cyrilzakka/clinical-trials huggingface dataset:
Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:

1. Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.
2. Control: Conventional thyroidectomy and parathyroid identification by the surgeon.

Measurements:

PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.

Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.

An interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand patient information and to give written informed consent
* Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.

Exclusion Criteria:

* Not able to understand patient information and to give written informed consent
* Previous parathyroid surgery or other parathyroid decease
* Age under 18
Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice

Medical call center have no phone advice protocol within out of hospital cardiac arrest in France. The purpose of the present study is to compare a group of patients with protocol phone advice delivered by the dispatchers ("CONTARM" group) versus usual phone advice ( "CONTHAB" group). Comparison will be performed on survival to seven days. The hypothesis is that CONTARM group has an higher survival at seven days. A second goal is to measure the survival to 15 and 30 days. The trial is randomized, controlled and will include 2600 patients. The patients will be enrolled in 19 hospitals in France.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* initial call to 15
* out of hospital cardiac arrest
* patient proximity to witness

Exclusion Criteria:

* first aid professionals on site
* rigor mortis
* location not allowing resuscitation
* inability to realize actions or misunderstanding
* no flow \> 5 minutes
Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer

The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male 18 years and older
* Histologically confirmed pT2 prostate cancer
* Post radical prostatectomy
* PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months
* Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml
* Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* Confirmed brain and/or leptomeningeal metastases
* Prior androgen deprivation therapy or orchiectomy for prostate cancer
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against prostate cancer
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment
Vascular and Metabolic Effects of Rosuvastatin

The investigators hypothesize that rosuvastatin does-dependently worsens insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* hypercholesterolemia

Exclusion Criteria:

* overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse
Evaluation of Predictors of Aortic Aneurysm Growth and Rupture

The goal is to non-invasively study the metabolic processes within the aortic wall that are thought to explain progression to clinical manifestations of an aortic aneurysm.

Hypothesis is that the non-invasive imaging of Abdominal Aortic Aneurysm (AAA) with contrast ultrasound, coupled with serum biomarker measurements will allow the identification of the vulnerable aortic wall and patients who are at risk of AAA growth or rupture.

Aim#1: Prospective Contrast Ultrasound (CUS) imaging of patients with AAA to predict AAA growth and test gender differences in rate of growth and rupture.

Aim#2: Serum biomarker testing of patient with AAA. CUS findings will be correlated with serum biomarkers and AAA wall histology.

Prospective Contrast Ultrasound imaging of patients with AAA as part of a pilot feasibility study to predict AAA growth and test gender differences in rate of growth and rupture. CUS findings will be correlated with serum biomarkers and AAA wall histology. Potential significance: This study will evaluate the AAA wall and will be based on detecting areas of increased vasa vasorum density within the aneurysm wall and intraluminal thrombus, which indicate regional ischemia and inflammation of the aortic wall and propensity for weakening, enlargement or rupture. This novel evaluation of the aortic wall in patients with AAA will allow individualized treatment based on the biological potential for growth and rupture.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
* 21 years of age or older
* ability to give informed consent.

Exclusion Criteria:

* Inability to provide an informed consent
* Known allergy to Definity
* Unstable cardiopulmonary conditions
* pregnancy
Compare the Effect of a Remote Monitoring System Using the EXACT Tool to Reduce Hospitalizations Due to Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. EXACT = Exacerbations of Chronic Pulmonary Disease Tool.

The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system using a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in preventing hospitalization from Chronic Obstructive Pulmonary Disease (COPD) exacerbations in a COPD population at high risk of exacerbation, compared to those managed by usual care.

This study uses two parallel groups of approximately 100 patients in each arm. After a screening period to confirm eligibility, patients will be randomized to either the RPM system group, or the usual care group. Both groups will be followed for 52 weeks until the end of study. There are only 4 planned study visits and patients will continue on their usual treatment.

The remote patient monitoring system will issue an alert to the clinical site once the established threshold change has been reached. The alert notification will require the clinical site to contact the patient and treat the patient based on clinical judgment and clinical practice. Patients in the usual care arm will be managed through their normally nurse/physician contact.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), GOLD grade 2 or higher as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, Updated 2011, including:
* Current or ex-smokers with a smoking history of at least 10 pack years nt
* Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% of the predicted normal value within 12 months prior to screening or at screening
* Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \< 70% within 12 months prior to screening or at screening
* A documented history of at least 2 COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics in the previous 12 months prior to the screening visit, at least one of which required hospitalization.

Exclusion criteria:

* Use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* Patients who have a COPD exacerbation not clinically resolved within 30 days prior to screening.
* Patients with a history of asthma, indicated by (but not limited to) the onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40 years.
Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)

Primary objectives of the study are:

* To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP).
* To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.

Secondary objectives of the study are:

* To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
* To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.


Eligibility Criteria:
Inclusion Criteria:

1. Patient was treated in study VGFTe-ROP-1920
2. Age \<13 months of chronological age
3. Signed informed consent from parent(s)/legal guardian(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

1. Patient has a condition preventing participation in the study, or performance of study procedures

NOTE: Other Inclusion/Exclusion criteria may apply
Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.

This study will be to prospectively determine differences in SSI if a prolonged course of post-operative antibiotics are used following liver transplantation. All adult patients, admitted to the University of Virginia (UVA) Medical Center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days.

Patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years of age.
* Eligible for liver transplantation by UVA standard protocol.
* First-time transplantation.
* No active infections - requiring antibiotics - excluding antifungals.

Exclusion Criteria:

* All patients \< 18 years of age.
* Previous liver transplantation.
* Active infections - requiring antibiotics.
* Allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or UVA standard alternatives for Penicillin allergic patients: ciprofloxacin and vancomycin).
Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors.

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).
* At least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).
* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

Exclusion Criteria:

* More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).
* Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.
* Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).
Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD

This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.


Eligibility Criteria:
Inclusion Criteria:

* Able to consent
* Age 18 years or older
* Diagnosis of COPD
* Ability to ambulate without assistance
* Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all

Exclusion Criteria:

* Pregnancy
* Being on bedrest
* Inability to consent or cooperate with the study
* Using of \> 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime
* Hemodynamic instability (resting heart rate \> 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)
* Metal implants in the thoracic regions (pacemakers, Automatic Implantable Cardioverter Defibrillator (AICD), plates, screws, rods, and disc replacements)
Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis

Lung adenocarcinomas (LUADs) from Asian ancestry are reported to have different genomic architectures compared with LUADs from Caucasian ancestry. However, due to lack of available cases, few studies controlled the clinical attributes during the comparisons of the genomic alterations. In this study, the investigators will identify Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital. Then, Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets \[MSK-IMPACT\]) will be identified in the GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations. Finally, genomic alterations regarding somatic mutations, copy number variations, fusions, mutational signatures, oncogenic pathways, and therapeutic actionability will be comprehensively compared between these two cohorts after adjusting age, sex, smoking status, and pathologic stage using propensity score matching. This study will elucidate important ancestry differences between Asian and Caucasian lung adenocarcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Primary lung adenocarcinoma
* Broad-panel next-generation sequencing
* Asian

Exclusion Criteria:

* Inadequate clinicopathological information
* Low-quality next-generation sequencing
Nurse Health Pilot: Feasibility and Acceptability of a Virtual ACT-intervention in Nurses During COVID-19

Frontline nurses increasingly face challenges between executing their jobs to the best of their ability and caring for their own physical and mental health. Such a stressful and fast-changing work environment impacts the nurses' psychological wellbeing, resulting in high levels of stress and burnout, which in turn negatively affects patient care and outcomes.

The aim of this study is to investigate whether a short virtual intervention, based on Acceptance and Commitment Therapy (ACT) and adapted to caregivers, can lead to a reduction in psychological distress that may be associated with caregiving during the COVID-19 pandemic.

The intervention will be held online in a group setting during two half-day workshops using a conference application (e.g. Zoom).

Note: This study is part of an international joint research project "Nurse Health" between the Faculty of Psychology (University of Basel) and the Nethersole School of Nursing (Chinese University of Hong Kong), funded by the Swiss State Secretariat for Education, Research and Innovation (SERI), with the Leading House for the Bilateral Science and Technology Cooperation Programme with Asia at ETH Zürich (Project No. COV_09_062020).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* degree in nursing
* working 40% or higher in a team of nurses in the somatic area
* currently or previously in contact with COVID-19 patients
* working in Switzerland

Exclusion Criteria:

* working in non-somatic areas (e.g. psychiatry)
* working in non-hospital environments (e.g. home treatment)
* not owning an electronic device
* unable to understand and speak German
Acupuncture for Pain Relief During Perineal Repair After Childbirth

Midwives and obstetricians are currently using acupuncture for several health problems during pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used as pain relief during the repair of lacerations in the female pelvic floor following childbirth.

Three acupuncture points in the ear have been reported highly effective for perineal pain relief. A scientific trial will compare acupuncture with traditional local anaesthetics when midwives conduct perineal repair just after delivery in the hospitals of Southern Denmark.

A randomised trial has been initiated. 226 healthy primipara are invited to participate if they deliver a child after gestation week 36 and sustain a perineal laceration or an episiotomy during childbirth.

The randomisation is done using a computer-controlled voice response system and the compared treatments are:

A: Acupuncture in Shen Men, GV20, BL36 and 2 needles in the upper ear.

B: Local anaesthetics (lidocaine 10 ml/mg) directly in the wound area.

Primary outcomes are:

1. Need for additional pain relief during the perineal repair.
2. Pain experienced during perineal repair reported 1 day after delivery.
3. Wound healing evaluated 1 and 14 days after delivery.
4. Patient satisfaction with the given pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Primipara
* Healthy mother and child
* Danish speaking
* Perineal laceration or episiotomy that can be sutured by a midwife.

Exclusion Criteria:

* Large perineal lacerations
* Heavy bleeding after childbirth
* No need for pain relief
Evaluation for NCI Surgery Branch Clinical Research Protocols

Background:

The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.

Objective:

This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.

Eligibility:

Patients 18 years or older must meet the minimum eligibility criteria for an NCI-SB treatment protocol.

Design

Patients will undergo testing and evaluations as required by the appropriate NCI-SB treatment protocol.

...

Background:

Potential research candidates undergo thorough screening including laboratory tests, scans, x-rays, and review of pathology slides to determine initial eligibility for National Cancer Institute Surgery Branch (NCI-SB) research protocols.

Objectives:

Permit evaluation of patients referred to the NCI-SB in order to identify individuals who will be suitable candidates for NCI-SB clinical research protocols.

To assess frequency of HLA type, gene specific mutations or expression of neo antigens in malignant tumors across the population of cancer patients undergoing screening for NCI-SB protocols.

Collect results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values.

Eligibility:

Age \>= 18 years.

Patient suspected of having, or with biopsy proven, malignant disease.

Patient is able to understand and willing to sign a written informed consent document.

Patient is being evaluated for treatment on an NCI-SB protocols..

Design:

Patients enrolled on this protocol will be evaluated by NCI-SB physicians to determine the individual's suitability for participation in a clinical research protocol. An accrual ceiling of 7,000 patients has been set to meet the screening needs of the NCI-SB.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age \>= 18 years.

Patient suspected of having, or with biopsy proven, malignant disease.

Patient is able to understand and willing to sign a written informed consent document.

Patient is being evaluated for treatment on an NCI-SB protocols.

EXCLUSION CRITERIA:

Women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus.