bioihbjkbjnl/mcl2 huggingface dataset:
Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
Condition: Postoperative Nausea; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and
      vomiting.

      The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and
      dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous
      history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large
      surgery.
    

Detailed description: 
      Double blinded randomized clinical trial. Fifty patients will be selected for each group.
      Group A will receive 10mg olanzapine in the preoperative and group B will receive placebo in
      the preoperative period. Both groups will receive intravenous general anesthesia combined
      with epidural. All patients will receive epidural PCA.

      The primary outcome of this study is the incidence of post-operative nausea and vomiting. The
      power of analysis was based on the following parameters: type error I (α = 0.05), error II (β
      = 0.8), 95% confidence interval and hypothesis test two-tailed. Thus, 42 patients are
      indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the
      population risk from 60% to 30%. The population will be composed of 100 patients because it
      is assumed that percentage of loss of 10% per group.

      The statistical analysis will be performed in program R version 3.5.1. The results obtained
      will be presented as mean + standard deviation for continuous data or absolute frequency for
      described data.

      For quantitative variables, the Student's t-test will be used for with normal distribution or
      Mann-Whitney for non-distributed data normal.

      For qualitative variables, the chi-square test will be used or Fisher's exact test.
      Significant difference is defined as p, 0.05.

      Data will be collected and managed using REDCap data capture tools
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): olanzapine 10 mg is given before surgery
Other intervention name(s): Treatment
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: nausea and vomiting
18-months Safety Follow-up Study of AADvac1, an Active Tau Vaccine for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This follow-up study continues to observe patients who have completed the phase 1 trial of
      AADvac1, for another 18 months.

      Long-term safety and behavior of the immune response to AADvac1 over time are the main points
      of interest.

      AADvac1 is a vaccine directed against pathologically modified Alzheimer tau protein that is
      the main constituent of neurofibrillary tangles (NFTs), and is intended to be a
      disease-modifying treatment for Alzheimer's disease, i.e. to halt its progress.

      As this study is a Phase I study focused on tolerability and safety, efficacy will be
      assessed in an exploratory manner.
    

Detailed description: 
      AADvac1 is a candidate therapeutic vaccine for Alzheimer's disease that targets misfolded tau
      protein, a common denominator of neurofibrillary pathology. Based on preclinical results, the
      intervention is expected to reduce the number of neurofibrillary tangles, remove
      hyperphosphorylated tau protein and reduce the amount of oligomerized and insoluble
      pathological tau in the brain, to halt the spread of neurofibrillary pathology through the
      brain, and thus prevent associated cognitive decline.

      The vaccine's antigenic determinant is a synthetic peptide derived from a tau protein
      sequence, which is coupled to keyhole limpet hemocyanin (KLH) and uses aluminum hydroxide
      (Alhydrogel) as an adjuvant.

      At present AADvac1 is intended as an active immunotherapy for patients with diagnosed
      Alzheimer's disease (AD). According to need, patients will receive additional immunization
      doses beyond those administered in the preceding pase 1 trial; the raised titers of
      therapeutic antibodies and possible benefits of the treatment can extend beyond the duration
      of the study.

      Because of the central role of pathological misfolded tau protein in the etiology of AD, the
      vaccine is expected to be more effective than active or passive immunotherapies aiming to
      eliminate the amyloid β plaques that have been clinically investigated so far.
    

Intervention name(s): AADvac1
Intervention type(s): Drug
Intervention description(s): Active immunization against pathological Alzheimer's disease tau protein
Other intervention name(s): Axon peptide 108 (coupled to KLH), 40ug/0.3mL; Axon peptide 108 conjugated to KLH
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; tau; dementia; elderly; cognitive; disease modifying; treatment; immunization; vaccine
Laterality Discrimination in Patients With Non-specific Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult
      population, and the fourth leading cause of disability. The recognition of laterality is the
      ability to recognize a part of the body that belongs to the left or right which is used as a
      tool to create a normal process of motor planning.
    

Detailed description: 
      The most consistent data come from the investigation of the primary motor cortex, in which
      the cortical representations of the altered body part are affected when there is chronic
      pain. Occasionally, the primary motor cortex is smaller on the affected side than on the
      contralateral side.

      Recognition of the body schema is altered in the presence of painful disorders. The most
      common way of assessing the body schema is by motor imagery through the laterality
      discrimination of the left and right.
    

Intervention name(s): Neck Laterality; Foot Laterality
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients who belonged to the neck group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program; Patients who belonged to the foot group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the "Vanilla" program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Laterality task, neck pain
Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness
Condition: Intermittent Exotropia
MeSH terms: Exotropia
Study type: Interventional

Summary: 
      This study was conducted to evaluate results of slanted recession of the lateral rectus
      muscle for intermittent exotropia with convergence weakness
    

Detailed description: 
      This prospective study included 31 patients who underwent slanted lateral rectus muscle
      recession for intermittent exotropia with convergence weakness. Measurements of preoperative
      and postoperative deviation angle, stereopsis was performed.
    

Intervention name(s): Slanted recession of the lateral rectus muscle
Intervention type(s): Procedure
Intervention description(s): All patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to study the pharmacokinetics of pyrotinib and
      docetaxel plus Trastuzumab in HER2 Positive MBC.

      The secondary objective of the study is to evaluate the safety and efficacy (ORR) of
      pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
    


Intervention name(s): Docetaxel, trastuzumab; Pyrotinib
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel and trastuzumab once per cycle; Pyrotinib 400/320 mg orally daily
Intervention MeSH terms: Docetaxel; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PT003 MDI Cardiovascular Safety Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is primarily a safety study. The primary and secondary endpoints are based on
      24-hour Holter monitor assessments obtained on Day 14 relative to baseline.
    


Intervention name(s): PT005 MDI; PT001 MDI; PT003 MDI; Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PT005 MDI administered as two puffs BID for 14 days; PT001 MDI administered as two puffs BID for 14 days; PT003 MDI administered as two puffs BID for 14 days; Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
Other intervention name(s): Foradil® Aerolizer®
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT)
Condition: Charcot-Marie-Tooth Disease Type 1A
MeSH terms: Tooth Diseases; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy; Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether PXT3003 is effective and safe in the
      treatment of Charcot-Marie-Tooth disease - Type 1 A (CMT1A). This double-blind study will
      assess in parallel groups 2 doses of PXT3003 compared to Placebo in CMT1A patients treated
      for 15 months.
    

Detailed description: 
      PXT3003 is a fixed dose combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol
      selected via a Systems Biology approach and developed by Pharnext, with the aim to limit the
      production of PMP22 and protect/improve axonal function in patients with CMT1A. On September
      18th 2017, PXT3003 dose 2 was prematurely discontinued, due to an unexpected investigational
      medicinal product quality event (failed month 18 stability testing). This resulted in a large
      proportion of missing data that led us to reconsider the efficacy analysis that was initially
      planned in the protocol.The independent data safety monitoring committee did not identify any
      safety concern on September 5th 2017. All patients randomised to dose 2 were requested to
      undergo the end of study visit, and were offered to enter the extension study
      (CLN-PXT3003-03).
    

Intervention name(s): PXT3003 dose 1; PXT3003 dose 2; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Liquid oral solution, 5 ml twice a day, morning and evening with food; Liquid oral solution, 5 ml twice a day, morning and evening with food; Liquid oral solution, 5 ml twice a day, morning and evening with food
Other intervention name(s): DOSE 1; DOSE 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PXT3003
Assessment of NAPS Performance.
Condition: Competence in Propofol Sedation for Endoscopy
Study type: Observational

Summary: 
      To measure competencies in propofol sedation for endoscopic procedures (NAPS)through
      development, test and validation of a reliable assessment tool in a simulator setting.

      Hypothesis: That the tool will demonstrate content and construct validity, ie. enable
      reliable measuring of necessary competencies of different levels in a reproducible way.
    


Intervention name(s): unexperienced endoscopy nurses; Experienced endoscopy nurses
Intervention type(s): Behavioral; Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Endoscopy nurses of different competencylevel
      
Keywords: Propofol; Sedation; Endoscopy; nonanesthesiologist
Mapping the Endocrine Determinants of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this project is to identify autocrine, paracrine and endocrine factors which are
      associated with intercycle variation in cyclical follicle recruitment.

      Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the
      stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or
      placebo during ovarian stimulation.
    

Detailed description: 
      The primary aim of this project is to explore the putative cyclic recruitment 'gatekeeping'
      functions of gonadotropins, sex steroids, anti-muellarian hormone and pregnancy associated
      plasma protein A in normal ovulatory cycles, and the impact of ovarian stimulation on cyclic
      follicle recruitment in the following cycle.

      It is further proposed that supra-physiological levels of estradiol and progesterone which
      arise from ovarian stimulation may modulate the size of the secondarily recruited follicle
      cohort in the next cycle. In order to explore the relative contribution of sex steroids as
      determinants of the size of the next cycle 'wave' of recruitment further, a second aim of
      this study will be investigate whether limiting the rise in sex steroid levels during ovarian
      stimulation, by co-treatment with aromatase inhibitor impacts on cyclic recruitment.
    

Intervention name(s): Placebo; Letrozole
Intervention type(s): Drug; Drug
Intervention description(s): Adjuvant therapy to recFSH during ovarian stimulation; Adjuvant therapy to recFSH during ovarian stimulation
Other intervention name(s): Lactose Monohydrate; Aromatase Inhibitor
Intervention MeSH terms: Letrozole; Aromatase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin
      elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the
      T-cell activation. These cells are involved in the inflammatory component of the disease.
      This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid
      treatment (commonly used in eczema) in patients with severe atopic dermatitis.
    


Intervention name(s): Pimecrolimus plus topical corticosteroid (TCS); Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)
Intervention type(s): Drug; Drug
Intervention description(s): Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily; twice daily administration
Other intervention name(s): Elidel
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic dermatitis; T-cell; pimecrolimus; children; topical corticosteroids
Relative Bioavailability and Food Effect Study of CVN424
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate
      the Relative Bioavailability of CVN424 Suspension and Tablet Formulations in Healthy
      Volunteers Under Fasted and Fed Conditions.
    

Detailed description: 
      32 healthy male or female participants will be enrolled in 1 of 6 sequences (designated as 1
      through 6, respectively) in an ascending fashion. Sequences 1, 3, 4, and 5 will have 5
      participants each, and Sequences 2 and 6 will have 6 participants each.

      Each sequence will proceed through the three cross-overs (suspension-fasted, tablet-fed, and
      tablet-fasted) according to the schematic above, with dosing to occur on Days 1 of Periods 1,
      2, and 3. Participants in the fasted portion of each sequence will be dosed under overnight
      fasted conditions and will remain fasted for 4 hours post-dose. Water consumption is
      permitted as desired except for 1 hour before and after administration of the Study Drug.

      To assess the effect of food on CVN424 bioavailability in tablet formulation, the single dose
      will be administered after ingestion of a standardized high-fat, high-calorie meal according
      to FDA Guidance for Industry (Food-effect bioavailability and fed bioequivalence studies, Jun
      2022).

      Participants for all sequences will be admitted to the study unit 1 day prior to dosing and
      remain in the unit for safety and pharmacokinetics (PK) assessments through 96 hours
      post-dose. The total confinement period will be 5 nights for each period unless extended at
      the discretion of the Investigator, e.g., for monitoring and/or management of adverse events
      (AEs).

      Once 96-hour post-dose PK has been collected, participants will be discharged from the unit
      for the remainder of the washout period and return the day prior to their next scheduled
      dosing period
    

Intervention name(s): CVN424
Intervention type(s): Drug
Intervention description(s): 150 mg of either tablet or suspension formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia
Condition: Breast Hypertrophy; Pain, Postoperative
MeSH terms: Pain, Postoperative; Hypertrophy
Study type: Interventional

Summary: 
      In breast reduction surgery, pain control is usually performed with tumescent anesthesia,
      thoracic epidural anesthesia, intercostal nerve blocks and paravertebral block applications.
      Tumescent anesthesia is also preferred by plastic surgeons because of the varying risk of
      thoracic epidural anesthesia and paravertebral block applications.

      After the Erector spinae block was first described by Forero in 2016, it was reported to have
      been applied in many cases, including breast surgery.

      It is considered to be a safer block because of the presence of paravertebral block-like
      activity and the location where the needle is guided away from the pleura. The investigators
      aimed to compare postoperative analgesia consumption, pain scores and patient satisfaction of
      erector spine block with tumescent anesthesia in patients who underwent reduction mammoplasty
      operation under general anesthesia in this double-blind prospective randomized study.
    

Detailed description: 
      Patients aged 18-65 years undergoing bilateral reduction mammoplasty. Patients were randomly
      divided into two groups with closed envelope to perform tumescent anesthesia and erector
      spinae block.

      All patients were premedicated with oral midazolam 0.5 mg/ kg preoperatively. All patients
      received standard general anesthesia protocol as induction with 2-3 mg/kg iv propofol and
      1-1.5 mcg/kg fentanyl and 0.6 mg/kg iv rocuronium. Endotracheal intubations were performed
      7.0 or 7.5 endotracheal tubes with the patient in a supine position. Anesthesia maintenance
      was with sevoflurane 0.5/kg/mg remifentanil infusion and in a 50% O2 -50% air mixture.
      Standard monitoring of the patients included of heart rate, invasive systolic, diastolic and
      mean blood pressure and peripheral oxygen saturation and the operating times were recorded.

      At approximately 30 minutes before the end of surgery, 8mg dexketoprofen IV was administered
      to all patients. At the end of the operation, all the patients were performed with iv
      PCA(Patient Controlled Analgesia).

      Demographic data such as age, weight, and height of the patients were recorded. After
      patients informed about pain score NRS (Numeric Pain Rating Scale) and patient satisfaction
      score ( one to ten) recorded by the nurse of PACU and ward.
    

Intervention name(s): Erector Spinae Plane Block; Tumescent Anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Erector Spinae Plane Block was performed; Tumescent Anesthesia was applied
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment