cyrilzakka/clinical-trials huggingface dataset:
Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma Patients

The purpose of this study is to evaluate efficacy and safety of Radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. Ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy.

Nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. Performing nephrectomy in these patients is not without risk, however. The very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. Patient selection for surgery remains critical for success.

Radiofrequency ablation (RFA) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. The benefits of RFA in selected metastatic renal cell carcinoma patients with small primary tumor (\<5 cm) will be evaluated in this Phase I/II study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven renal cell carcinoma before RFA;
* Primary tumor no grater than 5 cm;
* CT-confirmed metastatic measurable sites;
* Good prognosis by adapted MSKCC criteria;
* No treatment for RCC;
Topical KB105 for the Treatment of TGM1-deficient Autosomal Recessive Congenital Ichthyosis (ARCI)

KB105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of KB105 in children and adults with autosomal recessive congenital ichthyosis (ARCI).


Eligibility Criteria:
Key Inclusion Criteria:

1. Subject, or legally authorized representative, must be willing and able to give informed consent/assent
2. Aged ≥6 months
3. A genetically confirmed diagnosis of TGM1-deficient ARCI
4. Clinical diagnosis of lamellar ichthyosis
5. Two target areas located on similar anatomical regions with the same scaling severity by IGA and scaling severity ≥3
6. Subjects taking systemic retinoids must be on a stable regimen for at least 4 weeks and agree to continue to take the medication consistently throughout the study. If the subject prefers to withhold systemic retinoids during the study, then a minimum 4-week washout period is required
7. Clinically stable and in good general health

Key Exclusion Criteria:

1. Subject has a physical condition or other dermatological disorder (e.g., atopic, seborrheic, or contact dermatitis, psoriasis, tinea infections, etc.) which, in the Investigator's opinion, might impair evaluation of the target areas or which exposes the subject to unacceptable risk by study participation
2. Participation in another clinical study or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer
3. Any condition or illness (including a history or current evidence of substance abuse or dependence) that, in the opinion of the Investigator, would impact a subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of KB105
4. Women who are pregnant or nursing
5. Subject who is unwilling to comply with contraception requirements per protocol
6. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator
A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Patients With Myelodysplastic Syndromes

The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).


Eligibility Criteria:
Inclusion Criteria:

Patients must satisfy the following criteria to be enrolled in the study:

* Have a documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) 2008 classification
* Age ≥ 20 years;
* Written informed consent;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Resolution of any toxic effects of prior anti-cancer therapy; and
* Negative urine or serum pregnancy test on females of childbearing potential.

Exclusion Criteria:

The presence of any of the following will exclude a patient from enrollment:

* Treatment with chemotherapy, radiotherapy, or surgery within 4 weeks of study registration;
* Pregnant or breast-feeding females;
* Previous or concomitant malignancy other than MDS;
* Significant active cardiac disease within the previous 6 months;
* Uncontrolled systemic infection or
* Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Heart Health After Cancer Treatment (HEART-ACT)

This is a pilot study testing multi-disciplinary health behavior intervention in breast cancer survivors who have been treated at Zuckerberg San Francisco General (ZSFG).

OBJECTIVES:

1. Evaluating feasibility and acceptability of the program.
2. Evaluating the effects of the program on health outcomes including change in exercise capacity, change in quality of life, change in risk factors, and adverse events.
3. Evaluating changes in patient-reported measures.

OUTLINE:

Participants with a history of breast cancer who receive care at Zuckerberg San Francisco General Hospital (ZSFG) will receive the intervention which is comprised of a 12-week multi-disciplinary health behavior program. Each participant will have an individualized assessment, goal and plan for each component of the program. Follow-up for outcomes will occur at 3 months, 6 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Diagnosis of breast cancer
* Treated with curative intent
* Able to communicate in English, Spanish, or Cantonese
* Able to consent for self
* Receive care at Zuckerberg San Francisco General Hospital

Exclusion Criteria:

* Chemotherapy, radiation, or surgery planned in next 3 months
* Life expectancy \< 1 year
Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery

Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* EHRA class ≤ 2
* Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
* Patients will have elective coronary surgery planned Able of providing informed consent

Exclusion Criteria:

* Patients ≥70 years of age
* Pregnancy Patients with contraindications for oral anticoagulant agents
* Patients undergoing emergency operation
* Patients undergoing concomitant valve replacement
* Severely enlarged LA (\>50 mm) on echocardiography
* Prior AF ablation or AF surgery
Effectiveness of Sealants and Fluoride Varnish in Caries Prevention in Children With Autism Spectrum Disorders

The aim of the study is to compare application of sealants together with fluoride varnishes versus only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with ASDs.

The aim of the study is to evaluate if the application of pit and fissure sealants together with fluoride varnishes is more effective than the application of the only fluoride varnishes in preventing caries lesions development in the occlusal surface of first permanent molars of children with ASDs.

Patients with at least 10-year follow-up and ASDs are recruited and allocated to two cohort according to the strategy adopted for prevention of caries in first permanent molars: FA group (only fluoride varnishes) and FA+S group (sealants together with fluoride varnishes).

Caries incidence and sealants retention after the follow-up period are recorded. Demographic and clinical characteristics of patients at first dental visit are also recorded (age, level of cooperation, presence of systemic diseases other than ASDs, caries severity) to evaluate if they play a potential protective and/or risk factors for caries development.

Logistic and multivariate analysis are run to evaluate caries incidence and retention rate of sealants in first permanent molars over a period of at least 10 years.

Eligibility Criteria:
Inclusion Criteria:

* ASDs
* age less than 14 years
* written declaration of informed consent signed by parents/guardians

Exclusion Criteria:

* incomplete clinical records
* missing five or more dental check-ups over the follow-up period
* oral or dental care provided in sedation or general anesthesia
* follow-up less than 15 years
A Study for Japanese Participants With Rheumatoid Arthritis (RA)

This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period. All participants will be followed for up to 12 weeks after the last study drug administration.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
* Diagnosis of RA
* Active RA
* Current, regular use of Methotrexate, at a stable dose
* Body weight between 40 and 105 kilograms (kg), inclusive

Exclusion Criteria:

* Use of excluded medications (reviewed by study doctor)
* Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
* Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation
* Evidence of tuberculosis
* Have systemic inflammatory condition other than RA
Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL

The purpose of this study to collect information on the safety, especially localized injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are beginning to receive the treatment with ORENCIA Subcutaneous Injection 125mg Syringe 1mL under the approved indications, dosage, and administration
Corticosteroids Before Extubation in Pediatric Intensive Care Unit

Fifty to 60% of children admitted to a pediatric intensive care unit (PICU) are placed under invasive mechanical ventilation (MV) at least once during their stay. After extubation, about 30% of these patients will experience respiratory distress due to upper airway obstruction (RDUAO), and about one-third of these cases will require re-intubation. Treating this RDUAO extends the length of stay in the PICU.

Pre-extubation corticosteroid therapy has been validated in adults as a preventive treatment for the occurrence of RDUAO. However, the lack of robust data in pediatrics has not allowed for a consensus on the benefit of its use in children on MV in the PICU.

The investigators propose to conduct a randomized, multicenter, double-blind, placebo-controlled study evaluating the effect of intravenous dexamethasone (IV-DXM) before extubation on the incidence of RDUAO in children.


Eligibility Criteria:
Inclusion Criteria:

* Patients intubated with an endotracheal tube with or without a cuff,
* Aged from 2 days post-term to 6 years,
* On mechanical ventilation for at least 36 hours,

And meeting the following extubation criteria:

* Extubation planned by the medical team
* Fraction of inspired oxygen (FiO2) ≤ 45%,
* Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate according to the pathology,
* Positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,
* Peak inspiratory pressure ≤ 22 cmH2O or presence of cough.
* Affiliated with a social security system,
* Collection of informed consent from the parental authority, by both parents or the legal guardian(s).

Exclusion Criteria:

* Refusal of consent by at least one parent or by the legal guardian(s),
* Patient with a contraindication to IV-DXM:

  * Uncontrolled local or general infection,
  * Active viral infections (hepatitis, herpes, chickenpox, shingles),
  * Live vaccines,
  * Severe coagulation disorders,
  * Ongoing gastrointestinal bleeding,
  * Known hypersensitivity to IV-DXM or one of its excipients.
* Patient participating in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable,
* Patient receiving State Medical Aid,
* Patient on long-term NIV,
* Known upper airway pathology (UAP) before intubation or at the time of extubation,
* History of UAP surgery within the month preceding inclusion,
* Any situation deemed incompatible with the child's participation in the trial at the discretion of the investigating physician,
* Decision to limit or stop therapeutic interventions.
* Premature patients aged less than 40 weeks of gestation
* Newborns aged less than 2 days after post-term birth
Heart-health Promotion

The researchers intend to use the Expanded Health Belief Model in enhancing heart-health preventive behaviors among high school female students

The study intervention will be derived from the Expanded Health Belief Model which includes adhering to healthy diet, encouraging healthy weight, nutrition, and physical activity stress management, and smoking cessation and smoking avoidance.

Eligibility Criteria:
Inclusion Criteria:

* High school female students who do not experience any psychiatric-mental disorder

Exclusion Criteria:

* High school female students who experience any psychiatric-mental disorder
Cells of Monocytic Origin as Surrogate Markers for Individual Drug Effects and Hepatotoxicity

Drug metabolism in the liver is subject to large fluctuations (differences between women and men, people of different ethnic backgrounds, children and adults). These large differences are responsible for very different drug effects and side-effects (and especially liver damage caused by drugs) between individuals. Recent scientific findings suggest that blood derived cells can be used to model individual effects of drugs on the liver reflect inter-individual differences. Since liver damage caused by drugs is a diagnosis of exclusion, the aforementioned cells can be used to identify patients that show higher sensitivity to hepatotoxic side-effects and - in case several drugs are involved - identify the causal agent or possible interactions.

Drug-induced liver injury (DILI), especially its idiosyncratic for is often an unpredictable complication of drug therapy. Until now it is very challenging to predict occurrence, severity and outcome of DILI. Previous data provide evidence that cells from peripheral blood may reflect hepatocellular damage (Fannin RD, Hepatology. 2010). Own research could show that peripheral monocytes are capable to obtain several hepatocyte-like functions while maintaining individual characteristics of the donor, especially cytochrome P450 metabolism (Benesic, Gerbes, et al, Lab Invest 2012). This study investigates the effects of potentially hepatotoxic drugs on cells generated from patient blood in comparison to the clinical presentation. Its aim is the evaluation of in vitro tests using monocyte derived cells for diagnosis and exclusion of DILI and the potential to use the patient derived-cells for mechanistic investigations of DILI. 4 groups are investigated: 1) donors without liver disease 2) patients who will start a therapy with DILI-potential; 3) DILI patients; 4) patients with liver injuries other than DILI.

Patient history and clinical data are obtained and a single blood sample will be collected after informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 2 years
* Informed consent given by the patient or in case of inability to give informed consent informed consent of the legally nominated consultee

Exclusion Criteria:

* Anemia requiring blood transfusion
* acute or chronic hepatitis B, C or human immunodeficiency virus infection
* lack of informed consent
Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants

The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
* Body mass index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive.

Exclusion Criteria:

* Any significant acute or chronic illness.
* Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
* History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds.
* Other protocol-defined inclusion/exclusion criteria apply.
Post-market Study of the Biodesign Hernia Graft

The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.

This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair.

This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site.

This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.

Eligibility Criteria:
Inclusion Criteria:

1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft

Exclusion Criteria:

1. Known sensitivity to porcine material

   For the study, the following patients will also be excluded:
2. Age \< 18 years
3. Unable or unwilling to provide informed consent
4. Life expectancy of less than one year from the date of the index procedure
5. Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.
Improving Patient-Provider Communication to Reduce Mental Health Disparities

The purpose of this study was to develop and pilot test an intervention to reduce mental health disparities for racially and ethnically minoritized Veterans receiving outpatient VA mental health services. The program was delivered by trained VA peer navigators. The specific aims of the program were to enhance navigation of mental health services, increase patient engagement, and improve patient-provider communication.

Study participants were randomized into one of two study groups, which determined when they received the study intervention. Regardless of study group, participants had the opportunity to receive services in addition to their regular mental health treatment (either immediately after enrollment into the study or after a 6-month waiting period).

Participants were asked to complete study questionnaires at different timepoints throughout the study to assess their overall satisfaction with the study program and the mental health services that they received. Some participants also completed an interview to discuss their experience in the program.


Eligibility Criteria:
Inclusion Criteria:

To be eligible:

* Must be a Veteran belonging to a racial/ethnic minoritized group
* Must be actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
* Must have started receiving mental health care as a new patient in the Outpatient Mental Health within 12 months prior to enrollment into the study

Exclusion Criteria:

Not eligible if:

* Is a Veteran not belonging to a racial/ethnic minoritized group
* Not actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
* Started receiving mental health care as a new patient in the Outpatient Mental Health outside of the 12-month window
CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma

This study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT), safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.

This is an open label, dose escalation study. Cohort of 3\~6 patients receive escalation doses of CKD-581 until the maximum toleated dose(MTD) is determined. The MTD is defiend as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Eligibility Criteria:
Inclusion Criteria:

* must have received at least one prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2014)
* Eastern Cooperative Oncology Group performance status ≤ 2
* Life expectancy 12 weeks
* must have the following laboratory values within 3 weeks prior to first dose of study drug

  * ANC(absolute neutrophil count) ≥ 1,500 mm3
  * PLT(platelet count)≥ 100,000 mm3
  * Hb ≥ 8.0g/dL
  * AST(SGOT) and ALT (SGPT) ≤ 3 x UNL(upper limit of normal)
  * Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
  * Serum Cr ≤ 1.5 x UNL
* One more measureable disease following values

  * Serum M-protein ≥ 1g/dL
  * Urine M-Protein ≥ 200mg/24hr
  * in that case serum M-protein, urine M-Protein nonmeasurable and FLC ratio abnormal, Serum FLC level ≥ 100mg/L(≥10mg/dL)
* more than 24 weeks prior to last bortezomib dose
* must have signed the consent form

Exclusion Criteria:

* Patients with central neurological disease
* Patients with clinically significant heart disease within 24weeks prior to first dose of study drug
* patients with clinically significans abnormal EKG, echocardiography at screening
* patients with active hepatitis, HIV positive(exception, non active hepatitis)
* peripheral neuropathy ≥ CTCAE grade 2 or peripheral neuropathy ≥ CTCAE grade 1 with pain within 2 weeks prior to first dose of study drug
* Patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer
* Patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs ≤ 4 weeks prior to first dose of study drug and during treatment period
* Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Male patients whose sexual partners are not using effective birth control.
* patients with hypersensitive reaction of bortezomib or dexamethasone
* patients without best overall response is above minimal response based on IMWG 2015 past all treatment for multiple myeloma
* patients with refractory to past bortezomib treatment(ex; under minimal response) or progress within 60days prior to last bortezomib treatment