cyrilzakka/clinical-trials huggingface dataset:
Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy

Therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. In recent years, BRAF and KIT have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. Circulating free DNA may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. The aim of the study is to determine the mutational status in circulating DNA in melanoma metastatic patients, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be compared with the primary tumor genotype.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Surgical biopsy for histologic diagnostic
* All melanoma subtypes
* Known genotype BRAF V600
* Affiliation social security
* Consent form signed

Exclusion Criteria:

* Patient with histories of cancer or the other synchronous cancer
* Pregnant women
* Breast-feeding women
* Vulnerable patients: major under guardianship; patient deprived of its rights
Observational Study of Vision Improvement in Patients With Retinal Disorders

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Eligibility Criteria:
Inclusion Criteria:

1. - Female or male
2. - Any race
3. - Patient is at least 50 years old
4. - Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
5. - Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
6. - Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s)
7. - Patient CDVA records are available at baseline and at 1m or longer post-Tx times

Exclusion Criteria:

1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study

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Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery

Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile.

Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing.

Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.


Eligibility Criteria:
Inclusion Criteria:

* Men or women age 18 through 64 years
* Major abdominal surgery
* Body weight ≥ 100 and ≤ 300 pounds
* Negative serum pregnancy test
* Pain intensity score at least 40 (moderate pain) on 100 mm visual analog scale
* Minimum 48 hour hospital stay and 5 day maximum stay
* Able to provide written informed consent
* Willing and able to comply with all testing requirements of the protocol

Exclusion Criteria:

* Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
* Allergy or significant reaction to opioids
* Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)
* Current upper respiratory tract infection or other respiratory tract condition that could interfere with absorption of the nasal spray or adverse event assessment
* Use of any intranasal product in past 24 hours
* Clinically significant abnormality on screening lab tests
* History of cocaine use
* Active peptic ulcer disease or significant history of peptic ulcer disease or gastrointestinal bleeding
* Advanced renal impairment or risk for renal failure
* History of other medical problems that could interfere with the study participation
* Pregnancy or breastfeeding
* Participation in another investigational study within past 30 days
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).

The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of mycophenolate mofetil (MMF) and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
2. Written informed consent before any study-specific procedures were performed.
3. In the opinion of the investigator, subject required continued immunosuppressive therapy.
4. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
5. Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study.

Exclusion Criteria:

1. Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
3. A planned kidney transplant within study treatment period.
4. Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.
Biomarker Study of Blood Samples From Patients With Non-Small Cell Lung Cancer Treated With Carboplatin and Paclitaxel With or Without Bevacizumab

RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for non-small cell lung cancer may help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at proteomic patterns in stored blood samples from patients undergoing treatment for non-small cell lung cancer.

OBJECTIVES:

Primary

* To develop a serum proteomic classifier using matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry analysis of blood samples from patients with non-squamous cell non-small cell lung cancer to predict benefit, in terms of survival and time to progression, from treatment with bevacizumab in combination with carboplatin and paclitaxel.

Secondary

* To better quantitate candidate biomarkers by using more advanced mass spectrometric technologies, including multiple-reaction monitoring and heavy-labeled peptides.

OUTLINE: Previously collected pre-treatment samples of serum or plasma are randomly selected from patients enrolled on protocol ECOG-4599 (i.e., 60 from the bevacizumab arm and 30 from the control arm). Samples are analyzed by matrix-assisted laser-desorption/ionization time-of-flight mass spectrometry to identify patterns from protein spectra that correlate with patient survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Available serum and plasma samples from patients with previously untreated locally advanced, metastatic, or recurrent non-squamous cell non-small cell lung cancer
* Enrolled on clinical trial ECOG-4599

  * Treated with carboplatin and paclitaxel with or without bevacizumab

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting.

Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.

This is a national, observational, cross-sectional study. The study will assess the general QoL among CD participants with CPFs in the Portuguese routine clinical practice.

This study will enroll approximately 80 participants. All participants will be enrolled in one observational cohort.

The data will be collected retrospectively, from the medical records, on healthcare resource utilization and on the pharmacological and surgical treatments used for the management of CPFs in the three years prior to the inclusion visit.

This multi-center trial will be conducted in Portugal. The overall duration of this study is approximately 8 months.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with CD.
2. Presence of CPF(s), defined as \>=1 of the following criteria:

   * High intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric location;
   * \>=2 external openings;
   * Associated collections.
3. Attending routine gastroenterology appointments at the participating hospitals.

Exclusion Criteria:

1. Diagnosed with ulcerative colitis or indeterminate inflammatory bowel disease (IBD).
2. With non-complex fistulas or with fistulas types other than perianal (example, rectovaginal).
Engineering Evaluation of an Eye Movement Monitor Device

The objective of the engineering evaluation is to verify and validate the design of an eye movement monitor device, the Retitrack, for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses in human eyes when viewing a visual stimulus.

This engineering evaluation is not an applicable clinical trial. This is a design validation of the mechanism of action of the device to measure eye movement. This is not a clinical trial to evaluate the effect of an intervention on biomedical or other health-related outcomes.

This non-significant risk device evaluation involves obtaining retinal images and eye movement measurements with the Retitrack device for purposes of design verification and validation testing. These measurements are not intended for use in diagnosing, preventing, monitoring, or alleviating a medical condition. This evaluation is not intended to assess biomedical or other health-related outcomes.

The evaluation involves the voluntary participation of up to 40 healthy adults who participate in a single device testing visit conducted over one or two days. The Retitrack is used to assess the alignment of the eye for image capture, the ability to measure and analyze eye movements for fixational and visually guided saccadic responses, and the usability of the device.

Eligibility Criteria:
Inclusion Criteria:

* History of good health
* Willing to participate in testing over 1 to 2 days with rest periods
* Willing to participate in device testing involving viewing visual targets, moving eyes as directed, and holding head steady
* Willing to have retinal images recorded for eye movement measurements

Exclusion Criteria:

* Refractive correction with glasses or contact lenses of more than 12 diopters of myopia or 4 diopters of hyperopia in either eye
* Active eye disease in either eye
* History of ocular surgery or ocular trauma in either eye within the past three months
* Ocular conditions in either eye that could interfere with obtaining a clear retinal image
* Ocular conditions in either eye that could affect the ability to view a stimulus or limit eye movement
* Neurological conditions that could affect eye movements
Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.

This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas


Eligibility Criteria:
Inclusion Criteria:

* No previous diagnosis of adenocarcinoma of the prostate
* No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations)
* Active urinary tract infection

Exclusion Criteria:

* Prior pelvic radiotherapy
* Prior androgen deprivation therapy
* Evidence urinary tract infection or significant urinary retention
* Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI.
* Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)
A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

This study aims to assess safety and effectivness of long-term treatment with vamorolone in boys with Duchenne Muscular Dystrophy (DMD) who have completed prior studies with vamorolone.

All subjects in this study have completed previous studies with vamorolone and continued to receive vamorolone under special programs: Compassionate Use Program \[CUP\], Named Patient Program \[NPP\] or Expanded Access Protocol \[EAP\]. All subjects will continue treatment with vamorolone under Guardian protocol instead. The primary objective of this study is to evaluate the safety of long-term treatment with vamorolone in boys with Duchenne Muscular Dystrophy regarding vertebral fractures. Secondary study objectives will evaluate the safety of long-term treatment with vamorolone on non-vertebral fractures, cataracts, delayed puberty, overall safety as well as ambulatory and non-ambulatory function.

Eligibility Criteria:
Inclusion Criteria:

* Subject and/or subject's parent(s) or legal guardian has provided written informed consent
* Subject has previously completed either the VBP15-LTE or VBP15-004 study, and transitioned through the Compassionate Use Program, Named Patient Program or Expanded Acess Protocol
* Subject is on vamorolone on day of enrolment
* Subject and parent / legal guardian are willing and able to comply with the protocol schedule, assessments and requirements

Exclusion Criteria:

* Any medical condition, which in the opinion of the Investigator, would affect study participation, performance or interpretation of study assessments
* Vamorolone treatment discontinued for ≥ 6 months within the year prior to enrolment for a non-safety reason, or vamorolone treatment previously discontinued at any time for a safety reason
* Severe hepatic impairment
SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)

The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
* Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis

Exclusion Criteria:

* Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
* Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
* Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination
The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings

We will investigate whether the use of Virtual Reality (VR) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. The VR intervention will be studied during short hand surgeries normally performed using local anesthesia and sedation.

Virtual Reality (VR) is a powerful and inexpensive technology that has been effectively used in healthcare settings to treat anxiety and pain, with minimal side effects. In the last two decades, opioid abuse and deaths related to opioids have increased, and opioid naive patients are at increased risk of opioid abuse when opioids are used during their surgical procedures. In addition, anesthetics, anxiolytics and analgesics, namely opioids, have a myriad of side effects that worsen patient experience, and lead to complications and increased costs. There are limited studies on the use of VR in the perioperative setting. Our study is a randomized controlled trial to investigate the use of VR to treat anxiety and pain in perioperative settings. We will recruit 56 patients, 28 in the control group and 28 in the VR group, undergoing short (\<2 hrs) hand or upper extremity surgeries under local anesthesia and monitored anesthesia care (MAC). The control group will receive standard anesthetic management and the VR group will be exposed to VR in the preoperative setting and during the surgical procedure, using the clinically validated AppliedVR software. The data collected will included satisfaction questionnaires and pain scores for anxiety/pain pre- and post- procedure, vital signs trends to assess sympathetic response during surgery, and amount of anesthetics used. We hypothesize that the VR group will show decreased anxiety and pain, increased satisfaction, and decreased use of anesthetics during the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older and less or equal to 75 years old.
2. ASA physical status I-II.
3. English speaking.
4. Undergoing elective surgery with local anesthetic with sedation.
5. Surgical time less than 2 hours.

Exclusion Criteria:

1. ASA physical status III or above.
2. Allergy to fentanyl, midazolam or propofol.
3. History of seizure, migraines.
4. Chronic Pain Syndrome.
5. Use of high dose opioids or long acting opioids.
6. Severe anxiety, on daily anxiolytics.
7. Psychiatric comorbidities that preclude the use of VR.
8. Physical disabilities that preclude the use of VR technology in a comfortable manner.
9. Patient refusal.
Comparison of Anti-Ischemic Drug Therapy and Percutaneous Transluminal Angioplasty After Myocardial Infarction

Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the SWISSI 2 study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy on long-term outcome in patients with recent myocardial infarction and silent ischemia.

Silent ischemia has been shown to negatively affect prognosis in patients after myocardial infarction (MI). Despite these consistent findings, there are almost no prospective data unequivocally documenting a benefit of antiischemic therapy on prognosis in patients with silent ischemia. There is some indirect evidence of a better outcome after repeat angioplasty for silent restenosis. In patients with a recent MI, the Asymptomatic Cardiac Ischemia Pilot study documented a short-term benefit of antiischemic drug therapy and angioplasty in patients with silent and symptomatic ischemic episodes. However, long-term outcome data in totally asymptomatic patients is missing and it is unknown whether angioplasty in addition to secondary preventive measures is superior to antiischemic drug therapy in these patients. Therefore, the (SWISSI 2) study was started 15 years ago with the aim of comparing the effects of angioplasty with medical therapy, each combined with secondary preventive advice, aspirin and statin therapy, on long-term outcome in patients with recent MI and an exercise test without symptoms but silent ischemia verified by stress imaging.

Eligibility Criteria:
Inclusion Criteria:

* Recent myocardial infarction within last 3 months
* Documented silent myocardial ischemia (type I)

Exclusion Criteria:

* Symptomatic myocardial ischemia