cyrilzakka/clinical-trials huggingface dataset:
Stress Management Training for Nursing Professionals in a Tertiary Care Center in Nepal

The goal of this clinical trial is to learn if stress management programs can help alleviate existing and prevent future symptoms of stress in nursing professionals working in a tertiary care center in Nepal.

Researchers will compare the treatment group (exposed to stress management training) to the control group (not exposed to stress management training) to see if

1. Stress management sessions lead to reduction of levels of stress among nurses at tertiary level hospital in Nepal.
2. To compare the pre and post training stress levels among participants of intervention and control group

Participants will Fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale before either being exposed to a 4-session stress management training (treatment group) or not being exposed to such training (control). All participants (both groups) will fill out the Depression, Anxiety and Stress Scale 21 and the Perceived Stress Scale for pre-post comparative measure.

This study will aim to explore the effectiveness of a stress management program in nursing professionals in a community teaching hospital in Nepal. A 4-day stress management training program will be conducted and pre and post-training stress levels will be measured using the Perceived Stress Scale (PSS) and the Stress-Subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21) one week prior to and after the training program. This experimental pre-post double arm study will involve 86 participants - all nursing staff from the Dhulikhel Hospital. Participants will be divided into 2 groups - treatment and control. The treatment group will be further divided into 2 groups of 20-25. The stress management training program will be held across 4 weeks with both groups receiving one training course each week (eg. Week 1 - session 1; Week 2 - session 2). Both questionnaires will be distributed again to both groups, 1 month after the last stress management session (1 - month follow up) .The control group whilst not being subjected to the Stress management training during the study period, will obtain the training upon study completion.

Eligibility Criteria:
Inclusion Criteria:

* Nurses employed at the Dhulikhel Hospital
* Minimum one year work experience
* Minimum qualification certificate level of nursing
* Fluent in spoken and written English

Exclusion Criteria:

* Nurses with the post of nurse manager and above
* Nursing Students
* History having undergone stress management training in the past
* Absent for one or more sessions
* Incidence of a major stressful/critical life event during the study (e.g., divorce, death, and other critical events)
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA \< 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with \< HBV DNA 60 IU/mL level and HBeAg positive status.

Exclusion Criteria:

* Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
* Subjects should have ALT \< 10 x ULN, and no evidence of hepatocellular carcinoma.
* Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
* Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
Localized Analysis of Normalized Distance From Scalp to Cortex and Personalized Evaluation (LANDSCAPE)

Scalp to cortex distance (SCD), as a key technological parameter of brain stimulation, has been highlighted in the guidelines of non-invasive brain stimulation. However, in the context of age-related brain changes, the region-specific SCD and its impact on stimulation-induced electric field in different types of neurodegenerative diseases remain unclear.

Objective: This study aimed to investigate the region-specific SCD and its relationship with morphometric features and cognitive function in age- and disease-specific populations. Methods: The SCD and cortical thickness (CT) of left primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) were measured in cognitively normal adults and dementia patients. CT-adjusted SCD was used to control the influence of CT on SCD. Head model was developed to simulate the impact of SCD on the electric field induced by transcranial electrical stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed as assessed by the Edinburgh Inventory
* Able to attend TMS interventions
* Consent
* Independent in daily life activities

Exclusion Criteria:

* Uncorrected visual or auditive deficits not allowing the realization of the test
* Evolutive disease (such as cancer)
* Neurological or psychiatric antecedent
* Counter-indication to MRI
Physical Fitness, Exercise Self-efficacy, Physical Activity Level in People With Spinal Cord Injury (SCI)

This is a single blind randomized controlled trial study which will conducted on people with paraplegia wheelchair users. The objectives of this study is to investigates the effects of 16 weeks of 'Graded Exercise Integrated Education' over conventional physical therapy on physical fitness, exercise self-efficacy and the level of physical activity. There will be a significant difference between the experimental and control group.

A study protocol will be a single blinded randomised controlled trial. 40 subjects with diagnosed of paraplegia (T1 and below) and dependent with wheelchair will be randomly assigned into 2 groups, Graded exercise (n=20) or Conventional Physical Therapy (n=20). In 8 weeks, the graded exercise group will receive strengthening and aerobic exercise for 2 times a week, and the controlled group will continue their normal routine. The strengthening exercise will consist of strength training for major upper limb muscles in the multigym station and free weights dumbbell whereas the aerobic exercise will perform by using arm ergometry, boxing and wheelchair wheeling. The exercise will be graded and progressed for each week in 8 weeks. The graded exercise group also will receive educational intervention to increase the exercise self-efficacy and physical activity level which will conduct in face to face for 2 times a week in 8 weeks during in-rehabilitation program and once on every 4 weeks in 8 weeks after discharge from in-rehabilitation program. The outcomes are the strength and endurance of upper limb which will be measure by using a BIODEX® Isokinetic Machine and hand grip strength by JAMAR® Hand-held dynamometry. The cardiovascular endurance will be measure by using 6 minute wheelchair push test (6MWPT). The exercise self-efficacy and physical activity level will be measure by using 'Exercise Self-Efficacy Scale (ESES)' and 'Physical Activity Scale for Individual with Disability (PASIPD)'. The outcome measure will be evaluated at the baseline level, week 4th, week 8th, week 12th, and 16th. Statistical analysis will be carried out using the SPSS 21.0 program for Windows and a significant level of p ≤ 0.05 will be used for all tests.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic and Non-traumatic paraplegia
* Wheelchair dependent
* Age range between 18 and 65 years old

Exclusion Criteria:

* Pregnancy
* Individual who suffered from progressive neurological diseases, depression and mental disorder
* Individual with frequent autonomic dysreflexia and hypotension
* Individual with comorbid recent fracture
* Individual with severe heart diseases and pain
* Individual who not understand Malay and English
* Individual who not understand instructions and obey commands
* Individual who difficult to reach via telephone, email or social media
Outcomes Study of Glycosylated Hemoglobin Control in Cox-Maze IV During Cardiac Surgery

In recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. How to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. Glycosylated hemoglobin (HbA1c) is the product of a non-enzymatic reaction in which hemoglobin in red blood cells is combined with sugars in the serum (mainly glucose). The purpose of this multicenter, randomized controlled study is to compare the effects of different glycosylated hemoglobin control strategies on the effectiveness of Cox-Maze IV procedure for atrial fibrillation during cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Elective cardiac surgery
* A clear diagnosis of diabetes mellitus, and HbA1c ≥ 7.5% at the time of initial diagnosis and treatment
* Preoperative combination of persistent or long-term persistent atrial fibrillation

Exclusion Criteria:

* Emergency surgery or limited-term surgery
* Previous cardiac surgery
* Left atrial diameter \> 65 mm
* Serum creatine \> 1.8 mg/dL
* Previous severe liver disease
* Pregnant or planning to become pregnant
* Have a malignant tumor
A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients

The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

Age 14 to 75 years (no gender limitation) Newly diagnosed with intermediate- or high-risk AML (excluding M3) Liver function: ALT and AST ≤ 2.5 times upper limit of normal; bilirubin ≤ 2 times upper limit of normal Renal function: creatinine ≤ upper limit of normal No uncontrolled infections, organ dysfunction, or severe mental illness ECOG performance status score of 0-2 and predicted survival ≥ 4 months No severe allergic constitution

Exclusion Criteria:

Allergy or contraindication to the study drug Pregnant or breastfeeding female patients Known history of alcohol or drug addiction (due to potential non-compliance) Mental illness or conditions preventing protocol compliance Less than 6 weeks after major organ surgery Liver function: ALT and AST \> 2.5 times upper limit of normal; bilirubin \> 2 times upper limit of normal Renal function: creatinine \> upper limit of normal Deemed unsuitable for the clinical trial (poor compliance, substance abuse, etc.)

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Severe Complications Triplicate the Costs of Major Surgical Procedures

The purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.

To prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality

Eligibility Criteria:
Inclusion Criteria:

* Undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections)

Exclusion Criteria:

* Missing data of in-hospital costs
* Mortality
Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension

This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.

The primary aim of the study is to evaluate the efficacy of nifedipine gastrointestinal therapeutic system (GITS) on lowering blood pressure in Chinese adults with mild-to-moderate hypertension. The secondary aim of the study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in hypertensive patients with different urinary sodium levels. Based on sample size estimation, the plan is to recruit 700 patients from 16 centers. At baseline, patients'demographic characters, disease history and anthropometric indices will be collected, laboratory tests will be performed for blood routine examination, urinalysis, renal function, hepatic function, urinary sodium and 24-hour urinary sodium. All eligible patients will be assigned to a treatment of Nifedipine GITS and followed up for 8 weeks. At 0 day, 2,weeks, 4 weeks and 8 weeks of the study, seated blood pressure, vital signs, medication and adverse events were collected. At the end of the study, 24-hour ambulatory blood pressure monitoring (ABPM) will be performed for all participants.

Eligibility Criteria:
Inclusion Criteria:

* a seated systolic BP (SBP) ≥140 mmHg and \<180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and \<110 mmHg;
* an age ≥18 and ≤75 years;
* those who had not taken any BP-lowering medications in 1 month before the study.

Exclusion Criteria:

* a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg;
* secondary hypertension;
* diagnosed heart failure or stroke;
* Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine \>177 µmmol/L (2mg/dL), or liver cirrhosis;
* subjects with carotid stenosis or systolic murmur
* subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months;
* subjects who were within lactation period, pregnant, or planning to become pregnant during the study;
* hypersensitive to Nifedipine GITS or with SAE;
* subjects who are participating in other clinical trials;
* considered not fit for the study due to other reasons according to the researchers (such as Malignant tumor, psyche or nervous system dysfunction, or special diseases).
SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.


Eligibility Criteria:
Inclusion Criteria:

* Read, sign, and date the Informed Consent Document;
* Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
* Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
* Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
* History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye;
* Use of any concomitant topical ocular medications during the study period;
* Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;
* Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;
* Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;
* Other protocol-defined exclusion criteria may apply.
Delirium Related to Proton Pump Inhibitors Use

Delirium is a frequent and severe condition, especially in old adults. Its occurrence is due to a drug in 30% of cases. In 2009, the French national health authority (Haute Autorité de Santé) mentioned proton pump inhibitors (PPIs) among the drugs causing delirium. Most reports of delirium associated with PPI use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. However, a few case reports have described the occurrence of delirium PPI without hyponatremia related to PPI use. In 2016, a prospective observational study including 675 old adults found an association between PPI use and the occurrence of delirium.

Evidence linking delirium and PPI use is thus scarce. By using data from the pharmacovigilance database of the World Health Organization (WHO), the investigators aim to describe the characteristics of delirium reports in which PPI were suspected to be involved, and to evaluate the association between PPI use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.


Eligibility Criteria:
Inclusion Criteria:

* PPI use
* Delirium mentioned in the safety report
Children's Use of the Built Environment for Physical Activity

The study aims are to develop and test the feasibility of a pediatric physical activity intervention that incorporates personal information on use of the built environment, and test the intervention's preliminary efficacy at increasing physical activity. The investigators hypothesize that it will be feasible to incorporate and measure changes in empiric GIS (geographic information system), GPS (global positioning system), and accelerometer feedback in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data collection (primary measure of feasibility), ii) Participation rates among adolescents in the intervention group compared to the control group, and iii) Acceptability to patients as measured by adolescent satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents ages 10-16 years
* BMI \> 85th percentile for age and sex

Exclusion Criteria:

* Physical conditions impairing ambulation
* Adolescents who do not speak English
* Adolescents who have missed more than 2 scheduled doctor's appointments during the past 5 years
* Adolescents who are receiving any other form of physical activity counseling/intervention at the time of enrollment
Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension

The goal of this study is to test the hypothesis that hydroxyurea is effective for the specific treatment of secondary pulmonary hypertension found on screening in children and young adults with sickle cell disease.

Increasing evidence suggests that pulmonary hypertension, defined by an elevated tricuspid regurgitant jet velocity (TRJV) on echocardiogram, is a major cause of morbidity and mortality in adults with sickle cell disease (SCD). However, both the prevalence and optimal treatment of pulmonary hypertension in children and young adults with SCD are unknown.

We hypothesize that short term therapy with hydroxyurea will decrease TRJV in children and young adults with pulmonary hypertension found on screening. Patients eligible for treatment will have had evidence of pulmonary hypertension on at least 2 screening echocardiograms. Baseline laboratory tests will be obtained and other causes of secondary pulmonary hypertension will be excluded prior to initiation of treatment. Patients will be treated with hydroxyurea according to a standard dose escalation schedule for a total of 12 months. A clinic visit will be required every 2 months and standard screening for toxicity will be performed monthly. There will be an interim analysis of the primary outcome at 6 months following therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 10 and 25 years old
* Sickle cell disease with hemoglobin SS, SC or S-B\^0 thalassemia confirmed on hemoglobin electrophoresis
* Tricuspid regurgitant jet velocity (TRJV) equal to or greater than 2.5 m/sec on 2 baseline Doppler echocardiograms at least 3 months apart

Exclusion Criteria:

* Patients already being treated with hydroxyurea
* Patients on a chronic transfusion protocol
* Patients with evidence of hepatic (alanine aminotransferase \[ALT\] equal to or greater than 2 SD above normal) or renal dysfunction (creatinine \[Cr\] equal to or greater than 2 SD above normal)
* Patients who are pregnant
* Patients with documented causes of severe pulmonary hypertension other than from SCD
Assessment of Activity Limitation in Asthma Patients

Limitation of activity is one of the main item used by composites scores designed to assess the level of asthma control. Since this item is systematically subjectively assessed by the patient, the investigators would like to know if these subjective data are correlated with objective data.

Aims of this study are: 1) To describe what means "limitation of activity" for asthma patients and how they deal with; 2) To describe the objective exercise capacity and characteristics of daily activity in two situations (on exacerbation, out of an exacerbation).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma made by a pulmonologist.
* Age ≥ 18 yrs-old, \< 65 yrs-old.
* Moderate or severe exacerbation of asthma (as defined by Reddel et al in 2009) at the time of inclusion.

Exclusion Criteria:

* All other diseases than asthma that can affect the physical activity (e.g. orthopaedic or neuromuscular disease, cardiac or vascular disease).
* Pregnancy or suspicion of pregnancy at the time of inclusion. The women who become pregnant during the study period will be excluded.
SPI-1005 Treatment in Moderate COVID-19 Patients

The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years of age
* Positive nCoV2 PCR test by nasopharyngeal, oral, saliva, or respiratory sample
* Clinical signs, symptoms, and respiratory status consistent with moderate COVID-19
* Score of 3-4 on the WHO Ordinal Scale
* Onset of moderate COVID-19 symptoms ≤3 days of study enrollment
* Subject is in-patient at time of randomization to study treatment
* Subject or legally authorized representative is willing and able to provide informed consent, and agrees for subject to comply with planned study procedures including reproductive requirements.

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding.
* Participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent.
* Patients with impaired hepatic or renal function.
* Subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.