cyrilzakka/clinical-trials huggingface dataset:
A Study of Mitomycin C, Irinotecan, and Cetuximab

Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned. This study will also evaluate any rash that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C, Irinotecan, and Cetuximab.

We propose a phase II trial which combines mitomycin C, irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated K-Ras. The goals of this investigation are to develop an effective systemic therapy for previously treated patients with CRC with wild type K-Ras, to further explore the relationship of mitomycin C induced topoisomerase 1 gene expression and response to irinotecan, and to define and characterize the biology of cetuximab induced skin rash.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologic diagnosis of colorectal cancer.
2. Clinical and/or radiologic evidence of metastatic disease.
3. One previous systemic treatment for metastatic disease.
4. Age \> 18.
5. Presence of at least one measurable lesion.
6. Adequate hematopoetic (absolute neutrophil count \> 1500/mm3, platelet count \> 100,000/mm3), renal (serum creatinine \< 1.5 mg/dl), and hepatic function (bilirubin \< 1.5 and transaminases \< 5.0 x upper normal limit).
7. ECOG performance status 0-2.
8. Life expectancy \> 3 months.
9. Patients must be informed of the investigational nature of this study and provide written informed consent in accordance with the institutional and federal guidelines prior to the initiation of therapy.

Exclusion Criteria:

1. No recognized brain metastasis.
2. No previous treatment with mitomycin C or cetuximab.
3. No other systemic malignancy requiring treatment within the past one year.
4. Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method.
5. Patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
Development and Validation Phase of Diffusion Tensor Imaging and Arterial Spin Labelling at 3 Tesla Using a Long-term Effort Model Applicable to Skeletal Muscle Characterization.

The aim of this study is to demonstrate and quantify the micro architecture and micro vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow parameters will be registered before and after the long-distance run on the lower leg. Axial T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory markers will be collected in blood and urine samples and compare with both MRI and Near-infrared spectroscopy (NIRS).


Eligibility Criteria:
Inclusion Criteria:

* Realizing between 2:10 and 4:30 in the marathon.

Exclusion Criteria:

* Smoker
* Subject with medical treatment or with a treatment interrupted for less than 30 days.
* Subject with a osteo-articular, cardiovascular, infectious, lung pathology and/or a metabolic chronic pathology.
* MRI Contraindication : Claustrophobic subject ; subject with a intra-cranial vascular clip, with a pacemaker, with a neurostimulator or a cochlear implant ; subject with intraocular metallic foreign bodies.
Collection of Blood From Patients With Pancytopenia

Aplastic anemia is a condition in which the cells normally found in blood are greatly decreased. The normal levels of white blood cells, red blood cells, and platelets are much lower in patients with aplastic anemia.

Because of these low levels of blood cells, patients with aplastic anemia have a variety of immune system abnormalities. However, low levels of blood cells make it difficult to collect specialized white blood cells (mononuclear cells) for research studies.

This study was designed to collect lymphocytes from patients with low levels of all blood cells (pancytopenia) for use in research. Patients participating in the study will undergo a special procedure known as lymphapheresis. During lymphapheresis blood is taken from the patient in a manner similar to blood donation. The white blood cells are selectively removed by spinning (centrifugation), and the remaining red blood cells and platelets are placed back (re-infused) into the donor s blood stream.

Patients participating in this study will not benefit directly from it. However, cells collected in this study may increase scientific knowledge and improve understanding and treatment for diseases like aplastic anemia.

Patients with aplastic anemia, myelodysplasia, and other marrow failure syndromes have a variety of immunologic abnormalities including lymphocyte phenotypic and lymphokine production dysregulation. Because of their low blood counts, it has been difficult to obtain sufficient peripheral blood mononuclear cells for research studies. Patients agreeing to this protocol will be lymphapheresed the equivalent of one or two units of cells (approximately 1-2 x 10(8) cells), which will be used for research purposes.

Eligibility Criteria:
* INCLUSION CRITERIA:

All patients with aplastic anemia or other bone marrow failure in which we would not expect to obtain 1 X 10(8) mononuclear cells from 100 mls of peripheral blood (i.e. an absolute lymphocyte count approximately less than 2000 per mm(3)).

Age greater than or equal to 18.

EXCLUSION CRITERIA:

Patients unable to comprehend the investigational nature of the procedure.

Patients unable to tolerate a temporary reduction of blood volume the equivalent of one unit of blood.
Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy

The main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible.


Eligibility Criteria:
Inclusion Criteria:

* Patients consecutively operated on between February 1, 2012 and December 1, 2013
* Total thyroidectomy +/- lymphadenectomy
* Respect of clinicobiological protocol presented above
* The ( the ) patient ( e) was informed ( e) on the implementation of the study 's objectives, constraints and patient rights
* The ( the ) patient ( e) is under ( e) at least 18 years

Exclusion Criteria:

* The ( the ) patient ( e) is under guardianship, curatorship or under guard saves justice
* It is not possible to give to ( the ) patient ( e) informed information
* History of cervical radiotherapy
* Previous history of dysfunction of the parathyroid glands
* Previous history of surgery of the parathyroid glands
* A history of kidney failure or hepatocellular
* History of osteomalacia or Paget's disease
* unhealed cancer antecedent
* History of sarcoidosis
Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease

This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL.


Eligibility Criteria:
Inclusion Criteria:

* Renal/ureteral stones \> 4 mm

Exclusion Criteria:

* Anatomical abnormalities
Reversal of Residual Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine

The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.

Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.

Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.

Eligibility Criteria:
Inclusion Criteria:

* 1 age of 18 to 65 yr,
* 2 body mass index 18.5 to 25.0 kg/m2,
* 3 American Society of Anesthesiologists physical status I to III
* 4 scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask
* 5 patients having given informed consent to the study

Exclusion Criteria:

* 1 patients who had participated in another clinical trial within 1 month
* 2 Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease
* 3 known neuromuscular disease
* 4 suspected malignant hyperthermia
* 5 hepatic or renal dysfunction
* 6 glaucoma
* 7 allergy to the medication that used in this trial
* 8 taking medicaments that might influence the effect of NMB agents
* 9 pregnant, or breastfeeding state
* 10 taking medication known to alter the effect of neuromuscular blocking agents( toremifene .etc)
Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process \[ZOSTAVAX™ (AMP)\] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.


Eligibility Criteria:
Inclusion Criteria:

* No fever on day of vaccination
* History of varicella or residence in a VZV-endemic area for ≥30 years
* Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component
* Prior receipt of any varicella or zoster vaccine
* Prior history of herpes zoster
* Have recently had another vaccination
* Pregnant or breastfeeding
* Use of immunosuppressive therapy
* Known or suspected immune dysfunction
* Concomitant antiviral therapy
A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage

A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin µs for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic.

All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service.

First objectives: demonstrating the early positivity of CD26 compared to ultra-sensitive troponin.

Eligibility Criteria:
Inclusion Criteria:

* Subject with compatible symptoms with an acute coronary syndrome, for at least 15 minutes and not older than 3 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or two arms, pain in the jaw, pain in the back / neck / stomach, breathlessness , cold sweats, nausea / vomiting , dizziness )
* Man or woman,
* Patient Did not receive heparin or low molecular weight heparin (LMWH ) before the initial blood sample ,
* Patient Agreeing to participate in the study and who signed an informed consent

Exclusion Criteria:

* Minor or major patient trust
* Patient Not having signed informed consent (refusal , physical or mental disability ... )
* Patient Who received anticoagulation before carrying blood samples
* Patient With a progressive septic processes , neoplasia undergoing treatment, dialyzed kidney failure, a history of surgery or coronary angioplasty less than six months.
* Transplanted heart, renal or hepatic
* heart attack
* Subject Whose symptoms clearly eliminates acute coronary syndrome ( penetrating trauma, traumatic injury by crushing ... )
* Patient Died between the time of inclusion and arrival in the cardiology intensive care ( SIC )
* Patient Withdrawing consent under study
Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse

The main of this study is to assess the feasibility of a patients follow-up visit receiving trastuzumab subcutaneous by Advanced Practice Nurse.


Eligibility Criteria:
Inclusion Criteria:

* Patient care at the Cancer Institute Lucien Neuwirth
* Patient aged over 18 years
* Patient with breast cancer overexpressing HER2 adjuvant
* Patient having finished their chemotherapy treatment with IV followed the oncologist day hospital
* Patient under Trastzumab subcutaneously
* Patient affiliated or entitled to a social security scheme (mandatory requirement for all studies)

Exclusion Criteria:

* Refusal to participate, most patient protected under guardianship.
* Patient in inability to understand the course of the study
* Patient with documented history of cognitive or psychiatric disorders.
* Patients pregnant or lactating
* Patients under guardianship or curatorship
Diversity and Inclusion in Research Underpinning Prevention and Therapy Trials

This proposal brings together multidisciplinary teams from four New York City institutions charged with reducing cancer disparities that affect approximately two million people residing in some of the most diverse and underserved communities in the United States. The intent of this collaborative research is captured by its acronym, DISRUPT: Diversity \& IncluSion in Research Underpinning Prevention \& Therapy Trials. To disrupt the norms that maintain heightened risk and poorer outcomes experienced by BIPOC, the research team propose three integrated and synergistic aims to improve diversity and inclusion in CTs through disruptive approaches at the community (Aim 1), provider, system and patient (Aim 2), and basic and translational scientist levels (Aim 3). All three aims focus on metrics for changing norms reified in institutional policies and established practice that will provide essential evidence to translate and scale these changes to institutions and networks involved in cancer treatment research. In Aim 1, the research team will partner with local organizations to formulate and disseminate new norms regarding cancer care and research and diffuse these new norms throughout the community via community organizations and Health Ambassadors bringing a different vantage point on CTs, raising awareness and increasing demand for access to cancer research. In Aim 2, the research team will create an electronic approach to identify key clinical characteristics of patients and trials and match patients and trials and bring these data to patients and their physicians at the time of key decisions. In Aim 3, the research team will provide and integrate essential experiential training in diversity, social determinants of health and the importance of conducting community-relevant work into basic and translational science training. This DISRUPT proposal provides the foundation to disrupt norms about cancer clinical trials in our communities, delivery systems and scientific research enterprises.


Eligibility Criteria:
Inclusion Criteria:

* All patients \>21 years of age with invasive breast, lung or liver cancer, who face a treatment decision
* patients of doctors who have consented to participate
* able to give consent and speak either English or Spanish
* For provider recruitment, oncologists, and advanced practitioners caring for patients with breast, lung, liver cancer including medical and surgical oncologists, interventional radiologists \& hepatologists will be eligible

Exclusion Criteria:

* Patients who are unable to give consent
* unable to understand English or Spanish
* lack of invasive breast/liver cancer
* those who do not face an imminent treatment decision
Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma

Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma

The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer cells.

This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of metastatic renal cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared to immunohistochemical staining (IHC).

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for the study, patients must fulfill all of the following criteria:

  1. Patient must be 18 years of age or older.
  2. Patient must have suspected metastatic renal cell carcinoma with at least one identifiable lesion \>2.0 cm as diagnosed by CT, MRI, or ultrasonography within 60 days prior to enrollment.
  3. Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN.
  4. Patient must provide written informed consent prior to enrollment.
  5. Patients must provide a formalin-fixed, paraffin-embedded tissue sample of either the primary or metastatic or recurrent site(s) for IHC staining for the presence of folate receptors from either a previous surgical/biopsy procedure or from a surgery/biopsy scheduled within 30 days of FolateScan. A fine needle aspirate is not acceptable.

Exclusion Criteria:

* Any of the following criteria will make the patient ineligible to participate in this study:

  1. Patient is pregnant or breastfeeding.
  2. Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
  3. Patient has received an investigational agent or therapeutic chemotherapy within 7 days prior to enrollment.
  4. Patient is unable to tolerate conditions for radionuclide imaging.
  5. Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Brain Abscesses in Transplant Recipients: a Multicentre Retrospective Study (BAT-STUDY)

Allotransplantation is the process of transferring organ(s), tissue(s) or cell(s) from a healthy donor to a recipient. The two main applications of allotransplantation are solid organ transplantation and allogeneic hematopoietic stem cell transplantation. For several reasons, including the need to use immunosuppressive drugs after transplantation, recipients of allografts carry a high risk of infectious complications.

Central nervous system infections are dreadful complications of transplantation, which can be divided into brain abscesses, meningitis, and encephalitis. In particular, brain abscesses pose major diagnostic and therapeutic challenges to transplant physicians, and are frequently fatal in transplant recipients. As compared with immunocompetent patients, transplant recipients and other immunocompromised patients have an increased risk of brain abscesses due to opportunistic pathogens, including fungi, parasites, bacteria, and mycobacteria.

Determining the epidemiology of brain abscesses is critical to guide transplant teams regarding the diagnosis and management of brain abscesses in transplant recipients.

Because the incidence of brain abscesses is low after transplantation, transplant teams often have limited clinical experience in the management of these infections. Similarly, most publications focusing on post-transplant brain abscesses are either case reports, small case series, or review articles.

We therefore aim to conduct a multicentre retrospective study on the epidemiology, the characteristics, and the outcome of brain abscesses in transplant recipients in the era of new diagnostic tools and progress in prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Transplant recipient (i.e., solid organ transplant recipient or allogeneic hematopoietic stem cell transplant recipient)
* Radiological evidence of brain abscess(es) after transplantation
* Brain abscess(es) classified as either proven, probable or possible (see definitions below)Diagnosis of brain abscess made between January 2010 and December 2021

Exclusion Criteria:

* Opposition of the research
* Patients under guardianship