cyrilzakka/clinical-trials huggingface dataset:
BI 2536 Infusional Treatment in Patients Over 60 Years of Age With Refractory or Relapsed Acute Myeloid Leukaemia

The present trial will be performed to determine the MTD and to evaluate the efficacy of BI 2536 in the treatment of elderly patients with relapsed or refractory AML. Different schedules will be compared to identify the better dosing schedule for the further development programme of BI 2536. Dose escalation starting with the maximum tolerated dose previously determined in patients with advanced solid cancers will be performed to determine the maximum tolerated dose for AML patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients older than 60 years of age
* Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy
* Leukocyte count \<= 25,000 /mcl (25 x 10e9/Liter)
* Patient not eligible for intensive treatment options
* Life expectancy \>= 2 months
* Eastern co-operative oncology group performance score of 2 or less
* Signed written informed consent consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation

Exclusion Criteria:

* Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3)
* Hypersensitivity to the trial drug or the excipients
* Secondary malignancy requiring therapy
* Known central nervous system involvement
* Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver involvement
* Bilirubin greater than 1.5 mg/dl (\> 26 mcmol/l, SI unit equivalent)
* Serum creatinine greater than 2.0 mg/dl
* Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia
* Psychiatric illness or social situation that would limit compliance with trial requirements
* Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
* Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug
* Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant
* Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.)
* Patient unable to comply with the protocol
Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction

This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline

The critically ill patients treated with tigecycline in in tensive care unit will be recruited and divided into tigecycline-induced coagulation dysfunction group and non-coagulation dysfunction group. The multi-omics will be used to screen out biomarkers for early prediction of coagulation dysfunction caused by tigecycline. Afterwards, machine learning methods will be adopted to establish the the early prediction model of tigecycline-induced coagulation dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
* Intravenous tigecycline ≥ 3 days
* Monitoring the plasma concentration of tigecycline

Exclusion Criteria:

* Missing clinical data
Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis

Systemic Scleroderma (SCS) is an autoimmune disease characterized by vascular involvement, a dysimmune condition, cutaneous and visceral fibrosis. Interstitial lung disease (ILD) affects 75% of SSc patients and is the leading cause of death in SSc. No diagnostic or prognostic biomarkers of SSc-associated ILD have been validated to date. The search for such a serum biomarker is essential to assess the severity of these patients and to help the therapeutic management.

We have shown that soluble fractalkine is elevated in SSc patients, especially in SSc patients with ILD. The fractalkine is both an endothelial adhesion molecule and a chemokine that binds to the CX3CR1 receptor expressed by immune populations. It would thus reflect the vasculopathy and inflammation that lead to the fibrosing pulmonary involvement of this disease.

Objectives and means: We aim to perform a low-risk interventional biomedical research which main objective is the quantitative evaluation of soluble fractalkine in SSc patients with ILD in comparison with SSc patients without ILD. This epidemiological, explanatory, analytical, single-center study will comprise three groups: 1 / SSc without ILD (control group in the context of SSc), 2/ SSc with ILD and 3/ patients with idiopathic pulmonary fibrosis (IPF) (control group of the ILD). Secondary objectives are evaluation of: 1 / fractalkine levels in the IPF, 2 / correlations between fractalkine levels and severity of ILD and of SSc disease over time, 3 / correlations between fractalkine and 2 other biomarkers: KL-6 (marker of pulmonary fibrosis) and soluble CD146 (sCD146, marker of vasculopathy), 4 / predictive values of the decline in lung function of these 3 markers.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 with SSc with or without ILD with a medical follow up in AP-HM
* Patients, followed at AP-HM, with IPF

Exclusion Criteria:

* Impossibility of taking blood
* Known diagnosis of respiratory disorders other than SSc-associated ILD and IPF
* An infection in progress
* An evolutive cancer
* Chemotherapy or radiation therapy in progress
* Minors
* Pregnant or lactating women
* Majors under guardianship
* People staying in a health or social facility
* People in emergency
* Non-beneficiaries of a social security scheme
* Persons deprived of their liberty
Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression

The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.


Eligibility Criteria:
Inclusion Criteria:

* 2 to 12 weeks after first ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as previous stroke)
* Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke
* Presence of spasticity:

  * either symptomatic, based on symptomatic spasticity criteria (i.e. at least one of the following items: impacted passive/active function, involuntary movements, or pain ≥4 on a numeric pain rating scale \[NPRS\]), in addition to increased muscle tone \[Modified Ashworth Scale, MAS ≥2\])
  * or only increased muscle tone (MAS≥2)

Exclusion Criteria:

* Neuromuscular junction (NMJ) diseases, or any other neurological disorders (including prior local joint, tendon, and intrinsic muscle disorders) that could potentially interfere with assessment of spasticity in the primary targeted muscle group selected by the Investigator and in agreement with the subject
* Currently receiving drugs affecting NMJ transmission e.g. aminoglycosides, aminoquinolines, cyclosporine, D penicillamine
* Previous surgery of the affected muscles/ ligaments/tendons
* Severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple organ failure, hepatic renal failures, severe infections)
Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma

This prospective study aims to clarify the clinical efficacy and survival prognosis of neoadjuvant immune checkpoint inhibitor (ICI) combined with chemotherapy for esophageal cancer. It also explores predictive biomarkers and potential therapeutic targets for locally advanced esophageal cancer based on plasma metabolomics and peripheral blood immune cell clustering analysis. Each patient received 2-3 cycles of neoadjuvant immunotherapy with programmed cell death 1 (PD-1) blockade in combination with albumin paclitaxel and platinum. Exploratory analysis of plasma metabolomics combined with peripheral blood subsets of immune cells can reveal biomarkers that predict the efficacy and prognosis of patients undergoing neoadjuvant immunotherapy for locally advanced esophageal cancer, which also provide new ideas for the selection of immune adjuvants and therapeutic targets in ICIs combination therapy strategies.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years and ≤89 years;
2. pathological histological examination confirmed the diagnosis of esophageal squamous cell carcinoma and esophageal adenocarcinoma;
3. clinical stage II-IVA;
4. adequate organ function;
5. no previous chemotherapy or radiotherapy;
6. voluntarily signed informed consent.

Exclusion Criteria:

1. the presence of concurrent malignancies that interfere with the prognosis of esophageal cancer;
2. patients with immunodeficiency or autoimmune diseases that seriously affect the body's immune system, such as those who test positive for HIV;
3. patients undergoing systemic corticosteroid or other immunosuppressive treatments;
4. patients with a history of allergy to the components of this test drug.
Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL)

The main purpose of this study is the description of all French cases of PPBL and the establishment of minimal criteria for the pathology diagnosis and its follow-up.

The secondary objective is the immunologic and genetic characterization of lymphoid cells causing the disease.


Eligibility Criteria:
Inclusion Criteria:

* PPBL diagnosis established during a previous medical visit

Exclusion Criteria:

* None
The Safety Management of Cardiac Toxicity in Breast Cancer Patients Under Multidiscipline Therapy.

This trial is to explore the optimal strategies for guaranteeing the cardiac safety of breast cancer patients following adjuvant radiotherapy in the modern era of multidisciplinary treatment.

With the development of modern radiotherapy techniques, the dose-volume of heart irradiated could be kept in much low level. However, until now, the optimal dose-volume parameters for limiting heart irradiation, the optimal follow-up interval for cardiac safety after adjuvant radiotherapy, the optimal screening examinations and treatments for irradiation-induced cardiac toxicity are unclear. We designed this trial to find answer for above questions to establish rationalization proposal for prevention, treatment and follow-up for cardiac toxicity associated with adjuvant radiotherapy for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate the research and sign the informed consent file;
* Patients aged 18-80 years;
* KPS≥70;
* Pathological diagnosis for invasive breast cancer;
* Patients received anthracycline/paclitaxel based chemotherapy, or herceptin based targeted therapy;
* No functional heart disease;
* LVEF≥50%;
* Patients received breast conserving surgery;
* Patients received modified radical mastectomy: T1-2 with N1-3 or T3-4 with any N;
* Tumor margin negative;
* No metastases;
* No other malignant tumor history.

Exclusion Criteria:

* Patients with metastases;
* Tumor margin positive;
* Patients received modified radical mastectomy with T1-2 and N0;
* Patients have other malignant tumor;
* Patients have a history of heart disease;
* Patients received chest radiotherapy previously;
* Patients with severe organic and functional disease;
* Unqualified patients with sufficient reasons;
* Cannot or no willing to sign the informed consent file;
* Patients with autoimmune disease;
* Women with pregnancy, planned pregnancy or lactating.
The Implementation of Computer-aided Detection in Training Improves the Quality of Future Colonoscopies

Computer-aided detection (CADe) based on artificial intelligence (AI) may improve colonoscopy quality. An increasing number of young endoscopists are trained in an AI environment. However its impact on trainees' future outcomes remains unclear. The study aimed to evaluate the quality indicators of endoscopists trained in an AI environment compared to those trained conventionally.

Computer-aided detection (CADe) based on artificial intelligence (AI) may improve colonoscopy quality. An increasing number of young endoscopists are trained in an AI environment. However its impact on trainees' future outcomes remains unclear. The study aimed to evaluate the quality indicators of endoscopists trained in an AI environment compared to those trained conventionally. A study included 6,000 adult patients who underwent a colonoscopy for various reasons. The study retrospectively evaluated the first 1,000 procedures performed by six endoscopists after completing training relying entirely on endoscopists' detection skills without AI enhancement. Three of those young endoscopists were trained with CADe, and three without additional assistance. Quality indicators were assessed in both groups. The morphology of detected polyps was evaluated to determine the influence of AI-enhanced training on laterally spreading tumors (LST) detection rate.

Eligibility Criteria:
Inclusion Criteria:

* adult participants who underwent a colonoscopy for various reasons performed by specific endoscopists that were assessed in terms of quality indicators

Exclusion Criteria:

* a history of bowel resection
* confirmed inflammatory bowel disease
* suspicion of polyps or cancer in other imaging tests
* suspicion of familial adenomatous polyposis
Short and Medium-term Effects of Pulmonary Rehabilitation in Mild to Critical Post-acute COVID-19

As a direct consequence of the COVID-19 pandemic, it is assumed that the number of patients with COVID-19-related disabilities will increase significantly. Patients with mild, severe, and critical forms of the disease show long-term sequelae in different systems (respiratory, muscular, psychological, cognitive etc.).

Persistent dyspnea is a frequently described symptom after the acute phase of the disease. Coupled with reduced oxygen saturation, an increased risk of developing lung fibrosis has been observed. Specialized rehabilitation medicine (e.g. pulmonary rehabilitation) might counteract these long-term consequences and therefore seems to be a promising approach to treat long-term COVID-19 consequences.

Further, there is scarce evidence about COVID-19 specific rehabilitation contents. It was suggested to use treatment regimes in analogy to patients with idiopathic pulmonary fibrosis.

There is evidence that pulmonary rehabilitation improves physical performance, quality of life and reduces anxiety and depression symptoms in patients with idiopathic pulmonary fibrosis and other chronic respiratory diseases.

Since impairments related to idiopathic pulmonary fibrosis also play an important role in COVID-19, the aim of this study is to evaluate the short and medium-term effects of a standardized 3-week pulmonary rehabilitation program. The results will be analyzed within the two cohorts (mild/moderate and severe/critical COVID 19) as well as between the two cohorts for the primary outcome. Furthermore, the effects of pulmonary rehabilitation will be compared with a retrospective cohort of idiopathic pulmonary fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Post-acute phase COVID-19 patients with mild, moderate, severe or critical course
* written informed consent

Exclusion Criteria:

* patients who are unable to walk
The Role of Routine Bacterial Culture Including Tuberculosis During Bronchoscopy: A Prospective Study

Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined.

Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined. Unnecessary bronchial cultures of bacteria may lead to over treatment in patients without clinical evidence of infections and may increase the drug resistant strains.

In areas with a high prevalence of TB, routine bronchial cultures may detect clinically unsuspected TB in an appreciable proportion of cases. However, in population with a low prevalence of TB, routine culture of bronchial aspirates may incur an unnecessary expanse and may lead to over diagnosis and over treatment of patients with non pathogenic atypical mycobacteria detected by acid-fast bacillus strains.

Eligibility Criteria:
Inclusion Criteria:

1. patients who will undergo a bronchoscopy examination at pulmonary department in Meir Medical Center
2. patients who will sign on informed consent. -

Exclusion Criteria:

* 1)age under 18 years
Brief Intervention to Increase Safety Belt Use Among ED Patients

DESCRIPTION (adapted from applicant's abstract): Injury control experts suggest that consistent SBU is the most effective means for motorists to reduce1he risk of death or serious injury in a crash. Sadly, the SBU prevalence among Massachusetts' residents is among the lowest in the nation. In accord with Healthy People 2010, Objective 15-19, and the CDC's Injury Research Agenda, the investigator will test the utility of a brief intervention to increase SBU among ED patients with self-reported SBU that IS less than "always". A secondary aim is to determine if the brief intervention is more effective among persons being treated for a motor vehicle crash (MVC)-related injury during a "teachable moment" than other non-injured ED patients receiving the same intervention. The research staff will systematically sample ED patients, screening for SBU among eligible participants during a 3-month period. Upon obtaining verbal consent, researchers will ask participants to complete a self-administered screening form on health and safety issues, including SBU. Patients that screen positive, (i.e., give an answer of less than "always use" safety belts) on a SBU screening question will be asked to participate in an intervention to promote health and safety among ED patients. Participants will be reimbursed for their time, and asked to do the following: to give written informed consent via IRB-approved forms and a HIPAA release form; complete an intake form, and agree to a follow-up phone interview at 3 and 6 months post-enrollment. Participants will be randomized into one of two groups: an Intervention Group that will receive a brief intervention designed to increase SBU, and a Control Group that will receive only standard care. Research staff will contact participants for a follow-up phone survey at 3 and 6 months to test the hypothesis that individuals randomized to the Intervention Group will have a higher self-reported SBU than those in the Control Group that received only standard care. Likewise, for the secondary (exploratory) analysis, the hypothesis is that among those treated for MVC-related trauma--and randomized to the intervention group--will have a higher self-reported SBU than others with non MVC-related trauma due to a greater receptivity to brief intervention techniques during the ED visit (i.e. the "teachable moment").


Eligibility Criteria:
Inclusion Criteria:

* ED patients greater than 18 years old, speak English, normal mental status, can give free and autonomous consent,

Exclusion Criteria:

* patient does not have a telephone or is homeless, altered mental status, is a prisoner, under psychiatric evaluation
The Effect of Task-oriented EMG-triggered ES on Upper Limb Motor Function in Hemiplegic Cerebral Palsy

The purpose of our study; to investigate the effects of EMG-induced ES treatment on hand functions, muscle strength, and quality of life in patients with hemiplegic CP.

Upper limb spasticity greatly affects the hand functions of patients with cerebral palsy (CP) and impairs quality of life. The most important goal in rehabilitation; despite the existing deficiencies, the highest level of functional independence of the patient is to increase the quality of life. EMG-triggered biofeedback electrical stimulation (EMG-triggered-BF-ES) increases the patient's active participation and motivation in rehabilitation, creates visual or auditory BF, provides muscle reeducation, decreases spasticity, prevents atrophies and increases joint mobility and increases muscle functionality by increasing the patient's functionality. There are areas of use the EMG-triggered-BF-ES such as cerebrovascular disease (CVO), spinal cord injury, and CP. When the literature is examined; studies were found to be few, and no study evaluating the upper extremity was found in children with CP. The purpose of our study is the investigation of the effects of EMG-triggered-BF-ES treatment applied on hand functions, muscle strength, and quality of life in patients with CP.

Eligibility Criteria:
Inclusion Criteria:

* having a diagnosis of CP
* age between 4 and 18 year
* at least 10° of the active wrist and finger extension in the affected limb but less than normal
* upper limb spasticity (shoulder, elbow, wrist, and fingers) less than or equal to grade 2 according to the modified Ashworth scale (MAS)
* should be able to receive command

Exclusion Criteria:

* Mental retardation
* Passive range of motion (ROM) limitation in the upper extremity
* Sensory impairment in the upper extremity
* The visual and auditory deficit in the upper extremity
* MAS is more than 3.
* Botulinum toxin application to the upper limb in the last 6 months
* Any surgical application to the upper limb in the last 6 months
Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases

Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment. Thus, how to better prevent such diseases is currently a key research topic in the international field. The use of cord blood-derived mononuclear cells may promote to save lives and improve patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* For children with hypoxic-ischemic encephalopathy (HIE): meet the diagnostic criteria for HIE.

For children with bronchopulmonary dysplasia (BPD): 1) preterm infants with definite gestational age of 25-30 weeks; 2) birth weight 401-1249 g; 3) the risk of BPD was assessed to be greater than 60%. The scoring was based on the BPD high risk scoring system established by the NCHD Neonatal Cooperative Network; 4)parents read the subject's instructions, agreed to the treatment and signed the informed consent.

For children with short bowel syndrome (SBS): 1) postoperative short bowel syndrome caused by neonatal necrotizing enterocolitis and other causes (developmental malformations of the digestive tract: intestinal atresia, anal atresia, intestinal stenosis, etc.); 2) parents read the subject's instructions, agreed to the treatment and signed the informed consent.

Exclusion Criteria:

* For children with HIE: unable or unwilling to provide informed consent or unable to comply with trial requirements.

For children with BPD: 1) with severe anemia, severe intracranial hemorrhage, pulmonary hemorrhage, congenital respiratory malformations (posterior nostril atresia, tracheoesophageal fistula, cleft palate, etc.), complicated congenital heart disease, diaphragmatic hernia, shock, other serious comorbidities or complications (congenital inherited metabolic diseases, endocrine diseases, severe congenital malformations and other diseases that affect lung development); 2) unable or unwilling to provide informed consent or unable to comply with trial requirements.

For children with SBS: unable or unwilling to provide informed consent or unable to comply with trial requirements.