cyrilzakka/clinical-trials huggingface dataset:
Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis

A multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.

This study is a multicenter, exploratory clinical research, to map the radiation or immune checkpoint inhibitor pneumonitis in patients with alveolar lavage single-celled map. Find out the pathogenesis and prevention strategies of radiation or immune checkpoint inhibitor pneumonitis. Specific treatment is given based on the recommendation of the treatment guidelines for radiation or immune checkpoint inhibitor pneumonitis and the results of single cell sequencing, which will become a new technology for clinical application.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent has been signed, and according to the judgment of the investigator, the patient can comply with the study protocol and sign the written informed consent;
2. NSCLC patients who have been clinically diagnosed with RP or CIP after histopathologically confirmed radiotherapy or immunocheckpoint inhibitor treatment and have not received glucocorticoid or other drugs.
3. ≥18 years old, less than 75 years old;
4. ECOG PS score 0-3 in the Eastern Tumor Collaboration group;
5. Patients without contraindications to alveolar lavage;

Exclusion Criteria:

1. Poor patient compliance and violation of test regulations;
2. Liver and kidney dysfunction, such as myocardial infarction, angina pectoris, liver transaminase significantly increased;
3. Had any medical condition requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment;
4. Severe infection occurred within 4 weeks prior to enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia;
5. Severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic treatment within 14 days prior to enrollment;
6. Untreated patients with chronic hepatitis B, HBV carriers with HBV DNA≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Non-active hepatitis B, surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \& LT; 500 IU/mL), patients with cured hepatitis C could be enrolled;
7. Known history of HIV infection;
8. Received any other investigational drug or participated in any other clinical trial within 28 days.
OP2C : Prialt® Observatory in Clinical Practice

Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies.

It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis.

However, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration).

In recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options.

However, there is a lack of data on the current use of ziconotide in current practice.

The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Severe refractory chronic pain requiring intrathecal analgesia
* Candidate for intrathecal analgesia treatment with ziconotide
* Patient informed about the study and agreeing to take part in.

Exclusion Criteria:

* Contraindications to ziconotide
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers

This research is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.

The purpose of this research is to determine if a smartphone mobile application, also referred to as a mobile app or simply an app, designed to capture wound measurements and analyze wound tissue distribution in real-time, can be a practical patient-centered solution for regular wound management and assessment. The app will be compared to traditional in-person wound monitoring. One of the major limitations of most literature describing remote monitoring technologies is the lack of a control group. By randomizing half of the enrolled patients to remote monitoring via standard of care, the investigators will be able to compare patient and provider satisfaction with remote vs. in-person monitoring, as well as the wound healing outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years old
* In treatment for lower extremity wound related to diabetic foot ulcer
* Able and willing to use a smartphone to assess the wound for the duration of the study
* English language proficiency

Exclusion Criteria:

* Patients with less than 1 dressing change per week
* Patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg)
* Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans
PrognostICate- Study:Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040

The Objective of this retrospective multicenter- study is to forecast Intensive Care Unit (ICU) length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases.

Adequate resource allocation in Intensive Care Medicine is especially challenging due to limited resources and increasing demands for ICU capacities due to an aging population and medical advances. Several studies in the past were trying to predict ICULOS using different models. The Objective and aim of our retrospective multicenter study are to forecast ICU length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models.

To achieve this objective, historical ICU data spanning from 2005 to 2023 is collected from international ICU databases worldwide as well as population data from national and international databases and employ different statistical forecasting models (ARIMA-Model (Auto-Regressive Integrated Moving Average), logistic regression, Poisson Regression and ETS (Exponential smoothing)) to make these predictions. The Validity of the 4 different models is assessed with out-of-time-cross validity by splitting the data in 2 subsets for generation and testing of the model in a ratio of approximately 75:25 of the dataset. The most valid model of the 4 different models will be chosen. The statistical analysis follows he guidelines for Accurate and Transparent Health Estimates Reporting (GATHER Statement) von Stevens et al. from the year 2016.

The ultimate goal of this project is to provide valuable insights to healthcare system decision-makers worldwide regarding future requirements of ICU beds and ventilator capacities. With this insight we want to enable healthcare- system decision makers worldwide to proactively anticipate and allocate appropriate ICU resources for the future.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to an ICU between the years 2005-2023

Exclusion Criteria:

* Patients without ICU admission or ICU admission \< 4 hours
An Investigation of the Cervical Region Biomechanics in Patients With Chronic Obstructive Pulmonary Disease

The aim of this study is to investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy subjects.

The secondary purposes are to investigate the correlation between cervical region biomechanics and posture, functional exercise capacity, depression \&anxiety level,neck disability, cough severity. In accordance with this purposes, 17 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3-4, being clinically stable for 4 weeks and 17 healthy controls will be included ages\>40. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Photographical analysis in lateral and posterior views will be used for evaluation of cranioservical region static and dynamic biomechanics. To analyze of chest wall, radiographic evaluation will be performed. Goniometry will be used for evaluation dynamic craniocervical kinematic analysis. Cranioservical region muscle strength and endurance tests will be performed. Respiratory muscle strength tests and cough evaluation test will be performed. Neck disability index, cough evaluation test questionnare, beck depression and anxiety questionnares, Nordic Musculoskeletal questionnare will be used. 6 Minute Pegboard and Ring Test, 6 Minute Walk Test will be performed. According to the results to be obtained, relationship between cranioservical region biomechanics and posture will be investigated based on the severity of disease in patients with COPD. It will guide professional working in the field.

Eligibility Criteria:
Inclusion Criteria:

* • Being diagnosed with stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system,

  * Being \>40 years old,
  * Being cognitively competent to understand and answer evaluation questions.
  * Being clinically stable for the last 4 weeks,
  * Being under control of accompanying comorbid conditions (such as hypertension, diabetes),
  * Volunteering to participate in the research.

Exclusion Criteria:

* • Having been hospitalized due to exacerbation in the last 3 months,

  * Having a musculoskeletal, neurological, rheumatological or oncological disease that affects the craniocervical \& cervicothoracic joints and/or may prevent evaluation,
  * Having undergone any surgical intervention on the craniocervicofacial region and spine in the last six months,
  * Having lung malignancy, neoplasm, adenocarcinoma,
  * Being a lung cancer patient or having received cancer treatment (head and neck lung radiotherapy), having undergone pneumonectemia, lobectomy or resection surgery,
  * Being treated for anxiety and depression,
  * Having scoliosis,
  * Having a congenital anomaly of the craniocervicofacial region.
  * Having 3 out of 4 findings according to the diagnostic criteria for cervical radiculopathy,
  * Having thoracic outlet syndrome (TOS)
Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure

This study aims to evaluate the safety and clinical feasibility of epicardially delivered autologous atrial appendage micrografts in the treatment of heart failure. The micrografts consisting atrial-derived cells and their extracellular matrix, are placed on an infarction scar during CABG surgery.

The atrial appendages are a tissue reservoir for cardiomyocyte stem and precursor cells. During coronary artery bypass graft (CABG) surgery part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. This study aims to address the surgical feasibility and patient safety of epicardially delivered atrial appendage micrografts during CABG surgery.

Autologous cardiac cells are harvested from right atrial appendage during CABG of six patients. Micrografts consisting atrial appendage-derived cells (AADCs) and their extracellular matrix (ECM) of the atrial appendage are mechanically processed. The cells are placed on a tissue-engineered sheet with fibrin gel and tissue clue and further delivered epicardially on top of a infarction scar. Parameters including echocardiography reflecting cardiac insufficiency are studied pre- and post-operatively as well as at three and six months of the follow-up. Cardiac functional magnetic resonance imaging is performed preoperatively and at six-months follow-up. 20 patients will be recruited to serve as a control group. They are scheduled for elective CABG and are treated according to the normal hospital protocol, without the ECM sheet.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
* New York Heart Association (NYHA) Class II-IV heart failure symptoms

Exclusion Criteria:

* Heart failure due to left ventricular outflow tract obstruction
* History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator
* Stroke or other disabling condition within 3 months before screening
* Severe valve disease or scheduled valve surgery
* Renal dysfunction (GFR \<84 ml/min/1.73m)
* Other disease limiting life expectancy
* Contraindications for coronary angiogram or MRI
* Participation in some other clinical trial
The Effect of Glucose Level and Diabetes Mellitus on Ctrough of Olaparib

Monitored therapy of olaparib concentrations in the blood of diabetic population probably will assess the need for individual dosing of the drug.

The project concerns on the monitored therapy of olaparib in a population of patients with DM, hyperglycemia and normal glucose level.

Currently, there are no studies assessing the effect of comorbidities and of the administered drugs on the pharmacokinetics of olaparib.

The research is conducted at the Poznan University of Medical Sciences, and the Poznan, Poland with the approval from the Bioethics Committee, University of Medical Sciences, Poznan, Poland (697/20). The subjects of the research: the C through of olaparib in the patients with ovarian cancer who received olaparib The patients included in the study if they met the following criteria: treatment with olaparib above four days, age \>18 years; no history of allergy to olaparib. The chief criteria for exclusion included allergy to olaparib, age under 18 years, status of the patient which do not allowed the patient to continue the study.

Administration and blood sampling The patients with an ovarian cancer treated with olaparib (tablets in dose 300mg/12h, 250mg/12h, 200 mg/12h or capsules 400mg/12h, 200mg/12h, 100 mg/12h).

Blood samples (2 mL) collected at steady state before morning drug administration. The blood samples transferred into heparinised tubes and centrifuged at 2880 g for 10 min at 4 °C. Next the plasma transferred to propylene tubes and stored at - 20 °C until analysis.

Assays The concentrations of olaparib in plasma assayed using the high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection. The method validated according to European Medicines Agency guideline. The method validation confirmed good precision (CV% \<15%), accuracy (92.3-115.0%) and linearity (r=0.9994) in the range of 100-4000 ng/mL.

The severity of olaparib adverse effects assessed by CTCAE (Common Terminology Criteria for Adverse Events) v.5.0 scale.

Eligibility Criteria:
Inclusion Criteria:

* ovarian cancer patients treated with olaparib above than 4 days
* patient who gave permission to take part in the trial
* age \>18 years
* no history of allergy to olaparib

Exclusion Criteria:

* allergy to olaparib,
* age under 18 years,
* status of the patient which do not allowed the patient to continue the study.
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake

The study team previously demonstrated that patients are more likely to receive flu vaccine after learning that they are at high risk for flu complications. Building on this past work, the present study will explore whether providing reasons that patients are considered high risk for flu complications (a) further increases the likelihood they will receive flu vaccine and (b) decreases the likelihood that they receive diagnoses of flu and/or flu-like symptoms in the ensuing flu season. It will also examine whether informing patients that their high-risk status was determined by analyzing their medical records or by an artificial intelligence (AI) / machine-learning (ML) algorithm analyzing their medical records will affect the likelihood of receiving the flu vaccine or diagnoses of flu and/or flu-like symptoms.

Geisinger has partnered with Medial EarlySign and developed an ML algorithm to identify patients at risk for serious (moderate to severe) flu-associated complications on the basis of their existing electronic health record (EHR) data. Geisinger will apply this algorithm to current patients during the 2021-22 flu season.

This study will evaluate the effect of contacting patients identified as high risk with special messages to encourage vaccination. These communications will inform patients they are at high risk with either (a) no additional explanation, (b) an explanation that this determination comes from an analysis of their medical records, along with a short list of the top factors from their medical record that explain their risk, and (c) the additional explanation that an AI or ML algorithm made this determination, along with a short list of the top factors from their medical record that explain their risk.

Included in the study will be current Geisinger patients 18+ years of age with no contraindications for flu vaccine and who have been assessed by the Medial algorithm and assigned a risk score. The primary study outcomes will be the rates of flu vaccination and flu diagnosis during the 2020-21 season by targeted patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* Current Geisinger patient at the time of study
* Falls in the top 10% of patients at highest risk, as identified by the flu-complication risk scores of machine learning algorithm (which operates on coded EHR data)

Exclusion Criteria:

* Has contraindications for flu vaccination
* Has opted out of receiving communications from Geisinger via all of the modalities being tested
Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

The study seeks to evaluate a novel treatment approach for performing continuous real-time glucose sensing and insulin delivery at the same subcutaneous tissue site.

The treatment of type 1 diabetes usually comprises the measurement of glucose in blood obtained by finger pricking and the administration of insulin via subcutaneous bolus injection or continuous subcutaneous infusion.

This study seeks to test a new treatment approach where glucose sensing and insulin administration are combined and performed at a single subcutaneous tissue site (single-port treatment approach). A single-port device consisting of a continuous glucose sensor and an insulin infusion cannula is inserted into the subcutaneous tissue of 10 type-1 diabetes patients and used for insulin infusion and simultaneous glucose sensing over a 7-day period. The performance of the single-port device is assessed by comparing the obtained glucose readings with those of a blood glucose meter and an additionally worn control sensor.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age, both inclusive
* Type 1 diabetes treated with Continuous Subcutaneous Insulin Infusion (CSII)
* HbA1C \< 10%
* Signed informed consent before any study-related activities

Exclusion Criteria:

* Severe acute diseases
* Clinically overt diabetic complications
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Taking of any vasoactive substances or anticoagulation medication
* Diseases of the skin which could interfere with application of the catheters and Sensors as judged by the investigator
* Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception.
* Increased tendency towards development of hypoglycaemia
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
* Concurrent participation in another study
Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)

Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).

This is a placebo-controlled, randomised, double-blind, multicentre, Phase III clinical trial to assess the efficacy of IV metoprolol in newly intubated ARDS patients, assessing survival and days free of invasive mechanical ventilation during the first 28 days. Eligible participants shall have had orotracheal intubation (OTI) and mechanical ventilation within 72 hours prior to randomisation, moderate-severe ARDS (PaO2/FiO2: ≤200 mmHg under standardised conditions (PEEP≥5 cm H2O), a heart rate ≥ 60 bpm and invasive systolic blood pressure ≥ 110 mmHg.The trial will include a total of n=350 patients, with two treatment arms: metoprolol vs. placebo (1:1). Each of the 7 days of treatment, participants will be receive 15 mg of iv metoprolol tartrate or matching placebo in 100 ml of saline for 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients (≥18 years and \<80 years) with a clinical diagnosis of ARDS of any aetiology (pneumonia, including SARS-CoV-2, sepsis, pancreatitis, bronchospasm and trauma) admitted to the ICU.
* Orotracheal intubation (OTI) and mechanical ventilation within 72 hours prior to randomisation.
* Moderate-severe ARDS (PaO2/FiO2: ≤200 mmHg under standardised conditions (PEEP≥5 cm H2O).
* Heart rate ≥ 60 bpm.
* Invasive systolic blood pressure ≥ 110 mmHg.

Exclusion Criteria:

* Prolonged hospital admission prior to randomisation (i.e. ≥7 days at the time of randomisation).
* Reduced left ventricular ejection fraction (LVEF \<50%).
* Life expectancy due to other processes (cancer, degenerative diseases, etc.) of less than 6 months.
* Right ventricular (RV) systolic dysfunction.
* Concomitant acute heart failure (cardiac index ≤2.5 L/m2 or pulmonary capillary pressure ≥15 mmHg or clinical suspicion).
* Second-degree atrioventricular (AV) block, 2:1 AV block, high-grade/advanced AV block and third-degree AV block. Also significant sinus bradycardia, which would be implied by having a heart rate \>60 bpm as an inclusion criterion.
* Pregnant or breastfeeding women.
* Cardiogenic shock.
* Persistent invasive blood pressure \<110 mmHg despite vasopressor agents.
* Use of noradrenaline at concentrations greater than 0.2 µg/kg/min at the time of the randomisation.
* Use of dobutamine within 48 hours before randomisation.
* Concomitant pulmonary embolism.
* Known severe peripheral arterial disease.
* Known asthma before admission (with active bronchodilator therapy).
* Active beta-blocker treatment prior to admission (i.e. within 3 months prior to admission).