bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare median overall survival of the test arm
      (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent
      gastric cancer.
    

Detailed description: 
      Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per
      year. Advanced gastric cancer (AGC) is considered nearly incurable with less than 10% of
      subjects alive 5 years after diagnosis. Therefore, new treatment regimens are needed for
      subjects with AGC.

      S-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT)
      and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate),
      in a molar ratio of 1(FT):0.4 (CDHP):1(OXO) is commercially available since late 90'in Japan.
      Phase II trials have demonstrated that S-1 is active, as a single agent, for the treatment of
      gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and
      pancreatic cancers. In gastric cancer, phase III trials (JCOG 9912) comparing 5-FU alone and
      CPT-11/CDDP combination are currently underway and these results are awaited. Despite of JCOG
      9912 study is ongoing, 80% of patients of AGC are already treated by S-1, because of high RR
      and convenience use for out-patient basis. P-II studies S-1/CDDP, S-1/CPT-11 and
      S-1/Docetaxel showed high RR(55-76%) and long MST(12-14M). Furthermore, P-III studies are
      already conducted S-1 vs. S-1/CDDP and S-1 vs. S-1/CPT-11 in Japan. The aim of this study is
      to compare S-1/Docetaxel vs. S-1 alone in the patients of AGC. This study is a prospective,
      multicenter, multinational, non-blinded, randomized phase III study.

      Patients: Inoperable or relapse gastric cancer. Informed consent must be obtained in writing
      before treatment. Subjects meeting all of the inclusion criteria and exclusion criteria will
      be considered for enrollment into study. Then patients will be randomly assigned into two
      groups S-1/Docetaxel(Treatment Arm A) or S-1 alone(Treatment Arm B).
    

Intervention name(s): docetaxel + S-1; S-1
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks; S-1 po days 1-28 every 6 weeks
Other intervention name(s): taxotere; TS-1; TS-1
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; advanced gastric cancer; S-1; docetaxel; phase III study
Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital
Condition: Head Injuries With Non Missile Penetrating Objjects
MeSH terms: Craniocerebral Trauma
Study type: Interventional

Summary: 
      A retrospective study was done in Neurosurgery trauma unit, Sohag University. Eighteen
      patients reported with different mechanisms of trauma. All patients clinically tested
      involving neurological evaluation. Computed tomography brain was done for them at the time of
      admission. Cautious removal of the penetrating object with local debridement of surrounding
      tissues including skin, skull, dura and brain tissue and watertight closure of the dura
      should be done. Patients transferred to the Intensive care unit (ICU) for 48 - 72 hours.
    

Detailed description: 
      Traumatic intracranial penetration of foreign non-missile object rarely occurs. Early
      mortality may be caused by hemorrhages, major vascular injury or contusions; while epileptic
      seizures and infections are among the possible complications in later stages. Complete
      excision of the foreign object should be done for all patients and any dural and/or vascular
      injuries should be repaired during surgical treatment.

      Neurological level, hemodynamic and respiratory status at hospital admission, type of
      penetrating the object, pupil size, and reactivity, as the CT findings, all these factors
      will affect the prognosis so they should be evaluated carefully before the decision of the
      line of management. Intracranial infection, CSF leak and recurrent attacks of convulsions are
      the most common complications.

      Our goal in this study to report cases with non-missile penetrating head injuries and
      evaluate the possible predictive factors in a series of 18 patients sustaining penetrating
      head injuries, admitted to our hospital over a period of 2 years, to be used as a guide for
      the surgical management.
    

Intervention name(s): Debridement and dural repair
Intervention type(s): Procedure
Other intervention name(s): Removal of foreign bodies with dural and vascular repair
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Penetrating brain trauma (PBT),Traumatic brain injury (TBI), Intensive care unit, non missile.
Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      Recently, researchers have paid attention to the development of new products such as
      supplements food and nutraceuticals for identify and develop integrative therapies to be used
      in cardiovascular disease. As suggested by literature, some nutritional components (creatine,
      ribose) can enhance the fundamental energy levels for the functioning of the heart muscle and
      can enhance the body's antioxidant capacity through the reduction in free radicals activity,
      one of the main pathogenic mechanisms of these diseases. In this context, the investigators
      have developed a research with the principal purpose to establish whether a supplement of
      creatine and ribose can improve the total work capacity during exercise in a population of
      patients with known ischemic heart disease.
    

Detailed description: 
      The investigators will enroll patients with previous acute coronary syndrome treated for at
      least 30 days by hospital discharge. The treatment regimen of all patients will be optimized
      in accordance with European Society of Cardiology guidelines. Standardized pharmacological
      treatment during cardiac rehabilitation period will include administration of angiotensin
      converting enzyme inhibition (ACE), beta-blockers and antiplatelet blockers. Furthermore, in
      order to keep patients free from angina symptoms, in some cases calcium channel blockers
      and/or nitrates will be used. The investigators will randomize participants into two groups,
      one receiving treatment Creatine, D-Ribose, B1 Vitamin, and B6 vitamin, and one receiving
      placebo in a double blind study design, for 6 months.
    

Intervention name(s): Creatine, D-Ribose, B1 Vitamin, and B6 vitamin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The treatment will consist of taking 2 sachets / day for the first two weeks, and then continuing with 1 sachet/day for the next month.; Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.
Other intervention name(s): Crebox
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Creatine, ribose, ischemic heart disease.
Hypertension and Injury
Condition: Arterial Hypertension; CAD
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Membrane microparticles are submicron fragments of membrane vesicles shed from various cell
      types. Circulating endothelial microparticles have been proposed as markers of endothelial
      injury. However, which mechanical forces contribute to their release is not clear.
    

Detailed description: 
      In a first series subjects (50% hypertensives) with and without arterial hypertension and no
      Coronary Artery Disease (CAD) (n=50) will be recruited. MP subpopulations will be
      discriminated by flow cytometry according to the expression of established surface antigens
      including CD31+/41-, CD144+, and CD62e+. Besides office and ambulatory 24h blood pressure
      measurements, pulse wave analysis will be performed to determine central blood pressure,
      augmentation index (AIX), and pulse wave velocity. Endothelial function (Flow-mediated
      dilation, FMD), arterial pulsatile stretch (fractional diameter changes, FDC), and
      wall-shear-stress (WSS) will be measured in the same segment of the brachial artery (BA) by
      ultrasound. In a second series, the investigators will take measurements in subjects with
      hypertensive crises (SBP>180 mmHg) (n=20) before and after 4h and normalization of arterial
      BP by urapidil. In a third series, the investigators will take measurement in subjects with
      stable CAD (n=10) before and after transfemoral coronary diagnostic angiography.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with or without arterial hypertension
      
Keywords: arterial hypertension; microparticle; endothelial function
The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression
Condition: Psychotic Depression
MeSH terms: Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and effectiveness of the combination of
      aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with
      psychotic major depression.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study.
Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia.
You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Assessment of Talar Cartilage in Patients With Unilateral Traumatic Transtibial Amputation
Condition: Traumatic Amputation of Lower Extremity; Cartilage Degeneration
MeSH terms: Amputation, Traumatic
Study type: Observational

Summary: 
      Increased risk of osteoarthritis (OA) has been previously demonstrated in patients with lower
      limb amputation. Although there are many studies on knee joint of intact limb of amputees in
      the literature, the number of studies on intact foot and ankle is extremely limited. The
      primary aim of the study is to compare the intact talar cartilage, tibialis anterior and
      gastrocnemius muscle thickness measurements of traumatic unilateral transtibial amputee
      patients with that of healthy individuals using ultrasound. The secondary aim is to
      investigate the relationship between cartilage and muscle thickness measurements with
      clinical parameters.
    

Detailed description: 
      Methods: A total of 36 patients with unilateral transtibial amputations and 36 age and body
      mass index (BMI)-matched male controls will be participated in this cross-sectional study.
      Functional performance will be assessed by 6-minute walking distance (in meter). The Foot and
      Ankle Outcome Score (FAOS) will be used for the assessment of the symptoms and the functional
      limitations of the foot and ankle. The health-related quality of life of the subjects will be
      evaluated with Short Form-36 (SF-36). Subjects' talar cartilage, tibialis anterior and
      gastrocnemius muscle thickness measurements will be performed using musculoskeletal
      ultrasound.
    

Intervention name(s): Musculoskeletal ultrasound
Intervention type(s): Other
Intervention description(s): Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 36 patients with unilateral transtibial amputations and 36 age and BMI-matched
        healthy controls
      
Keywords: Amputation; Transtibial; Prosthesis; Cartilage; Muscle
Efficacy of Inhalation Technique Training.
Condition: Asthma; Chronic Obstructive Pulmonary Disease
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional

Summary: 
      Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The aim of the
      study is to determine if short training of inhalation technique in patients with obstructive
      diseases may influence the course of asthma and COPD.
    

Detailed description: 
      Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD
      is based mainly on inhalations. The inhalation technique is the key factor for effective
      management of bronchial obstruction. At the same time, a significant proportion of patients
      with asthma or COPD do not use inhalers properly.

      The aim of the study is:

        -  to analyze the frequency and type of common mistakes in inhalation technique and

        -  to determine the impact of short individual training of inhalation technique on the
           course of asthma and COPD.

      Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in
      the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the
      study.

      The stage of severity (COPD) and control of the disease (asthma), quality of life, proper
      inhaler intake will be assessed at the study onset and at a second visit after 6 months.

      At the second visit all patients will get a short, individual information about the etiology,
      course and general treatment plan of asthma / COPD. Patients will be randomized into two
      groups:

      A. group of patients trained in proper inhalation technique B. group of patients without
      inhalation technique training Control visits will be held 3 and 6 months after training.
    

Intervention name(s): Inhalation technique training
Intervention type(s): Other
Intervention description(s): Training in inhalation technique in asthmatics and COPD patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: asthma and COPD treatment; inhalation techniques; training of inhalation
MyoVista Measurements in Patients With Atherosclerosis and CAD
Condition: Coronary Artery Disease (CAD); Atherosclerosis
MeSH terms: Coronary Artery Disease; Atherosclerosis
Study type: Observational

Summary: 
      The MyoVista system is a novel electrocardiogram technology that provides non-invasive
      assessment of myocardial abnormalities by analyzing energy changes at the cellular level of
      the myocardium.
    

Detailed description: 
      The MyoVista iECG Electrocardiograph is a diagnostic device used to process electrical
      signals transmitted through electrocardiograph electrodes and to detect ischemia
      abnormalities based on electrical waveform, patient data, demographics, algorithmic
      sensitivity and software based informatics. The MyoVista provides the clinician with a
      standard ECG conventional waveform, along with an additional report derived from the
      proprietary informatics exclusive to the MyoVista.

      The device holds a lot of promise for early intervention to properly diagnose and treat
      patients under risk timely and effectively. The MyoVista captures and amplifies signals from
      the myocardial tissue. These signals are then processed and compared to an algorithm that
      looks for certain changes occurring in these processed waveforms. The changes that have been
      identified occur much sooner than those processed by a traditional electrocardiogram (ECG).
      These recordings focus on early detection of myocardial abnormalities by non-linear analysis
      of electrical activity and physiological phenomenon. This novel assessment might be capable
      of detecting subclinical myocardial dysfunction in a variety of heart diseases.

      The study would compare MyoVista results to subclinical measures of atherosclerosis (CAC and
      CT angiography) in 200 subjects at risk for coronary disease. Correlations between the
      MyoVista reading and the presence of calcified plaque, soft plaque, CTA stenosis, will be
      determined.

      This study has the potential to confirm MyoVista as a reliable and sensitive marker of
      atherosclerosis. Findings may provide a strong indication for the value of a MyoVista test to
      confirm CAD in clinical practice, and for the clinical application of MyoVista in management
      of coronary disease and atherosclerosis.
    

Intervention name(s): MyoVista
Intervention type(s): Device
Intervention description(s): The clinical set up of MyoVista™ is identical to that of a traditional 12-lead ECG but it obtains and processes signal information in a way that permits much greater resolution of the electrical activity associated with the myocardium MyoVista.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing cardiac CT for clinical reasons in the outpatient center.
      
Biospecimen description: 
      Cholesterol measurements, Inflammatory markers (Interleukin-6 and C-reactive protein).
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers
Condition: Circadian Rhythm Sleep Disorders
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of VEC-162 compared to
      matching placebo on circadian phase shift and sleep parameters.
    


Intervention name(s): VEC-162
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy
Condition: Patients Undergoing Laparoscopic Nephrectomy
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in
      patients undergoing laparoscopic nephrectomy
    


Intervention name(s): Sufentanil group; Fentanyl group
Intervention type(s): Drug; Drug
Intervention description(s): PCA device containing sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.; PCA device containing fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.
Intervention MeSH terms: Fentanyl; Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: laparoscopic nephrectomy; Patient-controlled analgesia (PCA); sufentanil; fentanyl
Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot, exploratory study is to evaluate the safety, tolerance,
      pharmacokinetics and potential anti-inflammatory activity of an investigational agent,
      HE3286, when administered orally for 29 days to patients with rheumatoid arthritis that are
      taking a stable dose of methotrexate.
    

Detailed description: 
      This is a Phase I/II, open label, dose ranging study of the safety, tolerance, and
      anti-inflammatory activity of HE3286 in patients with rheumatoid arthritis. Patients will
      receive study treatment (one of three open label doses) in addition to their current stable
      dose of methotrexate. Safety (via monitoring of vital signs, physical examination changes,
      ECG results, laboratory results, and adverse events), pharmacokinetics profiles (of HE3286
      and methotrexate) and anti-inflammatory activity will be assessed over a treatment period of
      29 days.
    

Intervention name(s): HE3286; HE3286; HE3286
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HE3286 will be administered orally. Dosing will be 10 mg per day for 29 days.; HE3286 will be administered orally. Dosing will be 20 mg per day for 29 days; HE3286 will be administered orally. Dosing will be 40 mg per day for 29 days
Other intervention name(s): Triolex; Triolex; Triolex
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase I; safety; tolerance; rheumatoid arthritis; pharmacokinetics; methotrexate; anti-inflammatory
Parent Mentors Using Positive Deviance in Childhood Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      A feasibility study randomizing participants (parents of children age 2-5 years old) to
      receive either education or a parent mentor with the aim of improving health behaviors and
      improving their body mass index z-score.
    


Intervention name(s): Promotion of positive deviance behaviors; Promotion of healthy behaviors
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Using locally derived positive deviance findings to inform a behavioral intervention; Using standardized healthy behavior education (EatPlayGrow curriculum from NHLBI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Positive deviance; Peer mentors
Crossover Study to Evaluate the PK Effects of Two Different Wafer Administration Protocols.
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will look at whether it is preferable to administer two wafers simultaneously or
      separately.
    


Intervention name(s): Sublingual ketamine wafers
Intervention type(s): Drug
Intervention description(s): Two sublingual ketamine 25 mg wafers
Other intervention name(s): Wafermine
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment