cyrilzakka/clinical-trials huggingface dataset:
Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy

Neutropenia after induction or consolidation therapy for acute myeloid leukemia (AML) patients is associated with a high morbi-mortality rates, especially due to infectious complications. These are managed according to international recommandations (ECIL and IDSA) with antibiotherapy and antifungal strategy. Although the patients suffer of digestive symptoms, intestinale complications are really less explored. Neutropenic enterocolitis (NE), cytomegalovirus (CMV) colitis, Clostridium difficile colitis, specific lesion, ischemic colitis are not well-known. No prospective study evaluate NE and these digestive complications which have high morbi-mortality rates.

This is the first prospective study on digestive affections in an homogeneous cohort of hematological patients. These affections are unknown in neutropenic patients with digestive symptoms after induction or consolidation courses pour AML although causing high morbi-mortality rates (infections, denutrition, loss of autonomy...).

The aim of the study is to evaluate incidence of NE by clinical signs and with a systematic CT scan performed at day 5 of fever during aplastic period. An early diagnostic could decrease complications and evaluate gravity criteria which could imply surgery therapy.

The physician will performe a CTscan with injection during the induction and/or every consolidation, at the same time as the thoracic CTscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs.

The clinical, microbiological, radiological symptoms will be registered at every time of febrile neutropenia with digestive symptoms at induction and each consolidation courses. The patient will be get out of the study when the AML is refractory, hematopoietic stem cell transplantation is required or if whenever he want. The last visit will be at the end of consolidation courses.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* inclusion criteria:

Every patient of hematology:

* Able to receive an intensive treatment for AML (induction then intensive consolidations) causing a neutropenia with high infectious risk
* In state to give its consent
* Affiliated to a social security system

Exclusion Criteria:

* The minor patients
* The patients affected by AML not being able to receive an intensive therapy
* The patients affected by acute promyelocytic leukaemia
* The pregnant women
* The patients with HIV, hepatitis B or C
* The patients under guardianship or guardianship or deprived of freedom by a court or administrative order (according to articles L1121-6 and L1121-8 of the Public health code)
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment

Exclusion Criteria:

* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease
Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis

The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of unilateral or bilateral Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (2) with at least frontal and maxillary sinus involvement
* Documented failed medical treatment of CRS
* Eighteen (18) to sixty-five (65) years of age
* Employed in full time position or equivalent
* Planned FESS for treatment of CRS
* Must have an American Society of Anesthesiologists physical status of P3 classification or less
* Able to provide informed consent by signing the informed consent document at the screening visit prior to any study activities
* Able to read and understand English

Exclusion Criteria:

* Previous sinonasal surgery
* Pregnant
* Cystic Fibrosis
* Diagnosed immotile cilia syndrome
* Samter's Triad
* Diagnosed immunodeficiency syndrome
* Diagnosed fungal sinusitis
* Concurrent septoplasty or turbinate surgery
* Diagnosed recurrent acute sinusitis
* Current smoker
* Presence of grade 2 or greater nasal polyps
* Sinonasal tumors or obstructive lesions
* History of substance or alcohol abuse within the past 12 months
* Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements
* Participation in a research study 30 days prior to surgery
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

The purpose of this study is to determine the way by which Alprazolam (Xanax) an anti-anxiety drug affects specialized molecules in your brain called GABA (A) receptors that alter your body's ability to defend itself from low blood sugar (hypoglycemia). We hypothesize that prior activation of GABA (A) receptors may result in blunting of counterregulatory responses during subsequent hypoglycemia and exercise.

The ultimate goal of this project is to identify treatments and approaches that will allow patients with diabetes to enjoy all the benefits of good glycemic control without the damaging limitations of severe hypoglycemia. The specific aim of this study is to determine if gamma aminobutyric acid (GABA A) receptors plays a role in the development of exercise associated autonomic dysfunction in type 1 diabetes and healthy man.

Eligibility Criteria:
Inclusion

* 14 Type 1 DM patients (7 male and 7 female) aged 18-50 years
* HBA1c \> 6%
* BMI\<35 kg/m2
* 14 healthy individuals (7 male and 7 female) aged 18-50 years, BMI matched

Exclusion

* Pregnant women
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
* Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
* Subjects with a recent medical illness
* Subjects with a history of hypertension, heart disease, cerebrovascular incidents
* Subjects with known liver or kidney disease Physical Exam Exclusion Criteria
* History of uncontrolled severe hypertension (i.e., blood pressure greater than 150/95)
* Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia)
* Pneumonia
* Hepatic Failure /Jaundice
* Renal Failure
* Acute Cerebrovascular/ Neurological deficit
* Fever greater than 38.0 C

Screening Laboratory blood tests Exclusion Criteria according to protocol
The Effects of Anodal tsDCS on Chronic Neuropathic Pain After SCI

The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who have chronic neuropathic pain.

Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tsDCS (2 mA) over tenth thoracic vertebra for 20 min (reference electrodes on the head vertex). Treatment order was randomly assigned. A evaluator rated the pain using the visual analogue scale for pain, Patient Global Assessment and Present Pain Intensity.

Eligibility Criteria:
Inclusion Criteria:

1. cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20\<=age\<90
2. neuropathic pain (LANSS score \>= 12), stable chronic pain for at least the three preceding months but not over 5 years
3. score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (VAS) for pain perception at the baseline/start of the treatment
4. refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months)
5. informed consent

Exclusion Criteria:

1. patients with any clinically significant or unstable medical or progressive neurologic disorder
2. contraindication for electrial stimulation such as pacemaker implant
3. Women of childbearing age or pregnancy
4. significant cognitive deficit
5. Syringomyelia
6. neuropsychiatric comorbidity
7. depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory)
8. history of substance abuse
9. skin defect under the electrodes
10. progressive neurological disease or other secondary conditions that could impact neuropathic pain
The Effects of Pelvic Floor Muscle Training Combined With Otago Exercises in Elderly People With Incontinence

Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems.

The aim of this study is to examine whether pelvic floor muscle training (PFMT) combined with Otago exercises is effective on symptoms, balance and functional status in elderly people with UI living in nursing homes, compared to PFMT alone.

The research was conducted on participants over the age of 65 with urinary incontinence living in a nursing home. After these participants were informed about the content of the study, a signed informed consent form will be obtained. This study is an assessor-blinded, randomized controlled trial. Participants with incontinence aged 65 and over living in a nursig home were randomly assigned to intervention (IG) and control group (CG). The intervention group attended an exercise program that included Otago exercises combined with pelvic floor muscle training (PFMT). The control group was included in the PFMT program with different positions. Duration of exercise for both groups was 45-60 minutes per session three times a week for 12 weeks. Incontinence symptoms and severity (Pelvic Floor Distress Inventory-20, bladder diary), PFM muscle function (superficial electromyography), balance (Berg Balance Scale), functional status (Senior Fitness Test) and fear of falling (Falls Efficacy Scale) was measured at baseline and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Having signed the informed volunteer consent form
2. Being 65 years or older
3. Having urinary incontinence
4. Ability to walk unaided and not use any walking aids

Exclusion Criteria:

1. Having severe walking and balance problems
2. Severe cognitive impairment (Mini mental state assessment test score below 23)
3. Having a serious neurological problem
4. Having serious heart diseases
5. Having a genito-urinary infection
6. Having pelvic organ prolapse
7. Six months ago he received medication for incontinence
8. Having had incontinence and abdominal surgery
9. Having metastatic cancer
10. Having any vision problems
Effects of Anti-VEGF Targeted Drugs on Patients' Blood Pressure and Endothelial Function

Explore the effects of anti-VEGF targeted drugs on blood pressure and endothelial function in cancer patients.

Thirty tumor patients with anti-VEGF drugs were selected. Demographic information and clinical information of all patients were collected before chemotherapy. Ambulatory blood pressure monitoring and endothelial function measurement (PWV, EndoPAT) were performed. Ambulatory blood pressure and PWV were reviewed at 2 weeks and 1 month. And EndoPAT, to evaluate the effects of anti-VEGF drugs on blood pressure and endothelial function in cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Tumor patients using anti-VEGF drugs

Exclusion Criteria:

* Hypertension, coronary heart disease, valvular heart disease, cardiomyopathy and other organic heart diseases, exclude liver and kidney failure, severe cerebrovascular disease, chronic obstructive pulmonary disease, rheumatic immune system disease
Evaluation of Three Dimensional Echocardiography in Critical Care Medicine

Comparison of volumetric measurements obtained by three dimensional echocardiography with measurements obtained by thermodilution using a pulmonary artery catheter in the intensive care unit.

Prospective, observational study evaluating three dimensional echocardiography for measuring hemodynamic variables versus the current gold standard (pulmonary artery catheter).

Critically ill patients with a severly compromised circulation due to a shock state with an advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will be included.

While performing an echocardiography study stroke volume measurements using the bolus method for thermodilution will concomittantly be measured.

In case of insufficient image quality we are planning to use SonoVue echo contrast. Once the image quality has improved we will repeat the stroke volume measurements with the bolus thermodilution method while performing the echocardiography.

The acquired echocardiography loops will then be analysed and measured offline once deferred consent has been obtained. We will then compare the echocardiographic measurements with the measurement obtained by the pulmonary artery catheter (bolus method) - since this is the current reference method.

Eligibility Criteria:
Inclusion Criteria:

* advanced hemodynamic monitoring with pulmonary artery catheter and arterial catheter in place
* patient intubated or tracheostomy in place
* clinical indication for performing an echocardiography
* ongoing sedation requirement

Exclusion Criteria:

* Heart rhythm other than sinus rhythm or paced atrial rhythm
* Known allergy to sulphur-hexafluoride (SonoVue©)
* Artificial heart valves in place
* Any form of mechanical cardiac assist
* contraindication to performing a transesophageal echocardiography
* presence of significant cardiac valve regurgitation
* presence of an intracardiac shunt
Hypotension Prediction Index Study (HPI Study)

A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent;
2. Age ≥ 18 years;
3. ASA Physical Status 3 or 4;
4. Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery);
5. Planned pressure monitoring with an arterial line;
6. General anesthesia;
7. Surgery duration expected to last ≥ 3 hours from induction;
8. Planned overnight hospitalization.

Exclusion Criteria:

1. Participating in another (interventional) study;
2. Contraindication to the invasive blood pressure monitoring;
3. Patient who is confirmed to be pregnant and/or nursing mothers;
4. Emergency surgery;
5. Known clinically important intra-cardiac shunts;
6. Patient in whom an intraoperative MAP target will be \< 65 mmHg;
7. Known aortic stenosis with valve area ≤ 1.5 cm2;
8. Known moderate to severe aortic regurgitation;
9. Known moderate to severe mitral regurgitation;
10. Known moderate to severe mitral stenosis;
11. Patient or surgical procedure type known as an SVV limitation (5) (e.g. tidal volume \<8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate (HR/RR) ratio \<3.6);
12. Current persistent atrial fibrillation;
13. Known acute congestive heart failure;
14. Craniotomy;
15. Surgery duration expected to last \< 3 hours;
16. Burn surgeries;
17. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
18. Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.
ART-Pro: Clinical Trial Evaluating Biparametric MRI and Advanced, Quantitative Diffusion MRI for Detection of Prostate Cancer

This is a multicenter, multinational trial to evaluate advanced MRI techniques for improved detection of clinically significant prostate cancer (csPCa). The study will enroll 500 participants at 5 clinical centers (100 participants per center). The current standard MRI technique for prostate cancer screening is multiparametric MRI (mpMRI), but two drawbacks include need for intravenous (IV) contrast and dependence on radiologist expertise. The investigators expect that the combination of two other techniques, biparametric MRI (bpMRI) and Restriction Spectrum Imaging restriction score (RSIrs), will help non-expert radiologists achieve similar performance to expert radiologists using bpMRI or mpMRI for detection of csPCa, while avoiding the drawbacks that are present when using mpMRI.

ART-Pro will be conducted in two phases (ART-Pro-1 and ART-Pro-2) and will evaluate bpMRI, mpMRI, and RSIrs (an advanced quantitative diffusion technique), for detection of csPCa. ART-Pro-1 will evaluate these techniques prospectively, by having each patients' MRI exam read by 2 expert radiologists, both using different subsets of the images to evaluate the different techniques. ART-Pro-1 will additionally evaluate RSIrs as a stand-alone quantitative biomarker. ART-Pro-2 will evaluate these same techniques retrospectively using radiologists of varying experience levels (novice, basic, and expert), and findings will be evaluated against the expertly created dataset from ART-Pro-1. Patients will be followed after initial enrollment for the purpose of extracting relevant medical outcomes, such as biopsy results or surgery pathology.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Referred for mpMRI of the prostate for suspicion of prostate cancer
* MRI is conducted using the standardized ART-Pro acquisition protocol

Exclusion Criteria:

* Currently incarcerated
* Previous diagnosis of prostate cancer
* Active non-prostate tumor(s) in structures of the body near the prostate
* Previous prostate surgery
* History of hip implant
* Metal implants or implanted devices in the body or other criteria that are deemed to require deviation from the usual acquisition protocol or scanning procedures
Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 \[figitumumab\] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
* Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
* No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
* Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
* ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

* Patients with symptomatic central nervous system (CNS) metastases are not permitted.
* Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
* Patients with other active cancer types are not permitted.