left ventricular functions using tissue Doppler imaging and speckle-tracking
      echocardiography), pain assessment with a clinical scale and heart rate variability analysis.
    


Intervention name(s): echocardiography with postural support; echocardiography with standard condition (usual)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Echocardiography; postural support; preterm neonate
Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the pharmacokinetic profile of a Fixed Dose Combination nefopam
      hydrochloride (30 mg) / paracetamol (500 mg) and individual components taken alone or
      concomitantly after oral single dose.
    


Intervention name(s): nefopam hydrochloride 30mg X2; paracetamol 500 mg X2; Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): nefopam hydrochloride 30mg X2; paracetamol 500 mg X2; Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2
Other intervention name(s): acetaminophen
Intervention MeSH terms: Acetaminophen; Nefopam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open-label, randomized, four-period, four treatments, cross-over trial in healthy volunteers
Masking: None (Open Label)
Primary purpose: Health Services Research
Comparison of On-Site Versus Off-Site Evaluation of Cholangioscopy-Guided Biopsies of the Bile Duct
Condition: Bile Duct Stricture
MeSH terms: Cholestasis; Constriction, Pathologic
Study type: Interventional

Summary: 
      This study will test two different methods for processing biopsy specimens taken from the
      bile duct. Patient;s who are asked to participate int his study have a stricture in the bile
      duct that needs a single operator cholangioscopy-guided biopsies during endoscopic retrograde
      cholangiopancreatography (ERCP) so that a diagnosis can be made. Standard of care includes
      performing single operator cholangioscopy-guided biopsies in the bile duct and sending the
      tissue to the lab for testing to make a diagnosis. Using this method the investigators can
      establish a diagnosis only about 50% of the time. The investigators believe that if a
      cytopathologist is available in the endoscopy suite during the procedure to evaluate the
      biopsy specimens onsite, the investigators can improve the diagnostic accuracy. The purpose
      of this study is to compare two methods for processing biopsies obtained from the bile duct
      (Onsite vs. Offsite).
    

Detailed description: 
      The diagnostic accuracy rate of single operator cholangioscopy-guided biopsy is only 50%.
      This translates to the need for performing repeat procedures to establish a diagnosis and
      therefore delays patient treatment. The biopsy specimen obtained at cholangioscopy are
      usually processed offsite in the pathology lab. We believe that if a pathologist can assess
      the tissue sample during the procedure itself (onsite) and provide feedback, the diagnostic
      accuracy rate will improve. This translates to better (faster) diagnosis and early treatment.
      Therefore, we will be comparing onsite versus offsite evaluation of bile duct biopsy
      specimens to determine which method yields a better diagnosis.
    

Intervention name(s): on-site specimen evaluation; off-site specimen evaluation
Intervention type(s): Other; Other
Intervention description(s): The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis; The specimen will be evaluated off-site by a cytopathologist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
The Analgesic Efficacy of Wound Infiltration With Tramadol
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This double-blind, randomized trial examined whether tramadol wound infiltration decreased
      postoperative pain following cesarean delivery under general anesthesia or reduced the need
      for analgesics in the immediate postoperative period. Patients in the tramadol group consumed
      significantly less morphine at all time intervals than those in the control group. The
      investigators suggest that the use of wound infiltration with tramadol may be a useful
      technique in patients who undergo cesarean section under general anesthesia to reduce
      postoperative pain, improve recovery, and facilitate early contact of mothers with their
      babies.
    


Intervention name(s): Tramadol
Intervention type(s): Drug
Intervention description(s): A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
Other intervention name(s): Placebo (0,9% saline solution)
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tramadol; Postoperative analgesia; Infiltration; Cesarean section
Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries
Condition: Analgesia
Study type: Interventional

Summary: 
      This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae
      versus single level versus general anesthesia for breast cancer surgeries
    


Intervention name(s): Bilevel erector spinae plane block; Single level erector spinae plane block; Intravenous morphine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Bilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels; Single level erector spinae plane block at 5th thoracic vertebrae; Intravenous morphine 0.1 mg/kg
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.

      Also, for axillary positive node patients, optimum chemotherapy regimens are still under
      discussion. Some previous studies suggest that, in the subset of node-positive patients,
      treatments based on sequential administration of anthracyclines and taxanes are more
      efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic
      index (activity/toxicity).

      The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of
      proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8
      weekly paclitaxel administrations (100mg/m2).

      The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The
      investigators expect to increase this by 8% with the experimental treatment. With an alpha
      error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250
      patients are needed, 625 per arm.
    

Detailed description: 
      The primary endpoint of study-5-year disease-free survival (DFS) will be assessed by Kaplan
      Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic
      and predictive value of clinical and molecular markers. Associations and interactions will be
      assessed with a multivariable Cox proportional hazards model for DFS for the following
      covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy,
      tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical
      tests will be two-sided.
    

Intervention name(s): paclitaxel; Fluorouracil; Epirubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Taxol; 5-FU; 4-Epirubicin
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Axillary node positive breast cancer.; Sequential drug administration.; Weekly paclitaxel.
Body Composition Monitoring(BCM) for Determination of the Fluid Status in Patients Undergoing General Anesthesia
Condition: Fluid Overload
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a recently developed device, which measures body
      composition (i.e. the water content of the body) in the perioperative setting. Specifically
      the investigators will test the hypothesis, that extracellular water content after surgery
      correlates to the amount of intraoperative infusion and positive fluid balance. Furthermore
      the investigators will test, if preoperative evaluation of body water helps to determine
      intraoperative fluid requirements and to guide fluid administration.
    

Detailed description: 
      Patients undergoing anesthesia and surgery receive intravenous fluids during the procedure.
      The amount of administered fluid depends on the type of surgery, cardiovascular stability and
      intraoperative losses like hemorrhage. Fluid overload as well as hypohydration might be
      detrimental and might adversely effect outcome after surgery. Specifically overhydration
      results in significant weight gain, tissue edema and increased morbidity. Technically
      assisted assessment of volume status before surgery may be useful to direct intraoperative
      fluid administration and to prevent postoperative volume overload. As a prerequisite the
      investigators will test a recently developed whole-body bioimpedance spectroscopy device to
      determine the pre-to postoperative fluid distribution. This body composition monitor (BCM,
      Fresenius Medical Care, Germany) separates between extracellular and intracellular fluid
      volume non-invasively by applying a frequency sweep from 3-1000 kilohertz through the entire
      patient via electrodes placed on the wrist and ankle.

      The investigators will test the hypothesis that

        1. the amount of administered fluid correlates with the amount of overhydration measured
           postoperatively.

        2. that preoperative BCM measurements and thus information about the preoperative hydration
           state might help to guide fluidmanagement and to reduce the amount of over/
           hypohydration postoperatively.
    

Intervention name(s): Body Composition Monitoring
Intervention type(s): Device
Intervention description(s): Pre- and postoperative measurements of body composition (intracellular and extracellular water content)via bioimpedance spectroscopy
Other intervention name(s): Fresenius Healthcare Germany
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Intraoperative Fluid Administration; Body Composition Measurement