cyrilzakka/clinical-trials huggingface dataset:
A New Fast DWI-based MR Protocol for Surveillance in Patients With a High Risk of Ovarian Cancer Recurrence During PARP-inhibitors Maintenance to Enhance Secondary Cytoreduction Results

In ovarian cancer (OC), complete surgical debulking and platinum-based chemotherapy are the standard treatment, now followed by maintenance therapy with PARP inhibitors or Bevacizumab. However, in advanced-stage ovarian cancer, recurrence is common, with a progression-free survival of about 16 months. Secondary cytoreductive surgery (SCS) at the time of recurrence prolongs the overall survival and gives the possibility to extend the use of PARP-i. SCS is possible only when recurrence has limited extension. However, in OC, there is no well-established and widely accepted scheme for surveillance during maintenance therapy; ESMO guidelines suggest physical examination for the follow-up and allow ultrasound, CT, PET-CT and MRI to confirm the recurrence and plan surgical treatment if appropriate.

Patients with OC in surveillance after first-line treatment usually have a scheme of clinical visits and serum marker evaluation every three months, associated with alternated transvaginal ultrasound and chest, abdomen and pelvis CT with contrast every three months and MRI with a confirmatory role in some cases.

We will use an abbreviated MR protocol of the abdomen (the most common location of relapse and the only one that can be treated by surgery) in association with CT. The abbreviated protocol is based on axial b50, b600 and b900 DWI with three-dimensional coronal maximum intensity projection (MIP) reconstruction of b900 values, ADC maps and axial single-shot T2-weighted sequences, which will take less than 20 minutes. This MRI protocol does not need contrast injection and does not add any risk for patients.

Any positive findings will be discussed at the Multidisciplinary Tumour Board and secondary cytoreductive surgery will be evaluated. Surgery outcome and subsequent clinical information (secondary PFS and OS) derived by normal clinical practise will be registered in a dedicated database.

Eligibility Criteria:
Inclusion Criteria:

* Patients with BRCA wild-type, HRP, high-grade serous ovarian cancer
* No residual tumour at first debulking surgery
* More than 6 months since the last platinum-based therapy

Exclusion Criteria:

* Patients who will not consent to participate in the study
Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation

Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.


Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilated patients within 48 hours after the transition from a controlled mode to PSV

Exclusion Criteria:

* History of neuromuscular disease
* History of diaphragm dysfunction and surgery
* History of esophageal, gastric or lung surgery
* Decreased level of consciousness
* Central respiratory drive dysfunction
* Considered withholding of life support
A Biomarker-driven Therapeutic Strategy for Esophageal Cancer Chemoradiotherapy in Patients With Resectable Adenocarcinoma of the ESophagus and Esophagogastric Junction

Preoperative chemoradiotherapy followed by surgery has been accepted as the standard of care for resectable adenocarcinoma of the esophagus and esophagogastric junction (EGJ). However, in a large part of the cases the tumor is extremely resistant to chemoradiotherapy, and those patients do not benefit from this treatment but are exposed to its negative consequences such as toxicity and delayed surgical therapy. The hypothesis is that a biomarker-driven therapeutic strategy in which patients will receive preoperative chemoradiotherapy or upfront surgery based on the basal tumor expression of BIRC3 could improve the R0 resection rate if compared with a standard strategy in unselected patients.

BoRgES trial is a multicenter, randomized phase II study of BIRC3-expression directed preoperative chemoradiotherapy in patients with resectable adenocarcinoma of the esophagus and EGJ. The main objective of this proposal is to provide evidence for a novel therapeutic strategy with enormous significance for patients affected by this disease.

Only a part of the patients with esophageal adenocarcinoma benefit from neoadjuvant therapy, and the clinical efficacy of chemoradiotherapy is reduced by the pre-existence of cellular drug resistance. Thus, there is an urgent need to identify patients who could not benefit from preoperative treatment. The study will define an innovative therapeutic strategy directed by the expression of BIRC3 as a predictive marker for discriminating patients who will most likely be resistant to preoperative chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the esophagus and EGJ (Siewert I/II) surgical resectable (cT2-4a, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and or PET-TC scan. cT1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible.
* If tumor extends below the EGJ junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach (Siewert III). Gastric cancers with minor involvement of the GE junction or esophagus are not eligible.
* Age \>18, no age upper limit unless patient would be unable to tolerate chemoradiotherapy.
* Have given written informed consent prior to any study-specific procedures.
* ECOG performance status 0-2.
* No prior thoracic radiotherapy allowed.
* Adequate hematological, renal, cardiac, hepatic and pulmonary functions.

Exclusion Criteria:

-
Early Goal Directed Therapy for Acute Kidney Injury

Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury


Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* occurence of the early phase of acute kidney injury
* stay on intensive care unit

Exclusion Criteria:

* chronic haemodialysis
* not given informed consent
Biological Markers of Functional Effects of Physical Activity in an Elderly Population

Circulating biomarkers are promising tools for the early diagnosis of aging-associated pathologies. Inflammation and immunity are associated with the risk of sarcopenia and frailty in elderly patients. The investigators investigate the effect of an adapted physical activity program on the metabolism and function of circulating immune cells and miRNA in frail and non-frail elderly subjects. Induced immune changes are analyzed together with that of motor abilities and of frailty status.

Circulating biomarkers are promising tools for early diagnosis of pathologies associated with aging. Inflammation and immunity are associated with the risk of sarcopenia and frailty in elderly patients. The investigators investigate the effect of an adapted physical activity program on the metabolism and function of circulating immune cells and miRNA in frail and non-frail elderly subjects. The main objective is to establish the link between biological markers of aging (immune cells phenotypes and function, miRNA) and motor capacities alteration/improvement. The secondary objectives are: (1) to characterize the functional and immunometabolic dimensions of frailty from objective indicators; (2) to propose a management system through adapted and individualized physical activity, based on objective indicators; (3) to evaluate the clinical impact of both frailty and its preventative management through physical activity; and (4) to identified new biomarkers of frailty. A total of 100 patients categorized as frail, pre-frail, and non-frail after a standardized geriatric evaluation are included in a comparative and interventional study. Exercise intervention consists in a 12-weeks physical activity program. Blood sample and physical/psychological functional measurements are performed before and after the 12-weeks physical activity program. ANOVA tests and correlational analysis will be performed. The finality of the study is to improve the medical prescription of physical activities in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient who signed the informed consent
* Older men and women ≥ 65 years
* Can walk without technical help

Exclusion Criteria:

* Patient with protective measures (guardianship, curatorship, and deprivation of liberty).
* Patient with a neurological problem
* No affiliation to a social security scheme (beneficiary or assignee)
* Knee and / or hip prosthesis
* Orthopedic complications with repercussions on walking activities
Hot and Cold Applications on PVC Insertion

Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.

Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. PVC was inserted, the researcher applied a hot or cold application to the catheter insertion site for one minute.

Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.

Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. The sample was comprised of 90 individuals, including 30 in the cold application group, 30 in the hot application group, and 30 in the control group receiving treatment in the Cardiology Clinic between November and December 2018.

Eligibility Criteria:
Inclusion Criteria:

* being able to speak and understand Turkish,
* being over 18 years of age,
* having unimpaired sense of time or place orientation,
* having no psychiatric disorders,
* having no visual or hearing problem,
* having indication of IV catheter application,
* having no administration of analgesic or anaesthetic agents prior to IV catheter insertion,
* having catheter inserted in one attempt,
* having no allergy to hot and cold applications,
* being voluntary to participate in the study.

Exclusion Criteria:

* infection
* previous history of surgery,
* scarring in the catheter insertion site,
* psoriasis in the catheter insertion site,
* active dermatitis in the catheter insertion site,
* peripheral nerve disease,
* diabetes,
* peripheral neuropathy in the catheter insertion site
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Anti-VEGF Agent in Subjects With Retinal Vein Occlusion

Eligibility Criteria:
Inclusion Criteria:

* Has a clinical diagnosis of RVO in the study eye
* Has a CST of ≥ 300 µm in the study eye
* Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
* Is naïve to local pharmacologic treatment for RVO in the study eye

Exclusion Criteria:

* Any active ocular disease or infection in the study eye other than RVO
* History of glaucoma, intraocular pressure \> 21 mmHg or ocular hypertension requiring more than one medication
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any evidence of neovascularization in the study eye
A Study in Benign Prostatic Hyperplasia

The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.


Eligibility Criteria:
Inclusion Criteria

* Present with benign prostatic hyperplasia
* Provide signed informed consent at the screening
* Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile Dysfunction or Overactive Bladder (including herbal treatments) during the study

Exclusion Criteria

* Have prostatic cancer or are being treated for cancer.
* Any condition that may negatively influence the transrectal ultrasound.
* Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
* Any evidence of moderate to severe cardiac disease
* Have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention.
* Have very high or very low blood pressure.
* Have uncontrolled diabetes.
* Have certain problems with your kidneys, liver, or nervous system.
Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study

The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.

Accurate staging of mediastinal lymph nodes (MLNs) in patients with lung carcinoma (LC) is paramount as the N stage largely determines treatment strategy, prognosis and outcome. Surgical staging such as mediastinoscopy is considered the gold standard. A less invasive alternative is transbronchial needle aspiration (TBNA). This technique is limited however by moderate and operator dependent accuracy. Recently less invasive strategies such as esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial ultrasound guided TBNA (EBUS-TBNA) were introduced. These strategies have largely complemented TBNA and surgical staging, with high accuracy and low morbidity. Disadvantages compared to TBNA however are required specific expertise, higher equipment and maintenance costs, the need for more assisting personnel and the need for sedation. Advances in computer generated image processing based on available CT and PET images enable (quasi) real-time virtual bronchoscopy that can assist minimal invasive surgical performance including bronchoscopy. Optimizing the traditional TBNA procedure with these modern imaging techniques might be equally accurate and more cost effective.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Proven or suspected lung cancer, base on clinical picture and/or CT-PET findings
* Suspected involvement of mediastinal lymph nodes on CT-PET scan
* Written informed consent

Exclusion Criteria:

* None
Buprenorphine Maintenance for Opioid Addicts - 2

The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence and cocaine abuse.


Eligibility Criteria:
Please contact site for information.
Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients

Research purpose: Lymphedema is a very common complication in breast cancer patients. However, since there is currently no curable treatment, it is important to prevent and reduce the severity of lymphedema. The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery. For secondary outcome, the preventive effects of exercise on other upper extremity dysfunctions (eg. pectoralis tightness, Axillary web syndrome, Adhesive capsulitis), which are common in breast cancer patients, were assessed.

Study subjects:

* Patients aged 20 or older who were first diagnosed with breast cancer
* Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design: Prospective randomized controlled comparative clinical study
* Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery.
* Treatment group: Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.
* Control group: One session of flexibility exercise training, diet management education through nutritional counseling

Result variable:

* Primary outcome variable:

  1) Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography
* Secondary outcome variables:

  1. Clinical information: Demographic, disease and treatment-related data
  2. Physical-related: height/weight/waist circumference measurement, body composition test, physical examination (axillary membrane evaluation)
  3. Upper extremity function (shortening of the pectoralis major muscle, adhesive capsulitis): evaluation of shoulder range of motion, upper extremity muscle strength/grip strength
  4. Quality of life assessment: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast cancer module 23(EORTC QLQ-BR23)

Assessment Schedule:

* Initial treatment and evaluation: Immediately after breast cancer diagnosis
* Follow-up evaluation: Immediately after completion of exercise intervention (preoperatively), and at 1, 3, and 6 months postoperatively.

Number of study subjects:

* This study will be conducted as a preliminary study for future research, and will be conducted on a total of 60 patients (30 in the experimental group and 30 in the control group) with an allocation ratio between groups of 1:1.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 or older and younger than 80 who were first diagnosed with breast cancer
* Patients scheduled for surgery and starting neoadjuvant chemotherapy before surgery

Exclusion Criteria:

* Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention
Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration

The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2 different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when administered at 4-week intervals for a total of 3 intravitreal injections in subjects with neovascular age-related macular degeneration (AMD).

This study has 2 arms with a 1:1 randomization. Randomization will be stratified by Japanese ethnicity. Half of the subjects in each arm will be of Japanese ethnicity. The other half of the subjects in each arm will be non-Japanese. Subjects in both arms will have visits at Screening, Day 0 (Baseline), Day 1 (24 hours post first injection), Day 3, Day 14, Day 21, Day 28, Day 56, Day 57 (24 hours post the injection on Day 56) and Day 84.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent;
* Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the central subfield in the study eye;
* Best Corrected Visual Acuity (BCVA) \> 23 letters in the study eye at Baseline;
* 50 years of age or older at the time of Screening.

Exclusion Criteria:

* Any active ocular infection or inflammation;
* Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), ranibizumab (LUCENTIS®), brolucizumab, or an investigational drug for neovascular AMD prior to enrollment in the study, as specified in protocol;
* Ocular surgery in the study eye, as specified in protocol;
* Uncontrolled glaucoma in the study eye, as specified in protocol;
* Use of steroids in the study eye, as specified in protocol;
* Medical conditions that may prevent study completion;
* Pregnant or nursing (lactating) women;
* Women of child-bearing potential unless using contraception;
* Uncontrolled blood pressure, as specified in protocol;
* Other protocol-specified exclusion criteria may apply.
LEVANT Japan Clinical Trial

To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.

The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female ≥20 years of age;
* Rutherford Clinical Category 2-4;
* Length ≤15 cm;
* ≥70% stenosis
* Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
* A patent inflow artery as confirmed by angiography
* At least one patent native outflow artery to the ankle

Exclusion Criteria:

* Life expectancy of \< 2 years;
* History of hemorrhagic stroke within 3 months;
* Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
* History of MI, thrombolysis or angina within 2 weeks of enrollment;
* Renal failure or chronic kidney disease
* Severe calcification that renders the lesion un-dilatable
Neonates With Neurological Complications

The purpose of this retrospective study is to identify all neonates (newborns \< 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery. This retrospective study is important to identify the incidence, care and follow-up of neurological complications at this institution

Studies have shown that between one-quarter and one-half of infants undergoing cardiac surgery will suffer brain injury during surgery (the perioperative period). Some infants with congenital heart disease have neurological injury prior to cardiac surgery as a result of cyanosis, acidosis and abnormal circulation. The spectrum of neurological injury ranges from agitation and subtle disturbances in learning and new memory acquisition to visual and motor development abnormalities, seizures, stroke and encephalopathy.

The patient will be identified from the cardiothoracic surgery database. Their hospital medical records and the neurological database will be reviewed for type of neurological complication (i.e. seizure, stroke), neuro-imaging and any mortality for these patients. We will review the patient outcome data that is available, after the initial surgery, through June 20, 2006. No patients will be contacted.

Eligibility Criteria:
Inclusion Criteria:

* Children's Healthcare of Atlanta patients
* January 1, 2002 through June 20, 2006
* \< 30 days of age
* neurological complications following cardiac surgery

Exclusion Criteria:

* Those who do not meet inclusion criteria