cyrilzakka/clinical-trials huggingface dataset:
Effects of a Nursing-led Communication Using Mobile Health Information in Breast Cancer Patients Undergoing Concurrent Chemotherapy

Breast cancer is the most common malignant tumor among women. Side effects from initial chemotherapy include sleep disorders, anxiety, depression, and reduced quality of life. Mental health distress is also a major issue in cancer care. This study integrates mobile health information with a nurse-led communication support plan, aiming to improve patients' physical and mental outcomes during chemotherapy.

The objective of this study is to explore the effects of a nursing-led communication support program using mobile health information on physical and mental state in breast cancer patients undergoing initial chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

breast cancer initial chemotherapy

Exclusion Criteria:

Patients whose cancer has recurred without undergoing the first course of chemotherapy
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis

The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA, VIT E and Choline (n=30)or an identical placebo (n=30) given orally for a period of 12 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.

Patients will undergo a medical evaluation every three months during the 12-month study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonography of the liver will be repeated after six months at the end of the study period.

Eligibility Criteria:
Inclusion Criteria:

* persistently elevated serum aminotransferase levels
* diffusely echogenic liver on imaging studies suggestive of fatty liver
* biopsy consistent with the diagnosis of NAFLD

Exclusion Criteria:

* hepatic virus infections (HCV RNA-PCR negative)
* Hepatitis A, B, C, D, E and G
* cytomegalovirus and Epstein-Barr virus
* alcohol consumption
* history of parenteral nutrition
* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
* autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria
OcupApp: Occupational Self-analysis Intervention Through an Mobile Application

The goal of this clinical trial is to test the effectiveness of the use of mobile application ("OcupApp") to generate a personal self-analysis about meaningful activities in which adults between the ages of 50 and 70 with anxiety and subclinical depression participant.

A randomized study will be carried out comparing the effects of the use of the application "OcupApp" with a control intervention on the quality of life related to health, mental health, frequency of participation on meaningful activities, and perceived occupational balance.

OcupApp is a mobile application developed within the research team, which aims to promote occupational self-analysis in adults with depression and/or anxiety. The mobile application allows to offer feedback to participants about the meaning of the activities they carry out daily and their perception of occupational balance, which generates a subjective self-reflection that can lead to the implementation of some personal changes in their weekly routine. For this, the person must register the activities they carry out throughout a week and mark each one of them with a punctuation related to the meaning of the following dimensions: identity, pleasure, competence, importance and value of the activity by other people. The punctuation give will be on a Likert-type scale from 1 to 5. The application also allows to collect other information such as where the activity takes place, its duration, and the people with whom it is carried out. Also, at the end of the week, the application will ask users about their perceived occupational balance. All the information registered in the mobile application will be returned to the person in a dynamic and understandable way. Based on this, the person can establish two goals to accomplish. In this sense, OcupApp will offer personalized recommendations based on the objectives to be achieved related to the dimensions of meaning.

Eligibility Criteria:
Inclusion Criteria:

* Have a smarthphone and know how to use mobile apps to exchange information.
* Have a low or moderate depression (DEP 5 \<= 4) or low or moderate anxiety (ANX5 \<= 3) or DEP5 or ANX5 =3).

Exclusion Criteria:

* Have a serious mental illness or psychosis.
* Have a diagnosis of dementia
* Have language problems or cognitive alterations that doesn't allow comprehension of assessment tools.
Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing

The aim of this study is to compare the effect of antioxidant dressing (active product) on chronic wound healing with the use of non-active wound dressing for healing in a moist environment (standard clinical practice) in patients with hard-to-heal wounds


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients with leg ulcers (venous, ischemic, traumatic or diabetic foot ulcer).
* Patients with dehisced surgical wounds healing by second intention.
* Patients with pressure ulcers.
* Wound area between 1 and 250 cm2.

Exclusion Criteria:

* Systemic inflammatory disease or oncological disease.
* Wounds with clinical signs of infection.
* Terminal situation (life expectancy less than 6 months).
* Ulcers from other etiologies: tumours, infectious.
* Wounds treated with negative pressure therapy.
* Pregnancy.
* History of sensitivity or allergy to any of the components of the study dressing.

In addition, criteria for withdrawal from the study will be considered:

* Worsening of the wound according to the clinical judgment of the professional (appearance of clinical signs of infection or others).
* Appearance of allergies or hypersensitivity to the dressing.
* Death.
* Hospital admission that interrupts or complicates the continuity of care in the Nursing Consultation.
* Transfer to another Health District where there can be no continuity of care with the active dressing.
Visual Stimulus and Eye Movement

This study is designed to understand how we see visual patterns and how these patterns lead to eye movements.

Normal volunteers participating in this study face a screen on which spots or patterns of light are projected. They are asked to respond to the patterns by voice, eye movements or hand movements. Eye and lid movements are recorded in one of the following ways:

1. Electro-oculogram \< small disc electrodes taped to the skin near each eye measure the eye movements as the eyes change position.
2. Infrared detector \< an infrared beam is reflected off the eye and picked up by detectors that record the eye movements.
3. Contact lens ring \< a smooth plastic ring is placed on the white of the eye surrounding the cornea and eye position is measured using a magnetic coil.

Study sessions last less than four hours.

The purpose of this protocol is to study the physiology of the visuo-motor system in normal humans. This will be accomplished by recording eye movements and other responses (such as reaction time to bar press or verbal responses) to differing stimuli. The stimuli will be primarily visual but may include auditory or tactile stimuli.

Eligibility Criteria:
* INCLUSION CRITERIA:

Normal adult volunteers age 18 and over are included.

Only normal volunteers are studied under this protocol. Normal volunteers are recruited from the NIH volunteer office and the NIH web page. Women and minorities are actively recruited.
Topical Coconut Oil Application and Incidence of Sepsis in Neonates

The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.

Purpose and Specific Aims

The purpose is to determine the effect of twice daily topical coconut oil application on late onset sepsis in neonates admitted to the Neonatal Intensive Care Units of Indira Gandhi Institute of Child Health, Cloudnine Hospital at Old Airport Road, and Cloudnine Hospital at Jayanagar in Bangalore, India. The aim is to determine the effect of topical coconut oil application on:

* The incidence of neonatal late onset culture positive sepsis
* Neonatal skin integrity versus a no treatment control using standard skin evaluation methods
* Biomarkers of neonatal innate immune function
* Temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality.

The investigators hypothesize that twice daily topical coconut oil application will reduce the incidence of late onset sepsis (LOS) in premature and full-term infants versus the current standard of care, i.e., no treatment. The oil treatment will increase the neonatal skin barrier integrity measured by validated clinical and instrumental methods. Skin surface biomarkers of innate immune function collected from coconut oil treated skin will indicate less inflammation (lower proinflammatory cytokine levels) than in untreated control skin.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants 24-36 weeks gestational age
* Full-term infants 37-42 weeks gestational age
* Less than 48 hours of age at enrollment
* Admitted to the neonatal intensive care unit of Indira Gandhi Institute for Child Health, Cloudnine Hospital at Old Airport Road and Cloudnine Hospital at Jayangar, Bangalore
* Expected to be in the neonatal intensive care unit for at least 4 days after enrollment
* Able to tolerate study procedures as described
* Parent/guardian willing to provide written informed consent

Exclusion Criteria:

* Medically unstable
* Parent/guardian unable to provide written informed consent
* Presence of inherited cutaneous condition e.g., scalded skin syndrome, epidermolysis bullosa
* Presence of major congenital anomalies
* Infants undergoing surgery
SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma

The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.

This is an open-label, single-arm study in patients with HER2-expressing recurrent, advanced or metastatic endometrial carcinoma. HER2-expression is defined as a 1+, 2+ or 3+ score on immunohistochemistry (IHC) or positive by in situ hybridization (ISH). Eligible patients for this study should have progressed on or after first line platinum-based chemotherapy. Patients who have had two or more lines of chemotherapy for advanced/metastatic disease are not eligible.

Eligible patients will receive SYD985 until disease progression or unacceptable toxicity. Patients who have stopped study treatment for other reasons than disease progression will continue their tumor evaluations in an observation period until disease progression or start of a new anticancer therapy.

Eligibility Criteria:
Main Inclusion Criteria:

* Females with histologically confirmed recurrent, advanced or metastatic endometrial carcinoma
* Eligible patients should have progressed on or after first line platinum-based chemotherapy for advanced/metastatic endometrial cancer. Patients who have had two or more lines of chemotherapy for advanced/metastatic disease are not eligible, taking into account the following:

  * Patients may have received up to one additional line of chemotherapy if given in the neoadjuvant or adjuvant setting. If such treatment was completed less than 6 months prior to the current tumor recurrence or progression it is to be considered first-line treatment;
  * No more than one line of non-cytotoxic systemic cancer therapy (such as immunotherapy, trastuzumab or protein kinase inhibitors) is allowed.
* HER2 tumor expression defined as a 1+, 2+ or 3+ score on IHC or positive by ISH
* At least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumours (RECIST version 1.1);
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

Exclusion Criteria:

* Current or previous use of a prohibited medication as listed in the protocol;
* History of infusion-related reactions and/or hypersensitivity to trastuzumab;
* History of keratitis;
* Severe, uncontrolled systemic disease at screening;
* Left Ventricular Ejection Fraction (LVEF) \< 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab;
* History of clinically significant cardiovascular disease;
* Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;
* History or presence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming.

TherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles.

Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known.

The purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale.


Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with a pacemaker featuring the TherapyGuide function
* Patient more than 18 years of age.
* Patient able to sign a data release authorization form

Exclusion Criteria:

- Unwillingness or inability to provide written consent
Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis

The aim of the study is to investigate the link between pro-inflammatory T cells responses arising in the skin in patients with cutaneous psoriasis and those present in the joints of patients developing psoriatic arthritis.

The study is based on the hypothesis that a fraction of T cells with memory phenotype can recirculate from the skin and relocalize at extracutaneous sites including enthesis or synovial tissue thus propagating the pro-inflammatory cycle. This could represent a pathogenic mechanism in the development of PsA.

The main aim of the study is to define the phenotypic and functional differences of circulating T cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in control group of healthy subject.

To this end the investigators analyze the expression of cell surface markers of central memory (TCM), effector memory (TEM) and effector (Teff) cells, within this subsets the investigators evaluate the expression of chemokine receptors as well as skin and tissue homing molecules. There will be also an evaluation of the T cell polarization towards Th1/Tc1 or Th17/Tc17 phenotype by evaluating the cytokine expression profile.

In selected patients with PsA the researchers analyze in parallel the phenotype and the cytokine profile of T cell subpopulations in peripheral blood and in synovial fluid, The results of this study could possibly allow to define distinctive features of circulating T cells in patients with PsA and to understand the link between circulating and synovial fluid T cells in patients with PsA.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of cutaneous psoriasis without clinical signs of PsA,
* Patients with a diagnosis of PsA
* Healthy subjects with a negative family and personal anamnesis for psoriasis.
* Absence of acute and chronic systemic or cutaneous infections during sample collections.

Exclusion Criteria:

* Treatment with cyclosporin A, methotrexate, systemic corticosteroids or any other immunosuppressant agent within 3 weeks before the blood samples collections.
Resistance Exercise Training in Chronic Kidney Disease

The investigators aim to evaluate the feasibility of a resistance exercise training program among individuals with CKD and its impact on endothelial and vascular function.

Resistance exercise training has been shown to improve cardiovascular health including endothelial function in general populations, but studies in patients with chronic kidney disease (CKD) are limited. The investigators aim to evaluate the feasibility and acceptability of a resistance exercise training program among individuals with CKD and its impact on endothelial and vascular function as measured by brachial artery flow-mediated dilation, pulse-wave velocity and carotid artery stiffness. To accomplish this goal the investigators propose to conduct a 12-week pilot randomized controlled trial of twice a week resistance exercise training among 32 adults with CKD. The results of this study will inform the design and implementation of a larger trial evaluating the impact of resistance exercise training on adverse outcomes in patients with CKD including CKD progression.

Eligibility Criteria:
Inclusion Criteria:

* CKD stage 3 or 4 (eGFR 15-60 ml/min/1.73m2)

Exclusion Criteria:

* Currently institutionalized
* Kidney transplant or dialysis
* NY Heart Association class 3-4 heart failure
* Dementia or cognitive impairment
* Unstable angina or coronary revascularization within the last 3 months
* Uncontrolled arrhythmia
* Severe chronic lung disease
* Orthopedic, neurologic or other condition that would preclude resistance exercise training
* Pregnancy
* Uncontrolled hypertension (systolic \> 160 mmHg and diastolic \>90 mmHg)
N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage

The purpose of this study was to test the hypothesis by comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC).

Gastric variceal hemorrhage (GVH) has a poorer prognosis than esophageal variceal hemorrhage. However, data on its optimal treatment are limited. We designed a prospective study to compare the efficacy of endoscopic band ligation (GVL) and endoscopic N-butyl-2-cyanoacrylate injection (GVO). Liver cirrhotic patients with or without concomitant hepatocelluar carcinoma (HCC) and patients presenting with acute GVH were randomized into two treatment groups. Forty-eight patients received GVL, and another 49 patients received GVO. Both treatments were equally successful in controlling active bleeding (14/15 vs. 14/15, P = 1.000). More of the patients who underwent GVL had GV rebleeding (GVL vs. GVO, 21/48 vs. 11/49; P = .044). The 2-year and 3-year cumulative rate of GV rebleeding were 63.1% (95% confidence interval \[CI\], 44.5%-81.7%), 72.3% (95% CI, 51.3%-93.3%) for GVL and 26.8% (95% CI, 12.5%-41.1%), 26.8% (95% CI, 12.5%-41.1%) for GVO; P = .0143, log-rank test. The rebleeding risk of GVL sustained throughout the entire follow-up period. Multivariate Cox regression indicated that concomitance with HCC (relative hazard: 2.453, 95% CI: 1.036-5.806, P = .041) and the treatment method (GVL vs. GVO, relative hazard: 2.660, 95% CI: 1.167-6.061, P = .020) were independent factors predictive of GV rebleeding. There was no difference in survival between the two groups. Severe complications due to these two treatments were rare. In conclusion, the efficacy of GVL to control active GVH appears to have no difference with GVO, but GVO is associated with a lower GV rebleeding rate.

Eligibility Criteria:
Inclusion Criteria:

\* Patients who were aged between 18 and 80 years and had endoscopy-proven acute gastric variceal hemorrhage (GVH)

Exclusion Criteria:

* Cases with concomitant large GV and large EV, but without stigmata of recent bleeding
* Cases had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt for GVH
* Cases had a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or nonhepatic malignancy
Alveolar Ridge Augmentation With Curcumin Combined With Xenograft

A study was performed to investigate the effect of curcumin on the osteogenic differentiation of human periodontal ligament stem cells (hPDLSCs) and its underlying potential mechanism. The Results was that Curcumin at an appropriate concentration had no cytotoxicity and could promote osteogenic differentiation of the hPDLSCs

Patients will be selected from the outpatient clinic of Oral Medicine, Periodontology and Oral diagnosis Department, Faculty of Dentistry, Ain Shams University. The purpose of the study will be explained to all patients and an informed consent will be signed before the conduction of the study .The faculty research ethics committee will review the proposal.

The study will be conducted in the form of Patient Intervention Comparative Outcome (PICO) question (Patient "P", Intervention "I", Comparative "C", Outcome "O"). (Stone 2002) "P": Patient in the study will have enough alveolar ridge height ,suffering from missing from 1 to 3 upper maxillary anterior and /or premolar with insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement. The minimum BL width included in the study will be 4 mm. "I": Ridge splitting with interposition grafting with curcumin and particulate xenograft grafting. "C":Alveolar ridge splitting with interposition grafting with use of particulate xenograft alone without curcumin . "O":Clinical and radiographic outcome.

Eligibility Criteria:
Inclusion Criteria:

* Male and female with age range 25-45 years.
* Patient with enough alveolar ridge height, suffering from missing single or multiple maxillary anterior and /or premolar with insufficient alveolar ridge buccolingual (BL) width that interfere with conventional straight forward implant placement. The minimum BL width included in the study will be 4-5 mm to facilitate ridge splitting and expansion.
* Systemically free from any diseases as evidenced by Burket's oral medicine health history questionnaire.
* Patient available during follow up periods.

Exclusion Criteria:

* Smokers.
* Pregnant and breast feeding females.
* Patient unwilling to comply to oral hygienic instructions.
* Patients under any medication or medical condition that affect the bone quality.
* Vulnerable groups. (e.g decisions impaired individual).