bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)
Condition: Diabetes Mellitus; Diabetic Macular Edema
MeSH terms: Macular Edema; Diabetes Mellitus; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with
      diabetic macular edema (DME). This study will evaluate the percent change from baseline in
      excess central subfield thickness (CST) in the study eye as assessed by spectral
      domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.
    


Intervention name(s): ASP8232; ranibizumab; Placebo; Sham intravitreal (IVT) injection
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): oral capsule; intravitreal (IVT) injection; oral capsule; intravitreal (IVT) injection
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP8232; Diabetes Mellitus; ranibizumab; Diabetic Macular Edema
Risk Factors and Machine Learning Model for Beta-Lactam Drugs Related Acute Kidney Injury
Condition: Acute Kidney Injury; Beta-Lactam Antibiotic Toxicity (Diagnosis)
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Acute kidney injury (AKI), also known as acute kidney failure (ARF), is a common and complex
      kidney disease in clinic and an important factor related to poor prognosis of patients in
      clinic. In the present study, a single-center retrospective study was conducted in our
      center. The clinical data of hospitalized patients received β-Lactam drugs from January 2018
      to December 2020 was retrospectively analyzed. The multiple logistic regression analysis
      suggested that complicated with hypertension, anemia, pneumonia, shock, sepsis, heart
      failure, combined use of proton pump inhibitors (PPI), angiotensin-converting enzyme
      inhibitor (ACEI), angiotensin Ⅱ receptor antagonist (ARB) were independent risk factors for
      AKI related to β-Lactam drugs. In clinical practice, patients with acute kidney injury risk
      factors should be closely monitored for changes in their blood creatinine and urine output to
      avoid acute kidney injury. For patients who have suffered from acute kidney injury, the cause
      should be removed in time and corresponding symptomatic treatment should be given.
    


Intervention name(s): Beta-Lactam Drugs
Intervention type(s): Drug
Intervention description(s): During hospitalization，patients used Beta-Lactam drugs.
Intervention MeSH terms: Lactams; beta-Lactams
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients were included if received treatment with β-lactam drugs and discharged from
        the hospital between January 1, 2018 and December 31, 2020
      
Keywords: Beta-Lactam drugs; Acute kidney injury; Pharmacoepidemiology; Miss diagnosis; Risk factors; Logic regression
Characterization of Aerosol Generation and Transport in the Human Lung of Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study is aiming at evaluating the characteristics of particle emission in subjects with
      different stages of chronic obstructive pulmonary disease (COPD) compared with healthy
      smokers.
    


Intervention name(s): Exhaled particle analysis
Intervention type(s): Other
Intervention description(s): At visit 2, the exhaled particle analysis will be performed. Subjects will be asked to breath through the device and to perform several breathing maneuvers such as deep breathing, shallow breathing, rapid breathing, slow breathing. These measurements will be repeated after 2 hours on the same day.
Visit 3:
After a baseline exhaled particle analysis, the subjects will inhale nebulized saline (2.5 ml of a 0.9 % NaCl-solution). Aerosol generation and transport will be recorded immediately after the end of inhalation as well as 2 hours and 4 hours after the start of inhalation using the same techniques as in visit 2.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: COPD
Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the adoption of a chronic care model in
      conjunction with tele monitoring and case management can reduce the risk of death,
      hospitalization, emergency room visits, or admission to a skilled nursing facility in
      patients with chronic kidney disease compared to usual care.
    

Detailed description: 
      Chronic kidney disease (CKD) is a major public health issue. Approximately, 11% of the US
      population has CKD with an increased prevalence among individuals great than 65years. Many
      individuals with CKD go unrecognized because they are typically asymptomatic. Individuals
      with CKD have been demonstrated to have a greater risk for mortality, hospitalization and
      development of end stage kidney disease. Also, individuals with CKD consume a significantly
      greater proportion of health care expenditures compared to other patients. This study aims to
      determine if the adoption of a chronic care model in conjunction with telemonitoring and case
      management can reduce risk of death, hospitalization, ER visits or admission to a skilled
      nursing facility in patients with CKD compared to usual care. This study will use a
      randomized controlled trial. Few interventions have been demonstrated to improve clinical
      outcomes in patients with CKD. If successful, this study will enable the VA to provide high
      quality care to patients with CKD while potentially reducing the cost of providing care.
    

Intervention name(s): Video Telemonitoring Device with Clinical Care Modules
Intervention type(s): Device
Intervention description(s): Telemonitoring of vital signs; videoconferencing, remote titration of diabetes, blood pressure, and lipid medications using evidence based treatment algorithm, and cooperative goal setting using education modules to enhance lifestyle changes
Other intervention name(s): Telehealth; Telemonitoring; Chronic Disease Management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Telemonitoring; Chronic Kidney Disease
Comparison of Thoracic Paravertebral Block and Pectoral Nerve Block
Condition: Thoracic Paravertebral Block; Video-assisted Thoracoscopic Surgery; Postoperative Analgesia
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with
      TPVB for postoperative analgesia after VATS.
    

Detailed description: 
      52 patients (ASA I-III) between 18 and 65 years of age, who were to undergo VATS, were
      randomized and divided into two groups. (26 patients in each of the PECS and TPVB groups)
      Thoracic paravertebral block was administered from two consecutive levels for TPVB group and
      a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was
      provided by intravenous morphine infusion using a patient-controlled analgesia device.
      Postoperative 24-hour total morphine consumption and duration of analgesia were the primary
      outcome measure. Perioperative remifentanil use, visual analog scale values during at rest
      and coughing, time of the first analgesic request, and additional analgesic consumption were
      recorded.
    

Intervention name(s): paravertebral block; pectoral block
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators performed Paravertebral block to that patient group for postoperative analgesia; The investigators performed pectoral block to that patient group for postoperative analgesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Thoracic paravertebral block,; pectoralis block,; Video-assisted thoracoscopic surgery,; Postoperative analgesia
A Prospective Study of Two Daily Disposable Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the performance of a novel silicone hydrogel
      contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY
      ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact
      lens-related dryness symptoms.
    

Detailed description: 
      Three study visits occurred over the course of 28 ± 3 days.
    

Intervention name(s): Delefilcon A contact lenses; Etafilcon A contact lenses
Intervention type(s): Device; Device
Intervention description(s): Silicone hydrogel contact lenses for daily wear, daily disposable use; Hydrogel contact lenses for daily wear, daily disposable use
Other intervention name(s): DAILIES TOTAL1®; 1-DAY ACUVUE® MOIST™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myopia; contact lenses; dry eyes; comfort; replacement
PRF+1% MF for Class II Mandibular Furcation Defects
Condition: Furcation Defects
MeSH terms: Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of
      mandibular class II furcation defects and its comparison to PRF and access therapy alone.
    

Detailed description: 
      Background: For improving efﬁcacy and outcomes of regenerative therapy for furcation defects,
      various materials has been investigated in addition to access therapy. Platelet-rich fibrin
      (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious
      member of biguanide group are known to enhance periodontal regeneration. The aim of the
      present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class
      II furcation defects and its comparison to PRF and access therapy alone.

      Methods: This randomized trial was conducted on 75 patients with mandibular class II
      furcation defects. Defects were surgically treated with either access therapy alone (Group
      1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical
      parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and
      horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index
      (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of
      bone defect fill was done at baseline and 9 months.
    

Intervention name(s): Open flap debridement (OFD); OFD with Platelet rich fibrin (PRF); OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Open flap debridement (OFD) alone; Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement; Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Erector Spinae Plane, Paravertebral Versus Intercostal Nerve Block for VATS Surgery
Condition: Thoracic
Study type: Interventional

Summary: 
      The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains
      controversial. 105 patients scheduled to undergo video-assisted thoracic surgery under
      general anesthesia will be included. Patients will be randomly allocated to receive
      ultrasound-guided ESP blocks on T4 and T6 levels (Group ESPB, n = 35),PVB (Group PVB, n = 35)
      after the anesthesia induction and turning the patient in the lateral position or (Group
      ICNB, n=35) with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon
      through the thoracoscope .
    

Detailed description: 
      Standard general anesthesia was applied Patients will be randomly allocated to receive single
      shot of ESP blocks (Group ESPB), Paravertebral blocks (Group PVB) or (Group ICNB )at T4 and
      T6 levels according to a random number list that will be generated by a computer and will be
      stored in sealed envelopes. An independent experienced anesthesiologist will perform the
      first two blocks or surgeon will perform the third one through the thoracoscope according to
      the random number. The study coordinator, attending anesthesiologist, data collection
      resident and the patients will be all blinded to the treatment group assignment. All blocks
      will be applied on patient's back in a lateral position. Postoperative analgesia regimen
      consisted of a continuous infusion of iv iboprofen and morphine as a second rescue drug.
      Demographic data, past medical history, surgical and anesthetic data will be documented.
      Postoperative pain scores, consumption of analgesia and quality of recovery will be recorded
      to evaluate the analgesic effect.
    

Intervention name(s): Regional analgesia of thoracic surgical patients
Intervention type(s): Other
Intervention description(s): ultrasound-guided erector spinae block on T4 and T6 levels ,paravertebral block or intercostal nerve block after the anesthesia induction and turning the patient in the lateral position with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Erector spinae plane; paravertebral; intercostal nerve block; VATS
Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of
      metformin, a probe drug for organic cationic transport.
    


Intervention name(s): Metformin/CP-690,550
Intervention type(s): Drug
Intervention description(s): Single oral 500 mg dose of metformin on Days 1 and 4 and multiple oral 30 mg doses of CP-690,550 every 12 hours on Days 2-4.
Intervention MeSH terms: Metformin; Tofacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug Interaction Healthy Volunteers CP-690; 550 Metformin
Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial
Condition: Microsurgical Free Flaps
MeSH terms: Reperfusion Injury; Ischemia
Study type: Interventional

Summary: 
      This study aimed to evaluate the possible protective effect of anesthetic technique
      balanced(with sevoflurane) compared with total intravenous anesthetic technique
      (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect
      in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap
      during transfer to receiving area. The investigators will evaluate the continuous flap tissue
      oximetry and the level of biochemical markers.
    


Intervention name(s): Balanced anesthesia; Total intravenous anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml; Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion
Other intervention name(s): Inhalation anesthesia; TIVA-TCI
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balanced anesthesia; Inhalation anesthesia; Reperfusion injury; Microsurgical Free flap
Message Testing in Aging African American Smokers
Condition: Smoking; Smoking Cessation
Study type: Interventional

Summary: 
      The goal of this study is to examine different messages to motivate smokers who self-identify
      as an African American current smoker, between the ages of 50-80 years old to quit smoking.
      Participants will be asked to complete a survey and look at two messages.
    


Intervention name(s): Rate Emotional Response; Rate Impact of Message
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will view their assigned video package, and will be asked to rate their emotional response to the message; Participants will view their assigned video package, and will be asked to rate the impact of the presented messages on motivation to quit smoking.
Other intervention name(s): Video message and flyer; Video message and flyer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Inflammatory Response After Muscle and Skeleton Trauma
Condition: Multiple Trauma
MeSH terms: Multiple Trauma
Study type: Observational

Summary: 
      The purpose of this study is to determine the inflammatory response after multiple trauma in
      humans.
    

Detailed description: 
      Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for
      an uneventful outcome in the posttraumatic phase. One of the main functions of the
      inflammatory response is the recognition and elimination of damaged tissues and
      microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has
      to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It
      remains unclear whether, when and how an interplay of complement system, NF-kB, danger and
      pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be
      beneficial and harmful. Differing activation of the complement system, pro-inflammatory
      biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead
      to varying outcome. Therefore, this prospective observational study will enroll n=60
      polytraumatized patients with an ISS>18 to monitor longitudinally their inflammatory response
      after trauma and to find out whether there is a discriminating pattern of the cross talk
      between complement system, biomarkers and apoptosis in patients with beneficial or harmful
      outcome.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Polytraumatized patients with an ISS > 18 Controls: healthy volunteers
      
Biospecimen description: 
      Whole blood, serum, white cells, and tissues will be retained.
    
Keywords: humans; patients; polytrauma; complement; inflammation; inflammatory response; biomarkers; cytokines; cell surface markers; apoptosis; NF-kappaB; functional polymorphisms; mesenchymal stem cell; severity of injury; ISS; infections; systemic inflammatory response syndrome; SIRS; sepsis; severe sepsis; shock; organ dysfunctions; SOFA; severity of disease; APACHEII; SAPSII; SPAPS3; length of stay; wound healing; outcome; mortality
Desaturation Validation of INVSENSOR00031
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to compare the accuracy of a noninvasive measurement of oxygen
      saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial
      blood samples will be collected from healthy adult subjects while undergoing a desaturation
      procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's
      arterial oxygen concentration is approximately 70%. During the desaturation, the subject's
      hand and arm without the arterial line will be subjected to motion at various times during
      the study. The subject will then be returned to breathing room air.
    


Intervention name(s): INVSENSOR00031
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Uric Acid and the Endothelium in CKD
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      This study will test the hypothesis that uric acid impairs the function of vessels in
      patients with kidney disease
    

Detailed description: 
      The purpose of the study is to understand the effect of lowering serum uric acid levels on
      vascular function in individuals with chronic kidney disease by comparing the effects of:

      1) Allopurinol therapy and 2) Placebo.

      Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of
      serum uric acid levels and vascular function.
    

Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Xanthine oxidase inhibitor- effective at lowering uric acid levels.; Placebo tablets with no active ingredient
Other intervention name(s): Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: uric acid kidney disease endothelial dysfunction
Study of Milk Allergy and Tolerance in Children
Condition: Food Hypersensitivity; Milk Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if children who are allergic to milk can increase
      tolerance through frequent dose-escalation every 6 months versus 12 months leading to
      eventual tolerance of less heated milk and ultimately unheated milk.
    

Detailed description: 
      Milk is among the most common food allergens in infants and children. The majority of
      children outgrow their milk allergies; however, the exact mechanisms by which food tolerance
      is achieved are unknown. Strict avoidance of the offending food is currently the only known
      therapy. However, some have been known to tolerate milk products cooked at high heat such as
      when baked in foods.

      This clinical trial involves a diet containing extensively baked milk protein to investigate
      the effects of ingestion of heat-denatured milk on development of oral tolerance to non-baked
      milk.
    

Intervention name(s): Baked Milk; Non-baked Milk
Intervention type(s): Biological; Biological
Intervention description(s): At baseline, each subject will undergo sequential oral food challenges with the products that contain increasing amounts of milk protein that are baked: Stage 1 (muffin), Stage 2 (pizza), and Stage 3 (rice pudding) doses of baked milk to determine the extent to which they tolerate various baked milk proteins. Based on the outcomes of the baseline oral food challenges, subjects will be assigned to one of the 5 study arms.; Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food Allergy; Milk Allergy