cyrilzakka/clinical-trials huggingface dataset:
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)

This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.


Eligibility Criteria:
Inclusion Criteria:

* Aged 75 years and above
* Standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy
* ECOG(Eastern Cooperative Oncology Group) performance is 0-3
* Life expectancy greater than 3 months
* serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0\*ULN, or AST and ALT≤5\*ULN with hepatic metastasis; Total serum creatinine ≤1.5\*ULN
* Signed informed consent form

Exclusion Criteria:

* Current pregnancy or lactation
* History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer)
* Uncontrolled epilepsy, central nervous system diseases or mental illness
* arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study
* Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation
* Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes
* Allergic to any of the ingredients used in the study
* A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy
* Acute and chronic tuberculosis infection
* Other disorders with clinical significance according to the researcher's judgment
Evaluating the Real World Performance of an AI Based Lung Nodule Detection Tool

chest x-rays will be analyzed by AI software for a secondary read of lung nodules. Chest x-rays will either be sent to the AI tool to be read or to radiologists to read. If the image is sent to the AI tool, the AI software will generate a report on if it detects a lung nodule or not. The image will then be sent to a radiologist to determine if there is agreement or disagreement with the AI tool.

The study is a prospective study for measuring the performance of an AI software in detecting lung nodules from chest X-rays. Data collected during the study will be analyzed for study purposes after end date of data collection.

There will be two study arms: the control arm and the interventional arm.

Control Arm:

There will be no interruption to the existing standard of care pathway.

Interventional Arm:

Use of AI will occur in parallel to the standard of care pathway.

Consistent with the control Arm, the radiologists or clinicians interpreting the chest x-ray images will proceed as usual based on the existing standard operating procedures of the study site. In addition, the AI software will function as a second reader; meaning images will be processed by the AI software which will generate a report.

In the event that the radiologist and the AI tool do not agree, cases will be reviewed by qualified study team members twice per week.

Eligibility Criteria:
Inclusion Criteria:

* Chest X-ray images of patients aged 18 - 89 years.
* Modality: CR/DR/DX.
* PA/view
* Lung nodules measuring 6 mm -30 mm (for chest X-ray images where presence of nodules is required).

Exclusion Criteria:

* Incomplete view of the chest.
* Lateral view
* Known lung cancer at the time of Chest x-ray images.
Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.

To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Esophageal candidiasis.
* Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
* HIV infection or other predisposing risk factor.
* Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
* Evidence of systemic fungal infection.
* Underlying clinical condition that would preclude study completion.
* Judged to be unreliable in regard to following physician's directives.

Concurrent Medication:

Excluded:

* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.
* H2 blockers.
* Continual antacids.
* Any investigational drug (expanded access drugs are allowed).

Patients with the following prior conditions are excluded:

* History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
* History of hypersensitivity to imidazole or azole compounds.

Prior Medication:

Excluded:

* Other orally administered antifungal therapy within 3 days prior to study entry.
* Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
Predicting Mortality in Kidney Transplant Recipients

Accurately predicting kidney recipient risk of death has a crucial interest because of the organ shortage, the need to optimize allograft allocation by identifying high-risk patients who may not benefit from a transplant and improve the clinical decision-making after transplant to ensure that each patient survives as long as possible.

However, according to a literature review the investigators performed, studies attempting to develop a kidney recipient death prediction model suffer from many shortcomings, including the lack of key risk factors, use of biased registry data, small sample size, lack of external validation in different countries and subpopulations, and short follow-up.

The present study thus aimed to address these limitations and develop a robust, generalizable kidney recipient death prediction model.

The number of individuals suffering from end-stage chronic renal disease (ESRD) worldwide has increased over time, exceeding seven million of patients in 2020. For individuals with ESRD, kidney transplantation is the best treatment in terms of patient survival, quality of life and from a cost-effective standpoint, as compared with dialysis, even in comorbid or elderly populations.

Although the number of kidney transplantations performed each year has increased as well, it follows a lower pace than the increase of individuals on the waiting-list, resulting in an organ shortage. There is therefore a need to optimize allograft allocation by identifying the high-risk patients who may not benefit from a transplant and improve the clinical decision-making after transplant to ensure that each patient survives as long as possible.

In this context, a kidney recipient death prediction model may improve transplant clinical practice, allowing for the ability to evaluate the individual risk of post transplant mortality, already before undergoing transplantation, thereby guiding decision making. However, developing such a model is a very difficult task, as death after kidney transplantation depends on many parameters, such as donor age, history or cause of death, imaging parameters, patients' past medical history (e.g. diabetes, dialysis duration, hypertension), patients' biological parameters, as well as the function of the allograft, which depends on patients' immunological factors, or allograft related parameters such as HLA mismatches or cold ischemia time.

The goal of the present study was therefore to identify the determinants of death after kidney transplantation, and to develop and validate a prediction model that would help optimize allograft allocation and post-transplant patient management, using a large, international, highly phenotyped cohort of kidney recipients with extensive data collection and long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adult kidney recipients

Exclusion Criteria:

* Multi-organ transplantation
* Prior kidney transplant
Evaluating Bubble-PAPR for Healthcare Workers

This project will produce a low cost, ergonomic, hood integrated PAPR for use initially within the NHS. It will focus on user centred design, engineering optimisation, feasibility testing, certification and intellectual property protection.

This study will evaluate the pre-CE marked Bubble PAPR prototype PPE in the clinical environment and gather usability data from consenting participants (staff).

Aim: To develop low cost, ergonomic, personal protective equipment to prevent virus transmission to NHS healthcare workers.

This project aims to address these problems by taking a user centred design approach to develop and manufacture a highly functional Hood Integrated Personal Air Purifying Respirator (HI-PAPR) at a low cost. The design team brings together Manchester University NHS Foundation Trust (MFT) ICU frontline clinical staff, an experienced product design consultancy, Designing Science Limited (DSL) and the technical expertise of the School of Engineering at the University of Manchester (UoM). The project will run through a rapid design and evaluation cycle in simulated and clinical environments to refine the concept to meet regulatory requirements. The final product could be used in primary/secondary care and in the community and will be ready for wide-scale manufacture and supply for the UK NHS within six months of the project start.

This study will evaluate Bubble PAPR in the clinical environment and gather usability data from frontline healthcare staff.

We hypothesise that:

* The Bubble PAPR will meet or exceed the British and European standards for PAPRs.
* That participating staff who subsequently use the PAPR will rate the PPE as:
* More comfortable than current PPE
* Safer than current PPE
* Easier to communicate with colleagues than current PPE
* Easier to communicate with patients than current PPE

Our research question is:

• Do clinical staff report that the Bubble PAPR is more comfortable than current FFP3 facemasks.

Eligibility Criteria:
Inclusion Criteria:

Provision of informed consent; bedside clinical staff (medical, nursing, allied healthcare professional) who manage patients with COVID-19 disease during routine clinical duties.

Exclusion Criteria:

Refusal to participate; unable to, or unwilling to wear the Bubble PAPR
Functional Magnetic Resonance Imaging (fMRI) of Anosognosia in Amnestic Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)

This is a three year fMRI study conducted at the University of Wisconsin (UW) Hospital and the William. S. Middleton VA Hospital. This study is guided by the hypothesis that reduced fMRI activity and connectivity cortical midline structures (i.e., medial frontal and ventral posterior cingulate cortex) are physiologic abnormalities that relate strongly to the compromised insight into cognitive deficits, or anosognosia, shown by a subset of individuals with amnestic MCI (aMCI) and AD. Further, the investigators hypothesize that these regional changes in fMRI activity are predictive of faster progression from aMCI to AD.


Eligibility Criteria:
Inclusion Criteria:

* Amnestic MCI:

  1. Observation of memory decline by informant.
  2. Mini Mental Status Exam (MMSE) score between 24 and 30.
  3. Objective memory impairment on neuropsychological tests.
  4. Intact functional abilities, and 4) no diagnosis of dementia.
* AD:

  1. A diagnosis of probable AD according with the NINDS-ADRDA and DSM-IV diagnostic criteria.
  2. MMSE score between 16 and 27. All AD patients will have capacity to provide informed consent as judged by the referring physician.

Exclusion Criteria:

* MRI incompatibility; history of neurologic disease (including prior loss of consciousness of more than 10 minutes); prior neurosurgery; or chronic medical diseases (such as poorly controlled diabetes, renal disease, or poorly controlled hypertension).
* Excluded medications include neuroleptics, short or long acting nitrates, and Warfarin.
* Other exclusions include: less than 10 yrs of education; Hachinski scale of 4 or more; first language other than English; poor visual or auditory acuity; pregnancy.
Wound Bacterial Microbiota and Their Antibiotic Resistance

The purpose of the study is to explore the microbiology in war-associated wounds of hospitalized patients from the Syrian armed conflict. Cultures collected from acute wounds with clinical signs of infection will be analyzed.

War-associated injuries often result in soft tissue and bone being contaminated with foreign material, leading to infection (Fares et al. 2013; Covey, Lurate, and Hatton 2000). Wound infections remain the greatest risk to life and restoration of function in war-wounded that survive the first few hours (Tong 1972; Murray 2008).

The Syrian armed conflict broke out in 2011 and quickly deteriorated. Médecins Sans Frontières/Doctors Without Borders (MSF) runs an emergency trauma project in the Ministry of Health hospital in Ar Ramtha, Jordan, less than five kilometers from the Syrian border. At this facility patients from the Syrian armed conflict receive treatment for blast- and gunshot-injuries. Wounds are treated according to the International Committee of the Red Cross war surgery protocol (Giannou and Baldan 2010). Wound management and healing has been difficult and time consuming, often complicated by infections and antibiotic resistance.

Recommendations for treatment of war-associated infections are generally not supported by cohort studies (Murray et al. 2008). High rates of war wound infections caused by antimicrobial drug resistant organisms have been shown in the Middle East but reports generally only include combatants. Due to the use of body armor and forward medical therapy this data may not be applicable to a civilian setting. Furthermore, available studies are either performed on old wounds (Teicher et al. 2014) or on all available culture samples, disregarding infection signs (Sutter et al. 2011; Dau, Tloba, and Daw 2013). Without clinical signs of infection, routine collection of peri-debridement culture samples is inappropriate in war-associated injuries (Murray et al. 2008). The differentiation between contamination and infecting organisms is crucial in order to avoid unnecessary medication, especially limit the use of broad-spectrum antibiotics as overuse may lead to development of multi-drug resistant organisms (Eardley et al. 2011). Cultures collected from acute wounds with clinical signs of infection will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients that receive surgical treatment for war-associated injuries, irrespective of injury location, injury mechanism, time from injury and prior treatment
* Patients that receive treatment during the study period and are later re-admitted will only be counted as one patient

Exclusion Criteria:

* Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by MSF before study initiation
Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.


Eligibility Criteria:
Inclusion Criteria:

* known or suspected COPD
* known or suspected obstructive ventilation disorder
* pulmonary healthy controls

Exclusion Criteria:

* pregnancy
* inability to participate
Quality of Life, Nutritional Status and Functional Capacity in People With Advanced Chronic Kidney Disease

This study evaluates the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.

Randomized study including two parallel groups: patients from the advanced chronic kidney disease (CKD) consulting room of the Malaga University Regional Hospital and controls. The main objective is to assess the clinical response (quality of life, nutritional status, functional capacity, and disease knowledge) of advanced CKD patients who undergo an individualized dietary intervention and a nutritional education program (group workshops) using motivation coaching techniques, compared to controls who receive general hygiene-nutritional education at every visit.

Both groups will be composed of 54 participants. The control group will be provided general dietary and lifestyle recommendations (standard procedure in the nephrology consulting room), whereas the intervention group will receive treatment and individualized dietary follow-up using coaching techniques, supported by information and communication technologies, and will participate in a nutritional education program composed of four on-line sessions.

Two visits (basal and three months after) will be scheduled during the study to obtain and analyse the data. Moreover, in these visits researchers will collect a blood sample in order to perform an assessment of the metabolism, inflammation, and oxidation, and a stool sample in order to evaluate the gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

- Patients \>18 years old with advanced CKD (GFR \<30ml/min) starting follow-up in the advanced CKD consulting room of the Malaga University Regional Hospital and who clearly understand the study and give their informed consent.

Exclusion Criteria:

* Patients presenting any of these conditions:

  * Active cancer
  * Being already participants of another study that may affect the results
  * Pregnancy or possible pregnancy
  * Informed consent refusal
  * Hospital admission during one month previous to the study
  * Severe mental disorders (SMD), prolonged mental disorders involving a high level of disability and social dysfunction, which requires attendance by the mental health and social care network
  * Alcohol or any other substance abuse that, in the researcher's opinion, may interfere with the study
Impact of Empaglifozine on Cardiac Ectopic Fat

There is substantial evidence supporting the fact that ectopic fat accumulation is an important contributor to type 2 diabetes complications and cardiovascular risk \[1\]. Epicardial adipose tissue (EAT), located between the myocardium and the visceral layer of the pericardium has been associated with atrial fibrillation and with coronary artery disease \[2, 3\] and its abundance predicts the number of cardiac events within 8 years \[4\]. In addition, myocardial steatosis has been shown to be an independent predictor of diastolic dysfunction \[5\] \[6\]. Furthermore, in type 2 diabetic patients, bariatric surgery can reduce cardiac ectopic fat accumulation and improve cardiac function \[7\] \[8\]. When added to standard care, 10 or 25 mg/d of empagliflozin, an inhibitor of sodium-glucose cotransporter 2 (iSGLT2), significantly reduces the risk of death, cardiovascular death, and hospitalisation for heart failure among individuals with type 2 diabetes and established cardiovascular disease when compared to placebo \[9\]. The mechanisms of empagliflozin-improved cardiovascular outcomes in type 2 diabetic patients at high risk of cardiovascular events are not known. We hypotheses that empaglifozin could modulate cardiac ectopic fat and cardiac metabolism in obese type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years,
* Type 2 diabetes based on the disease diagnostic criteria as described by the WHO,
* HbA1c \> 7% and \< 10 %
* Stable glucose-lowering therapy for at least 3 weeks before randomization
* Estimated glomerular filtration rate \> 60/ml (MDRD)
* Signed informed consent form obtained prior to any study procedure

Exclusion Criteria:

* Evolutive or planned pregnancy during the six months
* Lactation
* Recent weight loss (\>5% of body weight within one month),
* Treatment modifying adipose distribution such as corticoids
* Acute coronary syndrome or instable angina during the last 2 months,
* MRI contraindication (metal cardiac valve, pace maker, metal foreign body, claustrophobia)
PET/MR in Locally Advanced Nasopharyngeal Carcinoma

PET/MR in Locally Advanced Nasopharyngeal Carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing carcinoma.
* Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
* Performance status: KPS\>70
* With normal liver function test (ALT, AST \<1.5ULN)
* Renal: creatinine clearance \>60ml/min
* Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
* Written informed consent

Exclusion Criteria:

* Adenocarcinoma
* Age \>70
* Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin)
* Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
* Patient is pregnant or lactating
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), or emotional disturbance.
The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy

women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy

Patients were asked to urinate to evacuate the bladder. Posterior vaginal retractor was introduced to expose the cervix and ( embryo transfer catheter was introduced throught the cervix passing the internal os and intrauterine and intracervical instillation of to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline.

After 5 mins the procedure was started A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.

Post procedure pain management by optional dose of 75 mg of diclofenac potassium when requested.

Eligibility Criteria:
Inclusion Criteria:

* all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: AUB, infertility

Exclusion Criteria:

* Women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are contraindications for office hystroscopy