bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      TACE is considered the standard treatment for unresectable HCC and is widely used as a
      palliative treatment. However there is no consensus of the protocol of TACE.One of the
      variation is does the stability of the suspension by emulsified the lipiodol and the contrast
      medium used to dissolve the anticancer agents really effect the survival.Thus the
      investigators conduct this prospective,randomized controlled study to find out if the
      different method of preparing chemotheraputic drugs can cause a different survival benefit.
    

Detailed description: 
      Transcatheter arterial chemoembolization is currently the mainstays of palliative treatments
      worldwide for patients with unresectable HCC. However there is no standard protocol exists
      for TACE currently. One of the controversy is does the way of emulsified the anticancer
      agents and lipiodol to get a high stability suspension really effect the survival rates.

      Anticancer drugs play important role in survival benefit. Many studies have innovated
      different methods to get a high stability suspension of lipiodol and anticancer drugs
      ,because they think lipiodol can selectively retained in HCC and used as a drug-carrying
      which allow a slow release of the anticancer drug from lipiodol microdroplets. Thus ,A
      stability suspension might get a maximize tumor drug uptake,which can caused a more tumor
      necrosis, and minimize systemic drug levels ,which get a less toxicity, hence survival
      benefit. While the other researcher think a stability emulsion can't get a positive effect
      ,such as pharmacokinetic and systematic toxicity of the anticancer drugs, tumor response,
      biologic response and so on.
    

Intervention name(s): Solvent with specific gravity less than lipiodol; Solvent with specific gravity equivalent to lipiodol
Intervention type(s): Other; Other
Intervention description(s): TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in distilled water and emulsified lipiodol followed embolization with polyvinyl alcohol particles (PVA); TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water,then emulsified with lipiodol followed embolization with polyvinyl alcohol particles (PVA)
Intervention MeSH terms: Ethiodized Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carcinoma,Hepatocellular; Liver Neoplasms; Survival analysis; treatment outcome; administration drugs; Chemoembolization,; TACE; polyvinyl alcohol; water-soluble contrast mesium; iopamidol; lipiodol; distilled water
Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Observational

Summary: 
      Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful
      therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most
      guidelines consider systemic treatments only in rapidly progressive disease with wider
      surface areas. This delay in halting the immune attack, may give the chance for further
      disease progression as well as establishment of resident memory T cell population
      predisposing to future disease relapses. The aim of this study was to assess the ability of
      early systemic therapy of localized (<2% BSA), recent onset (<6 months) vitiligo to control
      disease activity and minimize the possibility of recurrence.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with active localized vitiligo
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover
      study, conducted at a single site in Austria, outside of the normal grass pollen season. An
      allergic reaction will be induced by exposing subjects to grass pollen in the Vienna
      Challenge Chamber (VCC). Subjects will receive a single dose of each of the following
      treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release
      capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a
      minimum of a 5-day washout period between each treatment. Subjects will complete symptom
      evaluations throughout the study. The nasal decongestant effects of phenylephrine will be
      compared to those of placebo using the subjective symptom evaluations. The safety profile
      (adverse events and vital signs) of the treatments will also be evaluated.
    


Intervention name(s): phenylephrine; pseudoephedrine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): immediate-release 12 mg capsules for oral administration; 60 mg immediate-release tablets for oral administration; placebo capsules
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female
Condition: Gallbladder Diseases
MeSH terms: Gallbladder Diseases
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the optimal Ce of remifentanil for
      preventing emergence cough following extubation during general anesthesia in female patients
      who receive the palonosetron or not.
    

Detailed description: 
      Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug
      effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases
      the at-risk time during extubation. In addition, cough suppression of remifentanil enables
      smooth extubation with reduced complications. However, the infusion of remifentanil
      suppresses the emergence cough effectively in clinical practice, whereas it still delays the
      awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil
      during emergence would decrease the adverse events that are associated with remifentanil
      infusion.
    

Intervention name(s): Normal saline injection; Palonosetron Injection [Aloxi]
Intervention type(s): Drug; Drug
Intervention description(s): Normal saline 2 mL, intravenous injection; Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection
Intervention MeSH terms: Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
microRNAs Role in Pre-eclampsia Diagnosis
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational

Summary: 
      Pre-eclampsia is one of the most threatening pregnancy complications. So far neither a
      secure, competent therapy for PE nor effective biomarkers for a premature discovery has been
      achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in
      exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned
      media released exososomes in patients with PE, as valuable markers for PE early prediction.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        PE group included 100 females with a mean age of 28.77 ± 5.72 years, while control group
        comprised of 100 females with a mean age of 28.06 ± 5.65 years. All enrolled patients were
        clinically diagnosed by physical examination and laboratory investigations.
      
Keywords: microRNAs; exosomes; preeclampsia; mesenchymal stem cells
Network-Level Mechanisms for Preclinical Alzheimer's Disease Development
Condition: APOE 4
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this project is to test the hypothesis that AGB101 low dose levetiracetam
      extended release formulation can reduce abnormal hyperfunctional activity in the hippocampus
      in normal, healthy adults. The investigators will compare the functional connectivity results
      after taking AGB101 or placebo.
    

Detailed description: 
      In this study the investigators want to find out whether the use of a perturbation, such as
      AGB101 low dose of levetiracetam extended release formulation, in healthy adults can reduce
      abnormal hippocampal network activity. The investigators also want to study whether this low
      dose of LEV can improve memory function.

      Generic levetiracetam is a type of drug called an anti-epileptic or anti-seizure medication.
      It is FDA approved worldwide for adults and children as young as one month with seizures. It
      is a generic drug used in long-term epilepsy treatment. It is relatively safe and has an
      acceptable side-effect profile.

      AGB101 has been developed as a novel extended release formulation of low dose levetiracetam
      (below clinically marketed doses for epilepsy) for slowing the progression of amnestic mild
      cognitive impairment.

      It is known that age and the APOE 4 gene are important risk factors for late-onset
      Alzheimer's disease. Further studies have shown that cognitively normal, older adults have
      more hyperfunctional brain network activity, increased alpha beta accumulation, decreased
      memory function, and decreased brain volume, which is consistent with Alzheimer's disease
      patterns.
    

Intervention name(s): AGB101 220 mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.; Placebo, oral capsule given once-daily.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled crossover study in which a low dose of AGB101 (220mg QD) or placebo will be administered to 50 healthy 55-75-year-old subjects, with the order of treatments counterbalanced in a within-subject crossover design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Healthy; Adult; Normal Memory; APOE 4; Brain; Magnetic Resonance Imaging; MRI; Alzheimer's disease; Hippocampus; Genetic testing; Dementia; AGB101
Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and
      Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral
      administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered
      orally together in the fasted state and to demonstrate the BE of Saxagliptin and
      Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral
      administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered
      orally together in the fasted state. Demonstrating bioequivalence refers to showing that the
      FDC tablet and co-administration of the individual components yield similar blood
      levels/concentrations of the drug and are handled by the body similarly.
    

Detailed description: 
      Primary Purpose: This study is designed to demonstrate the bioequivalence of Saxagliptin and
      Dapagliflozin from a FDC tablet after oral administration relative to Saxagliptin and
      Dapagliflozin tablets administered orally together in the fasted and fed state
    

Intervention name(s): Saxagliptin; Dapagliflozin; Saxagliptin/Dapagliflozin FDC
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Onglyza®; BMS-477118; Farxiga®; Forxiga®; BMS-512148; BMS-986098
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration
Condition: Delivery; Injury, Maternal
Study type: Interventional

Summary: 
      Pregnant participants will be recruited at the obstetrics outpatient clinic during their
      visits 4 weeks before the due date. They are randomized into two groups. The first group will
      be educated to do digital perineal massage. They will be also educated to do pelvic floor
      muscle exercises and will receive the usual education program for strengthening the pelvic
      floor. The second group will receive the usual education program for strengthening the pelvic
      floor. Occurrence of perineal laceration will be reported at time of delivery.
    

Detailed description: 
      Pregnant participants will be recruited at the obstetrics outpatient clinic during their
      visits 4 weeks before the due date. They are randomized into two groups. The first group will
      be educated to do digital perineal massage. They will be also educated to do pelvic floor
      muscle exercises and will receive the usual educational pelvic floor dysfunction prevention
      program for strengthening the pelvic floor. The second group will receive the usual education
      program for strengthening the pelvic floor. Occurrence of perineal laceration will be
      reported at time of delivery.
    

Intervention name(s): perineal massage program; Pelvic floor muscle exercise program; Educational pelvic floor dysfunction prevention program
Intervention type(s): Other; Other; Other
Intervention description(s): The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day; The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day; This educational pelvic floor dysfunction prevention program includes instructions about: control of her weight, adequate cleaning for the perineal area, adequate fluid intake, smoking cessation, right posture and frequency of micturition and adequate ingestion of fiber to avoid constipation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Glyceryl Trinitrate Versus Lidocaine Cream for IUD Insertion
Condition: IUD Insertion
Study type: Interventional
Phase: Phase 4

Summary: 
      The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive
      method that may be underutilized due to fear of pain during insertion. Although providers
      frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there
      is no evidence for any pain reduction. Women can experience high levels of pain when the IUD
      is placed inside the uterus, and fear of this pain could be a reason that women decide not to
      use this method.
    


Intervention name(s): glyceryl trinitrate cream; lidocaine cream; placebo cream
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lidocaine; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I)
      Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA
      (BOTOX®) in adults with chronic migraine.
    


Intervention name(s): OnabotulinumtoxinA; Normal saline (placebo)
Intervention type(s): Biological; Drug
Intervention description(s): OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.; Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Other intervention name(s): botulinum toxin Type A; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Ginkgo Biloba Special Extract LI 1370 on Dual-tasking in Patients With MCI
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effects of Ginkgo Biloba Extract (GBE) in executive
      function-impaired Mild Cognitive Impairment (MCI) patients by assessing gait while walking
      alone as well as under differing dual-task conditions.

      The primary endpoint in the evaluation of GBE efficacy is gait speed. The secondary endpoint
      is cycle time variability under dual-task conditions.
    


Intervention name(s): Ginkgo biloba
Intervention type(s): Drug
Intervention description(s): The participants will be randomly allocated to either the intervention group or the placebo control group at a ratio of 1:1. After six months, GBE will be administered to all participants for another 6 months for free. The daily administered dose (taken with meals in the morning and evening) will consist of either twice-daily 1 capsule of Symfona® forte 120mg GBE or identically appearing placebo.
Other intervention name(s): Symfona® forte
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gait, Ginkgo biloba, mild cognitive impairment
Chinese Assessment for Vinpocetine In Neurology
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Observational

Summary: 
      Trial Title：The treatment of Vinpocetine（Cavinton）in patients with cerebral infarction, an
      open, randomized, multi-center control study

        1. Objectives Evaluate the efficacy and safety of Vinpocetine（Cavinton）for treatment of
           cerebral infarction

        2. Design Open, randomized, multi-center control study

        3. Trial Population:Patients with acute cerebral infarction

        4. Number of Subjects 720 patients in test group and 240 patients in control group, totally
           960 patients will be recruited.

        5. Administration Test group: intravenous infusion drip of Vinpocetine 30 mg and Citicoline
           0.4g once daily; additionally oral take aspirin 75-100mg or clopidogrel sulfate tablets
           75mg once a day.

           Control group: intravenous infusion drip of Citicoline 0.4g once daily; additionally
           oral take aspirin 75-100mg or clopidogrel sulfate tablets 75mg once a day.

        6. Outcome evaluation 6.1 Primary end points: 6.1.1 Modified Rankin Scale. 6.1.2
           Mini-Mental State Examination (MMSE) 6.2 Second end points 6.2.1 Barthel index 6.2.2
           NIHSS score 6.2.3 Transcranial Doppler (TCD) examination 6.3 Safety data 6.3.1 Serology,
           hepatic and renal function examination 6.3.2 Adverse events

        7. Statistical Analysis: SPSS 11.0 will be used to make the data analysis.
    

Detailed description: 
      The design of this study is a randomized, open, multi-center and control study. The patients
      with cerebral infarction are as the study objects. Coronal CT / MRI examination combined with
      NIHSS and Modified Ranking Scale, MMSE, Barthel index, Transcranial Doppler (TCD) examination
      are applied to evaluate the Vinpocetine treatment efficacy and safety for cerebral infarction
      [14]. From ethical side, all patients will receive a conventional therapy, and based on it,
      the test group will be given intravenous injection of Vinpocetine as add-on treatment.
      Observation period is 10-14 days, and follow up for 3 months.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Totally 610 subjects were recruited, 469 in test group and 141 in control group.
      
Keywords: acute cerebral infarction, Vinpocetine
Theophylline in Treating Cancer Patients With Shortness of Breath
Condition: Pulmonary Complications; Quality of Life; Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Theophylline may help to relieve shortness of breath in patients who have cancer.
      It is not yet known whether theophylline is more effective than no further treatment for
      shortness of breath.

      PURPOSE: Randomized phase III trial to determine the effectiveness of theophylline in
      treating shortness of breath in patients who have cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine whether theophylline will improve the dyspnea rating of patients
      with cancer who are short of breath and have evidence of respiratory muscle weakness. II.
      Determine whether this drug will improve the ability to perform daily activities in this
      group of patients. III. Determine whether this drug will improve objective measures of lung
      function (e.g., FEV-1, FVC) and maximum inspiratory pressure in these patients. IV. Determine
      whether the serum theophylline level is related to the magnitude of the effect that is
      observed in this patient population. V. Determine whether this drug will improve a global
      rating of quality of life in this patient group.

      OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified
      according to those who can complete a 6 minute walking test versus those who cannot. Patients
      receive either oral theophylline or placebo once daily for 3 days. In the absence of dose
      limiting toxicity (DLT), patients receive an increased dose for an additional 4 days. In the
      presence of DLT, patients receive a decreased dose or treatment is stopped. Following
      completion of the 7 day study period, patients may be given the option to continue on active
      drug or placebo for 1 additional month unless toxic side effects develop. Quality of life is
      assessed on days 1 and 8 and at the end of the additional 1 month period.

      PROJECTED ACCRUAL: A total of 60 patients (30 in each arm) will be accrued for this study.
    

Intervention name(s): theophylline; quality-of-life assessment
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: unspecified adult solid tumor, protocol specific; pulmonary complications; quality of life