cyrilzakka/clinical-trials huggingface dataset:
Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma

To evaluate the efficacy and toxicity of Nimotuzumab combined with VMAT in the treatment of elderly patients with nasopharyngeal carcinoma (\> 70 years old), and to provide high-level clinical evidence for the optimal treatment of elderly patients with nasopharyngeal carcinoma.

The incidence of elderly patients with nasopharyngeal carcinoma is increasing with a rapidly ageing population. However, the prognosis is worse than that of young patients. Some patients can benefit from intensive treatment such as concurrent chemoradiotherapy, but are always with obvious toxicity. With the advancement of radiotherapy technology and the emergence of molecular targeted drugs, radiotherapy combined with Nimotuzumab has shown good therapeutic efficacy and tolerance. The investigators plan to testify VMAT combined with Nimotuzumab in elderly patients with nasopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathology confirmed squamous cell carcinoma of nasopharynx; Aged ≥ 70 years old; Stage III-IVB diseases according to 8th AJCC Staging; Treatment for the first time; ECOG scores ≤ 1; Normal hepatic, renal and bone-marrow function; ACE-27 scores ≤2; Life expectancy≥12 weeks; Can understand and sign the consent.

Exclusion Criteria:

* Past malignancies history (except for non-melanoma skin cancer or cervical carcinoma in situ or cured prostate cancer of early stage); Allergic to Nimotuzumab; Severe comorbidities including cardiovascular, cerebral vascular, mental and uncontrolled diabetes disease; Chemotherapy, surgery or other molecule-target treatment; Severe malnutrition.
Comparison of 3 RF Delivery Modes of the QDOT Catheter for Paroxymal Atrial Fibrillation (AF) Ablation

Pulmonary vein isolation is the main treatment of paroxysmal and persistent atrial fibrillation.

The aim of our study is to prospectively compare the efficacy and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions

Pulmonary vein isolation (PVI) is the main treatment of paroxysmal and persistant atrial fibrillation.

PVI is achieved by point-by-point radiofrequency ablation that creates flexible lesion set within targeted area.

PVI using standard ablation catheter with limited power (50W) have been described in case series with favorable efficacy and safety.

QDOTMicro™ is a radiofrequency ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.

QDOT Micro™ provides several options regarding radiofrequency administration :

* Q-MODE : provides high power short duration (HPSD) unitl 50W radiofrequency,
* Q-MODE+ : provides very high power very short duration (vHSPD) until 90W radiofrequency,
* Hybrid Q-MODE/Q-MODE+ : is a combination of two methods. In our experience, stability is a prerequisite for PVI with QDOT Micro™.

Small series have described encouraging results (85% isolation, unpublished data) with stabilization tools such as low-volume ventilation or apnea, high-rate simualtion, Vizigo bi-directional sheath (Vizigo™).

Recently, preliminary animal data argue in favor or reducing the interpoint distance with QDOT™.

To date, there is no study comparing the 3 options of radiofrequency delivery. The aim of our study is to prospectively compare the efficacity and safety of the 3 options of radiofrequency delivery with QDOT Micro™, with systematic use of catheter stabilization tools and tighter lesions.

The same device is used in all three randomisation groups. The difference between the intervention is the intensity of the radiofrequency applied.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* First atrial fibrillation ablation
* Paroxysmal atrial fibillation defined as atrial fibrillation lasting less than 48 hours
* Early atrial fibrillation defined as atrial fibrillation lastiing between 7 days and 3 months
* At least one episode of atrial fibrillation in the year preceding study entry
* Patient affiliated to a health insurance

Exclusion Criteria:

* History of atrial fibrillation ablation (surgery or catheter)
* Documented left atrial thrombus
* Left atrial (LA) diameter \> 60mm / LA area \> 35cm2 / Left atrial volulme index (LAVI) \> 45ml/m2
* N/STEMI replacement or angioplasty or valve within 3 months prior to registration
* Any contraindication mentioned in the instructions for use of the QDOT MICRO™ bidirectional navigation catheter
* Patient unable to understand study information
* Patient deprived of liberty by judicial or administrative decision
U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia

Administration of opioids for the treatment of acute pain after open umbilical hernia repair is associated with many side effects. Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region.TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen.

TAP block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique and decreases postoperative pain and opioid consumption.

Erector spinae plane (ESP) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region. However, its first use was for the treatment of chronic pain, but recently it has been used as a postoperative regional analgesia technique in different surgeries from the shoulder to hip regions (3-4) The present study will be carried out to compare the preemptive analgesic efficacy between the ultrasound-guided bilateral ESP block versus bilateral oblique subcostal TAP block on patients undergoing open umbilical hernia repair.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of anesthesiologists I-II, scheduled for open umbilical hernia repair.
2. Age range of 18-65 years.

Exclusion Criteria:

1. patient refusal.
2. Patients belonging to ASA grade III and grade IV.
3. Extreme obesity (BMI \>35).
4. hepatic or renal insufficiency.
5. preoperative cognitive dysfunction or communication disorder.
6. allergy to amide-type local anaesthetics.
7. back puncture site infection.
8. Coagulation disorders, pregnancy, drug abusers.
Risk Factors of Minor Head Injury

Introduction and Aims:

The objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.

Minor head injury (MHI)is one of the most common diagnoses in emergency rooms and traumatological outpatient departments. The aim of this study is to find clear evidence which risk factors are the most important in MHI patients to develop intracranial bleeding. We hypothetize that anticoagulation is one of the main risk factors for intracranial bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Minor head injury, dizziness, nausea, vomiting

Exclusion Criteria:

* no injury to the head
A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant

This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Must have understood and voluntarily signed the Informed Consent Form (ICF)
2. Age ≥ 18 years at the time of signing the ICF
3. Newly diagnosed with multiple myeloma
4. Must not be eligible for transplant
5. Will be treated with a first-line lenalidomide-containing or nonlenalidomide-containing regimen, or currently is being treated with a first-line regimen and has received less than 2 cycles.

Exclusion Criteria:

1. Prior treatment for Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line Multiple myeloma (MM) therapy.
2. Prior treatment with lenalidomide, thalidomide, or pomalidomide or any agent considered to be a first-line MM therapy through clinical trial participation or patient access program
3. Two or more complete cycles of first-line therapy or any agent considered to be a firstline MM therapy for newly diagnosed multiple myeloma (NDMM) treatment before study enrollment
4. Refusal to participate in the Revlimid Transplant noneligible (TNE) Newly diagnosed multiple myeloma (NDMM) Post-authorization safety study (PASS) or current participation in the treatment phase of an interventional clinical trial.
Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer

Dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. The two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. This study is exploring the response to chemotherapy when these drugs are given every 14 days. In addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.

All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance.

The target enrollment is 45 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;
* IIIA: T1-3 N2 M0, T3 N1 M0
* IIIB: T4 N0-2 M0, T 1-4 N3 M0
* Measurable or evaluable disease
* Previously untreated with chemotherapy or radiotherapy for lung cancer;
* No brain metastases;
* No prior XRT
* Performance status 0-2
* ≥18 years of age
* Informed Consent
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelets ≥ 100 x 109/L
* Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)
* SGOT and SGPT ≤ 2.5 x ULN for the institution
* Creatinine ≤ 1.6 mg/dL
* Hemoglobin ≥ 8.0 g/dL
* Peripheral neuropathy ≤ grade 1

Exclusion Criteria:

* Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);
* Use of IV systemic antibiotics within 72 hours prior to chemotherapy;
* Known HIV infection
* Lithium or cytokines within 2 weeks prior of entry
* Additional concurrent investigational drugs
* History of myelodysplastic syndrome
* Pregnant, nursing or having unprotected sex
* Not available for follow-up assessment
* Unable to comply with protocol procedures
* Illnesses that may compromise ability to give informed consent.
* Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers

The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.

In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs) and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID).

The existence of an AID indicates a lack of Tregs. Our team has discovered that low-dose interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may improve AID. Exploiting this potential requires i) to better target the dose with the best benefit / risk ratio and also ii) to better understand the mechanism of action of this molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes, multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very thorough immunological follow-up is carried out in order to discover biomarkers of treatment efficacy. Exploitation of these results will benefit both the cross-analysis of the effects of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it possible to define the most effective dose of IL-2.

Eligibility Criteria:
Inclusion Criteria:

* Without any chronic diseases diagnosed (including allergies);
* Effective contraception\> 2 weeks before the first administration of the experimental drug or its placebo and β-hCG negative at the verification of the selection criteria;
* Affiliated to a social security system;
* Free, informed and written consent, signed by the subject and the investigator, before any action required by the research.
* Not taking any treatment

Exclusion Criteria:

* Subject in a period of exclusion of participation in other biomedical research;
* Participation in another research ≤ 1 month and during the study except for research Transimmunom (Non-interventional research involving the human person);
* known antecedents of autoimmune diseases;
* Hypersensitivity to any of the excipients of the investigational drug (mannitol, sodium laurilsulfate, monosodium phosphate dihydrate, disodium phosphate dihydrate);
* Evolutionary infection requiring treatment;
* Viral infection and benign infection less than 2 months old;
* Venous capital not allowing blood samples;
* Pregnant or lactating women;
* Men and women of childbearing potential without effective contraception during the study;
* Live attenuated virus vaccination in the month prior to inclusion or during the study;
* Surgical intervention ≤ 2 months or planned during the study;
* Psychiatric pathology or drug addiction that may impair ability to comply with protocol requirements or give informed consent;
* Presence or history of cancer that has not been cured for less than 5 years, except in situ cervical cancer, or basocellular cancer;
* Subject under a legal protection measure.
Application of "I-Anticoagulation"in Patients With Atrial Fibrillation

The goal of this prospective, multicenter, cluster randomized controlled trial is to assess the effectiveness of a shared decision-making tool, "I-Anticoagulation", for anticoagulation management in AF patients. The main questions it aims to answer are:

* whether "I-Anticoagulation" could help improve the rational use of anticoagulants in AF patients;
* whether "I-Anticoagulation" could help increase the adherence and satisfaction of AF patients receiving anticoagulants.

The anticoagulation therapy of AF patients will be determined by clinicians with the use of "I-Anticoagulation", and AF patients will be managed using "I-Anticoagulation" during their anticoagulation therapy.

Researchers will compare the outcomes with the control group, in which patients with AF will receive standard care.


Eligibility Criteria:
Inclusion Criteria:

* patients who are 18 years or older and have received a new diagnosis of paroxysmal, persistent, or permanent AF confirmed by electrocardiogram (ECG) or 24-hour Holter monitors
* must be willing to participate in the study and sign the informed consent

Exclusion Criteria:

* those who are pregnant
* those whohave experienced therapeutic or subtherapeutic bleeding complications in the last 6 months
* those who have severe renal insufficiency (creatinine clearance rate, CrCl ≤ 20 ml/min)
* those who have severe hepatic insufficiency (Child-Pugh ≥ 10 points)
* those who have severe heart failure (cardiac function New York Heart Association, NYHA grade IV and above)
* those who have severe infection and respiratory failure
* those who are unable to comply with the study requirements.
Steroid-induced Diabetes Mellitus in Systemic Lupus Erythematosus (SLE) Patients

The aim of the study is to determine the prevalence of steroid-induced diabetes mellitus (SDM) among systemic lupus erythematosus (SLE) patients and identify and assess the associated risk factors .

120 SLE patients who attend the SLE and Rheumatology Clinic will be recruited into the study. All patients need to fulfil at least four criteria from the American College of Rheumatology Classification Criteria for SLE 1997(28). All patients need to be receiving corticosteroid therapy. SDM cases is defined as the development of DM after commencement of steroid treatment. Prevalent cases of SDM will also be included in the study.

Diagnosis of DM will be made according to the American Diabetes Association(29), that is fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5 or 2-h plasma glucose ≥ 11.1 mmol/L during an oral glucose tolerance test (OGTT). SLE patients who receive corticosteroids treatment will be screened with fasting blood sugar during out-patient clinic visit. If fasting blood glucose level is high , an additional HbA1C or OGTT will be performed.

All patients included in this study will be subjected to:

1. Full history taking: including age, sex, duration of the SLE disease , age at onset of symptoms of SLE, the progression of disease, type of corticosteroid used, dosage, duration of treatment and other types of drugs used, presence of hypertension, dyslipidemia, smoking.
2. Complete clinical examination: A standardized physical examination will be performed in all patients to measure blood pressure, waist circumference and body mass index.
3. Laboratory investigations:

   * Fasting plasma glucose.
   * HbA1c.
   * 2-h plasma glucose.
   * Total cholesterol, triglyceride, low density lipoprotein (LDL) and high density lipoprotein (HDL) levels.

Eligibility Criteria:
Inclusion criteria

* Both males and females
* Patients aged of 18-75 years.
* Clinically diagnosed as SLE patients.
* Receiving corticosteroid therapy.
* Prevalent cases of SDM with SLE.

Exclusion criteria

* SLE patients who do not receive corticosteroid therapy.
* SLE patients with other types of diabetes mellitus.
Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy

Patients being treated with non-invasive home mechanical ventilation (NIV) may experience morning dyspnea after each night of NIV use, when the therapy is abruptly ended. This study aims to show that dyspnea intensity can be significantly reduced by a gentle NIV therapy end, delivered by a continuously decreasing pressure level (inverse pressure ramp) after therapy end in the morning, a feature called softSTOPP, which can configured in prismaVENT NIV devices. This could also improve therapy adherence.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency
* Therapy with prismaVENT 30, firmware V 3.3 or higher, mode S/T, stable device settings at the time of inclusion without need to adapt ventilation parameters
* May have co-existing obstructive sleep apnea syndrome
* Subjective dyspnea ≥3 (Borg scale) after end of ventilation therapy in the morning
* Written informed consent for study participation including data protection

Exclusion Criteria:

* Missing written informed consent for study participation including data protection
* Contraindication for positive airway pressure therapy
* Use of the softSTOPP feature before study inclusion
* Participation in another study, which influences NIV therapy by defining device settings or titration
* Concomitant oxygen therapy
Phase I/II Study of Fractionated Stereotactic Radiotherapy for Early Stage Non-Small Cell Lung Cancer

A new type of treatment called stereotactic radiotherapy has recently been developed in hopes of improving the success of the treatment and improving the convenience to patients, while reducing the side effects. This study is developing stereotactic radiotherapy as a state-of-the-art treatment for lung cancer patients.

OBJECTIVES:

Primary Objectives

* To determine the efficacy of hypofractionated, image guided radiotherapy in treating patients with lung tumours, with the primary outcome being local control at one year.
* To determine the toxicity of high dose, small field,hypofractionated radiotherapy to the lung, based on the RTOG and CTCAE scales.

Eligibility Criteria:
Inclusion Criteria:

* T1-T3N0 non-small cell lung cancer (maximum dimensions of 5cm, T3 by chestwall involvement only)
* Medically inoperable due to co-morbid conditions or patient preference for radiation
* adequate pulmonary function to withstand radical treatment (ie. FEV1 greater than 40% of predicted), as assessed by consulting radiation oncologist
* age greater than or equal to 18, and Karnofsky performance status greater than of equal to 70

Exclusion Criteria:

* Presence of mediastinal metastases or distant metastases
* Life expectancy less than 1 year due to other co-morbid conditions
To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees

This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment. The use of the Point Partial outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.


Eligibility Criteria:
Inclusion Criteria:

* Partial finger amputees with partial absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
* Fluent in English
* Individuals aged 18 or greater
* Patients may present with either fused or mobile MCP joints.

Exclusion Criteria:

* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon OT evaluation
* Serious uncontrolled medical problems as judged by the project therapist.