cyrilzakka/clinical-trials huggingface dataset:
Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer

The purpose of this study is to observe the routine clinical care of patients who have been diagnosed with breast cancer and have undergone Guardant360 testing.

Patients who have been diagnosed with breast cancer and have undergone Guardant360 testing will be approached regarding participation in the study. After being informed about the study and potential risks, all patients providing informed consent and access to their medical records, will provide a list of their health care providers related to their cancer treatment. Data related to their routine clinical care will be abstracted from medical records.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years of age and older) with a diagnosis of breast cancer
2. Guardant360 test results released to the patient's physician no less than 14 days prior to initial patient contact
3. Patient has previously provided contact information (either email or phone) to Guardant Health
4. Able and willing to complete the electronic informed consent process
5. Must have access to a computer terminal or personal computing device
6. Willingness to consent to the release of medical records

Exclusion Criteria:

1. Unable to understand English
The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker

Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to avaluate the ability of peripheral perfusion index to detect changes of hemodynamics in postcardiotomy patients with pacemakers.

Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to evaluate the ability of peripheral perfusion index to detect changes of hemodynamics (cardiac output or storke volume,et al) in postcardiotomy patients with pacemakers.

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 years old;
* postcardiotomy
* placement of temportary pacemaker during the surgery
* dependence of pacemaker (abscence of autonomic cardiac rhythm）

Exclusion Criteria:

* hemodynamic unstable （high dose of vasoactive drugs）
* fingers ischemia, cannot monitor the peripheral perfusion index
Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease

Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease is responsible for increased morbidity and mortality. Recent studies have pinpointed the frequency of somatic sequelas and persistent alteration in quality of life despite the cure of the disease. More specifically, a few studies have described persistent psychopathology, maladaptive personality and cognitive impairments in patients with a history of Cushing's disease. Among these, hippocampal memory deficits have been found in the majority of studies, a finding that is consistent with the alterations described in hippocampal neurons during chronic exposure to glucocorticoids. However, the tools currently available to assess hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and to analyze or may lack of diagnostic sensitivity. The investigators have recently developed an original tool, the virtual radial task in 3D, which has shown to be reliable to detect subtle alterations in hippocampal-dependent memory in several human diseases. The primary aim of the study is the evaluation of persistent cognitive impairments (hippocampal memory) in patients cured of Cushing's disease for at least one year using the virtual radial task in 3D and to compare it with that obtained with classical cognitive tests.


Eligibility Criteria:
Inclusion Criteria:

Patients :

* history of Cushing's Disease
* aged : 18 - 60 years
* Biological remission of Cushing's disease for at least one year
* Affiliation to Social Security
* Informed consent signed by patient and investigator (at the latest the inclusion's day, before study's exams)

For controls :

* People aged 18 to 60 years matched to patients for age, sex and educational level
* Affiliation to Social Security
* Informed consent signed by patient and investigator (at the latest the inclusion's day, before study's exams)

Exclusion Criteria:

For patients :

* Persistent hypercortisolism (even mild)
* Current treatment of hypercortisolism with drugs
* Obesity (BMI \>30 kg/m²)
* Alcohol or drug addiction present or past
* Growth hormone deficit
* Diabetes mellitus with hemoglobin A1c \> 7.5% and/or fasting blood glucose \> 1.4 g/L
* History of pituitary radiotherapy
* History of cerebrovascular or neuro-cerebral disease
* untreated dysthyroidism
* Current psychotropic drug treatment
* Pregnancy
* Use of glucocorticoids in the last 3 months before study (aside hydrocortisone replacement therapy)
* Excessive hydrocortisone replacement therapy (unadjusted to weight and/or with evening administration)

For controls :

* Obesity (BMI \>30 kg/m²)
* Alcohol or drug addiction present or past
* Current psychotropic drug treatment
* History of cerebrovascular or neuro-cerebral disease
* Current pregnancy
* Chronical use of corticoid (\> 1 month), current or past
* Use of glucocorticoids in the last 3 months before study (aside hydrocortisone replacement therapy)
* Diabetes mellitus with hemoglobin A1c \> 7.5% and/or fasting blood glucose \> 1.4 g/L
* Obesity (BMI \>30 kg/m²)
* untreated dysthyroidism
Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime

Oxaliplatin is a cytotoxic platinum compound and is one of the chemotherapeutic agent used in advanced colorectal cancer. It is used combined with Fluorouracil (5 FU) and Leucovorin. The main and most suffering side effect of oxaliplatin is polyneuropathy. Oxaliplatin-induced polyneuropathy (OIPN) can be acute and/or chronic neurotoxicity.

The early detection of the neurotoxicity and changing the medication dose and/or schedule can prevent its development. It has been used different neurotoxicity scales in grading OIPN. In this study the investigators try to investigate whether the evaluation of the vibrotactile perception VTP, by using a multi frequency tactilometry in a patients hand and foot is a good indicator and superior to the standard of care to detect the underlying OIPN in patients undergoing adjuvant chemotherapy treatment with FOLFOX, FLOX or XELOX regime.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed written informed consent.
* Fulfils the indication of the treatment with 3-6 months oxaliplatin combined adjuvant chemotherapy.
* Polyneuropathy grade according to CTCAE before treatment start ≤ 2.
* Performance status according to WHO ≤ 1.

Exclusion Criteria:

* Age \< 18 years.
* The patient does not consent to the examination
* Polyneuropathy grade according to CTCAE before treatment start \>2.
* Performance status according to WHO \>1.
The Role of CT Chest Scan in the Pre-anesthetic Assessment of Suspected or Confirmed COVID -19 Patients

The role of CT scan of the chest in Pre-anesthetic assessment of the severity of COVID-19 and the correlations between CT measurements of the aortic and pulmonary arteries diameters and severity of pneumonia.

Patients who were scheduled for emergency surgery during COVID-19 pandemic should have be screened for COVID pre-operatively given the prevalence f asymptomatic or mildly symptomatic cases that could be carriers to infection and possibly cause cross infection to the operating room staff especially the anesthetists who deal with the upper airway during intubation with high possibility of getting infected with SARS-COV 2 virus. Waiting respiratory tract PCR (RT-PCR) test for COVID can delay the surgery which may increase patients morbidity and mortality. RT-PCR test has limited sensitivity and specificity.

Patients who are confirmed to have COVID-19 infection (have positive RT-PCR) or patients who have possible COVID-19 infection (have symptoms but were not tested with RT-PCR) will undergo non-enhanced CT scanning of the chest (without giving IV contrast).

Chest CT scan will be interpreted by 2 Consultants radiologists with an experience of at least 10 years in their field.

The radiologists are going to be requested to comment on the lung parenchyma, describing the findings , assess the pulmonary artery, aorta diameters and the aorta:pulmonary diameters ratio will be then calculated. The degree of pneumonia severity index will then be described as well.

The radiologists will be blinded to the aim of the study.

All data will be collected and then correlation between the data sets will be statistically tested.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for emergency surgery with symptoms suggestive of COVID-19 infection.

Exclusion Criteria:

* Pregnancy.
* Haemodynamic instability (Mean arterial blood pressure above 65 mmHg or the need for of inotropic drugs to maintain mean arterial blood pressure above 65 mmHg).
* Active bleeding.
* Any indication by the surgeon or the anesthesiologist to proceed for immediate surgery for the patient safety.
* Patients refusal to do CT scanning.
Study To Assess The Efficacy Of A Cholesterol Lowering Drug On Top Of Statins In Patients After Myocardial Infarction (MI)(0653A-150)

Collecting local data, safety and experience trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients; Post Acute Coronary Syndrome

Exclusion Criteria:

-
Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis

A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
2. Patients with moderate to severe UC, determined by a 3-component Mayo score of 5-9 with an endoscopic subscore ≥ 2.Endoscopy must be performed within 90 days of ozanimod initiation
3. Elevated CRP (greater than upper limit of normal on assay) and/or fecal calprotectin (\>250 mcg/g) within 90 days of drug initiation

Exclusion Criteria:

1. Diagnosis of Crohn's disease or indeterminate colitis
2. Total (procto)colectomy
3. Ileoanal pouch anastomosis
4. Current ileostomy or colostomy
5. Untreated Clostridium difficile infection
6. Known pregnancy
Physical Actitvity and Blood Pressure Among Ambulance Personnel During Work and Leisure

The aim is to describe physical activity and blood pressure during work and leisure time among Swedish ambulance personnel, and to relate this to work- and lifestyle factors.

The work environment for ambulance personnel consists of several factors that might have negative effect on health, for example shift work, long working hours, stress and physical demanding work. Associations between these work-related factors and increased risk of disease, for example cardiovascular- and musculoskeletal disease, have been observed in several studies. However, few studies have specifically been focusing on ambulance personnel.

There is lack of knowledge regarding how work environment factors affect physical activity during work and leisure time among ambulance personnel. Further, the knowledge about blood pressure during work and leisure time is limited for this group.

Eligibility Criteria:
Inclusion Criteria:

* Employed in the ambulance organisation at the time for data collection

Exclusion Criteria:

* Managers and administrative personnel in the ambulance organisation
Effect of Plasma Sodium Concentration on Blood Pressure Regulators During Hemodialysis

Intradialytic hypotension (IDH) is a frequent and serious complication that may occur during hemodialysis treatment. The investigators and others have shown that the Hemocontrol biofeedback system is associated with improved hemodynamic stability. Hemocontrol is a technique that guides the patients' blood volume along a pre-set trajectory by continuously adjusting the ultrafiltration rate and dialysate conductivity. In a recent pilotstudy, the investigators found significantly higher plasma vasopressin levels during the first hour of dialysis with Hemocontrol in comparison with standard hemodialysis. Increased vasopressin levels may contribute to intradialytic hemodynamic stability during hemodialysis by enhanced vasoconstriction. These results, however, did not prove directly that the improved hemodynamic stability with Hemocontrol is indeed caused by higher initial plasma vasopressin levels. Alternative explanations might be that 1) the higher initial plasma sodium levels with Hemocontrol dialysis enhance activity of the sympathetic nervous system directly, causing vasoconstriction and thereby improved hemodynamic stability and/or 2) that the higher initial plasma levels of sodium in Hemocontrol inhibit the release of nitric oxide by the vascular endothelium. Another goal of this study is to investigate whether vasopressin is removed with hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* A thrice-weekly 4 hours hemodialysis schedule
* Dialysis on an arteriovenous fistula
* A usual interdialytic weight gain of ≥2.0 kg

Exclusion Criteria:

* Age\<18 years
* Dialysis duration of \<4 or \>4 hours
* Dialysis frequency of \<3 or \>3 times a week
* Dialysis on a central venous catheter
* A usual interdialytic weight gain \<2 kg
Evaluation of New Hemodynamic Indices

The objective is to determine the sensitivity and specificity via Receiver Operating Characteristic (ROC) curve of Global Longitudinal Strain (GLS) The secondary objectives are the same for the change in the amount of carbon dioxide exhaled (ΔEtCO2) and dynamic arterial elastance (Eadyn). it will also determine the sensitivity and specificity of these indices, either individually or combined to determine persistent responders to volemic expansion.

The best practice recommendations are to evaluate the preload dependence before performing a vascular filling test. This evaluation is based on the analysis of dynamic hemodynamic indices such as the variation of pulsed pressure (VPP), the variation of the volume of ejection (VVE) or the variation of the cardiac output during the realization of a test of rising of passive leg (ELJP). However, these indices require strict validation conditions.

New hemodynamic indices have appeared recently and appear promising in the evaluation of preload dependence. Among them, the analysis of longitudinal myocardial deformity by speckle tracking (GLS) and its variation during an ELJP (ΔGLS). The analysis of changes in the amount of CO2 exhaled (ΔEtCO2) reflects cardiac output in ventilated patients or the analysis of dynamic arterial elastance (Eadyn) calculated by comparing the VPP and the EVV which is a reflection of the coupling between the left ventricle and the arterial network.

In this work the assumption that the analysis of Δ GLS, ΔEtCO2 and Eadyn can predict the response to volume expansion in the ventilated patient, in septic shock under vasopressor.

The investigators include at least 51 patients, ventilated, under vasopressors with septic shock. GLS, cardiac output, VVP, VVE, blood pressure, Eadyn, EtCO2 will be measured before and after ELJP. In the event of an increase of more than 10% in cardiac output during the ELJP, patients will receive a volume expansion of 500ml of balanced crystalloids. The same measurements will be repeated immediately at the end of the volume expansion and 20 minutes after the end of the infusion. Patients with a 15% increase in cardiac output at the end of volume expansion will be classified as responders. Patients with a 15% increase in cardiac output 20minutes after the end of volume expansion will be classified as persistent responders.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting a shock whose etiology is considered as septic.
* Patient whose hemodynamic state justifies the infusion of vasopressor.
* Patient monitored by a cardiac output measurement system calibrated by transpulmonary thermodilution.
* Intubated patient with expired capnia monitoring
* Patient with signs of low cardiac output

Exclusion Criteria:

* Patient with a contraindication in the leg lift test.
* Patient with abdominal compartment syndrome.
* Patient with amputation of one or both lower limbs.
* Pregnant woman eliminated by a systematic pregnancy test at the entrance to the intensive care unit.
* Minor patient.
* Refusal to participate in the study.
Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* male and female subjects \>= 18 years of age
* moderate to severe symptoms of PBS/IC
* minimum pain/urgency/frequency scores
* female subjects on hormone therapy must be on stable dose for \>= 3 months

Exclusion Criteria:

* positive pregnancy test or pregnant or lactating
* narcotics or medical marijuana within 3 months
* use of any investigational drug or device within 30 days
* bacterial cystitis within 30 days
Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy

The objective of this study is to assess the effectiveness of the "Re Spine" mattress, which was designed as an alternative to physiotherapy in the treatment of low back pain (LBP).


Eligibility Criteria:
Inclusion Criteria:

* Low back pain

Exclusion Criteria:

* None
Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.

The purpose of this study is to assess the utility of the Modified version of VascuQol Scale as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.

In the prior study, the original 25-item VascuQol Scale demonstrates the limitation of dimensional mixing. As a result, we suggest improving the original scale by integrating the five dimensions and simplifying the objects. 480 patients will be recruited to complete the Chinese version of VascuQol Scale and the modified version. Reliability, validity, responsiveness, and diagnostic accuracy for CLTI will be used to evaluate whether the modified scale could serve as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.

Study Procedures :

After signing the informed consent form, eligible patients and/or their legal guardians will complete the questionnaires.

Outcome measures:

Patient-Reported Outcomes via specific questionnaires

Participant numbers:

480 patients will be recruited

Data management:

Data will be collected directly from the patients. All paper patient records will be kept in locked filing cabinet. Electronic files will be saved on password protected folder

Oversight :

i) Data will be collected in a electric database; ii) all documents containing the identity of the participating subjects (non-objection, list of correspondence, etc.) will be kept away from personal data; iii) If it is a computerized document, it will be kept on the center's information server with access control by password.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-90
2. The patient is diagnosed with lower extremity peripheral arterial disease
3. The patient is willing to comply with specified follow-up evaluations at the specified times
4. The patient understands the nature of the procedure and provides written informed consent before enrolment in the study
5. Before enrolment, the guidewire has crossed the target lesion
6. No restrictions on Rutherford grading, TASC grading, GLASS grading

Exclusion Criteria:

1. Pregnant women or Female patients with potential childbearing
2. The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
3. Patients unwilling or refusing to sign informed consent
4. Patients with other diseases that may seriously affect the quality of life, such as tumors, severe liver disease, cardiac insufficiency, etc., or those with a life expectancy of less than 2 years
Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation

This study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

This study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.

The trial aims to include patients experiencing dermal exhaustion during the process of skin soft tissue expansion. We will extract SVF components from autologous adipose tissue and injected intradermally into the expanded skin. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by Doppler ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography.

Eligibility Criteria:
Inclusion Criteria:

* had undergone tissue expansion treatment;
* show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (\<2mm) with no improvement after suspending expansion for 2 weeks;
* require further expansion to achieve the size for defect reconstruction.

Exclusion Criteria:

* Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
* Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
* Patients allergic to iodine or iodine-containing preparations;
* Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
* Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
* Patients with severely loose skin or insufficient subcutaneous fat tissue;
* Patients who request to withdraw informed consent and exit the clinical trial.
Rheumatological Manifestations in Inflammatory Bowel Diseases

IBD-related arthropathy is one of a group of inflammatory arthritides considered as seronegative spondyloarthropathies, a group of disorders that also includes ankylosing spondylitis, psoriatic arthritis, reactive arthritis, and undifferentiated SpA. IBD-related SpA is mainly characterized by axial involvement but may also be associated with peripheral symptoms, such as synovitis, dactylitis, or enthesitis


Eligibility Criteria:
Inclusion Criteria:

* any patient with inflammatory bowel diseases complaining of rheumatological manifestations

Exclusion Criteria:

* chronic hepatitis (c) patients
* Rheumatoid factor positive patients
* psoriatic patients.
* systemic lupus.