cyrilzakka/clinical-trials huggingface dataset:
Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect

This study is to evaluate the ability of a newly designed device, Optic Nerve Glass (O-Glass) to detect relative afferent pupillary defect (RAPD). In this prospective study, 44 patients (diagnosed RAPD- positive) enrolled the study. They were examined for an RAPD by O-Glass and also manual swinging flashlight method (SFM) . This newly designed instrument captures and records eye pictures. The images will be processed and analyzed using computerized software to calculate pupillary measurements.

Pupil response to light stimulation is a basic clinical approach to the assessment of a patient with visual loss. Asymmetric response may indicate a relative afferent pupillary defect (RAPD). The rapid detection device for relative afferent pupillary defect (present device) is a newly designed portable facility with computerized software on a mobile device. This allows for field ophthalmic examination and identification of RAPDs quickly and accurately and also record pupillary movements for further processing and analysis or send the information and images via Wi-Fi. We aimed at comparing and evaluating this device with available methods to develop a test which is practically easy and quick with objective results and no need for specialist interpretation, so that any technician can perform the test automatically. Distinctive software allows simple use of the device by field personnel with minimal training. Each patient was investigated by swinging flashlight method and the newly constructed automated O-glass. The swinging flashlight test procedure, also called as Marcus Gunn Test, is well known in ophthalmology science.The hardware for this device includes 4 different parts: Camera and optics, light control system, power control system, and the microcontroller.The two main components of the software are the ability to communicate with the hardware wirelessly, and the pattern recognition system.

Eligibility Criteria:
Inclusion Criteria:

* positive relative afferent pupillary defect

Exclusion Criteria:

-
Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer

Determine the effects of the Computerized Symptom Assessment Tool (C-SCAT) versus usual care on the primary outcomes of self-efficacy for symptom management and symptom self-management behaviors

This is a multi-site two-group randomized control trial (RCT) design to evaluate the effects of the Computerized Symptom Assessment Tool (C-SCAT) for improving symptom self-management versus usual care in 126 adolescents and young adults (AYAs) who are within the first three months of a diagnosis of cancer and who are receiving cancer treatment. For this study, cancer treatment will be defined as a prescribed infusion ( e.g., chemotherapy, immunotherapy).

Eligibility Criteria:
Inclusion Criteria:

* Has received at least 1 cycle of cancer treatment and is within 3 months of initial cancer diagnosis
* Receiving regularly scheduled cancer treatment and will be receiving at least three more cycles
* Reports at least 1 symptom related to cancer and/or its treatment
* Able to speak, read, and write English as required for completion of the C-SCAT and study measures

Exclusion Criteria:

- Cognitive and/or physical inability to complete study measures.
Post-Marketing Surveillance Study of Micardis® Plus in Patients With Hypertension

Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice prescribing-conditions


Eligibility Criteria:
Inclusion Criteria:

* Adult (Age \>= 18 years) males and females for whom a medical antihypertensive therapy is indicated

Exclusion Criteria:

* Age \< 18 years
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure requiring hemodialysis or hemodiafiltration 3 times a week
* Daily urine volume of ≥ 500 mL/day
* Male or female patients age 20 to 80 years, inclusive
* Use of one of the specified contraceptive methods until 4 weeks after final IMP administration
* Capable of providing their own written informed consent prior to any trial-related procedures being performed

Exclusion Criteria:

* Patients with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
* Patients with NYHA class IV heart failure
* Patients with impaired hepatic function(chronic hepatitis, drug-induced liver injury)
* Patients with serious ischemic heart disease who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
* Patients with serious arrhythmia who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
* Patients with serious secondary hyperparathyroidism(intact parathyroid hormone \> 500 pg/mL)
* Patients who are concomitantly undergoing peritoneal dialysis
* Patients with a history of cerebrovascular disease or coronary artery disease within 4 weeks prior to informed consent, a history of hypersensitivity to any ingredient of tolvaptan or benzazepine derivatives such as mozavaptan hydrochloride or a history of impaired hepatic function(chronic hepatitis, drug-induced liver injury)
* Patients with any of the following abnormal laboratory values: hemoglobin \< 8.0 g/dL, total bilirubin \> 3.0 mg/dL, ALT (GPT) or AST (GOT) \> 2 times the upper limit of the reference range, serum sodium \> upper limit of the reference range, serum sodium \< 125 mEq/L, or serum potassium \> 6.0 mEq/L
* Patients who are unable to sense thirst or who have difficulty with fluid intake
* Patients who have received OPC-41061 in history.
* Participation in any other clinical trial or post-marketing clinical study within 4 weeks prior to informed consent for the present trial
* Female patients who are pregnant, possibly pregnant, or nursing
* Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Infection in DiGeorge Following CHD Surgery

We propose a retrospective review of patients with DiGeorge syndrome having undergone cardiac surgery to evaluate the incidence of blood stream and/or surgical site infection. The hypothesis is that we will find an increased number of infections for this sub-group. We will compare the incidence of infection to children of similar age and diagnosis to evaluate for variances in the incidence of infection.

DiGeorge syndrome is a common genetic disorder that frequently results in congenital heart defects such as truncus arteriousus, coarctation of the aorta, interrupted aortic arch, tetralogy of Fallot, pulmonary atresia with VSD, and several others. The defect is usually due to a deletion in the long arm of chromosome 22. Approximately 25% of patients with DiGeorge have a congenital heart defect. These patients also have varying degrees of thymic hypoplasia with associated T cell dysfunction. They are at increased risk of infections and can be at risk for opportunistic infections when the degree of T cell dysfunction is severe. Children undergoing cardiac surgery are at risk for infections in the post-operative period, prolonging hospital stay and increasing morbidity and mortality. The patient with DiGeorge syndrome may have higher rates of infection due to associated immune system dysfunction, however, this has not been previously reported from a large group of DiGeorge syndrome patients. Children's Healthcare of Atlanta follows over 200 patients with DiGeorge syndrome, with the majority having previously undergone cardiac surgery. This group of patients may benefit from more extensive antibiotic prophylaxis following surgery if they indeed have significantly higher rates of infection, but the true incidence needs to be determined.

Eligibility Criteria:
Inclusion Criteria:

* Children's Healthcare of Atlanta patients, Egleston DiGeorge Syndrome Cardiac Surgery 200 medical charts between Jan 1, 1998 and April 31, 2005 with cardiac surgery and DiGeorge Syndrome 200 medical charts between Jan 1, 1998 and April 31,2005 with cardiac surgery and no DiGeorge Syndrome

Exclusion Criteria:

* Those who do not meet inclusion criteria
SFEE Diet Management for Gestational Diabetes Mellitus

This study aims to evaluate the impact of the Self-Family-Environment Empowerment (SFEE) diet management intervention on glycemic control, maternal outcomes, and dietary adherence in pregnant women with gestational diabetes mellitus (GDM).

Gestational diabetes mellitus (GDM) is a common complication of pregnancy, posing risks to maternal and fetal health. Effective management of GDM is critical to improving outcomes. This study aims to evaluate the potential of the Self-Family-Environment Empowerment (SFEE) diet management intervention in empowering pregnant women with GDM to improve glycemic control, dietary adherence, and maternal outcomes.

The study is conducted as a parallel-group controlled trial at the First Affiliated Hospital of Shanxi Medical University. Participants are allocated to two groups: an intervention group receiving routine care combined with the SFEE program and a control group receiving routine care only. The SFEE intervention integrates self-management strategies, family empowerment, and community learning, designed to support adherence to dietary recommendations and enhance participants' understanding of GDM management.

Primary outcomes include fasting blood glucose, postprandial glucose, and HbA1c levels measured after a 3-month intervention. Secondary outcomes include dietary adherence (assessed via a validated scale), GDM knowledge (measured using a questionnaire), and perceived social support (measured using the Perceived Social Support Scale)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gestational diabetes mellitus (GDM) based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria.
* Aged 18-45 years.
* Pregnant women between 24-28 weeks of gestation at the time of enrollment.
* Able to provide informed consent.
* Access to a mobile phone and internet for study communication and follow-up.

Exclusion Criteria:

* Pregnant women with complications such as placental abruption, miscarriage, or induced abortion during the study period.
* Those unable to give informed consent or adhere to the intervention due to medical or personal reasons.
* History of severe medical conditions or other factors that might interfere with study participation (e.g., severe mental health conditions).
Frailty Assessment Among Kidney Transplant Candidates

Frailty is common among chronic kidney disease patients who are on the kidney transplant (KT) waiting list.

The aim of this study is to assess frailty according to different frailty tools among KT candidates and to establish potential biomarkers of frailty.

This is an observational study where KT candidates will be assessed for frailty according to:

* Frailty Fried Phenotype and
* FRAIL scale

Sociodemographics and clinical variables will be collected and serum samples will be obtained in order to implement further studies regarding biomarkers of frailty..

Eligibility Criteria:
Inclusion Criteria:

* KT candidates accepted for the KT waiting list

Exclusion Criteria:

* No willing for participating
* Difficulty in understanding Spanish or English
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* Have a history of at least 1 unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Diabetes mellitus
* Change in body weight greater than 5 kg within 3 months prior to starting study
* Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
* History of pancreatitis
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
REported Outcomes in COPD With Trixeo in Real worlD in Germany

Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms (including breathlessness, cough, and sputum production), which has a substantial impact on health-related quality of life (HRQoL). Medical treatment of COPD aims to reduce these symptoms, reduce exacerbations, and improve patients' ability to perform exercise and daily activities. TRIXEO is a triple therapy indicated as a maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.

The RECORD study is a prospective, non-interventional study to be conducted in the United Kingdom (UK) and Germany. The study aims to generate data to describe the real world effectiveness of TRIXEO for patients with COPD who receive TRIXEO in routine clinical practice. It also aims describe patients HRQoL, physical activity and treatment satisfaction, and will explore patients' sleep quality and adherence to inhalers in the real-world. This data may provide important information for practicing physicians.

The study will include approximately 500 patients with moderate to severe COPD from approximately 50 sites (including hospitals and GP practices) in Germany. Patients eligible for TRIXEO therapy may be enrolled by their treating physicians. The decision to treat with TRIXEO must be independent of the study and made by the treating physician according to the patients' medical need and local routine clinical practice. Patients' data will be collected for 12 months after starting therapy with TRIXEO.

Demographic and clinical data will be extracted from patients' health care records. Patient reported outcomes will be collected remotely by asking patients to answer questionnaires on health status and HRQoL, physical activity, sleep quality, treatment satisfaction, and inhaled medication adherence through electronic surveys.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed COPD
* Having been prescribed treatment with TRIXEO according to label and local market reimbursement criteria
* Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol
* After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* COPD due to α-1 antitrypsin deficiency
* Previous treatment with any other triple fixed-dose combination during screening
* Hospitalisation due to COPD exacerbation within the last 4 weeks prior to enrolment
* Pregnancy or lactation period
* Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomised clinical trial in the last 30 days.
* Patient still recovering from Covid-19 infection
Passive Mobilization and Vascular Function

With aging, vascular function (VF) declines. Inactivity and sedentary life style have been shown to contribute to the worsening of VF. Furthermore, bed rest, a condition commonly used for the management of many chronic conditions, has been proven to lead to even more deleterious consequences, including VF decline.

This study evaluates the effect of passive mobilization of the lower limbs on VF in bedridden oldest-old. Half of the participants will undergo passive mobilization treatment in addition to standard therapies, while the other half will receive only standard therapies. We hypothesize that passive mobilization may improve nitric oxide (NO)-mediated endothelial function.

Normally, cardiovascular function declines with age. Furthermore, cardiovascular function declines with immobility, promoting other adverse effects such as postural hypotension, impaired cardiac function, and thrombogenic events. Bed rest, a condition normally used in the management of many chronic pathologies in elderly people, leads to significant functional decline, reduction in physiologic reserve of most of the organ systems, including further cardiovascular decline. Fortunately, several studies have suggested interventions that may counteract immobility-induced cardiovascular dysfunction and ensure beneficial adaptations in the aging population. For example, passive mobilization of the limbs has been shown to improve cardiovascular function in bedridden oldest-old. However, the effect of passive mobilization on NO-mediated endothelial function have not been studied yet. Thus, the main aim of the study is to determine whether passive mobilization is an effective strategy to counteract endothelial dysfunction in bedridden oldest-old. For this purpose, bedridden individuals will be recruited and randomly assigned to two groups: one group will undergo passive mobilization treatment (PM) in addition to standard therapies, the other group (CTRL) will undergo standard therapies only. On the basis of preliminary data on a subgroup of ten participants, a sample of eighteen individuals will be allocated in each group so to reach a statistical power \>0.80 and an alpha \<0.05. The PM treatment will include knee flexion-extension and it will be performed for 30 minutes, 2 times a day, 5 days a week for 4 weeks.

Before, after the 4-week treatment, and 1 month after the end of the treatment NO-mediated endothelial function of all participants will be evaluated by means of flow-mediated dilation and passive limb movement tests.

Eligibility Criteria:
Inclusion Criteria:

* Bedridden

Exclusion Criteria:

* Neurodegenerative disease (i.e.Parkinson's disease, Alzheimer's disease)
* Heart failure
* Organ transplantation
* Liver failure
* Kidney failure
* Hemorrhage
* Neuromuscular diseases
Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease

The aim of this study is to investigate the effect disease activity on resting energy expenditure (REE), body composition, inflammatory markers, food intake and quality of life in subjects affected by Crohn's Disease (CD)

Malnutrition is a common sequel among patients affected by Crohn's disease (CD). The pathogenic mechanisms include poor dietary intake, increased resting energy expenditure (REE), nutrient malabsorption and loss. So far, few studies have been carried out in CD adult patients, assessing the effect of disease activity on both REE and body composition. Vaisman et al (2006) studied sixteen CD patients in remission (\> 3 mo) and showed no effect of REE on lower BMI, although in the presence of similar energy intake in according with previous studies (Al-Jaouni et al., 2000; Schneeweiss et al., 1999). While, Gong et al., 2015 found that patients with active disease had an increase in REE compared to patients in remission as already shown by Rigaud et al., 1993; Kushner and Schoeller, 1991. Overall, the effect of disease activity on REE is still uncertain and requires further investigation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Crohn's Disease

Exclusion Criteria:

* Comorbidity affecting energy metabolism (diabetes mellitus, thyroid dysfunction, etc.)
* History of acute or chronic liver or kidney disease
* Current parenteral nutrition
* Presence of fistulae, ileostomy or colostomy
* Presence of extensive small bowel resection (residual small bowel \< 2 meters)
* Pregnancy or lactation
Continuous Subcutaneous Insulin Infusion Versus Multiple Dose Insulin Injections in Routine Clinical Practice

Observational study about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.

Cross-sectional analysis about effectiveness and safety of continuous subcutaneous insulin infusion compared to multiple dose insulin injections in T1DM adult patients in routine clinical practice.

All clinical variables are gathered from four EMR softwares (Mambrino XXI, Carelink Pro®, Emminens eConecta® and FreeStyle Libre®).

Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age.
* Diagnosed of Type 1 Diabetes Mellitus.
* Be attended in Ciudad Real General University Hospital.
* Current treated with CSII (CSII cohort) or MDI (MDI cohort) during ≥6 months.

Exclusion Criteria:

* Less than 18 years old.
* Other types of diabetes mellitus.