cyrilzakka/clinical-trials huggingface dataset:
Clinical Characteristics And Outcome Of COVID-19 Infection In Patients With Chronic Respiratory Diseases.

1. To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases
2. To asses the severity of COVID-19 in patients with chronic respiratory diseases
3. To identify the outcome of COVID-19 in patients with chronic respiratory diseases

Genomes analysis reveal that SARS-CoV-2 presents unique features: optimal affinity for angiotensin converting enzyme 2 (ACE2) receptor and a polybasic cleavage site at the S1/S2 spike junction that determines infectivity and host range \[3-4) Patients with SARS-CoV-2 infection may present symptoms ranging from mild to severe with a large portion of the population being asymptomatic carriers. The most common reported symptoms include fever (83%), cough (82%) and shortness of breath (31%) \[5-6\]. Patients suffering from chronic respiratory diseases (CRD) such as chronic respiratory failure, asthma, chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), pulmonary hypertension (PH), sarcoidosis or cystic fibrosis (CF), were immediately considered to be at risk of severe forms of COVID-19 \[7\]. Indeed, COVID-19 is responsible for various respiratory symptoms, from cough with dyspnea to acute respiratory distress syndrome (ARDS) in its most severe presentation \[8-9\]. In parallel, it has been shown that COVID-19 patients have an increased risk of venous thromboembolic disease \[10\]. There is concern that the respiratory complications of COVID-19 could be deleterious in patients with prior CRD. \[11-12-13\] During COVID-19 pandemic, studies mostly demonstrated that COPD was related with worse outcomes. There may be a few reasons why the course of COVID-19 in COPD patients has been worse. Firstly, COPD patients tend to be older and have more comorbidities which may increase COVID-19 severity \[14\]. Respiratory failure and hypoxemia, which are the most important causes of death in COVID-19 patients, are more common in COPD patients \[15\]. Although the exact mechanism of acute exacerbation of ILD is not fully understood, the current belief is that it can be caused by numerous triggers, including infection, or it can be idiopathic.(16) It is likely that respiratory infection with COVID-19 could trigger an exacerbation of underlying ILD and result in poor outcomes. There is similar concern regarding the possibility of exacerbation in patients with sarcoidosis, especially those with fibrotic manifestations.(17)

1. To identify the pattern of presentation of COVID-19 in patients with chronic respiratory diseases
2. To asses the severity of COVID-19 in patients with chronic respiratory diseases
3. To identify the outcome of COVID-19 in patients with chronic respiratory diseases

Eligibility Criteria:
Inclusion Criteria:

1. patients with chronic respiratory diseases diagnosed with covid-19 infection by PCR
2. Patients aged 18 years and above

Exclusion Criteria:

1. Patient aged below 18 years old.
2. Patients refuse to share in our study
Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept

Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at the origin of type 2 diabetes and about its complications could make it possible to improve the prevention and the treatment of this disease.

Research team developped a new research axis : the microbiota of the intestinal mucosa. They proved a translocation process of intestinal bacteria from the intestinal mucosa to different tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes and obesity is ongoing.

In parallel, the same team explored the role of intestinal immunity modifications in the bacteria translocation from the gut to the blood circulation. They already have some results on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4 Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity development and type 2 diabetes.

The aim of this study is to explore this hypothesis in human to have therapeutic solution later.


Eligibility Criteria:
Inclusion Criteria:

* Coloscopy indication
* Capacity to give a written informed consent

Exclusion Criteria:

* Type 1 diabetes
* Severe renal failure
* Antecedent of liver fibrosis and/or liver failure
* Antecedent of inflammatory bowel disease, lymphocyte colitis, celiac disease or colon cancer
* Antecedent of obesity surgery or of total colectomy
* Antecedent of documented intestinal ischaemia
* Acute infection the week before the inclusion
* Congenital of acquired immune deficiency
* Chronic viral infection
* Antibiotic of probiotic the month before the coloscopy
* Pregnancy
* Patients participating to another research with an exclusion period
* Patients under guardianship
Neonatal CMV-Ganciclovir Follow-up Study

The purpose of this study is to document the developments associated with puberty and determine if any of the children who previously participated in another research study have been diagnosed with cancer. The previous study was a Collaborative Antiviral Study Group (CASG) protocol entitled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections." One of the medications used in this study to treat cytomegalovirus (CMV), ganciclovir, has been known to cause cancer and affect the development of gonads (ovaries in females and testes in males) when administered to animals. Children, 9-14 years old, who participated in the previous research study, will participate in this study for 1 day. Subjects will be evaluated by an endocrinologist and will have the following procedures performed: a complete physical examination, a single blood sample collected, an x-ray of the left wrist.

Ganciclovir has been shown to be carcinogenic, teratogenic, and gonadal toxic in animal models. Mice treated with ganciclovir experienced an increase in the incidence of tumors of the preputial gland (males), harderian gland (males), forestomach (males and females), ovaries (females), uterus (females), mammary gland (females), clitoral gland (females), vagina (females), and liver (females). While the preputial and clitoral glands, forestomach, and harderian glands of mice do not have human counterparts, ganciclovir is considered a potential carcinogen in humans. Animal data indicate that administration of ganciclovir causes inhibition of spermatogenesis and subsequent infertility, possibly due to inhibition of rapidly dividing cell populations including spermatogonia. In the animal models, these effects were reversible at lower doses and irreversible at higher doses. In both male and female mice, ganciclovir has been shown to cause decreased fertility. Gonadal toxicity in rats, mice, and dogs included testicular atrophy in males and, more variable, ovarian atrophy in females. There are no data in humans that demonstrate these effects following treatment with ganciclovir. This study seeks to formally establish the overall sexual development, cancer incidence, and pubertal status of those study subjects who previously received six weeks of ganciclovir as they now approach puberty. The original study was performed from 1986 to 1991, and therefore subjects who were enrolled are now nine to fourteen years of age.

Eligibility Criteria:
Inclusion Criteria:

Children who received ganciclovir during the earlier study ("Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections), and if the parent or legal guardian signs an informed consent and the child signs an assent (where appropriate).

Exclusion Criteria:

Any individuals not previously enrolled in the CASG protocol titled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections"
Risk Factors and Deep Learning Model for CI-AKI

Contrast-associated acute kidney injury (CI-AKI) is a sudden and significant decline in renal function resulting from the use of a contrast agent.

Contrast-associated acute kidney injury (CI-AKI) is a sudden and significant decline in renal function resulting from the use of a contrast agent. Despite the frequent use of iodinated contrast agents in medical investigations, predictive models for CI-AKI are scarce. This study aimed to construct and validate interpretable deep learning models for the early risk prediction of acute kidney injury (AKI) associated with iodinated contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* patients who received iodinated contrast agents during hospitalization
* age ≥ 18 years
* hospitalization length ≥ 48 hours
* at least two serum creatinine tests during hospitalization

Exclusion Criteria:

* patients with stage 4 or 5 chronic kidney disease prior to admission
* patients undergoing hemodialysis, hemofiltration or peritoneal before admission
* a history of nephrectomy or kidney transplantation during hospitalization
* incomplete clinical information
* Serum creatinine always ≤ 40 μmol/L during hospitalization
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes

This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.

This is an observational, prospective, multicenter cohort study of 2,600 lung transplant donors and adult (18 years and older) lung transplant candidates and recipients that will collect longitudinal clinical data, and serial biological (blood) specimens and PROs to support a broad range of clinical and translational future research. Data and biospecimens will be rigorously collected and monitored to ensure high quality future studies that will address unmet needs and optimal management at each stage of the transplant journey from listing, to donor selection, to postoperative management. Subjects are recruited to the study either prior to undergoing lung transplant at the time of listing or within 30 days of having undergone a lung transplant at one of the enrolling centers.

The study design will generally follow the SOC practices at each center to minimize additional research related visits. Participants will follow the SOC transplant protocols at each site. Every attempt will be made by the site to collect study data and research specimens from participants at the time of SOC visits. Participation in this study will include scheduled data extraction or data transfers at specified time intervals, serial prospective blood collection (including plasma, serum), recipient DNA sample collection (with donor DNA sample collection optional), and PRO measures.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and provide informed consent
2. ≥ 18 years of age at the time of written informed consent
3. Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days

   * Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion/exclusion criteria.

Exclusion Criteria:

1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol
2. Pregnancy or plans to become pregnant
3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®

open label, active-controlled, randomized, parallel group, comparative study.

This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.

Eligibility Criteria:
Inclusion Criteria:

* WHO group II
* Clomiphene citrate resistance
* BMI: 17\~29 kg/m\^2
* Irregular menstrual cycle
* Normal blood concentration of FSH, E2, prolactin and TSH

Exclusion Criteria:

* Uncontrolled endocrine disease
* Ovarian cystic tumor which are NOT related to PCOS
* Severe endometriosis
* Chronic cardiovascular disease, liver complaint
Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the ICU

Despite the known benefits of geriatric care models among hospitalized older adults outside the intensive care unit (ICU), few studies have addressed the needs of older adults in the ICU; for example, sensory impairment, functional decline, and de-prescribing of potentially inappropriate medications (PIMs) are rarely addressed in routine ICU practice. This pilot study will evaluate the feasibility, acceptability, and barriers to implementation of a geriatrics bundle (occupational therapy, assessment and treatment of hearing impairment, and de-prescribing PIMs) in the ICU.

Outcome 4 was updated 11/8/23.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 65 years
2. Hospitalized in the Medical Intensive Care Unit (MICU) on the York Street campus of Yale-New Haven Hospital.
3. Has not opted out of research

Exclusion Criteria:

1. Unable to provide informed consent and no proxy available
2. Advance directive of "comfort measures only" (CMO) or change to CMO anticipated during this hospital admission
3. Planned discharge to hospice
4. Primary language other than English
5. Tracheostomy with long-term ventilator dependence
6. Patients with non-family conservators (e.g. a lawyer serving as the conservator for the patient)
7. Unable to participate in the OT and hearing impairment interventions due to cognitive status (e.g. advanced dementia, anoxic brain injury, vegetative state, etc) or the need for deep sedation (e.g. if treatment of the critical illness requires deep sedation and neuromuscular blockade, such as in severe ARDS \[the acute respiratory distress syndrome\])
8. COVID-19 positive
9. Already receiving OT in the ICU
Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants

AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152.

This is a Phase I, randomised, double-blind, placebo controlled study evaluating the safety, tolerability, PK and PD of AZD3152 in healthy Japanese adult participants, 18 to 55 years of age. Approximately 24 healthy participants will be randomised at up to 2 study sites.

Eligibility Criteria:
Inclusion Criteria:

* Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
* No positive results of SARS-CoV-2 NAT and/or rapid antigen tests.
* Healthy participants by medical history, physical examination, baseline safety laboratory studies, and screening parameters, according to the judgement of the investigators, with no concomitant disease or concomitant medication.
* ECG without clinically significant abnormalities.
* Able to complete the Follow-up Period through Day 361 as required by the protocol.
* Body weight ≥ 45 kg and ≤ 110 kg and BMI ≥ 18.0 to ≤ 30.0 kg/m2.

Exclusion Criteria:

* Known hypersensitivity to any component of the IMP.
* History of allergic disease or reactions likely to be exacerbated by any component of the IMP.
* Previous hypersensitivity, infusion related reaction or severe adverse reaction following administration of mAbs.
* Fever above 38.0°C on day prior to or on day of randomisation/dosing.
* AST, ALT or serum creatinine above ULN; bilirubin and ALP \>1.5 × ULN.
* Any vaccination except for COVID-19 vaccine (e.g., inactivated influenzae vaccine) planned.
* SARS CoV-2 or COVID-19:

Receipt of a COVID-19 vaccine within 3 months. COVID-19 infection within 3 months prior.
Magnesium Loading in Chronic Obstructive Pulmonary Disease

Dietary magnesium (Mg) intake has been shown to be independently related to lung function, airway reactivity, and respiratory symptoms in the general population. Inhaled Mg and IV Mg administration have been shown to promote bronchodilation and to improve lung function in asthmatic patients. Some studies have suggested that COPD patients exhibit decreased body levels of Mg. The purpose of the present study was to investigate the effects of acute IV Mg loading on parameters of respiratory function and maximal exercise capacity of stable COPD patients.The study hypothesis is that Mg administration will be associated to improvements on airflow and vasodilation leading to improvements of pulmonary function and exercise performance.

Patients are required to have a diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria.

This is a randomized, double-blind, placebo-controlled, cross-over study. Twenty five patients are going to be included. They are going to come to the laboratory to receive IV placebo or IV Mg sulfate at two distinct occasions about 48 hours apart. Half of the patients are going to receive Mg first and Placebo at the second day, while the other half are going to receive the treatments in an inverse order. Tests are going to be performed before and about 40 minutes after the IV infusions. Tests to be performed are: spirometry, arterial blood gases, Mg plasma level measurements, and a maximal exercise test protocol in cycloergometer.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis according GOLD criteria
* Men between 45 and 80 years old

Exclusion Criteria:

* History of asthma or atopy, renal failure, heart failure, arrhythmias or cardiac electrical disturbances, and other significant disease other than COPD.
* Individuals on chronic oral steroids, diuretics, or use of mineral supplementation.
* Locomotor impairment.
A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection

The purpose of this study is to evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic Coronavirus Disease 2019 (COVID-19) Infection.


Eligibility Criteria:
Inclusion Criteria:

* Coronavirus Disease 2019 (COVID-19) positive diagnosis by locally obtained viral diagnostic test (example, polymerase chain reaction \[PCR\]). This may be nasal swab or saliva test or other available technology to demonstrate current infection
* Confirm that participant is known to health system, with at least 1 contact in electronic medical records (EMR) prior to screening
* Symptoms attributable to COVID-19 (example, fever, cough, loss of taste or smell, muscle aches, shortness of breath, fatigue)
* Initial treatment plan does not include hospitalization
* Presence of at least 1 additional risk factor: a) age more than or equal to (\>=) 60 years; b) prior history of VTE; c) history of thrombophilia; d) history of coronary artery disease (CAD); e) history of peripheral artery disease (PAD); f) history of cerebrovascular disease or ischemic stroke; g) history of cancer (other than basal cell carcinoma) h) history of diabetes requiring medication; i) history of heart failure; j) body mass index (BMI) greater than or equal to (\>=) 35 kilogram per meter square (kg/m\^2); k) D-dimer greater than (\>) upper limit of normal for local laboratory (within 2 weeks of the date of the COVID-19 test and prior to randomization)

Exclusion Criteria:

* Increased risk of bleeding such as a) significant bleeding in the last 3 months; b) active gastroduodenal ulcer in the last 3 months; c) history of bronchiectasis or pulmonary cavitation; d) need for dual antiplatelet therapy or anticoagulation; e) prior intracranial hemorrhage, f) known severe thrombocytopenia g) active cancer and undergoing treatment
* Any illness or condition that in the opinion of the investigator would significantly increase the risk of bleeding (example recent trauma, recent surgery, severe uncontrolled hypertension, gastrointestinal cancer, renal failure requiring dialysis, severe liver disease, known bleeding diathesis)
* Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
* Positive COVID-19 antibody or serology test after 2-week period of acute, symptomatic COVID-19 infection
* Known diagnosis of triple positive (positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies) antiphospholipid syndrome
Homocysteine in Patients With Sepsis

After stimulation by lipopolysaccharide (LPS), the one-carbon metabolism of macrophages was significantly up-regulated, the expression of key enzyme 5,10-methylenetetrahydrofolate reductase increased. In vitro experiments we found that LPS stimulation can increase the expression of MTHFR mRNA and protein in macrophages, suggesting that aerobic glycolysis may trigger cytokine storm through one-carbon metabolism. Homocysteine (homocysteine, Hcy) is an important intermediate product of one-carbon metabolism. A number of studies have shown that Hcy is positively correlated with the level of pro-inflammatory factors, significantly enhancing cytokine storm. However, the relationship between Hcy and serum pro-inflammatory factors in patients with sepsis and the effect of Hcy on the prognosis of patients with sepsis are still unclear. Based on the previous work, our research group intends to carry out single-center, prospective, observational clinical research to observe the relationship between homocysteine and the mortality of patients with sepsis, and to provide new indicators for accurately judging the prognosis of sepsis , To provide new targets for clinical development of drugs for the treatment of sepsis.


Eligibility Criteria:
Inclusion Criteria:

Patients with sepsis and the age limits between 18-80 years.

Exclusion Criteria:

* Non-septic patients with hyperhomocysteinemia caused by various reasons. ②After the onset, other medicines for the treatment of folate deficiency and hyperhomocysteinemia have been used. ③Women during pregnancy and lactation. ④ Suspected or did have a history of alcohol or drug abuse. ⑤Patients who are participating in clinical trials of other drugs.