bioihbjkbjnl/mcl2 huggingface dataset:
Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS
      mutations and tumor sideness in patients with metastatic colorectal cancer treated with
      regorafenib and FOLFIRI as a third- or fourth-line setting.
    

Detailed description: 
      Primary objective:

      Progression-free survival

      Secondary objecive:

      Overall survival, best objective response, disease control rate and adverse events

      Number of Subjects: 41 patients with metastatic colorectal cancer treated with regorafenib
      and FOLFIRI as a third- or fourth-line setting.

      Plan of the Study:

        1. This is a retrospective study.

        2. Study Schedule Study date: the time getting approval letter issued by both regulatory
           authority and institutional review board (IRB). Duration of the study: 5 years.

        3. Duration of Treatment: Treatment was administered until disease progressed.
    

Intervention name(s): Regorafenib; UGT1A1 genotyping (TA6/TA6); UGT1A1 genotyping (TA6/TA7); UGT1A1 genotyping (TA7/TA7)
Intervention type(s): Drug; Genetic; Genetic; Genetic
Intervention description(s): Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle; The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2; The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2; The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
Other intervention name(s): stivarga
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EGFR; KRAS; tumor sideness; FOLFIRI; regorafenib; metastatic colorectal cancer
Streptococcus Dentisani Colonization Capacity in a Split Mouth Model
Condition: Oral Health
Study type: Interventional

Summary: 
      Pilot study with healthy subjects to test the in vivo potential colonization ability of S.
      dentisani. Phase I, exploratory, prospective, mechanistic pilot clinical trial with two
      parallel follow-up groups. Probiotic will be applied topically as an adhesive gel with a
      dental splint under different dosing regimes. Saliva and plaque samples will be obtained at
      day 0, 14 and 28.
    

Detailed description: 
      Phase I study, exploratory, prospective, mechanistic, to evaluate the capacity of

      Streptococcus dentisani CECT 7746 of colonizing the tooth surface. The study will be carried
      out with 10 healthy subjects divided into two groups (n = 5 per group) that differ in the
      number of applications of probiotic:

      Group A: participants who will receive a single application of the product during the initial
      visit Group B: participants who will receive 7 applications on consecutive days, with the
      first in the start visit. Probiotic will be applied topically as an adhesive gel with a
      dental splint under different dosing regimes.The total dose received will be the same for
      both groups, and the total duration of the follow-up will be of 4 weeks from the first
      application also for both groups.

      On day 0: Participants who meet the inclusion and exclusion criteria will be randomized in
      one of the two groups. Saliva and plaque samples will be obtained by the dentist, and all the
      participants will receive an professional teeth cleaning in one half of the mouth (quadrants
      1-4). Afterwads, treatment will be applied by the dentist according to assigned group, and
      the randomized participants in the multiple-dose group will be explained how to perform the
      six successive applications at home every 24 hours.

      On day 14: follow-up visit, saliva and plaque samples will be obtained from all participants.
      Patient assigned to the multi-dose group will return the used material On day 28th: final
      visit, saliva and plaque samples will be obtained.
    

Intervention name(s): Streptococcus dentisani CECT7746
Intervention type(s): Other
Intervention description(s): Treatment will be applied topically as an adhesive gel with a dental splint
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase I, exploratory, prospective, mechanistic pilot clinical trial with two parallel follow-up groups that differ in the number of treament applications.
Masking: None (Open Label)
Primary purpose: Other
Keywords: oral health; Streptococcus dentisani
Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome
Condition: Dry Eye
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to access the possible beneficial effects of oral use of
      pilocarpine in relieving signs and symptoms of patients with Sjogren's syndrome
    

Detailed description: 
      After being informed about the study, its potential risks and having signed the informed
      consent form, this placebo-controlled, crossover study involved patients with Sjögren's
      syndrome to use oral pilocarpine or placebo for ten weeks and after two weeks of medication
      withdrawal, to invert the treatment for the same period of time. The assessments applied were
      the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time,
      traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and
      rose bengal dyes, Schirmer test, and tear ferning test. Side effects observed during the
      treatment period were also assessed.
    

Intervention name(s): Pilocarpine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral pilocarpine hydrochloride 5mg tablets were administered four times a day for 10 weeks to half the group of selected patients. The other half ingested placebo in the same way. At the end of this period and after two weeks of washing out the medications, the patients had to invert the treatments.; Placebo
Other intervention name(s): Salagen
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a placebo-controlled, crossover study that involved patients with Sjögren's syndrome to use 20mg/day of oral pilocarpine or placebo for ten weeks and after two weeks of medication withdrawal, to invert the treatment for the same period of time. The assessments applied were the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time, traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and rose bengal dyes, Schirmer test, tear ferning test, osmolarity and the activity of lysozyme. R
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dry eye; Sjogren; pilocarpine hydrochloride
An Epidemiological Study to Assess the Psychosocial and Symptomatic Remission and Community Integration Status in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      The purpose of this study is to estimate the level of symptomatic and psychosocial remission
      of patients with schizophrenia and schizoaffective disorder in standard clinical practice as
      a function of the degree of adherence to antipsychotic treatment. The secondary objectives
      are to study the level of community integration of the patients included in the study, and
      its influencing factors, to analyze the role of various sociodemographic factors, factors
      related to the course of disease and the psychopathological status of the patient in
      community integration and remission, to analyze the potential predictors of a favorable
      course (symptomatic and psychosocial remission) and a poor course (no symptomatic or
      psychosocial remission), to assess the impact of treatment adherence on the change in the
      functional and community integration status of patients (based on the occupation,
      independence level, and degree of disability variables), to assess the significance of
      premorbid (academic and social) adjustment in the symptomatic and functional remission and
      the community integration status of patients and to correlate the level of insight to the
      remission and integration status of patients.
    

Detailed description: 
      This is a retrospective, cross-sectional, non-interventional observational, cohort
      epidemiological study conducted in the outpatient mental health facility setting in patients
      with schizophrenia. The inclusion of two patient cohorts is contemplated, recruited in mental
      health facilities. One cohort will involve patients estimated to have inadequate adherence to
      antipsychotic treatment, while the other will consist of patients with adequate adherence to
      such treatment. N/A
    

Intervention name(s): Patient assessment
Intervention type(s): Other
Intervention description(s): 2 scales will be used to assesss the remission of schizophrenia (APA scale and PSRS scale). The BPRS scale will be used to assess the clinical integration of patients.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients seen in Spanish outpatient mental health facilities, with schizophrenia or
        schizoaffective disorder
      
Keywords: Schizophrenia; Schizoaffective Disorder; Remission; Psychosocial; Symtomatic; Integration; Schizoaffective; Adherence
A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly
      version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide
      once weekly in Japanese patients. This study is designed to evaluate safety and tolerability
      of exenatide once weekly in Japanese patients and determine whether the dose selected for US
      and European development is appropriate for Japanese patients with Type 2 diabetes.
    


Intervention name(s): exenatide once weekly; placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, once weekly; subcutaneous injection, once weekly
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: exenatide; Byetta; diabetes; Amylin; Lilly
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence
      of two formulations of biphasic insulin aspart 50 in healthy male subjects.
    


Intervention name(s): biphasic insulin aspart 50
Intervention type(s): Drug
Intervention description(s): A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ADVANCED Phase II Trial of Weekly vs 3 Weekly Docetaxel and Cisplatin Followed by Gemcitabine in Non-small-cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, open-label, randomized phase II trial whose aim is to assess the
      antitumor activity of two sequential schedules of docetaxel and cisplatin followed by
      gemcitabine.
    


Intervention name(s): Docetaxel and cisplatin followed by gemcitabine; docetaxel and cisplatin followed by gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): docetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles; docetaxel 25 mg/m2 day 1,8,15 + cisplatin 25 mg/m2 days1,8,15 repeated every 28 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles.
Intervention MeSH terms: Cisplatin; Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to
      evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and
      administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U
      cartridge.
    


Intervention name(s): Technosphere® Insulin 10U + 20U; Technosphere® Insulin 30U
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Insulin; Inhaled Insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks to explore the feasibility, sensitivity, validity, and specificity of a
      Remote Wireless Sensor Network (RWSN) approach to the detection of cocaine use/intoxication
      in the inpatient human laboratory, as well as in the outpatient setting ("real world").
      Lastly, we look to design an algorithm for reliably detecting cocaine use in real-world
      settings and inference techniques for understanding the relationship between cocaine use and
      user contexts.
    


Intervention name(s): Cocaine hydrochloride; Exercise; Nicotine
Intervention type(s): Drug; Behavioral; Drug
Intervention MeSH terms: Cocaine; Nicotine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Fast Identification of Pathogen in the Setting of Pneumonia Using Multiplex PCR
Condition: Acute Lower Respiratory Tract Infection; Pneumonia
MeSH terms: Pneumonia; Respiratory Tract Infections
Study type: Observational

Summary: 
      With this study the investigators want to determine, if a fast identification of germs,
      causing infections of the lower respiratory tract, is possible through the use of Multiplex
      PCR technology - a method that allows on time detection of bacteria in medical specimen by
      identifying DNA sequences that are known to be specific for the respective microbe. Therefore
      aspiration samples from the respiratory tracts of ventilated patients, which are suspected to
      develop such an infection, will be collected and analyzed by using a multiplex PCR
      (polymerase chain reaction) application situated on the intensive care unit. The
      investigators want to determine if Multiplex PCR diagnostic could be a faster alternative to
      conventional microbiological methods. The results of the Multiplex PCR analyses therefore
      will be compared with results of conventional microbiological methods.
    

Detailed description: 
      In this clinical observational study it is to be investigated if Multiplex PCR analyses of
      clinical samples from ventilated critically ill patients could be a fast and accurate
      alternative to conventional microbiological diagnostic methods in the identification of human
      pathogenic microbes in the setting of pneumonia. Therefore aspiration samples from intubated
      and ventilated critically ill patients, which are suspected to develop such an infection,
      will be collected and analyzed by using a multiplex PCR application situated on the intensive
      care unit. The samples will be investigated for DNA sequences that are known to be specific
      for pneumonia causing microbes. Analyses will take place in a point of care setting and will
      be carried out by intensive care physicians. According to the standard protocols of our
      intensive care units, conventional microbiological investigations, including MALDI-TOF, will
      be carried out parallel to the Multiplex PCR analyses.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients will be recruited from two intensive care units of the university hospital.
      
Biospecimen description: 
      aspiration samples from the respiratory system (tracheal secretion sample, BAL) containing
      microbial DNA
    
Keywords: multiplex PCR; MALDI-TOF; pneumonia; microbiological investigation; intensive care
Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults
Condition: HIV Infection
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of an immune response to an
      investigational HIV vaccine, ADMVA, at three different dosage levels, in adults who are not
      infected with HIV
    

Detailed description: 
      This is a dose escalation trial. Study site staff and volunteers will be blinded. Blinding
      will not apply to the assignment of dose levels (low, middle or high).

      Volunteers will be screened up to 42 days before enrolment and will be followed for 18 months
      after the first vaccination.

      16 volunteers will be randomized in a 3:1 ratio of active vaccine to placebo. Safety and
      tolerability of the ADMVA vaccine/placebo will be evaluated at least 14 days after the 12th
      volunteer in the low dose group receives the second injection before proceeding to the middle
      dose group.
    

Intervention name(s): ADMVA
Intervention type(s): Biological
Intervention description(s): experimental HIV vaccine, MVA vector expressing HIV clade C env, gag, pol, nef, and tat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine
Predicting Infant Extubation Using Diaphragm Surface Electromyography
Condition: Infant, Newborn, Disease
MeSH terms: Infant, Newborn, Diseases
Study type: Observational

Summary: 
      This study aims to assess whether the electrical signal of the diaphragm (diaphragm
      electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of
      the lungs) can predict which infants will be successfully extubated (have the breathing tube
      removed without needing it replaced.)
    

Detailed description: 
      This study aims to assess whether the electrical signal of the diaphragm (diaphragm
      electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of
      the lungs) can predict which infants will be successfully extubated (have the breathing tube
      removed without needing it replaced.)
    

Intervention name(s): Recording of diaphragm EMG
Intervention type(s): Device
Intervention description(s): Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants mechanically ventilated on NICU without major congenital abnormalities
Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers
Condition: Healthy Subjects; Dyslipidaemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effects of single and repeat doses of GSK256073
      with placebo in HVT subjects.
    


Intervention name(s): GSK256073A tablets
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: Dose Escalation; GSK256073A,
Evaluation of Oral Midazolam in First-trimester Surgical Abortions
Condition: Pain; Anxiety; Nausea
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the level of pain, anxiety and side effects that
      women experience with a surgical abortion and the effect that the anti-anxiety medication,
      midazolam, might have when used along with ibuprofen and a paracervical block (PCB) instead
      of the standard pain treatment of only ibuprofen and a PCB.
    

Detailed description: 
      Women in the study will be randomized to receive either midazolam or placebo. Every
      participant will still receive the standard oral medications for pain (ibuprofen) as well as
      an injection of numbing medicine (lidocaine) near the cervix (PCB). The co-primary outcomes
      are patient perception of anxiety and pain with uterine aspiration reported on a 100 mm
      visual analogue scale (VAS). Secondary outcomes include reported anxiety and pain at time
      points before, during, and after the procedure, as well as subject satisfaction with anxiety
      and pain control and overall abortion experience. Due to the dose-dependent anterograde
      amnesic effect of midazolam, we will also investigate the effects on memory and recall, which
      has not previously been studied. In addition, we will also collect data on side effects
      frequently associated with oral midazolam such as nausea and sleepiness. Women will also be
      responsible for completing a one-page survey 1-3 days after the procedure visit and return it
      by mail using a pre-addressed and stamped envelope.
    

Intervention name(s): Midazolam; Ibuprofen; Placebo-Cherry syrup; Lidocaine
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure; 800 mg oral ibuprofen 30-60 minutes prior to procedure; 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure; injection of 20 mL 1% lidocaine without epinephrine
Other intervention name(s): Versed; Motrin; placebo cherry syrup; lidocaine injection
Intervention MeSH terms: Ibuprofen; Lidocaine; Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain; anxiety; surgical abortion; midazolam; benzodiazepine