cyrilzakka/clinical-trials huggingface dataset:
The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy

This is a prospective, randomized, single-center pilot trial of term and near term (≥ 36 weeks gestation) infants with encephalopathy or seizures comparing a "EEG Seizure Treatment Group" or ESG with a "Clinical Seizure Treatment Group" or CSG.

The investigators hypothesize that the accurate detection and treatment of EEG seizures will decrease the seizure burden and improve outcomes in newborn infants with seizures and/or hypoxic-ischemic encephalopathy (HIE).

This is a prospective, randomized, pilot trial of term and near term (≥ 36 weeks gestation) infants with encephalopathy or seizures comparing a "EEG Seizure Treatment Group" or ESG with a "Clinical Seizure Treatment Group" or CSG. Eligibility is based on clinical criteria for moderate/severe encephalopathy or seizures. We will recruit near term or term infants (≥ 36 weeks gestation) with a diagnosis of seizures or encephalopathy admitted to the neonatal intensive care unit (NICU) at St. Louis Children's Hospital within the first 72 hours of life. Infants will be randomized into an EEG Seizure Treatment Group (ESG) or a Clinical Seizure Treatment Group (CSG) (n=20 in each group). Patients in both groups will have EEG monitoring. While treating physicians will have access to EEG data in the ESG, no EEG data in the CSG will be available to the clinician for treatment of seizures. AED treatment will be initiated/escalated using stringent EEG seizure criteria (EST) or clinical criteria (CST) with the goal being seizure cessation. The specific AED, dosage, and duration of treatment is standardized in both groups. Monitoring will continue for a period of upto 96 hours in both arms. Other than the anticonvulsant drugs, treatment thresholds and dosing schedules, treatment in both arms will be at the discretion of the bedside physician.All infants will undergo an assessment of neuromotor disability and neurodevelopmental evaluation at 18 to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Term or near term infants ≥ 36 weeks gestation admitted to the neonatal intensive care unit
* ≤ 72 hours of age
* Screening for the "at risk" infant by the clinical team to include any one of the following:

  * Apgar score \<5 at 5 min
  * Cord blood or postnatal gas with pH \<7.0 or BE \> -12
  * Need for respiratory support at 10 min of life
  * Suspected or definite seizures
  * Encephalopathy defined by recognition of altered neurological behavior
* Infants identified in the above screen will be examined by the research team and will be eligible if they satisfy at least one of the following:

  * Moderate-severe neonatal encephalopathy (3 out of 6 criteria)
  * Suspected or definite neonatal seizures

Exclusion criteria:

* Infants \< 36 weeks gestation
* \> 72 hours of age
* Infants with congenital anomalies of the central nervous system
* Moribund infants for whom no further aggressive treatment is planned
* Metabolic disorders or documented CNS infection
* Neuro-muscular blockade
Non- Clinical Coagulation Activation During Hemodialysis

Every patient included in the study will undergo 1 conventional hemodialysis treatment, ie 1 study visit. During the conventional hemodialysis treatment lasting 4 hours, 2 blood samples will be taken at different time points (5 minutes after dialysis start and 240 minutes after dialysis = at the end of the dialysis session) to evaluate coagulation activation (TAT, PF1+2). Hemodialysis session parameters (arterial and venous pressure, TMP, OCM, BVM and prefilter pressure) will be noted at different time points (T5, T30, T60, T120, T180, T240). After discontinuation of the dialysis session, total cell volume will be measured using the Renatron II system® and the number of open fibers will be determined using micro-CT scanning.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Patients able and agree to provide signed informed consent.

Exclusion Criteria:

* Known allergy for polysulphone dialysis membrane.
* Use of vitamin K antagonists or novel oral anticoagulant therapy.
* Use of chronic heparin treatment, UFH or LMWH.
Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-40 kg/m2
* Patients undergoing elective video-assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* History of chronic analgesic or opioid therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Emergency surgery
Comparison of a Minimally Invasive Technique for Total Knee Replacement to a Standard Technique

Comparison of a minimally invasive technique for total knee replacement to a standard technique


Eligibility Criteria:
Inclusion Criteria:

* No inflammatory arthritis,
* no other lower limb problem,
* no major comorbidity

Exclusion Criteria:

-
Effects of Neural Flossing and PNF on Lumbar Radiculopathy

the goal of this clinical trial is to determine the effects of neural flossing with and without proprioceptive neuromuscular facilitation on pain, range of motion and disability in patients with lumbar radiculopathy. the main question it aim to answer is :- Does proprioceptive neuromuscular facilitation added benefit when combined with neural flossing to pain, range of motion and disability in lumbar radiculopathy patients? Research will compare the neural flossing group with the group receiving neural flossing with proprioceptive neuromuscular facilitation to see if there is any difference in the outcomes.

Lumbar radiculopathy is a mutual condition amongst persons presenting to a spinal physician for consultation. Lumbar radiculopathy is a term used to describe the pain that is started in low back and radiated along the nerve root. The patient mostly complains from a low back pain that radiates toward the legs. Symptoms may include radiating pain, weakness, hypo-reflexia and gait abnormalities. The pain is caused by the neurological manifestations of a compressive force along a specific nerve route. The main cause of radiculopathy is compression or irritation of nerve root exited from spinal cord. Lumbar radiculopathy can affect anyone regardless of their age, gender, race and geographical locality. About 40% people developed low back pain at some points in their life and out of them 3-5% population developed lumbar radiculopathy.

A study conducted to find out the influence of nerve flossing technique on acute sciatica and hip range of motion with sample size of 32. It was concluded that as a result of nerve flossing technique since no statistically significant changes occurred between the two groups. Hence, for effective reduction of sciatic pain and possible improvement in hip range of motion, nerve flossing technique should be combined with conventional physiotherapy. A study conducted on mobilization of Neurodynamic system using proprioceptive neuromuscular facilitation (PNF) decrease pain and increase mobility in lower extremities and spine suggested that PNF based rehabilitation approach results in improvement of pain, nerve mobility and balance.it also has positive effects by supplying oxygen to nerve, increase nerve mobility and decrease pain.

Some studies have been done testing the effects of neural flossing technique and PNF techniques individually as a treatment option for lumbar radiculopathy. But, up to the researcher's knowledge there is little literature on comparing both treatments with respect to pain, range of motion and disability in lumbar radiculopathy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35-50 years.
* Both males and females.
* Pain intensity is 4 out of 10 on numeric pain rating scale.
* History of radiculopathy for more than 3 weeks.
* Pain radiating below to knee.

Exclusion Criteria:

* Cognitive impairment.
* Using pain modulating medicines.
* Patients with comorbidities.
* Pain radiating above to knee.
The Effect of Minimally Invasive Surgery on Systemic Inflammatory Response in Rectal Cancer

As a hypothesis and shown in many meta-analyses and randomized controlled studies, minimally invasive surgery causes less surgical trauma and therefore less proinflammatory response and immunosuppression develop, and postoperative recovery is faster. Although various prognostic studies on the relationship between gastrointestinal cancer types and SII (systemic inflammatory index) and the use of minimally invasive surgery have been published, the high level of this response and the type of surgery in the treatment of colorectal cancer have not yet been shown to have a direct effect on SII.

Minimally invasive surgery has been demonstrated to significantly enhance the host immune response in colorectal cancer. The effect and the SII marker may be reliable indicators of this enhancement. A retrospective analysis was conducted on the records of patients who underwent surgery for colorectal cancer at our clinic over a four-year period. The patients were divided into three groups according to the surgical approach employed: open surgery, laparoscopic surgery and robotic surgery.

The primary outcome is: A comparison of the open surgery group with those undergoing minimally invasive surgery (laparoscopic and robotic) revealed lower SII values in the robotic surgery group than in the laparoscopic surgery group.

The secondary outcome : The SII values were determined as neutrophil/lymphocyte and platelet/lymphocyte, which had been previously investigated in other studies.

A comparison will be made with the relevant markers. The research team adheres to the principles set forth in the Declaration of Helsinki and Good Clinical Practice guidelines. They will conduct the study in an appropriate manner.

No intervention will be made in the follow-up and treatment of patients, in accordance with the approval of the hospital ethics committee.

The laboratory records typically examined in the postoperative phase will be re-examined in a retrospective manner. Furthermore, the personal data of the participants will not be incorporated into the study.

Eligibility Criteria:
Inclusion Criteria:

Patients operated for rectal cancer

* Open surgery
* Laparoscopic surgery
* Robotic surgery

Exclusion Criteria:

* Patients with diagnosed immune deficiency
* Patients with recurrent colorectal cancer
* Patients with co-existent tumors
Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.


Eligibility Criteria:
Inclusion Criteria:

* age between 18-80
* written informed consent (IC)

Exclusion Criteria:

* pregnant and lactating women
* patients operated for a transplantation
* patients with a increased myopathy risk
* patients with a creatinine clearance \< 30ml/min; patients on hemodialysis
* patients after a previous sternotomy
* treatment with any antibiotics 14 days prior study start
* treatment with Daptomycin or Cefuroxime within 3 month prior study start
Performance Assessment of the Fluorescence Technique Alone in the Search for the Sentinel Node in Breast Surgery

Cohort, interventional, multicenter, non-randomized study to compare the performance of the ICG fluorescence technique (ICG) alone to the combined ICG + isotopic technique in the detection of sentinel node.

Comparison of the performances of two techniques used in current practice, without modification of the patients' care plan. Indeed, all patients receive both techniques, but the protocol allows to standardize the collection of the performances of each of the two techniques in order to compare them.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age on the day of inclusion,
* Presenting with breast cancer,
* Fulfilling the Sentinel Node search criteria of:

  * Patient with carcinoma in situ with high risk of microinvasion:
* nodular presentation, high grade with necrosis,
* suspicion of microinvasion at biopsy,
* radiological size of more than 40 mm,
* need for mastectomy or extensive resection requiring a complex oncoplasty surgery (no size criteria, at the surgeon's discretion)

  * Patient with T1-T2 invasive carcinoma AND no lymph node involvement according to Tumor-Node-Metastasis (TNM) classification (N0) on clinical and imaging (negative axillary echo or negative lymph node biopsy):
* unifocal or bifocal proximal tumor
* \< 5 cm (clinical), palpable or non-palpable (subcentimetric allowed)
* in case of neoadjuvant chemotherapy: before or after if N0 and negative axillary echo or negative biopsy
* Benefiting from a French social security system
* Having been informed of the study and having freely given their informed consent to participate in the study.

Exclusion Criteria:

* Pregnant or breastfeeding patient
* Patient not eligible for the sentinel node procedure (contraindication to surgery, N+ and/or M+ clinical or radiological, T3 and more, history of homolateral breast cancer surgery)
* Patient under guardianship or curators
* Patient under court protection
* Patient who does not understand French
* Patient already included in the study
Disconnection and Unilateral Spatial Neglect

Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward after a first hemispheric stroke. Unilateral spatial Neglect (USN) and other cognitive impairments (including attention, executive functions, memory) have been assessed in routine care at the subacute phase (\<6 months). MRI scans have also been done in routine care.

The study aims at linking lesion characteristics, disconnections induced and expression of the different modalities of USN


Eligibility Criteria:
Inclusion Criteria:

* First hemispheric adult stroke patient
* Non-opposed to inclusion
* Confirmed by MRI
* Assessment of cognitive functions during the subacute phase (3 weeks to 6 months after stroke onset

Exclusion Criteria:

* History of previous stroke or neurological disorders
* Inability to perform cognitive assessment due to severe comprehension, cognitive or psychiatric disorder
* Uncorrected severe loss of visual acuity
* Contra-indications to MRI
A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 Cells/mm3

To define the safety and efficacy of sibling-supplied, HIV antigen-pulsed dendritic cells in increasing the immune response in HIV-infected patients.

Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.

Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.

Dendritic cells from an HIV-negative sibling are obtained and treated with various viral proteins (HIV vaccines) or immunomodulators. The treated dendritic cells are infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HLA A2+.
* Same cell type as donor sibling.
* CD4 count \> 350 cells/mm3.
* HIV asymptomatic status.
* No HIV antivirals during study.
* Normal labs and chest x-ray.

Donor siblings must have:

* HLA A2+.
* HIV negativity.
* Ability to donate cells on multiple occasions.
* Negative status for hepatitis B and C.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Antiviral therapy (unless CD4 count declines to \< 350 cells/mm3).

Prior Medication:

Excluded:

* Antiviral therapy within 90 days prior to study entry.
Neuropathic in the Acute Post Operative Phase

Investigation of thermal thresholds and sensory mapping to thermal stimuli


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old

Exclusion Criteria:

* do not under stand Danish
* cognitive reduction
* previous thoracic surgery
* Pregnant or nursing
* inability to cooperate to pain scoring
The Effects of Medical Clowns in Children Undergoing Blood Tests

The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.

Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.

Eligibility Criteria:
Inclusion Criteria:

* Children needing venous blood sampling or the insertion of an intravenous canula

Exclusion Criteria:

* Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
* Absence of a parent during the procedure
* Abnormal development according to parents
The Progress of Diabetes Mellitus After HMS5552 Treatment in Type 2 Diabetes Mellitus

At present, there are few studies on the clinical remission rate of diabetes after one year discontinuation of oral hypoglycemic drugs after intensive treatment. HMS5552 is a kind of GKA hypoglycemic drug. This study intends to observe the clinical remission rate of diabetes mellitus, beta cell function and blood sugar fluctuation of patients with type 2 diabetes mellitus who have been treated with HMS5552 for 52W or 28W and whose glucose control is up to the standard.


Eligibility Criteria:
Inclusion Criteria:

* Complete HMS5552 treatment and safety visit;
* HbA1c \< 8.0% was detected in our laboratory;
* Researchers judged the stability of glucose control based on the data of subjects'visits during HMS5552 treatment and the indicators of our hospital;
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise;
* Willing to sign written informed consent and abide by the research program.

Exclusion Criteria:

* There was a state of illness in the subjects who could not complete the follow-up during the observation period.
* The researchers judged that subjects'compliance with HMS5552 was affected during treatment.
Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol

Opioid-Induced Constipation (OIC) is often associated with a compromised quality of life of patients in palliative care (PC) setting. Among the Peripherally-Acting Mu-Opioid Receptor Antagonists, Naloxegol is the most effective to treat OIC and to improve OIC-related aspects of quality of life in patients with non-cancer pain.

This observational study aims to assess the impact of a 4-weeks Naloxegol therapy on the quality of life in advanced cancer patients with OIC assisted by a home PC program.

The study is enrolling cancer patients with OIC (defined according to Rome IV criteria) not relieved by first-line laxatives, starting the therapy with 25 mg/day of Naloxegol. The main parameters evaluated at the beginning of the therapy (T0) and after 28 days (T28) are: Patient Assessment of Constipation Quality-of-Life (PAC-QoL, 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, satisfaction), evaluation of objective (number of weekly evacuations) and subjective constipation (Bowel Function Index, BFI, normal score\<30), pain assessment by NRS.


Eligibility Criteria:
Inclusion Criteria:

* cancer patients with advanced disease;
* age higher than 18 years;
* mentally competent;
* naloxegol therapy for no more than 1 week according to clinical practice;
* sign of a written informed consent.

Exclusion Criteria:

* patient with pain not controlled by opioids;
* therapy with other PAMORAs;
* intestinal obstruction;
* risk of intestinal perforation.
* severe renal failure.