bioihbjkbjnl/mcl2 huggingface dataset:
Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are:

        -  To determine the mass balance recovery (expired air, urine and faeces) and route and
           rate of elimination of 14C-Debio 1450.

        -  To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and
           faeces.

        -  To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and
           Debio 1452 (active moiety) in plasma and urine.
    


Intervention name(s): [14C-pos 1]-Debio 1450 BES Solution; [14C-pos 25]-Debio 1450 BES Solution
Intervention type(s): Drug; Drug
Intervention description(s): A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1; A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability
National Lung Screening Trial (NLST) Screening
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan
      curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT)
      screening is more effective than chest radiography (CXR) screening in reducing death from
      lung cancer.

      PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR
      in screening individuals who are at high risk for developing lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare whether screening with low-dose helical CT scan vs chest x-ray reduces lung
           cancer-specific mortality in participants who are at high risk for developing lung
           cancer.

      OUTLINE:

      NLST participants were randomized to either low-dose helical CT or chest x-ray in equal
      proportions. A total of 53,454 participants were enrolled (26,722 in low-dose CT and 26,732
      in chest radiography) at 33 screening centers across the United States. Screening was offered
      three times (at baseline and two annual follow-up examinations). The primary endpoint of the
      study was lung cancer mortality. The study arms were compared with regard to overall
      mortality, lung cancer incidence, and screening-related complications.

      All low-dose scanners and chest x-ray machines were certified for use and met NLST protocol
      requirements and American College of Radiology guidelines. Low-dose CT acquisitions and chest
      radiographs were interpreted by trained radiologists. Participants and their health care
      provider were informed of study examination results. Participants with abnormalities
      suspicious for lung cancer were contacted for information regarding diagnostic evaluation.
      Medical records were collected on diagnostic evaluation, medical complications, and initial
      treatment.

      Participants were then contacted at least annually by mail or telephone.

      The National Lung Screening Trial (NLST) represents the union of two NCI-sponsored efforts,
      the NCI Lung Screening Study and the American College of Radiology Imaging Network (ACRIN).
    

Intervention name(s): low-dose helical computed tomography; chest radiography
Intervention type(s): Device; Device
Intervention description(s): A LDCT is a computerized tomography image with low-dose technique without contrast. The scan is done from the neck to the diaphragm in one breath-hold.; The chest x-ray in this study was a single posterior-anterior film done with the participant upright.
Other intervention name(s): LDCT; CXR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: small cell lung cancer; non-small cell lung cancer
Reducing Traffic Pollution Exposure Improves Blood Pressure
Condition: Air Pollution
Study type: Interventional

Summary: 
      This randomized trial assessed the effect of modifying building envelop and level of air
      filtration on blood pressure over two hour exposure sessions.
    

Detailed description: 
      Living close to major roadways is associated with elevated blood pressure (BP) amongst other
      adverse health effects. There is growing evidence that ultrafine particles (UFP, <100 nm in
      diameter), which are elevated near major roads and highways, contribute to such risks. We
      assessed the efficacy of high efficiency particulate arrestance (HEPA) filtration and
      building envelope adjustment at reducing exposure to and health effects of air pollution next
      to major highways.

      We used a randomized three-period crossover trial design to assign 77 participants (aged
      40-75 and without diagnosis of hypertension) to three two-hour exposure sessions. Sessions
      were conducted in one of two rooms immediately adjacent to highways. High, medium and low
      exposures were attained by varying the degree of air exchange and amount of HEPA filtration
      in the room. During high exposure sessions, the room was ventilated with outdoor air and no
      filtration was used. During low exposure sessions, leakage of outdoor air into the room was
      minimized and HEPA filtration was maximized. During medium exposure sessions, a moderate
      amount of HEPA filtration was used (less than half of that used in low sessions). Indoor
      particle number and black carbon (BC) concentrations (i.e., markers of traffic-related air
      pollution) were monitored continuously.

      During each session participants sat quietly and wore noise-cancelling headphones, while
      their BP was monitored every ten minutes using an ambulatory BP monitor. We monitored pulse
      and oxygen saturation continuously.
    

Intervention name(s): Air filtration and building envelop modifications
Intervention type(s): Other
Intervention description(s): Air filters and closing and sealing of windows and doors was used to reduce infiltration of air pollution from outdoors in rooms next to major highways at rush hour.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross over trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: Traffic-related air pollution; Air filtration; Blood pressure; Controlled exposure
Hypnoanalgesia for Dermatological Surgery in Children
Condition: Anesthesia
Study type: Interventional

Summary: 
      This randomized clinical trial will evaluate the effect of hypnosedation on the need of
      sedation and analgesia in a pediatric population undergoing dermatological surgery, both
      during the procedure, and 24 hours after surgery. In addition, a secondary objetive is to
      evaluate the effect by specific age groups.
    

Detailed description: 
      In this clinical trial, pediatric patients scheduled for removal of benign skin lesions in a
      single center willbe randomised to receive hypnosis (intervention group) or
      attention-distracting techniques (control group). Endpoints will be the sedative dose
      (propofol) during surgery, and the need for analgesia (paracetamol and others) immediately
      after surgery (recovery) and after 24 hours. Randomization will be systematic in blocks
      depending on the day the surgery is programmed. Hypnosis will be delivered by an experienced
      anesthesist trained in the technique. Patients and families will be informed of the special
      treatment during surgery, but will be unaware of whether the patients are experiencing
      distraction or hypnosis techniques. Distraction is already a useful technique, and it is
      expected that patients will be satisfied with the procedure; however, the hypothesis to be
      tested is that hypnosis reduces the need for sedation and analgesia compared to distraction
      techniques, as well as improves satisfaction.
    

Intervention name(s): Hypnosis; Attention-distracting techniques
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Rapid conversational hypnosis; i-pad with movies, games and music
Other intervention name(s): Hypnoanalgesia; Hypnosedation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomly distributed to one of the following groups:
Intervention group: Technique of rapid conversational hypnosis, with focus on therapeutic suggestion (guiding the patient into a hypnotic trance), adapted to child's cognitive development. Induction with hypnotic suggestion focuses and accompanies the child's body sensations and allows their active participation. After standard sedation, therapeutic suggestion is maintained throughout the surgery and in the post-hypnotic period before awakening.
Control group: High-tech distraction technique (Apple®), passive and chosen by the child, either an animated video or his or her favourite music. After standard intravenous sedation, the child is taken to the operating theatre to watch his or her favourite video or music and this is maintained throughout the procedure.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: analgesia; anxiety; pain; paediatric surgery; dermatology; Hypnosis; Nervous System Diseases Central; Hypnotics and Sedatives; Nervous System Depressants; Physiological Effects of Drugs
Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Condition: Recurrent Respiratory Papillomatosis; Extra Oesophageal Reflux; Laryngeal Cyst
MeSH terms: Respiratory Tract Infections; Papillomavirus Infections; Papilloma; Gastroesophageal Reflux; Recurrence
Study type: Interventional

Summary: 
      The purpose of the study was to determine, whether patients with recurrent respiratory
      papillomatosis (RRP) suffer from extra oesophageal reflux more often than patients with
      laryngeal cyst (control group).
    

Detailed description: 
      Recurrent respiratory papillomatosis (RRP) is a chronic viral disease, which affects children
      and adults as well. It is characterised by grow of squamous cell tumours on mucosa of
      aerodigestive tract, with predilection for the larynx. The disease is caused by the human
      papillomavirus (HPV). However, in contrast to the low incidence of RRP, HPV prevalence is
      common. It is indicated that other factors may contribute to the pathogenesis of RRP. One
      such factor might be extraesophageal reflux (EER). We investigated whether patients with RRP
      suffer more often from EER.
    

Intervention name(s): Surgical collection of histology specimen; Performance of immunohistochemical analysis
Intervention type(s): Procedure; Procedure
Intervention description(s): Collection of a histology specimen from the vocal cords and rear laryngeal commissure; Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent respiratory papillomatosis; extra oesophageal reflux; laryngeal cyst; phonosurgery; oesophageal impedance
Restore Myocardial Function With CorMatrix® ECM® Particulate (P-ECM)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this CorMatrix P-ECM safety and feasibility study is to evaluate the safety
      and functional effect of the CorMatrix P-ECM.
    

Detailed description: 
      Evaluate the safety of the CorMatrix ECM Particulate (P-ECM) delivered trans-epicardially to
      subjects with left ventricular ejection fraction (LVEF) 25 to 40% during coronary artery
      bypass grafting (CABG)
    

Intervention name(s): P-ECM Implant
Intervention type(s): Device
Intervention description(s): P-ECM Implant into damaged ischemic and/or infarcted myocardium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to compare the bronchodilator efficacy of three doses
      (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and
      tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives
      include comparing the effects on dyspnea and health status.
    


Intervention name(s): BEA 2180 BR; Tiotropium Bromide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution; Solution; Solution
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Histological Change of The Dentinal-Pulp Complex and Root Resorption
Condition: Laser; Intrusion; Histology; Resorption
MeSH terms: Root Resorption
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is evaluate the histological changes of the dentinal-pulp complex
      and root resorption in maxillary premolars with intrusive orthodontic movement under a low
      power laser effects.
    

Detailed description: 
      Orthodontics movements can cause inflamatory changes in the pulp and external inflamatory
      root resorption, different methods have been suggested to control that changes as the use of
      the low power laser. The objective of this study is to evaluate the low power laser effect on
      the inflamatory pulpar change and inflamatory external root resorption in maxillary premolars
      with intrusive orthodontic movements of 4 ounces during 12 weeks. Total sample were 34
      healthy teeth, 16 were used to evaluate the normal standar and 18 were divided in two groups,
      the experimental group with the low power laser effect had a dose of 18 joules after
      activations of the orthodontic intrusion and the control group had a simulated effect in the
      same orthodontic movement. Teeth were extacted after 12 weeks and histological changes were
      evaluated in the dentinal-pulp complex and the pesence of external inflamatory root
      resorption. Findins suggest that low power. Laser decreased the inflamatory changes of the
      dentinal - pulp complex and the severity of the external inflamatory root resorption.
    

Intervention name(s): Low power laser in teeth after intrusive movement; Simulated laser in teeth with intrusive movements
Intervention type(s): Radiation; Other
Intervention description(s): Low power laser was aplied to premolar teeth under an intrusive movement to study histological changes and root resorption; Simulated laser in teeth with intrusive movements for histological and root resorption changes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: root resorption; low-power laser; orthodontic tooth movement; pulp changes
Preeclamptic Patients and Pentraxin 3 & Lipoprotein-associated Phospholipase A2
Condition: Pre-Eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Observational

Summary: 
      In particular, pentraxine 3 (PTX3) molecule was assumed to have a prognostic value in acute
      myocardial infarction.In patients affected by acute myocardial infarction, early plasma
      elevation of PTX3 appears to predict a worse outcome in these patients in the longer term.

      The inflammatory basis of preeclampsia resembles an atherogenic process.It is planned to
      investigate the role of these two molecules in endothelial dysfunction typical of
      preeclampsia.

      The level of circulating PTX3 and Lp-PLA2 in preeclamptic patients and their serum levels
      according to the severity of preeclampsia and presence of IUGR, and comparison with the
      control group without preeclampsia and It is planned to investigate the cut-off values and
      sensitivity and specificity of both molecules together and separately in preeclampsia.
    


Intervention name(s): Pentraxin 3 ; new biomarker; Lipoprotein-associated phospholipase A2 ; new biomarker
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Pentraxin (PTX3) is an inflammatory molecule that belongs to a recently identified, well-known C-reactive protein (CRP) family.
PTX3 plasma levels increase in vascular disorders including myocardial infarction and correlate with small vessel vasculitis and outcome or disease activity.
These biological and clinical features of PTX3 have led us to investigate this molecule in preeclampsia, a syndrome characterized by a prominent vascular component.; Lp-PLA2 is a recently described and potentially useful plasma biomarker associated with cardiovascular diseases. Because of this effect, we will investigate that preeclampsia also be beneficial.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        blood from 40 healthy pregnant women, 40 preeclamptic pregnant women; Serums will be stored
        at -80 degrees. Then, serum Pentraxin 3 and Lp-PLA2 levels will be examined in these blood
        by ELISA method.
      
Keywords: Pentraxin 3; Lipoprotein-associated phospholipase A2; preeclampsia; risk markers
Nicotine Differences in Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this project is to determine the threshold dose of nicotine, which the
      smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine
      infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco
      cigarette or electronic cigarette), allowing precise and reproducible nicotine delivery. Four
      nicotine doses (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) which are within the range of
      nicotine doses that are delivered by cigarettes with very low to regular nicotine content.
      These doses will be delivered as a cluster of 4 pulsed-nicotine infusions of 2 sec duration
      with a 28 sec interval between each dose.
    

Detailed description: 
      Twenty participants will have 2 Experimental Session on 2 separate days. Experimental Session
      1 will determine if smokers can reliably discriminate 0.1mg nicotine/pulse nicotine from
      saline. Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and
      0.0125 mg nicotine/pulse of nicotine from saline.

      Hypothesis: The threshold for discrimination will be 0.05 mg nicotine/pulse and the doses
      below that (0.025, and 0.0125 mg nicotine/pulse) will be subthreshold.

      Exploratory Aim: To explore the relationship between the threshold for subjective drug
      effects and drug discrimination.
    

Intervention name(s): 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.; Saline will be use to determine if smokers can discriminate from the nicotine/pulse of nicotine and saline
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Twenty participants will have 2 Experimental Session on 2 separate days. Experimental Session 1 will determine if smokers can reliably discriminate 0.1mg nicotine/pulse nicotine from saline. Experimental Session 2 will determine if smokers can discriminate 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine from saline.
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Effects of Continuous Veno-venous Haemofiltration on Plasma Lactate in Critically Ill Patients
Condition: Kidney Injury, Acute
MeSH terms: Acute Kidney Injury
Study type: Observational [Patient Registry]

Summary: 
      Continuous Veno-Venous Hemofiltration (CVVH) can eliminate metabolic products effectively and
      replace renal function partly. It is widely used in intensive care units (ICUs), especially
      for patients with acute kidney injury/failure in an unstable hemodynamic status. Lactate is a
      molecule smaller than glucose, which can pass through filtration membrane freely in CVVH.
      Therefore, the blood lactate concentrations would no longer reflect tissue oxygenation status
      in patients with unstable hemodynamic status. However, there is no prospective study
      evaluated the effect of CVVH on lactate removal in critically ill patients. The influence of
      different dose of CVVH on lactate elimination is not clear in patients with different level
      of serum lactate. Our study aimed to find out how the dose of CVVH effects on lactate
      clearance, and then re-estimate the prognostic value of lactate in critically ill patients
      with CVVH.
    


Intervention name(s): Plasma lactate were measured
Intervention type(s): Other
Intervention description(s): Three different doses (20 ml/kg/h, 35 ml/kg/h and 45 ml/kg/h) of CVVH were applied to critically ill patients who experiencing CVVH. Each dose of CVVH was sequentially gave to each patient and lasted for 30 minutes separately
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was carried out in Surgical Intensive Care Unit (SICU) of the first affiliated
        hospital, Sun Yat-sen University.The project has been approved by Ethics Committee of Sun
        Yat-sen University. All the subjects have signed written informed consent.
      
Keywords: Continuous veno-venoous haemofiltration; Plasma lactate; Critical illness; Acute kidney injurytissue perfusion; Multiple organ dysfunction syndrome