bioihbjkbjnl/mcl2 huggingface dataset:
Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Observational

Summary: 
      Post-operative acute renal failure is a severe post-operative complication and is associated
      with high mortality. The enhanced prediction score, including pre-as well as intra-operative
      predictors accurately predicted ARF following hepatic surgery. This prediction score allows
      early identification of patients at high risk of ARF and may support decision-making for
      protective kidney treatment.
    

Detailed description: 
      To enhance and validate an already pre-existing score accurately predicting post-operative
      acute renal failure (ARF) after hepatic surgery

      We will enhance a pre-existing score predicting ARF based on pre-operative as well as
      intra-operative predictors.

      Development process: we will identify the strongest predictors of ARF in a multivariable
      logistic regression model followed by a stepwise backward logistic regression analysis and
      bootstrapping.

      Validation process: we will perform an internal validation by calibrating the prediction
      model as well as by k-fold cross validation (c statistics) and bootstrapping. Additionally,
      we will calculate the discrimination by the area under the curve (AUC).

      Decision curve analysis: Furthermore we will perform a decision curve analysis to evaluate
      the clinical consequences of both prediction scores whether a patient with increased ARF risk
      would post-operative benefit of a treatment on the ICU.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        We included consecutively patients undergoing any type of hepatic surgery for benign as
        well as malignant diseases between July first, 2002 and October 31, 2007 in a single
        tertiary care center (Swiss Hepato-Pancreato-Biliary (HPB) Centre, University Hospital of
        Zurich, Switzerland.
      
Keywords: Development; Pre- and intra-operative predictors; Acute renal failure; Liver Surgery; Prediction score; Validation; Clinical consequences; Decision curve analysis; predictors of acute renal failure after liver resection
Geldanamycin Analogue in Treating Patients With Advanced Cancer
Condition: Unspecified Adult 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: This phase I trial is studying the side effects and best dose of a geldanamycin
      analogue in treating patients with advanced cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose for a geldanamycin analogue,
           17-allylamino-17-demethoxygeldanamycin (AAG), in patients with advanced malignancies.

        -  Determine the toxic effects and dose-limiting toxicity of AAG in this patient
           population.

        -  Determine the safe dose of AAG for a Phase II study.

        -  Measure the pharmacokinetic and pharmacodynamic profiles of AAG in these patients.

        -  Assess time to tumor progression and any antitumor activity in patients treated with
           AAG.

      OUTLINE: This is a dose-escalation study.

      Patients receive a geldanamycin analogue, 17-allylamino-17-demethoxygeldanamycin (AAG), IV
      over 15-30 minutes every week. Treatment continues in the absence of disease progression or
      unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of AAG until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
      patients experience dose-limiting toxicity.

      Patients are followed at 4 weeks.

      PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
    

Intervention name(s): tanespimycin
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT
Condition: Bone Metastases
MeSH terms: Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial was to assess the diagnostic performance and safety of Sodium
      Fluoride F-18 Positron Emission Tomography / Computed Tomography (18F-NaF-PET/CT) in bone
      metastases of malignant tumors compared with Technetium[99mTc] Methylenediphosphonate Bone
      Scintigraphy ± Single Photon Emission Computed Tomography (99mTc-MDP-BS±SPECT).

      The enrolled subjects were randomly assigned to two sequences A and B at a ratio of 1:1.
      Within 7 days, 18F-NaF-PET/CT and 99mTc-MDP-BS±SPECT bone imaging were performed alternately.

      The sensitivity, specificity, positive and negative predictive value of 18F-NaF-PET/CT and
      99mTc-MDP-BS±SPECT were calculated respectively based on the diagnostic data of standard of
      truth.
    


Intervention name(s): Sodium Fluoride F-18 Injection; Technetium[99mTc] Methylenediphosphonate Injection
Intervention type(s): Drug; Drug
Intervention description(s): Each subject was given 5-10 mCi intravenously. Images were collected 90-120 min after injection.; Each subject was given 10-25 mCi intravenously. Images were collected 3-6 hours after injection.
Other intervention name(s): 18F-NaF Injection; 99mTc-MDP Injection
Intervention MeSH terms: Methylene diphosphonate; Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lung Cancer; Breast Cancer; Prostate Cancer
Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether whole body exercise training alters the
      immunity in the lungs of people with COPD and reduces the incidence of chest infections over
      the longer term.
    

Detailed description: 
      Patients will undertake an 8 weeks pulmonary rehabilitation program of exercise and
      education. Those who decline to take part in pulmonary rehabilitation will have the same
      outcome measures collected at the same timepoints.
    

Intervention name(s): Pulmonary rehabilitation
Intervention type(s): Other
Intervention description(s): 8 weeks of exercise training (twice weekly) of education and exercise
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD,; Pulmonary rehabilitation,; Airway immunity
Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy
Condition: Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory System
Study type: Interventional
Phase: Phase 4

Summary: 
      Pre-operative anxiety leads to higher sympathetic stimulation. Propofol in the main drug used
      during interventional or imaging techniques that need sedation. Also, dexmedetomidine causes
      sedation, analgesia, sympatholytic properties, without respiratory depression.In stereotactic
      brain biopsy; patient discomfort due to drilling a hole through the skull and the advancement
      of the biopsy needle make the patient in need for good sedation and analgesia.
    


Intervention name(s): dexmedetomidine/ propofol
Intervention type(s): Drug
Intervention description(s): The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of
      the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus
      influenzae type b.
    


Intervention name(s): Pneumococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Streptococcus pneumonia, vaccine
Monocenter 6-period Study in Patients With Seasonal Allergic Rhinitis to Birch Pollen to Establish a Challenge Model With Natural Birch Pollen in an Environmental Challenge Chamber (ECC)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      This clinical validation study is aimed at establishing a birch pollen challenge in the
      Fraunhofer ECC in patients allergic to birch pollen. The symptoms will be recorded on a
      validated symptom score as Total Nasal Symptom Score (TNSS), allowing to determine whether
      the challenge is dose dependent and reproducible.
    

Detailed description: 
      This is a mono-center, single-blind, placebo controlled study assessing nasal symptoms in
      patients with allergic rhinitis upon exposure to birch pollen in an environmental challenge
      chamber during a 4 hour challenge period with different concentrations of birch pollen versus
      placebo.

      Subjects with allergic rhinitis to birch pollen will be recruited from the Fraunhofer ITEM
      database or the surrounding communities. After the screening evaluation eligible subjects
      will undergo six challenge sessions in the environmental challenge chamber at intervals of at
      least one week. In order to determine dose response, the concentration of birch pollen in the
      atmosphere of the challenge chamber will be varied from 1000 birch pollen/m³ in the first
      period, 2000 birch pollen/m³ in the second period, 4000 birch pollen/m³ in the third period,
      8000 birch pollen/m³in the fourth period to 0 birch pollen/m³ (only air) in the fifth period.
      In order to investigate reproducibility in addition to dose response, a challenge with one
      concentration previously used will be repeated in period six. The dose will be chosen by the
      Investigator according to the observed nasal symptoms. According to previous experience with
      grass pollen (Dactylis glomerata) the target symptom level for TNSS is around 6. Therefore,
      the dose to study reproducibility will be chosen where the average mean TNSS of the last two
      hours will be closest to six. If two doses are equally close, the higher dose will be chosen
      because this will allow to optimize the particle monitoring technique. In this regard, it is
      better to have a high particle concentration in order to separate specific particles from
      unspecific particles (originating from the subjects themselves).
    

Intervention name(s): Exposure to birch pollen
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      single ascending doses of PF-06852231 after first-time administration to healthy adult
      subjects. The safety, tolerability, and pharmacokinetics of an active metabolite
      (PF-06892787) will also be evaluated in this study.
    


Intervention name(s): Placebo; PF-06852231
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with placebo; Treatment with PF-06852231
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: PF-06852231; Safety; Tolerability; Pharmacokinetics; First-in-human; Healthy subjects
Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I study investigates how well a health service program called Witness CARES
      Services works in increasing access and adherence to colorectal cancer screening in patients
      who have not undergone a colorectal screening in the past year. Providing patients with
      navigational and screening services via Witness CARES Services may improve access to and
      adherence levels of colorectal screening.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC)
      screening for non-adherent Medicaid clients.

      II. Develop an algorithm for predicting CRC screening outcomes following intervention
      services.

      OUTLINE:

      Patients who are not prepared for a colonoscopy or stool test receive educational materials,
      messages, and videos electronically or by mail with information about colorectal screening
      and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator
      assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling
      appointment, prep materials and process, transportation, escort). Patients desiring a stool
      test receive navigator assistance by facilitating fecal tests.

      After completion of study, patients are followed up periodically.
    

Intervention name(s): Community Health Service; Survey Administration
Intervention type(s): Other; Other
Intervention description(s): Receive Witness CARES services; Ancillary studies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Alemtuzumab Induction in Islet Transplantation
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Our experience suggests that further research with alemtuzumab is attractive in islet
      transplantation. Therefore, in this study we propose to combine alemtuzumab induction
      pre-transplant, with tacrolimus and mycophenolate mofetil maintenance immunosuppression
      post-transplant. In the critical early phase post transplant, we anticipate that this regimen
      will prove to be more effective in control of autoimmunity or rejection events, and have a
      more desirable side-effect profile, than previously tested combinations of induction and
      immunosuppressive agents.
    

Detailed description: 
      This trial is a single-center, prospective, open-label study in 12 Type 1 diabetic
      participants receiving an islet-alone transplant along with alemtuzumab induction therapy
      followed by combination tacrolimus and MMF maintenance immunosuppression. Participants will
      receive 1 to 3 infusions of pancreatic islets of sufficient quantity to attain insulin
      independence.

      The primary objective of this protocol is to assess the safety of a treatment regimen
      utilizing alemtuzumab induction and a combination of tacrolimus and MMF maintenance
      immunosuppression in adult Type 1 diabetic participants receiving their first islet
      transplant.
    

Intervention name(s): alemtuzumab; islet transplant
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Alemtuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: islet; transplantation
Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease
Condition: GERD; Larynx Disease
MeSH terms: Gastroesophageal Reflux; Laryngeal Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to establish the clinical application of a new device that
      records pH changes in the hypopharynx. The investigators also aim to compare the consistency
      of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long"
      catheters in patients.
    

Detailed description: 
      Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed
      through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register
      the duration, pattern and symptom correlation of distal esophageal acid exposure. This can be
      accomplished via a catheter probe connected from outside the body and placed through a
      nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH
      detector temporarily implanted in the distal esophagus during endoscopy can record reflux
      events. However, despite available technologies, there has long been a deficiency in
      detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest
      for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of
      extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus,
      and non-cardiac chest pain. Until now, there has not been a device sensitive enough for
      accurately detecting extra-esophageal reflux (EERD) and clinicians have relied upon
      subjective response to empiric treatment with acid reducing medications to determine whether
      acid reflux was at the root of the symptoms. There are currently no well designed published
      studies with this device to assess its role in this group of difficult to treat patients.
    

Intervention name(s): Dx-pH Probe; Manometry
Intervention type(s): Device; Procedure
Intervention description(s): 24 hour ph monitoring; procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Healthy volunteers
A Study of EPEG in Beta Thalassemia Patients
Condition: Beta-Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label study in which 6 patients will receive once-weekly subcutaneous injections of
      EPEG for 4 weeks. Final visit will occur 60 days after study entry
    

Detailed description: 
      Following the provision of informed consent, screening visit procedures to be performed will
      include: a detailed medical history (including concomitant medications), physical exam, vital
      signs (non-invasive systolic and diastolic arterial blood pressure, heart rate, and
      respiratory rate, temperature, and oxygen saturation by pulse oximetry,), laboratory testing
      of blood samples collections for safety (hematology and chemistry), and urinalysis (dipstick
      and microscopy, if necessary). A serum pregnancy test for all female patients (of
      child-bearing potential) will be measured during the Screening Visit. Urine pregnancy test
      for all female patients (of child-bearing potential) will be measured at each dosing visit
      prior to dosing.

      Eligible patients will receive either subcutaneous injection of EPEG (0.9 µg/kg, 1.2 µg/kg,
      and 1.5 µg/kg,) for four weeks followed by follow up for 5-6 weeks after 4th dose of IP.

      Vital signs will be recorded for study documentation at 1 hour after dosing and at discharge
      of the day (to occur 2 hours after the time of dosing). All patients will receive standard of
      care as per investigative site standard practice.
    

Intervention name(s): EPEG
Intervention type(s): Drug
Intervention description(s): (Pegylated erythropoeitin)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Exercise Intensity on Energy Intake, Appetite and Enjoyment in Overweight and Obese Females
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Interval exercise involves short bouts of high intensity exercise interspersed with periods
      of lower intensity exercise. The benefit is that a shorter total duration of exercise may be
      required to achieve cardiovascular benefits similar to or even superior to traditional longer
      bouts of steady state endurance exercise. However how this type of exercise affects appetite
      and energy intake, particularly in overweight and obese females is not well known.

      This study involves two trials of exercise, one at high intensity and one at low intensity,
      followed by a buffet lunch, in overweight and obese females.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Vaginal Elasticity Assessment Before and After Surgical Repair for Urinary Stress Incontinence.
Condition: Stress Incontinence, Female
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Female patients with USI will be evaluated for vaginal elasticity using vaginal tactile
      imaging both before and after surgery for the repair of the USI. Surgical repair will be
      performed by a single surgeon who will perform a tension free vaginal tape obturator (TVT-O)
      repair.
    

Detailed description: 
      Patients will be recruited and sign a consent form. The patients included are patients with
      USI that are candidates for a TVT-O repair.

      Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different
      points:

        -  The day of surgery before surgery.

        -  The day after surgery.

        -  3 months post-operational. Every patient will serve as her own control. Demographic,
           gynecologic and obstetric history will be obtained from patients' electronic files.
    

Intervention name(s): Vaginal tactile imager
Intervention type(s): Device
Intervention description(s): Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Clinical Evaluation of Two Monthly Contact Lenses
Condition: Refractive Errors
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact
      lenses as compared to BIOFINITY® contact lenses after one week of wear.
    


Intervention name(s): Comfilcon A with Digital Zone Optics™ contact lenses; Comfilcon A contact lenses
Intervention type(s): Device; Device
Intervention description(s): Silicone hydrogel spherical contact lenses with Digital Zone Optics™; Silicone hydrogel spherical contact lenses
Other intervention name(s): BIOFINITY® ENERGYS™; BIOFINITY®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment