bioihbjkbjnl/mcl2 huggingface dataset:
Zero-fluoroscopy Approach Versus Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
Condition: Paroxysmal Supraventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Supraventricular; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic
      approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus
      fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
    

Detailed description: 
      Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac
      arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the
      operation staffs. Recently,three-dimensional navigation systems have been developed and
      implemented in electrophysiological procedures for guiding catheters inside the heart
      chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system
      used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal
      supraventricular tachycardia. This study is aimed to compare the feasibility, safety and
      efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic
      approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular
      tachycardia.
    

Intervention name(s): Zero-fluoroscopic ablation; Conventional fluoroscopic ablation
Intervention type(s): Device; Device
Intervention description(s): Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.; Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fluoroscopy; Ablation; Three dimensional; Paroxysmal supraventricular tachycardia; Radiation
A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary
      Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)
    


Intervention name(s): ICP-022; ICP-022; ICP-022; Placebos
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other intervention name(s): Orelabrutinib; Orelabrutinib; Orelabrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mild to Moderate
Predict Transpulmonary Pressure Through ZAM
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable
      breathing pattern) and EAdi >8 uV. Four modes of mechanical ventilation were performed under
      different support level for the measuring of EAdi, air way pressure and other parameters.
    

Detailed description: 
      1. Mode NAVA spontaneous breathing select a NAVA level that gives peak pressure about 9-10
           cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure
           not to disturb the patient). Insp Hold after every ZAM.

           Increase NAVA level by 50% and repeat the protocol when patient's breathing has
           stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb
           the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one
           end-inspiratory hold-maneuver and one end-expiratory occlusion.

        2. Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes,
           do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every
           ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one
           end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing
           has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb
           patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one
           end-inspiratory hold-maneuver and one end-expiratory occlusion.

           Make record of RR, Vt, Flow, Ti during both periods.

        3. Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern
           observed during NAVA

        4. Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8
           to 20 in steps of 1 cmH2O every 2 minutes.
    

Intervention name(s): different modes of mechanical ventilation
Intervention type(s): Other
Intervention description(s): Four different ventilation modes were performed one by one and respiratory parameters were recorded.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Bio-equivalency Study of Moxifloxacin Tablets, 400 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study in human subjects under fasting conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of moxifloxacin tablets 400 mg of Dr. Reddy's
      Laboratories Limited, comparing with Avelox ® Tablets 400 mg of Bayer Healthcare
      Pharmaceuticals Inc. in healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Moxifloxacin Tablets 400 mg
Intervention type(s): Drug
Intervention description(s): Moxifloxacin Tablets 400 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This open-label, balanced, randomized, two-treatment, four-period, two-sequence, single dose,
      crossover fully replicated study was conducted on fixed-dose combination of quinapril 20 mg
      and hydrochlorothiazide 25 mg tablets of OHM Laboratories Inc. (division of Ranbaxy
      Laboratories Limited) and Accuretic 20-25 mg tablets of Parke-Davis (division of Pfizer Inc.)
      in healthy, adult, human, male, subjects under fed conditions.
    

Detailed description: 
      The subjects received a single oral dose of either Test or Reference product, containing
      fixed-dose combination of Quinapril 20 mg and Hydrochlorothiazide 25 mg after an overnight
      fast of at least 10 hours. The study drug was administered as per the SAS generated
      Randomization Code, 30 minutes after serving of a high-fat high-calorie breakfast under
      supervision of a trained Medical Officer in each period.Blood samples were collected predose
      and at intervals over 72 hours after each dose. A 7-day interval was maintained between each
      dosing in the Study Periods I-IV.

      During the course of the study safety parameters assessed were vital signs, physical
      examination, medical history, clinical laboratory safety tests (hematology, biochemical
      parameters and urine analysis) at base line. Laboratory parameters of hematology and
      biochemistry were repeated and sodium & potassium levels were estimated at the 24 hours post
      dose of the last period of the study.

      A total of 40 subjects were randomized to receive fixed-dose combination of quinapril 20 mg
      and hydrochlorothiazide 25 mg tablets and 37 subjects completed all the four periods of the
      study.
    

Intervention name(s): fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide; Quinapril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence fixed-dose combination of quinapril 20 mg and hydrochlorothiazide 25 mg tablets
Evaluating the Effect of Laser Vision Surgery, Phakic Intraocular Lens Implantation, Cataract Surgery, and Pupil Dilation on the Iris Recognition Scanner Function of Smartphone
Condition: Cataract; Myopia; Myopic Astigmatism
MeSH terms: Cataract; Astigmatism
Study type: Interventional

Summary: 
      This study included patients who visit for refractive surgery (photorefractive keratectomy,
      photorefractive keratectomy with with corneal collagen cross linking, laser in situ
      keratomileusis, small incision lenticule extraction), phakic Intraocular Lens implantation
      (Implantable Collamer Lens, artiflex), and cataract surgery. Patients will be examined
      whether iris recognition scanner of smartphone works before and after surgery. In addition,
      before and after pupil dilation (5mm, 6mm, 7mm, 8mm), patients will be examined whether iris
      recognition scanner of smartphone works well.
    


Intervention name(s): iris recognition scanner
Intervention type(s): Device
Other intervention name(s): Galaxy Note 7 (Smartphone)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of
      Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis
      of this study is that montelukast is superior to placebo in the treatment of nasal symptoms
      in SAR.
    


Intervention name(s): Montelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days; Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
Other intervention name(s): montelukast sodium
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to learn the biodistribution of injection of
      BMS747158 at stress and assess the safety of two doses of BMS747158
    


Intervention name(s): BMS747158
Intervention type(s): Drug
Intervention description(s): 2 IV injection of ~11 mCi (total) F-18 labeled compound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Preoperative Oral Carbohydrate Administration in Thoracic Surgery Patients
Condition: Non Small Cell Lung Cancer; Fasting; Postoperative Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Preoperative carbohydrate loading has been shown to reduce pre-operative discomfort and
      postoperative nausea and vomiting. There is no need for prolonged preoperative fasting of the
      patients, but the traditional approach still continues especially in thoracic surgery
      patients. For this purpose, we aimed to evaluate the effect of preoperative carbohydrate
      loading on postoperative morbidity in the patients.
    

Detailed description: 
      The study was conducted on 94 patients. The patients in the control group were fasting after
      midnight. Experimental group patients consumed carbohydrate drink as liquid two hours before
      the operation. 47 patients were in the control group (A) and 47 patients were in the
      experimental group (B). The groups were compared in terms of length of hospital and intensive
      care unit stay, vomiting, gas-stool outlet, postoperative pain conditions (VAS), inflammation
      parameters, blood glucose, and mobilization time.

      SPSS 11.0 (SPSS, Inc., Chicago, IL, USA) was used for statistical analyses. All means were
      presented with 95% confidence limits. In the empirical analysis, t-test and chi-square test
      were used. In addition, correlation analysis was used to determine the relationship between
      fasting time and surgical recovery time.
    

Intervention name(s): Oral carbohydrate
Intervention type(s): Dietary Supplement
Intervention description(s): 100 ml oral carbohydrate two hours ago preoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preoperative fasting, postoperative morbidity, preoperative carbohydrate drinking, thoracic surgery
A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      A proof of concept study to evaluate the safety and effectiveness of FK778 in liver
      transplant patients.
    


Intervention name(s): FK778
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Malononitrilamide; Immunosuppression; treatment efficacy; treatment effectiveness
Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma
Condition: Bladder Cancer
MeSH terms: Carcinoma, Transitional Cell
Study type: Observational

Summary: 
      Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality
      from the disease. However, current urinary biomarkers have insufficient specificity to
      warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising
      noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from
      patients with BCa and controls to compare the glycosaminoglycan profiles between groups.
    


Intervention name(s): Free glycosaminoglycan profiling
Intervention type(s): Diagnostic Test
Intervention description(s): Free glycosaminoglycan profiling (GAGome) analysis was performed at a single blinded central laboratory using commercial kits wherein the concentration (in µg/mL) of 17 chondroitin sulfate (CS), heparan sulfate (HS), hyaluronic acid (HA) disaccharides were detected and quantified using a UHPLC-MS/MS system.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective case-control study to compare patients elected for transurethral resection of
        the bladder (TURB) for bladder cancer (BCa) [cases] versus patients with no evidence of
        disease (NED) during the follow-up of previously localised BCa [controls].
Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      It is known that dieting (restricted energy intake) without resistance training leads to a
      reduced metabolic rate, and the loss of both fat and muscle mass. When exercise is not
      included in a period of restricted energy intake, the degree to which muscle mass is lost is
      highly dependent upon protein consumption. Whey protein is a high quality protein isolated
      from milk and is known to stimulate new protein synthesis for all proteins in your body.
      Previous research has established that the consumption of whey protein has been correlated
      with retaining muscle mass while stimulating fat loss. However, the mechanisms behind these
      findings is still unknown. The purpose of this study is to establish a mechanistic
      underpinning to the efficacy of whey protein versus soy protein and a carbohydrate control
      (maltodextrin), in promoting fat mass loss and lean mass retention during a period of
      short-term controlled dietary energy deficit (-750 kcalories/day).
    


Intervention name(s): Weight loss; Soy; Whey
Intervention type(s): Behavioral; Dietary Supplement; Dietary Supplement
Intervention description(s): -750kcal/d; 2 x 25g/d SPC; 2 x 25g/d WPI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; overweight; muscle; protein; muscle protein synthesis; muscle protein breakdown; whey; soy; caloric restriction
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism
      that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled
      inflammatory response, however may lead to catabolism, tissue damage and organ failure.
      Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of
      the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells,
      they trigger intracellular signalling pathways that result in a less pro-inflammatory
      response. They modify gene and protein expression, modulate membrane protein activity and act
      as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by
      mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve
      erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and
      wound healing.

      The investigators hypothesize that the perioperative administration of intravenous omega-3
      fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby
      reducing the postoperative inflammatory response and improving erythrocyte function in
      patients undergoing colorectal surgery.
    


Intervention name(s): Omegaven; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 infusions, 2 ml/kg, one the night before operation and one the day after operation; 2 infusions, 2 ml/kg, one the night before operation and one the day after operation
Other intervention name(s): purified fish oil; omega-3 fatty acids; eicosapentaenoicacid (EPA); docosahexaenoicacid (DHA); dl-a- tocopherol (antioxidant); Omegaven-Fresenius; NaCl 0,9%; Natriumchloride 0,9%; glass container NaCl 0,9% Fresenius Kabi
Intervention MeSH terms: Tocopherols; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: fish oil; omega-3 fatty acids; postoperative inflammatory response; erythrocyte function
Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789
Condition: Alzheimer Disease; Healthy Subjects
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and
      tolerability in healthy subjects and subjects with Alzheimer's Disease
    


Intervention name(s): NSA-789; placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; schizophrenia
LVA on Serum Profiling in Patients With Lymphedema
Condition: Lymphedema
MeSH terms: Lymphedema
Study type: Observational

Summary: 
      The correlation between oxidative stress and increased lymphedematous limb volume lacks
      supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to
      investigate the link between oxidative stress, limb volume, and cellulitis after
      supermicrosurgical lymphaticovenous anastomosis (LVA).
    

Detailed description: 
      In this study, we focused on the changes in serum antioxidant biomarkers before and after
      LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based
      quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative
      Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented
      for precise lymphedematous limb volume measurements. Correlations were made between changes
      in oxidative stress, limb volume, and cellulitis before and after LVA.
    

Intervention name(s): pre-LVA; post-LVA
Intervention type(s): Other; Other
Intervention description(s): Venous serum samples were collected from patients before LVA.; Venous serum samples were collected from patients one-month after LVA.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Written informed consent was obtained from all patients. Between June 2018 and May 2019, 26
        patients with lower limb lymphedema confirmed with lymphoscintigraphy were recruited.
        Patients with upper limb and bilateral lower limb lymphedema were excluded.
Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions
Condition: Breast Disease
MeSH terms: Breast Diseases
Study type: Observational

Summary: 
      Objective: To explore the potential association between the multimodal ultrasound
      characteristics and pathological classification of BI-RADS category 4 breast lesions, so as
      to clarify the diagnostic characteristics of multimodal ultrasound in different pathological
      types BI-RADS category 4 breast lesions.

      Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong
      First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their
      general clinical features, information on preoperative ultrasound diagnosis, and
      postoperative pathologic data were reviewed.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who visited in The First Affiliated Hospital of Shandong First Medical University
        ＆ Shandong Provincial Qianfoshan Hospital were collected.