cyrilzakka/clinical-trials huggingface dataset:
A Study of Bevacizumab in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma (AMBER)

This is a randomized, blinded, placebo-controlled, multicenter, Phase II study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Previously diagnosed with multiple myeloma
* Relapsed or refractory multiple myeloma with disease progression following one to three prior treatment regimens
* Measurable multiple myeloma disease

Exclusion Criteria:

* Grade ≥ 2 peripheral neuropathy
* Use of corticosteroids within 21 days prior to Day 1
* Use of other anti-myeloma therapy within 21 days prior to Day 1
* Intolerance to bortezomib or compounds containing boron
* Life expectancy of \< 12 weeks
* Current, recent, or planned participation in an experimental drug study
* Active malignancy other than multiple myeloma within 5 years before screening
* Prior treatment with bevacizumab
* Inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
* Decreased left ventricular function at study entry
* History of myocardial infarction or unstable angina within 6 months prior to Day 1
* History of stroke or transient ischemic attack within 6 months prior to Day 1
* Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to Day 1
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, including placement of a vascular access device within 7 days prior to Day 1
* History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
* Serious, non-healing wound, active ulcer, or untreated bone fracture (for pathologic bone fractures consistent with multiple myeloma, patients may be eligible if no treatment is planned)
* Albuminuria
* Known hypersensitivity to any component of bevacizumab
* Pregnancy (positive pregnancy test) or lactation
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
3. Active SLE disease.
4. Autoantibody-positive.
5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

1. Pregnant or nursing.
2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
3. Have received treatment an investigational biological agent in the past year.
4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
5. Have severe active lupus kidney disease.
6. Have severe active central nervous system (CNS) lupus.
7. Have required management of acute or chronic infections within the past 60 days.
8. Have current drug or alcohol abuse or dependence.
9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.
The Effect of Prophylactic Hemodialysis on the Morbidity and Mortality of the Patients With Chronic Kidney Disease Stages 3-4 Undergoing Coronary Artery Graft Bypass

Coronary artery disease is a major cause of death in patients with renal dysfunction Among patients who undergo coronary artery bypass grafting ,renal dysfunction is known To be a major predictor of in-hospital and remote mortality As little is known about the impact of non-dialysis-dependent renal dysfunction on short and mid term Outcomes following coronary surgery we have decided to investigate the effect of prophylactic Hemodialysis on the mortality and morbidity of the patients with ckd (stage 3,4 ) and compare these Effect with the control group


Eligibility Criteria:
Inclusion Criteria:

* 80\<age\>18
* ckd patients with stage 3,4
* CABG for the first time

Exclusion Criteria:

* age\<18
* previous CABG (coronary artery bypass grafting)
* AKI(acute kidney injury)
* dialysis patients
Anatomical and Functional Macular Changes in Retinal Detachment

The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.


Eligibility Criteria:
Inclusion Criteria:

* Rhegmatogenous retinal detachment

Exclusion Criteria:

* Epiretinal membrane
Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that produces significant morbidity and hea1th care costs. It is likely that BPH is just as common among Chinese men. Debate exists as to whether currently available surgical and pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this condition. Evidence suggests that the consumption of soy isoflavones is related to lower rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies may include better patient compliance, improved safety and lower cost. Despite the fact that soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism of action, no randomised control trial has been performed using isoflavones to treat BPH. Therefore, a randomised control trial is proposed to test the tolerability and effectiveness of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will be reviewed every three months with maximal urine flow rate, international prostate symptoms score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize that this intervention will reduce lower urinary tract symptoms and slow the progression of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity
* Age between 45-85 years
* Diagnosed to have watchful waiting BPH (Qmax\< 15 ml/sec together with a voided volume of more than 150 mls)
* Not on any concurrent alternative medications for BPH
* Mentally capable to give informed written consent and willing to comply with study requirements

Exclusion Criteria:

* Prefers to have conventional medical or surgical treatment for BPH
* Concurrent treatment for unstable chronic diseases including unstable angina, poorly controlled DM (HbA1c \>7.5), less than 3 months post-MI or frequent exacerbation of COPD (more than 3x in the last year)
* Known to have prostate cancer or kidney and/or liver failure
* Urinary symptoms due to known causes other than BPH including neurogenic bladder, urinary tract infection, bladder cancer, bladder stone, urethral stricture
* Previous history of prostatic surgery
* Illiterate or having difficulty in filling in a patient diary
Sleep Apnoea Syndrome Without Chronic Heart Failure

It is the objective of this study to collect scientific data of sleep apnoea syndrome patients´ cardiac and respiratory function by additional sensors.


Eligibility Criteria:
Inclusion Criteria:

* patients with supected sleep apnoea syndrome and scheduled diagnosis at a sleep laboratory
* male and female patients aged at least 18 years
* persons who understand and follow the instructions of the study staff
* singed informed consent

Exclusion Criteria:

* persons being housed in an institution by court or governmental order
* pregnancy or breastfeeding
* patients who are not able to consent
* acute or chronic inflammations of the external and middle auditory canal
* abnormal anatomic proportionsof the external and middle auditory canal which are pathological or congenital, for example limitation of the auditory canal
* persons in a dependence or in an employment contract to the investigator
* participation in another study at the same time
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CD for at least 3 months prior to baseline
* Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
* Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
* If female, subject must meet the contraception recommendations

Exclusion Criteria:

* Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
* Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
* Have a stoma, ileoanal pouch or ostomy
* Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
* Have ever received any monoclonal antibodies binding IL-23
Cohort Study for Atrial Fibrillation Risk Stratification

AFHRI is planned as a prospective, single-center cohort study in patients at high risk of AF.

The primary aim of the study is to evaluate and improve atrial fibrillation risk prediction, which takes into account clinical, psycho-social, environmental and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint, AF (paroxysmal or permanent).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85 years;
* Personally signed informed consent

Exclusion Criteria:

* Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation;
* Physical or psychological incapability to cooperate in the investigations
A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle

Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability. Preventing the thromboembolic risk associated with FMD is therefore a public health issue. The reference treatment is oral anticoagulation but this treatment is contraindicated in patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle is a recent technique which makes it possible to exclude this appendix from the left atrium where the majority of thrombi are formed in the framework of the AF. Comparative studies have shown the effectiveness of this technique, appearing to be similar to that of anticoagulation. However, in view of the per-procedural risk, the indication of closure was retained by the health authorities only in the event of a contraindication to oral anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients with a history of intracranial hemorrhage are therefore candidates for this technique, but there are few studies where these patients were included. The risk-benefit must be demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming functional and cognitive.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Affiliation to a social security scheme
* Non-valvular, paroxysmal, persistent or permanent atrial fibrillation
* CHA2DS2-VASc greater than or equal to 2
* History of intracranial haemorrhage: Intra-parenchymal hematoma, subacute or chronic subcutaneous hematoma And
* Patients having benefited from the percutaneous closure of the auricle at the University Hospital of Amiens
* Either patient admitted to the CHU of Amiens in neurology, neurosurgery or geriatrics for intracranial haemorrhage, who received standard medical treatment for the comparison group.

Exclusion Criteria:

* CHADS2VASC2 less than 2
* Extradural hematoma
* Arachnoidal haemorrhage by rupture of aneurysm
* Haemorrhagic transformation of ischemic stroke
* Other indication of anticoagulation than FA
* Modified Rankin scale greater than 4 following intracranial hemorrhage.
* Early death, in the month following the onset of intracranial hemorrhage.
A Study of MORAb-009 in Patients With Solid Tumor

MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.


Eligibility Criteria:
Inclusion criteria;

1. Japanese male and female patients aged from 20 to less than 80 years at obtaining informed consent
2. Patient with histologically or cytologically diagnosed solid tumor
3. Patient who is mesothelin-positive confirmed by immunohistochemistry (IHC) (except for pancreatic cancer and mesothelioma that mesothelin-positive is frequently reported)
4. Patient with solid tumor who is non responder to or resistant to standard therapy and has no other appropriate treatment
5. Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group ECOG criteria

Exclusion criteria

1. Brain metastasis presenting clinical symptoms or requiring medical treatment
2. Serious and systemic infection requiring medical treatment
3. History of hypersensitivity to protein formulations including monoclonal antibody
4. With active multiple carcinoma (except for carcinoma in situ and intramucosal carcinoma)
5. With celomic fluid (pleural effusion or ascites) uncontrolled by drainage, or with a large volume of celomic fluid
Effect of High-intensity Interval Training on Cardiac Function and Regulation of Glycemic Control in Diabetic Cardiomyopathy

According to data of the International Diabetes Federation (IDF), diabetes in general affects approximately 415 million people worldwide and this number is still increasing. Cardiovascular diseases, one of the major complications of diabetes, are the leading cause of mortality and morbidity in the diabetic population. One of the cardiovascular complications is diabetic cardiomyopathy, in which structural and functional changes occur in the heart impairing cardiac function.

Exercise training has already proven the benefits on glycemic control in diabetes. This is also the case for the effects on cardiac function. However, as results are conflicting, it remains unclear which elements of exercise training should be focused on. For instance, high-intensity interval training (HIIT) is gaining interest as positive effects are already shown on glycemic control. Therefore, the potential of HIIT to improve cardiac function in diabetes should be investigated. Further on, the effects of exercise training on cardiac function are mainly investigated during rest by the use of transthoracic echocardiography. Therefore, as data are lacking, it remains unclear how the diabetic heart functions during exercise.

The aim of the present study is to investigate the effects of different training modalities (e.g. HIIT) on heart function in diabetes both during rest and during exercise itself. Therefore, cardiac function will be evaluated by the use transthoracic (exercise) echocardiography. This will be combined by the evaluation of several biochemical parameters.

The results will provide more insight in the pathology of diabetic cardiomyopathy as well as the potential of exercise training for this cardiovascular complication. Eventually, this research will contribute to the optimization of exercise programs for patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes patients:

  * BMI \> 20kg/m²
  * diagnosis of T2DM as stated in guidelines of ADA (American Diabetes Association)
  * stable medication for at least 3 months
* Healthy controls:

  * BMI \> 20kg/m²
  * no diabetes

Exclusion Criteria:

* iron deficiency anemia
* participation in another clinical trial
* heart diseases: CAD (coronary artery disease), ischemia, valvular diseases, congenital heart diseases
* neurological, pneumological, oncological, orthopedic disorders
* diabetes complications: renal diseases, retinopathy
Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

This is a prospective randomised controlled trial that will compare the outcomes of rectus sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower midline abdominal incision for bladder cancer.

This study will compare the outcomes of two different pain control techniques, used as standard of care, following major abdominal surgery for bladder removal. Rectus sheath catheters are small tubes that are positioned into a specific area of the cut abdominal wall at the end of surgery; whereas an epidural is a tube that is positioned into the back. Both allow administration of local anaesthetic for pain control. The current gold standard is an epidural. This study will aim to evaluate this and show the comparative efficacy of the rectus sheath catheter, which anecdotally the investigators have found superior in practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients over or equal to the age of 19 years old who can understand the study protocol and are able to give consent
* Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
* Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30mg morphine equivalents
* Patients must be able to understand and be able to use patient controlled analgesia
* Patients must be undergoing a cystectomy with an infra-umbilical midline incision

Exclusion Criteria:

* Patients with BMI greater than 40
* Patients with an allergy to local anaesthetics
* Patients who are contraindicated to having an epidural (e.g. coagulopathic, distorted anatomy, patient refusal, infection at the site of proposed insertion)
* Patients with previous spinal surgery at the proposed site of epidural
* Patients with neurodegenerative disorders or spinal cord injury
* Patients with known anatomy that would not permit placement of the rectus sheath catheters e.g. Prune Belly Syndrome
* Patients undergoing another complex abdominal procedure in addition to cystectomy and reconstruction requiring extension of the abdominal incision above the umbilicus.
The Symptomatic Cerebral Cavernous Malformation Trial of REC-994

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to investigate the safety, efficacy and pharmacokinetics of REC-994 (200 mg and 400 mg) compared to placebo in subjects with symptomatic cerebral cavernous malformation (CCM).


Eligibility Criteria:
Inclusion criteria:

1. 18 years of age or older with anatomic CCM lesions demonstrated by brain MRI
2. Have symptomatic CCM
3. Have provided written informed consent to participate in the study
4. Have NOT participated in a clinical trial utilizing an investigational agent within 28 days or within 5 half-lives of the investigational drug (whichever is longer) prior to Screening

Exclusion Criteria:

1. Symptoms deemed by the study Investigator to be caused exclusively by irreversible neuronal damage from prior stroke or neurosurgical instrumentation
2. History of cranial irradiation or surgical/radiosurgical treatment of the primary symptomatic CCM lesion
3. Pregnant or breast feeding
4. Be unable or unwilling to participate in MRI assessments (e.g., claustrophobia, metal implant or implanted cardiac pacemaker)
5. Liver dysfunction or active liver disease as defined by baseline serum transaminases \>2x upper limit of normal (ULN)
6. Have moderately or severely impaired renal function (estimated glomerular filtration rate \[eGFR\] \<60ml/min) or active renal disease or have previously received a kidney transplant
7. Have had a previous diagnosis of skeletal muscle disorders (myopathy) of any cause or have a baseline creatine kinase level \> 5x ULN
8. History of alcohol or substance abuse within 1 year prior to screening
9. Clinically significant laboratory abnormality
10. Have had an intracerebral hemorrhage within 3 months of screening or any brain surgery within 6 months of screening (not including the primary symptomatic CCM lesion)
Impact of Adipose Tissue in COVID-19

Overweight or obese patients are particularly exposed to severe forms of COVID-19. Few data suggest that adipose tissue infected with SARS-CoV-2 could be involved in the onset of the cytokine storm seen in severe forms of COVID-19. The aim of this study is to determine the pathogenesis of SARS-CoV-2-infection of adipose tissue. In particular the investigators will study how this virus enters the adipocyte and how it modulates metabolism and inflammation in the adipose tissue. From these data, the investigators hope to determine at the adipose tissue level, original therapeutic targets to modulate the effects of SARS-CoV-2 at the systemic level.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* All patients who are obese or overweight (\> 25 kg/m2) or non-obese (\< or = 25 kg/m2) operated for abdominal vascular surgery
* Beneficiary or entitled to a social security scheme (except AME)

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient refusal
* Patient deprived of liberty or subject to a legal protection measure (guardianship, curatorship)