cyrilzakka/clinical-trials huggingface dataset:
Direct Oral Anticoagulant Management for Cardiac Device Implantation

Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited data currently exist on the perioperative management of DOAC-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. Especially, the time of DOAC resumption after the procedure is controversial.

We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed DOAC resumption \> 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We propose here an observational multicentre national study to find out the optimal strategy.


Eligibility Criteria:
Inclusion Criteria:

* receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment
* undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy
* informed
Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy

To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Pathological examination would include mitosis counts, particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor (GIST) of malignant potential is essential.

So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and complications between EUS-FNB \& unroofing biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Older than 19 years old and younger than 80 years old
* Suspected upper gastrointestinal subepithelial tumors(≥15mm, ≤35mm) that were originated from muscularis propria layer on endoscopic ultrasonography(EUS)

Exclusion Criteria:

* Patient who had bleeding tendency
* Any previous surgery on esophagus, stomach or duodenum
* Patients who can not be underwent sedated endoscopy
* Gastrointestinal subepithelial tumor that was not origianted from muscularis propria layer on EUS
* Constrast related allergic disease
Perfetti Method in Upper Extremity of Stroke Patients

The cognitive sensory motor training therapy (Perfetti's technique) might be more effectiveness than conventional occupational therapy on upper extremity function recovery after acute stroke patients.

Globally, stroke is the second leading cause of death above the age of 60 years, and the fifth leading cause of death in people aged 15 to 59 years old. Upper extremities problem is still faced with poor prognosis for recovery. Cognitive sensory motor training therapy (Perfetti's technique) might be better helped for recovery of upper extremity function in stroke than conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* First ever stroke
* Impaired upper extremity function
* Given signed inform consent

Exclusion Criteria:

* Unstable medical condition
* Any upper extremity functional impairment prior to stroke
* Can not adequately cooperate in training
* Severe communication problems
* Severe cognitive - perceptual deficits
* Fixed contracture more than 30 degree in every upper extremity joint
Examining the Experiences of Children With Blood Disorders

This is a 3-phase mixed methods study design. A literature review (Phase 1) has been completed to determine the areas of exploration and to identify challenges faced and the impact of the blood disorder on pediatric patients. Based on Phase 1, Phases 2 and 3, as proposed in this study, will be completed and will include interviews of patients diagnosed with bleeding and thrombotic disorders (phase 2). The interviews will be individual, semi-structured, and consist of open-ended questions to elicit unbiased and in-depth responses to gain an understanding of participant's perspectives on themes predetermined in the study design phase.

The purpose of this study is to explore the experiences of pediatric patients with blood disorders, specifically thrombotic, including venous thromboembolism (VTE), and hemostatic or bleeding disorders. The information gleaned from this study will help identify specific challenges faced by patients with hemostatic and thrombotic disorders - information that is necessary to develop impactful, evidence-based solutions to support patients with hemostatic and thrombotic disorders cope with the physical, emotional, and psychological impact of blood disorders. Participants with blood disorders in this study will participate in open-ended, semi-structured interviews with a study investigator focusing on the psychosocial experiences of patients with diagnosis and treatment of their underlying disorder and the understanding of their diagnosis. Female participants additionally will be asked questions about the unique effects of heavy menstrual bleeding, either from their underlying blood disorder or secondary to anticoagulation, on similar aspects of the impact of having a blood disorder. Validated questionnaires will be completed to obtain concurrent quantitative data. The interviews will be recorded and transcribed. Participation is complete after the interview has finished; participants will continue to receive standard of care treatment during and beyond the study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible to participate if they are between the ages of 12 and 21 years of age, English speaking and have a formal diagnosis of a hemostatic or thrombotic disorder. For thrombotic disorder patients, an additional eligibility criterion will be to include participants within 1 year of diagnosis.

Exclusion Criteria:

* Patients will be excluded if they do not have access to the technology needed to participate in a virtual interview visit (by telephone).
Using Ex-vivo Normothermic Machine Perfusion With the Organox Metra™ Device to Store Human Livers for Transplantation

This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. Participants will be followed for 3 months following transplantation and their outcomes recorded.

Liver transplantation is a life-saving procedure but its success has been limited by a shortage of suitable donor organs. Much emphasis is now placed on optimising the condition of those organs that are available, to enable more higher risk organs to be transplanted safely. An effective means of pre-transplant viability assessment would not only allow greater use of higher risk donors but also minimise the risk of primary non-function by identifying and excluding non-viable organs before subjecting a patient to the risk of surgery. Organ storage under normothermic perfusion conditions enables organ function to be evaluated prior to transplantation and further has been shown to prevent organ injury which is sustained during standard cold storage. This trial will examine the safety and feasibility of using the OrganOx Metra device to transport and store donor livers under normothermic conditions prior to transplantation. This study will evaluate liver function post-transplantation using standard clinical parameters. Participants will be followed for 3 months following transplantation and their outcomes recorded. Participants will undergo no other study procedures. Feasibility will be measured using the ratio of actual / eligible candidate donors recruited to the study and will also encompass logistical issues with respect to transportation, and ease of use. Safety will be assessed by rates of device failures resulting in organ discard, primary graft non-function, re-transplantation, and recipient death.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or more)
* Active on the waiting list for liver transplantation
* Able to give informed consent

Exclusion Criteria:

* Age less than 18 years
* Acute/fulminant liver failure
* Transplantation of more than one organ (e.g. liver and kidney)
* Refusal of informed consent
* Unable to give informed consent
* Re-transplantation Diagnosis of Hepatopulmonary Syndrome
Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia

In this pilot study we propose to gather preliminary data on whether transdermal magnesium chloride can improve quality of life in patients with fibromyalgia. Forty women with fibromyalgia will be enrolled in this study. Participants will be asked to apply a topical solution of magnesium chloride on their extremities 3 times daily for 28 consecutive days. Three questionnaires measuring quality of life will be administered at baseline, at 2 weeks, and at 4 weeks (end of study).

Fibromyalgia is a chronic pain syndrome with no known etiology. Fibromyalgia is generally diagnosed in patients reporting widespread musculoskeletal pain, and tenderness. In addition to widespread pain, fibromyalgia is also characterized by chronic fatigue, depression, sleep disturbances, and poor concentration. It has been reported that approximately 3.5% of women and 0.5% of men in the United States suffer from fibromyalgia. While the primary cause of fibromyalgia remains unclear, a growing body of evidence indicates that the widespread pain associated with fibromyalgia is due to abnormalities in the central nervous system. The pain threshold, both mechanical and thermal, in fibromyalgia sufferers are lowered such that it requires a lesser than normal stimulus to elicit pain.

Recent reports suggest that fibromyalgia is an oxidative stress disorder and deficiency in trace elements and antioxidants play an important role in the development of fibromyalgia. Magnesium is a trace element that is important for many metabolic functions. It affects cell membrane permeability and electrical activity. The similarity in the clinical symptoms of fibromyalgia and magnesium deficiency along with the histopathological findings of tender points (such as hypoxia and adenosine triphosphate deficiency) raises the possibility that magnesium may play a role in fibromyalgia etiopathogenesis.

In this pilot study we propose to explore the feasibility and ease of 2 times a day application of a topical solution to the arms and legs. We will also gather preliminary data on whether transdermal magnesium chloride can improve quality of life in women with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with fibromyalgia at Mayo Clinic Rochester's Fibromyalgia Clinic
* Postmenopausal women (no menstrual period for 1 year or more)
* Women age 40-70 that have had a hysterectomy
* Willing to travel to Mayo Clinic Rochester for the initial instruction visit
* Able to apply the transdermal magnesium chloride as directed
* Able to complete the questionnaires and daily diary
* Able and willing to give informed consent
* Able to speak, write and understand English

Exclusion Criteria:

* Patients on dialysis
* Individuals who decline to participate in the study
* Diagnoses of bipolar disorder, schizophrenia or dementia
* Patients with myasthenia gravis and myasthenic syndromes
* Patients on magnesium supplements
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device

This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate exacerbation and stable state asthma and COPD.

This is a prospective observational study comprised patients with moderate or severe COPD or asthma exacerbation in primary care settings. Patients will be examined twice - during an exacerbation of the disease and in a stable phase. Patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and LungPass device. Moreover, symptoms and anamnesis data, results of symptoms questionnaires (CAT for COPD and ACQ-5 for asthma), result of diagnostic questionnaire from the LungPass App, spirometry data, serum procalcitonin (for COPD patients), C-reactive protein, white blood cell count and blood eosinophil count, results of sputum cytology examination, Х-ray results (if carried out according to indications) will be collected.

Eligibility Criteria:
Inclusion Criteria:

For COPD patients:

* Patients able and willing to sign an informed consent to participate in the study;
* Patient is aged 40 years or older with a smoking history of ≥10 pack years;
* Patients with COPD confirmed previously by a detailed medical history and examination;
* Patients presenting with moderate or severe exacerbation of chronic obstructive pulmonary disease.
* Patient is treated by a monotherapy long-acting muscarinic antagonist (LAMA), or LAMA plus long acting beta2-agonist (LABA), or inhaled corticosteroid (ICS) plus LABA, or LAMA plus LABA plus ICS.

For asthma patients:

* Patients able and willing to sign an informed consent to participate in the study;
* Patient is aged 3 years or older;
* Patients with asthma confirmed previously by a detailed medical history and examination;
* Patients presenting with moderate or severe exacerbation of asthma;
* Patient is treated by a monotherapy ICS or ICS plus LABA or other controllers.

Exclusion Criteria:

* Age up to 3 years for asthma patients and up to 40 years for COPD patients;
* Patient refusal to participate in the study;
* Patients with subcutaneous emphysema, with damaged skin on the surface of the chest, with drainage in the pleural space, patients undergoing mechanical ventilation;
* Patients with asthma-COPD overlap or presence of other known chronic lung conditions such tuberculosis, cystic fibrosis or clinically significant bronchiectasis;
* Mental illness, other known acute diseases or known chronic decompensated diseases, such as a known active malignancy or severe heart failure, other known ongoing infection.
Open Radical Prostatectomy and Erector Spinae Plane Block

In the proposed study, a bilateral erector spinae plane (ESP) block \[10 ml 1%lidocaine + 10 ml 0.5 % bupivacaine vs normal saline (NS)\] will be performed preoperatively to patients undergoing open radical prostatectomy. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intra- and 24 h post-operative narcotic consumption.

It has been reported that the ESP block produces effective postoperative analgesia for abdominal surgeries by relieving both somatic and visceral pain. In the present study, the investigators presume that an ESP block will decrease narcotic consumption and NRS values both intraoperatively and during the first 24 postoperative hours.

Patients will be divided into two groups:

Group LB (Lidocaine-Bupivacaine): A bilateral ESP block will be performed preoperatively (10 ml 1%lidocaine + 10 ml 0.5% bupivacaine). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.

Group S: A bilateral ESP block will be performed preoperatively (20 ml NS).In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Eligibility Criteria:
Inclusion Criteria: AmericanSociety of Anesthesiologists (ASA) I-III patients between the ages of 18 and 65 who are scheduled for elective open radical prostatectomy.

Exclusion criteria:

* Patients who do not give informed consent or do not want to participate in the study
* Ages \<18 or\>65
* ASA IV patients
* Obesity (\>100 kg, BMI \>35 kg/m2)
* Contraindications of regional anesthesia (coagulopathy, thrombocytopenia, or infection at injection site)
* Serious renal, cardiac, or hepatic disease
* Hypersensitivity to local anesthetics or a history of allergy
* History of opioid or steroid use longer than four weeks
* Psychiatric disorders
* Analgesic preoperative treatment within the preceding 48 hours
* In order to establish better standard surgery, operations shorter than 60 minutes and longer than 180 minutes will also be excluded
Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better?

Urine cytology can be collected with spontaneous urine or by washing the bladder. It is commonly accepted among urologist that instrumental bladder washing is the method of choice. There are, however, no solid recommendations regarding the method to collect the urine for bladder wash cytology during cystoscopy. There are mainly two possibilities: 1) the use of an intermittent bladder catheter after the removal of the cystoscope or 2) bladder lavage through working channel of the flexible cystoscope itself. The first choice may increase the number of collected cells because of the larger caliber of the catheter compared to the working channel and thus the better efficacy of bladder wash. However, this method is certainly more invasive and possibly more expensive. To the best of our knowledge and according to available literature, none of both collection method can be defined as gold standard. The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient. If our study confirms the non-inferiority of "direct" collection through the cystoscope, this will allow the establishment of recommendations in this sense in order to simplify the procedure and reduce as much as possible the manipulations within the urogenital tract.

The aim of the study is to show that use of flexible cystoscope brings the same results in terms of quality of the urine collection for analysis as the use of intermittent bladder catheter and is less unpleasant for the patient.

Group A: Urinary cytology will be collected using a Ch.14 bladder catheter after the removal of the cystoscope. Catheter will be placed at the bladder neck level.

Group B: Urinary cytology will be collected through the flexible cystoscope itself at the end the cystoscopy. Before starting the urinary collection, the cystoscope will either be placed in front of a suspected intravesical lesion (if present) or at the bladder neck (if no lesion present).

Eligibility Criteria:
Inclusion Criteria:

1. Men aged \> or = 18 years
2. Patients scheduled for a flexible cystoscopy and urinary cytology.
3. Patients who have signed the informed consent.
4. Patients who speak French

Exclusion Criteria:

1. Manipulations or instrumentation of urinary tract, including but not limited to Double-J stent placement or removal, and/or bladder biopsy
2. Inability to give informed consent or without capacity of discernment
Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay

This is a post-marketing surveillance on MiniMAX Stem


Eligibility Criteria:
Inclusion Criteria:

1. Patient with a clinical condition requiring THA
2. Patient receiving a MiniMAX® stem
3. Patient aged more than 18 years
4. Patient having a Social Insurance or a similar protection regime
5. Patient eligible for an AMIS procedure
6. Patient able to follow the study requirements
7. Patients who are willing to give informed written consent

Exclusion Criteria:

1. Patient with local or systemic infection
2. Participation to biomedical research
3. Patient whose BMI exceeds 40
4. Patient with less than 18 years
5. Protected adults
6. Vulnerable person according to article L1121-6 of the Code de la Santè Publique.
7. Pregnant or lactating woman
8. Patient unable to express his/ her opinion about the participation to the study
The Impact of Artificial Sunlight on Human Sleep and Circadian Rhythms

The purpose of this study is to examine, in healthy controls, whether LED lighting that has a color spectrum similar to that of sunlight is able to differentially impact mood, circadian rhythms, sleep, and behavior, as compared to standard fluorescent lighting.


Eligibility Criteria:
Inclusion Criteria:

* Good self-reported health
* Normal color vision

Exclusion Criteria:

* No sleep disorders
* No extreme chronotype
* Regular smoker
* Significant hearing loss
* Depression
* Alcohol use disorder
* Use of illegal drugs
* Pregnant
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients

The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:

* Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.
* Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.

Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.

Participants will:

* Stop VEN-DASA treatment
* Be closely monitored by regular evaluation of the disease


Eligibility Criteria:
Inclusion Criteria:

1. Female/Male ≥ 18 years of age;
2. Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;
3. VEN-AZA given as first-line treatment;
4. Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;
5. Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);
6. Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD \<0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers \<0.1% in the blood);
7. ECOG \<3;
8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
9. Affiliated to the French Social Security or beneficiary of such a health Insurance;
10. Signed informed consent.

Non inclusion Criteria:

1. VEN-AZA given as salvage therapy;
2. Prior allogeneic stem cell transplant;
3. Discontinuation of treatment because of absence or loss of response;
4. Patient in emergency situation or unable to give consent;
5. Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.