cyrilzakka/clinical-trials huggingface dataset:
Recurrent Acute Myocarditis Registry

The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

Acute myocarditis (AM) is an inflammatory disease of the myocardium caused by different infectious and non-infectious triggers. It is a major cause of sudden cardiac death, with also long-term adverse outcomes in survivors. The incidence and predictive factors of recurrent AM (RAM) are unknown.

Arrhythmogenic cardiomyopathy (ACM) is a genetically-determined or acquired arrhythmogenic disorder of the myocardium. With an incidence of 1/5000, genetic ACM is the consequence of pathogenic variants in genes encoding for desmosomal and cytoskeleton proteins. Originally described as a right ventricular disease (ARVC), genetic ACM is increasingly recognized as a left (ALVC) or biventricular entity. Genetic ACM may manifest with various clinical presentations, with a predisposition to acute and chronic heart failure, ventricular arrhythmias and sudden cardiac death. Pathophysiology of genetic ACM at early stages remain widely elusive.

Myocardial inflammation has been consistently reported in patients with genetic ACM, but the exact nature of their association is a matter of debate. The temporal association between RAM episodes and the later diagnosis of genetic ACM is speculative, and it has been hypothesized recently that RAM episodes might reflect early active phases in the development of a genetic ACM.

The investigators aim to study the temporal association between RAM episodes and the later diagnosis of an ACM.

Consecutive patients with at least two episodes of AM and referred to a tertiary university referral center (pop. 1.500.000 inhabitants) for clinical expertise, follow-up and etiological work-out were prospectively included in this registry.

Eligibility Criteria:
Inclusion Criteria: patients with at least two episodes of acute myocarditis as defined by the European Society of Cardiology diagnostic criteria.
Efficacy of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis

A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction.

A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction. All the patients were divided into two groups: preoperative enema group and no intervention group. The peritoneal dialysis malfuction were observed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18;
* Maintenance peritoneal dialysis treatment is required for end-stage Renal Disease;
* First-time open surgeon peritoneal dialysis catheterization patient;
* Only straight double-cuff Tenckhoff dialysis catheters were used.
* Willing to participate in this study and sign informed consent form.

Exclusion Criteria:

* peritoneal dialysis contraindication;
* Enema contraindication;
* Patients refuse enema;
* Expected survival time \< 3 months;
* Catharsis such as Senna Leaf and lactulose used before operation or colonic dialysis and enema used 3 days before operation.
Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features

Corynebacterium spp have been considered as innocuous commensals of human skin, but are now accepted as important opportunistic pathogens responsible for various nosocomial infections, especially implicating foreign materials. In particular, they accounted for up to 10% of prosthetic joint infection (PJI), and are mostly identified in chronic forms of bone and joint infections (BJI). However, little is known about the pathophysiological pathway implicated in Corynebacterium BJI, species distribution and antimicrobial susceptibility, and the management of these difficult-to-treat clinical entities.

This study aims to report a retrospective cohort of patients with Corynebacterium spp BJI, aiming to : i) describe microbiological characteristics of the implicated clinical isolates, including species identification and antimicrobial susceptibility (and especially according to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with BJI chronicity, including biofilm formation and bone cell invasion, to better understand mechanisms of Corynebacterium spp and to evaluate their ability to distinguished colonizing and infective isolates; iii) describe the medical (nature and duration of antimicrobial therapy) and surgical management of these patients; and iv) evaluate the patient outcome according to this management strategy, and highlight risk factor for treatment failure in order to improve patient's management.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (i.e age ≥ 18-year-old) with microbiologically proven Corynebacterium bone and joint infection, with or without implant

Exclusion Criteria:

* diabetic foot osteomyelitis
* pressure ulcer-associated osteomyelitis
Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy.

The objective of our study is therefore to study the evolution of the respiratory microbiome of hospitalized newborns, its interaction with viral infections and their impacts on the evolution of newborns.


Eligibility Criteria:
Inclusion Criteria:

* Newborn hospitalized in intensive care or neonatal intensive care.
* Whose parents were able to be informed of the study and who signed consent.
* Parents affiliate to the social security system

Exclusion Criteria:

* Refusal of parental consent
* Parents who are minors or under guardianship, curatorship, safeguard of justice or legal protection.
* Newborn having already left the hospital/returned home before inclusion
* Hospitalization beyond the first 48 hours of life
* Only palliative care.
Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer

Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization.

Patients with head and neck cancer (H\&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities.

The most important protective factor for psychopathology is psychological resilience, which is "the capacity of a person to protect themselves and their mental health when facing life adversities," such as a GBM or H\&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life.

To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature.

Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H\&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations.

The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H\&N-C and GBM patients.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive glioblastoma and head and neck cancer patients undergoing a long course of radiotherapy
* Patients in adjuvant RT
* Patients in radiotherapy plus chemotherapy (RTCT) adjuvant regimen
* Ability to understand and complete the questionnaires
* Age \> 18 years
* Informed consent signed

Exclusion Criteria:

* Age \> 75 years
* Glioblastoma and head and neck cancer patients undergoing palliative radiotherapy
* Patients with inability to express informed consent
* Patients denying informed consent
* Patients affected by severe language deficits
Fabry Disease Registry & Pregnancy Sub-registry

The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

The primary objectives of the Registry are:

* To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease;
* To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care;
* To characterize and describe the Fabry population as a whole;
* To evaluate the long-term safety and effectiveness of Fabrazyme®

Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.


Eligibility Criteria:
Inclusion Criteria

* Fabry Registry: All patients with a confirmed diagnosis of Fabry disease who have signed the informed consent and patient authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as a documented deficiency in plasma or leukocyte αGAL (alpha-galactosidase) enzyme activity and/or mutation(s) in the gene coding for αGAL.
* Fabry Pregnancy Sub-registry:

  * Eligible women must:

    * be enrolled in the Fabry Registry.
    * be pregnant, or have been pregnant with appropriate medical documentation available.
    * provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.

Exclusion Criteria Fabry Registry: There are no exclusion criteria. Fabry Pregnancy Sub-registry: There are no exclusion criteria.
Cardiac CT Angiography in Patients With Acute Ischemic Stroke

Mortality rates after acute ischemic stroke remain high despite continuously improving treatment. In this context, it is important to note that a relevant portion of acute ischemic stroke patients die from adverse cardiovascular events, such as myocardial infarction, rather than from complications associated with the stroke itself. A possible reason might be that this patient group often suffers from at least moderate asymptomatic coronary artery disease. This study seeks to integrate cardiac computed tomography angiography into the standard-of-care diagnostic protocol of acute ischemic stroke. The aim of this prospective mono-centric trial is to enable accurate diagnosis of therapy-relevant coronary artery disease, other concomitant cardiac findings and cardiac causes of acute ischemic stroke, without delaying stroke therapy. In the long-run, the goal is to investigate whether cardiac computed tomography angiography and the resulting therapeutic measures (interventions or medications added) can improve functional outcome and rate of adverse cardiac complications in patients with acute ischemic stroke compared to a retrospective matched-cohort of patients without cardiac CT imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 years or above, presenting at the Emergency Department of the University Medical Center Hamburg-Eppendorf with a suspected acute ischemic stroke and a relevant neurological deficit (NIHSS score \> 4).

Exclusion Criteria:

* A causal differential diagnosis for the acute stroke syndrome with absent intracranial vessel occlusion.
* No correlation for the patients' symptoms in the cranial CTA (no vessel obstruction).
Improving Pain Management in Patients With Nonhematologic Cancer

RATIONALE: A pain assessment and management system for people with cancer may help doctors accurately assess and plan more effective pain treatment for patients who have cancer.

PURPOSE: Clinical trial to determine the effectiveness of a pain assessment and management system in improving pain management in patients who have nonhematologic cancer.

OBJECTIVES:

* Develop and test a pain assessment and management system for people with cancer (PAMS-PC).
* Obtain feedback from patients with non-hematologic malignancies on the proposed features of the system and its usability and effectiveness.

OUTLINE: This is a multicenter study. The study contains 3 parts. Patients in part II are assigned to 1 of 2 assessment groups.

* Part I: Patients participate in a focus interview by telephone over approximately 45 minutes. The interview includes discussion of beliefs and concerns regarding pain and its management, strategies used by the patient for managing pain, the features of the proposed pain assessment and management system for people with cancer (PAMS-PC), and reactions of the patients to each proposed component of the system.
* Part II:

  * Group A: Patients participate in an assessment session over approximately 90 minutes, comprising completion of a questionnaire followed by use of a test version of the PAMS-PC.
  * Group B: Patients use the PAMS-PC first followed by completion of the questionnaire.

Thirty patients are then randomly selected from the 2 groups to repeat use of the PAMS-PC 3 hours after the initial assessment.

* Part III: Patients participate in a patient acceptance test over 30-60 minutes, in which patients test the demo version of the system, complete an evaluation questionnaire, and provide feedback by telephone.

PROJECTED ACCRUAL: A total of 180 patients (10 for part I, 150 (75 per group) for part II, and 20 for part III) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-hematologic cancer

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma

FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.

Eligibility Criteria:
Inclusion Criteria:

* patients in suspicion of oral carcinoma,
* 68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week;
* being able to provide basic information and sign the written informed consent form.

Exclusion Criteria:

* claustrophobia,
* pregnancy,
* breastfeeding,
* kidney or liver failure,
* inability to fulfill the study.
The Clinical Outcome of Anterior Cruciate Ligament Reconstruction

Retrospective cohort study. The investigators evaluated the early, middle and long term effects of different surgical methods of anterior cruciate ligament reconstruction on knee function.

In the evaluation, the investigators focused on the differences between different age groups, different genders and different basic motor states, the differences between early reconstruction and non-early reconstruction, and the differences in clinical outcomes of different surgical methods.

Age 13-65 included. Only include isolated anterior cruciate ligament(ACL) rupture. Excluded revision surgery. Excluded bilateral ACL rupture. Excluded the contralateral ACL tear after surgery. 40 patients at least in each group.

Eligibility Criteria:
Inclusion Criteria:

diagnosis of isolated anterior cruciate ligament rupture

Exclusion Criteria:

combined other ligament damage combined intraarticular injuries
Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Breathing and Sleep

The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on breathing and sleep of patients with pulmonary hypertension or with interstitial lung disease.

Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), breathing and sleep during a 2 day sojourn at moderate altitude are impaired in comparison to low altitude; b), breathing and sleep during a 2 day sojourn at moderate altitude are improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (St. Moritz Salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m). The order of stays at the different altitudes and of the treatments will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Precapillary pulmonary hypertension, or interstitial lung disease.
* New York Heart Association class 2-3.
* Residence at low altitude (\<800m).

Exclusion Criteria:

* Unstable or exacerbated condition
* Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
* requirement for oxygen therapy at low altitude residence
* hypoventilation
* more than mild or unstable cardiovascular disease
* use of drugs that affect respiratory center drive
* internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
* previous intolerance to moderate altitude (\<2600m).
* Exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
* Pregnant or nursing patients
Telemonitoring for the Recuperation of Patients With CPAP

This study is aimed at patients who do not achieve a minimum (≥4 hours/night) or optimal (≥5,5 hours/night) use of Continuous Positive Airway Pressure (CPAP) treatment and it is proposed to improve their adherence making a 4-weeks intervention using telemedicine tools: CPAP remote monitoring, a mobile application (app) and a voicemail. The concept of this work is to "recover" patients to minimum or optimal CPAP use.

Given the prevalence of Obstructive Sleep Apnea (OSA), the symptoms it produces, which is a risk factor for various entities and that, in addition, its treatment clearly improves others; its control must be optimized in an effective and cost-effective manner. The use of information and communication technologies (ICT) in this context can be very beneficial.

The design of the study is prospective, randomized, controlled, open and parallel.

A ICT-based out of hospital management of OSA is implemented to be compared with the classical in-hospital management.

The main objectives were to evaluate the effectiveness of of two OSA management programs: the in-hospital classic management versus a telemedicine program based on the use of ICTs in the recovery of patients with OSA who who do not meet the minimum treatment (4 hours) or in those who do not comply with the optimal use (5.5 hours).

This is a 4-weeks management randomized, with parallel groups study. Participants will be patients from the Sleep Unit of Hospital Clinic Barcelona with OSA diagnosis and CPAP treatment indication, who after a follow-up between 3-months and up to 5 years have a CPAP compliance below 5,5 hours/night.

Two management programs will be compared:

* In-hospital classic management: Patients are followed regularly in the hospital with a face-to-face visit by the Sleep unit nurse.
* Telemedicine management: telemedicine support with mobile app, voicemail and CPAP remote monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years,
* CPAP treatment initiated ≥1 month and \<12 months
* CPAP compliance below 5.5 hours per night,
* Regular use of Smartphone and mobile apps.

Exclusion Criteria:

* Clinical suspicion or other confirmed sleep pathology,
* Severe nasal obstruction that prevents the use of CPAP,
* Physical-psychological inability to follow questionnaires and the program,
* Patients undergoing uvulopalatopharyngoplasty,
* Cheyne-Stokes syndrome,
* Pregnancy,
* Rejection in the initial test with CPAP during the training and education session and
* Failure to obtain informed consent.