bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess The Effects Of Effexor XR On Cardiac Repolarization In Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate a lack of effect of venlafaxine (Effexor XR) on
      QTc intervals relative to time matched placebo in healthy volunteers
    

Detailed description: 
      This is a single-center, randomized, double-blinded, placebo- and moxifloxacin-controlled, 3
      period, 6-sequence, 3 treatment (venlafaxine and placebo blinded; moxifloxacin open label),
      3-way crossover thorough QT (TQT) study of the effects of venlafaxine on cardiac
      repolarization in approximately 54 healthy subjects
    

Intervention name(s): Venlafaxine; Moxifloxacin; Drug - placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple doses of Venlafaxine for 14 days plus 3 days of down titration; 400 mg single dose moxifloxacin; Placebo administered for 16 days
Other intervention name(s): Active drug; Positive control; Placebo control
Intervention MeSH terms: Moxifloxacin; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
The Effects of PXR Activation on Hepatic Fat Content
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat
      content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator)
      and placebo will be given for a week to volunteers. Hepatic fat content is measured with
      magnetic resonance imaging and blood samples are collected at the end of each study arm. The
      investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.
    


Intervention name(s): Rifampicin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Rifampin
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease
Condition: Pulmonary Rehabilitation; Chronic Obstructive Lung Disease; Neuromuscular Electrical Stimulation; Pulmonary Function (FEV1/FVC)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Background: Patients with COPD often experience skeletal muscle dysfunction. For those who
      are unable or unwilling to undertake physical training, neuromuscular electrical stimulation
      (NMES) may provide an alternative method of exercise training.

      Objective: To investigate the effects of adding neuromuscular electrical stimulation of
      gluteus maximus, quadriceps and calf muscles to chest physiotherapy, compared to chest
      physiotherapy alone, on muscles strength (gluteus max., quadriceps, calf muscles and anterior
      tibial group), femoral blood flow physical and pulmonary function in severe COPD Patients.
    

Detailed description: 
      Material and methods: This study include a group of 60 patients (30 males and 30 females)
      diagnosed with severe COPD), their age is ranged 65-75 years, they will be randomly divided
      into two groups; study group (A) 30 patients and study group (B) 30 patients. Study group
      (A): The patients in this group will receive the chest physiotherapy program for 20 min each
      day, for five days a week for three consecutive weeks. Study group (B): The patients in this
      group will receive the same chest physiotherapy program combined with neuromuscular
      electrical stimulation of gluteus max., quadriceps, calf muscles and anterior tibial group
      performed for 30 min /day for five days a week for three consecutive weeks. Femoral blood
      Flow, gluteus maximus, quadriceps and calf muscles strength and pulmonary function (FEV1/FVC)
      will be measured for both groups pre and post treatment.
    

Intervention name(s): Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES); Control Group Chest physical therapy
Intervention type(s): Other; Other
Intervention description(s): The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, calf muscles and anterior tibial group performed for 30 min /day for five days a week for three consecutive weeks.; The patients in this group were received the chest physiotherapy program for 20 min each day, for five days a week for three consecutive weeks
Other intervention name(s): Chest physical therapy plus NMES; Chest physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial
Condition: Fibromyalgia; Neurocognition
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to investigate whether milnacipran is safe and effective in improving
      cognitive function in fibromyalgia. In addition, this study was aimed to investigate whether
      improvement in neurocognitive status due to milnacipran correlates with improvements in pain,
      to investigate whether improvement in neurocognitive status due to milnacipran correlates
      with improvements in fatigue, and to determine whether treatment with improvement in
      neurocognitive status, pain and fatigue correlates with functional improvement.
    

Detailed description: 
      Cognitive dysfunction is observed in fibromyalgia, especially for episodic memory, learning,
      and working memory.There is evidence for dysregulation of the attention system from low-level
      sensory processes up to emotional processes, and increased sensitivity to
      distraction.Milnacipran's balance of norepinephrine (NE) to serotonin (5-HT) of 3:1, similar
      to amitriptyline, a tricyclic that has demonstrated efficacy in fibromyalgia, as compared to
      venlafaxine which is 1:30, or duloxetine which is 1:10.7 In addition, because of
      milnacipran's effect on 5-HT, it should also be effective in treating other symptoms such as
      sleep disturbances and mood changes, which are associated to fibromyalgia, as well as other
      functional somatic syndromes. It is worth noting that several medications to treat
      fibromyalgia are sedating (e.g pregabalin, opioids, muscle relaxants) and impair
      neurocognition.
    

Intervention name(s): Milnacipran; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Milnacipran; Fibromyalgia; Neurocognition
Study in Neuropathic Pain Patients With Peripheral Nerve Injury
Condition: Pain, Neuropathic
MeSH terms: Neuralgia; Peripheral Nerve Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a double-blind, placebo-controlled, parallel group study. After enrolment
      and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily
      (BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be
      recruited to obtain 142 evaluable subjects. This is a double-blind, randomized,
      placebo-controlled, parallel group study. Subjects will undertake a screening period which
      may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized
      treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a
      multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at
      least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to
      trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over
      28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable
      subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of
      GW856553 will be 7.5 mg BID.
    


Intervention name(s): GW856553; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): GW856553 is a film coated white tablet, 9mm round, biconvex, plain faced. It will be administered 7.5mg bid, orally with food at breakfast and dinner.; Matching Placebo is a film coated white tablet, 9mm round, biconvex, plain faced. It will be administered orally with food at breakfast and dinner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: peripheral nerve injury; p38 kinase inhibitor; neuropathic pain
Etomidate Emulsion for Sedation in Patients Scheduled for Upper Gastrointestinal (GI) Endoscopy
Condition: Complication of Gastrostomy
Study type: Interventional

Summary: 
      The study is designed to explore and compare the efficacy and safety of etomidate and
      propofol with or without analgesic for painless gastroscopy, and to provide more reliant
      support for implementation and promotion of comfort care.
    

Detailed description: 
      To widely implement painless gastroscopy is required by diagnose and treatment with
      gastroscopy due to the large number and significant suffering of the patients. Also,
      development and exploration of anesthesiology will be bound to prompt the development and
      exploration of painless gastroscopy. However, the anesthesia risk of painless gastroscopy are
      usually higher than that of general anesthesia performed in operating room due to the
      condition, monitoring and equipments as well as the staffing for its implementation. Thus,
      the finding of a safe and convenient approach for general anesthesia will have a profound
      impact on a full promotion and implementation of comfortable care.

      Etomidate, with the main advantage of little effect on circulatory and respiratory systems,
      and the features of rapid onset and metabolism, may be helpful to guarantee the safety of
      painless diagnosis and treatment, thus appropriate for the procedure with short duration of
      anesthesia. However, there is controversy regarding whether analgesic should be used in
      combination, as well as how to given the combined regimen.
    

Intervention name(s): Etomidate; Fentanyl; Propofol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Fentanyl; Propofol; Etomidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastroscopy; sedation; etomidate
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Liver Transplantation
Condition: Renal Function; Liver Transplantation
MeSH terms: Acute Kidney Injury
Study type: Observational

Summary: 
      The incidence of acute kidney injury after liver transplantation has been reported to be 17
      to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to
      identify and prevent reversible risk factors for acute kidney injury after liver
      transplantation. Previous studies have reported several preoperative clinical risk factors,
      but preoperative medication and intraoperative colloid administration and hemodynamic
      parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk
      factors and develop simplified clinical risk scoring model.
    

Detailed description: 
      Ischemia/reperfusion injury occurs during graft harvesting, cold storage, and surgical
      procedures in liver transplantation. Ischemia/reperfusion injury in liver graft results in
      major organ damage including kidney, lung and heart as well as graft dysfunction. Graft
      dysfunction and renal injury after liver transplantation are major clinical issues and are
      associated with prognosis and low survival rate. The incidence of acute kidney injury after
      liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has
      been reported yet. Therefore, it is important to identify and prevent reversible risk factors
      for acute kidney injury after liver transplantation. Previous studies have reported several
      preoperative clinical risk factors, but perioperative medication, metabolic variables
      (albumin, glucose, uric acid), intraoperative colloid administration and hemodynamic
      parameters have not been evaluated. In addition, a neutrophil-lymphocyte ratio (NLR), which
      has been reported to be related to systemic inflammation and associated with prognosis of
      cardiac and cancer patients, might be related to the development of AKI after LDLT.
      Therefore, we attempt to evaluate these perioperative risk factors and develop simplified
      clinical risk scoring model.
    

Intervention name(s): living donor liver transplantation
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients who underwent living donor liver transplantation between 2010 and 2013
      
Keywords: risk factor; acute kidney injury; liver transplantation; postoperative renal function
High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study
Condition: CNS Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX
      induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based
      combination consolidation chemotherapy
    


Intervention name(s): MTX, MVD, VIA
Intervention type(s): Drug
Intervention description(s): MTX: Methotrexate,Leucovorin MVD: Methotrexate,Vincristine,Dexamethasone VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary CNS lymphoma; MTX: Methotrexate,Leucovorin; MVD: Methotrexate,Vincristine,Dexamethasone; VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C); Newly diagnosed primary CNS lymphoma patients
Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival
      probability of less than 5% when all stages are combined. At present, only approximately
      10%-20% of patients are considered candidates for curative resection. The majority of
      patients (50%-60%) are present with metastatic disease, and substantial number of patients
      (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.

      Replication-competent Adenovirus-mediated Double Suicide Gene Therapy
      (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic
      cancer in phase I study. From the experience of prostatic cancer, the safety of combination
      with standard chemotherapy with Theragene treatment is assessed in this study.
    


Intervention name(s): Theragene®,Ad5-yCD/mutTKSR39rep-ADP
Intervention type(s): Biological
Intervention description(s): Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Adenovirus; Gene therapy
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a
      single oral drug. The purpose of this study is to assess the safety and effectiveness of
      vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to
      pioglitazone in people with type 2 diabetes not at target blood glucose levels on either
      pioglitazone or rosiglitazone alone.
    


Intervention name(s): Vildagliptin; pioglitazone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vildagliptin 50 mg tablets; pioglitazone 45 mg qd; Vildagliptin matching placebo
Other intervention name(s): LAF237; Galvus
Intervention MeSH terms: Pioglitazone; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Accuracy of CNAP PPV Under General Anaesthesia
Condition: General Anaesthesia
Study type: Observational

Summary: 
      Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is
      compared with the gold standard of invasive measurements. Cardiac output is derived by the
      PICCO monitor.

      Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the
      prediction of fluid responsiveness will be defined.
    

Detailed description: 
      Accuracy of PPV measured by two devices,PICCO and CNAP, is compared with the manually
      calculated PPV from the arterial line waveform. Established tests like passive leg raising
      and end-expiratory occlusion are used for prediction of fluid responsiveness. Intraoperative
      events like volume challenge are monitored.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing major surgery with the need for invasive arterial pressure monitoring
Anthropometric Angular Measurement to Determine Muscle Tonus in Patients With Peripheral Facial Paralysis
Condition: Peripheral Facial Paralysis
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis; Facies
Study type: Observational

Summary: 
      The current study sought to determine the reliability of the rehabilitation protocol using
      the labial commissure angle (LCA) as an indicator of both muscle tonus and therapeutic
      success. The investigators hypothesized that this measurement would provide objective data
      regarding the efficacy of rehabilitation for these challenging patients.
    

Detailed description: 
      CONTEXT AND OBJECTIVE: In cases of peripheral facial paralysis (PFP), diminished facial
      movements and their resultant cosmetic sequelae may have significant emotional repercussions,
      in addition to producing pronounced functional deficits. Abnormal muscle proprioception and
      deviation of the nasal-labial filter may also interfere with articulation of the labiodental
      and bilabial phonemes, thus diminishing speech intelligibility. In relation to stomatognathic
      functions, weakened labial occlusion decreases intraoral pressure, thereby hindering liquid
      retention in the buccal cavity and giving rise to vestibular stasis on the paralyzed side.
      The aim of this study was to evaluate the reliability of the labial commissure angle (LCA) as
      an anthropometric marker for objectively assessing changes in facial muscle tonus.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with PFP treated in the Hospital of Unicamp
      
Keywords: Facial paralysis; Muscle tonus; Rehabilitation; Myofunctional; Stomatognathic system
A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino
      acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee
      cartilage in subjects with bilateral osteoarthritis of the knee.
    


Intervention name(s): TPX-100 50mg; TPX-100 100mg; TPX-100 200mg; TPX-100 20mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): 50mg of TPX-100; 100mg of TPX-100; 200mg of TPX-100; 20mg of TPX-100
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee osteoarthritis; bilateral; osteoarthritis
Automated UltraSound Software for Identification of Lumbar Vertebral Levels
Condition: Anesthesia
Study type: Observational

Summary: 
      A novel automated ultrasound software system has been developed which identifies for the
      practitioner the intervertebral spaces in the lumbar area. This study aims to investigate
      whether this new technology has a greater accuracy of identifying intervertebral spaces that
      manual palpation.
    

Detailed description: 
      The use of ultrasound is one of the most accurate ways to identify the correct vertebral
      level for needle insertion in spinal/epidural anesthetics, however this is not commonly used.
      A novel automated ultrasound software system has been developed by the UBC Department of
      Engineering which identifies for the practitioner the intervertebral spaces in the lumbar
      area. This study aim to investigate whether this new technology has a greater accuracy of
      identifying intervertebral spaces that manual palpation.
    

Intervention name(s): Manual palpation identification lumbar spine; Automated ultrasound technology identification; Lumbar level identification gold standard ultrasound
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parturients scheduled for an elective Cesarean section at BC Women's Hospital
      
Keywords: Neuraxial anesthesia; Obstetrics; Ultrasound