cyrilzakka/clinical-trials huggingface dataset:
Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer

Study will deteremine the MTD and evaluate the safety profile of oral lenalidomide on days 1-14 when combined with pemetrexed on day 1 of a 21 days cycle. Subjects will continue on study until documention of disease progression.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must understand and voluntarily sign an informed consent document.
2. Age \>or= 18 years at the time of signing informed consent form.
3. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
4. Histological or cytologic documentation of advanced NSCLC.
5. Radiographic or clinical evidence of measurable advanced NSCLC. Subjects must have measurable disease at least 2 cm in diameter.
6. Subjects must have been treated and progressed following chemotherapy.
7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

   1. Absolute neutrophil count (ANC) \<1,500 cells/mm3 (1.5 x 109/L)
   2. Platelet count \<100,000 cells/mm3 (100 x 109/L)
   3. Serum creatinine \>1.5 mg/dL (133 mmol/L)
   4. Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
   5. Serum total bilirubin \>or = 1.5 mg/dL (26 mmol/L)
2. Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
3. Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for \> 1 year.
4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
5. More than one prior chemotherapy for advanced NSCLC.
6. Concurrent use of any other anti-cancer agents.
7. Any prior use of lenalidomide.
8. Pregnant or lactating females.
9. Prior \> or = to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
10. Prior \> or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
11. Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
12. Known Hepatitis C.
An Evaluation of a New Nonverbal Treatment for Global Aphasia

People with global aphasia (PwGA) post stroke have little to no meaningful communication abilities (ie limited comprehension, spoken language, reading and writing abilities).A proportion of PwGA will also have limited abilities to use any alternative means of communication e.g. gesture, pictures or computer devices. There is a suggestion in the literature that this is because of co-occurring cognitive deficits. The consequence is that these clients are unable to reliably communicate even their basic needs.This is commonly known as having no functional communication abilities. Such PwGA tend not to respond to standard speech and language therapy interventions.

This research will investigate the effect of a new cognitive intervention designed to improve basic functional communication abilities. The treatment will be nonverbal and involve computer and paperbased tasks ordered hierarchically from basic to more complex tasks. Six to eight participants will take part. All their sessions will take place in their own home. For some this may be a care home. They will first complete a diagnostic communication assessment in order for baseline abilities to be established. Further formal language and cognitive assessments will be conducted over a period of 6 weeks. A relative/friend will complete a questionnaires about mood/communication. The PwGA will also be videoed interacting with the research student e.g. looking at a magazine, completing a jigsaw, answering questions and making choices non-verbally.

The participants then receive the new intervention 3 times a week for 6 consecutive weeks. All intervention sessions will be videoed. Then participants will be reassessed over 2 weeks using the same assessments as prior to the intervention. The questionnaire with their relative/friend and videoed activity session will also be repeated. After a twelve week break the participant will be videoed interacting with the research student complete some of the assessments again and their relative will re-complete the questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* have global aphasia as diagnosed by an SLT
* have little or no verbal output
* inconsistent single word comprehension
* little or no ability to read or write
* little or no ability to use alternative modes of communication
* Little or no ability to make choices in function
* no diagnosis/history of a progressive neurological condition
* no diagnosis of hearing loss
* no diagnosis/history of a mental health condition
* English as a first language

Exclusion Criteria:

* has another form of aphasia
* is able to consistently express basic needs non-verbally or verbally.
* is able to participate in communicative interaction with a familiar other
* has a history of a progressive neurological condition
* has hearing loss
* has a diagnosis/history of a mental health condition
* does not have English as a first language.
A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)

The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.


Eligibility Criteria:
Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

* Participants with neuropsychiatric disorder.
* Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine

Duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. There are few studies examining its effect for acute pain. The objective of this study is to evaluate the analgesic effect of duloxetine combined with intrathecal morphine for patients subjected to major abdominal cancer surgery


Eligibility Criteria:
Inclusion Criteria:

* adult patients, subjected to major abdominal cancer surgery

Exclusion Criteria:

* patients on chronic opioid therapy
* patients allergic to study drugs (duloxetine+morphine)
* patients have uncontrolled hypertension and or ischemic heart disease
Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children

The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.

Long-bone fractures are a very common complain for visits in paediatric emergency departments. Since these fractures are often very painful, morphine is considered the cornerstone treatment in case of severe pain. Very few data are available concerning the assessment of analgesic treatment in this condition. In our previous study, less than 50% of patients with a limb fracture had a Visual Analog Scale (VAS) ≤ 30 mm after morphine administration. Thus, one study make the hypothesis that the use of a combination of morphine and/or paracetamol and/or NSAID could be an effective and safe option for the treatment of pain due to long bone fractures. We undertake to compare different combinations of paracetamol and ibuprofen with morphine to determine the efficacy and safety of these strategies in emergency department paediatric patients with acute traumatic limb pain.

The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.

Second objectives are

* to compare the long term analgesic efficacy of 4 analgesic regimens a)ibuprofen/morphine, b)paracetamol/morphine, c)ibuprofen/paracetamol/morphine and d)morphine for long bone fracture management in the paediatric emergency department.
* To assess the tolerance of these 4 regimens.

The study is considered as a success if children 2-6 years (6 years included) have a pain score Evendol \< 5 and children 7-17 years (17 years included) have a pain score assessed by Visual Analog Scale (VAS) ≤ 30 without additional analgesic treatment 30 minutes after drug administration.

Eligibility Criteria:
Inclusion Criteria:

* children aged 2 through 17 years (17 years included)
* suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department)
* within the first 12 hours after the injury
* at least one signed parental informed consent
* affiliated to health insurance

Exclusion Criteria:

* analgesic treatment within the 6 hours before inclusion
* contraindication to one of the experimental drug: Paracetamol or Ibuprofen
* contraindication to Morphine
* cognitive impairment
* multiple injuries
* resuscitation manœuvres
* suspected femur fracture
* open fracture
* pregnant women in the third trimester
Identification of Hematological Malignancies and Therapy Predication Using microRNAs as a Diagnostic Tool

MiRNAs are small (\~19-25 nucleotides) non-coding RNA molecules that bind to mRNA in a sequence-specific manner. MiRNAs regulate gene expression at the post-transcriptional level. MiRNAs regulate critical cell processes such as metabolism, apoptosis, development, cell cycle, hematopoietic differentiation and have been implicated in the development and progression of several types of cancers, including hematological malignancies. Over-expression, amplification and/or deletion of miRNAs and miRNA-mediated modification of epigenetic silencing can all lead to oncogenic pathways.

Hematologic cancers, which are caused by the malignant transformation of bone marrow cells and the lymphatic system, are usually divided into three major clusters: leukemia, lymphoma, and multiple myeloma. To date, some of the hematological malignancies are very aggressive that early diagnosis is essential for improving prognosis and increasing survival rates. However, current diagnostic methods have various limitations, such as insufficient sensitivity, specificity, it is also time-consuming, costly, and requires a high level of expertise, which limits its application in clinical contexts. Thus, development of new biomarkers for the early detection and relapse of hematological malignancies is desirable.

Some of the innate properties of miRNAs make them highly attractive as potential biomarkers. MiRNAs can be readily detected in small volume samples using specific and sensitive quantitative real-time PCR; they have been isolated from most body fluids, including serum, plasma, urine, saliva, tears and semen and are known to circulate in a highly stable, cell-free form. They are highly conserved between species, allowing the use of animal models of disease for pre-clinical studies. Furthermore, tumor cells have been shown to release miRNAs into the circulation and profiles of miRNAs are altered in the plasma and/or serum of patients with cancer. A growing number of publications confirm that miRNAs can be a useful biomarker for hematological malignancies diagnosis and progression.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnose patients with: Diffused large B cell lymphoma, Follicular lymphoma, Multiple myeloma and Hodgkin lymphoma.
* Patients after chemotherapy (5-30 days).
* Above age 18.

Exclusion Criteria:

* Non-HIV/HCV/HBV Below age 18.
To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c

This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
* Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
* OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
* Body Mass Index (BMI) less than or equal to 45 kg/m\^2

Exclusion Criteria:

* Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
* Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
* Any serious medical condition
Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Subject has mild to moderate hypertension

Exclusion Criteria:

* History of secondary hypertension
Pro-active Monitoring of Vital Signs in Oncology Patients Using a Smartwatch

The goal of this single center prospective observational study is to determine the effect of chemotherapy on (the change in) vital parameters. The main question it aims to answer are: Can changes in vital parameters be measured by using a Fitbit in patients with cancer while undergoing chemotherapy. Participants will be asked to wear a Fitbit for the first two cycles of chemotherapy to evaluate the changes in vital parameters.

The goal of this single center prospective observational study is to determine the effect of chemotherapy on (the change in) vital parameters. The main question it aims to answer are: Can changes in vital parameters be measured by using a Fitbit in patients with cancer while undergoing chemotherapy. Participants will be asked to wear a Fitbit for the first two cycles of chemotherapy to evaluate the changes in vital parameters. Patients will start measuring in the week prior to the first cycle of chemotherapy, target is at least 4 to 7 days before initiation of chemotherapy. Patients were the Fitbit as much as possible, during day and night. Patients continuously carry the Fitbit during the first 3 months of systemic treatment, which tracks their vital signs. At the starting day of the next cycle of chemotherapy patients will have an appointment with one of the researchers to evaluate the use of the Fitbit. Furthermore, it will be checked if a patient has returned to their baseline vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Diagnosis of stomach or esophageal cancer with an indication of starting chemotherapy
* Knowledge how to handle a Fitbit
* Mastery of Dutch language
* Able and willing to give written informed consent

Exclusion Criteria:

* Cognitive disorders or severe emotional instability
* Already participating in an exercise trial
Anterior Insula Regulation and Pain Empathy

The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts pain empathy.

In the present study, investigators plan to use the real-time fMRI neurofeedback to train healthy subjects to learn volitional control over their own anterior insula (AI) activity. Then the effect of AI regulation will assessed by examining subjects' empathic responses and functional connectivity changes. Subjects were separated into two groups randomly. While the experimental group received specific neurofeedback from their own AI, the control group received sham NF from an unspecific region.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* pregnancy;
* medical or psychiatric illness.
Structural and Functional Brain Reorganization in Neuropathic Pain. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic

Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).

This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity and reorganization of brain activity.

Previous studies in functional neuroimaging have focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally.

The objective of this study is to understand the brain dysfunction that induces allodynic pain considering the deafferentation of each patient and possible cortical losses.


Eligibility Criteria:
Inclusion Criteria:

* with neuropathic pain
* in the case of central lesions, the lesion must be unique and small
* treatment not stable opioid for one week
* consent signed

Exclusion Criteria:

* severe psychiatric history
* presence of an evolutive lesion, expansive, cancerous or tumorous underlying
* patient needing of opioid therapy
* contraindication at MRI scan
Gastric Sonography in the Fasted Term Pregnant Patient for Elective Cesarean Delivery

Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. In pregnant patients scheduled for elective surgery, standard preoperative guidelines apply as the general non-pregnant surgical population (8-hour fasting of solid food and 2-hour fasting of clear fluids). A bedside ultrasound assessment of the status of the gastric content and volume would be of great value for the clinician. This technique has recently been shown very promising in fasted non-pregnant patients scheduled for elective surgery. Therefore, it is important to study its feasibility in the pregnant population scheduled for elective Cesarean Delivery.

The investigators hypothesize that no residual solid contents will be found in the gastric sonography, and a small volume of gastric fluid will be observed in the antrum in both supine and right lateral decubitus.

The aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted pregnant undergoing elective Cesarean delivery.

The investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective Cesarean delivery after standard preoperative fasting guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Non-labouring pregnant women at term (≥ 36 weeks)
* 18 years or older
* ASA Physical Status I-III
* 50-120 kg of weight
* 150 cm of height or taller
* Ability to understand the rationale of the study assessments and to provide signed informed consent
* Written informed consent

Exclusion Criteria:

* Known pre-existing abnormal anatomy of the upper gastrointestinal tract
* History of upper GI tract surgical procedure
Silicone Gel Vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause

The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is:

- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care?

Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Confirmed postmenopausal age
* Diagnosed genitourinary syndrome of menopause
* Access to a smartphone, tablet or computer, and to a functional email address.

Exclusion Criteria:

* Contraindication for the use of estrogen therapy
* Unable to provide informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products
Neuromodulation Techniques in the Treatment of Chronic Tinnitus With Hearing Loss

This study aimed at trying transcranial magnetic stimulation and transcranial direct current stimulation as potential treatments to decrease tinnitus in patients with significant hearing loss.

Tinnitus is a very common condition and affects approximately 15% of the population, disrupting sleep, emotional balance and social life of the patients. Acoustic deprivation causes hearing loss and is responsible for a cascade of processes that result in the reorganization of the cortex through a synchronization of neuronal activity related to a cortical re-mapping. Consistent with the hypothesis that tinnitus is caused by abnormal activation of the auditory cortex, repetitive transcranial magnetic stimulation (rTMS) can temporarily reduce cortical hyperactivity through direct neuromodulation of the temporal cortex. Furthermore, studies have shown that transcranial direct current stimulation (tDCS) can also suppress tinnitus. Objective: To determine the effectiveness of rTMS and TDCS in the treatment of patients with chronic tinnitus and auditory loss. Methods: We performed an analytical experimental double-blind study using rTMS and tDCS in patients with chronic tinnitus and hearing loss.

Eligibility Criteria:
Inclusion Criteria:

* chronic tinnitus
* hearing loss

Exclusion Criteria:

* neurological diseases
* use of drugs affecting the central nervous system
* evidence of dementia
* clinical diagnosis of depression
Study of Antibiotic Utilization Measures and Control of ESBLs in China

A single-center, prospective, comparative, antibiotic intervention study for patients admitted to MICU1 and MICU2

1. To determine the value of using β-lactamases inhibitors in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection after 12 months.
2. To compare the acquisition rates of ESBL producing E. coli or K. pneumoniae at MICU1 and MICU2 after 12 months

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted or transferred to the ICU/burn units.
* Patients of either sex, 18 years of age or older.

Exclusion Criteria:

* Patient with hypersensitivity to penicillins, cephalosporins, and beta-lactamase inhibitors.