cyrilzakka/clinical-trials huggingface dataset:
The Effect of Simulation to Improve of Nurse's Attitudes Towards Elderly Patient

The elderly population is increasing in the world. Therefore, it is necessary to competent nurses who can diagnose the care needs of the elderly. Trainings should be planned in order to improve nurses' perception of individualized care in the care and attitudes positively of elderly patient. In post-graduate education, the use of traditional teaching methods and innovative simulation-based education will facilitate the increase of knowledge and skills. The aim of this study is to examine the effect of simulation-based education on the improve of nurses' perception of individualized care and positive attitudes towards the elderly. The study is quasi-experimental with a pre-test post-test design. Before the data collection phase, a simulation-based training program consisting of three stages was created. The data of the study were collected in a university hospital between October 2021 and April 2022, with the socio-demographic characteristics form, the perception of individualized care and the attitude scale towards the elderly. The data will be analyzed in the package program and the study will be reported.


Eligibility Criteria:
Inclusion Criteria:

* Completed undergraduate education
* Have been working in the geriatric clinic for at least 6 months
* Volunteer to participate in the study

Exclusion Criteria:

* Not completing the stages of the study
* nurses with less than 6 months of experience in the geriatric clinic
* not volunteer to participate in the study
Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation

The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease. In this study, we would also like to screen for cardiac risk factors that can be modified either through life-style changes or medications, to uncover significant abnormal heart findings in which treatments may be needed, and to see if there is a link between cardiac health and quality of life.

* On the day of the patient's scheduled follow-up visit with their oncologist, additional blood work will be obtained and the patient will fill out questionnaires concerning their general health and assessing quality of life.
* A separate cardiology visit with a preventative cardiologist will be performed. At this visit, the patient will undergo a Stress Echocardiogram.
* A Stress Echocardiogram is made up of three parts: Resting echo study, stress test and repeat echo while the heart is still beating fast.
* A resting echo provides the baseline examination and demonstrates the size and function of various chambers of the heart.
* The stress test involves exercise using a treadmill or a stationary bike. In patients who are unable to complete a high level of exercise due to physical limitations, stress to the heart is provided by a pharmaceutical or chemical stimulation to the heart. Exercise is started at a slower, warm-up speed and then increased every 3 minutes. Exercise is abruptly stopped once the patient exceeds 85% of the target rate. EKG recordings are made every minute of exercise and then again after exercise is stopped. Blood pressure is recorded at three minute intervals during exercise and then again at rest.
* Immediately after exercise is stopped, the patient will undergo a repeat echocardiogram.
* If no cardiac abnormalities are detected, the screening tests will be repeated every 3 years, if the patient is less than 10 years out from their initial treatment. If the patient is more than 10 years from initial treatment, then the tests will be repeated at approximately 18 months from the initial screening and once more at the end of the third year.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated at Brigham and Women's Hospital or Dana-Farber Cancer Institute for Hodgkin's disease with mediastinal irradiation
* Age \> or = to 15 years of age
* Five years or longer after initial treatment
* Relapse-free interval of \> 1 year

Exclusion criteria:

* Patients treated for Hodgkin's disease outside of Brigham and Women's Hospital or Dana-Farber Cancer Institute
* Current age \< 15 years of age
* Less than 5 years out from initial treatment
* Relapses within 1 year
The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

Hypothesis:

By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.

Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of tetralogy of Fallot, transposition of the great vessels with a systemic right ventricle, or Fontan type palliation
* Patient followed regularly at Washington University-affiliated institution
* If female, willing to use 2 forms of contraception including one barrier method during protocol

Exclusion Criteria:

* GFR \<30 ml/min
* Potassium \>5.0 mmol/L
* Unable or unwilling to comply with study protocol
* Use of potassium sparing diuretics
* Use of an aldosterone blocker currently or previously
* Known intolerance of eplerenone or aldosterone blockade
* Pregnant, breastfeeding, or actively trying to get pregnant
Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject over the age of 18
* Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension
* Subject is a candidate for filtering surgery with intraoperative anti-metabolites
* IOP \> 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
* Subject willing to attend all follow-up evaluations
* Subject willing to sign informed consent.

Exclusion Criteria:

* Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma
* Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)
* Subject has history of penetrating keratoplasty (PKP)
* Subject underwent large incision extra capsular cataract extraction
* Subject had cataract phacoemulsification within the last month
* Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter
* Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements
* Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated
* IOP of ≤18mmHg
* Subject participates in any other concurrent ocular investigation.
the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.

investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.

This study will be randomized controlled trial will be performed at the Obstetric and Gynecological Department at Beni-Suef University Hospital, Faculty of Medicine Target Population: All females with first time use of IUD inserted at the Obstetrics and Gynecology department through 3 months from the start of July 2023 till the end of November 2023.

Participants will be assigned in a 1:1 ratio to the use of vitamin B 1 or placebo, in accordance with a random table produced by an Excel program, with A being assigned to the intervention group and B to the control group. All women will sign a written informed consent prior to data collection.

Each woman within the intervention group will receive a packet containing 30 pills (vitamin B 1 or placebo), each month for three months.

Eligibility Criteria:
Inclusion Criteria:

* Females with first time use of the IUD
* a history of normal menstrual bleeding with duration of 3 to 7 days without spotting, a menstrual cycle lasting 23 to 35 days,
* use of 10 to 14 sanitary pads per cycle before IUD insertion
* gravidity ranging between 1 and 4.

Exclusion Criteria:

* Patients with cardiac, hepatic or renal diseases.
* Patients with bleeding disorders.
* Patients with systemic diseases.
Hypoalgesic Effect of Cervical Manipulation

This study evaluates the hypoalgesic effect of global and specific cervical joint manipulation in healthy individuals. At first the participants received one of the interventions and after 48 hours, the other.

Cervical Joint Manipulation (CJM) are often used for pain treatment.

Joint manipulation generates a series of stimuli within the central nervous system through the activation of proprioceptors located in the joint capsule or muscles, stimulates the PAG, causing pain inhibition by activation of non-opioid descending inhibitory pathways.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects of both sexes
* without pain complaints in the last 90 days

Exclusion Criteria:

* previous spinal surgeries
* spinal canal stenosis
* vertebral fracture
* spondylolisthesis
* cancer
* acute infections
* hemorrhagic disorders
* active tuberculosis
* deep vein thrombosis
* osteoporosis
* rheumatic diseases
* metabolic diseases
* cardiorespiratory diseases
* smoking injury
* musculoskeletal injury
* use of pacemaker
* women in menstrual period
* pregnant women
* use of pain-killers in the last 48 hours
* use of anti-inflammatory drugs in the last 48 hours
* previous joint manipulation treatments
* aversion to cervical joint manipulation
* positivity in the vertebral artery test
* headache in the last seven days
The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants

This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit (NICU) care team and participating in the daily care of VLBWIs, as well as the influence of FIcare on parents' outcomes.

This study is a multicenter randomized controlled trial which mainly explores the effect of Family integrated care (FICare) on melatonin levels in very low birth weight infants (VLBWIs) in neonatal intensive care unit (NICU). The intervention group will use a FICare intervention program, mainly for families who have been fully trained by the NICU professional team and need to stay in the NICU to accompany and care for the VLBWIs for not less than 6 hours a day for at least 3 weeks. All non-medical care measures and developmental supportive care will be provided by parents as much as possible. The control group received routine nursing interventions in which all non-medical interventions are led by NICU staff and without parental involvement. The level of melatonin, clinical and parental outcomes in VLBWIs are compared between the intervention group and the control group to evaluate the effect of FICare intervention program.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1500g;
* Gestational age \< 32w;
* Admit within 24 hours of birth;
* The parents are conscious and able to cooperate, have certain learning and reading comprehension skills, and are capable of caring for their babies. They are committed to receiving training and caring for their babies for not less than 6 hours a day for at least 21 days;
* Voluntarily participate in this study and sign informed consent.

Exclusion Criteria

* Newborns who require palliative care or surgical intervention;
* OI (oxygenation index) \<300 ;
* Newborns with severe congenital malformations;
Fibro-inflammatory Progression From Acute to Chronic Pancreatitis

Observational prospective study evaluating the developement of chronic pancreatitis based on imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress.

Chronic pancreatitis (CP) represents the end-stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent acute pancreatitis (RAP). Due to the irreversible nature of CP, early detection and prevention is key. The study uses state-of-the-art imaging modalities as well as biochemical markers of to evaluate fibrosis progression in patients with pancreatitis.

The included participants have either first time AP, RAP, early CP with preserved pancreatic exocrine and endocrine function or end-stage CP with exocrine insufficiency. Included patients will be followed prospectively for 15 years with advanced MRI and contrast enhanced EUS with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential biomarkers for the progression of disease eventually leading to CP.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CP (N=50) of any aetiology except gallstone induced CP: CP will be diagnosed based on MANNHEIM criteria .
* Cohort 2: Patients with their first attack of AP of any aetiology except gallstone induced AP (N=50). The revised Atlanta criteria for acute pancreatitis will be used as diagnostic criteria.
* Cohort 3: Patients with RAP (N=50) except gallstone induced RAP. RAP is defined as two or more cases of AP as diagnosed by the revised Atlanta Criteria.

Exclusion Criteria:
Impedance Cardiography to Decrease the Risk of Preeclampsia

To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.

Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output is occurring. The test is easy to perform and non invasive. The treatment for an elevated cardiac output in pregnancy is a beta-blocker while a vasodilator is used for vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make the cardiovascular parameters worse, leading to no improvement in future pregnancy issues. Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it could potentially make the cardiovascular parameters worse.

All centers in the United States that choose to prescribe an antihypertensive medication for use in pregnancy do so by trial and error, whereas impedance cardiography can help the clinician choose the best medication from the start. Many pregnant patient patients have chronic hypertension and this population is at increased risk for superimposed preeclampsia and other pregnancy complications. The current recommendation for pregnancy is to NOT treat mild hypertension because studies have not shown any benefit. These studies, have also not shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not improving the rate of superimposed preeclampsia and other pregnancy related complications.

Eligibility Criteria:
Inclusion Criteria:

Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic hypertension - Not on antihypertensive medications

Exclusion Criteria:

Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy Patients who have a blood pressure 140/90 or greater -
Smartwatch ABPM vs. Conventional ABPM

This study aims to investigate the accuracy and precision of the Samsung Smartwatch with conventional ambulatory blood pressure monitoring in healthy volunteers.

Blood pressure (BP) monitoring outside of the medical care environment is an increasingly important part of clinical hypertension assessment and management. Ambulatory BP monitoring (ABPM) uses automatic detection and recording devices for repeated determinations during an extended period, typically 24 hours. This technique has been shown to substantially enhance the clinician's understanding of BP behavior in patients and aid in diagnosis and therapeutic decision making. The ABPM is superior to office BP in predicting target organ, hypertensive cerebrovascular disease, retinopathy, renal abnormalities, and alterations in vascular compliance.1-4) Most of these studies have also demonstrated that a loss of nocturnal decline in BP (so-called non-dipper) conveys excessive risk for stroke and myocardial infarction.

Although conventional ABMP is usually well tolerated by patients, a few problems do exist. A minority of patients do not sleep well with the recorders and tend to have somewhat higher BP values. Cuffs can also rotate, and different arm positions can change BP significantly. Rarely, patients may develop erythema, ecchymoses, petechiae, or superficial phlebitis in the area distal to cuff placement.

Recently, smartwatches that measure BP without a cuff have become available. Since these measurements are relatively more user-friendly than conventional cuff-based measurements, they may aid in more frequent BP monitoring. Currently, only one study compared a non-commercial armband wearable pulse transit time (PTT) system for 24-hour cuff-less BP measurement with ABPM.5) We will investigate the accuracy and precision of Samsung Smartwatch with ABPM in young, healthy volunteers.

Eligibility Criteria:
Inclusion criteria

* Ambulatory healthy subjects
* Subjects aged 20 years or more
* Subjects willing to participate in this study voluntarily Exclusion criteria
* Subjects inability to provide informed consent
* Subjects with any medical history
* Subjects with irregular heart rhythm (e.g. atrial fibrillation, atrial flutter, or bigeminy)
* Subjects unable to wear a watch due to wrist circumference
* Subjects with BP difference 10mmHg or more between left and right arm
Comparison of Esophageal and Central Venous Pressure for Estimating Transpulmonary Pressure Changes

Central venous pressure (CVP) is characterized by a low-frequency pleural-dependent as well as a high-frequency cardiac pulsatile component. The aim of the study is to compare the low-frequency component of CVP with the esophageal pressure (Pes), as surrogate of pleural pressure, to estimate trans-pulmonary pressure (PL).

The investigators will enroll mechanically ventilated patients admitted to the intensive care unit with the diagnosis of respiratory failure monitored with a dedicated nasogastric catheter and a central venous catheter for measuring Pes and CVP, respectively. Electrocardiogram trace, Pes, CVP and airway pressure (Paw) will be recorded at the end of inspiratory and expiratory pauses. The CVP waveforms will be analyzed off-line using a dedicated low-pass digital filter to obtain the low-frequency component of CVP (filtered CVP, fCVP). Paw, Pes and fCVP will be used to calculate PL using transpulmonary driving pressure formula (PL-Pes and PL-fCVP, respectively). The PL values obtained with fCVP and Pes will be compared to assess the correlation of the two methods.

Eligibility Criteria:
Inclusion Criteria:

* adult patients receiving invasive mechanical ventilation
* diagnosis of acute respiratory failure (defined as the ratio of partial oxygen pressure and fraction of inspired oxygen below 200 mmHg)
* esophageal balloon catheter
* central venous catheter

Exclusion Criteria:

* age under 18 years old
* Hemodynamic instability
* Esophageal diseases (varices, stenosis..)
* Refusal of the patient
* evidence of active air leak from the lung (pneumothorax, pneumomediastinum, existing chest tube....)
* history of lung/abdominal surgery
* pregnancy
* severe coagulopathy
Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis

OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol in patients with at least 5% of their body covered with psoriasis.

II. Evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis.

III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.

PROTOCOL OUTLINE: This is a part placebo-controlled (arm I) study. Patients either apply topical petrolatum (Vaseline) with calcitriol (vitamin D3) on a psoriatic lesion daily and petrolatum only on an other similar lesion daily to serve as a control (arm I) or receive oral calcitriol nightly (arm II).

Arm I patients continue treatment for at least 2 months. At the end of 2 months of topical treatment, one biopsy is taken of the lesion treated with calcitriol, one biopsy of the lesion treated with petrolatum alone, and one biopsy of skin unaffected by psoriasis. Lesions are also photographed prior to therapy, 2-4 weeks during therapy for the first two months, then once every 1-3 months, and then once at end of treatment.

Arm II patients increase dosage of oral calcitriol every 2 weeks up to a maximum dosage daily in the absence of adverse effects (high urinary calcium or serum calcium levels). Patients continue treatment for at least 1 month. Lesions are photographed prior to therapy, 2-4 weeks during therapy, and then once at end of treatment.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Psoriasis covering at least 5% of body

--Prior/Concurrent Therapy--

At least 30 days since prior systemic therapy for psoriasis

At least 14 days since prior topical therapy for psoriasis

No other concurrent treatment for psoriasis for the first 2-4 months of study

No calcium supplement greater than 1,000 mg per day

--Patient Characteristics--

No hypercalcemia

No hypercalciuria

Not pregnant

Effective contraception required of all fertile patients
Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease

This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* having coexisting cardiovascular disease or a history of cardiovascular diseases
* having electrocardiogram record conducted within seven days before the start of the mirabegron treatment (including the first day of administration)

Exclusion Criteria:

* having serious cardiovascular disease
* having significant long QT (QTc \> 500 msec)