cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers

The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

\[PART A\] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302

\[PART B\] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102

Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers
* 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery

To assess if information about aortic calcification obtained from routine preoperative ultra low-dose chest CT lowers the postoperative stroke rate in patients undergoing heart surgery by optimizing surgical strategy compared to the normal work-up with a conventional chest X-ray.

During heart surgery the aorta is clamped to initiate cardiopulmonary bypass. This may crush aortic calcifications causing them to embolize to the brain causing a stroke which is a devastating complication for the patient. A chest X-ray is routinely performed prior to heart surgery. It provides no information about aortic calcification. Imaging by a chest computed tomography (CT) scan provides detailed information on aortic calcification but has higher radiation exposure and thus is not used routinely. Recently iterative reconstruction (IR) techniques have become available that allow chest CT to be performed at markedly reduced dose with retained image quality. Routine use of low dose chest CT with IR prior to heart surgery may identify patients with a severely calcified aorta in which the surgery may subsequently adapted to minimize or avoid aortic manipulation which may reduce stroke rate.

In this multicenter randomized controlled clinical trial the effect of preoperative chest CT on postoperative stroke is investigated. In total 1724 patients will be included of whom 862 patients will receive an additional CT to standard care and 862 patients will receive routine care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Scheduled to undergo heart surgery
* Provide written informed consent

Exclusion Criteria:

* Patient not meeting inclusion criteria
* Pregnant women
* Scheduled to undergo transcatheter aortic valve insertion procedure (since these patients receive a standard preoperative CT)
* Chest or cardiac CT in the past three months
* Emergency surgery
* Concomitant or previous participation in a study that prohibits the patient from participating in a study that exposed the patient to radiation
* Unwillingness to be informed about unrequested findings on the CT scan
Web-based Addiction Treatment: Cultural Adaptation With American Indians

The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial intervention for substance use disorders adapted with American Indians/Alaska Natives \[AI/AN\]) to determine whether a future large-scale effectiveness trial is warranted. Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient addiction treatment services will be conducted to (1) estimate preliminary effect size of 12 weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in outcome.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Identify as American Indian or Alaska Native
* Recent alcohol or drug use
* Within first 30 days of current outpatient treatment episode

Exclusion Criteria:

* Planned treatment episode of less than 3 months
* Insufficient ability to provide informed consent
Prostate Resection After Microwave Ablation (PRAMA)

This phase I trial tests the safety of magnetic resonance imaging (MRI)/ ultrasound (US) fusion guided transperineal targeted microwave ablation (TMA) before a radical prostatectomy (RP) and how well it works in treating patients with prostate cancer. Prostate cancer is the second most common cancer in men and most will never become aggressive. Despite this, most men choose to undergo treatment which may include surgery. Removing the prostate gland and sometimes the lymph nodes (radical prostatectomy) is an invasive treatment for prostate cancer that can have a significant negative on quality of life. TMA is a less invasive procedure that uses high temperatures given through the skin between the scrotum and the rectum (transperineal). Using focused high energy and heating tumor cells to several degrees above normal body temperature may kill them without affecting the surrounding tissue. Using multiparametric (mp)MRI/US to create a 3-dimensional picture of the tumor may help in planning and preventing damage to healthy tissue. Giving MRI/US fusion guided transperineal TMA prior to radical prostatectomy may kill tumor cells, and may improve the quality of life in patients with prostate cancer.

PRIMARY OBJECTIVE:

I. To determine the feasibility of transperineal targeted microwave ablation of an MRI-identified index prostate cancer in patients undergoing radical prostatectomy.

SECONDARY OBJECTIVES:

I. KOELIS Trinity ability to plan and guide treatment needles and ablations in the prostate index lesion.

II. Impact of treatments on functional outcomes and quality of life. III. Predictability of Medwaves Avecure microwave ablation charts. IV. Predictability of post microwave ablation mpMRI.

OUTLINE:

Patients undergo MRI/US fusion guided transperineal targeted TMA and then undergo standard of care RP same day or at 30 days post-TMA on study. Patients undergo planning mpMRI of prostate prior to TMA. Patients also undergo blood sample collection at screening and post RP.

Eligibility Criteria:
Inclusion Criteria:

* Adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice
* Index lesion visible on multiparametric MRI confirmed by targeted biopsies using KOELIS Trinity (registered trademark)
* Patient suitable for intravenous (IV) sedation or general anesthesia and TMA
* Free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial

Exclusion Criteria:

* Past medical history of prostate surgery
* Past medical history of radiotherapy or pelvic trauma
* Past treatment for prostate cancer (PCa) (radiation, ablation, androgen deprivation therapy \[ADT\], chemotherapy)
Risk Factors for Sudden Unexplained Death in Epilepsy

The main purpose of this study is to develop a North American registry for SUDEP cases; requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to contact the study team. The family members who decide to participate in the study will be asked to complete a brief telephone interview about their loved one's epilepsy and seizure history and the circumstances of his or her death. If the death has occurred within the past 24 hours, and the family is willing to consider donating tissue to the study, the subject will be transferred to the Autism Tissue Program, and the remainder of the phone interview will be conducted at a later time.

In addition to the phone interview, the family will be asked to provide access to the deceased's medical records. Any costs involved in obtaining medical records will be covered by the study, and all medical information will remain completely confidential.

SUDEP stands for sudden unexplained death in epilepsy; a witnessed or unwitnessed, non-traumatic and non-drowning death occurring in benign circumstances, in a person with epilepsy with or without evidence of a seizure and excluding documented status epileptics (seizure duration of 130mins or longer, or seizures without recovery in between), in which a postmortem examination does not reveal a cause of death. SUDEP is not a cause of death so much as it is a descriptive term for a category of unexplained deaths in people with epilepsy or epilepsy-related conditions. Little is known about SUDEP and its mechanisms and risk factors.

One of the main objectives of this study is to investigate the role of various risk factors in the development of sudden unexplained death in patients with epilepsy, with a particular focus on the role of antiepileptic medications. In addition, we want to elucidate the pathophysiologic mechanisms leading to SUDEP.

Eligibility Criteria:
Inclusion Criteria Sudep Group Subjects diagnosed with epilepsy whose cause of death was sudden and unexplained, and whose families are willing to participate, will be included in the study.

Control Group For the control group, we will include any patient diagnosed with epilepsy currently in the care of the NYU Comprehensive Epilepsy Center, willing and able to participate in the study.
Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique

In Martinique, about 33 new cases are diagnosed per year, with a high incidence rate of type 2 endometrial carcinoma which has a poor prognosis with few therapeutic options. Although targeted therapies are used in many types of cancer, they are still possible a minority of patients. In current practice, endometrial cancers do not benefit these therapies. Characterization of the molecular mechanisms involved in the genesis of type 2 endometrial carcinoma could help to identify biomarkers predictive of a response to targeted therapies. We propose to identify the genetic profile of type 2 endometrial carcinomas in Martinique.

Type 2 endometrial carcinomas are often diagnosed at advanced stages, with an high risk of metastatic recurrence and death even when diagnosed at early stages. They also have few therapeutic options. The Characterize the mutations responsible of cancer development has led to develope "precision medicine" that targets "actionable genes" by a drug. This concept of actionable mutation refers to a change in the DNA molecule that can predict the response to a drug defined as targeted therapy. Although targeted therapies are used in many types of cancer, they still target a minority of patients. Some tumor sites still do not benefit from these treatments. Specifically, type 2 endometrial cancers that have poor prognosis with few therapeutic options. The characterization of molecular mechanisms, by Next Generation Sequencing (NGS), involved in the carcinogenesis of endometrial cancers, particularly type 2 cancers, should allow the identification of predictive biomarkers for response to certain targeted therapies.

Eligibility Criteria:
Inclusion Criteria:

* Major subject living in Martinique with the following characteristics :

  * Patients with type 2 endometrial cancer, with anatomopathological confirmation
  * Affiliate or beneficiary of french social security.
  * Free, informed with a written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any research required by the research).

Exclusion Criteria:

* Type 1 adenocarcinoma
* Patients not affiliated to french social security
* Refusal to participate.
LSA Reconstruction With Laser Fenestration During the TEVAR

This study aims to evaluate the feasibility, effectiveness, and safety of in-situ laser-assisted fenestration on the left subclavian artery during the procedure of thoracic artery endovascular repair

This study is a single-arm, prospective study. All patients with type B aortic dissection (TBAD) present with the proximal tear site located approximately close to the left subclavian artery and a reconstruction of the left subclavian artery is necessary are included in the present study. During the procedure of thoracic artery endovascular repair (TEVAR), the left subclavian artery will be reconstructed with laser-assisted fenestration and the fenestrated stent will be covered stents (fluency, viabhan, lifestream).

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female over 18 years of age;
* Type B Aortic Dissection;
* The left subclavian artery should be reconstructed during the TEVAR procedure.
* Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule and medication regimen;

Exclusion Criteria:

* Life expectancy of \< 5 years;
* Patients need open surgery repair for the aortic diseases.
A Study to Evaluate First-line Ipilimumab + Nivolumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to collect and evaluate real-world data to describe the outcomes, patient characteristics, safety profile and treatment patterns of first-line nivolumab plus ipilimumab treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) in Italy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage), without known EGFR- or ALK-alterations
* Decision to initiate a first-line treatment with nivolumab plus ipilimumab for the treatment of NSCLC according to the Italy label has been made independently of the study
* Patient is at least 18 years of age at time of treatment decision
* Patient provided written informed consent to participate in the study

Exclusion Criteria:

* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
* Patients with known EGFR- or ALK-alterations
* Previous treatment with nivolumab and/or ipilimumab
* Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC (but: Patients who have completed their participation in an interventional trial, who are not receiving study drug any more, and who are only followed-up for OS, can be enrolled)
Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor

Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor oﬀers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.


Eligibility Criteria:
Inclusion Criteria:

* Are able to provide informed consent
* Have at least one arm

Exclusion Criteria:

* Active cardiac arrhythmias
* Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure)
* Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential)
* Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff
* Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure
* Diagnosis of dementia
Investigation of Genetic Determinants of Capecitabine Toxicity

The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).

Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.


Eligibility Criteria:
Inclusion Criteria:

* women with breast cancer in whom single agent capecitabine therapy is being considered
* aged 18 years and older

Exclusion Criteria:

* patients who have previously received capecitabine are excluded
* patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed
* serum albumin less than 3.0 g/dL within the last 30 days
* creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min \[/body surface area (BSA)\] (within the last 30 days)
* inability to understand and give informed consent to participate
* patients with a history of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus
* patients with prior or concurrent pelvic irradiation
* patients who use an ostomy for fecal excretion
* there is no limit on the number of prior chemotherapies; the decision to use capecitabine is determined solely by the treating physician
TURBt With Adjuvant Cryoablation to Treat Bladder Cancer

The purpose of this study is to evaluate the safety and efficacy of applying cryoablation as an adjuvant therapy with TUR to treat bladder tumor.

Bladder tumors are one of the most commonly diagnosed urinary tumors in the world. Worldwide, it has been estimated that 429,800 new cases of and 165,100 deaths due to bladder tumor occurred in 2012. Transurethral resection (TUR) is the gold-standard treatment for non-muscle invasive bladder cancer (NMIBC). In muscle-invasive bladder cancer, TUR also plays a vital role as a bladder-sparing procedure regardless of whether it is applied as a monotherapy or in combination with chemo-radiotherapy.

Whether radical resection of a tumor is initially performed can be essential in the treatment of bladder tumors. Incomplete TUR influences a patient's prognosis, regardless of whether it is part of a NMIBC treatment or part of bladder-sparing trimodal therapy. However, the quality of TUR is one of the greatest concerns in the treatment of bladder tumor. After initial TUR, approximately 70% of patients exhibit incomplete resection re-staging TUR. Of these patients, 30% exhibit residual tumors at the resection site. To solve this problem, a second TUR 4-6 weeks after the initial TUR is recommended by the guidelines, and these repeated TURs detect residual tumors in 26-83% of cases.

The investigators sought to identify other therapies that can be combined with TUR to eliminate residual tumors. As a minimally invasive method, cryotherapy has been widely used for urological tumors, including prostate tumor and kidney tumor. With respect to bladder tumors, cryotherapy remains in the exploration phase. Only a few studies of the use of computed tomography (CT)-guided percutaneous cryoablation for the treatment of bladder cancer have been reported. Unlike solid viscera, such as the prostate or kidney, the bladder exhibits the features of hollow viscera. Cryoablation through the transurethral approach could be possible if the safety of the procedure can be ensured. Our recent animal study conducted in a porcine model demonstrated the feasibility and safety of transurethral focal, full-thickness cryoablation. No perforations were observed during two eight-minute freeze cycles. Based on the success of transurethral cryoablation in animal experiments, the investigators performed this study to explore the safety and efficacy of cryoablation as an adjuvant therapy with TUR in the treatment of bladder tumors.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed bladder tumor, stage T1 or T2
* Number of lesions ≤ 3
* Tumor size ≤ 3cm

Exclusion Criteria:

* With other malignant diseases
* T3 or above
* Enlarged pelvic lymph node or distant metastasis
* Poor overall condition
Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment

The purpose of this study is to determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis.

During hemodialysis, waste products are removed from the blood by diffusion across the dialyzer membrane into an electrolyte solution known as dialysate. Dialysate is produced from acid concentrate, bicarbonate solution and water using a three stream proportioning system that mixes the acid concentrate, bicarbonate and water to produce the final dialysate. Patients are typically anticoagulated with heparin during dialysis to prevent blood from clotting in the extracorpoeial circuit. Heparin use is associated with significant risks including the possibility of bleeding, heparin induced thrombocytopenia (HIT) and contamination. For these reasons, the possibility of reducing heparin dose while maintaining HD adequacy is clinically attractive. Citrasate® is an FDA approved acid concentrate that contains citric acid (citrate) rather than acetic acid (acetate) which is traditionally used in acid concentrate. Citrate in higher concentrations is also a known anticoagulant. We are therefore conducting this study to determine whether the use of Citrasate, citric acid dialysate enables the reduction of the heparin requirements in patients undergoing hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Subject is capable of giving informed consent, or has an acceptable surrogate capable of giving consent on the subject's behalf.
* ESRD maintained on thrice weekly HD
* Stable Heparin prescription (Heparin dose) for the previous 4 weeks
* Dialyzed using bolus heparin anticoagulation with dose \>/= 2000 units per treatment
* Hgb \>/= 9.5 prior to study start
* eKt/V \>/= 1.0 (or spKt/V \>/= 1.2) in the monthly lab work prior to study start

Exclusion Criteria:

* Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
* Patient is maintained on Coumadin therapy or LMW heparin
* Known history of HIT, coagulopathy or any other bleeding and/or thrombotic disorders
* Patients dialyzed with \< 2000 units of Heparin per treatment
* Dialyzed without heparin
* Known pregnancy
* Dialyzed with reuse of hemodialyzers
* Documented clotted dialyzer or dialysis lines in last 30 days (1 month) requiring changing dialyzer, bloodlines or terminating treatment
* Randomized in a clinical trial involving anticoagulation in the last 30 days