cyrilzakka/clinical-trials huggingface dataset:
Development of a Biomarker to Predict the Efficacy of Anti-angiogenic Therapy in Ovarian Cancer

Epithelial ovarian cancer (EOC) is a highly angiogenic tumor and drug targeting of angiogenesis is effective in some selected groups of EOC patients. However, no biomarkers are available to predict the effectiveness of this expensive therapy.Investigators believe that Multimerin-2, an extracellular matrix molecule, could serve as a biomarker that can address this clinical need. Multimerin-2 is deposited throughout the vasculature and its expression in EOC-associated vessels is frequently lost, in part due to increased degradation. Multimerin-2 sequesters VEGFA and other angiogenic factors and their release upon degradation of Multimerin-2 could underlie resistance to anti-angiogenic therapy. Indeed, fragments of degradation of Multimerin-2 are found in high concentrations in sera of EOC patients. Furthermore, the loss of Multimerin-2 impairs the function of the vessels, and this could negatively affect the delivery of the drug and the efficacy of the treatment.

With the aim of predicting the efficiency of anti-angiogenic therapy, researchers will evaluate the angiogenic properties and expression of Multimerin-2 in EOC tumors, and develop a new Multimerin-2-based biomarker detectable by liquid biopsy, in order to manage EOC patients in a targeted manner based on the biological characteristics of their tumor.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged ≥18 years
2. Histological diagnosis of epithelial carcinoma of the ovary or fallopian tubes or primary carcinoma of the peritoneum, including mixed Mullerian tumours.
3. Stage IIIb, IIIc or IV
4. Performance Status 0-2 according to ECOG
5. Availability of tumor tissue samples and biological fluids for molecular analyses
6. Informed consent for the collection, storage and use of biological material for the CRO Biobank (as specified in the consent of the CRO Biobank, Rev 2 of 03/10/2016), signed and obtained before surgery for suspected EOC.

Exclusion Criteria:

1. Ovarian tumors of low malignant potential (i.e. borderline tumors)
2. Other malignacies within the last 5 years except carcinoma in situ of the cervix or early stage squamous cell or basal cell carcinoma of the skin, as long as they are adequately treated.
3. Active infection or uncontrolled chronic inflammatory disease
A Study of Pemetrexed and Folic Acid Given Before Surgery (Neoadjuvant Treatment) to Patients With Rectal Cancer.

The purpose of this study is to help answer the following research questions:

If the study drug Pemetrexed can help patients with rectal cancer; If molecular biological parameters are correlated respectively changing due to cytotoxic treatment with Pemetrexed; To evaluate adverse events


Eligibility Criteria:
Inclusion Criteria:

* no prior therapy for rectal cancer
* pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
* adequate organ function
* Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
* signed informed consent
* at least 18 years of age
* surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment.

Exclusion Criteria:

* concurrent administration of any other anti-tumor therapy
* treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* serious concomitant systemic disorders
* previously completed or withdrawn from this study
* pregnant or breast-feeding
* second primary malignancy
* history of significant neurological or mental disorder, including seizures or dementia
* inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
* presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry
* inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis

The objective of this study is to evaluate the long-term safety of IDP-118 lotion.

This is a multicenter, open-label study of the long-term safety of IDP-118 lotion in participants with plaque psoriasis.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, of any race, at least 18 years of age (inclusive).
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a Body Surface Area (BSA) of at least 3 percent (%), but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigators Global Assessment (IGA) score of 3 or 4 (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Key Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors

To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male or post menopausal female patients with histologically confirmed advanced refractory solid tumors for which no reasonable therapy exists. Patient is not required to have measurable disease.
* Age \>18 years
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see APPENDIX 1 for details).
* Patients who had prior surgery, radiation, or chemotherapy will be eligible provided at least 4 weeks have elapsed prior to study initiation. Patients must have recovered from treatment-related toxicities, and surgical wounds must be healed.
* Patients who have had prior immunotherapy with approved agents are eligible.
* Patients must have hemoglobin \>10.0 g/dL, ANC \>1,000/mm3, WBC \>3,000/mm3,000/mm3, platelets ³100,000/mm3, bilirubin £2.0 mg/dL, AST/ALT no greater than 5 times the upper limit of normal (ULN), and serum creatinine \<1.5 mg/dL (or calculated creatinine clearance ³60 mL/min).
* Patients must have prothrombin time (PT) and partial thromboplatin time (PTT) less than upper limit of normal or international normalized ratio (INR) less than 1.1.
* Patients must have thyroxine (T4) and thyroid-stimulating hormone (TSH) within normal limits.
* Patients must be informed of and understand the investigational nature of this trial and give written informed consent prior to receipt of any study medication or beginning study procedures.

Exclusion Criteria:

* Patient has known brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis.
* Patient has respiratory insufficiency requiring oxygen treatment, or has lymphangitic involvement of lungs.
* Patient has evidence of hematemesis, melena, hematochezia, or hematuria (2 or greater on urine dipstick).
* Patient has a history of a significant adverse event related to previously administered humanized monoclonal antibody.
* Patient has known HIV or hepatitis virus infection.
* Patient has prior myocardial infarction or angina, or uncontrolled hypertension (systolic BP \>140 mm Hg).
* Patient has either prior strokes or transient ischemic attacks.
* Patient has active infections requiring systemic antiinfective therapy or other physical or psychological illnesses that would preclude drug administration or patient compliance.
* Patient has donated blood or received an investigational agent in the last 4 weeks.
* Patient has a history of active illness or behavior, including substance dependence or abuse that, in the opinion of the investigator, might pose additional risk in administering the study drug to the patient.
* General medical or psychological conditions that would not permit the patient to complete the study or sign the informed consent
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population

The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to comprehend and sign an informed consent form;
* Able to complete all study visits required in the protocol;
* Chinese; diagnosed with cataracts in both eyes;
* Planned bilateral cataract removal by routine phacoemulsification;
* Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
* Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
* Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
* Clinically significant corneal diseases;
* Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
* Previous intraocular or corneal surgery;
* Pregnancy or lactation during study or planning to be pregnant/lactating;
* Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
* Other planned ocular surgical procedures;
* Patients who desire monovision correction.
* Other protocol-specified exclusion criteria may apply.
Safety Evaluation of Intracoronary Infusion of Extracellular Vesicles in Patients Following Coronary Stent Implantation

The purpose of this study is to determine the safety of using a biological drug called PEP in people who have had a coronary stent placed. A biological drug is a substance that is made from a living organism or its products (parts). In this case, PEP is made of certain parts of blood from living blood donors obtained from a certified blood bank. PEP comes in a powder form and is mixed with heparinized saline (a solution used to prevent clots in catheters) to create a solution that can be injected. The investigators want to see if PEP can be used to stop or slow heart damage.

Patients who undergo Percutaneous Coronary Intervention (PCI) will be treated with a single dose of PEP within 20 minutes after stent placement or post-dilation (whichever is last). Subjects will be screened at the time of emergency room presentation. Subjects will be treated in the cardiac catheterization laboratory where the PCI will be completed and PEP will be administered. Subjects will be followed for one year after PEP administration through clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing ≥1 elective, urgent, or emergent coronary stent implantation
* Angiographic evidence of TIMI 3 flow through the stented vessel after stent placement
* Angiographic evidence of residual stenosis visually \<30% after stent placement
* Willing and able to provide signed informed consent
* Lives within 90 mile radius of study site
* Willing and able to return to study site for all follow-up visits

Exclusion Criteria:

* Prior solid organ transplantation at any time
* Pregnant or lactating at screening
* Known presence of chronic systemic inflammatory disorder that requires ongoing therapy with immunosuppressive agents
* Known immune system compromise including but not limited to human immunodeficiency virus (HIV), hepatitis A, hepatitis B (HBV) or hepatitis C (HCV) infection
* Known history of malignancy of any type except non-melanoma skin cancer
* Known serum creatinine \>2 mg/dL or GFR ≤30 mL/min within the last twelve months
* Known AST, ALT, and/or bilirubin (total) elevated twice the upper limit of normal for age \& gender within the last twelve months
* Known Hemoglobin lower than 8.0 g/dL within the last twelve months
* Known current illicit drug use at screening
* Other major surgical procedure or major trauma within the previous 14 days prior to enrollment
* Female of child bearing potential who is unwilling to agree to use acceptable contraception methods for 3 months after receiving the investigational drug
* Pacemaker/ICD implant in place
* Adult lacking decision-making capacity
* Prisoner
* Non-English speaking
* English-speaking but illiterate
* Legally blind
* Known allergy to heparin or heparin-induced thrombocytopenia
* Known history of positive SARS-CoV2 testing within the last 30 days
* DNR/DNI status prior to PCI procedure or planned DNR/DNI status after PCI procedure
* Homeless or no permanent address at the time of enrollment
High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)

The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.

It is hoped that these newer technologies will:

1. allow a higher daily dose of radiation to the tumor and pelvic nodes
2. avoid nearby normal tissue and organs like the rectum and bladder
3. prevent the cancer from spreading or coming back

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, adenocarcinoma of the prostate
* T1-2N0M0 with risk of pelvic lymph nodes involvement \>25% by Roach formula \[(2/3xPSA) + (Gleason Score - 6)x10\], or any T3-4N0M0
* Karnofsky Performance Scale \> 70.
* Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.
* No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.
* Patients must sign a study-specific consent form prior to registration.
* No evidence of distant metastases (Bone scanning)

Exclusion Criteria:

* Clinical or pathological evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate
* History of prior chemotherapy
* History of prior pelvic radiation therapy
* Children (age \< 18).
Comparative Study of Cardiac Adrenergic Function Explored by I-123-MIBG and CZT Camera (D-SPECT) Versus Anger Camera in Patients With Heart Failure

Cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF stratification study based on cardiac adrenergic function after injection of a tracer: I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous publications from 1992 to the present day have reported encouraging results for the daily use of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961 patients. Typically, the camera used was an Anger camera with collimating Nai standard called parallel holes.

The main objective is to validate the measurements of cardiac adrenergic function evaluated by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection of I-123-MIBG in 80 patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years (except major patients under guardianship)
* patient who signed the consent form
* written and spoken French
* Beneficiaries of the social security system
* Stable heart failure with LV dysfunction (\<45%) of ischemic or nonischemic origin

Exclusion Criteria:

* Patients with a recent history (\<21 days) acute coronary failure (myocardial infarction, unstable angina)
* Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment)
* Major patients under guardianship
* Pregnant or lactating women
* Women in age and condition of childbearing
* Patients unable to understand the purpose of the study
The Reflex Mechanism Underlying Neuromuscular Effects Of The Whole Body Vibration

This study was conducted to determine whether the spinal reflex mechanism underlying the neuromuscular effects of whole body vibration (WBV) is tonic vibration reflex. Local and whole body vibration reflex latencies were measured in young adult healthy volunteers.

A total of eight volunteers were included according to the inclusion and exclusion criteria. The subjects were vibrated while standing upright with the WBV device (PowerPlate® Pro5). The 30, 35 and 40 Hz WBVs were applied for thirty seconds for each frequency with an amplitude of 2 mm. In the same session, 100, 135 and 150 Hz local vibrations were applied to the right Achilles tendon for thirty seconds for each frequency. 100, 135 and 150 Hz local vibrations were then applied to the right heel for thirty seconds for each frequency with an interval of five seconds. Vibration stimuli were recorded accelerometers. Reflex muscle responses were recorded from the right soleus muscle at a sampling rate of 40 KHz. Recording electrodes were placed on the belly of the right soleus muscle and the ground electrode was placed on the right medial malleolus.

The data were recorded with the PowerLab device, the records were processed and analyzed offline from the LabChart program. After the EMG records are filtered and rectified, reflex latencies were measured by cumulative averaging method using the accelerometer records as triggers (Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Türker KS.A new method to determine reflex latency induced by high rate stimulation of the nervous system.Front Hum Neurosci.2014 Jul 18; 8: 536.doi: 10.3389 / fnhum.2014.00536). After determining the Achilles tendon vibration reflex latency and the reflex latency induced by WBV, it was compared with statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Young adult (20-40 years old)
* Both gender
* Volunteer

Exclusion Criteria:

* Cardiac disorder (Rhythm / conduction disorder, Cardiac pacemaker, Ischemic heart disease)
* Finding or suspected active deep vein thrombosis,
* History of deep vein thrombosis and pulmonary embolism,
* Orthostatic hypotension
* Hypertension
* Presence of fracture in the lower limb
* Achilles Contractures
* Active inflammatory, rheumatological or infectious disease in the lower limb
* Peripheral nerve lesions such as polyneuropathy, radiculopathy in the lower limb
* Those with a history of Achilles tendinopathy / bursitis
* Those with a history of kidney stones
* Patients with dizziness and balance problems,
* Cases with lesions on the skin surface where electrodes were attached
* Those with communication-cooperation problems
* Having a history of panic attacks
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer

A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progression rate. The aim of this research is to evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of high-risk superficial bladder cancer

This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary urban teaching University Urological Department regarding sixty-four patients with high-risk superficial bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions (gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at 3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36 months.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of high risk superficial bladder cancer according to EAU guidelines (http://www.eortc.be/tools/bladdercalculator/),
* Having never been treated with other intravesical chemotherapeutic agents,
* And to consent to participate to the study

Exclusion Criteria:

* Concomitant tumours;
* Urinary tract infections (UTI);
* Altered function of the liver, kidneys and/or bone marrow;
* Major cardiovascular diseases;
* Life expectancy of less than 1 year;
* Intravesical chemotherapy in the previous 3 months or immunotherapy in the previous 6 months;
* Systemic chemotherapy and pelvic radiotherapy prior to TURB, and any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.