cyrilzakka/clinical-trials huggingface dataset:
Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.

Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.

The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Head and Neck Squamous Cell Carcinoma confirmed by biopsy
* Non metastatic disease
* Resectable tumour
* Locoregional recurrence or new localization in pre irradiated territory at a dose ≥ 50 Gy with or without chemotherapy
* Haematological constants, liver function and kidney function adapted in the 15 days before inclusion:

  * Haemoglobin ≥ 9 g / dL
  * Polymorphonuclear neutrophils ≥ 1.5 x 10 9
  * Platelet ≥ 100 x 109 / L
  * Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  * ALT and AST \<3 times ULN
  * Alkaline phosphatase ≤ 2.5 times ULN
  * Serum creatinine \<110 mmol / L or creatinine clearance\> 55 ml / min (method of Cockcroft)
  * Absence of proteinuria
* WHO 0 or 1
* Signed informed consent form
* Patient affiliated to the social security system.

Exclusion Criteria:

* Patient considered as non eligible for a salvage surgery
* Metastatic disease
* Hypersensitivity to indocyanine green or allergy to seafood or reaction to iodinated contrast agents
* Pregnant or breastfeeding women
Blind Fascia Iliaca Compartment Block Compared to Ultrasound-guided Femoral Nerve Block in Patients With Hip Fractures

The goal of this study is to compare the analgesic effect of a blind fascia iliaca compartment block to an ultrasound-guided femoral nerve block in patients that present to the emergency department with hip fractures.

Hip fractures often present to the emergency department and elderly, already fragile, patients are overrepresented. The pain associated with a hip fracture can be severe and have deleterious effects on the patient. Many studies, and a Cochrane review, have shown that a peripheral nerve block provides good pain relief and has many benefits compared to traditional pain relief, such as intravenous morphine. There is less consensus regarding which kind of nerve block, and which technique, is best to use. Many studies compared different kinds of nerve blocks to traditional methods, or more recently compared different kinds of ultrasound-guided techniques to each other.

This study proposes to compare the widely used technique of a blind fascia iliaca compartment block (FICB) to an ultrasound-guided femoral nerve block (FNB) that is currently being rolled out locally as an alternative. During the implementation period of this new clinical routine, it will be possible to compare the efficacy of FICB and FNB in reducing participant-reported pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult emergency department patient over 18 years of age with a radiologically verified fracture classified as hip fracture that are eligible for a peripheral nerve block according to local guidelines

Exclusion Criteria:

* Multi-system trauma
* Isolated pelvic or diaphyseal femur fracture
* Patients unable to communicate regardless of reason
* Patients with contraindications to receiving a peripheral nerve block with an amide local anaesthetic according to local guidelines
HPV Self-Test Intervention in Ohio Appalachia

This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test intervention among women from Ohio Appalachia in order to determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy. The intervention group will receive culturally appropriate materials and the control group will receive standard materials with their HPV self-test device.

PRIMARY OBJECTIVES:

I. To determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy and obtain preliminary efficacy data of culturally appropriate materials on self-test use.

OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I: Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing.

ARM II: Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing.

Participants are followed up at 4 weeks for return of their HPV self-test device and then for 2 months after notification letters are sent.

Eligibility Criteria:
Inclusion Criteria:

* Ages 30-65
* No Pap test in the last 3 years
* Resident of an Ohio Appalachia county
* Not currently pregnant or was not pregnant in the last 3 months
* No history of invasive cervical cancer
* No history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (RCT) if they participated in the focus groups that helped develop this study (focus groups were institutional review board \[IRB\] approved as Protocol 2014C0086) or the preliminary device test; we will also require women to read and understand English and have the ability to provide informed consent, which will be inferred upon completion and return of the study eligibility, consent, and Health Insurance Portability and Accountability Act (HIPAA) forms
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)

This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years with type 1 or 2 diabetes mellitus
* Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye
* BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

* Active proliferative diabetic retinopathy (PDR) in the study eye
* Uncontrolled diabetes mellitus, as defined by HbA1c \>12%
* Only 1 functional eye even if that eye is otherwise eligible for the study
Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer

This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh.

Sub-sites will be open for patient accrual in selected centers in the Kingdom.

The cisplatin/docetaxel is established standard in the first line management of metastatic non small cell lung cancer in the United States, Europe and Asia. However, the safety and efficacy of this regimen was not studied systematically in Middle Eastern population. The aim of this study is to study the efficacy and safety of this regimen in our patient population

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven non-small cell lung carcinoma
* Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.
* Patient should not be eligible for customization chemotherapy (if available at participating institutions).
* Having at least one measurable lesion
* Patient has life expectancy of 12 weeks or greater.
* Age \> 18 years.
* No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given more than 1 year ago is acceptable.
* WHO performance status 0-2 (See Appendix III )
* Adequate organ function:

  * Hematology: Neutrophils \> 2 x 10 9 /L, platelets \> 100 x 10 9 /L
  * Hepatic function: Total bilirubin \< 1.25 times the upper normal limits, ASAT (SGOT) \< 2 times the upper normal limits
  * Renal function: Creatinine \< 1.5 mg/dL; if value is higher than upper normal limit but less than 2 mg/dL, the creatinine clearance should be \> 60min/ml.
* Able to comply with scheduled follow-up and with management of toxicity
* Signed informed consent from patient or legal representative
* Negative urine pregnancy test (if indicated)

Exclusion Criteria:

* Pregnant or lactating women or women of childbearing potential using inadequate contraception.
* Uncontrolled brain metastatic disease. (CNS disease that is stable \> 4 weeks after radiotherapy in lieu of steroids reduction is eligible).
* Symptomatic peripheral neuropathy \> grade 1 according to the NCI Common Toxicity Criteria Version 3
* Other serious illness or medical condition:

  * Unstable cardiac disease requiring treatment
  * History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures
  * Active uncontrolled infection
* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
* Concurrent treatment with any other anti-cancer therapy
* Contraindication of steroid drug administration
* Past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix
Evaluating a Digital Cognitive Behavioral Therapy for Hazardous Alcohol Use: A Pilot Study in South Korea

The goal of this single arm pilot study is to investigate the feasibility, acceptability and preliminary effectiveness of the mobile app SOBER; for reducing and preventing hazardous alcohol drinking.

The main questions it aims to answer are:

* Feasibility: How well participants adhere to the app's lessons?
* Acceptability: Participants\&#39; satisfaction with and perceived usefulness of the app.
* Preliminary Effectiveness: The number of days participants remain abstinent.

Participants will:

* Use the mobile application SOBER, which delivers digital cognitive behavioral therapy, for four weeks.
* Wear a smartwatch to collect biometric data throughout the study.
* Visit the clinic three times: at baseline (V1), two weeks after the initial visit (V2), and four weeks after the initial visit (V3).
* Be evaluated using various questionnaires about their alcohol consumption, mood, and stress levels at each visit.
* Receive psychiatric consultation with a board-certified psychiatrist regarding their alcohol consumption, based on the data entered into the mobile app.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 19 and 65 years.
* Individuals classified as high-risk drinkers (hazardous drinking): Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
* Individuals who have been admitted for treatment of alcohol use disorder no more than once.
* Individuals who are assessed to have completed detoxification treatment for alcohol.
* Individuals who own a smartphone and can independently use apps on the smartphone.
* Individuals who voluntarily agree to participate in this clinical study and have signed the consent form (or whose representative has signed the consent form).

Exclusion Criteria:

* individuals with active and progressive physical illnesses or a life expectancy of less than 6 months
* individuals with major psychiatric comorbidities such as schizophrenia, bipolar disorder, or major depressive disorder
* pregnant women or those planning to become pregnant during the study
* individuals who had participated in another clinical study within four weeks prior to the screening for this study
Effects of Trunk-Focused Rehabilitation on Spinal Mobility, Trunk Control, and Hand Functions in Cerebral Palsy

Main Purpose: This study aims to investigate the effects of trunk-focused rehabilitation on trunk control, spinal mobility, and manual skills in adolescents with cerebral palsy (CP).

Secondary Purpose: To investigate its effects on functional health.

Muscle weakness in the trunk; reducing the support of children with CP, may cause increased distal tone and decreased function in their daily practices. When the effectiveness of interventions that can improve postural control is evaluated, trunk-focused training is one of the 5 interventions supported by a moderate level of evidence. In an intervention study where trunk training was structured individually, there may be an improvement in erector spinae muscle group scores when evaluated with sEMG. A study of 28 cases, including all subtypes of CP, aimed to evaluate the inter-rater reliability of Spinal Mouse (SM) and the effect on the spinal column with 4 hours a day, 1 week of intensive clinical rehabilitation application. In this population, SM was evaluated with therapeutic interventions, it has been reported that it may show significant posture differences, especially in total spinal inclination and spine length. In children aged 5-12 years with Gross Motor Function Classification System (GMFCS) Level 1, 2 CP, there are significant improvements in the Trunk Control Measurement Scale (TCMS) score after only Trunk Focused Rehabilitation (TFR). It is emphasized that with TFR, which is described as a unique approach, postural control of the whole body can be improved by the use of intermediate postures and postural activities involving the trunk and better participation of the affected muscles. Only after TFR intervention, the findings of improvement in the assessments on a 3D force platform were highlighted in postural sway, early sternal and sacral decelerations. It is carried out with active participation, individualized, intensive, and time-limited, considering possible content limitations and the needs and preferences of the adolescent and the family. It is stated that trunk-targeted interventions can be given together with conventional physical therapy programs to support functional improvements.

Eligibility Criteria:
Inclusion Criteria:

1. Levels 1 and 2 according to Gross Motor Function Classification System (GMFCS)
2. Viking Speech Scale Turkish version/(VSS-T) 1-2 level, understood to speak and able to take commands
3. Adolescents with CP between the ages of 12-18
4. Those whose guardian / legal representative and themselves have received an Informed Voluntary Consent Form
5. No hip dislocation
6. Scoliosis below 25 degrees according to the radiographic evaluation made in the last 6 months

Exclusion Criteria:

1. Having had any surgery related to the intrathecal baclofen pump
2. Having botulinum toxin injection treatment or orthopedic surgery within the last 6 months
3. Having severe vision, hearing, and cognitive deficiencies
4. Acute medical illness
Bone Health and Microbiome in Persons With Type 1 Diabetes

It is well-established that persons with type 1 diabetes (T1D) are at an increased risk for morbidity and mortality related to bone fracture due to poor bone health, however we do not fully understand the mechanism behind the increased fracture risk. We are examining bone health and the microbiome in adolescents and young adults with type 1 diabetes to better understand the reasons behind this increased risk.

This pilot study aims to look at measures of bone health, the gut microbiome and measures of glycemia/glycemic variability in those with preclinical and clinical diabetes. Our primary and secondary outcomes are to characterize these variables, with our long term objectives to better understand the natural history of bone health in T1D, help characterize the etiology of worse bone health in those with T1D, and try to identify potential time periods for intervention.

Eligibility Criteria:
Inclusion Criteria:

- Willing and able to comply with study protocol

For participants with type 1 diabetes (T1D):

- T1D diagnosed clinically by an endocrinologist as documented in medical records.

Exclusion Criteria:

* use of oral or parenteral antibiotics within 3 months
* use of probiotics/prebiotics/synbiotics within 3 months of enrollment; persons who eat yogurt will be asked to stop for 30 days prior to stool collection
* use of medications that will affect bone, including glucocorticoids, bisphosphonates
* chronic medications (other than insulin for those with T1D or a stable dose of thyroid hormone)
* uncontrolled chronic gastrointestinal disease including celiac disease (persons with T1D will be screened for celiac disease with a Tissue Transglutaminase Antibody (tTG)/Immunoglobulin A (IgA) if not done in prior 2 years)
* known genetic syndrome that predisposes the participant to fracture (such as osteogenesis imperfect) or skeletal dysplasia that would affect skeletal assessment (such as hypochondroplasia)
* pregnancy
* Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the subject participating in the study or would make it unlikely the subject could complete the study

Additional Exclusion Criteria for Healthy Controls:

* Presence of any diabetes autoantibody
* Presence of any type of diabetes or hyperglycemia (HbA1c≥5.7%)
Impact of Extubation Location After Surgery on Perioperative Times

The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates.

The additional time required to awaken a patient is one of the main reasons for not extubating him or her in the operating room (OR). Conversely, transferring an intubated patient to recovery room (RR), prolonging the duration of anesthesia and intubation, in a limited environment in human resources, may lead to increased complications' rates. Little is known about those time lengths and complications rates. The primary objective was to evaluate the additional OR occupancy time associated with awakening and extubation. Secondary objectives were to assess the rate of post-extubation complications and the need for ventilatory support. This was a prospective multicenter observational study involving intubated patients who underwent surgeries in the operating theatres of the Montpellier and Clermont-Ferrand university hospitals. Anesthesia teams were asked to complete a form including data related to the patient, surgical procedure, anesthesia procedure (induction and recovery) and the occurrence of any complications during the procedure. A multivariate analysis was conducted on the full cohort, using a propensity score (IPTW, inverse probability of treatment weighting) to account for imbalances between groups.

Eligibility Criteria:
Inclusion Criteria:

* Adult (older than 18 years old)
* Patients admitted to any operative room of participating centre for a surgical or endoscopic procedure under general anaesthesia requiring endo-tracheal intubation
* Subjects must be covered by public health insurance
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

* Patient extubated in intensive care unit
* Patient extubated during on-call hours (because of a reduced number of medical and paramedical staff)
* Patient extubated following cardiac surgery
* Refusal of study participation or to pursue the study by the patient
* Absence of coverage by the French statutory healthcare insurance system
* Protected person
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer

The overall purpose of this study is to investigate whether younger subjects report pain with pegfilgrastim (or biosimilar substitution) more often and/or at higher levels (greater intensity) than older subjects.This study will be carried out throughout the course of your chemotherapy treatment, which will be prescribed by your study doctor. Participation in this study will not affect your cancer treatment.

This study will measure pain using ESAS self-reported pain scores over the course of one week following each dose of pegfilgrastim (or biosimilar substitution). At the end of that week, blood will be drawn from each subject to directly measure the WBC/ANC, which can then be compared to self-reported pain and evaluated for any correlation. Finally, subjects will be divided into two groups by age: 45 years or younger, and over 45 to look for any differences in pain or WBC/ANC measurements based on age.

Eligibility Criteria:
Inclusion Criteria

Subject must meet all the following applicable inclusion criteria to participate in this study:

1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
2. Age ≥ 18 years at the time of consent
3. Female
4. Histological or cytological confirmation of invasive breast cancer.
5. Planned to undergo adjuvant or neoadjuvant chemotherapy treatment for invasive breast cancer AND pegfilgrastim (or biosimilar substitution) treatment for neutropenic prophylaxis.
6. Ability to read and understand the English and/or Spanish language
7. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion Criteria

Subjects meeting any of the criteria below may not participate in the study:

1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
2. Have previously received chemotherapy or radiation other than the first cycle of the planned adjuvant or neoadjuvant chemotherapy as indicated in Inclusion #5
3. Taking chronic narcotics, as determined by treating physician
4. Diagnosis of distant metastatic breast cancer
5. Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis, etc.)
6. A baseline ESAS pain score of greater than 8.