bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg
      and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered
      alone in health male volunteers.
    


Intervention name(s): DP-R207; Rosuvastatin; Ezetimibe
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: DP-R207; Rosuvastatin; Ezetimibe
TAC Versus TC for Adjuvant Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to find out what effects (good and bad) TC or TAC has
      on early stage HER2- breast cancer.
    

Detailed description: 
      Both TAC (docetaxel, doxorubicin, and cyclophosphamide) and TC (docetaxel and
      cyclophosphamide) are established adjuvant chemotherapy regimens for early stage breast
      cancer. TAC, however, due to the inclusion of the anthracycline doxorubicin, carries a high
      risk of hematologic and cardiotoxic adverse effects. Substantial evidence supports the
      concept that early stage HER2-negative breast cancers will benefit similarly from
      anthracycline-based adjuvant and non-anthracycline-based chemotherapy.

      Further, approximately 0 to 9% of HER2-negative breast cancers have alterations in the TOP2A
      gene, which may predict for benefit from anthracycline-based chemotherapy.

      We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the
      treatment of early stage HER2-negative breast cancer and that TC will have less toxicity. If
      this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the
      regimen while obtaining similar efficacy in this population of patients, it would not only be
      an important advance in the understanding of the biology of cancer, but it would also be of
      significant clinical benefit to women with breast cancer.
    

Intervention name(s): Docetaxel; Doxorubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide; • Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).; 600 mg/m2 IV over 15-30 minutes on Day 1.
Other intervention name(s): Taxotere; Adriamycin; Cytoxan
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Age and Gender on the Advantage of Sniffing Position for Laryngoscopic View
Condition: Laryngeal View
Study type: Observational

Summary: 
      The sniffing position has been regarded as a standard position for direct laryngoscopic view.
      This study evaluated the effects of the age and gender on the advantage of the sniffing
      position compared with simple head extension for laryngeal view during direct laryngoscopy.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult patients who are scheduled for elective surgery under general anesthesia
Position and Communication Skills Simulation
Condition: Comparing to Effect Two Simulation Models
Study type: Interventional

Summary: 
      The goal of this study was to compare two different simulation applications in developing the
      positioning skill, one of the most common nursing practices, and the communication skill,
      which forms the basis of nursing practices.
    


Intervention name(s): Standard patient simulation model
Intervention type(s): Other
Intervention description(s): Nursing students were trained with a standard patient simulation model for position and communication skills education.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The population of the study consisted of 112 second-semester nursing students who took the "Nursing Fundamentals" course in the spring semester of the 2021-2022 academic year, and the sample included volunteers who took the course for the first time. A power analysis was performed on the G*Power (v3.1.7) software to determine the sample size. The power of a study is expressed as 1-β (β = probability of type II error), and in general, studies should have 80% power. According to Cohen's effect size coefficients, assuming that the evaluations between two independent groups would have a large effect size (d = 0.8), the sample size was calculated as 60 subjects. Students were randomly assigned to groups using computer software.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Standardized patient; Simulation; Nurse; Positioning skills; Communication skills
Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of esketamine compared to placebo on
      driving performance as assessed by the mean difference of standard deviation of lateral
      position (SDLP) from an on-road driving test in healthy participants.
    

Detailed description: 
      This is a Phase 1, randomized (study medication assigned to participants by chance),
      double-blind (neither Investigator nor participant knows which treatment the participant
      receives), placebo-controlled (placebo is an inactive substance that is compared with a drug
      to test whether the drug has a real effect in a clinical trial), single-center, single-dose
      and 3-way crossover (the same medications provided to all participants but in different
      sequence) study of esketamine in healthy participants. Participants will be randomly assigned
      to 1 of 6 treatment sequences. The study will consist of 3 parts: Screening Phase (between 21
      days and 1 day prior to the first dose administration), a 3-way crossover double-blind,
      single dose treatment Phase (45 days) and follow-up Phase (7 to 10 days after last dose
      administration). The maximum study duration for each participant will not exceed 7 weeks.
      Participants will receive either Treatment A (esketamine 84 milligram (mg) intranasal and 1
      placebo capsule), Treatment B (placebo intranasal and 1 mirtazapine 30 mg capsule) or
      Treatment C (placebo intranasal and placebo capsule) in each treatment period. Driving
      performance will be assessed primarily by the mean difference of SDLP from an on road driving
      test. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Esketamine; Mirtazapine; Placebo (Matched to Esketamine); Placebo (Matched to Mirtazapine)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.; Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.; Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.; Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
Other intervention name(s): JNJ-54135419
Intervention MeSH terms: Mirtazapine; Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy; Esketamine; Mirtazapine; Psychomotor.
Improving Asthma Care for Very Low Birth Weight Infants
Condition: Asthma
MeSH terms: Asthma; Birth Weight
Study type: Interventional

Summary: 
      Children born less than 1500 grams are being enrolled into a study to test the effectiveness
      of a parental educational intervention in reducing the risk of future breathing problems. The
      intervention teaches parents of these children how to reduce the risk of / and recognize
      breathing problems.
    


Intervention name(s): Asthma education for parents of very low birth weight infants
Intervention type(s): Behavioral
Intervention description(s): Asthma education is provided to parents of children in the experimental group prior to nicu discharge.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Blackcurrant Supplementation on Eye Health
Condition: Eye Strain; Eye Fatigue
MeSH terms: Asthenopia; Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the potential for supplementation with black currant
      to support eye health among otherwise healthy adult women who spend 6+ hours per day using
      digital screens.
    

Detailed description: 
      Women who are informed about the study and provide informed consent will be randomized to one
      of two groups: supplement and placebo. Group assignment will be a 1:1 ratio to supplement
      (455mg of blackcurrant standardized to 50mg anthocyanins in 2 capsules/day) or placebo (2
      capsules/day). Outcomes will be assessed at baseline and again on day 70.
    

Intervention name(s): Blackcurrant; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Two capsules containing 455mg of CurrantCraft 11% black currant extract.; Two capsules containing an inert material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: black currant; blackcurrant; Ribes nigrum; digital eye fatigue; eye health; computer vision syndrome; dietary supplement
Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multiple vaccination study to find out if it is a safe treatment and what effects
      it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80
      years. Approximately 40 study sites in Europe will be involved. Patients will be randomized
      to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.
    

Detailed description: 
      AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component
      is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.
    

Intervention name(s): active: AFFITOPE AD02; control: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): vaccination; vaccination
Other intervention name(s): AFFITOPE AD02; placebo; control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bipolar Proteomic Assay Validation Study
Condition: Major Depressive Disorder, Bipolar I and Bipolar II
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this study is to validate a set of signatures, based on a panel of proteomic
      markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive
      episode.
    

Detailed description: 
      This is a hypothesis-driven confirmatory study to validate the diagnostic signature (model)
      for distinguishing BDI from MDD that also aims to optimize the models to discriminate BDII
      from MDD and BDI. A binary classification model, using linear discriminant analysis and based
      on 13 a priori-defined proteomic markers will aim to distinguish BDI from MDD. An alternative
      binary classification model based on multiple logistic regression and using 10 a priori
      -defined proteomic markers will aim for the same result. To improve the predictive
      performance of the signatures, items from self-report mood rating scales and
      treatment-emergent changes in proteomic markers will be analyzed. In addition, the study will
      examine if baseline or early treatment-emergent changes in proteomic markers predict
      treatment response.
    

Intervention name(s): Diagnostic test (LDT)
Intervention type(s): Other
Intervention description(s): Proteomic assay
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients seeking treatment for new on-set depression from academic programs and affiliated
        community mental health facilities (inpatient and outpatient
      
Biospecimen description: 
      Whole blood
Effects of Cyclooxygenase (COX) 1-2 Inhibitors on Prevention of Rocuronium Injection Pain
Condition: Injection Site Irritation
Study type: Interventional

Summary: 
      Purpose : The aim of the study is to investigate the effects of cox inhibitors as a rescue
      agent against the rocuronium pain Methodology : Sixty patients enrolled for the general
      anesthesia enrolled in this study. Patients were allocated into two groups (Group 1:
      Dexketoprofen group, Group 2: Control group) .Pain was evaluated by during rocuronium
      injection, patients were scored by a scale showed below.

      0;No movement response to injection

        1. Mild movement response to injection

        2. Hand withdrawal response to injection

        3. Arm withdrawal response to injection Investigators also evaluated the pain with 2
           questions when the patient was in the recovery room.

      Question 1.What was the last feeling before participants fall into sleep? question 2. Did
      participants feel any pain on participants's hand during medication injection for anesthesia?
    

Detailed description: 
      Purpose : Rocuronium bromide is a painful agent while general anesthesia induction. The aim
      of the study is to investigate the effects of cox inhibitors as a rescue agent against the
      rocuronium pain Methodology : Sixty patients enrolled for the general anesthesia enrolled in
      this study. Patients were allocated into two groups (Group 1: Dexketoprofen group, Group 2:
      Control group) .Pain was evaluated by during rocuronium injection, patients were scored by a
      scale showed below.

      0;No movement response to injection

        1. Mild movement response to injection

        2. Hand withdrawal response to injection

        3. Arm withdrawal response to injection Investigators also evaluated the pain with 2
           questions when the patient was in the recovery room.

      Question 1.What was the last feeling before participants fall into sleep? question 2. Did
      participants feel any pain on participants's hand during medication injection for anesthesia?
    

Intervention name(s): Dexketoprofen (KETAVEL 50 mg/2 ml); Saline (Isotonic Saline Solution 0.9% )
Intervention type(s): Drug; Drug
Intervention description(s): intravenous dexketoprofen (KETAVEL 50 mg/2 ml); intravenous 2 ml of saline
Intervention MeSH terms: Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: dexketoprofen, pain, rocuronium
Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether individuals with schizophrenia who will
      take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in
      their symptoms.
    

Detailed description: 
      Individuals with schizophrenia often experience disturbing residual symptoms, even with the
      best available current treatments. Homocysteine, normally found in the body, can interfere
      with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms
      of schizophrenia. This double-blind protocol will have study participants who suffer from
      schizophrenia take either a high-dose combination of folate, B12 and pyridoxine (a
      combination that can lower homocysteine in the body) or placebo for three months. Clinical
      measures (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin
      combination experience clinical benefit.
    

Intervention name(s): Capsule with folate, Vitamin B12 & pyridoxine; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): placebo capsule
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin; Pyridoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective Disorder; Homocysteine; Vitamins
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective
      treatment for ulcerative colitis after 52 weeks of treatment.
    


Intervention name(s): Etrasimod; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
A Study of JNJ-61393215 in Healthy Japanese Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      after single dose administrations of JNJ-61393215 in Japanese healthy adult male
      participants.
    


Intervention name(s): JNJ-61393215; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-61393215 will be administered orally.; Placebo will be administered orally.
Other intervention name(s): Orexin-1
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 16-week research study in which participants suffering from Social Anxiety Disorder
      (SAD) will receive Sertraline (a medication FDA approved for the treatment of SAD) for the
      first 8 weeks. If a participant remains symptomatic, he/she will enter the second phase of
      the study in which he/she continues taking Sertraline but also randomly receives either
      Seroquel or placebo in conjunction with Sertraline for additional 8 weeks. The purpose of
      this study is to determine the efficacy of adjunctive Seroquel in treating SAD.
    

Detailed description: 
      This will be a single-site study aimed at evaluating the safety, tolerability, and efficacy
      of quetiapine as compared to placebo in the treatment of generalized anxiety disorder. This
      will be an 8-week open-label sertraline trial followed by a randomized double-blind
      placebo-controlled, parallel-group prospective study. Participants will first receive
      sertraline (25-200 mg/day) for 8 weeks. Patients who remain symptomatic - are considered
      refractory - and meet inclusion criteria will be randomized and enter the double-blind phase.
      They will receive either adjunctive quetiapine (25-400 mg/day) or placebo for 8 weeks. The
      primary outcome measures are change in the Liebowitz Social Anxiety Scale(LSAS) and Clinical
      Global Impression of Improvement (CGI-I) scores. The proposed sample size is 80 subjects.
      Patients will be discontinued from the study if needed due to ineffectiveness or excessive
      side effects. Measurements of changes in efficacy and side effects will be carried out every
      weekly visit. Enrollment will occur over 12 months.
    

Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention description(s): Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Alpha-type-1 Dendritic Cell-based Vaccines in Patients With Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the administration, safety and immunologic
      effectiveness of an experimental vaccine for colorectal cancer patients.
    

Detailed description: 
      Dendritic cell (DC)-based vaccination, usually administered by a traditional intradermal
      route, is a new treatment option for cancer patients. While the previous DC-based vaccination
      trials have shown the safety of this approach and its ability to induce objective clinical
      responses, the overall efficacy of DC-based vaccines is still disappointing (Rosenberg et
      al., 2004). We hypothesize that the two likely causes of such limited clinical activity are:
      A) suboptimal type of DCs used as a vaccine and B) suboptimal modes of use of such vaccines
      that do not allow the vaccinated patients to fully benefit from DC biology.

      We will conduct a pilot evaluation of the therapeutic vaccination with DC1s loaded with
      autologous tumor material, in patients with metastatic colorectal cancer that have been
      resected to no or minimal evidence of disease.The proposed evaluation of the novel
      intralymphatic route of DC-based vaccination will allow us to administer the vaccine in a way
      that is more physiologic with respect to the kinetics of antigen appearance to the lymph
      nodes and is feasible to be performed in repetitive fashion, without damaging local lymph
      nodes.
    

Intervention name(s): DC-based vaccine; DC-based vaccine; DC-based vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 4 intradermal injections once a day for 4 days.; Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 1 intranodal injection.; Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of a 4-day intralymphatic infusion.
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal