cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)

International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Verified diagnosis of non-small cell lung cancer
* Verified progression of the disease after or during first-line chemotherapy based on platinum drugs
* Absence of mutation of EGFR and ALK genes
* ECOG score 0-1
* At least one lesion, that is measurable according to RECIST 1.1 criteria
* Absence of severe organ pathology
* Anticipated live duration more that 12 weeks after screening
* Brain metastases with clinical symptoms requiring glucocorticoids and/or anticonvulsant drugs

Exclusion Criteria:

* EGFR and/or ALK mutations
* Patients with severe of live-threatening acute complications of the disease
* Intersticial lung diseases or pneumonitis
* Concomitant diseases that affect safety evaluation
* Autoimmune diseases
* Endocrine diseases that could not be compensated by hormonal therapy
* Patient needs glucocorticoids
* Significant liver or renal diseases
* Lactate dehydrogenase exceeds upper limit of normal more that 2-fold
* More that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer treatment
* Anti-tumor treatment ending less then 28 days before screening
* Prior therapy with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 drugs
* Prior therapy with docetaxel
* Concomitant oncological diseases except treated cervical carcinoma in situ or radically resected squamous-cell carcinoma
* Allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe reactions to paclitaxel
* Pregnancy and lactation
The Correlation Characteristics Between Mental Health and Gut Microbiota of College Students in Qingyuan Vocational Education City

The goal of this observational study is to learn about the mental health status and gut microbiota characteristics of college students in Qingyuan Vocational Education City. The main question it aims to answer is:

How is the mental condition of college students in Qingyuan Vocational Education City? Is there a correlation between the mental condition and the microbial characteristics of college students in Qingyuan Vocational Education City? Participants will answer online survey questions about their demographic characteristics, disease history, gastrointestinal status, lifestyle habits, and psychological health information. 200 participants from each of the following groups will be included: healthy individuals, anxious Individuals and depressive Individuals. Fecal samples will be collected for microbiome testing and analysis to obtain their microbial characteristics and to analyze the impact of mental health status on microbial changes.


Eligibility Criteria:
Inclusion Criteria:

Healthy Individuals:

1. Ages 18 to 25 years old.
2. Resident in the local area for more than one month.
3. No obvious signs or symptoms of disease.
4. Good psychological condition.
5. College students currently enrolled in Qingyuan Vocational Education City.
6. Having signed an informed consent form, willing to provide relevant survey information and fecal samples.

Anxious Individuals:

1. Ages 18 to 25 years old.
2. Resident in the local area for more than one month.
3. Self-rating anxiety scale score greater than or equal to 50.
4. College students currently enrolled in Qingyuan Vocational Education City.
5. Having signed an informed consent form, willing to provide relevant survey information and fecal samples.

Depressive Individuals:

1. Ages 18 to 25 years old.
2. Resident in the local area for more than one month.
3. Self-rating depression scale score greater than or equal to 53.
4. College students currently enrolled in Qingyuan Vocational Education City.
5. Having signed an informed consent form, willing to provide relevant survey information and fecal samples.

Exclusion Criteria:

1.Pregnant and Lactating Women.
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch or central type).

The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to participation in the study.
2. Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
3. BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
4. CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
5. Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
6. Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

1. Macular edema in the Study Eye for reasons other than RVO
2. Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
3. Uncontrolled glaucoma in the Study Eye.
4. Active retinal disease other than the condition under investigation in the Study Eye.
5. Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
6. Active or suspected ocular or periocular infection or inflammation
7. Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
8. Women who are pregnant or lactating or intending to become pregnant during the study.
9. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
10. Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
11. History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
12. Other protocol-specified exclusion criteria may apply.
The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support

This research investigates the impact of a hypnosis-based intervention in alleviating state anxiety in Preterm Premature Rupture of Membranes (PPROM). Our main hypothesis is that a two-session intervention can decrease anxiety for pregnant women with PPROM compared to usual care. This research also studies the impact of the experience of a PPROM during a pregnancy on several variables such as perinatal depression, pregnancy-related anxiety, bonding and childbirth experience, as well as control and pain perceived during chilbirth. Our hypotheses are that the experience of PPROM negatively influences these variables, and that this impact is alleviated by the hypnosis-based intervention for the experimental group.


Eligibility Criteria:
Inclusion Criteria:

* Being an adult French-speaking woman,
* primi or multipara,
* less than 33 weeks and 6 days of amenorrhea
* having being diagnosed with PPROM

Exclusion Criteria:

* Women cognitively impaired or with important hearing issues,
* being placed under protective measures,
* caring more than one fetus,
* having a severe, preexisting or triggered during the pregnancy,
* psychiatric pathology,
* caring a fetus with an abnormality having required further medical investigations, or participating in another clinical trial comprising an intervention measuring psychological variables
Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Patients undergoing tracheal resection and reconstruction surgery are enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an Intensive Care Unit (ICU). Patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing The neck was maintained in flexion through chin-to-chest sutures. Infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation Richmond Agitation Sedation Scale, (RASS) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1.


Eligibility Criteria:
Inclusion Criteria:

* patients submitted to tracheal surgery
* elective surgery
* age ≥ 18 years

Exclusion Criteria:

* severe neurological disorder
* visual or hearing impairment
* acute cerebrovascular disease
* mean arterial pressure (MAP) \<55 mmHg or hypotension requiring the use of inotropes/vasopressors
* heart rate (HR) \<50 bpm
* second and third degree atrioventricular block (AV block) in the absence of PMK
* Sequential Organ Failure Assessment (SOFA) score \<2 index
* hepatic failure
* emergency surgery
* pregnancy
* patient refusal to give consent
* inability to give consent
* age ≤18 years
* ASA score ≥ IV.
Validation of the PECARN Clinical Decision Rule for Children With Minor Head Trauma

To date, the Pediatric Emergency Care Applied Research Network (PECARN) rule for identifying children who are at very low risk of clinically-important traumatic brain injuries after minor head trauma has not been validated prospectively in an independent population. Our goal was to evaluate the diagnostic performance of the PECARN clinical decision rule in a French pediatric population in multiple clinical settings.

Head injury is a frequent reason for consultation with pediatric emergencies, over 95% are mild head injury defined by a Glasgow score greater than or equal to 13. In October 2009, the Pediatric Emergency Care Applied Research Network has published a rule clinical decision support of mild head injury of the child with the aim to identify children at very low risk for clinically severe intracranial lesions in order to avoid the use of CT and unnecessary exposure to radiation ionizing. This clinical decision rule constructed from a multicenter prospective cohort 42,412 American children allows on anamnestic and clinical elements to guide medical decision for conducting brain imaging, hospital monitoring or discharge home placing the child in three levels of risk of clinically severe intracranial lesions.

Since March 2012, the French Emergency Medicine Society recommends for the treatment of mild head trauma the child's use of the clinical decision rule provided that it is the subject of a validation study externally. Indeed, after the construction phase and before its daily application, a clinical decision rule must be subject to an broad validation process so that its predictive performance can be definitively established.

The investigators' work aims to conduct this broad validation study prospective multicenter way in a French pediatric population, as recommended by the French Emergency Medicine Society, in order to confirm or deny its predictive performance and allow its application and generalization. The investigators will check and if the clinical decision rule is adapted or not to the management of mild head injuries in the French pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Children under 16 years admitted to an emergency room for mild head injury (Glasgow Coma Scale score ≥14) in the previous 24 hours
* Children who have agreed to participate in the study (if age\> 8 years)
* Patient Parents have accepted the participation of their child in the study

Exclusion Criteria:

* Children with bleeding disorders
* Ventricular shunt Presence
* Benin mechanism of trauma (fall of the height of the child or impact against an object while walking / running with no sign that the scalp dermabrasion)
* Penetrating trauma
* Known brain tumor
* Previously known neurological disorders
* Evaluation scanographic in another hospital before emergency review
Natera Ovarian Cancer Detection Assay

The purpose of this study is to enroll participants who present with an adnexal mass on imaging to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. The study will collect blood, tissue, and health information from these individuals.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging
* Must be planning surgical resection or biopsy
* Must be treatment naïve
* Must be 18 years or older
* Able to understand and sign a written informed consent document
* Able to provide 40mL of blood (at least 20mL) for each blood draw

Exclusion Criteria:

* Prior removal of either ovary for any reason
* Currently pregnant
* Blood transfusion within 3 months of study enrollment
* History of bone marrow or organ transplant
* Prior history and treatment for any malignancy, with exception of previously treated non-melanoma skin cancer.
* A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia
Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections

This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.

To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care.

Exclusion Criteria:

* Insufficient sample volume available after sufficient aliquot removed for usual care.
A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief

A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Current use of an artificial tear product
* Visual Acuity of at least 20/40 (while wearing glasses, if necessary).

Exclusion Criteria:

* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
* Cataract surgery, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy within 6 months
* Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months
* Diagnosis of glaucoma.
Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B

This study evaluates the addition of birinapant in subjects with chronic Hepatitis B who are currently receiving anti-viral therapy with either tenofovir or entecavir. Patients will receive either birinapant or placebo in addition to their anti-viral therapy.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of chronic Hepatitis B infection currently being treated with tenofovir or entecavir for at least 3 months
* Measurable titer of HBsAg
* HBV DNA level \< 2 log copies/mL or 10² copies/mL
* No more than Child-Pugh score of 5 plus a valid FibroScan® of at least 10 readings with a median score of \<7 and interquartile range of \< 30%
* Adequate liver function, aspartate AST and ALT ≤2 x ULN
* Adequate renal function as evidenced by creatinine ≤2 mg/dL

Exclusion Criteria:

* Participation in any interventional study within 4 weeks prior to Screening
* Known HIV infection, Hepatitis C, or other significant hepatic disorder including cirrhosis (Child-Pugh Class B or C)
* Serious illness or autoimmune disease or other known liver disease
* Uncontrolled hypertension
* Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
* Currently breast feeding, pregnant or planning on becoming pregnant
* Known allergy or hypersensitivity to any of the formulation components of birinapant or placebo, including citric acid
* History of cranial nerve palsy
* Current treatment with anti-TNF therapies or has received treatment with anti-TNF therapies within the last 6 months
* Use of non-steroidal anti-inflammatory drugs
Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary evidence and considering the potential benefits of the technique, we hypothesized that ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain relief at 3 months, when compared to intra-articular steroid (IAS) injection.

This study will allow us to determine if ultrasound-guided phenol genicular neurolys is superior to intra-articular steroid injection in terms of analgesia and functional outcomes, providing a more effective and long-lasting alternative for patients with chronic knee pain secondary to osteoarthritis

Eligibility Criteria:
Inclusion Criteria:

* Severe knee pain for more than 6 months, defined as Numeric rating scale (NRS) score of 6 and greater, unresponsive to conservative medical treatment
* Radiological OA grade 2 to 4 (Kellgren-Lawrence scale)

Exclusion Criteria:

* Previous total knee replacement on the index knee
* Prior knee radiofrequency ablation on the index knee
* Connective tissue diseases with knee involvement (e.g. rheumatoid arthritis)
* Body mass index ≥ 40 kg/m2
* Uncontrolled coagulopathy, defined as supratherapeutic dose of anticoagulation medication
* Allergy to local anesthetics
* Unstable opioid consumption, defined as an increase \>10% in dosage during the last 3 months prior to recruitment.
Comparison Between Hypoglycemic Counter Regulatory Responses in Type 1 Diabetics vs Control Subjects

This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia

Iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management of diabetes. It causes recurrent morbidity in most people with type 1 diabetes and in many patients with type 2 diabetes and can be fatal. Episodes of hypoglycemia impair physiologically protective mechanism in subsequent episodes of hypoglycemia. This phenomenon is known as hypoglycemia-associated autonomic failure (HAAF), the clinical syndromes of defective glucose counter regulation and hypoglycemia unawareness.

Eligibility Criteria:
Type 1 diabetics

Inclusion Criteria:

* More than 5 years of disease duration
* HbA1c 42-86 mmol/L
* No known HAAF
* BMI 22-28
* Written consent

Exclusion Criteria:

* Other disease than diabetes f.x epilepsy, ischemic heart disease or heart rhythm disturbance
* Medication f.x beta-blockade, steroids, psychotropics
* Smoking
* Drug abuse

Control subjects

Inclusion Criteria:

* BMI 22-28
* Written consent

Exclusion Criteria:

* Diseases f.x diabetes, epilepsy, ischemic heart disease or heart rhythm disturbance
* Medication f.x beta-blockade, steroids, psychotropics
* Smoking
* Drug abuse
Transgender In Transition

Prospective trial in gender dysphoric patients who undergo gender-affirming hormone therapy, aiming to investigate psychological, biological and behavioural consequences of hormonal therapy.

Gender-affirming hormone treatment impacts myriads of body functions, from which it has to be assumed that only a minority has already been elucidated so far. This project aims to investigate the consequences and health-related outcomes of various hormone therapies in the treatment of gender dysphoric patients. The main scientific interest lies in the research of the effects of sex hormones on psychological, metabolic and behavioural parameters. For this purpose, various investigations are aimed at, including a clinical-diagnostic interview (external rating) and psychometric measurements in self-rating, behavioral experiments (e.g. in a virtual reality Elevated Plus Maze and the computer-based Ultimatum Game) and genetic investigation of the body's own materials (blood samples, stool samples, hair samples and saliva samples). The results of this study should form the basis to better understand consequences of the long-term administration of sex hormones.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of gender incongruence (ICD-11) or gender dysphoria (DSM-5)
* written informed consent following adequate oral and written Information
* before gender-affirming hormonal treatment

Exclusion Criteria:

* pregnancy or breast-feeding
Clinical and Radiographic Success Following Regenerative Pulpotomy Using Chitosan Hydrogel Versus Platelet Rich Fibrin in Mature Mandibular Molars

The aim of this study is to assess the clinical and radiographic success and postoperative pain in mature mandibular molars following vital pulp therapy using chitosan hydrogel versus platelet rich fibrin.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Symptomatic pulpitis in mature mandibular molars only will be involved.
* Tooth should give positive response to cold test
* Haemostasis should be achieved after full pulpotomy
* The tooth is restorable and free from advanced periodontal disease, cracks and splits.
* Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
* Patients who will agree to the consent and will commit to follow-up period.
* Patients with mature root apices
* Patients with no internal or external resorption and no periapical lesions
* Soft tissues around the tooth are normal with no swelling or sinus tract

Exclusion Criteria:

* Patients with immature roots.
* Haemostasias after 10 minutes cannot be controlled after full pulpotomy Patients with any systemic disease that may affect normal healing.
* Patients with periapical lesions or infections.
* Pregnant females.
* Patients who could/would not participate in a 6 months follow-up.
* Patients with fistula or swelling
* Patients with necrotic pulp.
* Patients with old age.