cyrilzakka/clinical-trials huggingface dataset:
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck

This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients of ≥18 years of age.
2. Patients with a documented diagnosis of recurrent head and neck squamous cell cancer (squamous cell carcinoma, including nasopharyngeal cancer, or adenoid cystic carcinoma).

   Patients must have at least one confirmed and evaluable tumor site.\* The recurrence must have bidimensional measurements by clinical examination or CT/MRI/PET scan. A confirmed recurrence site may also be biopsy-proven
3. Tumor Recurrence which is surgically unresectable
4. Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) (see Appendix Performance Status Evaluation) and an expected survival of ≥ three months.
5. Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must have a platelet count of ≥150,000/ mm3
6. Pre-enrollment chemistry parameters must show: bilirubin\<1.5X the institutional upper limit of normal (IUNL); AST or ALT\<2.5X IUNL and creatinine\<1.5X IUNL.
7. Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
8. Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
9. Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
10. Patients who refuse surgery.

Exclusion Criteria:

1. Women who are pregnant or lactating.
2. Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
3. Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
4. Pre-existing cardiac or respiratory disorders
5. Unrelated malignancy within 3 years
6. History of hypersensitivity reactions to other EGFR inhibitors
7. Metastatic disease
8. Less than 6 months from prior Radiation Therapy (Arm 1)
9. Previous exposure to Cetuximab
Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis

Vascular access (VA) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. This study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis.

It is unknown whether central vein stenosis occurs after temporary or long term hemodialysis catheter in long-term hemodialysis patients. this study will aim to explore this question. Study design is randomized, controlled trial. One arm is temporary catheters in the internal jugular vein, and another arm is tunneled cuffed hemodialysis cather. 2\*2 is randomly distributed.

The main outcome: central vein stenosis diagnosed by venography. The secondary outcome: the time of infection, and catheter patency. Study period: one year

Eligibility Criteria:
Inclusion Criteria:

* need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts

Exclusion Criteria:

* Uremia with heart failure or lung function failure
Large-scale Expansion and Characterization of Mesenchymal Stem Cells for Clinical Application

According to many recent research, mesenchymal stem cells (MSC) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis.

Based on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of total knee replacement. The investigators are going to isolate and expand MSC from these two tissues respectively, and then compare the chondrogenesis ability for clinical application. In the other hand, the investigators plan to build techniques and procedures which comply with "Good Tissue Practices (GTP)"


Eligibility Criteria:
Inclusion Criteria:

Patient who have an total knee replacement surgery

Exclusion Criteria:

Patient who don't sign the agreement
Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients

The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. The main questions it aims to answer are:

1. Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea?
2. Does probiotics effective in reducing inflammation?
3. Is there any connection between fecal microbiome and immunological markers?

Participants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. Researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.


Eligibility Criteria:
Inclusion Criteria:

* Received living or deceased donor kidney, subjects will be monitored peri-operatively
* Presence of mild to severe diarrhea (\> 3 times loose stools/day); include type 6 and 7 in the Bristol Stool Chart.
* Has been on adjusted and/or maintenance dose of calcineurin inhibitors, antimetabolites and steroid regimen. Treatment of rejection including administration of steroids, intravenous immunoglobulin/plasmapheresis, rituximab and anti- thymocytes are also acceptable in this research.

Exclusion Criteria:

* Pregnant and lactating women
* Has been receiving probiotics treatment
* Recurrence of gastrointestinal diseases including inflammatory bowel diseases, diverticulosis, irritable bowel syndrome. Had past surgical history of gastric bypass.
* Diagnosed with cancer
* Presence of infectious diarrhea, fever and high white blood cells (WBC) count. Infectious diarrhea is defined by polymerase chain reaction (PCR) negative for community acquired diarrhea panel \[positive for Sapo virus, Noro virus, Clostridium difficile (positive for toxin A and B), Yersinia enterocolitica \[(positive for toxin A and B) and enteropathogenic E. coli (positive Shiga toxins)\].
A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults

This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian and Japanese male or female subjects 18 to 55 years old (inclusive) that meet the following criteria at Screening:

  * Japanese subjects defined as being born in Japan, having not lived outside of Japan for more than 10 years, and having both parents and four grandparents who are of Japanese ancestry.
  * Caucasian subjects, defined as having both parents and four grandparents descended from and of the peoples of Europe, the Middle East, or North Africa, who are body weight-matched (± 15%) 1:1 with Japanese subjects.
* Body weight in the range of ≥ 50 kg and ≤ 100 kg
* Body mass index of ≥ 18 kg/m2 and ≤ 30 kg/m2

Exclusion Criteria:

* Positive serology test for human immunodeficiency virus (HIV)-1 / 2 antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.
* Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study.
* Evidence of current active infection.
* Known malignancy or a history of malignancy in the past 5 years .
* Blood pressure or pulse rate measurements outside the normal range for the subject's age.
* Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable method of contraception
* Pregnant, breastfeeding, or not willing to cease breastfeeding.
* Donation or loss of more than 500 mL of blood within 3 months, or donated plasma within 7 days
* History of clinically significant arterial or venous thrombosis, bleeding disorder, or any abnormal coagulation test result
Hemodynamic Comparison of Peripheral and Central VA ECMO.

The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is:

* Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on hemodynamics and organ perfusion.

Participants require VA ECMO support, will be divided into two groups in an intention-to-treat analysis: central artery cannulation and peripheral artery cannulation.

Researchers will analyze different cannulation strategies for VA-ECMO and identify potential advantages and disadvantages for two groups of VA-ECMO.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* Participants with cardiogenic shock
* Obtaining informed consent from participants or their affiliated beneficiaries

Exclusion Criteria:

* Irreversible heart failure
* Contraindications to anticoagulation therapy
* Uncontrolled bleeding
* Irreversible neurological pathology
* Participants limited to extracorporeal cardiopulmonary resuscitation
TNFerade Biologic to Treat Locally Advanced Prostate Cancer

While radiation therapy with androgen ablation (hormone reduction) is the standard method of treating locally advanced prostate cancer. New treatments are being combined with radiation therapy in an effort to further improve the cure rates.

This study proposes to combine an experimental drug, TNFerade™ Biologic, (also called AdGVEGR.TNF.11D or "TNFerade") at different dose (amounts) levels in combination with radiation.

TNFerade™ Biologic is a form of gene transfer therapy that when injected into the tumor has shown to increase the effect of radiation therapy.


Eligibility Criteria:
Inclusion Criteria

* Histological documented high-risk localized prostate cancer defined by clinical stage \>=T3 or Gleason score ≥8.
* Lack of distant metastases (including bone, liver, or extrapelvic lymph node metastases) on standard CT and bone scanning. Patients with suspected or histologically confirmed pelvic lymph node metastases are eligible.
* Normal organ function defined by:

  * Hgb \> 10 mg/dl (may be transfused or on erythropoietin);
  * Platelets \> 100,000/l;
  * Absolute neutrophil count \> 1500/l.
* Bilirubin \< 1.5 mg/dl.
* AST and ALT \< 1.5X upper limit of normal.
* Written signed informed consent.

Exclusion Criteria

* Absolute or relative contraindication to prostate radiotherapy including but not limited to prior pelvic radiotherapy, active infectious or inflammatory colitis, and inability to lay supine for daily radiation treatments.
* Requirement for ongoing antithrombotic treatment with coumadin or one of its derivatives, heparin or one of its derivatives, or thrombin inhibitors. Low dose aspirin for prevention of cardiovascular events is acceptable.
* Active vascular disease defined as a stroke, transient ischemic attack (TIA), myocardial infarction, or any vascular procedure performed for ischemic disease within the last 6 months.
* History of thrombosis (pulmonary embolism (PE) or deep vein thrombosis (DVT)) or known thrombophilia.
* Coagulopathy (INR\>1.5, PTT ratio \>1.5)
* Major surgery within the last 1 month (excludes minor superficial surgeries, biopsies, or minimally invasive approaches).
* Chemotherapy or experimental medications within 4 weeks of study entry.
* Chronic treatment for greater than 6 months with oral steroids at doses above 10 mg/day prednisolone (or equivalent).
* Clinical evidence of active infection of any type.
* HIV-positive patients receiving combination anti-retroviral therapy.
* Other significant concurrent medical or psychiatric illness that would limit compliance with study.
* Unwilling to use condoms or another barrier method of birth control for at least 8 weeks following the last dose of TNFerade™ Biologic and some form of birth control for at least one year. -
St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)

The SPARC-C study is a prospective, single-centre observational study of patients referred for the management of large (≥ 20mm) non-pedunculated colorectal polyps (LNPCPs). Patients are managed consistent with current standards of care. Prospectively collected data includes: patient clinicodemographic details, lesion details, procedural details, and clinical outcomes.

Endoscopic resection techniques, including endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and cold snare resection (CSR), have become the primary treatment strategy for the vast majority of large non-pedunculated colorectal polyps (LNPCPs). This is because of the efficacy, safety, and cost-effectiveness of endoscopic techniques compared to surgery. Site-specific technical modifications and the development of auxiliary techniques/strategies have mitigated the risk of technical failure, clinically significant post-resection bleeding (CSPEB), significant deep mural injury (S-DMI)/perforation, and recurrence. However, questions still remain about the application and selection of these techniques.

This is a single-centre cohort study of consecutive patients referred for the management of LNPCPs to one of two interventional endoscopists with a tertiary referral practice in minimally invasive endoscopic resection techniques. It is based at St. Paul's Hospital and its affiliated sites, with the aim of enrolling 3500 participants over 10 years.

This cohort serves as a platform to continue refining the management of LNPCPs. We will evaluate LNPCP management outcomes, including technical success, clinical success, clinically significant intra-procedural bleeding (CSIPB), S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery. Findings will also help to further refine mitigating strategies for intra-procedural and post-procedural adverse outcomes (CSPIB, S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery). Finally, we aim to optimize the application of minimally invasive endoscopic resection techniques for the management of LNPCPs, including the development of artificial intelligence clinical decision support solutions (AI-CDSS).

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age referred for the management of an LNPCP
* Able to provide informed consent.

Exclusion Criteria:

* Unable to provide informed consent
* Pregnant or lactating women.
Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment

The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening.

Visit 1: Study information and delivery of informed consent. Recording of the patient's medical history, general examination, and prophylaxis. Alginate impressions will be taken of the upper and lower arches for all patients who meet the inclusion criteria. The impressions will be poured into plaster, and individualized bleaching trays will be made for each patient according to the predetermined assignment ( 1mm extended or 3 mm extended bleaching tray). A positioning guide tray will be fabricated for color measurement.

Visit 2: Initial color measurement with a spectrophotometer and the positioning guide. Each patient will receive their individualized trays. Additionally, they will be given 3 syringes of bleaching agent (Opalescence 16%, Ultradent Products). Each patient will be provided with an instruction sheet and recording sheets to fill out daily during the 3-week study period. They will record if they had gingival irritation and the degree of dental sensitivity.

Visit 3: First-week bleaching review. Data collection (gingival irritation + color + sensitivity).

Visit 4: Second-week bleaching review. Data collection (gingival irritation + color + sensitivity).

Visit 5: Third-week bleaching review and end of the study. Data collection (gingival irritation + color + sensitivity).

Eligibility Criteria:
Inclusion Criteria:

* No oral or systemic pathology
* Periodontally healthy
* No cavities
* Tooth shade of the upper and lower canines A2 or darker

Exclusion Criteria:

* Adhesive restorations or prostheses in the anterior region
* Enamel or dentin alterations
* Smoking
* Pregnant women
* Undergone prior bleaching treatment
Identifying Early Lung Cancer Cells in Malignant Pleural Effusion Samples From Patients With Primary Lung Cancer

RATIONALE: Studying samples of pleural fluid in the laboratory from patients with lung cancer may help doctors identify early lung cancer cells. It may also help the study of lung cancer in the future.

PURPOSE: This laboratory study is looking at malignant pleural effusion samples from patients with primary lung cancer to see if early lung cancer cells can be identified.

OBJECTIVES:

* Isolate and identify lung cancer precursor cells in discarded pleural fluid specimens obtained during routine thoracentesis procedures for the diagnosis and treatment of malignant pleural effusions.

OUTLINE: Malignant pleural effusion specimens obtained from the Pathology Department at the University Hospitals of Cleveland are analyzed using an immunomagnetic bead enrichment assay to isolate cells of epithelial origin. The isolated cells are then stained with fluorescent DNA binding dye, Hoechst 33342, and other markers (i.e., CD133, CD24/CD44) and sorted by flow cytometry into progenitor and nonprogenitor subpopulations. The sorted subpopulations are separated and examined functionally by in vitro and in vivo studies. Sphere culture studies are also performed on the sorted subpopulations. The specimens may also be utilized for transcriptional profiling studies, RNAi studies, and for the establishment of long-term cultures and cell lines. DNA is also isolated and stored from tumor and nonepithelial normal cell compartments for future genetic studies on known and unidentified genetic abnormalities contributing to the development of lung cancer, such as EGFR, ErbB2, K-ras, and p53 mutational status.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytologically positive malignant pleural effusion secondary to primary small cell or non-small cell lung cancer
* Recruited from the Division of Hematology/Oncology, the Multidisciplinary Thoracic Oncology Group of Ireland Cancer Center, or the inpatient or outpatient units of Case Medical Center-University Hospitals

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Transversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors

Transversalis fascia plane block (TFPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. It has been shown that TFPB and rectus sheath block (RSB) administration reduces opioid consumption and related side effects in patients undergoing surgery with general anesthesia. To our knowledge, there is no study examining TFPB in donor nephrectomy.

The investigators aimed to prospectively examine the effect of TFPB and RSB on opioid consumption in postoperative period on donors who will undergo laparoscopic nephrectomy in renal transplantation surgery.


Eligibility Criteria:
Inclusion Criteria:

* Donor patients scheduled for elective nephrectomy in renal transplantation surgery
* American Society of Anesthesiologists (ASA) I-II
* Patients who are aged between 18-75

Exclusion Criteria:

* Skin infection at the block area
* Coagulation disorder and using anticoagulant drugs
* End-stage organ and system failure
* Severe pulmonary and/or cardiovascular problems
* Substance addiction or known psychiatric or mental problems
* Chronic painkiller usage
Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort

The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.

This is an observational study. Data will be prospectively collected, starting with a detailed baseline description of disease and treatment status, followed by updates everything six months for the next three years.

Eligibility Criteria:
Inclusion Criteria:

* Patient correctly informed about the study
* Symptoms and/or clinical signs indicating that the brain stem is affected
* MRI shows punctate gadolinium highlights and/or curvilinear bridge and/or middle cerebellar peduncles
* Clinical and radiological cortico sensitivity
* If a cerebral biopsy has been performed, presence of a lymphocytic, histiocytic or lympho-hysticytic infiltrate

Exclusion Criteria:

* symptoms and/or clinical signs indicating impairment other than the central nervous system
* Cortical impairment present on MRI, microbleeds, stenosis on magnetic resonance angiography, or pacchymeningitis
* Presence of other diseases that could explain such clinical and radiological signs (see inclusion criteria)
* If a cerebral biopsy has been performed, presence of signs of malignancy (eg, clonal proliferation, cellular atypia), vasculitis, granuloma, or demyelination
Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)

This is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will be followed starting first dose-till 30 days after study treatment period completion.

This study was terminated - Please see "P04367 - Lebanon"


Eligibility Criteria:
Inclusion Criteria:

* Should be between 2 and 11 years.
* Should have nasal obstruction for at least 3 months.
* Should have evidence of adenoids hypertrophy by nasopharyngoscopy, which cause \>50% obstruction of the posterior choanae.
* May have concomitant allergic rhinitis, by history, \& and specific blood studies; however, the symptoms should be under control during the study period.

Exclusion Criteria:

* Patients with less than 50% obstruction of the post choanae.
* Patients with history of recurrent epistaxis or immunodeficiency.
* Patients with severe septal deviation.
* Patients with unilateral or bilateral choanal atresia, large nasal polyps or any nasal mass.
* Known allergy to the drug.
* Presence of chronic otitis media defined as: otorreha + perforation (concomitant otitis media with effusion, or recurrent otitis media are not excluded).
* Cystic fibrosis \& other causes responsible for nasal obstruction.
* Infection (ie; sinusitis).
* History of recent surgery or trauma to nose, unless all wounds have healed.