cyrilzakka/clinical-trials huggingface dataset:
Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)

This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Toripalimab combined with Chemotherapy and Antiangiogenic Agents in patients with Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 inhibitors)


Eligibility Criteria:
Inclusion Criteria:

* Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up;
* Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma (NSCLC) by cytology or histology;
* First-line PD-1/PD-L1 inhibitors treatment failure;
* Provide detectable specimens (tissue or blood) for genotyping before enrollment, and the patients should be with negative EGFR and ALK gene test results;
* Had at least one measurable lesion according to RECIST 1.1 criteria
* Anticipated overall survival more than 3 months;
* ECOG (Eastern Cooperative Oncology Group) scale 0-2;
* Normal organ function and bone marrow function;
* Resistant to first-line immune checkpoint inhibitor therapy and discontinued for more than 4 weeks;
* Women of childbearing age must have taken reliable contraceptive measures and performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and the results were negative, and were willing to use appropriate methods during the trial and 4 weeks after the last administration of the test drug.

Exclusion Criteria:

* Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) ;
* Patients who have previously permanently discontinued immunotherapy due to immune-related serious adverse reactions;
* Patients who previously treated with antiangiogenic agents;
* A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
* Active, known or suspected autoimmune disease;
* Active or chronic hepatitis C or/and hepatitis B infection;
* History of interstitial lung disease.
Risk Stratification of COVID-19 Patients Discharged From the Emergency Department

Risk stratification of COVID-19 patients is essential to define their appropriate treatment setting. So far, available studies have focused on morbidity and mortality prediction in patients admitted to hospital. In the Emergency Department (ED), decision on home discharge versus hospital admission for COVID-19 is cumbersome. While facing a dramatic second wave of SARS-CoV-2, shortage of hospital beds has further increased the challenge.

The present study will prospectively evaluate the clinical outcomes of patients discharged from the ED. Stratification will be based on a composite of demographic, clinical and lung imaging variables. Results will be used to develop standardized decision rules for safe home discharge of patients with COVID-19 evaluated in the ED.

Patients with inclusion criteria and without exclusion criteria, evaluated in the participating EDs, will be enrolled in the study. Patients will undergo standard medical evaluation by the attending physician(s), following local guidelines and best medical practice, independent of participation to the study.

The following data will be recorded, when available:

* Demographic/clinical: age, gender, symptoms (type, time from onset), comorbidities, Glasgow Coma Scale score, respiratory rate, peripheral oxygen saturation
* Biochemical: urea, creatinine, C-reactive protein, procalcitonin, lactate dehydrogenase, white blood cell count, lymphocyte count, d-dimer
* Lung ultrasonography: site/type of B lines, consolidations, pleural effusion
* Radiology: chest X-ray result, chest CT result

Upon discharge, patients will be encouraged to contact emergency medical services or return the ED if needed, in case of clinical worsening.

The following endpoint will be assessed at 30 days after ED discharge, through standardized telephone interview and healthcare/other database query: any further hospital admission (for COVID-19 or other disease), death (for COVID-19 or other disease), respiratory failure/ventilation/intensive care admission (only for hospitalized COVID-19 patients).

Data analysis will focus on the outcome incidence in the study cohort, stratified by a composite of demographic/clinical, biochemical and imaging variables. A key stratification tool will be the 4C mortality score (BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3339). Additional integration of study variables will be evaluated to improve stratification and prediction.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic COVID-19 confirmed by treating physician
* positive nasopharyngeal swab for SARS-CoV-2 (performed during the ED visit or within last 14 days)
* First ED visit for suspected or confirmed COVID-19 (within last 30 days)
* Home discharge from ED based on treating physician's or patient's decision

Exclusion Criteria:

* Age \<18 years
* Nursing home resident
* Already on home oxygen therapy
* Previous ED visit for suspected or confirmed COVID-19 (within last 30 days)
* Informed consent denial
* Follow-up not feasible
CP-481,715 Nickel Allergy Study.

To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist.


Eligibility Criteria:
Inclusion Criteria:

* A history of nickel allergy confirmed by a visual positive reaction (graded at least ++) to T.R.U.E. TEST.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding contact allergic dermatitis or untreated, asymptomatic, seasonal allergies at time of dosing).
The Role of Interactive Binocular Treatment System in Amblyopia Therapy

Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a complementary method of patching in amblyopia therapy.

Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) less than 10 years with either best corrected visual acuity (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of VA≥2 lines between two eyes will be included. Patients will be classified in the case and control groups (25 in each), randomly. Patching will be recommended in both, cases will also received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with conjugate colored filters. Patching was continued for one month more in both groups. VA and stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one month after I-BiTTM treatment.

In this clinical trial study, our case group will receive I-BiTTM in the format of three playing games which have been designed suitable to the age of our cases. The mechanism of I-BiTTM has been designed in three playing games with inducing more foveal stimulation for the amblyopic eye through presentation of movable targets with more detailed. In addition, unmovable targets will presented to the non-amblyopic eyes. Playing games were continued 30 minutes in each session for 5 days in each week within one month.

Eligibility Criteria:
Inclusion Criteria:

* BCVA \<= 0.3 LogMAR

Exclusion Criteria:

* Organic Amblyopia
* Age less than 4 years
* Nystagmus
Biomarkers for Identification of COVID-19 Infection

Acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test, including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 75 years, extremes included, male or female In conscious patients, ability to understand and the willingness to sign a written informed consent document; in unconscious patients informed consent will be signed from parents or legal tutors.

Exclusion Criteria:

* Patients that don't sign the informed consent
Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages

This is a clinical trial in which we will learn about the retinal findings in three clinical groups of children, who might be at risk of having retinal hemorrhages (RH). The aim of the study is to explore the occurrence of moderate to severe retinal hemorrhages in critically ill children, children with intracranial hemorrhages, hydrocephalus or signs of elevated intracranial pressure and in children with benign enlargement of subarachnoid spaces (BESS).

1. Are RHs associated with BESS?
2. What is the prevalence, distribution and extent of RHs in critically ill children?
3. What is the prevalence, distribution and extent of RHs in children with traumatic brain injury?
4. Does the prevalence, distribution and extent of RHs differ in children with witnessed traumatic brain injury from children with traumatic brain injury of unknown origin?
5. To what extent do the causes of RHs affect visual acuity, initially and during recovery? A retinal ophthalmoscopy through dilated pupils will be conducted and a fundus photograph will be taken by a handheld, non-touch camera.

The prospective study will take place at university hospitals in three Swedish regions, Stockholm, Skåne and Västra Götaland. The data collection from the three regions will proceed in parallel over a three-year period. An estimated number of children will be 400-500 per year. The study children will be consecutively referred to the pediatric ophthalmology units, where the ophthalmological examinations will take place. Bedside examinations will be performed when indicated at the pediatric intensive care units. Retinal fundus examination will be performed according to clinical standards following administration of pupil dilating eye drops in each eye. Visual function will be evaluated if ophthalmic abnormalities are detected.

Prospective observational study Group 1: All infants ≤ 18 months of age, who undergo neuroradiological examinations of the brain on the indication increased head circumference.

Group 2: All critically ill children \< 15 years of age, cared for at the hospitals, with neurological symptoms, that require neuroradiological examination of the brain.

Group 3: All children ≤ 2 years of age, who undergo emergency neuroradiological examinations of the head at the hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Infants ≤ 18 months of age, who undergo neuroradiological examinations of the brain on the indication increased head circumference
* Children \< 15 years of age, cared for at the ICU, with neurological symptoms, that require neuroradiological examination of the brain
* Children \< 5 years of age, who undergo emergency neuroradiological examinations of the head at the hospitals

Exclusion Criteria

- Infants with intraventricular hemorrhages due to prematurity, in the absence of increased head circumference
Removing Home Hazards for Older Adults in Affordable Housing

The investigators will conduct a hybrid effectiveness/implementation trial to simultaneously establish the effectiveness of home hazard removal in affordable housing in order to reduce falls, and conduct a process evaluation of how the intervention works in the context of low-income senior apartments.

The investigators, in collaboration with the community partner, will offer the program to all building residents in select low-income senior apartments. The eligibility criteria include a self-report of one or more falls in the preceding 12 months, a fear of falling, or unsteadiness while standing or walking. The investigators will screen residents and determine their risk for falling. Residents who are high risk will be referred to licensed occupational therapy practitioners for baseline assessments and home hazard removal. Residents will be re-assessed at 3 months. All assessments will be conducted in the residents' apartment buildings. Outcomes (falls, program evaluation) will be collected by our community partner.

Eligibility Criteria:
Inclusion Criteria:

* Residents who live in any of the eligible section 202 low-income senior apartment units managed by our community partner

Exclusion Criteria:

* Individuals who do not reside in any of the eligible units
A Phase I Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-910 in Healthy Participants

This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-910 in in Healthy Participants Detailed


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 55 years (inclusive) at the time of informed consent.
* Body mass index (BMI) between 18 to 32 kg/m2 and male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg

Exclusion Criteria:

* Any major surgery within 12 weeks prior to Day 1, or any planned surgery during the study.
* Poor pill swallowing ability
HAIC Combined With Toripalimab and Donafenib for Advanced BTC

This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age, of any sex;
* Histologically/Cytologically confirmed diagnosis of unresectable advanced adenocarcinoma of the gallbladder, intrahepatic bile duct and extrahepatic bile duct.
* At least one measurable lesion umder CT/MRI as defined by RECIST1.1 criteria
* Patients must have adequate organ and marrow function as defined below:

Blood test:

Hemoglobin (HB) ≥90 g/L Absolute neutrophil count (ANC) ≥1.5×10\^9/L； Platelet (PLT) ≥80×10\^9/L；

Biochemical test:

total bilirubin≤2×ULN (institutional upper limit of norm) AST(SGOT)/ALT(SGPT)≤2.5 ×ULN creatinine clearance≥ 50 ml/min as calculated by the Cockroft-Gault formula

* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
* Indocyanine Green Retention Rates at 15 min (ICGR15\<22%;
* Life expectancy of \> 3 months;

Exclusion Criteria

* Patients with other malignant tumors should be excluded
* Female patients who are pregnant or breast-feeding. Female patients who are pregnant during the study should also exit.
* Patient has enter any other clinical trails within 4 weeks prior to study entry.
* Patient known with a severe and/or uncontrolled medical disease.
* Chronic non-healing wound/bone fracture
* History of organ transplant
* Patients with abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), those have bleeding tendency (14 days prior to randomization must meet: INR is within the normal range without any use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogous therapy; use for preventive purposes is permitted provided that the international normalized ratio of prothrombin time (INR) ≤ 1.5, take low-dose warfarin (1 mg PO, QD) or low-dose aspirin (do not exceed 100 mg per day);
* Previous history of aterial/venous thrombosis such as cerebrovascular accidents, pulmonary embolism or deep venous thrombosis within one year prior to patients recruitment.
* Hitstory of psychiatric drug abuse and hasn't come clean, or with psychiatric illness/social situations that would limit compliance with study requirements
* History of immunodeficiency, or other acquired/congenital immunodeficiency diseases
* Concomitant diseases that severely endanger the safety of the subject or affect the study completion according to the judgment of the investigator
* Willingness to sign a written informed consent document, with good compliance.
Effect of Opioids in Neuropathic Pain in Postherpetic Patients

Postherpetic neuralgia (PHN) is often associated with pain and sensory changes and is the leading type of neuropathic pain in modern clinical pain research. It is characterized by a variety of sensory patterns, which may be categorized into "irritable nociceptor" and "impairment of nociceptor". At date, several lines of evidence lead to the assumption, that mechanical hyperalgesia in PHN is based - at least in part - on central nervous processes of sensitization.

In animal studies the investigators have discovered a previously unrecognized effect of opioids, the reversal of long-term potentiation (LTP) at C-fibre synapses, i.e. an opioid-induced depotentiation. In principle, synaptic depotentiation may be permanent or transient. In our study the clinically used ultra-short acting MOR agonist remifentanil normalized synaptic strength after wash-out of the drug. At present it is not known whether opioid-induced depotentiation can be used to the benefit of pain patients.

The aim is to study the hypothesis, that pain in a group of PHN patients with predominant mechanical hyperalgesia is reversed by intravenous remifentanil at a plasma target concentration of 18ng/ml (corresponding to about 0.75 µg/kg/min) for 60 minutes compared with PHN patients of other sensory types.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from PHN.
* Pain ≥ 4 out of 10 in numeric rating scale (NRS)
* Female and male patients above the age of 18
* Ability to understand/write/read german

Exclusion Criteria:

* Zoster affecting trigeminal-, opticus region
* Any somatic pain which is stronger than the neuropathic pain
* Severe progressive disease
* Acute cardiac decompensation
* Known cardiac valve dysfunction
* Known pulmonary hypertension
* Cardiac conduction disturbance
* Active herpetic lesion
* Opioid therapy
* Asthma bronchial
* Chronic obstructive pulmonary disease \>GOLD II
* Severe psychiatric condition
* Abuse of alcoholic beverages, drug abuse
* Negative neuropathic symptoms
* Pregnancy or breast feeding
* Participation in a clinical trial in the 2 weeks preceding the study
* Allergy against any medication used in the study protocol
Growth and Metabolic Biomarkers of Healthy Term Infants Fed Formulas With Staged Protein Concentrations Over the First Year of Life

Growth and metabolic biomarkers of healthy term infants fed formulas with staged protein concentrations over the first year of life

The overall objective of this study is to assess growth and biomarkers of energy and protein metabolism in healthy term infants fed with two different study formula regimens from birth to 12 months of age and to follow up the infants to 4 years of age.

Eligibility Criteria:
Inclusion Criteria:

Healthy infants will be enrolled in the study provided they meet the following inclusion criteria:

1. Having obtained his/her parents' (or his/her legally accepted representative's \[LAR's\]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the infant's parents/LAR have been informed of all pertinent aspects of the study.
2. Age ≤ 7 days after birth (date of birth = Day 0)
3. Full-term gestational birth (≥ 37 and ≤ 42 weeks)
4. Born to mothers with pre-pregnancy body mass index (BMI) ≥ 18.5 and \< 26 kg/m2
5. Born to mothers who independently elected, before study enrollment, not to breastfeed (not applicable for infants in the HM-fed comparator group)
6. Weight ≥ 2'500 g and ≤ 4'200 g
7. Infant's parent(s)/LAR is of legal age of consent, has sufficient command of French language to complete the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol
8. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the study

Exclusion Criteria:

Infants who exhibit one or more of the following criteria are excluded from enrollment in the study:

1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or gestational diabetes diagnosed according to standardized criteria)
2. Born to mothers who smoked \> 10 cigarettes per day during pregnancy
3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy
4. Cognitive or physical developmental disorders (e.g. malabsorptive disorders such as short bowel syndrome; neurological and congenital disorders that may delay growth such as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity such as Prader willi syndrome, Angelman syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders)
5. Received radiation therapy (eg. scannography or interventional radiology)
6. Participation in any other clinical trial prior to enrollment
7. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.


Eligibility Criteria:
Inclusion Criteria:

- Patients with acute symptomatic proximal deep vein thrombosis

Exclusion Criteria:

* Contraindication to comparator drugs
* Symptomatic Pulmonary embolism
* Conditions with increased bleeding risk
* Unstable patients with reduced life expectancy
* Severe renal impairment
* Impaired liver function
* Strong CYP 3A4 inhibitors
* Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics
* NSAIDs with half-life \> 17 hours