cyrilzakka/clinical-trials huggingface dataset:
Pupillometry in Pediatric Intensive Care Unit (PICU)

Assess the depth of sedation and analgesia in pediatric intensive care is critical to the management of intubated patients under mechanical ventilation. The responsiveness of the pupil is changed by the sedation and analgesia. Measuring the pupil diameter is proposed in anesthesia and intensive care to assess the quality of analgesia in adult population. Visually measuring the diameter of the pupil remains very imprecise, but this measure can be accurately and quickly performed thanks to portable devices called Pupillometers. Some devices including Algiscan® device (IdMed ) can measure in addition to the pupil diameter, the variation of pupil diameter, the latency of the pupillary reflex and the maximum speed of contraction. Pupillometry was tested in adult ICU patients, during painful and painless procedures \[1\]. In this study, pupillometry was more sensitive for detecting pain compared to the change in heart rate or bispectral index. The objective of this work is to perform measurements of pupil diameter during painful procedures (e.g. tracheal aspiration) in PICU. In parallel we will continue using the Comfort B-scale (has been validated for assessment of pain in children admitted to a pediatric intensive care unit \[2-5\] and compare the results of both types of assessment pain.


Eligibility Criteria:
Inclusion Criteria:

* children (age \< 18 years) hospitalized in PICU
* sedated because they are receiving mechanical ventilation,
* for whom parents (or their representatives) have given their oral consent after written information.

Exclusion Criteria:

* children receiving curare drugs
* with congenital or acquired neurological,
* with ophthalmologic pathology
* or who does not benefit from social insurance coverage.
PARTial BREast RECONstruction With Chest Wall Perforator Flap

The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.

The Main Outcomes and Measures are:

A) Patient Demographics and Tumour characteristics

1. Patient demographics: age, body mass index (BMI), comorbidities
2. Preoperative tumour characteristics and location influencing surgical planning

B) Treatment characteristics

1. Surgical: operative data, including flap types and distribution
2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing partial breast reconstruction using CWPF for primary breast cancer
* Delayed correction of breast deformity following previous BCS
* Each surgeon is to have performed a minimum of 10 CWPFs
* Each centre anticipates completing a minimum of 10/year

Exclusion Criteria:

* Patients undergoing volume displacement BCS
* Patients undergoing mastectomy +/- immediate breast reconstruction
NIFR Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose SWIG Technique

This research study will evaluate how near-infrared fluorescence (NIRF) imaging with low-dose second window indocyanine green (ICG) can assist in the radical resection and pathologic diagnosis of malignant soft tissue sarcoma, such as dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC) during surgery.

To improve the accuracy of radical resection by reducing the risk of missed diagnosis of positive margin, this study will explore clinical application of near-infrared fluorescence imaging with modified low-dose SWIG technique in guiding radical resection of malignant soft tissue tumor. The investigators conduct a multi-center, multi-subgroup, prospective randomized controlled trial. The participants will be first stratified according to histological type involving dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC). The patients with DFSP or sSCC will be then randomly assigned to three groups. Patients in the control group will not receive ICG administration. The ICG was injected intravenously 24 hours before surgery, at a dose of 0.25 mg/kg in the first experimental group and 25 mg/patient in the second experimental group, respectively. The patients in the control groups will undergo traditional assessment of surgical margins.The patients in the experimental groups, on the other hand, will be scheduled to intraoperative near-infrared fluorescence imaging to scan gross tumor, tumor bed and cross-sectional specimen. The 2-year local recurrence rate will be regarded as primary outcome. The number of positive margins will be compared among groups. The investigators will also calculate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence intervals based on fluorescent signal of tumor bed in the experimental groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with DFSPs or sSCC in heads, extremities or trunk

Exclusion Criteria:

* seafood/iodine allergy
* hyperthyroidism
* pregnancy
* myasthenia gravis
* acute severe hypertension
Study to Evaluate the Immune Response to Pneumococcal Vaccine in Alefacept-treated Adults With Chronic Plaque Psoriasis

A vaccine causes the immune system to produce antibodies (immune response) to specific germs to protect the patient. This study evaluates the immune response to the pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.

This is a 1 arm study designed to evaluate the immune response to pneumococcal vaccine in adults with Alefacept-treated chronic plaque psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Subject has chronic plaque psoriasis
* Subject has at least 5% body surface area affected with psoriasis

Exclusion Criteria:

* Skin disorder other than plaque psoriasis in affected area
* Previously immunized with any pneumococcal vaccine
* Subject has pustular or erythrodermic psoriasis
* Subject is immunocompromised
* Six or more herpes simplex virus outbreaks per year
* History or malignancy, chronic serious infection or hepatic disease
A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).

This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection.

Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 to 75 years.
* 2.ECOG 0-1 points.
* 3. The expected survival time is more than 3 months.
* 4. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.
* 5. IHC: CD70 positive.
* 6. At least one measurable lesion at baseline per RECIST version 1.1.
* 7. The functions of important organs are basically normal:
* 8. Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception.

Exclusion Criteria:

* 1. Use of cell therapy within the previous one month.
* 2. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
* 3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
* 4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
* 5. Active hepatitis B, HIV positive and HCV positive.
* 6. Active infection or uncontrollable infection.
* 7. Uncontrollable or significant heart disease.
* 8. Unstable respiratory diseases, including interstitial pneumonia.
* 9. Uncontrolled ascites and pleural effusion.
* 10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc.
* 11.Subjects who are using systemic steroids or steroid inhalers for treatment.
* 12.Pregnant or lactating female subjects.
* 13.Other investigators deem it unsuitable to participate in the study
The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control

The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in a double blind study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* age 18-80
* no chronic disease

Exclusion Criteria:

* Subjects who suffer from chronic pain / pain syndrome
* use of anti-depressant or anti-psychotic drugs
* food/ drugs sensitivity
* breast feeding
A Safety Study of SGN-CD48A in Patients With Multiple Myeloma

This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.

This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts:

1. Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose.

   The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design.
2. Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group \[IMWG\])
* Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
* Measureable disease, as defined by at least one of the following: serum M protein 0.5 g/dL or higher, urine M protein 200 mg/24 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Adequate hematologic, renal, and hepatic function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy greater than 3 months
* A negative pregnancy test (for females of childbearing potential)
* Patients must provide written consent

Exclusion Criteria:

* Pre-existing peripheral neuropathy Grade 2 or higher
* History of malignancy other than MM within the past 3 years
* Active cerebral/meningeal disease related to the underlying malignancy
* Uncontrolled Grade 3 or higher infection
* Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection
* Previous allogeneic stem cell transplant
* History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months
* Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
* Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
* Females who are pregnant or breastfeeding
Usability Study of OnTrack Tools

Aims: Assess the usability of OnTrack Tools, a clinician facing interface to manage stroke survivors using the OnTrack rehabilitation system. Background: Arm disability is a common problem after stroke that can lead to loss of independence, it affects

\~450,000 people in the UK. Repetitive activity is critical for recovery but research shows people can struggle with intensity and keeping track of progress. The OnTrack system being developed at Imperial College London is a potential solution to this problem. Intervention: The OnTrack system consists of two software applications, OnTrack App - used by patients, and OnTrack Tools - used by clinicians. OnTrack Tools pulls data generated by the OnTrack App and enables the monitoring of clients' arm activity, and management of goals and educational content. The software is used to inform selfmanagement coaching by helping therapists understand more about how and when patients use their affected arm between treatment sessions. Design and methods: This study will assess the usability of the OnTrack Tools component of the system. The study will recruit stroke therapists from Imperial College Healthcare NHS Trust to provide feedback on the experience and usability of OnTrack Tools' graphical user interface (GUI). The study will be divided into three progressive cycles of testing, feedback and iteration. Each cycle will see participants individually completing specific tasks related to system navigation and the management of patients under simulation. Participants will complete outcome measures and take part in focus groups. Researchers will analyse and use the feedback to improve the GUI ready for the next testing cycle. Patient and public involvement: The project team includes a PPIE group of stroke survivors who oversee the project and help us with public facing documentation. They are members of the research team and are reimbursed for their time and travel, according to INVOLVE guidance. Dissemination: Results of the study will be written-up for technical reporting and publication. Participants will be provided with a summary of results at the end of the study. The study team will be providing general updates on the progress of the study via their social media channels (e.g. Twitter @OnTrackRehab @ImperialIGHI @HelixCentre).


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years old or over) Occupational Therapists and Physiotherapists (Band 4 to Band 8) working in the stroke wards at ICHT.

Exclusion Criteria:

* No exclusion criteria has been defined.
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration.

SECONDARY OBJECTIVES:

I. To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.

OUTLINE:

Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.

After completion of study treatment, patients are followed up within 4 weeks, and then every 6 months for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
* Leukocytes \>= 3,000/uL
* Absolute neutrophil count \>= 1,500/uL
* Platelets \>= 60,000/Ul
* Serum creatinine =\< 1.5 mg/dL
* Distant metastatic disease of peritoneum may be visualized on imaging:

  * Positive peritoneal cytology
  * Carcinomatosis on diagnostic laparoscopy or laparotomy
* Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC

Exclusion Criteria:

* Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, lung)
* Infections such as pneumonia or wound infections that would preclude protocol therapy
* Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
* Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
* Subjects deemed unable to comply with study and/or follow-up procedures
* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
UVB Phototherapy Treatment of Oral Chronic GVHD

The purpose of this trial is to find out how effective Narrow Band-Ultraviolet Light B (NB-UVB) phototherapy is in treating oral cGVHD. NB-UVB Phototherapy involves exposing the inside of the mouth to light of a particular spectrum (a specific wavelength of light, 311nm) of the ultraviolet band, called NB-UVB. It is known that narrow band ultraviolet light therapy can improve symptoms in patients with skin chronic GVHD.

* At the first visit the following information will be collected about the participant: original diagnosis, the date and type of transplant, transplant conditioning regimen, cGVHD prophylaxis regimen, the time when oral cGVHD was first noticed, specific treatments for oral cGVHD, and any current medications.
* At each visit, and before the participant begins phototherapy treatment, they will answer a series of questions asking about how their mouth feels and what they are able to eat. A clinical examination of the mouth will be performed and recorded and photographs will be taken of the inside of the mouth.
* Participants will then receive phototherapy treatment. This will take approximately three minutes and will involve opening the mouth and closing the eyes. Following phototherapy, the participant will be asked several questions on how they tolerated the treatment. Phototherapy treatments will be done two or three times per week for a total of 24 treatments. After each treatment, if the participant has not experienced any discomfort, the phototherapy dose will be increased following a specific protocol.
* After 24 treatments the participant will have the option to continue phototherapy treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients with oral chronic graft-versus-host disease
* 4 years of age or older
* Stable cGVHD medication regimen for the four weeks prior to study enrollment

Exclusion Criteria:

* New immunomodulatory medications or increasing dosage of current immunomodulatory medications during the four weeks prior to study enrollment
* Concurrent extracorporeal photopheresis.
Spectroscopy in Diagnosing Dysplasia and Neoplasia in the Cervix in Women Undergoing Colposcopy

RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening test to help doctors find cervical cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia and neoplasia in the cervix in women undergoing colposcopy or Pap testing.

OBJECTIVES:

* To identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using fluorescence and reflectance spectroscopy.
* To measure the reflection and fluorescence spectra in vivo of sites in the human cervix.
* To further refine fluorescence spectroscopy for detection of cervical lesions via better classification of normal columnar tissue and non-neoplastic tissue with inflammation, and low- and high-grade squamous intraepithelial lesions.
* Evaluate and validate the wavelength selections for the spectroscopy device derived from in vitro measurements.
* Determine the sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia.

OUTLINE: This is a multicenter study. Patients are stratified according to menopausal status and current treatment (premenopausal not on oral contraceptive pills \[OCP\] vs premenopausal on OCP vs postmenopausal not on hormone replacement therapy \[HRT\] vs postmenopausal on HRT).

* Diagnostic study: As part of routine colposcopic evaluation, patients undergo placement of the probe on 1 to 4 sites in the cervix for 2-5 minutes. Up to two colposcopically abnormal sites and two normal sites are biopsied. Blood is drawn for hormone levels. Fluorescence excitation and emission matrix (EEM) data and reflectance spectroscopic information is acquired from patients with an abnormal Papanicolaou smear.
* Screening study: Fluorescence EEM and reflectance spectroscopic information is acquired from patients with a history of normal Papanicolaou smears.

PROJECTED ACCRUAL: A total of 800 patients with abnormal Papanicolaou smears and 1000 subjects with normal Papanicolaou smears are accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Referred to the Colposcopy clinic at Vancouver General Hospital, the MD Anderson Cancer Center, or the University of Texas at Austin
* Abnormal or normal Papanicolaou smear
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Pre or post-menopausal
* Not pregnant

PRIOR CONCURRENT THERAPY:

* Not specified
Ultrasound-Guided Intermediate Cervical Plexus or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery

• Neck pain and stiffness or sore throat, are common after anterior cervical spine surgery. Complications are rare but can be serious and even potentially life-threatening if they do occur. Rapid recovery and emergence from general anesthesia are important in cases of anterior cervical spine surgery.

* Null hypothesis (H0): No difference between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in patients undergoing anterior cervical spine surgery under general anesthesia.
* Alternative hypothesis (H1): There are differences between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in

Eligibility Criteria:
Inclusion Criteria:

* Patient acceptance.
* Age (21-60) years old.
* Both sex
* American Society of Anesthesiologist physical status I / II
* Elective anterior cervical spine surgery under general anesthesia.
* patient With Body Mass Index (BMI) (25-35kg/m²)

Exclusion Criteria:

* Local infection at site of puncture.
* Altered mental status.
* History of allergy to study drugs ( bupivacaine, fentanyl).
* Patients with chronic pain.
* Patients with severe hepatic or kidney impairment.
* Patients having a history of hematological disorders, including coagulation abnormality.