cyrilzakka/clinical-trials huggingface dataset:
PCA062 in pCAD-positive Tumors.

A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.


Eligibility Criteria:
Inclusion criteria:

1. Male or female ≥ 18 years of age
2. Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
3. Consent for a tumor biopsy at screening
4. Progressive disease and no effective therapy exists
5. Measurable disease as per RECIST v1.1 criteria
6. ECOG Performance status of ≤ 2

Exclusion criteria:

1. CNS metastatic involvement
2. Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
3. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
4. Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
5. Previously treated with anti-pCAD biologic therapies.
6. Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:

   * Conventional cytotoxic chemotherapy: ≤4 weeks
   * Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks
   * Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer)
   * Other investigational agents: ≤4 weeks
   * Radiation therapy (palliative setting is allowed.): ≤4 weeks
   * Major surgery: ≤2 weeks
7. Patient has out of range laboratory values defined as:

   * Hematological values:
   * Absolute neutrophil count (ANC) \<1.5 x 109/L
   * Hemoglobin (Hgb) \<9 g/dL
   * Platelets \<100 x 109/L
   * Hepatic and renal function
   * Total bilirubin \>1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin \>2.5 x ULN.
   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 x ULN for patients without tumor involvement of the liver or \>5 x ULN for patients with tumor involvement of the liver.
   * Serum creatinine \>1.5 x ULN and/or measured creatinine clearance \< 40 ml/min
The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section

This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II
* Patients aged between 20 and 40 years
* 18 kg/m² ≤BMI≤30 kg/m²
* singleton term pregnancy
* scheduled for elective cesarean section

Exclusion Criteria:

* Refused to participant in this trial
* Severe heart dysfunction or pulmonary insufficiency
* Poor blood pressure control in those with hypertension (BP \>160/100 mmHg in the ward)
* Previous history of Intracranial hypertension or hyperthyroidism
* Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium
* Allergy to drugs used in the study
Early Intervention for Morbidly Obese Patients After Roux-en-Y Gastric Bypass (RYGB) Surgery

Purpose and objective: To identify in the early post-operative period following laparoscopic Roux-en-Y gastric bypass patients likely to fail to progressively lose weight in expected fashion, and to institute intervention and assess for its efficacy.

Study activities and population group: Patients identified to have "poor weight loss" (≤ 11% of excess weight loss) at 1 month will be randomized into a control versus study group. Intervention for subjects randomized to the IV arm will be by enrollment in the Back on Track program. This is a seven-week group education, counseling, nutrition, exercise, and journaling program of the Duke Weight Loss Surgery Center designed to help postoperative bariatric surgery patients who are failing to progressively lose weight resume an expected pattern of weight loss and improved overall outcome.

Data analysis and risk/safety: Data will be collected and analyzed by the identified investigators. The goal of data analysis is to uncover any difference in the EWL of subjects who underwent intervention for falling in the lowest EWL quartile when compared with those who did not undergo intervention, and determine the statistical significance of any such difference. There are no physical risks associated with this study. There is, however, the potential risk of loss of confidentiality. Every effort will be made to keep your information confidential.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Patient is scheduled and consented for laparoscopic Roux-en-Y gastric bypass as part of their routine medical care

Exclusion Criteria:

* Younger than Age 18 years
* Patient is disabled and unable to participate in an exercise program
Continuous Quality Improvement for Diabetes

The purpose of this study is to compare health care delivery outcomes and costs achieved by two different approaches to health care delivery. The investigators will compare health outcomes for groups of adult patents with diabetes. One group will be managed by our traditional approach to diabetes care. The second group's care delivery is structured according to a design consistent with the Chronic Care Model (CCM).

The study is comparing the effect of an intervention targeting a subset of the diabetic patients within a primary care practice on the resource utilization of resources and disease outcomes on the entire population of patients with diabetes in that practice. The effect will also be compared across the entire panel of patients assigned to the physicians in the 2 arms of the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary care physicians practicing in a designated site with \> 200 patients assigned to their panel who have been diagnosed with diabetes

Exclusion Criteria:

* Refusal to give informed consent
Diabetic Patients With End-Stage Renal Disease

In diabetic patients with end-stage renal disease to investigate the prevalence of diabetic complications and quality of life and to compare with non-diabetic patients with ESRD and diabetic patients with normal kidney function.


Eligibility Criteria:
Inclusion Criteria:

* Presence of diabetes and treatment with either dialysis or renal transplantation

Exclusion Criteria:

* Age \< 18
* Pregnancy
Investigating Epstein-Barr Virus Associated Conjunctivitis

Conjunctivitis means inflammation of the conjunctiva, the thin transparent layer over the white of the eye and under the eyelids. Acute conjunctivitis caused by infection is the most common condition seen in ophthalmic emergency departments, accounting for up to 10% of cases. It is responsible for 41% of eye-related general practice consultations. A diagnosis is usually made on the patient's symptoms and signs, despite this being less reliable than laboratory testing. When a cause is found, it is usually a common cold virus called adenovirus, that gets better with time and does not require treatment.

Through investigating cases of conjunctivitis at Moorfields, it has been discovered that in addition to adenovirus, Epstein Barr virus (EBV) is sometimes detected in conjunctival swabs from individuals with conjunctivitis. EBV is a very common viral infection that 95% of adults have experienced. EBV infection mostly passes unnoticed but when symptoms do occur, they include a sore throat, high temperature, swollen glands and tiredness, often called glandular fever or infectious mononucleosis. Conjunctivitis can also occur. EBV remains in the body after infection and rarely causes further problems. The virus can become active again occasionally, which is known as reactivation.

Reactivation usually passes unnoticed but sometimes is associated with recurrence of symptoms. It is possible that reactivation may cause conjunctivitis. It is not certain, which is will be observed as a part of this study, as it might be the cause of some of the conjunctivitis seen.

Through a collaboration with University College London (UCL), the aim is to gain further insight into infectious conjunctivitis, particularly in relation to EBV. This will be done by taking a swab of the conjunctiva, a single blood test and a tiny (1-2mm) tissue sample from the inner eyelid. Improved knowledge will allow the research team to develop better guidance and treatment for patients with conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Participants shall be considered eligible for inclusion if:

  * Aged ≥16 years;
  * working diagnosis of infective (viral) follicular conjunctivitis (\&lt;4 weeks duration)
  * EBV positive conjunctival swab

Exclusion Criteria:

* • Present with symptoms/signs such that another diagnosis is deemed more likely, for example topical medication-induced conjunctivitis.

  * Participant declines diagnostic tests or appropriate corneal or conjunctival sample(s) not obtained for any reason
National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa.

Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization.

The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.

It consists of a study of a prospective cohort in 36 centers, for 3 years, from April 1st 2008. The data of all patients who received rFVIIa in traumatic situation were collected. The investigators colligated clinical and biological parameters; have been analyzed treatment received during initial care, in intensive care before and after they received rFVIIa, length of stay in ICU, secondary effects, complications and patients outcome.

ISS and TRISS score were calculated to predict mortality.

Eligibility Criteria:
Inclusion Criteria:

* people affiliated to social security
* patients admitted in ISU for haemorrhagic trauma
* patients received rFVIIa after the other treatment for bleeding control

Exclusion Criteria:

* allergy or hypersensitivity to rVIIa or one of its component
Food Talk: A New App for Daily Food Monitoring

This project will pilot test a new app for self-monitoring food intake using natural spoken language (by voice recognition or text) to provide daily estimates of energy and nutrient intakes with a phone app.

Self-recording food intake is recommended for weight management and healthy eating. However, current methods, including web platforms and apps, are often burdensome leading to short-term use by the consumer. The solution uses cutting-edge speech and language understanding technology to streamline the food logging process. With this technology, the user simply describes what they ate and the system automatically selects the appropriate items and quantities consumed from the USDA food database, which calculates the nutrition profile of the entry.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy men and women 18-65 years if age
* Currently participating in ongoing studies at the HNRCA
* Willing and able to sign written informed consent prior to study entry
* iPhone (iOS 11 or higher) user willing to download the COCO application and record food intake for 5 days

Exclusion Criteria:

* Android or iPhone (iOs 10 or lower) user unable to download and use the COCO application
* Holds a graduate degree in nutrition
Different Effects of Three Recruitment Maneuvers on the Lung Heterogeneity of Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) is the common disease in clinical, which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.

Acute respiratory distress syndrome (ARDS) is the common disease in clinical,which pathophysiology is a lot of alveolar collapse and heterogeneity. Recruitment maneuver is one of the important therapy for improvement of this phenomenon. The previous research focuses on the hemodynamic and oxygenation effect of recruitment maneuver on the lung of ARDS. Seldom investigators try to find the intuitive change of heterogeneity when recruitment maneuver is implemented. In this study, the investigators compare three recruitment maneuvers on the lung heterogeneity of ARDS.

Electrical impedance tomography (EIT) has been introduced as a true bedside and radiation-free technique which provides information on heterogeneity. The investigators compare effects of three recruitment maneuvers on lung heterogeneity before recruitment maneuver and do the same thing after three recruitment maneuvers.

Ninety-three patients with ARDS will be enrolled . These patients are treated routinly.They need to recept a time of ZEEP (PEEP is zero cmH2O)for ten respiratory cycles before RM(recruitment maneuvers).Implemente a kind of RM at random immediately after ZEEP,Then make the ventilator same as before ZEEP.The EIT images ,blood gases and hemodynamic variables will be examined as beseline between ZEEP and RM.Completion of this kind of RM lies that the P/F of blood gases 3 minutes after RM achieves (1) PO2/FiO2\>400mmHg or (2)PO2/FiO2+PCO2 ≥ 400mmHg(FiO2=1)，(3)the difference between this index before lung recriument and after lung recriument PO2/FiO2\<5%.In addition,3 minutes after RM,compare the indexs above between three methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are severe or moderate ARDS
* Patients who have signed ICF

Exclusion Criteria:

* Patients who are younger than 18 years old or older than 75 years old
* Patients whose vital signs are unstable
* Patients who are in other clinical trails
* Patients who are pregnant
ROS in TBI Patients in Relation to Level of Oxygenation.

This project an observational study performed on patients with severe Traumatic Brain Injury (TBI) treated at Neurosurgical ICU (NICU) at Karolinska University Hospital. The purpose of this study is to evaluate the effects of various oxygenation levels on production rate of Reactive Oxygen Species (ROS) in patients with severe traumatic brain injury (TBI). The patients will be included in the study after the placement of intracranial monitoring device consisting of intracranial pressure gage (Codman), microdialysis (MD), and Licox oxygen electrode for measurement of partial pressure of oxygen in brain tissue (pBtO2). Intracranial monitoring is inserted on clinical indications and is used for early detection of deleterious processes in brain tissue such as hypoxia or hypoperfusion and for purpose of guiding of given therapies such as cerebral perfusion pressure (CPP), oxygenation, dosage of vasoactive drugs etc. Despite the technical possibilities to monitor all these physiological parameters, there are no clear guidelines how to interpret the MD and pBtO2 data and implement it in clinical decision making. One of the controversies deals with optimization of oxygen levels: some authors point out the importance of adequate brain tissue oxygenation, whereas other researchers are worried about the possible negative effects of excessive oxygen levels such as increased production of ROS or facilitating pulmonary atelectasis, contributing to adverse outcome.

The purpose of this study is to investigate the effect of various oxygenation levels on ROS production in TBI patients.

This pilot study is designed to measure short-lived ROS in blood and microdialysis fluid samples of TBI patients during alternating periods of normal vs temporarily increased oxygenation levels under normobaric conditions (normal atmospheric pressure).


Eligibility Criteria:
Inclusion Criteria:

1. Severe isolated TBI (GCS\<8, AIS =\<3), CT-verified TBI (tSDH,tEDH, tSAH, contusion bleedings) caused by blunt or penetrating trauma.
2. Established intracranial monitoring (ICP, MD, LiCox pBtO2) at NICU.
3. Age \>= 18
4. Time from trauma from 0 to 4 days.
5. Informed consent from Close relative.
6. Systemic hyperoxygenation can be used in patients with pBtO2 \<20 mmHg, based on clinical decision.

Exclusion Criteria:

1. Major extracranial injury, AIS \>3
2. Brain dead or expected survival \<24 hours
3. Pregnancy
4. Respiratory insufficiency FiO2\> 40%

6. No consent from relative.
Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)

The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and/or multi-valve repairs/replacements; and
* At University Hospitals Cleveland Medical Center.

Exclusion Criteria:

* Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III);
* Patients undergoing emergent or emergent salvage surgery; and
* Patients actively participating in another clinical trial which could affect outcomes.
Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers

The purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker.

Patients with permanent pacemakers have a high risk of atrial fibrillation (AF), particularly those with hypertension, sinus node dysfunction, and those with short episodes of atrial arrhythmias, known as atrial high-rate episodes (AHRE). AHRE are felt to be a precursor to AF, and may be both the result and a cause of changs in the atrial electrophysiology, and structure (known as cardiac remodeling)that are associated with the development of AF.

Evaluating this process in human AF has been limited by the cumbersome nature of performing serial, invasive electrophysiologic studies. However, modern pacemakers now permit rapid, non-invasive electrophysiologic testing and can also accurately document AHRE, which allows the convenient study of therapy aimed at preventing the progression from AHRE to overt AF. In addition, this group of patients also affords the ability to evaluate the recurrence of AHRE on the progression of structural and electrical remodeling.

Comparison: Irbesartan compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Sinus Node Dysfunction (with or without AV conduction disturbance)
* Permanent, atrial or dual-chamber pacemaker implanted \> 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing
* History of at least 6 AHRE in the last 6 months (rate \> 220/min, duration of \> 2 minutes
* History of prior diagnosis of hypertension and/or treated for hypertension OR two documented BP \> 130/85 (measurements done at least one week apart)

Exclusion Criteria:

* Permanent or persistent AF or more than 6 episodes of symptomatic paroxysmal AF in the previous 6 months
* Documented Cr \>200 umol/L and K+ \>5.2 mmol/L in the previous 3 months
* Current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range
* LV ejection fraction known to be \< 40 %
* Moderate or severe mitral regurgitation (3+, 4 +)
* Mitral stenosis of more than mild severity
* Aortic stenosis with mean gradient of \> 25 mmHg
* Angina at rest in the last 2 months, or current CCS Class 3 or 4 angina
* Unipolar atrial lead
* Previous AV node ablation
* P-wave amplitude less than 1.5 mV
* Current therapy with an ACE inhibitor, ARB or aldosterone antagonist
* Current or planned (within 6 months) with an anti-arrhythmic medication (amiodarone, sotalol, flecainide, propafenone, quinidine, dofetilide
Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness

Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.

In order to identify patients with a good neurological outcome a combination of diagnostic tests is used.

Clinical rating scales

* Simplified evaluation of consciousness scale (SECONDs) and the full outline of unresponsiveness (FOUR) score
* Once a week

Blood biomarkers

* Neuron specific enolase, neurofilament light, glial fibrillary acidic protein
* Sampling timepoints: 24h, 72h, 7 days and 14 days after brain injury
* Serum (STG-5) and plasma (EDTA-6) tubes, aliquoted (4 x 0.5ml) and stored at -80°C

EEG with reactivity testing

* Standard 21-electrode montage
* Stimuli protocol I: a set of 5 stimuli repeated 3 times

  1. Auditory: clapping in hands, 2. Auditory: calling patients name loudly, 3. Visual: passive eye opening, 4. Tactile: nasal tickle, 5. Noxious: sternal rub Each stimuli is applied for a duration of 5 seconds and an interval between stimuli of 30 seconds
* Stimuli protocol II: Cognitive-motor dissociation test

MRI-scan

* Sequences considered essential for patient care i.e.T1, T2, FLAIR, DWI/SWI
* Preferably, performed between 4-6 weeks after hospital admission

Eligibility Criteria:
Inclusion Criteria:

All patients that are admitted to the ICU with the following criteria will be eligible for inclusion:

1. Severe brain injury (GCS ≤ 8) as a result of:

   1. Traumatic brain injury
   2. Ischemic cerebrovascular accident
   3. Intracranial hemorrhage
   4. Meningo-encephalitis
   5. Subarachnoid hemorrhage
2. Age ≥ 18 years old
3. Written informed consent from legal representatives

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Absence of informed consent
* Moribund at ICU admission
* Progressive neurodegenerative disease
* Pre-admission life expectancy ≤ 6 months based on comorbidity
* GCS has been \> 8 prior to inclusion
* Impossible to include within 24 hours after brain injury