cyrilzakka/clinical-trials huggingface dataset:
Zoledronic Acid and Positron Emission Tomography in Treating Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: A positron emission tomography scan is a procedure in which a small amount of radioactive sugar is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where tumor cells are found. This study is looking at whether the drug zoledronic acid interferes with the ability of a PET scan to find tumor cells.

PURPOSE: This phase II trial is studying how well positron emission tomography works when given together with zoledronic acid in finding tumor cells in patients with advanced non-small cell lung cancer.

OBJECTIVES:

* Determine the PET response rate after zoledronic acid in patients with non-small cell lung cancer.

OUTLINE: Patients receive 1 dose of zoledronic acid on day 1 followed by 3'-deoxy-3'-\[18F\]fluorothymidine/PET to determine standardized uptake value.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer

  * Stage IIIB (with pleural effusion) or stage IV disease
* Candidate for systemic therapy
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
* No active brain metastases

  * More than 7 days since prior radiotherapy for brain metastases
  * Must be neurologically stable with no seizures within the past 3 weeks

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST or ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present)
* Creatinine normal OR creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula
* No current active dental problems, including infection of the teeth or jawbone (maxilla or mandible)
* No dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures
* Not pregnant
* No uncontrolled intercurrent illness including, but not limited to, any of the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior or other concurrent bisphosphonates
* More than 2 weeks since prior surgery
* More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
* More than 7 days since prior palliative radiotherapy and recovered
* More than 6 weeks since prior and no planned dental or jaw surgery
* More than 30 days since prior participation in an investigational trial
* No other concurrent investigational agent
Cycle and Ovulation Study Expansion

The objective of this study was to collect menstrual cycle, health sensor data and general health information to understand correlations between menstrual cycle and health sensor data, and how those correlations may be affected by general health. Participants entered menstrual cycle information (such as start dates, end dates, symptoms, flow), basal body temperature as measured by a thermometer, and ovulation and progesterone test results via apps installed on their iPhone. Additionally, participants were provided with an Apple Watch and a wrist-worn hardware prototype wrist-worn sleep band to collect physiological sensor data. Both menstrual cycle information and physiological sensor data stored on the participants' iPhone prior to enrolling in the study (up to 18 months) was also collected. This study aimed to collect data from females aged 14 and older who are currently menstruating with irregular and regular menstrual cycles.


Eligibility Criteria:
* At least 14 years of age (19 for residents of Alabama and Nebraska and 21 for residents of Mississippi)
* Can communicate in written and spoken English
* Own functioning iPhone iOS 14 or later, with access to reliable data plan and Wifi
* Access to reliable Wifi in the bedroom
* Willingness to participate in remote visits and follow study procedures for the duration of the study, including use of Apple Watch and a wrist-work hardware prototype
* Able to read and understand the written consent form
* Reside in the US for the duration of the study
Aldosterone, Microvascular Function and Salt-sensitivity

Currently, the incidence of obesity and obesity-related disorders is reaching epidemic proportions, which entails an increasing burden for health care systems. The association of obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such as insulin resistance and hypertension, is often referred to as the metabolic syndrome. During recent years, salt-sensitivity of blood pressure has emerged as an additional cardiovascular risk factor that is related to obesity and other key components of the metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a link between insulin resistance and hypertension in obese individuals. In addition, impairment of microvascular function was found to be associated with salt-sensitivity of blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance. Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but was also found to impair endothelial function and thus lower NO-availability, which is characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are associated with both hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism, but also in the general population.

The investigators hypothesize that increased aldosterone levels in obese individuals lead to impairment of microvascular function through reduction of NO-availability. This microvascular dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive hypertension and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

Obese individuals

* Age 18-65 years
* Caucasian
* Waist circumference \> 102 cm (men)/\> 88 cm (women)

Lean individuals

* Age 18-65 years
* Caucasian
* Waist circumference \< 94 cm (men)/\< 80 cm (women)

Exclusion Criteria:

Obese/lean individuals

* Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
* Diabetes mellitus/impaired glucose metabolism (fasting glucose values \> 5.6 mmol/L
* Stage 3 hypertension (blood pressure \> 180/110 mm Hg)
* Unstable or severe pulmonary disease
* Unstable or severe thyroid disorders
* Inflammatory diseases
* Smoking
* Alcohol use \> 2 U/day (women)/\> 3 U/day (men)
* Use of antihypertensive, lipid-lowering or glucose-lowering medications
* Use of corticosteroids and regular use of NSAIDs
* eGFR\< 60 mL/min
* Impairment of hepatic function
* Pregnancy or lactation
SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 3045 patients and it's objective is to monitor patients for approximately 8 years.

Physicians are expected to manage patients as they would under normal practice conditions; patients will receive and use their medications according to their normal course of medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have medically documented Crohn's disease (CD)
* The decision to prescribe Cimzia or other medications has been made by the physician independent of inclusion in this study
* Patient (or his/her legally acceptable representative) is able to provide written informed consent to permit collection of data
* Patients participating in randomized, blinded clinical trials for CD or other conditions are not eligible for inclusion into the SECURE registry. Involvement in other registries, where patients follow routine clinical practice, is permitted, however
* For the Cimzia cohort: Patient is receiving treatment with Cimzia for the first time. Patient must receive Cimzia treatment within 2 months of enrollment into the registry
* Patient is currently receiving treatment with Cimzia for \<=12 months. Patient must also receive a Cimzia dose within 2 months following enrollment into the registry
* For the comparison cohort: Patient is switching CD treatment or beginning CD treatment for the first time. Previous Cimzia treatment is prohibited in the comparator group. Patient must receive new CD treatment within 2 months of enrollment into the registry. Patient is currently receiving anti-TNF treatment for \<=12 months. Patient must receive anti-TNF treatment within 2 months following enrollment into the registry. Patient is currently receiving immunosuppressant therapy for \<=12 months. Patient must receive immunosuppressant therapy within 2 months following enrollment into the registry. Patient is currently receiving systemic steroid therapy for \<=12 months. Patient must receive systemic steroid therapy within 2 months following enrollment into registry.

Exclusion Criteria:

* See inclusion criteria
Two Fraction Prostate SBRT With DIL SIB

Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient age greater than or equal 18
* Localized adenocarcinoma of the prostate
* Biopsy-proven diagnosis of prostate adenocarcinoma
* Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease

  * TX-T2c-8th addition staging
  * PSA\<20 ng/ml
  * Grade group 3 or less
* Proper rectal space replacement required as determined by the treating radiation oncologist
* Prostate size less than 60cc defined at time of simulation based on MRI
* Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion

  -- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized
* Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist
* Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills
* Ability to give informed consent

Exclusion Criteria:

* High risk disease
* Pelvic lymph node involvement
* Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
* Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion
* Prior radiation to the pelvis
* Prior malignancies within the last 5 years
* Inability to meet pre-specified 2 fraction DVH constraints
* Prostate size \> 60cc as measures at treatment planning MRI
* Active significant inflammatory bowel disease (IBD) or rheumatological disease
* Prior prostate surgeries

  * Previous uro lift
  * Transurethral resection of the prostate (TURP) within 6 months of SBRT
* "Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (\>50 overall summary score for each domain)
* Men of reproductive potential may not participate unless they agree to use an effective contraceptive method
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosis of Ulcerative Colitis for 3 or more months.
* Ulcerative colitis must be active beyond the rectum.
* Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points

Exclusion Criteria:

* Pregnant or breast feeding.
* Diagnosis of indeterminate colitis or Crohn's Disease
* Subjects with history of colonic or small bowel obstruction or resection.
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis

This is a phase II, proof-of-concept, placebo-controlled, double-blind, cross-over randomized clinical trial, assessing the effect of canagliflozin on peritoneal membrane function in patients on PD.

The primary aim of this trial is to determine the short-term effects of canagliflozin, an SGLT-2 inhibitor, on glucose absorption by the peritoneal membrane and on ultrafiltration, as assessed by a standardized peritoneal equilibrium test. The secondary aims are to determine the effect of canagliflozin on solute clearance and on effluent biomarkers of inflammation, angiogenesis, and fibrosis at 26 weeks. We hypothesize that canagliflozin will prevent glucose absorption by the peritoneal membrane, as compared with placebo, and will attenuate the development of inflammation, angiogenesis, and fibrosis of the peritoneal membrane, as assessed by relevant biomarkers in the dialysate.

Patients with kidney failure on peritoneal dialysis who meet the study inclusion criteria will be randomized at a 2:2:1 ratio to one of the following arms:

(i) canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by matching placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label).

(ii) placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label).

(iii) standard of care, with no active treatment, for 26 weeks (open label). Four in-person and one phone study visits have been scheduled: baseline visit, week 5, week 10, week 18 (phone visit), and week 26. A standardized peritoneal equilibration test (PET) will be performed at each of the in-person visits. There will also be two safety assessments at weeks 2 and 7, which will consist of blood tests. Patients who develop intercurrent illnesses or are hospitalized may temporarily discontinue the study drug if deemed appropriate by the treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with kidney failure on PD (both incident and prevalent) who are on a stable prescription of dextrose-based solutions for at least 3 months.
* Only high or high-average transporters, as classified by PET, will be included.

Exclusion Criteria:

* History of euglycemic ketoacidosis
* Known hypersensitivity to canagliflozin
* Active peritonitis or tunnel infection
* Kidney transplant scheduled in the next 6 months
* Severe liver cirrhosis (Child-Pugh class C stage)
* Recurrent severe genital or urine infections
* Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir if these agents cannot be safely discontinued
* Pregnancy or breastfeeding
Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial

This is a prospective multicentre (N=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ED.

Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate higher than 80% and 1-month mortality around 10%. There is scarce evidence of any clinical added value of a specific treatment to improve outcomes, and European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies highlighted that elderly patients often received suboptimal treatment: For example, less than a third of them received nitrates therapy while it is recommended. Furthermore, a recent preliminary study reported that only 50% of them are assessed for precipitating factors - although it has been reported that precipitating factors are independently associated with mortality.

The hypothesis of the Elisabeth Study s is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve AHF outcome in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years and older admitted to the emergency department with a diagnosis of acute heart failure determined by the emergency physician, based on the presence of:

  * at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea
  * one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (BNP or NT-pro-BNP).
  * Patients affiliated to French social security ("AME excepted")
  * Written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)

Exclusion Criteria:

* Patients are excluded if they have any of the followings:

  * other obvious cause of acute illness (severe sepsis, ST elevation Myocardial infarction)
  * systolic blood pressure less than 100 mmHg
  * severe mitral or aortic stenosis, or severe aortic regurgitation
  * known chronic kidney injury on dialysis
  * shock from any cause
  * Time from ED entrance to inclusion \> 6h
* Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
A Real World Study of Camrelizumab in the Treatment of Advanced Non-squamous Non-small-cell Lung Cancer

To provide sufficient scientific evidence for rational drug use of camrelizumab in the treatment of advanced non-squamous non-small cell lung cancer in China, efficacy，safety and cost-effectiveness of camrelizumab plus chemotherapy versus chemotherapy alone or chemotherapy plus antiangiogenic therapy in the first-line treatment of patients with advanced non-squamous non-small-cell lung cancer will be evaluated. Based on real world, the Markov Model was established to analyze the incremental cost-effectiveness in experimental group(camrelizumab plus chemotherapy), compared with control group (chemotherapy alone or chemotherapy plus antiangiogenic therapy). Deterministic sensitivity analysis and probabilistic sensitivity analysis will be performed.

1. Study on the safety and effectiveness of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer.
2. Safety and effectiveness of standard chemotherapy alone or chemotherapy plus antiangiogenic therapy in first-line treatment of EGFR mutation negative and ALK negative patients with advanced non-squamous non-small cell lung cancer.
3. Pharmacoeconomic evaluation of camrelizumab combined with chemotherapy in patients with EGFR mutation negative and ALK negative advanced non-squamous non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* 1) Histopathological diagnosis of non-squamous non-small cell lung cancer; 2) EGFR gene mutation negative and ALK negative, and did not receive systematic chemotherapy; 3) Older than 18 years of age; 4) Pathological stage IIIB or IV; 5) ECOG (Eastern Oncology Collaboration group) score 0-1; 4) Ecg and liver and kidney function are normal; 6) No second primary tumor disease or serious complications.

Exclusion Criteria:

* 1) Patients with lung squamous cell carcinoma diagnosed by histopathology; (2) Patients with serious cardiovascular disease, active gastrointestinal bleeding, obvious coagulopathy, complicated with other malignant tumors, and drug allergy were excluded; 3) Patients with poor treatment compliance and incomplete case data.
Child-centered Communication and Anesthesia Use for MRI

The goal of this project is to study the influence of child-centered communication on children's anxiety, satisfaction and the use of anesthesia for MRI

This study seeks to inspect the influence of a child-centered communication (CCC) on anesthesia use in magnetic resonance imaging (MRI) exams among four- to 10-year-old children. Children's levels of anxiety and satisfaction with the interaction also are assessed. Children are divided into three groups by order of arrival. Group 1 receives routine information about the MRI and simulates it with an MRI toy (EG1). Group 2 simulates the exam with the toy and receives the CCC. These two groups are compared with a third group of children who had received only the routine information about the exam and who served as a comparison group (CG).

Eligibility Criteria:
Inclusion Criteria:

* Ages between four and 10 years old
* Having a medical request for the MRI in the hospital
* The MRI performed for the first time

Exclusion Criteria:

* Presenting cognitive, psychiatric or neurological conditions that prevented the understanding of communication
* Having any intra-body devices that impeded performance of the MRI exam