cyrilzakka/clinical-trials huggingface dataset:
Impact of Immunoscore Colon Test on Adjuvant Therapeutic Strategy in Non-Metastatic Colon Cancer

Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.

On previous studies, Immunoscore Colon test identified subgroups of stage II and III colon cancer patients whose Chemotherapy could be adjusted.

The study hypothesis is that Immunoscore Colon Test will modify the therapeutic decision in MM.

With Alpha and Beta at 5% and p0=10% modification rate, the participating investigators need to include 280 participants, 140 in each cohort (stage II and stage III).

Participants will have tumor samples from their curative surgery tested with Immunoscore Colon. When the patients are evaluated in MM, a first therapeutic decision will be taken before disclosing the test result. ICT result will then be communicated and a second decision will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically/histologically proven colon adenocarcinoma
* non-metastatic cancer
* Stage II or III adenocarcinoma
* Surgical resection of primitive tumor within 6 weeks of multidisciplinary meeting
* No macroscopic or microscopic proof of residual disease during surgery (R0 margins)
* Available surgical material: FFPE tumor samples
* Post-operative adjuvant chemotherapy considered during multidisciplinary meeting
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Patient having signed a written informed consent prior to any trial specific procedures
* Patient affiliated to the social security system or equivalent

Exclusion Criteria:

* Other invasive cancer within 5 years of the colon cancer diagnosis, except for adequately treated basal cell carcinoma or squamous cell skin carcinoma or in sity cervical carcinoma
* Patients for which adjuvant chemotherapy is contra-indicated
* Any previous systemic or loco regional anticancer therapy for the studied colon cancer (e.g. neoadjuvant therapy)
* Patient enrolled or planned to be enrolled in another clinical trial that may influence the therapeutic decision
* Any psychological, social or geographical issue that may hinder the patient's understanding of the study or the study conduct
* Person deprived of liberty or under the authority of a legal guardian
* Person unable to understand the study or to comply with the protocol procedures
Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.

Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years
2. Staphylococcus aureus monomicrobial knee or hip PJI ˃3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT)
3. Staphylococcus aureus only in joint fluid within 6 months before randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months before pre-inclusion visit
4. Without preoperative diagnosis of superinfection due to another pathogen
5. Phagogram displaying the susceptibility of the strain to at least one of the phages.
6. Patient with a life expectancy of 2 years and more as determined by the principal investigator
7. Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration
8. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
9. Negative pregnancy test

Exclusion Criteria:

1. Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
2. Other germ found in culture of joint fluid sample
3. Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
4. Patients with ASA score ≥ 4
5. Severe sepsis or Septic shock or hemodynamic instability
6. Patients with an indication to prosthesis replacement or amputation
7. Immunosuppressed patients
8. ALT or AST \> 5 x ULN, creatinine \> 1.53 mg/dl in men and \> 1.24 mg/dl in women
9. Known allergic reactions to components of phages products
10. Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
11. Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug
12. Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.
A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.

The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.

Eligibility Criteria:
Key Inclusion Criteria:

* Capable of giving signed informed consent;
* Willing and able to follow all instructions and attend all study visits;
* Able to self-administer eye drops- in the opinion of the investigator;
* History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
* Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
* Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
* Ocular redness at baseline as specified in the protocol;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Known contraindications or sensitivities to the use of any of the investigational drug(s) or their components, or any other medication required by the protocol;
* Ocular surgical interventions within 6 months prior to Visit 1 or during the study;
* Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
* Disallowed medications or devices as specified in the protocol;
* Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
* Other protocol-defined exclusion criteria may apply.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for MS

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of multiple sclerosis

Multiple Sclerosis (MS) can be a devastating disease. There is evidence that mesenchymal stem cell treatment is safe and efficacious for the treatment of MS. Patients with MS will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
MaxAn Post Market Surveillance Validation

This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.

The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et.al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System.
* Subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits.
* Subjects or their representative must be willing and able to give informed consent.

Exclusion Criteria:

* Subject has spinal infection or inflammation at any level.
* Subject is morbidly obese, defined as a BMI greater than 40.
* Subject has a mental illness, alcoholism or drug abuse.
* Subject has a metal sensitivity/foreign body sensitivity.
* Subject has inadequate tissue coverage over the operative site.
* Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis.
* Female subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating.
* Subject who does not meet the specific indications for use of the MaxAn® Anterior Cervical Plate System.
* Subjects participating in another clinical research study.
* Any previous cervical spinal surgery.
Early Stage Lung Cancer Screening With Low-dose Computed Tomographic

The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. 6000 high-risk subjects (age 45-70) were recruited and randomized to the Active arm (Baseline + 2 biennial repeated LDCT screening) or to the Passive arm, followed up in usual care (Baseline + 2 biennial repeated questionnaire inquiries). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored from the Active arm in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were those aged 45-70 years, and with either of the following risk factors:

  1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  2. malignant tumors history in immediate family members;
  3. personal cancer history;
  4. professional exposure to carcinogens;
  5. long term exposure to second-hand smoke;
  6. long term exposure to cooking oil fumes.

Exclusion Criteria:

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years
Testosterone and Alendronate in Hypogonadal Men

This study will investigate the hypothesis that the combination of testosterone replacement and alendronate will improve bone density and parameters of bone quality more than either medication alone in older men with low testosterone levels and low bone density.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 60 or above
* Testosterone \<300 ng/dL
* DXA T score \< -1 OR FRAX Score of 3% or greater for hip fracture or 20% or greater for major osteoporotic fracture

Exclusion Criteria:

* Significant liver or kidney disease
* Elevated prolactin level
* Abnormal TSH
* Abnormal 25-Vitamin D
* PSA \> 2.5
* History of malignancy
* Calcium \> 10.6
* Alkaline Phosphatase \> 150
* Fracture within the last 6 months
* History of acute urinary retention
* Hematocrit \< 32% or \> 50%
* Fracture within the past 6 months
* American Urological Association BPH symptom index \> 21
* Sleep apnea
* Abnormalities of the esophagus which delay esophageal emptying
* Significant cardiopulmonary disease
Split Chest Breast Neurotization

Several members of the scientific community have suggested that breast neurotization can help return nipple sensation to patients undergoing implant-based breast reconstruction. There has been no randomized controlled study assessing the validity of these claims. The goal of this study is to evaluate if performing breast neurotization can help restore or improve return of nipple sensation to patients undergoing implant-based breast reconstruction. This will be a single-blinded, randomized controlled trial where patients undergoing bilateral reconstruction will serve as their own controls by receiving an intervention on one breast but not the other breast.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing bilateral nipple-sparing mastectomy (prophylactic or therapeutic) at a single institution
* Women receiving implant-based reconstruction (either direct to implant or tissue expander-based implant reconstruction of any size)
* Age 18 or older

Exclusion Criteria:

* Women with history of prior breast surgery given concern for potentially damaged nerves by prior intervention that could impact the procedure and results. Procedures include but are not limited to: prior breast reduction, prior breast augmentation, prior lumpectomy
* Pre-operative radiation or anticipated post-operative radiation
* Body Mass Index (BMI) \> 30 kg/m2 or patients with macromastia (larger breasts) as these patients frequently require larger implants that will not accommodate the longest nerve graft available (70 mm)
* Current tobacco or nicotine use
* History of diabetes mellites with a HgbA1c \> 7% due to lower rates of wound healing
* History of auto-immune disease
* History of allergy, sensitivity, or intolerance to porcine-derived materials
* Intraoperatively, patients may have to be excluded if during the mastectomy the lateral nerve targets were severely damaged or removed as part of the mastectomy. While these patients will be excluded from the formal analysis, the investigators will continue to follow them as a subgroup for analysis and comparison.
* Men as they infrequently receive bilateral mastectomies due to breast cancer. Male breast cancer is \<1% of all breast malignancies.
* Pregnancy as determined by urine pregnancy test on day of surgery
Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia

Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing complete endoscopic transurethral tumor resection (TUR-BT) for bladder cancer
* Patients undergoing TURP due to benign prostatic hyperplasia
* Patients undergoing open prostatectomy due to benign prostatic hyperplasia

Exclusion Criteria:

* Patients who underwent incomplete transurethral tumor resection for bladder cancer
* Patient who underwent TUR biopsy for restaging with no obvious macroscopic tumoral lesion
* Patients who underwent cystectomy for bladder cancer
Comparison of Different Subsequent Treatments After Radical Surgery

Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.

In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.

After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.

We have recruited 800 patients till November 2014.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed cervical carcinoma
* Original clinical stage must be Ib\~IIa （FIGO）
* Age between 18-65
* With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
* More than 3 months survival is to expect
* Patients must give signed informed consent

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Residual tumor which can not be removed in the surgery
* Investigator consider the patients can't finish the whole study
* With normal liver function test (ALT、AST\>2.5×ULN)
* With normal renal function test (Creatinine\>1.5×ULN)
* WBC\<4,000/mm3 or PLT\<100,000/mm3
* Receive the external pelvic irradiation before the surgery
Open Versus Laparoscopically-assisted Esophagectomy for Cancer

To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.

Open Versus Laparoscopically-assisted Esophagectomy for Cancer

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0, before any treatment
* Middle or lower third esophageal carcinoma, junctional tumor Siewert type I
* Patients who underwent or not neoadjuvant chemotherapy or chemoradiation
* Tumor deemed to be resectable in a curative intent at the preoperative setting
* Age less than 75 years old, OMS status 0, 1 or 2
* Patient who can undergo one or the other surgical modality
* Written informed consent form
* Possible follow-up

Exclusion Criteria:

1. General criteria: PO2 ≤ 60 mmHg; PCO2 \> 45 mmHg; FEV ≤ 1000 ml/sec

   * Hepatic cirrhosis
   * Recent myocardial infarction (in the previous 6 months) or progressive coronary disease
   * Distal arteritis (Leriche-Fontaine stage II upwards)
   * Concomitant cancer, other than subcarinal esophageal cancer
2. Disease-related factors

   * Invasion of subclavicular lymph nodes in a clinical examination or on biospy
   * Lymph nodes near the origin of the celiac artery with a diameter ≥ 1 cm on CT or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion)
   * Recurrent nerve palsy
   * Evidence of extension to the tracheobronchial tree
   * Signs of mediastinal invasion (vertebral contact, aortic contact ≥ 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.)
   * Distant metastasis
3. Laparoscopy-related factors

   * Patient presenting a general contraindication to laparoscopy
   * A history of median or subcostal laparotomy