cyrilzakka/clinical-trials huggingface dataset:
Early Administration of Ivabradine in Children With Heart Failure

This is a monocentric, prospective, single arm, not for profit study. It is designed to study the early use of ivabradine in patients with dilated cardiomyopathy and Ejection Fraction (EF) \< 45%.

The study is divided into a screening and enrollment visit (V1) where eligibility for treatment will be confirmed. Ivabradine will be administered to eligible patients with increasing dosage during the titration period (TP) which will last from a minimum of 3 days to a maximum of 15 days. This will be followed by a maintenance period (MP) of the drug for a further 14 days. The follow-up period (FU) will last 4 months.

The dose of ACE inhibitors will be introduced after 72 hours of clinical stability after the introduction of titrated ivabradine at maximum dose according to protocol. The anti-aldosterone will be introduced 24 hours after the introduction of ivabradine. The diuretic will not be modified during the titration phase of the drug, unless there is clinical necessity.

During the FU ivabradine will be continued at stable dosage, in order to maintain the target heart rate (HR) reached during the maintenance phase (HR \> 80 bpm, in the group of patients older than 6-12 months, or HR \> 70 bpm in patients aged 1-3 years or HR \> 50 bpm between 3-18 years). In all patients, the drug dose will be decreased or discontinued in case of bradycardia (HR\< 80 bpm in patients 6-12 months, HR\< 70 bpm in patients 1-3 years of age or HR\< 60 bpm in patients 3-18 years of age) and/or symptoms related to bradycardia or for other safety reasons.

Eligibility Criteria:
Inclusion Criteria:

* Dilated cardiomyopathy defined according to the indications of the Cardiomyopathy Task Force (dilation \> 2 Standard Deviations (SD) and hypokinesia);
* Class NYHA/Ross ≥ II;
* Ejection fraction \< 40%;
* Patients with acute heart failure episodes (both new episode and relapse) in the last three months;
* Systolic blood pressure \> 50° age and height;
* Heart rate: 6-12 months: ≥105 bpm, \>1 year \<3 years: ≥95 bpm, 3-5 years: ≥75 bpm, 5-18 years: \>70 bpm.

Exclusion Criteria:

* Cardiogenic shock in the three months;
* Hypertrophic, restrictive or mixed cardiomyopathy;
* Acute lymphocytic myocarditis diagnosed with endomyocardial biopsy;
* Significant Valvular Pathology;
* Sinus block and congenital long QT syndrome;
* Atrial Fibrillation;
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \> 2.5 times normal, bilirubin \> 3 and creatinine \> 2.5 mg/dL;
* Pregnancy and/or positive pregnancy test patients;
* Hypersensitivity to the active substance or any of the excipients;
* Participation in a clinical trial in which an experimental drug was administered within 30 days or 5 half-lives of the investigational drug;
* Chronic lung disease or other clinical condition that the investigating physician believes is incompatible with the study;
* eGFR \<15 mL/min/1.73 m2.
Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension

Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms.

In this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension.

Our hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.


Eligibility Criteria:
Inclusion Criteria:

* A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
* A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
* Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
* Age \> 18
* Informed written consent.
* Reliable anticonception for fertile women.

Exclusion Criteria:

* Rheumatic disease limiting walking capacity.
* Exacerbation in COPD during the study.
* Age\>80 years
* FEV1 \< 25 % of predicted.
* Allergy towards contents of sildenafil or placebo tablets.
* Fall in blood pressure of \> 30 mmHg systolic or \>20 mmHg diastolic after intake of the first dose of trial medication.
* Fall in peripheral saturation of \> 5% after intake of the first dose of trial medication.
* Treatment with nitrous vasodilators or aminophyllamines.
Study Evaluating MAC-321 in Colorectal Cancer

Assess the clinical activity of MAC-321 administered IV as a second-line or third-line antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete plus partial responses). Tumor response will be assessed following modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Histologic and/or cytologic diagnosis of metastatic or relapsed colorectal cancer at any time during disease but not candidates for surgical resection.
* Prior treatment with at least 1 conventional approved therapeutic regimen.
* Subjects who have failed prior cytotoxic chemotherapy regimens containing irinotecan (CPT-11), 5 fluorouracil (5-FU), and/or oxaliplatin for advanced (relapsed) metastatic colon cancer are eligible

Exclusion Criteria:

* Other chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks before signing the ICF (6 weeks if the previous chemotherapy included nitrosoureas or mitomycin)
* Prior radiotherapy to \>25% of bone marrow
* Prior exposure to MAC-321
Plasma Proteomics in Patients With Postoperative Delirium

Patients undergoing cardiac surgery were recruited. Baseline characteristics of all subjects were collected. The 3-minute Delirium diagnostic Scale (3D-CAM) was used to screen the POD group and non-POD group from the recruited subjects during the first 7 days after surgery. Peripheral blood samples were collected 1 day before surgery and 2 day after surgery. . Plasma was isolated from peripheral blood for subsequent proteomic analysis.

Patients undergoing noncardiac surgery were recruited. Baseline characteristics of all subjects were collected. The 3-minute Delirium diagnostic Scale (3D-CAM) was used to screen the POD group and non-POD group from the recruited subjects during the first 7 days after surgery. Peripheral blood samples were collected 1 day before surgery and 2 day after surgery. Plasma was isolated from peripheral blood for subsequent proteomic analysis. To study the characteristics of proteins on a large scale, including protein expression levels, post-translational modifications, protein-protein interactions, etc., so as to obtain a comprehensive understanding of disease occurrence, cell metabolism and other processes at the protein level. Assessment of imbalanced protein expression in peripheral blood using protein profiling may allow us to better understand the pathological changes occurring at the molecular level of POD. Early detection of patients at high risk of POD can optimize perioperative management and promote rapid postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years old, regardless of gender.
* The patient had clear consciousness and no cognitive impairment, and could cooperate with the investigation and follow-up.
* The ASA classification is I-Ⅲ.

Exclusion Criteria:

* severe neurological or psychiatric disorders.
* drug and alcohol abuse.
* Patients with cognitive impairment caused by various reasons such as neuropsychiatric symptoms.
* Exclusion criteria included incomplete medical records and failure to complete the postoperative follow-up.
Islet Allotransplantation With Steroid Free Immunosuppression

The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in 2000 new standards for islet transplantation in patients with brittle T1D by achieving insulin independence in 80 percent of patients. These seminal results have however proved much more difficult to duplicate than initially expected.

This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D.

The short term effectiveness of islet transplantation for alleviating hypoglycemia and controlling glucose homeostasis while limiting or even avoiding the nedd for exogenous insulin has been established despite protocol modifications in donor selection, islet preparation or recipient treatment, insulin independence with adequate metabolic control was however rarely prolonged beyond two years. The most frequently proposed explanations include chronic allogenic rejection, recurrence of autoimmunity and beta cell toxicity from administered immunosuppressive drugs.

Fourteen patients were enrolled in this single center phase 2 trial initiated in 2003. Eligible patients were males or females between 18 and 65 years of age, with type 1 diabeted documented for more than 5 years, arginine stimulated C-peptide lower than 0.2ng/ml, and hypoglycemia awareness or documented metabolic lability. Exclusion criteria included body mass index greater than 28Kg/m2, unstable arteriopathy or heart disease, active infection, previous transplantation, insulin daily requirements above 1.2 UI/kg, creatinin clearance below 60 ml/mn/m2 or urinary albumin excretion above 300 mg/day, malignancy, smoking, desire for pregnancy, psychiatric disorders and lack of compliance. The study primary efficacy endpoint was graft survival defined as insulin independence and HbA1c\<6.5%. Secondary outcomes were graft function and metabolic control.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes documented for more than 5 years
* arginine stimulated C-peptide lower than 0.2 ng/mL
* one of the following:hypoglycemia unawareness OR metabolic lability documented by one or more severe hypoglycemias or two or more hospital admissions for ketoacidosis within the previous year.

Exclusion Criteria:

* body mass index greater than 28 kg/m2
* non stable arteriopathy or heart disease
* active infection
* previous transplantation
* hyperimmunization
* insulin daily needs above 1.2 U/Kg
* creatinine clearance below 60 ml/mn or urinary albumin excretion above 300 mg/d
* malignancy
* smoking
* desire for pregnancy
* psychiatric disorders
* lack of compliance
The Effect of Serious Game on Hospitalized Children's Anxiety, Fear, Knowledge, and Anxiety Levels in Their Parents

Children may view hospitalization as a stressful experience. Children who are hospitalized show high levels of anxiety symptoms. During the hospitalization process, the family of the child as well as the children experience anxiety and stress. These fears and concerns are based on inadequate preparation for hospitalization and lack of knowledge.

Interventions to reduce the fear and anxiety of children during hospitalization include classical methods such as developing booklets and drawing pictures. While various benefits of these methods have been demonstrated, computer and web-based interventions have been shown to be the best way to prepare children for hospitalization. When computer and web-based interventions are examined, it is seen that they mostly focus on anxiety and pain control in children who are hospitalized for the operation process. More studies are needed to prepare hospitalized children for clinical procedures, to introduce the hospital environment, and to introduce the tools used in the hospital with computer and web-based interventions.

The research is a randomized controlled experimental study consisting of three stages. In the first stage of the research, serious game was developed. In the second stage, a randomized controlled study with experimental control group design was carried out. In the third stage, children's views and perceptions about serious play were determined and the effectiveness of the game was evaluated. The population of the research consisted of children aged 8-12, hospitalized in Pamukkale University Hospitals Pediatrics Service between October 2022 and February 2023. The G. Power program was used in the sample calculation and the sample size was calculated as 53 (Effect size 0.50, Power 95%). Considering that there may be data loss while collecting the data, it was increased by 20% and the experimental group was determined as 32 and the control group as 32.


Eligibility Criteria:
Inclusion Criteria:

* accept to participate in the study
* children hospitalized for the first time
* Inpatient treatment between the ages of 8-12-
* Comprehension and speech impairment
* without any mental disability
* Children and parents whose hospitalization is planned for at least three days

Exclusion Criteria:

* Daily and hospitalizations less than three days
* Repeated hospitalizations
* Speech, comprehension and mental problems
* Being treated for an oncological problem
* applied for trauma
* Children and parents who did not agree to participate in the study
Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation

Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed
* Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant)
* Patients who are not family member or employee of the investigator

Exclusion Criteria:

* Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Evaluating AI-Gatekeeper Software in Coronary Artery Stenosis Screening: a Multicenter RCT

The purpose of this study is to determine the efficacy, safety, and cost-effectiveness of AI-Gatekeeper software to assist clinicians in the diagnosis of coronary artery disease by predicting coronary artery stenosis (≥50%) from a multimodal AI technology that integrates clinical risk factors and baseline blood tests, including chest X-ray, electrocardiogram, and echocardiogram, in patients with suspected coronary artery disease (coronary stenosis).

Coronary artery disease (CAD) is a leading cause of global mortality, accounting for over 50% of heart disease-related deaths. Initial evaluations for CAD typically involve chest X-rays, electrocardiograms (ECG), risk factor assessments, and basic blood tests. However, these primary tests can't conclusively diagnose CAD. When CAD is suspected, coronary CTA (CCTA) or invasive coronary angiography (ICA) is performed, determining the need for procedures like stenting or revascularization.

Interestingly, over 50% of patients undergoing CCTA or ICA don't require treatment, as CAD is either absent or not severe enough. This leads to unnecessary procedures and significant healthcare costs. For instance, in the U.S., the cost of unnecessary ICAs reaches billions annually, with similar trends in South Korea.

AI-Gatekeeper software assists clinicians in diagnosing coronary artery disease by predicting coronary artery stenosis (≥50%) using multimodal AI technology. It integrates clinical risk factors and baseline blood tests, including chest X-ray, electrocardiogram, and echocardiogram, in patients with suspected coronary artery disease The purpose of this study is to determine the efficacy, safety, and cost-effectiveness of the AI-Gatekeeper software in a prospective, multicenter, randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* A patient with symptoms such as chest pain suggestive of coronary artery disease, who underwent routine evaluations including blood tests, electrocardiogram, chest X-ray, and echocardiography
* Low to Intermediate risk of pretest probabilities of obstructive CAD
* Voluntarily agreed to participate in this clinical trial and signed the written consent form

Exclusion Criteria:

* Acute chest pain (in patients who have not been ruled out for ACS)
* Previously diagnosed and treated coronary artery disease (myocardial infarction, PCI, CABG)
* Patients with a life expectancy of less than 2 years due to conditions other than heart disease
* Those who have not consented to the protocol
* Participated in a drug or medical device clinical trial within the last 3 months
* Pregnant or lactating women
* Allergic to iodine preparations
* Serum creatine level greater than 1.5 mg/dL or eGFR less than 30 mL/min
* Baseline irregular and uncontrolled heart rhythm
* Heart rate greater than 100 beats/minute
* Systolic blood pressure of 90 mm Hg or less
* Contraindications to beta blockers or nitroglycerin
* Patients with complex congenital heart disease
* Body mass index greater than or equal to 35
Strength or Power Training for Patellofemoral Pain

The objective of this study is to compare a novel 6-week strength training rehabilitation incorporating power exercises (STRIPE) program to a standard of care (SOC) program on short-term and long-term pain, subjective function, patellofemoral pain recurrence rates, and secondary outcomes (hip abduction and extension rate of torque development and single-leg squat kinematics). We hypothesize that participants with patellofemoral pain who complete the STRIPE program will have 1) decreased pain, 2) improved subjective function, 3) reduced patellofemoral pain recurrence rates, 4a) improved hip abduction/extension rate of torque development, and 4b) decreased hip adduction and pelvic drop during a single leg squat compared to participants who complete a SOC rehabilitation program.

The proposed study will compare strength-based exercises, which is the standard of care (SOC), that target the hip abductors, hip extensors, lumbo-pelvic, and quadriceps muscles, to a strength training program that utilized power-based exercises (Strength Training Rehabilitation Incorporating Power Exercises \[STRIPE\]). Individuals with patellofemoral pain, both within the military and general population, present with long-term pain, decreased subjective function, and high recurrence rates. Our primary outcomes are to determine intervention success with self-reported knee pain, measured by the visual analog scale, subjective function, measured by the anterior knee pain scale, and recurrence rates. Recent evidence suggests that two in every three individuals with patellofemoral pain report symptoms up to two years after seeking care, therefore we will assess patellofemoral pain recurrence rates for two years. Additionally, the proposed interventions target gluteal muscle function, supporting our selection of secondary outcome variables. We will assess rate of torque development, as power-based exercises are recommended to improve muscle capacity, of both the targeted gluteus medius and gluteus maximus. We will also assess frontal plane kinematics, as the gluteal muscles are responsible for controlling pelvic and hip motion during functional tasks.

Eligibility Criteria:
Inclusion Criteria:

* Participants to be between the ages of 18-40 years old.
* Insidious onset of symptoms greater than 3 months.
* Worst pain in the previous month of 3/10 with two of the following tasks: prolonged sitting, jumping, squatting, kneeling, running, and stair ambulation.

Exclusion Criteria:

* Other forms of anterior knee pain (Osgood-Schlatter, tendon pain, bursitis, etc.).
* History of lower extremity surgery.
* History of patella subluxation, meniscal injury or ligamentous instability.
* History of referred pain from the lumbar spine.
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma

The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to GM-CSF.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age ≥ 18 years
* Stage IIIb, IIIc or stage IV disease that is not surgically resectable
* Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance)
* At least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion \>= 10 mm in longest diameter or, multiple injectable melanoma lesions which in aggregate have a longest diameter of \>= 10 mm
* Serum lactate dehydrogenase (LDH) levels less than 1.5 x upper limit of normal (ULN)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Prolongation in International Normalized Ratio (INR), Prothrombin Time (PT), and Partial Thromboplastin Time (PTT) when the result is from therapeutic anticoagulation treatment are permitted for patients whose injectable lesions are cutaneous and/or subcutaneous such that direct pressure could be applied in the event of excessive bleeding

Exclusion Criteria:

* Clinically active cerebral or any bone metastases. Patients with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to randomization
* Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For patients with \< 3 visceral metastases, no lesion \> 3 cm, and liver lesions must meet Response Evaluation Criteria In Solid Tumors (RECIST) criteria for stable disease for at least 1 month prior to randomization