cyrilzakka/clinical-trials huggingface dataset:
Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling

X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens.


Eligibility Criteria:
Inclusion Criteria:

Males or females of all races and ethnicities

* ≥ 18 years of age
* Must be scheduled for breast cancer surgery which includes a sentinel lymph node biopsy and/or axillary dissection

Exclusion Criteria:

• Any person whose final pathology could be compromised in any way by the X-ray procedure
Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant

Recent published data suggest that specific alterations in intestinal metabolome signature of hematopoietic stem cell transplant (allo-SCT) recipients might influence incidence and severity of acute graft versus host disease (aGVHD). Nevertheless, this possible relationship has not been undoubtedly established, pathophysiologic mechanisms have not been elucidated and possible clinical implications have not been studied. We hypothesized that in the early phase of allo-SCT, specific alterations in faecal metabolome occurred related to loss of intestinal microbiota diversity and disbalance of specific bacterial taxa, and that both alterations determine reduced survival of patients through increased incidence and severity of aGVHD. To test this hypothesis, a prospective multi-center cohort of allo-SCT recipients will had faecal and plasmatic samples collected at predetermined time-points pre\&post-allo-SCT, and clinical relevant variables will be prospectively recorded throughout two years posttransplant follow-up. Metabolomic and microbiome analysis will be done to answer objectives of the study. To additionally explore if differential evolving characteristics in the intestinal metabolome and microbiome of donor/recipient sibling pairs influence the incidence and severity of aGVHD, probability of malignancy relapse and early and late mortality an additional cohort of family donors of enrolled patients will also have faecal and plasmatic samples collected and analysed.


Eligibility Criteria:
Patients Patients receiving an allotransplant at participating hospitals during the study period before initiating conditioning period.

Inclusion Criteria:

* Patients of any age who will receive allogeneic hematopoietic transplantation of any modality with any diagnosis.
* Agreement of the patient to participate by signing the informed consent or his/her legal representatives/assent (if applicable).

Exclusion Criteria

- Allotransplant recipients in stages after the initial pre-conditioning.

Donors

Family donors from patients included in the study:

Inclusion criteria:

* Agreement of the donor to participate by signing the informed consent or his/her legal representatives/assent (if applicable).
* Donor relatives with any degree of identity in the Human Leukocyte Antigens (HLA).

Exclusion Criteria:

* Unrelated donors
* Transplants from umbilical cord blood source.
Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (\<200 ug/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* patients with coeliac disease and having chronic diarrhoea (\>3 loose/ liquid motions a day for more than 4 weeks)
* Patients with a low faecal elastase (\<200 ug/g),
* Patients aged 16 years or over
* Patient able to give written consent to participate
* Patient not currently on Creon

Exclusion Criteria:

* Patients with normal faecal elastase (\> 201ug/g),
* Patients under the age of 16
* Patients allergic to pork or any pig product (advice from the drug manufacturer)
* Patients that are pregnant or are breast-feeding
* Patients taking alternative medication that could affect bowel frequency
* Where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial
* Patients who are unable to speak or understand English
A Clinical Study to Investigate if Transfusion of Patients Own Shed Blood Improves the Immunological Status in Comparison to Transfusion of Donor Blood ("Bank Blood")

The primary objective of the study is to compare the immunological status after either autologous blood transfusion as administered by Bellovac® ABT or allogenic blood transfusion, with regards to change in Natural Killer (NK) cell frequency in patients undergoing total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Male and female patients aged 18 years and over scheduled for total knee replacement
* Subjects classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology

Exclusion Criteria:

* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Pre-operatively haemoglobin below normal range as judged by the investigator
* Previous enrolment or randomisation to treatment in the present study
* Expected or confirmed participation in another clinical study during the study period
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
* Current symptoms of haemophilia
* History of or presence of malignant disease with propensity for systemic spread during the last 5 years
* Current or expected use of cytotoxic drugs
* Current untreated anaemia (e.g. sickle cell anaemia) as deemed by investigator
* Use of pre-donation
* Use of recombinant erythropoetin
* Use of other autologous blood transfusion than that with Bellovac ABT, e.g. washed and centrifuged blood like CellSaver
Safety Study of Tivanisiran to Treat Dry Eye

This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Have given their written consent to participate in the study
* Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection

Exclusion Criteria:

* Pregnant or breast feeding females with a postitive pregnancy test
* Women of childbearing potential not willing to use a medically acceptable contraceptive method
* Currently participating or has participated in another clinical trial within the 2 months prior to inclusion
* Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study
* Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial
Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

Aims of the study were to find vascular markers of inflammation and endothelial damage during the course of severe sepsis in septic patients and the effects of treatment with anti-inflammatory medication (such as Drotregocin alfa (activated)). Another aim is to find new markers and gene polymorphisms for prognosis and mortality of patients with severe sepsis. The hypothesis is that higher plasma concentrations of certain markers in septic patients are associated with a higher mortality rate.

During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Human activated protein C (Drotrecogin alfa (activated)), an important coagulation inhibitor plays a major role in regulating microvascular coagulation, inflammation and immunology. Little is known about prognostic vascular biomarkers during the time course of patients with severe sepsis.

Eligibility Criteria:
Inclusion Criteria:

* SIRS-Criteria
* Proven Infection
* One sepsis-induced organ-failure
* Adults \<18 years old

Exclusion Criteria:

* Anemia
* Pregnancy
* Blood donor in the last 3 month
RETR(Osteomyelitis)

This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.

Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with the risk of fracture and amputation. It is caused by the presence of bacteria in the bone marrow, sometimes responsible for an intraosseous abscess. Chronic osteomyelitis can have a hematogenous or more often exogenous origin, after trauma or surgery.

Despite the progress made in both antibiotics and surgical treatment, the probability of failure of this treatment (infectious recurrence) is of the order of 20%, and has unfortunately remained stable for more than 20 years.

An innovative treatment, Cerament-G (BONESUPPORT AB Laboratory, Sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin (CE marking), fills the "dead space" which is formed during surgery, prevents this cavity filled with blood from becoming infected, and promotes the regeneration of the bone within this space, limiting the risk of fracture in the medium and long term. It also locally delivers very high doses of gentamicin for several weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who presented with osteomyelitis between 2017 and 2021

Exclusion Criteria:

* Patients who objected to participating in the study
A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis

This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).

VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the treatment of RA.

This study will follow a "treat to target" (T2T) paradigm. T2T strategies have been followed in non-rheumatologic fields for decades. T2T trials have been conducted for RA from the late 1990's, and have substantiated the concept that treating to a target is associated with a better outcome than standard of care treatment. This has led to recommendations by experts to use T2T strategies in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed the assigned study drug treatment phase of a previous VX-509 study (e.g., Study 103).
* Subjects must voluntarily sign and date the Study 104 informed consent document.
* Subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria:

* Inflammatory and rheumatological disorders other than RA, where arthritis may be a prominent feature.
* History of any clinically significant illness that might, in the opinion of the investigator, confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* History of tuberculosis (TB), regardless of history of antimycobacterial treatment.
* Planned surgery during the study.
* History of alcohol or drug abuse, or excessive alcohol consumption as determined by the investigator, during the previous 12 months before Day 1.
* Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant
Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis

This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have psoriatic lesions measuring protocol specific BSA

Exclusion Criteria:

* Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
* Pustular psoriasis or erythroderma
Application of Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in Adult Patients Undergoing Major Thoracic Surgery

The primary aim of this study is to explore the relationship between alpha electroencephalographic oscillations, particularly Peak Alpha Frequency (PAF), pupillometry, intraoperative Nociception Level (NOL) and postoperative pain following major thoracic surgeries.

Goals to investigate the use of preoperative EEG as a biomarker for the prediction of postoperative pain to investigate the use of pupillometry in postoperative pain prediction and evaluation to test intraoperative NOL as a predicting factor of postoperative pain


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older scheduled for open lung lobectomy due to early-stage lung cancer.

Exclusion Criteria:

* 1) Severe neurological disorders (e.g. dementia) that could interfere with EEG recordings or pain testing.

  2) Severe psychiatric conditions such as major depression, schizophrenia, or active drug abuse.

  3) Preoperative analgesic therapy, which may alter EEG signals (Boord et al. 2008).

  4) Diabetes mellitus 5) Chronic pain of any etiology 6) Acute pain from any cause
e-ITAG Allergen Immunotherapy in the Management of Allergic Asthma

Allergy is defined as a specific abnormal and excessive reaction of the immune system to exposed allergen .

This reaction is reproducible with each new exposure allergen . A recent study by The European Academy of Allergy and Clinical Immunology" (EAACI) estimates that 30% of the population suffers from allergic rhinitis and/or conjunctivitis, 20% of children suffer from asthma, and 8% of the population suffers from food allergies in Europe, with a clear increase in prevalence.

Allergenic immunotherapy (AIT) remains a corner stone in the treatment of allergic diseases. It involves administering an increasing dose of allergens to induce immunological tolerance. The efficacy and safety of ITA have already been demonstrated. However, patient response is highly heterogeneous. This findinf illustrates the value of biomarkers in the selection of patients, enabling prediction of response to ITA and follow-up.

This is a prospective, observationel study conducted in Pneumology Department at the Military Hospital in collaboration with the Immunology Laboratory

We followed patients in 2 groups:

Group 1: patients with asthma or allergic rhinitis who had received allergen immunotherapy (AIT). Group 2: patients with asthma or allergic rhinitis who received a conventional treatment

Eligibility Criteria:
Inclusion Criteria Patients with symptoms of Asthma or moderate or severe persistent allergic rhinitis allergic rhinitis, with a positive prick test or specific IgE assay demonstrating the presence of allergens (1 or 2 allergens). A significant impact on the patient's quality of life Rhinitis associated with tracheitis or mild-to-moderate asthma. Patients with poorly controlled asthma despite optimal treatment Ineffective drug treatment Patients willing to adhere to our research protocol

Exclusion Criteria:

Patients with multi-allergenic asthma (more than 2 allergens) Pregnancy (at the time of ITA initiation). Autoimmune disease Immunosuppressive treatment Poorly controlled asthma HIV infection Cancer Severe psychiatric disorders. Cardiovascular diseases with a risk of complications during administration of adrenaline. Use of beta-blockers. Treatment with ACE inhibitors. Persistent lesions of the oral mucosa (chronic oral aphthosis periodontitis, etc.). Worsening of rhinitis. Acute febrile state. Recent administration of another vaccine (in this case, the ITA should not be administered on the same day).

ITA should not be administered on the same day).
A Wearable and a Self-management Application for Chronic Obstructive Pulmonary Disease (COPD) Patients at Home

Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with Chronic Obstructive Pulmonary Disease (COPD), which provides them with appropriate self-management tools and detects AECOPDs early to permit prompt treatment and prevent severe exacerbations requiring hospitalization.

Our overall research goal for this project is to create a wearable device and mobile application, appealing to patients with COPD, which provides them with appropriate self-management tools and detects Acute Exacerbations of COPD (AECOPDs) early to permit prompt treatment and prevent severe exacerbations requiring hospitalization. Currently, the investigators are developing a second version of this app, WearCOPDv2. This app will incorporate features identified as being desirable from our patient interviews: 1) new sensor that was requested by patients - oxygen saturation, and 2) the app will incorporate a patient-facing interface as patients requested a method to view their data as well as access to information to learn how to manage their condition better.

Research questions:

Can an app designed for patients with COPD that includes biosensor feedback improve self-management of COPD?

What is the accuracy of our sensor data (heart rate, activity, respiratory rate, oxygen saturation, coughing, and other sounds of interest) in detecting early AECOPDs?

Eligibility Criteria:
Inclusion Criteria:

* Able to speak English
* Moderate to very severe COPD (GOLD C and D) as defined by the GOLD guidelines
* Clinically relevant disease, as defined by a history of exacerbation in the previous 12 months
* Previous spirometry or Pulmonary Function Test results of Forced Expiration Volume/Forced Vital Capacity (FEV1/FVC) \<0.70 with an FEV1 below 80% predicted
* Patient resides at home (not long term care residence or another hospital)

Exclusion Criteria:

* Pulmonary condition other than COPD as the main respiratory disease such as bronchiectasis or asthma
* Rapid lethal disease, e.g. lung cancer, advance heart failure, end-stage renal disease
* Any medical conditions that would impair their ability to participate in the study
Neoadjuvant Chemotherapy With Cabazitaxel

This study is aimed at evaluating the efficacy regarding the response rate and metastasis-free survival time of cabazitaxel as a neoadjuvant treatment in patients with high risk prostate cancer.

Patients will be treated by 6 cycles of Cabazitaxel 25 mg/m2 every three weeks and extended radical prostatectomy and extended pelvic lymphadenectomy 4 weeks after completion of chemotherapy. Multiparametric MRI will be performed at baseline, after 3 cycles and after 6 cycles. If there will be evidence of clinical progression after 3rd cycle, patients can be removed from the study and given local therapy, including radical prostatectomy or external beam radiotherapy, at the discretion of the patient's physicians. If patients have evidence of response, they continue on treatment for a total of 6 cycles. If multiparametric MRI demonstrates stable disease an individual risk-benefit analysis has to be performed with regard to continuing or to stopping the neoadjuvant treatment since the definition stable disease includes patients with ≤ 20% tumour shrinkage or tumour progression

Eligibility Criteria:
Inclusion Criteria:

* Surgically resectable high risk prostate cancer with a 5-year relapse probability ≥ 60% according to the Kattan pre-operative nomogram (cancer 2009, 115: 1005-1010)

  * no prior therapy for prostate cancer such as androgen deprivation therapy, radiation therapy, or chemotherapy
  * ECOG performance status 0-1
* No evidence of active infection

  * Hemoglobin \>9.0 g/dL
  * Absolute neutrophil count \>1.5 x 109/L,
  * Platelet count \>100 x 109/L,
  * AST/SGOT and/or ALT/SGPT \<2.5 x ULN;
  * Total bilirubin \<1.0 x ULN,
  * Serum creatinine \<1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded)
  * Patient information and signature of informed consent
  * Male ≥ 18 years
  * Patients of reproductive age must take appropriate contraceptive precautions during and for 6 months after the end of their participation in the study

Exclusion Criteria:

* Evidence of lymph node, visceral or bone metastases

  * previous major intrapelvic surgery
  * previous radiation therapy to the small pelvis
  * any type of malignancies within the last 5 years except basalioma and non-muscle invasive urothelial cancer of the urinary bladder
  * previous chemotherapy with taxanes (docetaxel, paclitaxel, cabazitaxel) for any indication
  * Hypersensitivity to the active substance or to any of the excipients
  * Known or suspected brain metastases or leptomeningeal metastases
  * Active or symptomatic viral hepatitis or chronic liver disease
  * Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Effect of Nasal Highflow on Right Heart Function

In this study effect of NHF on pulmonary thermodynamic parameters will studied.


Eligibility Criteria:
Inclusion Criteria:

* stable disease
* hypoxemic respiratory disorder

Exclusion Criteria:

* decompensation
* acute illness
Acceptability Study of Sensor in Elderly People's House Living Alone (Fragility Box)

The Fragility box is a project lead by Mines de Saint-Etienne, Gérontopôle Auvergne-Rhône-Alpes (AURA) and Eovi Mcd Mutually to prevent autonomy loss in the elderly dwelling population. With non-intrusive sensors installed in their residence, it is possible to monitor and forecast the frail state of elderly people living alone. The current study focuses on the technical feasibility of the project and the acceptability of these types of devices within the elderly's home. About ten participants have volunteered to be a part of this study. Therefore, they had the sensors installed at their home for a 12 months duration. A qualitative study with focus groups and individual interviews are carried out to evaluate the project: user satisfaction, expectations, and fears.

This research tend to study the acceptability of captors which can measure the evolution of autonomy of older 65 people.

Eligibility Criteria:
Inclusion Criteria:

* People living alone
* Autonomous person

Exclusion Criteria:

* Person with a neurological disease
* Person under guardianship or curatorship