cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302

Primary objective:

To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study. (I10E-1302).

Secondary objective:

To assess the safety of I10E in this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient aged 18 years or more.
2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ≥1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
3. Covered by national healthcare insurance system as required by local regulations.
4. Written informed consent obtained prior to any study-related procedures.

Exclusion Criteria:

1. History of severe allergic reaction or serious adverse reaction to any Ig.
2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
6. Body mass index (BMI) ≥40 kg/m².
7. Glomerular filtration rate \<80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
8. Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
9. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
10. Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements.
11. Increasing dosage or introduction of a systemic corticosteroids therapy within the last 3 months prior to screening, at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted.
12. Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil and methotrexate) or haemopoetic stem cell transplantation.
13. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
14. Anticipated poor compliance of patient with study procedures.
Immune Reconstitution in HIV Disease (IREHIV)

The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms and decreased inflammation.


Eligibility Criteria:
Inclusion Criteria:

Adult patients \>18 years not subjected to HAART.

HIV-1 infected patients with CD4 T cells counts \>200 cells/ml.

Detectable plasma viral loads \>1000 copies/ml.

Exclusion Criteria:

Patients on HAART or other antimicrobial drugs (including bactrim).

Antimicrobial drug treatment in the past month.

Patients with medical contra-indication for biopsy such as bleeding tendencies.

Hypercalcaemia (serum calcium \> 3,0 mmol/L) identified at baseline.

Pregnant and breast feeding women.

Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.
Effect of Individualized Versus Standard Bp Management During MT for Anterior Ischemic Stroke

DETERMINE is a multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to evaluate two approaches of blood pressure (BP) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.

This study have to objective to evaluate the efficacy of an individualized BP control during mechanical thrombectomy (regardless of the sedation modality), by maintaining a mean arterial pressure (MAP) within 10% of the first MAP measured in the angiography suit, compared to the standard BP management, on the 3-month functional outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Acute ischemic stroke due to an anterior large vessel occlusion: occlusion of the M1 or M2 segments of the middle cerebral artery, anterior cerebral artery (A1 segment), intracranial internal carotid artery, or tandem occlusions.
* Indication for mechanical thrombectomy under general anesthesia or conscious sedation within the first 6 hours from symptoms onset or within the first 24 hours if DAWN or DEFUSE-3 criteria are met.
* Affiliation to social security assurance.

Exclusion Criteria:

* Contre-indication to mechanical thrombectomy
* Intubation or induction of general anaesthesia prior to randomization
* Acute ischemic strokes associated with a posterior circulation large vessel occlusion (basilar artery, vertebral artery, posterior cerebral artery)
* Intra-hospital onset of acute ischemic stroke, or secondary to a medical, interventional or surgical procedure (interventional cardiology, cardiac or vascular surgery) or any post-surgery ischemic stroke.
* Pre-existing neurological disability limiting neurological assessment at 3 months: mRS \>2 at randomization.
* Contraindication to iodinated contrast agents
* Known pregnancy or breastfeeding woman
Evaluation of the Benefits of Bilateral Fitting in BAHS Users

The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).

The patients included in this study are adult patients with a bilateral conductive or mixed hearing loss, that are already bilaterally implanted with two percutaneous bone-anchored devices (BAHS). The study consists of two visits. At visit 1, the patients are fitted unilaterally and bilaterally with the investigational device (Ponto 3 SuperPower). After fitting, the patients perform a test of spatial resolution (minimum audible angle, visit 1) and an auditory working memory test (visit 2). These two outcome measures are conducted in the laboratory using the Ponto 3 SuperPower unilaterally and bilaterally. Additionally, the patients fill in a questionnaire (SSQ12) to report perceived performance in their everyday life with their own devices. This is a post market study and all products used are CE marked and used in clinical practice worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Adult BAHS users, minimum 18 years and maximum 75 years.
* Native English speakers.
* Patients that are already bilaterally implanted.
* Patients with a bilateral conductive or mixed conductive-sensorineural hearing loss.
* Experience with bilateral Ponto of at least 6 months.
* Patients that are using both their sound processors daily.
* PTA BC (at 0.5, 1, 2, 3 kHz) on both sides lower or equal to 65 dB HL.
* If the masked BC is available on the patient's journal, the average difference in masked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
* If the masked BC is not available on the patient's journal, the average difference in unmasked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.

Exclusion Criteria:

* Not deemed suited by the principal investigator.
* If the physician assesses that the patient is not fit for trial participation at any stage.
* Audiogram at 1st visit shows too large masked BC thresholds (PTA BC - at 0.5, 1, 2, 3 kHz - on either side larger than 65 dB HL).
* Audiogram at 1st visit shows asymmetric masked BC thresholds (average difference in masked BC - at 0.5, 1, 2, 4 kHz - between L and R ear larger or equal to 15 dB).
The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery

Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM.

Patients who underwent major abdominal cancer surgery using ODM in the operating room of our hospital between November 2021 and November 2022 were identified from the Anesthesiology Clinic records and examined according to whether they were operated with open or closed (laparoscopic) methods. Demographic data, vital signs, amount of bleeding, type and amount of fluid administered, and the results of cardiac index measurements performed with the ODM device in the supine and trendelenburg positions (45 degrees) were analyzed. Parameters recorded with the ODM device; CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance.

Eligibility Criteria:
Inclusion Criteria:

* Elective operation
* ASA 1-4

Exclusion Criteria:

* Heart failure
* Valvular heart disease,
* Patients with symptomatic rhythm disturbances
* ODM placement contraindicated (coagulopathy, oesophageal varices, known aortic aneurysm)
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer

This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2) positive breast cancer.


Eligibility Criteria:
Key Inclusion criteria:

* Age 18 years or older
* Histologically or cytologically proven adenocarcinoma of the breast
* Subjects who have locally recurrent or metastatic disease with at least one measurable lesion
* HER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2
* At least 12 months since prior neoadjuvant or adjuvant chemotherapy
* At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions
* Adequate renal function
* Adequate bone marrow function
* Adequate liver function
* Adequate cardiac function

Key Exclusion criteria:

* Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer.
* Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer
* Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin
* Inflammatory breast cancer
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Clinically significant cardiovascular impairment
* Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.
* Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI)
* Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
* History of bleeding diasthesis
* Currently pregnant or breast-feeding.
* Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment
Postoperative Delirium: EEG Markers of Sleep and Wakefulness

Postoperative delirium is a condition in which patients develop temporary difficulties in maintaining attention and thinking clearly. These new problems can appear after surgery and change throughout the day. This confusion can last several days.

The overall purpose of this study is to measure brain activity during sleep and wakefulness to learn about their relationships to delirium after surgery. While participants may not feel like their normal self during the study, they are in the best position to help us learn how to improve the recovery of brain function and sleep in others having surgery. The investigators need to learn from those who have and have not become confused after their surgical procedure.

Postoperative delirium is a condition that can develop in some older patients after they have surgery and receive general anesthesia. Patients that develop delirium have difficulty maintaining attention and thinking clearly. Both of these issues can come and go throughout the day. The incidence of postoperative delirium is greater than 25% and is associated with longer hospitalization and increased risk of persistent mental and physical decline. It is thought that this disorder may be preventable, but there is no agreed upon way of identifying which patients are at risk for delirium prior to their surgery. Additionally, patients with atypical delirium are often misdiagnosed or undiagnosed postoperatively.

Based on previous research, the researchers have hypothesized that delirium may be directly related to wakefulness and sleep problems, as shown on electroencephalography \[EEG\]. EEG is a test that records the electrical activity of brain through placement of small wires on a person's scalp. In light of this, the purpose of this study is to evaluate sleep and wakefulness using EEG before, during and after surgery in order to discover any abnormalities of sleep or wakefulness that associate with postoperative delirium onset, severity, and length of recovery. Subjects in this study will have preoperative at home sleep testing performed, using a device called the Sleep Profiler, and questionnaires administered to characterize their mental function and brain function prior to surgery. When they arrive for their scheduled surgery, the subjects will be fitted with the Sleep Profiler to record brain activity during surgery and after surgery for 5 days. Postoperatively, the subjects will be asked to do simple tasks like move toes and fingers and to answer questions that assess their mental state.

Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. Age 60 or older
3. Scheduled for cardiac surgery requiring cardiopulmonary bypass for coronary artery bypass grafting and/or heart valve repair/replacement

Exclusion Criteria:

1. Pre-existing delirium or dementia
2. Legal blindness or severe deafness
3. Surgery requiring deep hypothermic circulatory rest
Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality

An observational analytic retrospective study was conduct using cross-sectional study. The subject were oocytes from in-vitro fertilization procedures using the ICSI method at the assisted reproductive technology clinic in a private hospital in Bandung for the period 2017 - 2019. Three variables were oocyte denudation time, ICSI time and embryo quality collected from samples that met the research criteria.

This study analyses the different oocyte denudation time after ICSI on all embryos generated during IVF procedures between 1 Januaryr 2017 and 31 December 2019. All oocytes arer categorised on how many hours their denudation times were and these were then assessed for their qualities.

Eligibility Criteria:
Inclusion Criteria:

* oocytes collected from in-vitro fertilisation procedures involving intracytoplasmic sperm injection

Exclusion Criteria:

* oocytes from patients \>40 years old
* oocytes from primary infertility \>5 years
* endometriosis
* polycystic ovarian syndrome
Kidney Function and Anorexia Nervosa

Anorexia nervosa (AN) is an eating disorder that can lead to severe medical complications. Kidney injuries are unknown in patients with extremely malnourished AN (BMI \<13). The primary objective of the study is to evaluate the frequency and to determine the profiles of patients who may develop kidney injuries. The secondary objective is to evaluate the evolution of kidney injuries after a phase of refeeding. Guidelines for medical treatments and dietary intakes will be recommended to avoid severe or irreversible renal disease.

Anorexia nervosa is an eating disorder that can lead to undernutrition and severe somatic complications. The clinical nutrition unit in Paul Brousse hospital provide care to adult patients with a severe forms of AN. Kidney complications are poorly known and little explored. Indeed, patients suffering from AN have a higher prevalence of kidney failure due to the absence of a reference methods. Kidney injuries come from multiple origin like chronic ionic disorders, dehydration and hyperprotein diet. The aim of this study will be to evaluate kidney injuries and to follow its evolution during refeeding. Blood and urine simple of Cystatine C will be add to routine analyses. This will allow us to know if, there is a concordance between the reference technique (measurement of glomerular filtration rate by isotopic method 99mTC-DTPA) and the measurement of Cystatin C. Thus, guidelines of dietary intake and medical treatments can be achieved in order to prevent severe forms requiring dialysis and kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patient with undernutrition (BMI \< 18,5);
* Patient with AN according to DSM-5 criteria, validated by Eating Disorder Diagnostic Scale and EDDS-questionnaire;
* Patient informed and signed a consent form;
* Patient affiliated to a social security plan.

Exclusion Criteria:

* Patient no-reponding to all criteria of DSM-5;
* Patient with a renal comorbidity no-related to AN;
* Patient under AME scheme;
* Pregnancy or breastfeeding;
* Participation to another interventional study.
Time to Intubation (TTI) of Obese Patients. A Comparison Macintosh Laryngoscope and Stortz Video Laryngoscope

The purpose of the study is to investigate wether the use of the Stortz video laryngoscope will render in shorter time for the intubation of obese patients compared with the use of a conventional Macintosh laryngoscope.

Obese patients are prone to develop desaturation soon after initiation of anaesthesia compared to patients of normal body weight. It is therefore important to keep the time from when spontaneous breathing to when the airway is secured with a orotracheal tube as short as possible. We will therefore investigate if it is possible to shorten this time by using a Stortz videolaryngoscope.

Patients 18-60 years with ASA grade 1-3 and BMI \< 35 that turn up for planned surgery that demands the use of orotracheal tubing and controlled ventilation will be randomly and consecutively enrolled in either of two groups. Patients in both groups will be anaesthetised with the same combination of drugs using Propofol and Remifentanyl or Fentanyl for induction of sleep, combined with Rocuronium for muscle relaxation.

After the induction and relaxation the intubation will be facilitated using either of two laryngoscopes. In the first group a conventional Macintosh laryngoscope, and in the second group a Stortz videolaryngoscope will be used. The time to intubation is defined as the time from grabbing the laryngoscope to when the tube has been inserted and end-tidal carbon dioxide appears on the monitor. Our hypothesis is that we will be able to achieve a faster intubation with the use of videolaryngoscope.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* Obesity defined as BMI \> 35
* ASA 1-3

Exclusion Criteria:

-known or suspected difficult airway
Electrode Positions in Cardioverting Atrial Fibrillation

Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important treatment to reduce symptoms and improve patient's quality-of-life. The treatment is performed by applying gel electrodes to the chest. Cardioversion is not always successful, and it is unknown which electrode-position provides the optimal efficacy.

This study aims to compare two electrode positions, which are in clinical use: Anterior-posterior (left front and left back) versus anterior-lateral (right front and left side of the chest).


Eligibility Criteria:
Inclusion Criteria:

1. Atrial fibrillation (documented on an ECG-12)
2. Able and willing to sign informed consent
3. Age ≥ 18 years
4. Anticoagulation according to guidelines (Patients with atrial fibrillation for \>48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting the absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin).

Exclusion Criteria:

1. Implanted pacemaker and/or cardioverter defibrillator (ICD)
2. Prior enrollment in the trial
3. Hemodynamically unstable atrial fibrillation
4. Untreated hyperthyroidism
5. Known or suspected pregnancy
to Explore the Influence of Longitudinal Muscle on the Prognosis of Achalasia Patients After Peroral Endoscopic Myotomy (POEM)

Achalasia is a disease characterized by lack of peristalsis and lower esophageal sphincter failing to relax. Longitudinal muscle, outer layer of esophageal smooth muscle, is recently found to be responsible for emptying of esophagus for achalasia patients, especially for those type Ⅱcases. Clinical observations also conclude that type Ⅱ achalasia which still preserve longitudinal muscle response best to treatment, among the 3 types. Thus, with high frequent intraluminal ultrasound, clinically applied as endoscopic ultrasound, to measure the function of longitudinal muscle in achalasia patients, the current research aims to explore the influence of longitudinal muscle on the prognosis of achalasia patients after peroral endoscopic myotomy, a routine treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of esophageal achalasia
* Patients or legal surrogates willing and competent to give informed consent

Exclusion Criteria:

* postoperative or post-POEM
* post-pneumatic dilation or post-stenting
* fail to go through high frequency intraluminal ultrasound （HFIUS)
* Patients with American Society of Anesthesiologists （ASA） score ≥3
AMS Evaluation Study

A study to evaluate the operational and functional features of the Ambulatory Monitor Solution (AMS) as well as the ease of use of the system.

The study is going to be conducted to collect feedback from the users about operation of AMS collect parameter raw data from patients in hospital ward setting using the investigational system for use in current and future AMS engineering and regulatory purposes as deemed appropriate by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 years or older (≥18 years);
2. Able and willing to provide written informed consent independently.

Exclusion Criteria:

1. Have previously participated in this study (no subject may participate more than once);
2. Have an implantable pacemaker;
3. Diagnosed with infection requiring isolation; OR
4. Known to be pregnant and/or breast feeding;