cyrilzakka/clinical-trials huggingface dataset:
Bronchoscopic Score for Prediction of Herpes Simplex-virus Type 1 (HSV-1) Reactivation

Tracheobronchial reactivation of HSV-1 is a common finding in critically ill patients and is associated with longer intensive care unit (ICU) stay and mechanical ventilation. At present it is unclear whether the presence of HSV-1 reactivation can be predicted by the clinical phenotype. In the present study, the performance of a bronchoscopic score of tracheobronchial inflammation for prediction of tracheobronchial HSV-1 reactivation is investigated

Critically ill adult patients having a first diagnostic or therapeutic bronchoscopy are included. A standardized bronchoscopic score (values from 0 to 6) is assessed by an experienced ICU physician.

The score compounds are mucosal redness, mucosal swelling and vulnerability on contact. Compounds are quantified as "none" = 0, "some, disseminated" = 1, or "profound, ubiquitous" = 2 and added.

HSV-1 reactivation is detected by quantitative polymerase chain reaction (PCR) analysis of HSV-1-DNA from standardized bronchoalveolar lavage fluid.

In addition, HSV-1-DNA from blood and markers of immunocompetence (lymphocyte subtype count, monocyte count and Human Leukocyte Antigen - DR isotype (HLA-DR) expression, immunoglobulins) are measured for secondary analyses.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult patients (age ≥18 years) 2. Indication for bronchoscopy during intensive care unit stay 3. Written informed consent

Exclusion Criteria:

* 1. Solid organ transplantation 2. Present coronavirus disease 2019 (COVID-19) infection 3. Previous bronchoscopy during present hospital stay 4. Pregnancy 5. Known primary or secondary severe immunodeficiency
A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening
* Have the following glycosylated hemoglobin (HbA1c) levels at screening:

  1. HbA1c \>/= 7.0% to \</= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and
  2. HbA1c \>/= 6.0% to \</= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (DPP-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (SGLT-2) inhibitor
* Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months
* Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
* Have a clinically significant abnormality ECG
* Have obesity induced by other endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome
* Are on any glucose-lowering medications other than metformin, SGLT-2 inhibitors and/or DPP4
* Have received chronic systemic glucocorticoid therapy (\>2 weeks) in the past 6 months
* Have an average weekly alcohol intake that exceeds 21 units per week (males 65 years of age or lesser) and 14 units per week (females and males 65 years of age or older)
* Smoke more than 10 cigarettes, or cigarette equivalent, per day
OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma

In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the treatment of patients with metastatic renal cell carcinoma. This trial will be one of the first phase II trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on Cancer Biology (VHL/HIF/VEGF/EGFr).

Upon determination of eligibility, all patients will receive:

Tarceva + Avastin

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic or unresectable clear cell kidney cancer confirmed by biopsy
* Previous nephrectomy
* Maximum of 1 previous regimen for metastatic disease
* Ability to perform activities of daily living with minimal assistance
* Measurable disease
* Adequate bone marrow, liver and kidney function
* Give written informed consent prior to study entry

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* Treatment with more than one previous regimen for metastatic disease
* Clinically significant cardiovascular disease
* Active brain metastases
* History of CNS disease
* Clinical history of coughing or vomiting blood.
* History of thromboembolic disease.
* PEG or G-tube are ineligible.
* Current use of full dose anticoagulants or thrombolytic agents
* Chronic daily treatment with aspirin or NSAIDS
* Any clinical evidence or history of a bleeding or clotting disorder

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Understanding COVID-19

This single-center prospective observational study will examine immune responses to to SARS-CoV-2 and how they correlate with its virological characteristics and clinical manifestations in infected patients. Household contacts will also be included so that early immune responses and viral kinetics can be captured. Patients and contacts will be followed for 8 and 2 weeks, respectively. The study will include a maximum of 250 participants.

The primary aim of this single-center prospective observational study is to establish how immune responses to SARS-CoV-2 or to cross-reactive viruses correlate with the virological and clinical characteristics of SARS- CoV-2-infected patients and their exposed household contacts. Through iterative sampling, the viral kinetics of at least 50 infected patients will be evaluated in relation to symptom severity and innate and adaptive immune responses, while their household contacts will be observed for viral detection and immune responses. Patients and contacts will be followed for 8 and 2 weeks, respectively. The study will include a maximum of 250 participants.

Eligibility Criteria:
Inclusion Criteria:

The following persons may be included:

* A patient of any age meeting the European Centre for Disease Control and Prevention's confirmed case definition: "A person with laboratory confirmation of virus causing COVID-19, irrespective of clinical signs and symptoms" (and/or high suspicion/actively being treated as CoVID+ cases pending test confirmation)
* Household contacts (defined as those sleeping in the same apartment/house as an infected patient) of a patient with laboratory-confirmed COVID-19 (and/or high suspicion/actively being treated as CoVID+ cases pending test confirmation), whether symptomatic or not, and whether testing positive or not during a period of 14 days

Exclusion Criterion:

* Long-term incapacity leading to the inability to provide informed consent while not having a patient representative with the ability to provide informed consent
Kyoto Congestive Heart Failure Study

The purpose of this study is to investigate the patient characteristics, selection of treatment, and factors associated with clinical outcomes in Japanese patients with acutely decompensated congestive heart failure.

Congestive heart failure (CHF) has been markedly increasing in Japan due to the rapid aging of the society and the Westernization of lifestyle that facilitates the development of coronary artery disease. The prognosis of patients with CHF still remains poor, despite the recent advances in medical and surgical treatment. Elderly heart failure patients with preserved ejection and multiple comorbidity may account for significant portion among CHF patients in the real world clinical practice, however; most of previous prospective cohort studies excluded these patients. The KCHF registry, an all-comer, prospective, multicenter registry, was designed to investigate all patients who admitted to the hospital due to acutly decompensated CHF. The aim of this study was to clarify the patients characteristics , selection of treatment, and prognosis of patients with acutly decompensated CHF in the real-world clinical practice in Japan.

Eligibility Criteria:
Inclusion Criteria:

* All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham criteria
* Patients who underwent heart failure treatment including intravenus drug

Exclusion Criteria:

* none
Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery

The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Those who are scheduled for cataract surgery

Exclusion Criteria:

* Those who with suspected ocular infections based on clinical findings in the study eye.
* Those who have any eye disease other than cataract which requires treatment in the target eye.
* Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine)
* Those who need to wear contact lenses during the study period
Which is Better to Start With DPP-4 Inhibitors or SGLT-2 Inhibitors in Egyptian Diabetic Patients?

Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 male/female diabetic patients
* Age 20-70 years
* A1C less than 10.5%

Exclusion Criteria:

* Type 1 diabetes; HbA1c \> 10.5%
* Pregnancy
* Chronic liver disease
* Elevated (more than twofold the upper limit of normal) ALT, AST and CPK.
* High bilirubin
* Albumin \< 3.5 g/dl
* INR \>1-2 Diabetic ketoacidosis
* Urinary tract infection (UTI)
* Pancreatitis \< 6 months prior to enrolment
* Renal impairment (creatinine clearance ≤50 ml/min)
* Treatment with anti-obesity drugs or glucagon-like peptide-1 receptor agonists (GLP-1RAs) 3 months prior to enrolment
* Non-compliance with follow-up visits.
Client-Centered Care Coordination for Black Men Who Have Sex With Men

The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are:

1. Determine the efficacy of C4 for increasing PrEP adherence among Black MSM.
2. Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence.
3. Describe the acceptability and feasibility of C4 implementation in community settings.

Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years of age
* Identify as Black, African American, Black African, Afro-Caribbean, or Black-Latino
* Cisgender male
* PrEP naïve or who prematurely stopped PrEP
* No prior HIV diagnosis confirmed through HIV testing
* Self-reported high risk for acquiring HIV
* Currently not enrolled in another HIV prevention study

Exclusion Criteria:

* Black MSM who received a reactive or positive HIV test at screening or self report HIV-positive
* Identifying as transgender
* Current participation in any research study via self-report
* Use of PrEP or post-exposure prophylaxis in the last 60 days prior to anticipated enrollment
Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-90 years.
* Has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. Self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. Breathlessness does not have to be the primary presenting symptom.
* Deemed clinically sufficiently stable to participate according to health care practitioner.

Exclusion Criteria:

* Inability to understand written local language at a year 5 level.
* Not being confident in use of digital technology (smartphone and/or tablet). This will become evident through an inability to use the system.
* Inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event.
* Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.
The Role of Fetal Ductus Arteriosus in Predicting Spontaneous Labour at Term

The exact mechanism stimulating the parturition in humans is still relatively unknown. Prostaglandins, by mediating cervical ripening and early stimulation of myometrial contractions, are likely to play a major role in the parturition process. Much of the unique fetal circulation is facilitated by the ductus arteriosus. Patency of the ductus arteriosus in utero is primarily maintained via prostaglandins which are highly expressed by smooth muscle cells located in the media of the ductus arteriosus. The aim of the study is to prospectively observe fetal ultrasound changes related to the ductus arteriosus. The primary objective is to prospectively assess, whether any changes in the fetal ductus arteriosus parameters exist at 40 weeks' gestation. The secondary objective is to investigate whether there is an association between the ductus arteriosus parameters and the time to delivery interval at 40 weeks' gestation.

The rationale is to assess whether physiological responses that occur around the time of delivery, in both the mother and the fetus (elevated prostaglandins level), can be quantified using ultrasound of the fetal ductus arteriosus.

Whether or not the DA plays an active physiological role in the initiation of parturition is still unknown. Since prostaglandins are physiologically highly expressed within the fetal ductus arteriosus and also linked to some critical steps throughout parturition, it is hypothesized that structural and doppler flow pattern variations of the ductus arteriosus exist in the period surrounding the birth. These changes might occur before or after the intrinsic rise of prostaglandins and could be quantified using prenatal ultrasound of the fetal DA.

Identifying new physiological based variables that can assist in predicting the onset of labour, as the one suggested in the current study, is thus of great importance and may provide invaluable information into the overall future care and decision making during pregnancy, especially around the time of delivery. It may assist in creating future recommendations for pregnant women and improved healthcare standards during the delivery process.

Eligibility Criteria:
Inclusion criteria:

* Low risk singleton pregnancy at 40 weeks gestation.

Exclusion criteria:

* Smoking
* Underlying cardiac or respiratory illness
* Fetal growth restriction
* Medicated gestational hypertension or evolving preeclampsia
* Gestational diabetes controlled with insulin or oral medications
* Use of steroids for lung maturation in the current pregnancy
* Known major congenital anomalies.
Savor-Aging: the Art of Savoring Positive Emotions

This study is part of the larger project to promote positive aging (PNRR Age-IT Project) in the elderly through the amplification of positive experiences and emotions. This study aims to evaluate the feasibility and preliminary effects in terms of effectiveness of the "Savoring: the art of savoring positive emotions project", which is a self-help e-savoring training aimed at increasing psychological and subjective well-being in elderly participants. As secondary goals, this study aims to decrease depression and feelings of loneliness. An additional objective is to investigate user experience regarding the online protocol. A between-subjects design will be used.


Eligibility Criteria:
Inclusion Criteria:

* Age over 60
* Adequate understanding of the Italian language
* Possession of a technological tool to be able to access the Internet

Exclusion Criteria:

* Having a score below 26 on the MMSE that will be administered by telephone (Itel-MMSE) before division into the two groups. The Itel-MMSE scores will be converted into MMSE scores.
Behavioral Memory Modulation in Nicotine Addiction

The purpose of the study is to see if a behavioral intervention known as retrieval-extinction training (RET) might affect craving in response to nicotine cues (e.g., pictures, videos and objects) and smoking behavior in men and women who smoke cigarettes.

In a recently published NIDA-funded study, the investigators found that lasting reductions in craving and smoking could be achieved with a brief behavioral intervention designed to alter memory processes underlying smoking-related nicotine addiction. The proposed project will replicate and extend these findings by 1) increasing the dose of intervention so as to bolster the observed treatment effects, 2) employing brain imaging methods to identify patterns of brain activity uniquely associated with the intervention and potentially predictive of treatment outcome, 3) extending follow-up period to more completely document the long-term effects of the intervention. Positive findings from this study could lead to the development of brief therapy that will not only improve treatment outcomes for smokers, but also be used in the treatment other substance use disorders and frequently co-occurring comorbidities such as PTSD.

Eligibility Criteria:
Inclusion Criteria

1. Healthy men and women, ages 25 to 65, who have smoked at least 10 cigarettes per day for at least 3 years.
2. Participants must live within a 50-mile radius of the research facility and have reliable transportation.
3. Participants must be willing to abstain from smoking starting the night before the baseline visit, and starting the night before visit 1 and remain abstinent for four consecutive days.
4. Participants must agree to forego any other medication or behavioral treatment for smoking cessation while enrolled in the study (with the exception of the SC Quitline).

Exclusion Criteria

1. Participants who are dependent on substances other than nicotine.
2. Women who are pregnant during the clinical assessment session or either of the fMRI sessions. These participants must agree to notify the study staff if they become pregnant during the study.
The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography)

The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. The "PRN" surveillance (pro re nata: an on-demand treatment with monthly follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular signs of activity. The monitoring is done during common practice via OCT B scans showing indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been recently enriched with new programs allowing the visualization of sub-retinal neovessels without the use dyes (OCT angiography). The OCT angiography is automatically done by a program using standard OCT sections. During the monitoring of a patient using the OCT A, the signs of renewed neovascular activity are represented by an "arterialization" or the development of an arteriole network of the neovessel with the reappearance of a hyper reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of the injections). Knowing that the injection time-table of ARMD patients treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is evaluated during routine clinical practice by very specific signs, observable on OCT B scans. The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this injection time-table, with an impact of the patient's visual acuity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥ 50 years old
* with exudative ARMD,
* treated with intra-vitreous anti-angiogenics following a PRN protocol (pro re nata)
* Absence of atrophy of the central pigment epithelium

Exclusion Criteria

* Opposition to participate in this research
* Persons enjoying legal protection measure
* Lack of affiliation to social security and universal health coverage
* Pregnant or lactating
* Another cause of Choroidal neovascularization
* Unbalanced glaucoma
* Eye surgery less than 3 months on the studied eye