cyrilzakka/clinical-trials huggingface dataset:
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.

OBJECTIVES:

* Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
* Determine the safety of this drug in these patients.

OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1.3-4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:

  * Measurable metastatic disease by one of the following methods:

    * Radiography

      * If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated
    * Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L
* Previously treated progressive disease meeting 1 of the following criteria:

  * Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed)
  * Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT)
  * Prior treatment with 1 cisplatin-based regimen (primary mediastinal nonseminomatous GCT)

PATIENT CHARACTERISTICS:

Age

* 16 and over

Performance status

* Karnofsky 70-100%

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic

* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 2 times upper limit of normal

Renal

* Creatinine no greater than 2.2 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunotherapy

Chemotherapy

* See Disease Characteristics
* No other concurrent cytotoxic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* No concurrent radiotherapy

Surgery

* Not specified

Other

* No other concurrent experimental or commercial anticancer medications or therapies
Waitlist-controlled Trial of a Psychological Education Program for Nurses

The purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. The investigators will explore efficacy of the intervention for reducing psychological stress and medical errors.


Eligibility Criteria:
Inclusion Criteria:

* Must have RN degree
* Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit

Exclusion Criteria:

* Participation in earlier pilot trial of the intervention
Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo for the treatment of alcohol use disorder (AUD).

This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo in 16 subjects enrolled in a 12 week, randomized, double-blind, outpatient trial. Each subject will receive randomly one of the drug combinations for 12 weeks plus medication management.

Primary Aim 1: To evaluate the safety, tolerability of Topiramate (TPM) and N-Acetyl Cysteine (NAC) in combination or Topiramate (TPM) + placebo for the treatment of Alcohol Use Disorder (AUD). This aim will be accomplished by testing the following:

•Hypothesis 1 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) will be well tolerated by participants as evidenced by less self-report cognitive side effects (word finding difficulties, difficulties with concentration, and confusion).

Secondary Aim 1: The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduce alcohol drinking. This aim will be accomplished by testing the following:

•Hypothesis 2 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduced alcohol drinking , as evidenced by a statistically significant reduction in percentage of heavy drinking days (PHDD) as compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Ages 18 and above
* Good physical health
* Current DSM-V diagnosis of alcohol use disorder
* Currently drinking ≥21 alcohol units/week for women and ≥28 alcohol units/week for men on average in the last 28 days prior to screen.
* Be seeking treatment for problems with alcohol
* Be able to take oral medication and be willing to adhere to the medication regimen.
* Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
* Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
* Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
* The pregnancy test for females at screen and prior to randomization must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.

Exclusion Criteria:

Please contact site for additional information
Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement

Postoperative pain and blood loss of non-use compared to partial-use of a tourniquet in bilateral total knee replacement: A Randomized- Control Trial This study aimed to compare the effects of non-use (NTU) and partial-use (before osteotomy to skin closure; BOO) of a tourniquet in bilateral total knee arthroplasty (TKA) on postoperative pain and complications.

Despite numerous meta-analyses, and randomized-control trials (RCTs), there is still no conclusive evidence on the most effective, and efficient method of using a tourniquet.

There is gap of knowledge of method of tourniquet usage. Hence this study will provide the best method to apply tourniquet.

Eligibility Criteria:
Inclusion Criteria:

* patients with over 50 years of age and diagnosed with bilateral severe knee osteoarthritis undergoing bilateral TKA

Exclusion Criteria:

* patients having undergone previous knee surgery
* patients being subject to uncontrolled hypertension, coagulopathy, or recent knee sepsis
* patients with an ASA physical status grade \> 2,
* inability to use patient-controlled analgesia (PCA), such as communication, or cognitive issues, or those patients who were allergic to medications used in the treatment process.
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Replacement of an existing implanted transvenous ICD system
* Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
* Age is \>= 18 years
* Appropriate pre-operative ECG as measured with a specially developed template

Exclusion Criteria:

* Subjects unable or unwilling to provide informed consent
* Any condition which precludes the subject's ability to comply with the study requirements
* Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
* Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
* Patients with a serious medical condition and life expectancy of less than one year.
* Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing
* Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
* Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR \<= 29.
Composites and Urinary Bisphenol-A Study

The Composites and Urinary Bisphenol-A Study (CUBS) is a clinical study of dental composite for its effects on urinary bisphenol-A levels. The study will enroll approximately 139 children recruited from study-affiliated clinical sites in New England.The primary aim of CUBS is to test the hypothesis that urinary bisphenol-A (BPA) concentrations increase after composite restoration placement. BPA is a chemical used in the synthesis of matrix monomers and has been shown to have harmful effects in toxicological studies in laboratory animals. Currently it is unknown whether dental composite restorative materials containing monomers that are derived from BPA result in chronic low-dose BPA exposure in children.

Study subjects will be new or existing patients of the clinical sites who are in need of dental restorations, meet all eligibility criteria, and provide informed consent/assent to participate. Subjects will be asked to provide two pre-treatment urine samples and three post-treatment samples. Urine collections occur next-day and 14 days after treatment, with one final urine collected approximately 6 months later (marking the end of the subject's active study participation). Data will be collected from the clinician's standard oral examination (including new and existing dental treatments), the data collector's measurements of height and weight and interviews administered to the parents/guardians to assess sociodemographic and other relevant factors (e.g., recent food/beverage consumption). Confidentiality will be maintained by assigning each subject a unique number and using only this number or aggregate data in all study reports. All study records will be securely maintained with access limited to essential study personnel only.

Eligibility Criteria:
Inclusion Criteria:

* Aged 3-16 (\<17) years at enrollment.
* 2+ posterior teeth with caries requiring restorations treatable by composite.
* Toilet-trained (not using diapers, pull-ups, or training pants during day or night).

Exclusion Criteria:

* Medical conditions that would render the subject physically unable to provide urine samples.
* Guardian is not proficient in spoken English or Spanish language
* Child is aged 8.0 years or older and not proficient in spoken English or Spanish language
* Living \>35 miles outside of the dental clinic or the NERI office (Watertown MA)
Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science

Crohn's disease(CD),a type of inflammatory bowel disease(IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. And Ustekinumab, a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23, is a newly targeted drug approved for the treatment of Crohn's disease in recent years.Based on the high-throughput imaging characteristic analysis technique, this study quantitatively analyzed the transmural inflammation of Crohn's disease, and discussed its prognostic value in the treatment of Ustekinumab, and further analyzed the increment of its relative clinical index.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients with Crohn's disease diagnosed in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University from January 2020 to June 2022
* Treated with Ustekinumab and followed up regularly for 20 weeks
* Complete pre-treatment cross-sectional imaging data (CTE/MRE and US)

Exclusion Criteria:

* The diagnosis is not clear
* Under the age of 18
* Lack of endoscopic and pathological data
Special Drug Use Investigation for PAXIL Tablet (Pediatric Panic Disorder)

The objectives of this survey was to retrospectively collect and evaluate the information on the efficacy and safety of PAXIL tablets ("PAXIL", hereinafter) in pediatric subjects (aged under 18) with panic disorder under conditions of actual use.


Eligibility Criteria:
Inclusion Criteria:

* Aged under 18 at the time of the panic disorder diagnosis
* Aged under 18 on the starting day of PAXIL treatment
* Having been making periodic visits to the hospital to receive treatment for panic disorder

Exclusion Criteria:

* Subjects who have been treated with paroxetine prior to this investigation
* Subjects with hypersensitivity to paroxetine
* Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide
Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

Posttraumatic Stress Disorder (PTSD) will be a severe problem in Canada in the wake of COVID-19, especially for Military Members, Veterans, First Responders, and Healthcare Workers (MVFH). However, gold standard face-to-face PTSD treatments do not meet current MVFH needs, which requires virtual interventions and minimal healthcare resources. Recognizing the need for a virtual, low-resource PTSD intervention for MVFH with PTSD and their loved ones, the investigators developed Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES is a secure, online self-help intervention for those with PTSD and their partners (www.couplehopes.com). However, MVFH are now particularly likely to be exposed to traumas related to COVID-19. It is essential to identify if Couple HOPES is safe and helpful for couples involving MVFH with COVID-19-related PTSD specifically. This project will therefore test the efficacy of Couple HOPES compared to a delayed waitlist control in 70 couples wherein one member is a MVFH with COVID-19-related PTSD. The investigators will examine if Couple HOPES is helpful in improving PTSD symptoms and relationship satisfaction for such couples, and if it is more or less helpful to this end for these couples compared to those with other forms of trauma exposure. 70 couples including a MVFH with COVID-19-related PTSD, will be randomly assigned to receive Couple HOPES or to a waitlist. PTSD symptoms and relationship satisfaction will be measured \~weekly during the intervention and one month after it. Related problems (e.g., depression, anxiety, healthcare use) will be measured before, in the middle of, after, and one month after, the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Individual who is a Canadian military member, veteran, first responder or healthcare worker with clinically significant levels of PTSD symptoms related to COVID-19
* Individual who is an American healthcare worker with clinically significant levels of PTSD symptoms related to COVID-19
* Must be willing to be audio-recorded for coaching sessions
* Intimate partner willing to participant and complete intervention modules together
* Access to high speed internet

Exclusion Criteria:

* Elevated suicide risk
* Severe physical aggression between partners in the past year
* Clinically significant PTSD symptoms in both members of the dyad
The Impact of Family Financial Support on Child Health

The investigators have partnered with financial coaching organizations to establish what the investigators have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health.The investigators will evaluate the MFP's impact on child overall health rating.

Financial coaching is a new tool in the field of community development, but it has already demonstrated significant financial impact in a number of studies, including one randomized trial conducted by the Urban Institute. Financial coaching improves participant financial literacy, budgeting, saving for financial emergencies, and debt level. The investigators' project will help clinicians and the field of community economic development understand health and well-being through a new economic lens and assess the health-related impacts of the emerging field of financial coaching. The investigators have partnered with financial coaching organizations to establish what they have termed a "Medical-Financial Partnership (MFP)" that offers financial coaching to improve financial and mental health. The investigators will evaluate the MFP's impact on parent-rated child overall health on a 5 point likert scale (Excellent to Poor).

Community-based participants will be recruited from South Los Angeles and randomized to receive either monthly financial coaching plus access to referral for social services (intervention) or access to referral for social services alone (control). Inclusion criteria include having dependents under age 18, having some form of income, and having a tax identification number (social security number or Individual Tax Identification Number). Participants will be surveyed quarterly regarding their parent-rated child overall health on a 5 point likert scale (Excellent to Poor).

Eligibility Criteria:
Inclusion Criteria:

* Participants will include caregivers and parents with one or more dependent children, some form of income, and a tax identification number.

Exclusion Criteria:

* Inability to take part in financial coaching or primary language other than English or Spanish.
Cohort of Patients With NSCLC Treated With Nivolumab Under the ATU Program

Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

Although the oncogene addiction concept has led to effective targeted treatments for certain histological non-small cell lung cancer (NSCLC) types, most patients with advanced tumors are still treated with first-line chemotherapy. In 2015, several studiess demonstrated the efficacy of nivolumab, an immunotherapy targeting immune checkpoints. In France, besides the clinical trials, this molecule has been made available in January 2015 under a Temporary Authorization for Use (ATU, compassionate use).

Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the ATU setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

Eligibility Criteria:
Inclusion Criteria:

* All patients with advanced NSCLC, non-eligible for thoracic radiation therapy, having received nivolumab (at least one injection), under nominative or cohort ATU, between 23-JAN-2015 and 31-AUG-2015 (end of ATU).

Exclusion Criteria:

* patients included in a biomedical research trial with nivolumab
* patients \<18 years old
* patients included under ATU to receive nivolumab administration, but never did
* patients with a psychiatric history that hinders the comprehension of the information leaflet
* patients refusing their data being collected
S. Aureus Decolonization in HPN Patients.

This trial focusses on identifying the most effective and safe long-term S. aureus carriage decolonization strategy in home parenteral nutrition patients. Half of the participants will receive a quick and short systemic antibiotic treatment combined with topical treatment, while the other half will receive only topical treatment on a periodic basis.

Patients on home parenteral nutrition (HPN) are exposed to a lifelong risk of developing S. aureus bacteremia (SAB). SAB pose a threat to both catheter and patient survival and may lead to a permanent loss of vascular access. S. aureus carriage eradication has proven successful in prevention of S. aureus infections. S. aureus decolonization is a key strategy to maintain venous access and avoid hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patient is fully able to understand the nature of the proposed intervention.
* Written informed consent by the patient before entering the trial.
* Age ≥ 18 years.
* Estimated life expectancy ≥ 1 year.
* Patient colonized with S. aureus.

Exclusion Criteria:

* Cannot be expected to comply with the trial plan (substance abuse, mental condition).
* Pregnant or breastfeeding women.
* Continuous exposure to Methicillin-resistant S. aureus (MRSA; e.g. pig farmer).
* Allergy for chlorhexidine and betadine.
* No options for oral and/or topical antibiotics due to allergies.
* Active S. aureus infection.
* Currently on treatment with antibiotics active against S. aureus.
* Decolonization (including mupirocin) treatment in the previous two months.
* The presence of a nasal foreign body.
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) levels more than five times the upper limit of normal or liver failure.
Multicenter Registry of Pediatric Lupus Nephritis in China

This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of lupus nephritis:

* Diagnosis of SLE according to the 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus
* Either of the following: Positive urine protein detected 3 times within a week, or 24-hour urine protein\>150mg, or UPC\>0.2mg/mg, or urinary microalbumin above normal range detected 3 times within a week, or microscopic examination erythrocyte\>5 RBC/HP, or renal dysfunction including glomerular and/or tubular dyfunction, or abnormal renal biopsy and the pathological changes are in accordance with lupus nephritis
* The pathological diagnosis of kidney conforms to the International Society of Nephrology and Society of Renal Pathology (ISN/RPS) standards in 2003

Exclusion Criteria (either of the following criteria):

* Complicated with other systemic diseases, including basic diseases with clinical significance
* Patients with tumors
* Patients with abnormal glucose metabolism
* Immunodeficiency patients
* Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C within three months before treatment
* Patients with other connective tissue diseases (such as Sjogren's syndrome, mixed connective tissue disease, etc.)
* Drug-induced lupus, congenital lupus and other secondary lupus
* Renal histopathology with non-inflammatory necrotizing angiopathy or thrombotic microangiopathy (TMA)