cyrilzakka/clinical-trials huggingface dataset:
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant

This is a pilot study to explore and identify changes in molecular processes within the oral mucosa that are associated with the development of oral mucositis (OM) in patients treated with Melphalan who undergo autologous peripheral blood stem cell transplantation.

This is an exploratory observational (non-therapeutic) study to collect blood and buccal mucosal samples to evaluate RNA expression, assess bacterial colonization, and plasma Melphalan concentrations in approximately 50 eligible patients.

All study samples will be collected from participants while they are hospitalized to receive standard of care high-dose Melphalan (HDM) chemotherapy and autologous peripheral blood stem cell transplantation (ASCT). Patients who receive this treatment are typically admitted the day before HDM. The day after HDM, patients receive ASCT and remain hospitalized for approximately 21 days, or until their absolute neutrophil count increases to at least 500 cells per mm3 and they are no longer considered neutropenic.

Patients will have blood samples collected for pharmacokinetic analysis at approximately 0 minutes (before infusion begins), 15 minutes (during the infusion), 30 minutes (at the end of infusion), 60 minutes, 90 minutes, 120 minutes, and 180 minutes after the start of Melphalan infusion.

A buccal swab will be done to collect mucosal bacterial samples using paper strips (Periopaper) or a sterile cotton tipped swab brushed against the right and left buccal mucosa for approximately 15-30 seconds at the following time points:

1. Within 24 hours PRIOR to administration of Melphalan
2. Day +3 AFTER transplantation
3. Upon development of OM (approximately on days +7-10)
4. Upon recovery of absolute neutrophil count (ANC) to greater than 500/mm3, or on discharge, whichever occurs first, in patients who developed OM

A buccal scraping will be done for gene expression using a dermatologic curette taken from the right and left buccal mucosa at the following time points:

1. Within 24 hours PRIOR to administration of Melphalan
2. Day +3 AFTER transplantation Note: Patients' mouths will be rinsed with Mary's Magic mouthwash prior to the procedure for 15 seconds, which will allow for removal of food particles, colonized bacteria and anesthetization of oral mucosa. During procedure, any signs of patient discomfort will be monitored. If patient expresses discomfort, additional oral topical anesthetic will be utilized to de-sensitive buccal mucosa.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with multiple myeloma (MM) or systemic light-chain amyloidosis who are receiving high-dose Melphalan (HDM) and autologous peripheral blood stem cell transplantation (ASCT).
2. Age is greater than 18 years old
3. Patients receiving a total Melphalan dose of 140-200 mg/m2 as the preparative regimen
4. No prior history of allogeneic stem cell transplantation
5. Patients otherwise meeting all standard institutional criteria for ASCT

Exclusion Criteria:

1. Patients who do not meet inclusion criteria
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence

The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females 18-65 years old
* VEINES Sym Score less than 75 points
* Varicose Vein clinical classification CEAP 2, 3, 4, or 5
* Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
* Superficial venous disease manifested by both symptoms and visible varicosities
* Ability to comprehend and sign an informed consent document and completed study questionnaires in English

Exclusion Criteria:

* Incompetence of the SSV which substantially contributes to the filling of visible varicose veins
* Current or previous Deep Vein Thrombosis
* Leg obesity
* Peripheral arterial disease in the leg to be treated
* Reduced mobility
* Planned prolonged travel with limited mobility with in 4 weeks of treatment
* History of pulmonary embolism or stroke
* Major surgery, prolonged hospitalization or pregnancy within 3 months
* Current anticoagulation therapy (within 7 days of enrollment)
* Participation in a clinical study involving a investigational product within 3 months
* Major co-existing disease or clinically significant laboratory abnormalities
* Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions
* Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
* Pregnant or lactating women
* Current alcohol or drug abuse
Novel Endovascular Access Trial (NEAT)

The objective of this study is to evaluate the safety and efficacy of the FLEX System when used to create an arteriovenous fistula (AVF or AV fistula) percutaneously in patients with Chronic Kidney Disease (CKD) who require hemodialysis vascular access.

This is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the FLEX system to create an endovascular AVF in patients with CKD who require hemodialysis vascular access.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
* Adult (age \>18 years old).
* Established, non-reversible kidney failure requiring hemodialysis.
* Written informed consent obtained.

Exclusion Criteria:

* Functioning surgical access in the planned treatment arm.
* Pregnant women.
* New York Heart Association (NYHA) class III or IV heart failure.
* Allergy to contrast dye.
Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus

Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The investigators then initiated a phase II clinical trial with Nimotuzumab plus Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.

In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin as perioperative therapy for patients with resectable esophageal squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
* Locally advanced disease that is technically operable with curative intent (R0)
* T3, N0 OR T1-3, N+ OR T4, Nx
* No T1-2, N0
* No inoperable T4 (unequivocal organ involvement)
* No distant metastasis, including M1a lymph node status
* Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
* No carcinoma of the cervical esophagus
* Obstructive tumors allowed

Exclusion Criteria:

* Not suitable to surgery
* cervical Esophageal Carcinoma(distance of incisor tooth\<19cm)
* early Esophageal Carcinoma(Stage I)
* complete esophageal obstruction，Esophageal perforation or hematemesis
* other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
* pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
* History of serious allergic or castor oil allergy
* Patients who are not suitable to participate in the trial according to researchers
Lung Disease Collection (Qatar): Evaluation of the Lungs of Individuals With Lung Disease

The purpose of this protocol is to obtain biologic samples from the blood and lungs from patients with lung diseases in order to study the causes and indications of these disorders, learn how these lung disease manifest and progress, and how the lung disease can be treated.

The lung diseases are disorders associated with functional and/or structural derangements to the alveolar structures, airways, pulmonary blood vessels, pleura and/or mediastinum. The purpose of this protocol is to obtain biologic materials from the blood and lungs from these patients in order to: (1) develop an understanding of the etiology and pathogenesis of these disorders; and (2) identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs. As such, this protocol is part of the "infrastructure" for all of our human lung-related studies such as genomic/gene expression studies of airway epithelium and alveolar macrophages in all individuals with chronic obstructive lung disease (COPD), asthma, bronchogenic carcinoma, and pulmonary fibrosis compared to normal non-smokers and smokers, and studies of mediators in bronchoalveolar lavage fluid.

This protocol, to be carried out at Weill Cornell Medical College - Qatar and Hamad Medical Corporation, Qatar, parallels a similar approved protocol IRB #0005004440, entitled, "Evaluation of the Lungs of Individuals with Lung Disease with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy", ongoing at Weill Cornell Medical College - New York.

Eligibility Criteria:
Inclusion Criteria:

Inclusion/Exclusion criteria for Part A

* Must provide informed consent
* Males and females, age 18 years and older
* Evidence of lung disease by at least one of the following:

  1. symptoms consistent with pulmonary disease;
  2. chest X-rays and/or chest CT consistent with lung disease;
  3. pulmonary function tests consistent with lung disease;
  4. lung biopsy consistent with lung disease;
  5. family history of lung disease;
  6. diseases of organs with known association with lung disease; and
  7. individuals suspected of having lung disease based on history and/or physical examination
* Undergoing fiberoptic bronchoscopy as dictated by their standard clinical care

Exclusion Criteria:

* Patient refuses consent.

Patients enrolled in Part A of the protocol will not undergo screening procedures/tests. These patients are undergoing a fiberoptic bronchoscopy as dictated by their standard clinical care and additional samples will be taken for research purposes.
A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy

Premenopausal women who are diagnosed with breast cancer are frequently treated with chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary loss of menstrual periods to permanent menopause. It is difficult to predict how an individual's ovarian function will be affected by chemotherapy. There are a number of hormones which can be measured in the blood which are related to fertility and ovarian function. The levels of these hormones may change with chemotherapy, and may relate to the effect of chemotherapy on the ovaries.

In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with breast cancer and will be treated with chemotherapy. We will check blood levels of the hormones before, immediately after, and 1 year after treatment with chemotherapy. We will only be checking these blood tests for this study; the type of chemotherapy given will be up to the patient and her oncologist. We will also ask some questions about factors that can influence the levels of these hormones, such as number of children, age of menopause of other family members, and smoking history. The results from this study will be used to help us develop future studies looking at changes in ovarian function with chemotherapy, and the effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be women with a histologically confirmed invasive adenocarcinoma of the breast (stage I, II, or III) with no evidence of metastatic disease.
* Patients must be planning to receive neoadjuvant or adjuvant chemotherapy. Patients may receive concurrent trastuzumab as indicated. If a patient has not yet undergone final surgical resection, it must be highly likely (but is not required to be definite) that the patient will be treated with adjuvant chemotherapy.
* Patients must have:

  * Reached their 25th birthday and not yet reached their 51st birthday at the time of study enrollment, AND
  * Had menses within 3 months prior to starting chemotherapy
* Patients must not have received prior cytotoxic chemotherapy for any oncologic, rheumatologic, or dermatologic condition.
* Patients must not have had prior bilateral oophorectomy or pelvic radiation, and must not have had prior hysterectomy
* ECOG performance status 0 - 2
* Pregnant or nursing women may not participate. Women of reproductive potential must agree to use an effective non-hormonal contraceptive method, such as condoms, tubal ligation, non-hormonal intrauterine device, partner sterilization, and abstinence during chemotherapy.
* All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Nebulized Morphine in Chest Trauma Patients: A Prospective Study

This is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. Each patient received a nebulization of 10 mg morphine. If Visual Analog Score (VAS) assessed after 10 minutes still\> 4, nebulization was repeated every 10 minutes until pain relief. At 30 minutes, VAS\> 4 means failure.

The aim of this study was to determine the predictive factors of nebulized morphine failure in patients with chest trauma and to establish a score based on these factors to guide the analgesic protocol.

Methods: This is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. Each patient received a nebulization of 10 mg morphine. If Visual Analog Score (VAS) assessed after 10 minutes still\> 4, nebulization was repeated every 10 minutes until pain relief. At 30 minutes, VAS\> 4 means failure.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years and over
* victims of isolated chest trauma,
* admitted to the intensive care unit

Exclusion Criteria:

* not consen
* pregnant woman
* polytrauma
* hemodynamic instability with systolic blood pressure less than 100 mmHg,
* treated with morphine during transport or in the emergency room
* need initial ventilatory support, bradypnea (respiratory rate less than 12 cycles per minute)
* allergy to opiods
* initial pain Visual Analog Scale (VAS) ≤ 4
Leflunomide Treatment for IgG4-RD

This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Aged 18 to 70 years old with informed consent
* All patients must meet the following diagnostic criteria of IgG4RD (2011):

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L);
  3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
  4. exclusion of other diseases.

Exclusion Criteria:

* Patients will not be included if meets any of the following criteria:

  1. Patients who were diagnosed as other autoimmune diseases;
  2. Patients who were diagnosed as malignant diseases;
  3. Pregnant and lactating women；
  4. Active infection: HIV, HCV, HBV, TB；
  5. Serious organ function failure, expected life time less than 6 months.
  6. Presenting with Mikulicz disease without other manifestations.
Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures

The goal of this pilot study is to learn about the feasibility about prescribing anti-depressants at discharge in patients aged 50 years and older with a lower extremity fragility fracture. The main questions it aims to answer are:

* What are the obstacles to enrolling patients and prescribing anti-depressants among older adults?
* Is it possible to start prescribing SNRI medication upon discharge?
* What is the prevalence of depressive symptoms amongst patients with different types of injuries and weightbearing status?
* What is a transition of care plan for patients who have geriatric depression and require further care?

Participants will:

* Undergo screening using the Geriatric Depression Scale
* Start on Duloxetine 30mg daily at time of discharge
* Report medication compliance and complete re-screening monthly
* Complete patient reported outcome measures and 3 months, 6 months, and 1 year
* Receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint

As with many mental health diagnoses, there continues to be a stigma against receiving treatment and potentially even more so receiving prophylaxis16. Identifying these hurdles at the patient level will allow us to better educate patients and physicians about the benefits of this intervention. Secondly, this pilot study will help us determine if it is possible to start prescribing SNRI medication upon discharge. It will allow us to navigate the procurement of medications through Medicare, prescribing practices at discharge and address patient concerns regarding starting a new medication.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric (greater than or equal to 65 years old)
* Lower extremity fragility fractures managed operatively

Exclusion Criteria:

* Polytrauma
* Pathological fractures
* Patients on hospice
* Patients with previously diagnosed psychiatric disorders
* Patients with previously diagnosed dementia
* Patients already taking Selective serotonin reuptake inhibitors (SSRI)s and Serotonin- norepinephrine reuptake inhibitors (SNRI)s
* Patients already taking mood stabilizing medication
* Unable to provide informed consent (no use of a legal authorized representative)
* Patients with pre-existing life limiting diagnoses (cancer, etc.)
Determine the Clinical Advantage of IV vs PO Acetaminophen

There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.

Eligibility Criteria:
Inclusion Criteria:

* ASA scores I-III
* Ambulatory surgery patients
* Ages 18-75
* Surgeries requiring general anesthesia for hernia surgery

Exclusion Criteria:

* Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
* Known allergy to acetaminophen
* Emergency surgery
* Patients who were not fasted
* Patients who cannot tolerate PO
* Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
* Pregnancy
* Weight less than 50kg
* Chronic daily narcotic use
* Patients who's anesthetic plan requires regional anesthesia
* Patient refusal to participate or do not have capacity to provide consent.
A Registry Study in Lymphoma Patients Treated With Liposomal Doxorubicin

This study is to evaluate the incidence of interstitial pneumonia in lymphoma patients treated with liposomal doxorubucin. The treatment response and other adverse events will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed lymphoma
* 18-80 years
* ECOG\<= 2
* newly diagnosed lymphoma
* liposomal doxorubicin is planned in the treatment
* normal lung function
* no history or malignancy
* informed consented

Exclusion Criteria:

* history of malignancy, now in the treatment
* pregnant
* serious infection
* other uncontrollable conditions judged by the investigator