cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Model-Based CBRN Training Program

The aim of the study is to evaluate the effect of the Education Program based on the Mastery Learning Model for Chemical, Biological, Radiological, and Nuclear threats and hazards (MLM-CBRN Education Program) on student nurses' knowledge, attitude, self-efficacy, and skill development in chemical, biological, radiological and nuclear threats and hazards. The complete experimental design type was used in the study.

The aim of the study is to evaluate the effect of the Education Program based on the Mastery Learning Model for Chemical, Biological, Radiological, and Nuclear threats and hazards (MLM-CBRN Education Program) on student nurses' knowledge, attitude, self-efficacy, and skill development in chemical, biological, radiological and nuclear threats and hazards. The complete experimental design type was used in the study. The study sample comprised 104 4th-year nursing students (52 in the experimental group, 52 in the control group). The MLM-CBRN Education Program was carried out with the students in the experimental group face-to-face as theoretical and practical education once a week for four weeks. As a criterion for starting a new unit, 80% of the participants needed to receive minimum 70 points from the unit follow-up tests in line with the "Learning Objective" determined within the scope of the Mastery Learning Model. The data were collected before and right after the intervention and in the 1st and 3rd months after the intervention using the "Personal Information Form," "Nursing Student CBRN Knowledge Test," "Nursing Student CBRN Attitude Scale," and "Nursing Student CBRN Self-Efficacy Scale." Moreover, only the knowledge scores of the students in the experimental group were collected using the unit follow-up tests, which enabled us to check whether the "Learning Objective" related to the unit taught was achieved. During the skill training, the "START Triage and JumpSTART Triage Skill Check List," Gas Mask Wearing-Removing Skill Check List, and Level C Clothes Wearing-Removing Skill Check List were scored for each student in the experimental group after observing the students twice.

Eligibility Criteria:
Inclusion Criteria:

* Being a senior nursing undergraduate student
* Not having received CBRN training

Exclusion Criteria:

* Be a full-time worker in a healthcare institution
* Having taken courses on disaster and CBRN
Adolescent Idiopathic Scoliosis and Body Schema

Adolescent idiopathic scoliosis is the most common form of scoliosis. Although an increasing number of studies suggest that an abnormal sensory-motor integration critically contributes to the cause of adolescent idiopathic scoliosis , there is uncertainty about the level of the central nervous system explaining this dysfunction. Therefore, the planned master's thesis study aims to compare proprioception, tactile acuity, right-left reasoning ability, motor imagery ability, including the evaluation of body schema, which is a sensorimotor representation in adolescent idiopathic scoliosis patients with healthy individuals. In addition, the relationship of these markers with posture results, body perception and quality of life of individuals with adolescent idiopathic scoliosis will be investigated as a secondary aim.


Eligibility Criteria:
Inclusion Criteria (Adolescent idiopathic scoliosis)

* Diagnosis of Adolescent idiopathic scoliosis
* Age ⩾19 years old
* Curve severity over 10°

Exclusion Criteria (Adolescent idiopathic scoliosis)

* History of spine surgery
* Surgery or trauma
* Secondary scoliosis
* Unable to fill out the questionnaires or attend the physical examination,
* History of musculoskeletal injury in the last six months
* Known systematic and psychological illness
* Use of prescription medication

Inclusion Criteria (adolescent healthy/untreated population)

-Age ⩾ 19 years Matched for age/height/weight (+/-5 years; +/- 10 lbs; +/- 10cm) to a scoliosis participant

Exclusion Criteria (adolescent healthy/untreated population)

* History of spine surgery
* Spine deformity
* Surgery or trauma
* Primer and Secondary scoliosis
* Unable to fill out the questionnaires or attend the physical examination,
* History of musculoskeletal injury in the last six months
* Known systematic and psychological illness
* Use of prescription medication
Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)

The purpose of this study is to estimate the effect of filibuvir on the pharmacokinetics of ethinyloestradiol \[EE\] and levonorgestrel \[LN\], to assess the safety and tolerability of 600 mg BID of filibuvir in healthy women and to investigate the pharmacokinetics of 600 mg BID of filibuvir in healthy women.

To investigate the effects of multiple oral doses of filibuvir on the steady state pharmacokinetics of oral contraceptive steroids in healthy female subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects between the ages of 18 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Subjects must have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1.
* Body Mass Index (BMI) of approximately 17.5 to 30.5 kg/m2; and a total body weight \>45 kg.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
* Must be willing to practice an alternative method of contraception for the duration of the study in addition to oral contraceptive use.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any medical reason which would contraindicate the administration of oral contraceptives (as per label). Including but not limited to history of unexplained vaginal bleeding, current breast cancer, active liver disease, uncontrolled hypertension, history of diabetes with vascular complications, history of venous thrombosis, stroke, ischemic heart disease, history of severe headaches with focal neurologic symptoms.
* Female subjects of non-childbearing potential who meet the following criteria:
* Post menopausal, aged between 45-55 who have been amenorrheic for \>2 years and who meet the criteria for serum FSH levels (\>30 IU/L), or
* Females who have undergone a hysterectomy, or
* Females who have undergone tubal ligation, or
* Females who have undergone bilateral oophorectomy.
* History of discontinued use of oral contraceptives for medical reasons.
* History of febrile illness within 5 days prior to the first dose.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
This is a Study to Evaluate the Safety and Tolerability of the Study Drug ABL001, and to Determine the Maximum Tolerated Dose and/or Recommended Phase 2 Study Dose of ABL001

The purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV1501 (ABL001).

This is an open-label, Phase 1 dose escalation and expansion study of NOV1501 (ABL001) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of ABL001 in patients with advanced solid tumors after failure of standard of care.

Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs will be assessed as the primary endpoint in this trial.

Eligibility Criteria:
Inclusion Criteria:

* ≥19 year old patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
* Lesions measured by tumor markers or by CT/MRI must be evaluable based on response evaluation criteria in solid tumors (RECIST) version 1.1.
* Life expectancy ≥12 weeks
* ECOG performance status ≤2
* Women of childbearing potential must have a negative pregnancy test outcome
* Patients must provide written informed consent to voluntary participation in this study.

Exclusion Criteria:

* History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class
* Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
* New York Heart Association (NYHA) class ≥II congestive heart failure (CHF)
* Persistent, clinically significant NCI-CTCAE v4.03 Grade ≥2 toxicities from the previous anticancer therapy
* Severe infections or severe traumatic systemic disorders
* Symptomatic or uncontrolled central nervous system (CNS) metastasis
* Pregnant or lactating women or patients planning to become pregnant during the study
* Participation in another clinical trial within 30 days prior to screening
* Administration of antiplatelets or anticoagulants within 2 weeks prior to screening
* Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
* HIV or other severe diseases that warrant the exclusion from this study
* Peritoneal and/or pleural fluid drainage within 28 days prior to screening
* History of hemoptysis within 28 days prior to screening
* Serious, untreated scar, active ulcer, or untreated fracture
A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.


Eligibility Criteria:
Inclusion Criteria:

* Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
* Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
* Tumor considered potentially resectable
* Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
* No prior therapy for lung cancer
* Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
* Life expectancy of at least 6 months
* Organs are functioning well (bone marrow reserve, liver, kidney, lung)
* Signed Informed Consent
* Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.
* Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.
* Be fit for surgery at the time of enrollment

Exclusion Criteria:

* Receiving or have received an investigational drug or device within the last 30 days
* Have previously completed or withdrawn from this study or any other study investigating pemetrexed
* Serious concomitant systemic disorder
* Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
* Receiving concurrent administration of any other anticancer therapy
* Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
* Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day
Effects of a Psycho-corporal Training on Postural and Cognitive Dual-task Performances in Patients With Schizophrenia

Beside these well-known symptoms (positive symptoms (such as delirium and delusions), negative symptoms (such as affective flattening and impoverishment of speech), disorganized behavior, patients with schizophrenia show different kinds of cognitive alterations and motor abnormalities. In schizophrenia, postural impairment could increase the attentional cost of daily motor tasks, leading to a lack of attentional resources, essential to achieve complex cognitive tasks. The intrication of cognitive and postural processings (both impaired in schizophrenia) can be explored by using of a dual-task paradigm.

This study assesses a psycho-corporal training (8 weeks psycho-corporal training) benefits on both postural (increased automation of balance control) and cognitive processings (smaller impact of the dual-task condition on attentional performances) in population of patients suffering from schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of schizophrenia (men or women)
* Men or woman aged 18-55
* Patients with no change in antipsychotic medication and clinical status within four weeks prior to the study
* Affiliates or entitled to a social security scheme
* Have given their informed consent before participating in the study.

Exclusion Criteria:

* Intelligence Quotient below 70 (score PM38)
* History of head trauma, neurological disease or not stabilized serious physical illness
* Disorders related to the use of a psychoactive substance, as defined by the DSM-IV (abuse, dependence or withdrawal) within 6 months.
Pharmacokinetics and Bioequivalence of Two Empagliflozin, With Evaluation in Healthy Jordanian Subjects Under Fasting and Fed Conditions

Background: The current study is a randomized, open-label, two-period, two-sequence, two-way crossover pharmacokinetic study in healthy Jordanian subjects to evaluate the pharmacokinetics and bioequivalence profile of two formulations of empagliflozin 10-mg under fasting and fed conditions administered orally.; (2) Methods: The plasma concentrations of empagliflozin were determined using High-performance liquid chromatography- Mass Spectrometry/ Mass Spectrometry (HPLC-MS/MS) method. This study included 26 subjects, 26 in each fasting and fed group.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* healthy
* Jordanian volunteers
* some private hospitals (Amman, Jordan) Phase I Clinical Unit

Exclusion Criteria:

* Smokers
* heavy drinkers
* those who used CYP enzyme inhibitors within the previous 60 days
* those who had taken any medicine within the previous four weeks
* those who had a history of medication allergies
* those who had participated in previous clinical studies within the previous six months
* those with any significant clinical abnormality
Efficiency of Electronic Multimedia Intervention With the Cardiac Implantable Electronic Device.

In this study, we aim to design a multi-media model through e-book for preoperative care of CIED intervention, which can enhance the knowledges of patients, reducing the stresses and uncertainties before the intervention. Therefore, patient may reduce the psychological internalization after CIED intervention, also needs to track the impact of emotional depression, psychological adaption and life quality status.

Arrhythmia is defined an abnormality in the heart transmission system related to heartbeat or heart rhythm problem (Li et al., 2017). Most of arrhythmia could diagnosed and treated effectively, including medication, cardiac implantable electronic device (CIED) and operation. Many patients have uncertainty about the implantation process, the results and possible complications after CIED, the lack of understanding about further progress of their disease, the change of lifestyle and the accident of electronic shock. Those causes are the physical and mental negative impacts on patient which makes anxiety or depressed and turn affects the quality of life.

At present, there are few clinical models for CIED utilizing electronic multi-media in Taiwan. The use of multi-media models may integrate clinical care and health education for helping patients to learn disease and care, also through vivid video and multi-media, we may make a clear education of disease causes, treatment and relevant care knowledges which are alleviate the uncertainty factors from patients (Hsueh et al., 2016). Therefore, the more overall understanding before CIED intervention, the more helpful to quality of living and psychological adjustment of the patient.

In this study, we aim to design a multi-media model through e-book for preoperative care of CIED intervention, which can enhance the knowledges of patients, reducing the stresses and uncertainties before the intervention. Therefore, patient may reduce the psychological internalization after CIED intervention, also needs to track the impact of emotional depression, psychological adaption and life quality status.

keywords：Cardiac Implantable Electronic Device、arrhythmia、electronic multimedia、quality of life、psychological adjustment、depression

Eligibility Criteria:
Inclusion Criteria:

1. Actual age \> 20 years-old adults.
2. Patients are willing to participate in this research.
3. Conscious clear, sanity, and be able to communicate with others in Mandarin or Taiwanese languages.
4. Be able to operate mobile electronic device, such as mobile phone, iPAD or laptop; Families and healthcare provider allows to assist.

Exclusion Criteria:

1. TDS \> score 19 (Severely depressed patient)
2. Patient of terminal stage cancer.
3. Patient with delirium during hospitalization.
Effects of Regular Brisk Walking in Chronic Stroke Patients

Chronic stroke patients (\>6 months) fulfilling including criteria were trained during 3 months. The physical training program was based on walking.

Participants had been evaluated 4 times during a long follow-up period of 7 months. Activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.

Eligibility Criteria:
Inclusion Criteria:

* Stroke onset \> or = 6 months
* Able to walk without human assistance (may use walking aid)
* Sign informed consent form
* Approval from physician for participation in study
* Live in Belgium or in Benin

Exclusion Criteria:

* cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure
* orthopedic, circulatory, or chronic pain conditions restricting exercise;
* dementia;
* severe receptive or global aphasia with inability to follow 2-step commands;
* co-morbid non-stroke neurological disorder that impairs mobility (e.g. MS or Parkinson's);
Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis

The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease and Alcoholic Hepatitis.


Eligibility Criteria:
Inclusion Criteria:

* •Patients over 18, under 70 years of age

  * The chronic alcohol intake patients

    * Current the heavy drinker over 3month, Day the average alcohol consumption Male\>=60g, Female\>=40mg y-GTP increase Male\>=75, Female\>=35
  * Over 1.5 ratio of AST to ALT
  * Patients who have chronoc alcohol disease

Exclusion Criteria:

* Patients who have liver disease with the cause different with the alcohol except
* Patients who have pyridoxine allergy or history
* Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
* Patients taking other investigational product within 90 days prior to the participation in the study.
* Patients who has been taken any medications that could affect the treatment : hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, lont-term use of NSAIDs, statins, neuroleptics, anti convulsive medications, high-dose acetaminophen(\>=2.5g/day)
* Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
* Patient who considered ineligible for participation in the study as Investigator's judgment
Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).


Eligibility Criteria:
INCLUSION CRITERIA:

1. Completion of Study E2080-A001-301 and full compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
2. Patient willing to participate and written consent signed by patient or legal guardian provided prior to entering this study or undergoing any study procedures. In addition, if the patient is unable to provide written informed consent and it is provided by a legal guardian, assent of the patient (if the patient is able) must also be obtained.
3. Female patients of non-childbearing potential by reason of surgery, radiation, or menopause (at least one year post onset); female patients of childbearing potential who are using at least two approved methods of contraception (such as an intrauterine device \[IUD\], implant, oral contraceptive, or barrier method plus spermicide). Use of a low-dose estrogen oral contraceptive alone will not be permitted. Female patients of childbearing potential must agree to continue to use two approved methods of contraception through the follow-up visit or for 30 days after their final dose of study medication, whichever is longer.

EXCLUSION CRITERIA:

1. Discontinuation from Study E2080-A001-301 for any reason, before the termination of the study.
2. Evidence of non-compliance with study drug or ongoing AED dosing during Study E2080-A001-301.
3. Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic (e.g., ALT \> 3x ULN), hematologic, renal, or psychiatric disease, etc.) that in the opinion of the Investigator could affect the patient's safety or trial conduct.
4. Progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
5. History of alcohol abuse in the past 2 years.
6. History of suicide attempt within the previous 10 years.
7. Multiple drug allergies (dematological, heatological or organ toxicity) or more than one severe drug reaction.
8. Concomitant use of felbamate or vigabatrin.
9. Pregnancy.
10. Clinically significant ECG abnormality.
11. All patients with a diagnosis of Congenital Short QT Syndrome. Patients with a family history of Congenital Short QT Syndrome may be excluded on the basis of the Investigator's clinical judgement.
12. Presence of major active psychiatric disorder. Patients will be allowed who are taking a stable dose of selective serotonin reuptake inhibitor (SSRI) or mixed serotonin and norepinephrine uptake inhibitor antidepressant.