cyrilzakka/clinical-trials huggingface dataset:
Non-interventional Study of Lenalidomide / Dexamethasone as First Line Therapy in Patients With Multiple Myeloma

The objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.

The introduction of new drugs that can be differently combined with conventional chemotherapy or low-dose dexamethasone has changed substantially the treatment paradigm for patients with multiple myeloma. A variety of treatment options is now available for elderly patients. To compare the efficacy and safety of continuous lenalidomide in combination with low-dose dexamethasone (Rd) until progression vs. Rd for 18 cycles/72 weeks (Rd18) vs. melphalan, prednisone and thalidomide (MPT) for 12 cycles/72 weeks a multicenter, open-label phase III study (MM-020/IFM 07-01, FIRST trial) was performed in transplant ineligible patients.

After market approval of lenalidomide for previously untreated transplant-ineligible patients with multiple myeloma, the purpose of the FIRST-NIS is to evaluate the safety, effectiveness and quality of life of lenalidomide in combination with dexamethasone as first line treatment of multiple myeloma in a real life setting.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma (2008 WHO classification) requiring treatment (as defined by IMWG)
* Indication for treatment as assessed by the treating physician
* Decision for first line combination therapy with lenalidomide and low-dose dexamethasone
* No previous systemic therapy for multiple myeloma
* Ineligibility for transplantation
* Aged 18 years or older
* Written informed consent signed
* The conditions of the risk management plan/pregnancy prevention program (refer to the SmPC Revlimid®) must be followed by female and male patients
* Other criteria according to the SmPC. Special warnings and precautions of the SmPC have to be considered by the treating physician

Exclusion Criteria:

* Pregnant or breast-feeding women
* Any objections or contraindications according to the SmPC
Molecular Mechanisms of the Development of Precancerous and Cancerous Lesions of the Oral Cavity

The aim of this study was to examine molecular alterations on the protein level in lesions of oral lichen planus (OLP), oral squamous cell carcinoma (OSCC) and healthy mucosa. Global protein profiling methods based on liquid chromatography coupled to mass spectrometry were used, with a special emphasis on evaluation of deregulated extracellular matrix molecules expression, as well as on analyses of insulin-like growtg factor 2 (IG2F) and insulin-like growth factor 2 receptor (IGFR2) expression in healthy mucosa, OLP and OSCC tissues by comparative semiquantitative immunohistochemistry.

Mass spectrometry based proteomics profiling of healthy mucosa, OLP and OSCC tissues (and accompanied histologically unaltered tissues, respectively) identified 55 extracellular matrix proteins. Twenty among identified proteins were common to all groups of samples. Statistically significant difference between final IGF2 and IGF2R IRS scores in favour to IGF2R may further corroborate the IG2FR antitumor role in OLP and OSCC where it acts as a negative regulator of IGF2 activity.

Although OLP is categorised as a precancerous condition associated with a significantly increased risk of oral cancer, molecular pathophysiology of OLP and its potential for malignant transformation in OSCC are poorly understood and remain controversial. Development of new analytical methods enhances research in the field of malignant disorders. Identification of novel biomarkers help in the diagnostic process, pre-symptomatic interventions or prediction of treatment response. Proteomics based on mass spectrometry enables analysis of novel, putative biomarkers. In this study, proteomics was used to analyse in more details extracellular matrix (ECM) proteins and proteins related to ECM signalization which have a well-established role in malignant transformation and invasion of tumor cells.

IGF2 and IGF2R are known biomarkers in cellular metabolism,but their role in oral precancerous lesions, namely oral lichen planus (OLP) as well as in oral squamous cell carcinoma (OSCC) has not been explored so far. The second aim of our study was to analyse IG2F and IGFR2 expression in oral lichen planus and oral squamous cell carcinoma tissues by comparative semiquantitative immunohistochemistry

Eligibility Criteria:
Inclusion Criteria:

* histopathologically confirmed oral lichen planus and oral squamous cell carcinoma
* healthy volunteers referred for alveolotomy

Exclusion Criteria:

* non-consent patients
* previously treated OSCC
* patients under immunosuppressive therapy
Transmagnetic Stimulation Pilot in Primary Progressive Aphasia

Frontotemporal degeneration (FTD) is a non-Alzheimer's dementia that is the 2nd most common cause of dementia in the United States. FTD may present with focal language symptoms that are clinically described as primary progressive aphasia (PPA). There are two types of PPA associated with FTD-semantic variant primary progressive aphasia (SV-PPA) and nonfluent/agrammatic variant primary progressive aphasia (NFV-PPA). Both diseases are progressive neurodegenerative disease processes that compromise dominant hemisphere large scale brain network function, ultimately resulting in mutism. There are currently no FDA-approved treatments for PPA and management is mostly supportive. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with PPA. In our prior studies of Alzheimer's disease (AD) and Lewy body Dementia (LBD) subjects, investigators have determined that the anterior temporal pole (area TGd and TGv) is an area that is commonly dysfunctional in dementia. The investigators have already embarked upon an fMRI guided study of iTBS in early stage Alzheimer's disease where subjects received a series of 5 treatments to distinct brain regions inclusive of area TGd. The investigators propose a case study of 3 PPA studies where rs-fMRI is applied to the large-scale language networks.


Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of NFV-PPA and SV-PPA based on criteria (Gorno-Tempini et al., 2011)
2. Prior brain imaging performed
3. Mini Mental Status Exam (MMSE)\>10
4. Subjects are between 40-90 years of age

Exclusion Criteria:

1. Non-FTD dementia including, but not limited to Alzheimer's, disease, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
2. Inability to tolerate rs-fMRI
3. Contraindication of rs-fMRI due to implants or metal
4. Seizure disorder
Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System.

Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic monitoring are under-utilized when translating research into decision support. Current medical informatic capabilities can be leveraged to calculate trends in measured parameters to initiate a paradigm shift in critical care from reaction-based treatment to proactive and plausibly preventative care. Therefore, the purpose of this study is to develop baseline understanding of our practice and how data collection utilizing a newly implemented system called T3. We would like to retrospectively review mechanically ventilated patients in which we have collected continuous data to test a newly developed analytic platform. Additionally we would like to compare these results to our standards of practice established by clinical practice guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Patient selection will be determined by available data collected in the T3 system. We estimate 50 patients in which mechanical ventilator data has been collected utilizing the limited intellibridge modules (4 systems currently available to collect ventilator data).

Exclusion Criteria:

* Patient not connected to T3 data collection system.
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease

This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as monotherapy is safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria

1. Clinical diagnosis of autosomal dominant polycystic kidney disease ADPKD
2. Chronic kidney disease (CKD) stage II / III
3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion Criteria

1. ADPKD patients with normal renal function
2. ADPKD patients with CKD stage IV
3. Patients with a history of subarachnoid bleeding
4. Patients with a history of severe infections
5. Patients with life-threatening urinary tract or cyst infection in the past
6. Patients who have received any investigational drug within four weeks prior to baseline
7. Patients who have been treated with any non-protocol immunosuppressive drug or treatment within one month prior to baseline

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome

Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old.
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

Exclusion Criteria:

* Best far corrected visual acuity \< 1/10
* Severe blepharitis
* Severe Dry Eye
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease

The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Age 40 - 75
3. Ambulatory with or without assistance
4. Hoehn and Yahr Scale score of 1 - 3
5. Patient able to consent and comply with protocol requirements
6. Abstention from use of Coenzyme Q10, vitamin E, Azilect and Idebenone two weeks prior to enrollment and during course of treatment with EPI-743

Exclusion Criteria:

1. Allergy to EPI-743 or sesame oil
2. Allergy to vitamin E
3. Clinical history of bleeding or abnormal baseline PT/PTT
4. Diagnosis of any other neurologic disease
5. Malignancy within past two years
6. Pregnant or plans to become pregnant
7. Concomitant ophthalmologic disease
8. History of stroke
9. History of brain surgery
10. Inability to undergo MRI scan or MRS
11. Hepatic insufficiency with LFTs greater than two times upper limit of normal
12. Renal insufficiency requiring dialysis
13. End stage cardiac failure
14. Fat malabsorption syndromes precluding drug absorption
15. Use of anticoagulant medications, azilect
Heart Rhythm After Intravenous Methylprednisolone Administration

High doses of intravenous (iv.) glucocorticoids (GCs) are commonly used as a treatment for many autoimmune and inflammatory disorders. According to the European Group on Graves' Orbitopathy (EUGOGO) guidelines, intravenous methylprednisolone (IVMP) is an accepted first-line agent for active, moderate-to-severe and very severe Graves' orbitopathy (GO). This treatment is proven to be more efficient and safer than oral GCs. However, some patients may experience adverse cardiovascular effects during the administration of iv. GCs, which in rare cases may even be fatal. There are limited data, mostly obtained from case reports, reporting the occurrence of cardiac arrhythmias, acute myocardial infarction or heart failure. Increased heart rhythm (HR) has drawn attention of researchers as a possible adverse effect correlated with IVMP. During this study, investigators performed 72-hours of Holter ECG and ambulatory blood pressure monitoring (ABPM) to evaluate the impact of IVMP on patients with moderate-to-severe GO, concerning HR and blood pressure (BP) changes. In order to elucidate possible mechanism of observed changes, researchers investigated the level of potassium in serum and urine and catecholamines (epinephrine, norepinephrine) in serum. All patients were treated routinely according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines active, moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).

The clinical status of patients was evaluated before each pulse, including blood pressure monitoring, glucose level monitoring and symptoms of infection. HR and BP was measured continuously for 3 consecutive days (the day before, the day of IVMP and the day after IVMP) during 1st, 6th and 12th IVMP pulse, using 24-hour Holter ECG and ABMP. Serum laboratory tests for potassium, epinephrine and norepinephrine were measured 3 times the day before and the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP. Additionally, urine samples for potassium were collected 5 times the day of first IVMP pulse and 1 time the second and sixth day after 1st IVMP.

Eligibility Criteria:
Inclusion Criteria:

* active, moderate-to-severe GO according to EUGOGO classification
* euthyroidism
* completion of 12 IVMP pulses.

Exclusion Criteria:

* cardiovascular morbidity (such as chronic heart failure and/or coronary heart disease)
* uncontrolled hypertension (defined as systolic blood pressure (SBP) more than 140 mmHg and/or diastolic blood pressure (DBP) more than 90 mmHg)
* contraindications to IVMP therapy
* previous GCs treatment in the last 6 months.
A Web Application to Reduce Heavy Drinking in First-time DWI Offenders

The overall objective of this project is to develop, evaluate, and disseminate a web application for first-time DWI offenders that will provide them with an age-appropriate brief motivational intervention (BMI) to motivate them to reduce their drinking and a cognitive behavioral intervention (CBI) for to help them achieve and maintain abstinence. The goal is to reduce heavy drinking and consequently the risk for future drunk driving.

The specific objectives of this Phase II are:

* Completing the development of the Right Turns prototype based on feedback from the Phase I pilot study participants. This includes: providing more structure and guidance as participants work in the Tool Box section of the program; simplifying the content of the Tool Box; further R\&D in the text messaging feature for 2nd and 3rd tier cellular providers; implement a customized pdf report function for progress reports from the program to users' probation officers (under control of the user); developing a follow-up component and outcome reports; and revising the videos in the Tool Box to reflect greater diversity and a younger population of drinkers.
* Conducting a randomized clinical trial of the program with first time DWI/DUI offenders who are recruited locally, collecting follow-up data, analyzing the data, and reporting the results.


Eligibility Criteria:
Inclusion Criteria:

* be a first-time DWI offender
* have a 5th grade reading level
* has a computer with Internet access at home
* own a cell phone with text messaging

Exclusion Criteria:

* age less than 18
* recent history of uncontrolled psychotic or bipolar behavior
* evidence of significant cognitive impairment from brain dysfunction (e.g., head injury)
Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer

All the preoperative biopsies of patients suffering colorectal cancer (CRC) will be immunohistochemically stained with a pancytokeratin marker to detect Tumor buds. then, the intratumoral buds (ITB) in the densest Region of Tumor buds, namely the "hot spot" will be counted. Subsequently, the probability of N stage (lymphnodes), M stage (metastases) and disease free survival (DFS) will be calculated based on an existing logistic Regression model already developed by our previous retrospective work. Additionally, a Standardisation of ITB using a well- established Software will develop an algorithm which will help to eliminate inter- observer variability of Tumor budding Counts.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed stages I and IV colorectal cancer (CRC)
* Age ≥ 18 years
* Written Informed Consent

Exclusion Criteria:

* No consent
* \< 18 years
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

Staging LaParscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA) study aims to investigate the safety and feasibility of ICG-guided SN retrieval in GC patients undergoing multimodal treatment. The pretreatment clinical variables potentially associated with the procedure will also be analyzed.

To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.

Comprehensive lymph node assessment seems to be critical for proper treatment strategy and survival prediction, particularly in advanced GC. Recent data on the sentinel node (SN) concept in early GC has shown favorable results regarding LN detection rate and clinical status determination. Staging laparoscopy (SL) with lavage cytology provides an additional value to the clinical staging of GC, particularly in detecting occult peritoneal disease. The role of Indocyanine green (ICG) guided SN mapping in GC confirmed its technical feasibility. ICG can be safely used to identify SN, determine the surgical resection line, improve the LN harvest, and reduce noncompliance in patients undergoing D2 lymphadenectomy.

The majority of the studies focused on the aspect of the increase in LN harvest. At the same time, no data exist regarding its potential role in GC nodal staging. To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
3. Stage II - III disease (cT2-4a, N0-3, M0) based on the pretreatment CT and 8th edition of TNM classification
4. Qualification for SL by the decision of the multidisciplinary tumor board
5. Written informed consent for endoscopy and SL

Exclusion Criteria:

1. Early GC (cT1N0-3M0) scheduled for endoscopic treatment by the multidisciplinary tumor board
2. Previous abdominal surgery which could interfere lymphatic basin of the stomach, including previous gastrectomy, endoscopic (sub)mucosal dissection
3. Distant metastasis (cM1) clinically apparent in pretreatment abdominal/pelvic CT
4. Technical inability to perform endoscopic ICG injection or ICG injection beyond the submucosa
5. Visual inability to identify the SN during SL
6. Positive cytology (cyt+) after SL
7. Other malignancies
8. History of allergy to iodine agents
Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

The purpose of this study is to find the highest dose that can be given safely to people who have had liver disease resected. This is a Phase I study. The goal of a phase I study is to find a safe dose range based on side effects. The drugs that will be given by vein are OXALIPLATIN ("Oxali") plus 5-FLUOROURACIL and LEUCOVORIN ("5FU" and "LV"). This is systemic chemotherapy, since it goes to the whole body. The drugs that will be placed in the pump are FLOXURIDINE (FUDR) and DEXAMETHASONE. (The dexamethasone is not an anti-tumor drug; it helps protect healthy liver tissue from possible side effects of the FUDR.) This is the regional chemotherapy, since it goes only to the liver. The researchers have studied these drugs and know the best doses of each when they are used in patients who have not had liver resections. We do not yet know how the drugs work with each other in patients with a liver resection. This study will tell us the best doses of each drug when they are given over the same period of time.


Eligibility Criteria:
Subject Inclusion Criteria:

* History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Confirmation of diagnosis must be performed at MSKCC.
* Potentially completely resectable hepatic metastases without current evidence of other metastatic disease.
* Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to registration. (MRI of abdomen may be substituted for CT of abdomen.)
* Lab values within 14 days prior to registration:
* WBC ≥ 3.0 K/ul
* ANC \>1.5 K/ul
* Platelets ≥ 100 K/ul
* Total bilirubin ≤ 1.5 mg/dl.
* Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study.
* KPS ≥ 60%
* Signed informed consent.

Subject Exclusion Criteria:

* Prior radiation to the liver. (Prior radiation therapy to the pelvis is acceptable if completed at least 4 weeks prior to registration.)
* Active infection, ascites, hepatic encephalopathy
* Prior oxaliplatin or cisplatin or HAI FUDR
* Female patients who are pregnant or lactating
Antibiotic Education for Children in an Emergency Care Unit

The purpose of this study is to determine if a patient education in acute condition about the intake of oral solution antibiotic in children under 6 year-old are effective to improve the satisfaction about the therapeutic education, the knowledge about antibiotics among the patients' families and thereby decrease the misuses of antibiotics.

Adherence to antibiotic regimen for common childhood illnesses, such as otitis media and streptococcal pharyngitis, is related to a variety of outcomes such as illness' remission, prevention of recurrent infections, maintaining of cost-effectiveness, and prevention of the growth of antibiotic-resistance. A patient and family 's therapeutic education about the intake of an oral solution of antibiotic should decrease the misuses of antibiotic, improve the family 's knowledge and the satisfaction of the patient and his family. Those factors are related to the understanding and adherence to the antibiotic prescription.

Eligibility Criteria:
Inclusion Criteria:

* French-speaking patients seen at the emergency department and discharged with a diagnosis of bacterial infections (urinary and respiratory tract infections, streptococcal pharyngitis, acute otitis media) requiring 5 to 10 days of an oral solution of antibiotic.
* Under 6 year-old.
* No opposition of the parents to be included in the study.
* Personal health insurance.

Exclusion Criteria:

* Chronic pathology such as: Sickle cell disease, AIDS.
* Parents with insufficient knowledge of French.
* Family not reachable by phone.
* Antibiotic's suspected allergy.