bioihbjkbjnl/mcl2 huggingface dataset:
Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is changing (improving), after initiating various doses of
      Paliperidone ER on schizophrenia patients.
    

Detailed description: 
      In this study, investigators are going to examine the effectiveness of Paliperidone ER on
      depressive symptoms toward schizophrenia patients who are previously unresponsive to other
      oral antipsychotics. In addition, the relationship between the change of depressive symptoms
      and adherence will be studied. Even though this study has a limitation of being designed as
      an open-labelled clinical study, it would be useful for clinicians because this study
      examines the influences toward adherence related to various factors and the changes of
      depressive symptoms related to switching to Paliperidone ER, which is well-proven medication.
    

Intervention name(s): paliperidone
Intervention type(s): Drug
Intervention description(s): paliperidone augmenting on ongoing medication
Other intervention name(s): Invega®
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia, depressive symptom, paliperidone
Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd
      for acute ischemic stroke.
    

Detailed description: 
      A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to
      examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke.
      Stroke patients were randomized equally to receive a 14-day infusion of placebo or
      ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points
      were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin
      scale at 15 days and 90 days. The safety end points included serious and nonserious adverse
      events, laboratory values and vital signs. Analysis was by intention to treat.
    

Intervention name(s): ginsenoside-Rd; placebo
Intervention type(s): Drug; Drug
Intervention description(s): infusion ginsenoside-Rd 20 mg once a day and continued for 14 day; infusion placebo once a day and continued for 14 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: randomized trial; ischemic stroke; Ginsenoside-Rd
A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients
Condition: Parkinsonian Syndrome; Parkinson Disease(PD); Multiple System Atrophy (MSA); Progressive Supranuclear Palsy (PSP); Essential Tremor
MeSH terms: Parkinson Disease; Tremor; Essential Tremor; Multiple System Atrophy; Shy-Drager Syndrome; Supranuclear Palsy, Progressive; Parkinsonian Disorders; Syndrome; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label, non-controlled, non-randomized, phase 3 clinical study to
      compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I)
      injection for patients with a clinical diagnosis of Parkinsonian syndrome (PS) involving
      striatal dopaminergic deficit (SDD; specifically, Parkinson's disease [PD] [SDD], multiple
      system atrophy [MSA] [SDD] or or progressive supranuclear palsy [PSP] [SDD]) as compared with
      patients with a clinical diagnosis of essential tremor (ET) (no SDD) and age-matched healthy
      controls.
    


Intervention name(s): DaTSCAN™ Ioflupane (123I) Injection
Intervention type(s): Drug
Intervention description(s): All participants (Participants with PS, ET, and HV) received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 megabecquerel (MBq) (3 to 5 millicurie [mCi]) per participant at a maximum volume of 5 milliliter [mL]) intravenously on Day 1.
Other intervention name(s): Ioflupane (123I)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
Condition: Overweight; Obesity; Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of intragastric balloon on bone,
      metabolic and respiratory parameters in 50 patients with metabolic syndrome.
    


Intervention name(s): Silimed Intragastric balloon
Intervention type(s): Device
Intervention description(s): Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Computer Assisted Vasopressor Titration in Critically Ill Patients
Condition: Closed-Loop Communication
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      The purpose of this pilot study is to evaluate the performance of a novel closed-loop
      (automated) vasopressor administration system that delivers norepinephrine using feedback
      from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac Edwards
      Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.
    

Detailed description: 
      The investigators have developed an automated closed-loop system for vasopressor
      administration . They will test it in critically ill patients. The investigators want to
      demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a
      very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the
      treatment time.

      The Investigators have shown this to be the case in simulation studies and in-vivo animal
      studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators
      will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring
      and under continuous norepinephrine infusion.

      These patients will typically include: septic patients, neuro ICU patients, ARDS patients,
      trauma patients or postoperative patients.

      The target MAP will be determined by the ICU physician in charge of the patient.

      Fluids will be given standard of care. The closed loop (automated) system will use an
      infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm
      developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor
      (norepinephrine)

      The goal is to register a period of two hours of closed-loop control of MAP.
    

Intervention name(s): closed-loop system for vasopressor administration
Intervention type(s): Device
Intervention description(s): The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.
Intervention MeSH terms: Vasoconstrictor Agents
Intervention model: Single Group Assignment
Intervention model description: SINGLE GROUP ASSIGNMENT
Masking: None (Open Label)
Primary purpose: Device Feasibility
EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING: A RETROSPECTIVE COHORT STUDY
Condition: Autism Spectrum Disorder; Premedication; Brain Neoplasms; Brain Pathology; Growth Retardation
MeSH terms: Brain Neoplasms; Emergence Delirium; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The aim of this study was to assess the anxiolytic and sedative effect of OZALIN® / OZASED®
      (ADV6209) 0,25mg/Kg in children undergoing magnetic resonance imaging (MRI) under
      inhalational anesthesia. Our hypothesis is that compared to children who do not receive any
      premedication, palatability of OZALIN® / OZASED® by allowing an easier acceptance of the
      drug, improves the quality of anesthesia induction and postoperative behavioral outcome
      improving sedation and reducing the need for inhalation anesthetic which has been recognized
      as the main cause of post-procedural behavioral changes, including emergence agitation.
    

Detailed description: 
      Magnetic resonance imaging is considered the primary investigative tool for evaluating a wide
      range of paediatric medical conditions. Sedatives are often needed in this population to
      ensure immobilization during the acquisition of the images.

      Midazolam has always been the most used anxiolytic-sedative drug in the pediatric population.
      Over time, the intravenous formulation of midazolam has been used also for oral, nasal or
      rectal administration but those alternative routes of administration represent an off-label
      use. Recently, in Europe was licensed ADV6209, a midazolam solution for oral use containing
      gamma-cyclodextrin (OZALIN® / OZASED®).

      The aim of this study was to assess its anxiolytic and sedative effect at a dosage of
      0,25mg/Kg in children undergoing magnetic resonance imaging (MRI) under inhalational
      anesthesia. Our hypothesis is that compared to children who do not receive any premedication,
      palatability of OZALIN® / OZASED® by allowing an easier acceptance of the drug, improves the
      quality of anesthesia induction and postoperative behavioral outcome improving sedation and
      reducing the need for inhalation anesthetic which has been recognized as the main cause of
      post-procedural behavioral changes, including emergence agitation.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        the IRCCS Agostino Gemelli Foundation of Catholic University of Rome
Internet-delivered Attention Training for Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The goal of this study is to investigate an attention training program for participants with
      Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task
      with picture stimuli related to washing and checking paired with neutral pictures.

      Participants are randomly assigned to an experimental and a placebo-control group. After a
      minimum of 4 weeks of attention training we expect to find differences between participants
      of the experimental and the control group in terms of attention bias, OCD symptoms, anxiety
      and depression.
    


Intervention name(s): Attention Training Program
Intervention type(s): Behavioral
Other intervention name(s): ATP; Attention Bias Modification Treatment; ABMT; Bias Modification; Attentional Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; Attention Training; Attention Bias Modification; Dot-Probe Task; Randomized Controlled Trial; Online Treatment; Washing; Checking
Assessment of Fluid Responsiveness in Patients After Cardiac Surgery
Condition: Hemodynamics; Patient Monitoring
Study type: Observational

Summary: 
      To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume
      and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg
      Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.

      Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the
      transition from controlled to spontaneous breathing in cardiac surgery patients
    

Detailed description: 
      In patients after elective off-pump CABG are enrolled hemodynamic measurements are performed
      in the postoperative period upon arrival in the ICU using a PiCCO2 system (Pulsion Medical
      Systems, Munich, Germany).

      Controlled fluid challenges (500 ml) are done at 3 time-points:

      A) during controlled mechanical ventilation B) during pressure support ventilation with
      spontaneous breathing and C) after extubation.

      Stroke volume (SV), SVV and PPV as well as standard hemodynamic parameters (MAP = mean
      arterial pressure, HR = heart rate) are assessed.

      A PLR is performed before fluid administration at all 3 time points. A positive response is
      defined as an increase in SV>15 %.

      Prediction of fluid responsiveness will be tested by AUC (area under the receiver operating
      characteristic - ROC - curve).
    

Intervention name(s): Passive leg raising test and fluid challenge
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective off-pump CABG
      
Keywords: functional hemodynamic parameter; passive leg raising; stroke volume variation; pulse pressure variation
Pharmacological Study on Absorption of WE 941 OD Tablets in Japanese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation whether Brotizolam is absorbed through the mucous membrane of oral cavity when WE
      941 OD tablets are administered in Japanese healthy male volunteers.
    


Intervention name(s): WE 941 OD tablets
Intervention type(s): Drug
Intervention MeSH terms: Brotizolam
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of FS VH S/D 4 S-apr for Flap Adherence in Rhytidectomy
Condition: Face-lift; Facial Rhytidectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the safety and efficacy of FS VH S/D 4 s-apr versus
      standard of care in adhering tissue and improving wound healing in subjects undergoing
      facelift.
    


Intervention name(s): FS VH S/D 4 s-apr
Intervention type(s): Biological
Intervention description(s): FS VH S/D 4 s-apr will be applied (using spray device provided by Sponsor) to the subcutaneous plane (intraoperative, topical administration) in both the neck and the face area.
Other intervention name(s): ARTISS
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effects of Varenicline on Cognitive Function in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this project is to examine the effects of varenicline treatment used
      concomitantly with antipsychotic medications, on cognitive dysfunction in people with
      schizophrenia. The secondary objective is to evaluate the effect of this combination therapy
      on smoking in people with schizophrenia. This study will be a randomized, double blind,
      parallel group, placebo controlled 8 weeks trial.
    

Detailed description: 
      Cognitive deficits have been considered as a core symptom domain of schizophrenia.
      Amelioration of or improvement in cognitive impairments is becoming an important focus of
      clinical treatment development. Varenicline is a potent and selective alpha 4 beta 2
      nicotinic acetylcholine receptor partial agonist that has been developed for smoking
      cessation. In animal studies, alpha 4 beta 2 receptor agonists significantly improve working
      memory and attention function. Subjects will be assigned in 1:1 ratio to receive varenicline
      or placebo respectively. Assessments will be done using several neuropsychologic tests,
      clinical rating scale including assessment of nicotine withdrawal scales.Varenicline has been
      found to be efficacious for smoking cessation in the general population and animal studies
      have demonstrated the cognitive benefits of this agent. However, no published work is
      available evaluating the cognitive effects in humans. Thus, patients may experience
      improvements in cognitive function and in people who are smokers, these people may be able to
      achieve abstinence in smoking. This will in turn improve long-term functional outcomes and
      health outcomes in people with schizophrenia. This is an exciting opportunity for discovery
      if indeed cognitive abilities could be improved with this adjunctive treatment.
    

Intervention name(s): Varenicline(Chantix); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dose of antipsychotic drug will remain fixed throughout the study and the titration of varenicline will be as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice per day for days 4 to 7, then 1 mg twice per day through week 8.; The dose of antipsychotic and concomitant medications remained fixed throughout the study and the titration of varenicline was as follows: Placebo will be supplied twice daily through week 8.
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; Varenicline
Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine whether 2 different dosages of a herbal extract
      (240 and 480 mg/day) are more effective than placebo in the treatment of patients with
      chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5
      and Visit 6.
    

Detailed description: 
      The clinical trial population consists of patients presenting with two or more typical
      symptoms of CRS and duration of symptoms of at least ≥12 weeks. The diagnosis should have
      been confirmed with the initial diagnosis of CRS by nasal endoscopy and/or computer
      tomography (CT) and by obligatory nasal endoscopy including exclusion of nasal polyps during
      screening phase.

      A total of 885 patients will be included in this clinical trial, which will last for
      approximately 12 months, including screening, treatment and medication-free follow-up period
      as well as final reporting. The duration for the individual patient is approximately 22 weeks
      (Visit 1 - Visit 7). After a 2-week screening phase, treatment will be started by application
      of either 240 mg or 480 mg daily dose (t.i.d.) or placebo for 12 weeks followed by a
      medication-free follow-up period.

      Symptoms often do not correlate to the findings in nasal endoscopy or CT. Therefore, efficacy
      in this clinical trial is defined as per clinical definition using five individual
      rhinosinusitis symptoms (MSS)graded by the investigator using increasing severity grading(0 =
      absent [none / not present], 1 = mild, 2 = moderate, 3 = severe).

      Secondary outcome measures include

        -  single rhinosinusitis symptoms of CRS (MSSINV and MSSPAT),

        -  Work Productivity and Activity Impairment patient questionnaire related to General
           Health [WPAI:GH],

        -  total symptom severity by Visual Analogue Scale

        -  response to treatment rated by investigator and patient

        -  20-Question Sino-Nasal Outcome Test [SNOT-20, only Germany]

        -  percentage of patients with permitted concomitant medication for the treatment of CRS

        -  premature termination due to exacerbations of symptoms

        -  post treatment course of CRS will

        -  pharmacoeconomic assessments

        -  safety and tolerability of trial treatment
    

Intervention name(s): BNO 1016
Intervention type(s): Drug
Intervention description(s): comparison of different dosages of drug and placebo
Other intervention name(s): herbal plant extract,; sinupret extract mite
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: randomized clinical trial; chronic rhinosinusitis; herbal extract BNO 1016; exacerbation; pharmacoeconomic; quality of life
Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the image quality and clinical feasibility of
      double low-dose liver computed tomography using a deep-learning-based iodine contrast
      boosting algorithm in participants at high risk for hepatocellular carcinoma.
    

Detailed description: 
      The purpose of this study is to investigate the image quality (CNR, subjective inage quality,
      vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double
      low-dose liver computed tomography using a deep-learning-based iodine contrast boosting
      algorithm in participants at high risk for hepatocellular carcinoma.
    

Intervention name(s): Low radiation dose CT; Conventional CT (radiation); Low contrast dose CT; Conventional CT (contrast agent); Deep-learning based contrast boosting algorithms
Intervention type(s): Radiation; Radiation; Drug; Drug; Other
Intervention description(s): Underwent liver CT with 30% lower radiation dose; Underwent liver CT without change of radiation.; Underwent liver CT 20% lower dose contrast media.; Underwent liver CT without change of contrast media doses.; Applied deep-learning based contrast boosting algorithms on acquired CT images
Other intervention name(s): Low contrast medium dosage; Standard contrast medium dosage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Keywords: CT