cyrilzakka/clinical-trials huggingface dataset:
Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes

Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression.

Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression. Tests will include the pre and post decompression MEP (motor evoked potential) latency and pre and post surgery walking speed and quality of life assessments.

Eligibility Criteria:
Inclusion Criteria:

* Central spinal stenosis
* Ability to ambulate prior to onset of symptoms

Exclusion Criteria:

* Arthritis affecting walking ability (hip, knee or ankle).
* Diabetes
* Implanted pacemaker or other electrostimulator.
Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia.

This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. The clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).

Bacteremia and fungemia are severe complications, sometimes life-threatening, of every sepsis. During septicemia, every hour matters to start an appropriate antibiotic or antifungal treatment as every hour of delay is associated to higher death rate.

The rapid multiplex PCR assay that is evaluated in this study allows to identify in 60 to 90 minutes, the bacteria or fungi that is present in the positive blood culture bottles and to identify resistance markers to first line antibiotics that are used to treat sepsis. This strategy allows quicker adaptation of antibacterial or antifungal treatment based on the species of the bacteria or fungi identified and on the results of the resistance markers compared to current diagnosis strategy of bacteremia or fungemia. This quicker adaptation could lead to improved survival rate, reduced complications of sepsis, reduced hospital stay length and could reduce the use of large spectrum antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Patient with bacteremia and/or fungemia defined by :

  1/ the presence of clinical signs of sepsis; AND 2/ a positive blood culture, i.e. the growth of at least one species of bacteria or micromyces in at least one blood culture vial
* Patient Hospitalized at Grenoble University Hospital (only North site) and seen by a physician from the antibiotic stewardship team
* First blood culture positive for the patient's sepsis episode
* Informed and written consent signed by the patient or his legal representative or the doctor in case of emergency.

Exclusion Criteria:

* Patients mentioned in the law articles L1121-5 to L1121-8 from French Health Code
* Patients hospitalized in palliative care unit
* Persons with an estimated survival of less than one month
Impact of BacT/Alert® VIRTUO®, BioFire® Blood Culture Identification 2-BCID2 and REVEAL® (bioMérieux) on the Optimization of Antibiotic Therapy for Gram-negative Bacteremia in the ICU

Bacteremia is a frequent infection in intensive care units. It is associated with a high mortality rate and the rapid implementation of appropriate antibiotic therapy is strongly correlated to patient clinical outcomes.

Innovative technologies have emerged to shorten the turnaround time of blood culture samples by obtaining susceptibility testing of the incriminated pathogen at an early stage, and therefore to rapidly adjust the antibiotic therapy of patients with Gram-negative Bacilli bacteremia.

The study investigators hypothesize that the implementation of the innovative BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® solutions for the analysis of blood culture samples will increase the proportion of patients with Gram-negative Bacilli bacteremia who receive appropriate and optimized antibiotic therapy 24 hours after blood culture collection.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be a member or beneficiary of a health insurance plan
* Patient admitted to the ICU with at least one positive blood culture for Gram-negative bacteremia

For the 'after' section of the study only:

* Patient must have given their free and informed consent or included by emergency procedure
* Patient signed the consent form or included by emergency procedure

Exclusion Criteria:

* The subject is participating in this study, or is in a period of exclusion determined by a previous study
* Consent refusal
* Patient with a polymicrobial blood culture
* Patient with a second episode of bacteremia
* Moribund patient
The Effect of tDCS on Motor Performance and Cortical Excitability

In this study the effect of tDCS intensity on motor performance and corticospinal (CS) excitability is evaluated. The investigators expect that a positive relationship between current intensity and motor performance/CS excitability.


Eligibility Criteria:
Inclusion Criteria:

- Healthy subjects

Exclusion Criteria:

* Contraindications for tDCS/TMS
* TMS measurements have to be possible
Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI)

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. Patient-specific computer simulation may improve outcome of TAVI by proposing the valve size that best fits the individual patient.

The aim of this study is to assess the added value of patient-specific computer simulation in valve size selection.


Eligibility Criteria:
Inclusion Criteria:

* Native severe aortic valve stenosis
* Planned for TAVI with the Evolut R Valve

Exclusion Criteria:

* Bicuspid aortic valve
* Extensive subannular calcifications
* Non-transfemoral access
* Poor CT quality
* Lack of written informed consent
Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are prescribed fingolimod as part of their routine medical care
* Patients who have participated in a prior fingolimod clinical trials

Exclusion Criteria:

* Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
* Any patient who has prematurely discontinued from the previous fingolimod trial

Other protocol-defined inclusion/exclusion criteria may apply
Fascial Closure and Post-caesarean Pain

This study will evaluate post-operative pain in patients undergoing elective caesarean sections based on the method of fascial closure. Patients will be randomised into one of three groups based upon the method of fascial closure and will be followed up over a 10 week period evaluating analgesia use in the acute setting, and also following up with pain scores using a visual analogue score throughout the follow-up period.

Participants will be approached prior to their elective caesarean section to be consented. If they agree to be a part of the study, they will then be randomised into one of three groups based upon the method of fascial closure after delivery of the foetus and closure of the hysterotomy site:

1. Fascia sutured with #1 polysorb braided absorbable suture, with the knot being superficial to the fascia, starting at the left angle of the fascial incision and closed in a continuous fashion. The contralateral angle is grasped with a kocher clamp and the suture is then tied behind the angle ensuring adequate closure.
2. Fascia sutured using #1 polysorb braided absorbable suture with a superficial knot, starting at the left angle and closed in a continuous fashion until the suture is above the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is tied behind the right angle with a superficial knot and run across in a continuous fashion to meet the opposing suture which are then tied together.
3. Fascia sutured using #1 polysorb braided absorbable suture with a buried knot below the fascia starting at the left angle and closed in a continuous fashion until the suture overlies the right rectus abdominis muscle belly. A second #1 polysorb braided absorbable suture is then tied behind the right angle with a buried knot below the fascia and run across in a continuous fashion to meet the opposing suture which are then tied together.

The remainder of the caesarean section is completed in the standard fashion.

Subsequent to this, patients are followed up with a modified brief pain inventory on post-operative day #1, day #7, day #14, day #42 and day #70 to evaluate their pain in the post-operative period. In addition, whilst being inpatients, participant's analgesia use is evaluated using the medication administration record within the unit.

Eligibility Criteria:
Inclusion Criteria:

* Women with singleton pregnancy undergoing elective lower segment caesarean section via a Pfannenstiel incision.
* Caesarean section done via regional anaesthesia (i.e. spinal regional anaesthesia, epidural anaesthesia, combo-spinal+epidural)

Exclusion Criteria:

* Multiple pregnancy
* General anaesthesia
* Caesarean section through laparotomy incision
* History of chronic pain
Telerehabilitation in Managing Chronic Low Back Pain

The purpose of this study is to determine whether telerehabilitation is as effective as in-person rehabilitation in treating patients with chronic back pain in actual clinical practice settings.T he study will recruit eighty-four individuals with chronic LBP, who will be randomly assigned to one of two groups: telerehabilitation (TR) or the control group, who will receive standard clinic therapy. The TR group will be treated remotely via phone calls and the Zoom platform. The intervention program will be customized according to the requirements and abilities of each patient. It will include self-management skills, education and support, including Pain Neuroscience Education , and customized exercises.


Eligibility Criteria:
Inclusion Criteria: Adults aged 18 and above with non-specific chronic low back pain more than 12 weeks.

Exclusion Criteria: Cancer, systematic or neurological diseases, fracture, recent surgery on the spine and/or extremities, cognitive impairment, pregnant women, and communication barriers or other medical conditions contraindicating TR. If there is any presence of red flags, such as cauda equina syndrome, spinal infection, spinal compression fractures, spinal stress fractures, ankylosing spondylitis, or aneurysm will also be excluded.
Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection

We are doing this research study to determine if taking vancomycin in addition to a broad-spectrum antibiotic will decrease the chance of developing recurrent Clostridium difficile infection.

To determine whether prophylactic use of oral vancomycin reduces the incidence of recurrent Clostridium difficile infection (RCDI) in hospitalized patients admitted from their home or another health care facility (HCF) who are exposed to concurrent broad spectrum antibiotics.

This is a randomized research study, which means that the treatment you get will be chosen by chance, like flipping a coin. You will have a 50/50 chance of receiving one of the following:

1. Group 1 (Treatment Group): single daily dose of vancomycin in liquid form (study medication).
2. Group 2 (Placebo Group): single daily dose of placebo (a placebo will look just like the study medication, but contains no medication, only a substance like sterile water).

Depending on the group you are placed in (which is chosen by a computer), you will receive either a daily dose of the study medication or a daily dose of the placebo for a total of ten days. If you are discharged from the hospital prior to ten days, you will be given the study medication to complete outside of the hospital with written instructions.

A member of the Research staff will monitor you daily during the 10 days of treatment for any adverse reactions or any signs and symptoms of recurrent Clostridium difficile infection. If you are discharged prior to ten days, the monitoring will take place via telephone call daily until completion of the ten day treatment.

You will be contacted again by telephone at 1, 3, and 6 months after completion of the study medication to inquire about your general health and any changes in health status.

Other medical information from your records and charts may also be collected by us for purposes of review for this study.

Eligibility Criteria:
Inclusion Criteria:

1. In patients \>19 years of age
2. History of C. difficile diarrhea within 16 weeks and treated with Flagyl or Vancomycin during last episode.
3. Patients started on antibiotics during current admission for any other indication at any point of time during hospital course.

Exclusion Criteria:

1. Current diagnosis of CDI
2. First episode of CDI during this admission.
3. Allergy to Vancomycin or other known intolerance
4. Pregnant

h) Patient has received broad-spectrum antibiotics for more than 48 hours for this admission j) Incarceration
A Study to Find the Maximum Tolerated Dose of the Experimental Combination of the Drugs INC424 and BKM120 in Patients With Primary or Secondary Myelofibrosis

The purpose of this phase Ib clinical trial is to evaluate the safety of the combination of INC424 and BKM120 in the myelofibrosis population and to establish the maximum tolerated dose and or the Recommended Phase II dose of the combination guided by the Bayesian dose escalation model. INC424 has shown efficacy in myelofibrosis (MF) and is approved in the US and EU for the treatment of MF. BKM120 is a PI3K inhibitor. Preclinical and early clinical experience support inhibition of the PI3K/mTOR pathway in MF as aberrant activation of the pathway has been observed in MF models and may contribute to the pathogenesis of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PMF, PPV-MF or PET-MF irrespective of JAK2 mutation status
* Myelofibrosis patients requiring therapy must be classified as intermediate risk level 1 )1 or more prognostic factors defined by IWG) with at least one criteria other than age
* Must have palpable spleen of at least 5 cm from the costal margin to the point of greatest splenic profusion at Screening
* Must have active symptoms of MF (one symptom score of at least 5 or two symptom scores of at least 3 at Screening) (per MFSSF 0-10)
* PLT counts \> or = 75X 10\^9/L at Screening or Cycle 1 Day 1 (not with aid of transfusions

Exclusion Criteria:

* Pregnant or nursing women
* WOCBP not using highly effective methods of contraception
* Sexually active males who refuse condom use
* Previous Treatment with one of the following: PI3 K inhibitors and AKT inhibitors; JAK inhibitors that resulted in clinically significant toxicities per the Investigator;
* Patients who have had splenic irradiation within 12 months prior to Screening
* Patients with specific mood disorders
* Any history of bleeding diathesis
* Patients receiving the following treatments / medications:

EIAED within 2 wks. prior to study treatment; medication known to prolong QT interval or induce Torsades de Pointes; treatment with potent systemic systemic inhibitor or systemic inducer of CYP3A4; any use of drug that interferes with coagulation or inhibits PLT function

-current and willing candidates for a stem cell transplantation
HSV Oral Reactivation in Children

In the proposed study, the investigators will carry out novel research to evaluate both symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy number in children with and without HIV.

Study Objectives:

1. To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children

   Secondary Objectives:
2. To determine the acceptability of performing daily oral swabs in children age 3-12


Eligibility Criteria:
Inclusion Criteria:

* age \> 3 and ≤12 years old
* parental/guardian consent and children's assent must be obtained and participants and parent/guardian must be able to comply with study procedures
* For HIV-infected group: Positive HIV serology by either ELISA x 2, ELISA + WB or PCR testing

Exclusion Criteria:

* age \<3 and \> 12 years old
* Acute illness which by opinion of the investigator makes enrollment in the trial unfeasible (including active tuberculosis, malaria or other opportunistic infection requiring treatment)
* co-enrollment in other therapeutic/intervention trials (observational trial enrollment is permitted).
* Stable co-administration of other medications is permitted (e.g. bactrim)
* For HIV-infected children; receiving or eligible for antiretroviral (ART) therapy by local standards
Hearables: Ear-ECG and PPG for Detection of Cardiac Arrhythmias

The goal of this observational study is to determine the feasibility of detecting abnormal heart rhythms, known as arrhythmias, by recording Electrocardiogram (ECG) and Photoplethysmogram (PPG) waveforms from the ears in patients who have already been diagnosed with arrhythmias. The main questions it aims to answer are:

* Can ECG and PPG signals from the ears reliably detect arrhythmias?
* How do ear-based ECG/PPG waveforms compare to standard single-lead ECG in detecting abnormal rhythms?

Researchers will compare data from healthy controls and arrhythmia patients to see if ear-based recordings are as effective as traditional methods.

The main goal of this study is to determine the feasibility of detecting abnormal heart rhythms, known as arrhythmias, by recording Electrocardiogram (ECG) and Photoplethysmogram (PPG) waveforms from the ears.

The study includes both healthy control subjects and patients who have already been diagnosed with arrhythmias. These individuals will be approached by a clinical member of the research team during their hospital stay or outpatient visit at Imperial College NHS Trust (ICHNT). Patients will be given comprehensive information about the study through a patient information sheet and will be asked for their written informed consent, with adequate time provided for questions and understanding.

To capture Ear-ECG/PPG waveforms, a variety of standard medical-grade sensors and electrodes will be placed in and around both ears. These include standard EEG electrodes on each mastoid secured with medical-grade gel, and an in-ear foam-based earpiece (like commercial earplugs) with cloth electrodes. An additional PPG sensor (MAX30101 from Maxim Integrated) will be attached to the back of the ear with adhesive medical tape. The patient will also be connected to a standard single-lead ECG and a blood pressure cuff, already part of their standard care on the hospital ward.

Once the setup is complete, each patient will follow 3 different recording protocols displayed on a screen. Patients will be asked to sit upright (Protocol 1) and engage in a series of simple activities with designated breaks in between, including head movements, counting aloud to 60, chewing gum (or simulating chewing), walking (if able) freely under medical supervision with assistance if needed (Protocol 2), slow controlled breathing and immersing their hand in cold water (Protocol 3). The total recording time including setup will be approximately 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent;
* Healthy and diagnosed with cardiac arrhythmias.

Exclusion Criteria:

* No abnormal ear anatomy
Natural Cycle vs Programmed Cycle Frozen Embryo Transfer

The goal of this\[ type of study: randomized controlled trial\]is to compare Preeclampsia following Natural vs. Artificial Cycle in patients undergoing frozen embryo transfer.

The main question\[s\] it aims to answer is

• Does NC-FET decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to AC-FET ?

The main objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer. Participants recruited will be divided into two ARM(1513 per arm). ARM 1 will undergo the Natural Cycle procedure of Embryo transfer, and ARM 2 will undergo the Artificial Cycle procedure of Embryo transfer. The primary outcome will be the proportion of preeclampsia. The duration of the study is around 2 year.

The Research question(PICO) addressed is Does NC-FET decreases the incidence of preeclampsia in patients undergoing frozen embryo transfer as compared to AC-FET . The hypothesis taken is NC-FET will decrease the incidence of preeclampsia compared to AC-FET. The sample size is taken as 3026 (1513 per arm). The Primary Objective is to compare the proportion of preeclampsia in women with a viable pregnancy with natural cycle protocol to artificial cycle protocol when practicing frozen embryo transfer. The study outcome of the proportion of preeclampsia after 20 weeks of gestation or 6 weeks post-delivery. There are two arms-Arm 1 Active Comparator: Natural Cycle and Arm 2 control: Artificial Cycle FET. The Randomization is done through Random Allocation as per computer generated sequence. The Blinding/masking is done Open labeled. The Study Duration is from Feb 2023 to Jan 2025. Participation Duration is 10 months.

Eligibility Criteria:
Inclusion Criteria:

* Endometrial preparation with Hormone replacement therapy/ Natural cycle.
* Age 21-45 years following an autologous IVF cycle (with or without preimplantation genetic testing for aneuploidy)
* BMI \> 18 and \< 30 kg/m2
* Endometrial thickness ≥ 7 mm after estrogen therapy or on the day of ovulation
* Blastocyst embryo transfer

Exclusion Criteria:

* Uterine diseases (e.g. submucosal fibroids, polyps, previously diagnosed Müllerian abnormalities)
* Hydrosalpinx untreated.
* Recurrent pregnancy loss (≥ 3 previous miscarriages)
* Recurrent implantation failure (≥ 3 previously failed embryo transfers of good-quality blastocysts)
* Allergy to study medication
* Pregnancy or lactation at recruitment
* Contraindications for hormonal treatment