cyrilzakka/clinical-trials huggingface dataset:
Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia

The HOMI-LUNG - HAP study is part of the HOMI-LUNG project, funded by the Horizon Europe program. The "HOMI-LUNG" project is an international, interdisciplinary project that aims to better understand the causal links between respiratory tract infections (i.e. pneumonia) and the progression of cardiovascular disease. More specifically, the project aims to quantify the burden of cardiovascular disease after pneumonia and assess patients\&#39; acceptability of long-term health alterations, as well as to define pneumonia endotypes with distinct pathobiological mechanisms associated with exacerbation of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

Group A (patients with acute cardiac disease)

* Male or female
* Age ≥ 40years old
* Hospitalized for acute coronary syndrome for less than 7 days.
* Informed consent from the patient
* Person insured under a health insurance scheme

Group B (patients with chronic cardiovascular disease)

* Male or female,
* Age ≥ 40 years old
* Undergoing coronary artery by-pass surgery
* Hospitalized in intensive care unit for \&gt; 12 hours
* Informed consent from the patient
* Person insured under a health insurance scheme

Group C (patients at risk of CVRD without chronic cardiovascular disease)

* Male or female,
* Age ≥ 40 years old
* Familial high levels of cholesterol or triglycerides
* With no personal history of CVRD, with a recent negative cardiac exercise test (last test inferior to 12 months)
* Follow-up for lipid abnormalities at high risk of CVRD events
* Informed consent from the patient
* Person insured under a health insurance scheme

Group D (patients with HAP)

* Male or female
* Age ≥ 40years old
* With one or more risk factors for CVD among:

smoking, abnormal lipidic levels, high blood pressure, obesity, diabetes mellitus, chronic kidney disease

* Cured from mechanically ventilated HAP during the current hospitalization
* Informed consent from the patient or relatives
* Person insured under a health insurance scheme

Exclusion Criteria:

* o Groups A, B, C and D
* Age \&gt;80 years old
* Immunosuppression pre-existing to the index hospitalisation, defined as lymphopenia \&lt; 500 elements/mm3, haematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug.
* Pregnant women, breastfeeding women.
* Adults under guardianship or trusteeship.
* Low probability of survival at day 28.

  o Groups A, B, C
* Community-acquired pneumonia or Hospital-acquired pneumonia within the last year.
Multicenter Registry for Angiography-Derived Quantitative Flow Ratio

1. to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with non-culprit lesion.
2. to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS)
3. to evaluate prognostic implication of contrast QFR in comparison with FFR

Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. Therefore, several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations. One of the novel methods, the contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction (TIMI) frame counts adjustment without hyperemic agent infusion.

Although diagnostic performance of contrast QFR for evaluation of functional significance, using FFR as reference standard, is well validated in patients with stable ischemic heart disease (SIHD), there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI.

Therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD. In addition, prognostic implication of contrast QFR will be also compared with that of FFR.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥18 years
* Patients suspected with ischemic heart disease
* Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
* Patients who were able to analyze QFR
* Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides

Exclusion Criteria:

* Left main (LM) or right coronary artery (RCA) ostial lesion
* Severe overlap of stenotic segments
* Severe tortuosity of target vessel
* Poor angiographic image quality precluding contour detection
* No optimal images with angles ≥ 25o
DM DEVICE DISRUPTION SURVEY

Rationale: Continuous glucose monitoring (CGM) and insulin pump therapy (CSII) have increased in utilization in the treatment of both type 1 and type 2 diabetes mellitus. Both types of devices are worn externally, with either a catheter or filament introduced into the subcutaneous space. Removal of these devices interrupts glucose monitoring or insulin delivery or both, which may have an adverse impact on patients' glucose control. Few studies have investigated the logistical and technical challenges that patients face when their insulin pump device or continuous glucose monitor (CGM) is interrupted.

Intervention: We will conduct a patient survey which seeks to identify and quantify the number of times insulin pump therapy or continuous glucose monitor has been disrupted, for what reason, how it was resolved and whether diabetes care had been adversely affected.

Objective: To determine the frequency and intensity of adverse health outcomes resulting from mandatory removal of CGM on insulin pump devices in healthcare or other settings.

Study population: Patients treated at Washington University outpatient clinics or Barnes Jewish Hospital between August 1, 2021- December 1, 2021. The study will include outpatients with diabetes mellitus who routinely utilize either CGM or insulin pump therapy or both. The target number of patients for the study will be 600, equally distributed between inpatients and outpatients, and with at least 100 having type 1 diabetes.

Study methodology: After providing consent, patients will complete an electronic questionnaire. Demographic information and diabetes history will be extracted from the patients' medical records.

Study endpoints: We will determine the incidence of disruptions to insulin pump therapy or continuous glucose monitoring in patients with diabetes mellitus as a result of hospitalization or medical test over a 1 year time period. We will also determine adverse health outcomes that resulted from device disruptions.


Eligibility Criteria:
Inclusion criteria

Female and male patients 18 years or older who meet all of the following criteria:

* Patients treated at Washington University outpatient clinics or Barnes Jewish Hospital.
* Patients with type 1 or type 2 diabetes mellitus who utilize CGM and/or insulin pump therapy.
* Patients who were able to read English.

Exclusion Criteria

* Patients who have not used a relevant device in the past 30 days
* Patients unwilling to or unable to provide consent or complete the questionnaire.
Food Addiction Clinical Treatment Program

The purpose of this current study is to establish the feasibility of, and preliminary support for, a clinical treatment program utilizing interventions from various empirically supported treatments for obesity-related eating disorders and substance use disorders

To establish the feasibility of recruiting, enrolling, and treating individuals who meet criteria for FA in a group behavioral intervention for 16 weeks. Data from the current study will be used for the purposes of further exploration of the FACT program in a larger randomized controlled trial. We hypothesize the study will demonstrate the feasibility of evaluating this treatment in future studies

Eligibility Criteria:
Inclusion Criteria:

* Age \> 25
* BMI \>25
* YFAS \> 6/11 (severe range)
* willing to commit to a 16 week group therapy program from 4 - 5:30 pm on Thursdays in Winston-Salem, NC
* English speaking

Exclusion Criteria:

* Current participation in professional weight loss program and unwillingness to suspend it for 16 weeks during treatment
* obesity medications with exception of diabetes medication with weight loss benefit (ie metformin),
* current nicotine use or substance use disorder (based on meeting the clinical cutoff for the Alcohol Use Disorders Identification Test and/or Cannabis Use Disorder Identification Test
* history of weight loss surgery,
* current/history of severe mental illness (\> 3 psychiatric hospitalizations since age 18,
* schizoaffective disorder, bipolar disorder, psychotic disorder, or personality disorder),
* current/history of lithium, abilify, saphris, vraylor, clozaril, latuda, zyprexa, seroquel, risperdal, or Geodon,
* current pregnancy or breastfeeding,
* prior diagnosis of anorexia nervosa, diagnosis of bulimia nervosa in the last 5 years,
* high currents rates of restrictive eating disorder symptoms based on the Eating Disorder Diagnosis Scale (EDDS; (i.e., any endorsement of vomiting or laxative/diuretic use to manage weight and endorsement of fasting or excessive exercise more than 2 or 3 times a week)
Prevention of Complications (SARS-CoV-2): Clinical Study

Viral diseases have always posed a threat to public health. Recently, the SARS-Cov2 virus spread in an epidemic that began in China and soon spread globally, making its study extremely relevant, in order to seek mechanisms to combat it. Therefore, this study seeks to evaluate the benefit of using Hydroxychloroquine with or without Apixaban in the early treatment of patients with suspected COVID-19. Prospective, randomized, double-blind, controlled study, performed at Hospital das Clínicas Samuel Libânio (Universidade do Vale do Sapucaí) UNIVÁS, Pouso Alegre, Minas Gerais, Brasil. Patients treated in the emergency department who are reported as suspected cases of COVID-19 patients will be included, according to current guidelines. Will be randomized into 4 groups: Hydroxychloroquine, Hydroxychloroquine + Apixabana, only Apixabana and Control group, all receiving standard treatment recommended. Included patients will be monitored during hospitalization or remotely assisted in home treatment. Clinical, laboratory, electrocardiographic and image evaluation criteria will be considered to assess the evolution in 7 and 14 days after inclusion. Results will be subjected to appropriate statistical analysis, with sample calculation. An early therapeutic approach is proposed in suspected and confirmed patients with COVID-19, with the hope of reducing hospitalizations and severe forms of the disease.

The early administration of HCQ or in association with apixaban, could prevent worsening of suspected COVID-19, as well as preventing hospitalizations and the need for intensive treatment. In patients with mild to moderate disease, the use of hydroxychloroquine or hydroxychloroquine with apixaban or apixaban alone, could be able to reduce disease progression on an ordinal scale of outcome (including use of mechanical ventilation and death) and decrease the likelihood of hospitalization or worsening of clinical conditions.

Eligibility Criteria:
Inclusion criteria:

* Patients with suspected or confirmed covid-19, above 18 years old
* Patients with time between symptom onset and inclusion ≤ 14 days
* Patients with time between hospital stay and inclusion ≤ 48 hours

Exclusion criteria:

* Patients tested negative for covid-19 by rt-pcr, serological or rapid test method
* Patients unable to swallow for any reason
* Patients with an extended qt interval, defined as a corrected qt (qtc) for heart rate above 450 ms for men and 470 ms for women
* Patients with liver toxicity, defined as ast / alt or increased bilirubin
* Patients with ventricular arrhythmias
* Patients with bleeding, major hematoma or blood dyscrasia;
* Patients who, at any time during the process, choose to give up participating in the study
Ultrasound Versus Palpation for Spinal Anesthesia Success

Aim is to investigate the difference in number of attempts to place neuraxial block comparing handheld ultrasound versus use of palpation alone for women with impalpable bony landmarks undergoing spinal anesthesia for elective cesarean delivery.

Patients will be recruited prior to cesarean delivery and their site of lumbar injection will be examined. Women with impalpable bony landmarks will be offered recruitment to the study. Women will be randomly assigned to the standard of care group - palpation attempts only, versus an ultrasound group, where the insertion point will be identified by the handheld ultrasound device

Inclusion criteria:

Lumbar spinous processes impalpable. Elective cesarean delivery for singleton pregnancies BMI \>30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned Exclusion Criteria Refuses informed consent Poor written Hebrew, no spoken English or Hebrew Patients will be randomized into two groups : an ultrasound (US) group and a palpation (PP) group.

The primary outcome of our study is the number of needle redirections, defined as any ventral advancement of the needle and/or introducer, as well as any new intervertebral space attempted.

Secondary outcomes include:

The insertion site identification time, patient verbal numerical pain score (0-10) after skin incision.

Eligibility Criteria:
Inclusion Criteria:

Lumbar spinous processes impalpable. Elective caesarean delivery for singleton pregnancies BMI \>30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned
Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study

In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.

RFA + adjuvant radioembolsation with Quirem Spheres

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \> 18 years
* Single HCC lesion with diameter of ≥ 2-5cm or up to three lesions with each lesion measuring no more than 3cm (confined to one lobe)
* HCC diagnosis is based on histology or non-invasive imaging criteria according to EORTC-EASL guidelines
* Child Pugh A or B ≤7
* ECOG performance status ≤ 2
* Bilirubin \< 2mg/dL
* ASAT \< 5x upper limit of normal
* ALAT \< 5x upper limit of normal
* Thrombocytes ≥ 50 X 10\^9/L

Exclusion Criteria:

* Recurrent HCC
* Tumor location precluding percutaneous RFA
* Bilobar tumor involvement
* Vascular tumor invasion or extrahepatic metastasis
* Hemihepatectomy
* Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections)
* Uncorrectable coagulopathy
* Large arterio-portovenous shunt
* Previous radiotherapy to the liver
* Surgical hepatico-enterostomy
* Hepatic resection with placement of surgical clips that may cause artefacts on MRI
* Incompetent/ mentally disabled
* Pregnancy, inadequate anticonception
* Calculated lung dose \>30Gy
* Creatinine clearance \< 50 ml/min
Different Doses of Roxadustat Treatment for Anemia in Peritoneal Dialysis Patients

A multi-center, randomized, controlled study to evaluate the effect of different doses of roxadustate on hemoglobin target-met in peritoneal dialysis patients

Roxadustat is an orally hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to promote erythropoiesis on patients with chronic kidney disease. Two phase 3 clinical trials have verified the efficacy and safety of roxadustate as therapy for anemia in patients with CKD and undergoing dialysis. A high increasing rate of Hb or Hb overshooting triggered by roxadustat need dosing reduction or even drug withdrawal, possibly leading to a large Hb variation and adverse subsequences. Therefore, we were of interest to investigate whether a lower starting dose of roxadustat could achieve comparable Hb target at week 12 while lowering the risk for Hb over 130g/L through a prospective peritoneal dialysis (PD) cohort. Peritoneal dialysis patients diagnosed with renal anemia will be divided into standard roxadustat dosage group and lower roxadustat dosage group. After 12 weeks, we will compare the target-met, overshooting and variation ratio of hemoglobin between these two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients diagnosed with Chronic kidney disease stage 5
2. Maintenance on PD for more than three months.
3. Weight between 45Kg and 110Kg
4. Renal anemia, and hemoglobin between 90g/L and 120g/L
5. Stop taking erythropoietin for enough time （erythropoietin treatment discontinuation for ≥3 days if using erythropoietin of 3000U single strength, or ≥7 days if using erythropoietin of 10000U single strength） or free of erythropoietin use
6. Signed the informed consent.
7. Willing to follow the study procedure

Exclusion Criteria:

1. Hematologic malignancy or aplastic anemia.
2. Blood loss or hemolysis.
3. Taking roxadustat, or Allergy or intolerance to roxadustat
4. Severe liver injury or active hepatitis.
5. Pregnancy or breastfeeding
6. Cancer, receiving radiotherapy and chemotherapy within 6 months.
7. Refractory hypertension
Photobiomodulation as a New Approach for the Treatment of Nipple Traumas

Inadequate care during pregnancy and postpartum are predisposing factors for the emergence of nipple fissures. The therapeutic approach of nipple trauma care guidelines aimed at the breast and the appropriate techniques for breastfeeding. These measures, however, have a much more preventive than curative, it is not, in most cases, sufficient to power the closing of nipple trauma. The objective of this study was to evaluate the effectiveness of a phototherapy device designed specifically for the treatment of nipple trauma.


Eligibility Criteria:
Inclusion Criteria:

* women should have a medical diagnosis of nipple trauma were not infected and aged 18 to 35 years

Exclusion Criteria:

* previous history of cancer; use of other therapeutic modalities that might interfere with the healing of the lesions; presence of infected wounds; history of photosensitivity to light; cognitive deficits that undermine the understanding and implementation of guidelines of care for breast
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery

The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine diphosphate (ADP) as a pharmacodynamics surrogate measure of ticagrelor levels in blood.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Males and females aged ≥18 years
* Patients treated with ticagrelor
* Emergency Coronary Artery Bypass Graft (CABG) surgery
* Cardiothoracic surgery requiring CPB ≤24 hours following the last dose of ticagrelor

Exclusion Criteria:

* Any cardiothoracic surgery \>24 hours after last dose of ticagrelor
* Resuscitation
* Any pre-operative coagulopathy unrelated to ticagrelor or standard of care (SoC) to undergo surgery with CPB
* Sepsis (according to Sepsis 3.0 definition)
* Malignant tumor
* Left ventricular ejection fraction (LVEF) \< 20%
* History or presence of significant pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurologic, or psychiatric disease which, in the opinion of the Investigator, increases risk to the patient or could confound the results of the study
* Presence of end-stage renal disease or currently receiving renal replacement therapy
* Patients with a history of major organ transplantation
* Patients in acute sickle cell crisis
* Patients concurrently requiring immunosuppressive therapy, with the exception of corticosteroids, or who are profoundly immune suppressed (e.g. CD4 \< 200 or neutropenia with ANC \< 1000/μL)
* Women of childbearing potential with a positive pregnancy test performed during the current admission or who are lactating. Women are considered not of child bearing potential if they have been sterilized at least 6 months prior to the study or if they are post-menopausal, defined as amenorrhea for at least 12 months
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.

Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.

Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.

Eligibility Criteria:
Inclusion Criteria:

You may be eligible for this study if you:

* Are 18 years of age or older.
* Have been diagnosed with aspergilloma within the last month.
* Have (or have a history of) at least one of the following:

  1. positive test for Aspergillus species.
  2. presence of antibodies to Aspergillus.
* Are willing to participate in the study for 2 full years.
* Are female and not pregnant.
* Are not breast-feeding.
* Agree to use barrier methods of birth control / contraception during the study and for 30 days after.

Exclusion Criteria:

You will not be eligible for this study if you:

* Have a history of allergy to triazole or imidazole drugs.
* Are unable to take oral medication.
* Are not expected to live for more than a month.
* Have had a lung biopsy indicating Aspergillus infection.
* Have had radiation therapy within the last 6 months.
* Require treatment with certain medications.
* Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.
* Received chemotherapy within the last 6 months.