cyrilzakka/clinical-trials huggingface dataset:
The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis

Web-based training based on the Self-Care Deficiency Theory has an effect on increasing self-care in in patients undergoing peritoneal dialysis.

Web-based training based on Self-Care Deficiency Theory has an effect on increasing self-efficacy in patients undergoing peritoneal dialysis.

Web-based education based on Self-Care Deficiency Theory has an effect on increasing perceived social support level in patients undergoing peritoneal dialysis.

In the study, which will last for 3 months, the patients in the intervention group will receive pre-test Web-based training based on the Self-Care Deficiency Theory. And an intervention group will be expected to use the website weekly. Also weekly reminder messages will be sent regularly.

Following the final test, individuals in the enterprise group will be asked to evaluate their views on the website in writing with the WAMMI test.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were receive peritoneal dialysis at Akdeniz University Hospital.
* Patients who receiving peritoneal dialysis treatment for at least one months
* Patients who were over 18 years of age,
* Patients who had orientation of individual, place and time
* Patients who were literate
* Patients who has Internet at home
* Patients who has computer or mobile phone
* Patients who no barriers to written or verbal communication
* Patients who agree to participate in the study

Exclusion Criteria:

* Diagnosis of psychiatric illness
* Malignancy diagnosed
* Visually and hearing impaired
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)


Eligibility Criteria:
Inclusion Criteria:

* Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
* Serum lactic acid dehydrogenase (LDH) \<= 2 x ULN
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
* History of brain metastases
PSMA-PET to Guide Prostatectomy

In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Significant prostate cancer:

   Gleason 3+4 ≥1 core with pattern 4 ≥20%

   Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR

   NCCN unfavorable intermediate risk OR

   Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
2. Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
3. The patient desires to maintain erections following treatment
4. Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
5. Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.

Exclusion Criteria:

1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Screening for NAFLD in Flanders

In the Belgian adult population more than half, and numbers are still increasing, of the population is overweight or obese. These people are at risk to develop NAFLD. However, we lack epidemiological data in Belgium. Therefore, it is important to do epidemiological studies to investigate NAFLD prevalence and disease severity based on a non-invasive approach and evaluate how patients are to be referred.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* able to understand Dutch,
* able to understand the informed consent

Exclusion Criteria:

* secondary causes of steatosis
* excessive alcohol abuse
TRK-3 Performance of Pachymetry

To evaluate the performance of a new tonometer.


Eligibility Criteria:
Inclusion Criteria:

1. Provide voluntary written consent for participation in the study.
2. Age at least 22 years old at the time of informed consent.

Exclusion Criteria:

1. Ocular condition that may affect the ability to perform corneal measurement (e.g., corneal perforation, bullous keratopathy, nystagmus)
2. Have or is suspected to have an ocular infection in either eye.
3. Otherwise considered unsuitable for the study by the investigator
4. Unable to tolerate ophthalmic testing.
Preservation of Ovarian Function Via LOT in Squamous Cell Carcinoma of the Cervix

The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Stages iB-iiiB squamous cell carcinoma of the cervix

Exclusion Criteria:

* Evidence of ovarian involvement on MRI
* Evidence of uterine involvement on MRI
* Evidence of distant mets on MRI
Apixaban in Adults With Congenital Heart Disease and Atrial Arrhythmias: the PROTECT-AR Study

The purpose of this study is to evaluate the safety and efficacy of apixaban for the prevention of thromboembolism in adult patients with congenital heart disease (CHD) and non-valvular atrial arrhythmias (AA)

Adult patients with congenital heart disease (ACHD) represent a rapidly growing population due to the progress of surgical techniques and optimal medical management. Non-valvular atrial arrhythmias (AA) carries a significant burden for long-term morbidity and potentially mortality in ACHD patients. AA occur three times more frequently in ACHD compared to the general population. When complicating ACHD, AA convey a twofold increase in the risk for stroke, contributing to an up to 100-fold higher prevalence of stroke in the ACHD population compared to age-matched healthy controls. At present, the European Society of Cardiology (ESC) Guidelines suggest oral anticoagulation (OAC) in all adult patients with AA and intracardiac repair, cyanosis, Fontan palliation, or systemic right ventricle. In the remaining ACHD patients with AA, OAC is suggested if CHA2DS2-Vasc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score is ≥1 (Class of recommendation IIa, level of evidence C).

Non-vitamin K oral anticoagulants (NOACs) are increasingly preferred over vitamin-K antagonists (VKAs) in most clinical scenarios due to improved safety (with regard to intracranial and other major bleeding) and efficacy (prevention of embolic stroke or systemic embolism) along with the convenience they offer for patients and physicians (fixed dose, no food and drug interactions, no INR monitoring). On the other hand, scarce data is available on the use of NOAC in ACHD.

In order to address this gap in evidence, we propose a prospective multicenter single arm, observational cohort trial, which will provide data on the efficacy and safety of apixaban used for the prevention of thromboembolism in ACHD patients with AA.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥18 years.
2. Presence of congenital heart disease (intracardiac repair, cyanosis, Fontan palliation, or systemic right ventricle or other congenital heart disease).
3. Non-Valvular Atrial Arrhythmia (including at least one electrocardiographically documented episode).
4. Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule.

Exclusion Criteria:

1. moderate-to-severe mitral stenosis or mechanical valves
2. patient unwilling or unable to complete follow-up procedures
CBD Repair Over T-tube or Primary Repair

the aim is to assess the benefits and harms of T-tube drainage versus primary closure without biliary stent after exploration common bile duct stones

Common Bile Duct Exploration is a surgery that involves opening the main bile duct that drains from liver and gallbladder into the first part of the small intestine (the duodenum). This is needed when a gallstone drops out of the gallbladder into the duct and partially or completely blocks up the duct. This can cause jaundice , fever and chills, severe abdominal pain due to infection / inflammation of the bile duct, gallbladder or pancreas. This most often involves admission to the hospital and urgent intervention. Most commonly, a procedure called an ERCP is used to clear out the stones from the bile duct. If gallbladder will have to be removed soon to prevent this potentially serious condition from occurring again.

During the operation the investigators remove gallbladder then a duct exploration is performed. This involves opening the duct directly and removing the stones.

Prior to Common Bile Duct Exploration surgery, patient will be asked not to eat anything after midnight prior to the surgery. patient will be given specific instructions from the surgeon or anesthesiologist about which medications he should or should not take prior to the surgery. patient should not take any blood thinning medications at least 5 days prior to your operation. This should be discussed with the surgeon at the preop visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo common bile duct exploration

Exclusion Criteria:

* patients who has failed ERCP for management of common bile duct exploration
* CBD diameter 2 cm or more
Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia

The primary objective of this study is to evaluate the safety and tolerability of AMG 330, administered in combination with pembrolizumab, in participants with relapsed or refractory acute myeloid leukemia (R/R AML).

This study will assess the safety and tolerability of AMG 330 in combination with pembrolizumab and whether pembrolizumab will enhance the anti-AML activity of AMG 330. Both cohort 1 and 2 will include AMG 330 and pembrolizumab with the difference being the initiation date for pembrolizumab treatment.

Eligibility Criteria:
Key Inclusion criteria

* AML as defined by the WHO Classification persisting or recurring following one or more treatment courses. Except APL
* Eastern Cooperative Oncology Group (ECOG) ≤1

Key Exclusion criteria

* Active extramedullary AML in the central nervous system.
* Known hypersensitivity to immunoglobulins.
* Non-manageable graft versus host disease.
Imaging HSP90 Inhibitor AUY922 on VEGF-89ZR-bevacizumab Positron Emission Tomography (PET)

Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute to customize this treatment for individual patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect, and may contribute to tailored made cancer treatment. The purpose of the present study is to evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.

This feasibility study is designed as a side study to the multicenter, international phase I-II trial with HSP90 inhibitor AUY922 (protocol CAUY922A2101), as part of the biomarker assessment. In protocol CAUY922A2101, section 4, the design of this phase I-II trial is described (p37, 38). Briefly, a dose-escalation study is performed according to phase I design in adult patients with advanced solid malignancies. This part is followed by a dose-expansion study according to a phase II design. In the latter part, breast cancer patients are enrolled that are either refractory to hormone- or trastuzumab treatment (both treatment arms, n=40 patients), on the maximal tolerated dose of AUY922 based on the phase I part of the study. Patients with ER positive, hormone therapy refractory breast cancer, will receive a 89Zr-bevacizumab PET scan as part of the present side study protocol, which will be performed in collaboration with the Royal Marsden Hospital (United Kingdom).

To this end, a 89Zr-bevacizumab PET scan will be performed before (baseline) and during treatment with HSP90 inhibitor AUY922, as described below.

A minimum of six patients will be entered to evaluate whether the effect of HSP90 inhibition by AUY922 can be detected with a 89Zr-bevacizumab PET scan

Eligibility Criteria:
Inclusion Criteria:

* patients with ER positive, hormone therapy refractory breast cancer
* participation in the phase I-II trial with HSP90 inhibitor AUY922 (in- and exclusion criteria for the study with AUY922 are described in protocol CAUY922A2101, Clinical Trials no NCT00526045A.

Exclusion Criteria:

* no participation in the phase I-II trial with HSP90 inhibitor AUY922
Neuromodulation and Dynamic Balance in Stroke

Portable Neuromodulation Stimulator (PoNS) is non-invasive stimulation device placed on the tongue to stimulate those brain regions understood to be important for maintaining balance. This research study aims to collect evidence that PoNS therapy along with balance training improves postural and walking stability post-stroke.


Eligibility Criteria:
Inclusion Criteria:

* At least six months since the onset of Ischemic or hemorrhagic stroke.
* Demonstrate residual paresis in the lower extremity (Fugl-Mayer lower extremity score \< 34).
* Are able to provide informed consent demonstrated by their ability to weigh the consequences of participating versus not participating in the study.
* Can walk at least 10 feet with and without assistive device.
* Functional Gait Assessment score \<22.

Exclusion Criteria:

* Pre-existing neurological disorders.
* Previous stroke affecting the other hemisphere .
* Severe arthritis or orthopedic problems that limit passive range of motion.
* Areas of recent bleeding or open wounds.
* Lack normal sensation on the tongue.
* Received treatment for cancer within the past year.
* Non-removable metal orthodontic devices.
* Oral health problems.
* Are sensitive to nickel, gold or copper.
* Chronic infectious diseases.
* Are pregnant.
* Have dementia
Swallowing Impairment After COVID-19 Infection

This is an observational study, in which people recovering from COVID-19 infection will attend an outpatient clinic for a comprehensive swallowing assessment. The assessment will include a videofluoroscopy, measurement of respiratory-swallow coordination using a digital stethoscope, measures of tongue and cough strength and patient reported measures that will help us to understand the presence and impact of swallowing impairment (dysphagia) in this population.

The recent spread of COVID-19 has led to an international pandemic, with \>3 million confirmed cases to date worldwide, of which 1 million confirmed cases and \>50,000 deaths have been reported in the USA. Infected individuals commonly experience severe respiratory difficulties and pneumonia, leading to hospital admission and the need for intensive care and mechanical ventilation. Emerging evidence suggests that impaired taste and smell may be early markers of the disease, and that in severe cases, there may be neurological damage in in the medulla, an important brainstem control site for both respiration and swallowing. Given the overlapping neuroanatomical regulation of breathing and swallowing, the investigators hypothesize that dysphagia (swallowing impairment) will be common in People recovering from COVID-19 (PrC-19) and associated with poorer outcomes.

The investigators will offer comprehensive swallowing assessments to PrC-19 after initial recovery and a confirmed negative test for continuing COVID-19 infection. Study sites will be located in the Toronto area (PI Steele); the Hamilton-Niagara region to the west of Toronto (Co-I Namasivayam-MacDonald) and in Gainesville, Florida (Co-I Plowman). The assessments will include the collection of case history information, videofluoroscopy (i.e., a dynamic swallowing x-ray), use of a digital stethoscope to measure respiratory-swallow coordination, measures of other risk factors for dysphagia (e.g. bulbar muscle strength) and patient-reported outcomes. Detailed analyses of the videofluoroscopy swallowing studies (i.e. dynamic x-rays) will identify specific measures of swallowing that fall outside the range of normal variation based on comparison to healthy reference values established through the PI's NIH-funded research program exploring swallowing physiology on liquids of different consistencies.

Eligibility Criteria:
Inclusion Criteria:

* People who tested positive or received a presumed positive diagnosis of COVID-19 infection not earlier than March 1, 2020 and who are at least 2 weeks post positive diagnosis and the initiation of medical management of COVID-19 infection
* Adequate comprehension of English to understand the consent form and follow study instructions

Exclusion Criteria:

* Age under 18 years old
* Current pregnancy
Comparison of Effect of cARvedilol Compared To bISoprolol on cenTral Pulse Pressure in Hypertension (ARTIST) Study

The purpose of this study is to compare of carvedilol, a vasodilating beta-blocker and bisoprolol, a beta1- selective beta-blocker for reducing the central pulse pressure and thereby left ventricular (LV) mass in never-treated hypertensive patients.

Carvedilol and bisoprolol are established beta-blockers for treating hypertension or chronic heart failure because these beta-blockers have cardio-protective effects. Recent studies have shown that the change in central pulse pressure is more closely associated with the change in cardiac load than the change in brachial pressure during hypertension treatment. Vasodilating beta-blockers may decrease central pulse pressure more than beta1- selective beta-blockers, because vasodilators reduced the magnitude of reflection wave by dilating peripheral muscular arteries. The investigators hypothesized that carvedilol, a vasodilating beta-blocker, would be more effective than bisoprolol, a beta1- selective beta-blocker in reducing central pulse pressure and thereby LV mass, through the reduction in the magnitude of reflection wave. The aim of the present study was to test this hypothesis in an active controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (PROBE) design study. At least 100 patients will be enrolled in each group and the follow up duration will be 48 weeks. The primary endpoint is to compare the change in central pulse pressure between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Never-treated hypertensive subjects, aged 20-80 years (at the time of informed consent), regardless of sex
* Clinic systolic BP/diastolic BP \> 140/90 mmHg in a sitting position.

Exclusion Criteria:

* Beta-blocker contraindications(asthma, COPD...)
* Heart rate less than 55 bpm
* Subjects treated with nitrates
* Grade 3 hypertension (≥180 and/or ≥110 mmHg)
* Secondary hypertension or malignant hypertension
* History of heart failure, coronary artery disease, and stroke
* Arrhythmia
* Renal dysfunction (serum creatinine ≥2.0 mg/dl)
* Hepatic dysfunction (AST and/or ALT ≥100 IU/l)
* A history of or a suspected malignant tumor within 5 years of enrollment
* Chronic inflammatory disease
* Pregnancy, childbearing potential with inadequate contraception, breast feeding
* Inability to give informed consent
Lidocaine In-situ Gel Before Intrauterine Device Insertion

Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the insertion tube, and removing the tube; and placement of the device in the uterus.


Eligibility Criteria:
Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to insertion
* No contraindication to or history of allergic reaction to lidocaine
* Women who will accept to participate in the study

Exclusion Criteria:

* Lidocaine allergy
* Any contraindication to device placement
Neuromodulation of Aspiration Secondary to Stroke

Aspiration could induce major respiratory affection. They are often present after stroke. The aim of this study is to facilitate swallowing recuperation in stroke patients using peripheral laryngeal stimulation and to understand its mechanisms using motor evoked potential and cortical evoked potential.


Eligibility Criteria:
Inclusion Criteria:

stroke aspiration

Exclusion Criteria:

pace maker tracheostomy epilepsy pregnancy