cyrilzakka/clinical-trials huggingface dataset:
International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension

The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 and ≤ 80 years of age at time of consent
* Subject must be able and willing to provide written informed consent
* Subject must be able and willing to comply with the required follow-up schedule
* Subject has office Systolic Blood Pressure ≥ 160 mmHg at confirmatory visit
* Subject has a daytime mean Systolic Ambulatory Blood Pressure \> 135 mmHg during the two week screening period
* Subject has an office Systolic Blood Pressure that remains ≥160 mmHg despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic or subject was previously on diuretic but documented to be diuretic intolerant, for a minimum of 14 days prior to the procedure and with an expectation to maintain for a minimum of 180 days post procedure.

Exclusion Criteria:

* Subject has significant renovascular abnormalities such as renal artery stenosis \> 30% in either renal artery
* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
* Subject has hemodynamically significant valvular heart disease as determined by the Study Investigator
* Subject has a life expectancy less than 12 months, as determined by a Study Investigator
* Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
* Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has active systemic infection
* Subject has renal arteries with diameter(s) \< 4 mm in diameter or \<20 mm in length
* Subject has an estimated Glomerular Filtrate Rate (eGFR) \<45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
* Subject has Diabetes Mellitus Type I
* Subject has multiple main renal arteries in either kidney
* Subject has an identified secondary cause of hypertension (for example, including, but not limited to, Polycystic kidney disease, Cushing's syndrome, Aldosteronism)
* Subject has evidence of significant abdominal aortic aneurysm (defined as maximum diameter of \>4 cm)
* Subject has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days prior to enrollment
* Subject is expected to have cardiovascular intervention within the next 180 days
* Subject has a condition which would interfere with the accurate interpretation of the study objectives including but not limited to a large arm diameter that is unable to accommodate the blood pressure cuff or arrhythmia that interferes with automatic pulse sensing.
Reduction of Nosocomial Vancomycin -Resistant Enterococci (VRE) Colonization and Infection by Active Surveillance and Intervention of Infection Control

Vancomycin -resistant enterococci(VRE) has emerged as one of the most common nosocomial pathogen of health-care associated infection since 1988. Although the new antimicrobial agents such as Tigecycline , Daptomycin, Linezolid have clinically effectiveness for the treatment of VRE, but there was not appropriate drugs for eradicating the colonization of VRE. So the active surveillance and strict contact precaution are the best methods for VRE colonization and transmission.

This is a one year study program, we select a unit as the study site. First month (January) is the prepare period. Therefore , we collect 3 months (from February to April) baseline data, then interrupted one month(May) for the health care worker's infection control education.

Then the intervention period are three months (from June to August), and the last four months(from September to December) are the analysis and evaluation period. In the baseline period, we only do the patient's active surveillance and environmental culture. In the intervention period, beside the patient's active surveillance and environmental culture, we add contact precaution as the infection control method. If patient has VRE infection, we prescribe appropriate antibiotic therapy until the culture result proved no growth of VRE.

The aim of this study is to compare and analyze these two period (baseline period and intervention period) for understanding the transmission, risk factors and carriage rate of VRE, as the important guidelines for the VRE infection control in the future.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to RCC unit

Exclusion Criteria:

* if the patients or family refused the exam of anal swab .
Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma

The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women ≥18 years of age
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as per the staging system of the American Joint Committee on Cancer
* Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1
* Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
* Known BRAF wild-type, as per regionally acceptable V600 mutational status testing. BRAF mutant patients and those with indeterminate or unknown BRAF status are not permitted to randomize

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Ocular melanoma
* Any active, known, or suspected autoimmune disease
PREVALENCE STUDY OF PNH CLONES IN PATIENTS WITH NEOPLASIES

Multicenter prevalence study of the PNH clone (paroxysmal hemoglobinuria nocturnal) in SMP Ph-. This multicenter, prospective study aims to evaluate the presence of an PNH clone in patients with a confirmed diagnosis of myeloproliferative neoplasia Phcon or without mutations in the 3 main genes involved in this disease (JAK2, MPL, and Cal-R),but showing signs of ongoing hemolysis or particular clinical conditions.

To this end, a multicolor flow cytometric test will be used to evaluate the presence of deficient GPI molecules in granulocytic, monocytic and other cells erythrocyte (flow cytometric test, based on the use of the FLAER reagent in peripheral blood samples).

The study will be conducted at clinical hematology centers in the wider area of the Romagna and at other Italian hematology clinical centers, where and analyzed the peripheral blood samples and clinical data to be included in the study.

The participating centers will carry out the flow cytometric diagnostic test at i own reference laboratories, while the biological material for subsequent studies genetic-molecular type (next generation sequencing) will be analyzed centrally at the Biosciences laboratory of the IRST IRCCS only for cases testing positive for the presence of the PNH clone. Clinical information will be collected for each patient enrolled in the study necessary for the classification of the case and all the laboratory data necessary for achievement of the objectives of the study. The main objective of the study is to evaluate the prevalence of PNH clones in patients with a confirmed diagnosis of myeloproliferative neoplasm Ph- with or without mutations affecting the 3 main genes involved in this disease (JAK2, MPL, e Cal-R), but showing signs of ongoing hemolysis or particular clinical conditions.

Secondary objectives of the study are:

- correlate the characteristics of the PNH clone with the clinical characteristics and laboratory of myeloproliferative neoplasms Ph- (the presence of phenomena thrombotics, the disease state, the DIPSS prognostic score index, and the state mutational).

· characterize the genomic architecture of the cases using NGS technology positive results


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of one of the following Ph-negative myeloproliferative neoplasms:

   polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis, according to i WHO 2016 criteria
2. Women or men, age ≥ 18 years.
3. Willingness and ability to give written informed consent and adhere to study procedures.
4. Availability of the result of the following molecular tests:

   * JAK2-V617F mutation,
   * JAK2 exon 12 in PV (if JAK2 negative) Cal-R, and MPL in MFI and TE (if JAK2 negative)
5. Obvious signs of hemolysis (defined as LDH≥1.5 x ULN, reduced haptoglobin, reticulocytosis) when not related to the underlying disease or significantly changed compared to baseline values OR Detection of a thrombotic event (subsequent to diagnosis) OR Appearance or worsening of anemia OR Symptom change (appearance or worsening of signs or symptoms) in a stable disease context.
Characteristics of Marrow Fatty Cells in the Ageing of Bone and Joints, Osteoarthritis and Osteoporosis

Obesity and other associated complications promote the development and the progression of osteoarthritis. The subcutaneous and abdominal fat release several factors that alter bone and the cartilage. The role of the marrow fat in close connection with bone has not been defined yet, whereas cellular and animal models indicate that this fat depot modifies bone and cartilage.

The aim of the study is to define if the marrow fat produces more joint-altering factors by comparison with subcutaneous fat. This fat depot can be characterized from removed pieces during the prosthetic surgery of the knee. Measuring before surgery the body weight, waist and hip circumferences, blood pressure, glucose, insulin and lipids in blood will also allow to determine if obesity and/or type 2 diabetes make this fat more dangerous for the joint. Such research will allow the elaboration of new therapeutic strategies in osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal woman
* with a symptomatic knee osteoarthritis requiring prosthesis
* able to handle general anaesthesia
* having given her consent
* able to understand the constraints associated with the study
* with health insurance
* able to understand the French language

Exclusion Criteria:

* with refusal to participate to the study
* more than 85-year-old
* with bone pathologies other than osteoarthritis or osteoporosis
* with active infection
* with evolving cancer
* with haematopoietic pathologies such as haemoglobin pathologies
* with thyroid pathologies
* with type 1 diabetes
* with anti-osteoporotic treatments (bisphosphonates, strontium ranelate, teriparatide, denosumab) except calcium and vitamin D supplementation or hormone replacement.
* with replacement of prosthesis
* with previous surgery at the surgery site

  --with a current participation to another study
* with guardianship
* with deprived liberty
The Effect of Assistive Airway Equipment on Intubation

In this study, investigators will research the types and incidence rates of airway complications seen in the perioperative period during airway management. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated.

Complications related to airway management rarely occur in the operating room; however, these complications can lead to life-threatening situations. There are many studies on the types and incidence rates of airway management complications in the perioperative period. However, although the types and incidence rates of airway complications have been investigated in these studies, the effect of airway equipment used in airway management on complications has not been investigated. There are many equipment used in airway management. Laryngoscopes, face masks, oral airway devices and many assistant airway management devices are used as basic equipment. Different airway equipment may be used in each center in each case. There is no standard between centers in this regard.

In this study, investigators will primarily research the types and incidence rates of airway complications seen in the perioperative period during airway management similar to the existing literature. In addition, unlike the literature, the relationship between the airway equipment used and perioperative airway complications will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18 and 75.
2. Patients who will undergo elective surgery.
3. Patients to be operated under general anesthesia.
4. Patients without difficult airway markers

Exclusion Criteria:

1. Patients to be operated with emergency surgical indication.
2. Patients to be operated with regional anesthesia.
3. Patients with expected difficult airway markers.
Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)

Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants of Israel are known to use carob extract to ease sores in the mouth, due to the tannins which create a complex with various proteins and polysaccharides, thus creating an impenetrable layer covering the sores, allowing spontaneous healing.


Eligibility Criteria:
Inclusion Criteria:

* Herpetic aphtomatitis
* Bacterial aphtostomatitis
* Viral aphtostomatitis
* Fungal aphtostomatitis

Exclusion Criteria:

* Oncology patients
* Systematic diseases (Colitis, Crohn, diabetes, Behcet)
* Pregnancy
* Arthritis
From Intention to Action:Scoring Your College Goals

The current study aims to prevent the developmental of mental health symptoms in first-year college students through providing a workshop aimed at preparing students for the academic, social, and personal challenges associated with typical college experiences. Specifically, the study hypothesizes that first-year student students who participate in a workshop on college readiness will report fewer symptoms of depression and anxiety, higher levels of self-esteem, and better academic performance compared to a similar group of students who do not receive the intervention (the control group). Students in the intervention group will participate in a one-time, two-hour workshop that discusses expectations about college, setting goals that are aligned with one's values, predicting barriers to achieving these goals, and how to overcome these obstacles. The workshop will provide students with external resources (both on and off campus) for obtaining additional support to address barriers that arise during their college experiences. Students will complete questionnaires about symptoms of depression, anxiety, and their ability to cope with stress before the workshop, after the workshop, and at the end of their first semester. At the end of the Fall 2021 semester, students will be asked to share information about their Grade Point Average (GPA) and academic status. The investigators predict that at the end of the semester, those students who participated in the workshop will report lower levels of depression, anxiety and stress, higher levels of self-esteem, and a higher GPA compared to students who did not receive the intervention. Students who participated in the workshop will also be more likely to continue (enrolled in the Spring 2022 semester) compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* First-year, first semester freshman enrolled in Psychology 100 courses at CUNY College of Staten Island.

Exclusion Criteria:

* Under 18 years old
* Violation of inclusion criteria
A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Evidence of gout/hyperuricemia, measured sUA \>8 mg/dL at screening.
* Experienced an episode of nephrolithiasis or ureterolithiasis.
Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.

The purpose of the study is to conduct surveillance for Hib disease.

Prospective active population-based surveillance for invasive Hib disease, conducted by the Center for Disease Control and Prevention (CDC) Active Bacterial Core (ABCs) program within geographic regions currently representing 12% of the US population, will provide Hib case-occurrence (numerator) data.

The ABCs program and the National Center for Health Statistics will provide annual estimates of the number of persons under surveillance, by age group, within the ABCs catchment area.

Ongoing telephone sample surveys, conducted by M/A/R/C, a national sampling organization, will provide brand-specific vaccine exposure data by age group within the ABCs program catchment area at appropriate pre-specified intervals (denominator data).

Eligibility Criteria:
Inclusion Criteria:

* Residence within the geographic scope of Active Bacterial Core surveillance (ABCs) during the period of surveillance
* Aged 0 through 59 months (prior to 5th birthday) on the day of inclusion for Hib disease surveillance and 2 through 23 months (prior to 2nd birthday) for Hib vaccine brand usage survey.
* 2009-2014 calendar years inclusive.
* For the Hib vaccine usage survey, agreement to complete the required survey.

Exclusion Criteria:

Not applicable.
Multidisciplinary Approach to Reduce Injury and Substance Abuse

The primary purpose of the project entitled: Multidisciplinary Approach to Reduce Injury and Substance Abuse, which is funded by the National Institute on Drug Abuse (5R01DA026088-02), is to compare the effectiveness of brief intervention, brief intervention plus a booster, and brief advice for adult patients who abuse drugs and present to a trauma department for treatment of an injury.

Multidisciplinary Approach to Reduce Injury and Substance Abuse is a randomized clinical trial evaluating the effectiveness of brief advice (BA), brief motivational intervention with feedback (BMI), and brief motivational intervention with feedback and booster (BMI+B) in injured patients with drug problems.

The setting is a level 1 Trauma Department, which serves a large and diverse patient population. Injured patients are screened for eligibility in the project based on a positive toxicology screen or self reported drug use in the past 90 days. The primary outcome of interest will be patients' subsequent drug use. Other outcomes of interest include: HIV-related risk behaviors, improved health outcomes (including injury reduction), increased employment, decreased engagement in illegal behavior, increased substance abuse treatment utilization, and enhanced quality of life at three, six, and twelve month follow-ups.

This study will also examine the potential moderating and mediating effects of patient readiness to change, use of experiential and behavioral processes of change and decisional balance considerations. In addition, this project will examine implementation factors at the organizational level and the cost effectiveness of BA, BMI, and BMI+B.

Study participants and their related identifying information will be collected during the time they are admitted to the recruitment hospital trauma department. Study participants must be 18 years or older, speak English or Spanish, have been admitted to the recruitment hospital trauma department, and test positive for illegal drugs or admit to illegal drug use when verbally screened. Additional information will be collected from participants in the in-person assessment interviews at three, six, and 12 month follow-up periods.

Eligibility Criteria:
Inclusion Criteria:

* Study participants must be 18 years or older
* Speak English or Spanish
* Been admitted to the level 1 Trauma Department
* Test positive for illegal drugs or admit to illegal drug use

Exclusion Criteria:

* Other penetrating trauma not related to motor vehicle collisions, violence or falls, such as poisoning and, bites
* Patients with traumatic brain injury, or a Glasgow Coma Scale score of less than 15
* Patients who do not pass the Mini-Mental Status Exam are excluded