bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Condition: Cerebrolysin
Study type: Interventional
Phase: Phase 4

Summary: 
      This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized,
      double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute
      stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the
      efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio
      of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of
      FMA at baseline) in patients with subacute stroke.
    


Intervention name(s): porcine brain peptide (Cerebrolysin); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Local Effects of Epinephrine on Lactate, Glucose, Lipid and Protein Metabolism in Bilaterally Perfused Human Legs
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to define the local metabolic effects of epinephrine in the
      bilaterally perfused human leg.
    


Intervention name(s): Epinephrine
Intervention type(s): Drug
Intervention description(s): unilateral leg infusion of Epinephrine 0.4 micrograms/m2/min
Other intervention name(s): Adrenaline
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Phenylalanine; Palmitate; hyperinsulinemic-euglycemic-clamp; Effects of epinephrine in healthy volunteers
Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study
Condition: Acute Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B
      single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of
      death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months
      follow up, and other important stroke outcomes
    

Detailed description: 
      We conducted the prospective study to compare the low-dose and standard-dose rtPa and
      identify the important factors predicted stroke outcomes in acute stroke patient received
      intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to
      received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim
      analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose
      rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS)
      by final score 0-1 or improvement > 4 points at discharge or 3 months follow up, absent of
      intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short
      hospital length of stay.
    

Intervention name(s): Intravenous Solution Ateplase
Intervention type(s): Drug
Intervention description(s): Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort A double blind Randomized controlled trial 0.6 or 0.7 or 0.9 mg/Kg Ateplase in78 patients (preliminary) Cohort B single arm standard dose 0.9 mg/kg Ateplase in 330 patients
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ateplase; Intravenous recombinant tissue plasminogen activator; Acute is hemic stroke; Low-dose Ateplase; rtPa; Modified Rankin 's Scale
Methylated DNA Detect in Paraneoplastic Syndrome of Nervous System
Condition: Paraneoplastic Neurological Syndrome
MeSH terms: Paraneoplastic Syndromes; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to verify whether the cell-free DNA of lung cancer in the blood
      can be used as a biomarker for early diagnosis and prognosis evaluation of patient with
      paraneoplastic syndrome of the nervous system.
    

Detailed description: 
      Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central
      nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant
      influence of the tumor. No tumor cells are visible in the neuropathy. The disease is a rare
      clinical syndrome, and lung cancer is the most common type of tumor that causes PNS.If PNS
      can be diagnosed when there are no tumor symptoms, not only can the cause of PNS be
      identified, but early tumors can be found for treatment time, and measures can be taken in
      the early stages of the tumor to improve survival. Tumor free DNA (cell-free DNA, cfDNA)
      methylation detection is to determine the cancer condition and cancer type of the subject by
      detecting the methylation of free DNA released by tumor cells. In normal cells, tumor
      suppressor genes are expressed and proto-oncogenes are silenced; in tumor cells, tumor
      suppressor genes are hypermethylated and silenced, and oncogenes are hypomethylated and
      activated. The release of free DNA into the blood will be quickly cleared in tens of minutes
      to several hours, which can reflect the body's cell damage in real time, and is of great
      significance for monitoring the early occurrence and development of the disease. At present,
      the sensitivity of lung cancer cf-DNA detection technology is close to 100%, and the
      specificity is 94%, which is an effective detection technology for early detection of lung
      cancer.
    

Intervention name(s): Lung cancer; Suspected lung cancer; Positive methylated DNA
Intervention type(s): Other; Other; Other
Intervention description(s): Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.; Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.; Tumor-free DNA (cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We recruited consecutive patients with paraneoplastic syndrome.
      
Biospecimen description: 
      plasma
    
Keywords: Paraneoplastic neurological syndrome; Cell-free DNA
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The Study objective is to assess the performance of the Vessix V2 Renal Denervation System
      for the treatment of uncontrolled hypertension using an innovative percutaneous Radio
      Frequency (RF) balloon catheter renal denervation device.
    

Detailed description: 
      This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be
      employed to reduce systolic and diastolic blood pressure at 6 months as compared to
      pre-treatment baseline blood pressures.

      Patient blood pressure will be measured by in the office according to recognized
      international techniques and standards.

      Procedural success shall be defined as ability to complete the renal denervation treatment
      using the V2 balloon catheter device and RF generator.
    

Intervention name(s): Renal Denervation
Intervention type(s): Device
Intervention description(s): percutaneous renal denervation using the Vessix RF balloon catheter
Other intervention name(s): Vessix V2 Renal Denervation System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension, renal denervation, uncontrolled hypertension, medication resistant hypertension
Epi Stim to Facilitate Standing and Stepping
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The overall aim is to assess whether task specific locomotor training and spinal cord
      electrical stimulation (SCES) can induce neural reorganization of the functionally isolated
      human spinal cord to improve standing and stepping in individuals with functionally complete
      SCI. The investigators propose that locomotor training will result in generation of more
      effective standing and stepping efferent patterns by restoring phase dependent modulation of
      reflexes and reciprocal inhibition, reducing clonus and mediating interlimb coordination. The
      investigators propose that the SCES will optimize the physiological state of the spinal cord
      interneuronal circuitry compromised by compensating for loss of supraspinal input for the
      retraining of these tasks.
    

Detailed description: 
      Participants will be screened for eligibility and then participate in pre-training motor,
      bladder and cardiovascular experiments, followed by 80 sessions of locomotor training.
      Participants will repeat experiments after the 80 training sessions to quantify that no motor
      pattern changes are achievable with locomotor training alone and will be evaluated for
      appropriate candidacy for surgery and epidural stimulation. Participants will be surgically
      implanted with an epidural stimulator and experiments will be conducted with and without
      stimulation. Investigators will identify appropriate stimulation parameters for inducing
      stepping and standing in combination with manual assistance using body weight support on a
      treadmill and/or overground. Participants will undergo 80-200 training sessions of locomotor
      training with epidural stimulation. Experiments will be repeated mid and post-training
      interventions.
    

Intervention name(s): Standing and Stepping with spinal cord Epidural Stimulation
Intervention type(s): Device
Intervention description(s): Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
Other intervention name(s): Stand-scES; Step-scES; Locomotor Training (LT)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Epidural Stimulation
Serology After BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine
Condition: Basic BBIBP-CorV Vaccination is Not as Effective as BNT162b
Study type: Observational

Summary: 
      In this prospective study, SARS-CoV-2 spike protein specific total immunoglobulin (Ig) levels
      are analyzed before and after BNT162b2 third mRNA booster vaccination in individuals
      previously administered with two doses of BBIBP-CorV vaccine in comparison to immunized
      participants with three doses of BNT162b2 vaccination. Questionnaires from recruited
      participants are reviewed prior to booster vaccination for the occurrence of a previous
      SARS-CoV-2 infection and hospitalization.
    

Detailed description: 
      Sixty-one volunteers (39 females, 22 males) vaccinated by BBIBP-CorV were included with the
      mean age of 63.9 years. To serve as a control group, 61 patients (41 females, 20 males) were
      vaccinated with BNT162b2 at a mean age of 59.9 years. At least four months after the first
      two-dose vaccination regimens, both groups received the third booster BNT162b2 vaccine based
      on the recommendations of the Hungarian Public Health Centre. Total Ig levels against
      SARS-CoV-2 spike protein 1 receptor-binding domain (anti-SARS-CoV-2 S1-RBD) were measured by
      an immunoassay (Roche Diagnostics) and their calculated ratios after/before booster dose were
      compared between the two groups. Vaccination efficacy via incidence of infection and
      hospitalization was monitored during study period. We found that BNT162b2 can successfully
      booster the effect of two-dose BBIBP-CorV vaccination to enhance humoral immune response
      against SARS-CoV-2 infection.
    

Intervention name(s): BBIBP-CorV and/or BNT162b2 vaccine
Intervention type(s): Biological
Intervention description(s): Booster immunization was carried out at least 4 months after the first two doses of basic immunization.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        As part of the regular clinical practice, all participants received the third vaccine dose
        at a general practitioner's (GP) office. Following the initial immunization period, a
        survey was conducted to monitor vaccine efficacy via the incidence of infection and
        hospitalization by patient questionnaire. Booster immunization was carried out at least 4
        months after the first two doses of basic immunization (two doses of BNT162b2 or
        BBIBP-CorV), and baseline (pre-booster) antibody level was measured on the same day of the
        administration of booster immunization (first sampling). Following the booster dose with
        BNT162b2, another serum sample was collected after 30 days in order to determine induced
        total level of anti-SARS-CoV-2 spike protein antibodies (second sampling).
      
Biospecimen description: 
      Serum samples were stored prior to laboratory analysis by an immunoassay to measure the level
      of anti-SARS-CoV-2 total Ig.
Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single-center study of XNW4107 and imipenem/cilastatin
      administered intravenously.
    


Intervention name(s): XNW4107, Imipenem/Cilastatin
Intervention type(s): Drug
Intervention description(s): Five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin
Intervention MeSH terms: Imipenem; Cilastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in
      Patients with Major Depressive Disorder (MDD)
    


Intervention name(s): Radafaxine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major Depressive Disorder (MDD),; Flexible; GW353162,
Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients
Condition: High Caries Risk Patients; Caries; Antimicrobial Effect; Side Effect
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial is to test the caries prevention effect of Arabic gum and Licorice root extracts
      compared to Chlorhexidine in high caries risk patients. The antimicrobial efficacy and oral
      side effects from using these mouthwashes will also be tested.
    

Detailed description: 
      To evaluate the effect of Arabic gum (Acacia gum) and Licorice (Glycyrrhiza Glabra)
      mouthwashes in comparison to Chlorhexidine mouthwash on reducing caries incidence
      (development of new caries lesions), antimicrobial efficacy and the prevalence of oral side
      effects (adverse events) in high caries risk patients.

      P: Population with high caries risk patients I1: Arabic Gum mouthwash I2: Licorice mouthwash
      C: Chlorhexidine mouthwash O1: (Primary outcome) incidence of new caries lesions O2:
      (secondary outcome) antimicrobial efficacy O3: oral side effects (adverse events) from
      mouthwash use
    

Intervention name(s): Arabic, Gum; Licorice Root; Chlorhexidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): natural gum of acacia tree: Antimicrobial, anti-inflammatory medicinal plant used as a traditional oral hygiene substance (anticariogenic). It is used in treating sore throats, colds, bronchitis, toothache, gingival bleeding and mouth ulcers.; natural licorice, herbal plant to relieve coughs, sore throats, and gastric inflammation. flavouring and sweetening agent. it's anti-caries, soothing anti-inflammatory and anticancer properties benefit against oral diseases and dental caries; chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
Other intervention name(s): acacia gum; Glycyrrhiza Glabra; Chlorhexidine gluconate or Chlorhexidine HCL
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Adrenomedullin for CADASIL
Condition: Cadasil
MeSH terms: CADASIL; Dementia, Multi-Infarct
Study type: Interventional
Phase: Phase 2

Summary: 
      Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy
      (CADASIL) is the most common form of hereditary cerebral small vessel disease, with no proven
      disease-modifying treatments. Adrenomedullin, a vasoactive peptide, has angiogenic,
      vasodilation, anti-inflammatory, and anti-oxidative properties and could have triple sites of
      action on components of the neuro-glial-vascular unit consisting of vessels, microglia and
      oligodendrocytes or, more specifically, on the white matter oligovascular unit. The aim of
      the AMCAD trial is to assess the safety and efficacy of Adrenomedullin in CADASIL patients.
    


Intervention name(s): Adrenomedullin
Intervention type(s): Drug
Intervention description(s): Dosing at 15 ng/kg/min for 8 hours is continued for 14 days.
Intervention MeSH terms: Adrenomedullin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relative Bioavailability of INS068 Injection With Two Different Formulations in Healthy Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design
      clinical trial. It is planned to enroll 24 healthy male subjects. Subjects will receive
      INS068 injection on Day1 and Day8.
    


Intervention name(s): INS068 injection; INS068 injection
Intervention type(s): Drug; Drug
Intervention description(s): Group A subjects were injected formulation T and formulation R of INS068 injection at Day1 and Day8.; Group B subjects were injected formulation R and formulation T of INS068 injection at Day1 and Day8.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial.
Masking: None (Open Label)
Primary purpose: Basic Science
Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in
      treating women who have metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate in women with metastatic breast cancer treated
      with vinorelbine and docetaxel. II. Determine the time to disease progression, time to
      treatment failure, response duration, and survival in this patient population treated with
      this regimen.

      OUTLINE: This is a multicenter study. Patients receive vinorelbine IV on days 1 and 8, and
      docetaxel IV over 1 hour on day 1 only. Treatment continues every 21 days in the absence of
      disease progression or unacceptable toxicity. Patients are followed for 1 month, and then
      every 1.5-3 months for 1 year.

      PROJECTED ACCRUAL: Approximately 69 patients will be accrued for this study.
    

Intervention name(s): docetaxel; vinorelbine ditartrate
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel 70mg/m2 on day 1 of every 21-day cycle; Navelbine 20mg/m2 on Day 1 and D8 of a 21-day cycle
Other intervention name(s): Taxotere; Navelbine
Intervention MeSH terms: Docetaxel; Vinorelbine
Intervention model: Single Group Assignment
Intervention model description: Open-Label Navelbine (vinorelbine tartrate) and Taxotere (docetaxel) as First-Line Therapy for Metastatic Breast Cancer
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)
Condition: Hypoxemic Acute Respiratory Distress; Infant Between 1 Month and 24 Months Old; Child Between 2 and 15 Years Old
Study type: Interventional

Summary: 
      The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver
      automatically oxygen in infants and children admitted at hospital for hypoxemic acute
      respiratory distress.

      In healthy volunteers adults, FreeO2 system provided a better control of the oxygen
      saturation in function of designed target, reducing the desaturation time and hyperoxia. Our
      hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute
      respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation,
      a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the
      number of intervention by nurses.
    


Intervention name(s): FreeO2 v2.0 automatic adjustment; FreeO2 v2.0 data collecting
Intervention type(s): Device; Device
Other intervention name(s): Automatic adjustment of oxygen through the "Free O2" device.; "FreeO2" device in mode medical data collecting(SpO2).; Manual adjustment of oxygen without the assistance of the "FreeO2" device.; Only "FreeO2" device in mode medical data collecting(SpO2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoxemic, Respiratory distress, infant