bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Course Format "NASIM25"
Condition: Emergencies; Trauma Injury
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The investigators intend to evauate the development and professional safety of aspiring
      prehospital emergency pyhsicians in a cross sectional and longitudinal modality. This compass
      objecitve and subjective evaluable professional skills essential in prehospital emergency
      medicine.
    

Detailed description: 
      In the course format "NASIM25" aspiring prehospital emergency physicians are trained in 25
      simulation based scenarios dealing about situations being rare on the scene having have a
      tremendous impact on the patients if not treated adequately.

      To evaluate the impact of the course format on the skills of the participants (i.e. aspiring
      prehospital emergency physicians) the investigators quantify the trained skills and
      professional safety in three dimensions of skills and professional safety:

        1. The influence on applying the ABCDE-Approach using the a validated score by Peran et al
           2020 (ABCDE cognitive aid tool in patient assessment -development and validation in a
           multicenter pilot simulation study. BMC Emerg Med. 2020;20(1)) and non technical skills
           using a validated score by Kim et al 2009 (Kim J, Neilipovitz D, Cardinal P, Chiu M.A
           comparison of global rating scale and checklist scores in the validation of an
           evaluation tool to assess performance in the resuscitation of critically ill patients
           during simulated emergencies (abbreviated as "CRM simulator study IB"). Simul Healthc.
           2009;4(1):6-16)

        2. The influence on the cource on the self- and external assessement of the participants
           using school marks

        3. The influence on the professional safety using a web based survey in a longitudinal
           modality throughout the entire qualification curriculum of prehospital emergency
           medicine.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        physicians that are aspiring the qualification: "prehospital emergency physician"
      
Keywords: emergencies; trauma; pediatric emergencies; prehospital emergencies
Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of the use of the
      combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in
      suboptimal responders to ADA monotherapy.
    


Intervention name(s): Adalimumab; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection every other week.; Methotrexate was provided as 2.5 mg tablets for oral administration.
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: methotrexate; adalimumab; biologic; psoriasis; Tumor necrosis factor (TNF)-α inhibitor
Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      Central South University in collaboration with Tianjin University developed the first
      domestically produced Chinese minimally invasive surgical (MIS) robot system which named
      "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial
      stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The
      Micro Hand S robot is safe and feasible in the preliminary study. However, the learning curve
      in low anterior resection for rectal resection with the Micro Hand S robot are unclear and
      whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve
      and the two robot can be trained simultaneously. Therefore, the investigators conduct this
      retrospective study to focus on this concern.
    

Detailed description: 
      The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The
      safey and feasibility has been evaluated. However, the learning curve of this procedure is
      unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a
      similar learning curve and the two robot can be trained simultaneously are unclear.Therefore,
      this srudy is conducted to evaluate the learning curve of the two robots in low anterior
      resection.
    

Intervention name(s): Micro Hand S robot and da Vinci robot; da Vinci robot
Intervention type(s): Device; Device
Intervention description(s): The surgeries are performed with the Micro Hand S robot and da Vinci robot; The surgeries are performed with the da Vinci robot
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to investigate the efficacy, safety and tolerability of four
      different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients
      with schizophrenia on stable antipsychotic treatment.
    


Intervention name(s): BI 409306 100 mg QD; BI 498306 50 mg QD; Placebo; BI 498306 25 mg QD; BI 409306 10 mg QD
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study To Evaluate The Efficacy And Safety Of Actikerall® Solution In Patients With Grade I-II Actinic Keratoses
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this vehicle-controlled study is to determine the efficacy and safety of
      a solution of Actikerall® (containing 5-fluorouracil 0.5% and salicylic acid 10.0%) in the
      field-directed treatment of grade I-II actinic keratosis, when it is applied to the affected
      area once daily for 12 weeks.

      A secondary objective of this study is to evaluate the efficacy of Actikerall® solution on
      subclinical actinic keratosis lesions in a subset of patients.
    


Intervention name(s): 5-fluorouracil/salicylic acid; Vehicle
Intervention type(s): Drug; Drug
Other intervention name(s): Actikerall
Intervention MeSH terms: Salicylic Acid; Salicylates; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study for Benzyl Alcohol Lotion 5%.
Condition: Head Lice
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 3

Summary: 
      To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5%
      with Ulesfia Lotion 5% in eradication of head lice in the study subjects.
    


Intervention name(s): Benzyl Alcohol Lotion 5%; Ulesfia (benzyl alcohol lotion) 5%; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): White topical lotion; White topical lotion; White topical lotion
Intervention MeSH terms: Ethanol; Benzyl Alcohol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Factors Associated With Pain During Unsedated Colonoscopy
Condition: Colonoscopy; Unsedated; Pain
Study type: Observational

Summary: 
      Colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due
      to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the
      examination and giving analgesic agents were recommended in several guidelines. However, use
      of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only
      mild discomfort with the unsedated colonoscopy, routine administration of sedative or
      analgesic agents to all patients was considered as unnecessary. However, unsedated
      colonoscopy was thought to be an option for some but not for all, therefore a method to
      identify which patients at high risk for painful colonoscopy in preoperational stage is
      necessary.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients of the training cohort were enrolled form Xijing Hospital of Digestive
        Diseases. The patients of the validation cohort were enrolled from the Shaanxi Second
        People's Hospital.
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be
      effective, safe and well tolerated in the treatment of patients with schizophrenia who are
      treated in a general psychiatric setting.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Civamide Patch in Treatment of Postherpetic Neuralgia and Post-Incisional Neuralgia
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof of concept study is designed to evaluate the safety and efficacy of topically
      administered Civamide Patch for the treatment of moderate to severe daily pain associated
      with postherpetic neuralgia localized to the trunk, and with localized post-incisional
      neuropathic pain syndromes on the trunk.
    

Detailed description: 
      There will be up to approximately 20 evaluable subjects in this open-label study. The study
      is composed of a 1-week non-treatment Baseline Period (Day -7 to -1), during which subjects
      will be required to complete a Daily Diary assessing overall pain and sleep interference. The
      1-week Baseline Period will be followed by a 4-week Treatment Period, in which subjects will
      apply the Civamide Patch (0.015%) daily 12 hours per day, for a period of 4 weeks, complete a
      Daily Diary assessing overall pain and sleep interference, followed by a 2-week
      Post-Treatment Observation Period. In the course of the study, subjects will visit the clinic
      a total of five times for physical examinations, vital signs, review of diaries, and
      distribution and collection of test patches. Efficacy assessment will be the mean change from
      Baseline Period in efficacy variables during the course of the study.
    

Intervention name(s): Civamide Patch
Intervention type(s): Drug
Intervention description(s): Patch containing Civamide (zucapsaicin) 0.015%, containing 0.210 mg Civamide per patch, applied once a day for four weeks.
Other intervention name(s): zucapsaicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postherpetic neuralgia of at least 6 months
Leucovorin, Fluorouracil, Cetuximab, and Oxaliplatin in Treating Patients With Stage IV Colorectal Cancer and Liver Metastases That Cannot Be Removed by Surgery
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin,
      work in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth
      in different ways. Some block the ability of tumor cells to grow and spread. Others find
      tumor cells and help kill them or carry tumor-killing substances to them. Giving more than
      one drug (combination chemotherapy) and giving them together with cetuximab may kill more
      tumor cells.

      PURPOSE: This phase II trial is studying how well giving leucovorin together with
      fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal
      cancer and liver metastases that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of this regimen by the measurement of objective response rate
           (RECIST criteria).

      Secondary

        -  Determine the toxicity of this regimen.

        -  Evaluate the duration of tumor response.

        -  Determine the duration and rate of tumor control.

        -  Determine the rate of secondary resectability of hepatic metastases.

        -  Evaluate progression-free survival

        -  Determine rate of progression of the tumor.

        -  Determine overall survival.

      OUTLINE: This is a multicenter study.

      Patients receive cetuximab IV over 1 hour, leucovorin calcium IV over 2 hours, and
      fluorouracil IV continuously over 46 hours. Patients also receive oxaliplatin by hepatic
      arterial infusion over 2 hours. Treatment continues for at least 3 months in the absence of
      disease progression or unacceptable toxicity.
    

Intervention name(s): cetuximab; fluorouracil; leucovorin calcium; oxaliplatin
Intervention type(s): Biological; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Cetuximab; Calcium; Levoleucovorin
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; recurrent colon cancer; stage IV rectal cancer; recurrent rectal cancer; liver metastases
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
Condition: Pre-hypertension; Hypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aim to evaluate subjects at high risk of future development of
      hypertension, those with a family history of hypertension and/or that already have high
      normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to
      investigate whether these subjects have the same markers (such as microscopic protein in the
      urine or C-reactive protein in the blood) in the blood and urine that people with high blood
      pressure have, and whether they are improved before and after taking the beta-blocker
      nebivolol.
    


Intervention name(s): Nebivolol
Intervention type(s): Drug
Intervention description(s): Oral nebivolol 2.5-5mg once daily
Other intervention name(s): Bystolic
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Genetic risk of hypertension
Bindex for Osteoporosis Diagnostics
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Observational

Summary: 
      Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture
      risk. Among 200 million osteoporotic patients most are diagnosed only after several
      fractures. Furthermore, the progressively aging population will increase the prevalence of
      osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and
      does not receive treatment for their condition. Bindex ultrasound device has been developed
      and validated in Caucasian female population. In this study, diagnostic thresholds for
      density index as determined with Bindex will be evaluated in two different ethnic
      populations.
    

Detailed description: 
      Currently, the diagnosis of osteoporosis is based on the measurement of bone mineral density
      (BMD), using axial dual energy X-ray absorptiometry (DXA) of the hip and/or the lumbar spine
      at special healthcare.

      Application of diagnostic thresholds determined against BMD have been suggested by
      International Society for Clinical Densitometry (ISCD) for use with peripheral bone
      densitometry devices (90% sensitivity and 90% specificity). These thresholds have been
      determined and validated for Bindex in Caucasian female population.

      This study focuses on clinical validation of the ultrasound device (Bindex®, Bone Index
      Finland Ltd., www.boneindex.com) device and Density Index (DI), a diagnostic parameter
      reported by Bindex. The predetermined thresholds for DI will be evaluated by measuring 70
      osteoporotic and 70 healthy patients with Bindex and DXA in each selected patient groups. The
      feasibility of DI for diagnostics of osteoporosis in these groups will be assessed.
    

Intervention name(s): Bindex measurement
Intervention type(s): Diagnostic Test
Intervention description(s): One time bone density measurement with ultrasound device
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Random sample of eligible female subjects who are being treated at collaborating clinic.
Dexmedetomidine Pharmacokinetics in Neonates During Therapeutic Hypothermia
Condition: Hypoxic-ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypothermia; Hypoxia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The goal of this proposal is to profile the pharmacokinetics of dexmedetomidine in newborns
      ≥36 weeks post-menstrual age during therapeutic hypothermia for hypoxic-ischemic
      encephalopathy.
    

Detailed description: 
      The goal of this proposal is to determine the pharmacokinetics (PK) of dexmedetomidine (DEX)
      in newborns in the neonatal intensive care unit (NICU) receiving therapeutic hypothermia (TH)
      for moderate to severe hypoxic-ischemic encephalopathy (HIE). In newborns with HIE, TH for 72
      hours is the standard therapy to mitigate brain damage. Most HIE patients receive mechanical
      ventilation during TH and are thus sedated with morphine. Unfortunately, morphine has
      negative side effects and does not specifically prevent shivering. Prevention of shivering is
      critical to success of TH, as shivering negates cooling. DEX is a particularly promising
      alternative sedative because it does prevent shivering and is already used in NICUs for
      sedation and pain management. In newborns, DEX PK data in the setting of TH is not available
      and needs to be determined to properly dose DEX for HIE patients.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine infusion
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Neonate; Pharmacokinetics; Therapeutic Hypothermia; Hypoxic-ischemic Encephalopathy; Adrenergic Agents; Adrenergic Agonists; Analgesics; Adrenergic alpha-2 Receptor Agonists; Central Nervous System Agents; Central Nervous System Depressants
Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the
      time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions
      experimentally induced after ultra violet radiation (UVR) exposure.
    

Detailed description: 
      The primary objective was to compare the efficacy of ME-609 cream vs placebo cream on the
      time to healing (loss of hard crust) of delayed classical herpes labialis (HSV) lesions
      experimentally induced after ultra violet radiation (UVR) exposure. Secondary objectives were
      to compare the time to normal skin, incidence of lesion development (number and type of
      lesions), maximum lesion size, length of lesion stages, frequency/severity/duration of pain,
      frequency/severity/duration of tenderness, redness and/or oedema in the UVR exposed area,
      frequency of virus positive lesions, time to cessation of viral shedding and safety of ME-609
      cream vs placebo cream.
    

Intervention name(s): ME-609; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Cream applied topically 6 times daily over the UVR exposed area; Treatment applied 6 times daily over the UVR exposed area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: UV-induced; Herpes labialis; time to healing