cyrilzakka/clinical-trials huggingface dataset:
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.

This project aims to develop a smart communication system for patients with amyotrophic lateral sclerosis (ALS), especially for stage 3 and stage 4 (late stage). Patients with ALS will be able to communicate with outer environment by means of mental control or eye tracking control, which would increase their life quality. This integrated research project includes experts from different domains and proposes a solution for smart communication system.

A multi-function brain- computer interface (BCI) communication system will be developed by combining a BCI system (subproject 1) and a 3D electro-cap (subproject 3). Then, this system and an eye-controlled device (subject 2) are further integrated to a smart communication system. The outputs of the system are presented with the original voice the ALS patients, which will be achieved by using the voice reconstruction technology (subproject 4) in this project. All the user-interfaces of the BCI and eye tracking systems will be re-deigned by employing human factors engineering to increase the usability of the proposed smart communication system for ALS. Finally, the validity of the system in improving the life quality of ALS will be assessed through clinical study.

Eligibility Criteria:
Part one:

Inclusion Criteria:

* ALS diagnostic criteria (Brooks et al., 2000).Must have the following characteristics:

  1. Degeneration of motor neurons (LMN) by clinical, electrophysiological or neuropathological evidence.
  2. Degeneration of upper motor neurons (UMN) is demonstrated by clinical examination.
  3. According to the medical history or examination, the symptoms or signs gradually disappear in a certain part.

Also, there are no features:

1. Electrophysiological or pathological evidence of other diseases that may explain signs of LMN and/or UMN degradation
2. Neuroimaging evidence of other diseases that may explain the observed clinical electrophysiological signs.

   * Use Mandarin as the main language.
   * Age limits minimum is 20

Exclusion Criteria:

* Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.
* The questionnaire cannot be completed without the assistance of others.

Part two:

Inclusion Criteria:

* ALS diagnostic criteria (Brooks et al., 2000).
* Use Mandarin as the main language.
* Age limits minimum is 20
* In everyday oral communication, people who are consciously difficult.
* Ability to perform equipment wear and system operators.

Exclusion Criteria:

* Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.
* After correction, the visual acuity cannot see the communication board.
* The scalp is sensitive or there is deep brain stimulation, etc. It is not applicable to brain wave measurement.
* -The questionnaire cannot be completed without the assistance of others.
Economic Analysis of Alliance A041202 CLL Study

The prospective cost-effectiveness (cost-utility) analysis from the perspective of the Canadian public healthcare system was completed in 2021. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tarrifs applied to calculate quality-adjusted life-years (QALYs). Costs were applied to resource utilization data (expressed in 20196 US dollars). We examined costs and outcomes (QALYs) associated with ibrutinib with rituximab (IR) and BR therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be eligible for the core CLC.2/A041202 protocol.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
* Patient must be able (i.e. sufficiently fluent), and willing to complete the health utilities questionnaire in English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the core protocol. However, ability but unwillingness to complete the questionnaires will make the patient ineligible for the core protocol.
* Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

Exclusion Criteria:

* None
Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption

Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:

* in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
* in the other group, patients will receive propofol and remifentanil both automatically administered.

Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.


Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled for an abdominal surgery

Exclusion Criteria:

* Age less than 18 years,
* Pregnant women,
* Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,
* Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
* Inflammatory bowel disease,
* Chronic pain,
* Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
* Alcoholic patients and patients taking opiates,
* History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,
* Emergency surgery
Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring

Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure. The optimal balloon volume is directly dependent on surrounding pressure. In the present study,the investigators will observe the optimal volume of esophageal balloon during the different PEEP in bench and clinical study.

The esophageal pressure (Pes) is used as a surrogate for pleural pressure to obtain transpulmonary pressure. Catheter with air balloon is the most commonly used method to measure the Pes. The optimal injected volume of the balloon is the key factor in accurate measurement of Pes. The recoil pressure of the balloon turns up while the balloon is over-filled, resulting in over-estimation of the PES; on the other hand, an under-filled balloon also cannot properly transmit the surrounding pressure of balloon. However, the researchers showed the optimal balloon volumes is related to the surrounding pressure and even is not correspond with manufacturer's recommendations. Theoretically, when balloon transmural pressure(PTM) is zero, representing the balloon in a condition with equivalent pressure inside and outside of the balloon, it was defined as optimal volume. However, in clinical settings, it is difficult to determine the balloon PTM, and therefore the optimal volume cannot be obtained, because the surrounding pressure of the balloon cannot be conveniently measured.

In the present study, the investigators will develop a simple method to obtain the optimal balloon volume and observe the effect of positive end-expiratory pressure on optimal balloon volume during esophageal pressure monitoring. The investigators want to validate the accuracy of method in the bench study and clinical feasibility in mechanical ventilated patients.

Eligibility Criteria:
Inclusion Criteria:

* postoperative patients with delayed emergence from general anesthesia admitted to the ICU for mechanical ventilation.

Exclusion Criteria:

* age under 18 years;
* diagnosed or suspected esophageal varices;
* history of chronic obstructive pulmonary diseases or asthma;
* history of esophageal, gastric or lung surgery;
* evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or an existing chest tube;
* evidence of severe coagulopathy.
Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
* 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

Exclusion Criteria:

N/A
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.


Eligibility Criteria:
Inclusion Criteria:

* Women who are postmenopausal or premenopausal/perimenopausal
* For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment
* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented ER-positive tumor and HER2-negative tumor, assessed locally
* Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting
* Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Adequate organ function

Exclusion Criteria:

* Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
* Treatment with any investigational therapy within 28 days prior to randomization
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
* Active cardiac disease or history of cardiac dysfunction
* Pregnant or breastfeeding
Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System.

This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System (Edwards LifeSciences).

Eligibility Criteria:
Inclusion Criteria:

* Patients able to give informed consent.
* Patients undergoing surgery that would routinely require use of an endotracheal, pulmonary artery catheter and arterial catheter.

Exclusion Criteria:

* Patients who do not speak English.
* Patients not competent to give informed consent.
Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method

In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture Cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).

Computed tomography (CT)-guided interventions for diagnostic and therapeutic purposes are standard approaches in clinical routine (e.g. in patients with low back pain). Numerous CT needle navigation systems have been developed with the aim to improve accuracy (and thus safety) of punctures while decreasing radiation exposure and procedure time. Their usability in clinical routine is limited either because of high sensitivity to interference, high expenses, bulkiness, or incompatibly with daily clinical practice and thus increasing procedure time and workflow complexity. The Puncture Cube® takes into account all these requirements. Furthermore, in an in vitro-phantom study (study submitted for publication), punctures with the Cube were found to be faster and more accurate compared to the free-hand conventional method.

In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture Cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a percutaneous therapeutic CT-guided intervention for
* lumbar pain (joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level)
* age ≥ 18 years
* Signed informed consent prior to intervention

Exclusion Criteria:

* Patients suffering from severe obesity (BMI \> 30 kg/m2)
Post Cond No Reflow

After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old,
* Male or female,
* Presenting first myocardial infarction, with the beginning of pains \< 12 hours,
* Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on IVA or RCA (not CA).
* Artery guilty with TIMI flow = 0

Exclusion Criteria:

* cardiac arrest before the angioplasty,
* Cardiogenic shock
* Occlusion of the artery circumflex responsible for the infarction
* Magnetic resonance imaging: contre indication
Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. Our goal is to obtain quality data, repeated over time, by limiting the technical variability.

The aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years admitted in ICU.
* Clinical evidence of infection, suspected or proved, during the 48hrs following the hospital entry.
* Systemic inflammatory response syndrome.
* Shock defined as arterial hypotension (\<90mmHg)not responding to adequated filling.

Exclusion Criteria:

* Minors
* Patient under guardianship or trusteeship
* Pregnant or lactating women
* Not affiliated to the social security
* Deprived of liberty by court decision
* Patients hospitalised without their approval
* Shock related to another cause than infection
* Long term corticothérapy
* On-going chemiothérapy, AIDS
* Bedridden patient
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age;
* Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
* Anticoagulant treatment completed
* No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria:

* Subjects with indications for long-term treatment with a vitamin K antagonist
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Impaired kidney or liver function
Feasibility and Effectiveness of an Additional Resistance and Balance Training in Cardiac Rehabilitation of Older Patients After Valve Surgery or Intervention

The aim of the study is to evaluate the short- and medium-term effectiveness of additional moderate dynamic resistance and balance training to the CR-program of old adults after valve surgery or intervention compared to usual care-CR.


Eligibility Criteria:
Inclusion Criteria:

* Patients after valve surgery and/or intervention
* Age 65 years and older
* Ability to start CR within 4 weeks after surgery,
* 6-minute walk distance (6-MWD) ≥100- ≤350 m (1)
* Patient's agreement to participate in the study.

Exclusion Criteria:

* Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
* Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in CR according to study protocol), including chronic heart failure New York Heart Association Class IV, hemoglobin less than 9 g/dL, wound healing disturbance, cognitive or linguistic deficits.
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.

Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.

Thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise the control group.

Every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months.

Clinical results will be analyzed after completion of 6 months of followup.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of active UC must have been confirmed by endoscopic and histological evidence.
* With mild and moderate disease.
* Men and women 18-65 years of age.
* Signed informed consent
* Capable of good communication with researchers and follow the entire test requirements

Exclusion Criteria:

* Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.
* With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
* Abnormal hepatic or renal function
* Prior history of malignancy
* Pregnant or unwilling to practice contraceptive therapy or breast feeding females
The Therapeutic Effect of Targeted Intrinsic Foot Muscles Exercises in Plantar Fasciitis

A reduction of intrinsic foot muscle sizes has been identified in patients with chronic plantar fasciitis. Weaker intrinsic foot muscles has been suggested to decrease the medial longitudinal arch height and subsequently increase extra tensile stress in the plantar fascia, resulting in the chronicity of the condition. Therefore, it is speculated that atrophic intrinsic foot muscles may be a significant risk factor of developing chronic plantar fasciitis. The purpose of this study is to investigate the effect of an 8-week targeted intrinsic foot muscles exercise regimen on the intrinsic foot muscle size, symptomatic relief, and foot function improvement in long-distance runners with chronic plantar fasciitis.

Distance runners are defined as running with more than 20km per week for more than 2 years. All recruited participants have \> 1 year of plantar fasciitis. The diagnosis were made based on clinical symptoms and the thickness of plantar fasciitis \> 4.0mm at the medial tubercle of heel by ultrasound imaging.

Arm 1: The purpose of this arm of the study is to determine if a 8-week targeted foot muscle exercise regimen, instructed with real-time ultrasound, affect the intrinsic foot muscle size, symptomatic relief, and foot function improvement of distance runners with plantar fasciitis. 32 participants will be recruited in this arm.

Arm 2: This group will not engage in any training, but will serve as a comparator for the intervention arm.

Eligibility Criteria:
Inclusion Criteria:

1. A weekly mileage of at least 20km
2. Have running experience of at least 2 years prior to the experiment
3. if they reported tenderness on palpation of the medial calcaneal tuberosity and exhibited one of the following complaints:

   * Plantar heel pain \> 1 year
   * Pain on visual analog scale of equal to or greater than 4 out of 10
   * pain on the first step in the morning or after prolonged sitting,
   * pain on prolonged standing and/or walking
   * pain when running

Exclusion Criteria:

1. Contraindications to MRI scans
2. had undergone surgery to the plantar fascia or
3. local steroid injection within the last 3 months or
4. Any of the following conditions:

   * systemic arthritis,
   * neurologic conditions
   * any coexisting painful musculoskeletal condition of the lower limb.