cyrilzakka/clinical-trials huggingface dataset:
A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy

A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.
2. DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.
3. Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.
4. Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.
5. Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).
6. Previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit (group 2) and treatment with an intraocular anti-VEGF therapy not possible.
7. Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician.

Exclusion Criteria:

1. IOP \>21 mmHg at screening in the study eye.
2. Historical rise in IOP \>25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
3. Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.
4. Patients that have vitreomacular traction in DME and opaque media in the study eye.
5. Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
6. Pregnant or breastfeeding.
7. Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye.
8. Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the study start date in the study eye.
9. Patients with contraindications according to the current SPC:

   1. The presence of pre-existing glaucoma.
   2. Active or suspected ocular or periocular infection.
   3. The patient is hypersensitive to the active agent or to one of the excipients.
Sleep Technology Intervention to Target Cardiometabolic Health

The goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, cardio-metabolic disease risk factors, and health behaviors among adults with elevated blood pressure/hypertension and short sleep duration.

Half of U.S. adults have at least one cardio-metabolic disease (CMD), including hypertension (HTN), heart disease, stroke, or diabetes. Even with advances in screening, education, and medication management, controlling these chronic diseases remains challenging. Despite the well-established negative effects of short sleep duration, surprisingly few studies have tested the benefits of sleep extension and even fewer studies evaluate the science of sleep extension interventions. Therefore, the goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, CMD risk factors, and health behaviors among adults with elevated BP/HTN and short sleep duration.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* 24h ABP readings indicating elevated blood pressure (BP) or hypertension (24h average systolic (SBP) of 115-145 mmHg or diastolic (DBP) of 75-90 mmHg). Patients taking antihypertensive medications will be permitted if stable dose for \>8 weeks
* Time in bed \<8 hours and habitual sleep duration \<7 hours via actigraphy;
* Smartphone user
* Able to read/write in English.

Exclusion Criteria:

* High risk or presence of moderate to severe comorbid sleep disorders (i.e., obstructive sleep apnea AHI 15 or greater, restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight obstructive sleep apnea at the baseline/screening
* Resistant hypertension, defined as \>4 antihypertensive medications or taking medications and standardized in lab BP \>130 mmHg SBP or 80 mmHg DBP at screening History of cognitive or neurological disorders (e.g. dementia, Parkinson's, Multiple Sclerosis)
* BMI\>50 kg/m2 or arm circumference greater than extra large cuff
* Presence of major psychiatric disorders (e.g. schizophrenia, bipolar disorder)
* alcohol abuse on the Audit-C (score \>4 for men, \>3 for women)
* drug use on the NIDA-Modified ASSIST (score \>3),90
* moderate to severe depressive symptoms (PHQ-8 \>10)
* Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis)
* Overnight work more than 1x per month
* Use of hypnotic or stimulant medications
* Situations that would significantly impact the ability to extend sleep, including overnight caregiving responsibility for children under the age 1, elderly or disabled adults \>1x per week
* Inability to read or write in English
* Pregnancy/desire to become pregnant during the study period.
QLB After Nephrectomy

Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).

Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the end of an operation, still under general anesthesia, 50% patients will obtain QLB with ropivacaine.

Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine solution (0.2 mL per kg).

Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative period.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of the operation. 24 -hours period.

At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Eligibility Criteria:
Inclusion Criteria:

* obtained consent
* nephrectomy procedure

Exclusion Criteria:

* coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs
Rainbow Acoustic Monitoring (RAM) in Patients Weighing up to 10kg Comparison Study

The objective of this clinical investigational study is to compare the acoustic respiration rates (RRa) obtained using the INVSENSOR0004 sensor in the subjects up to 10 kg with the respiration rates determined by manual annotations (RRref), and when applicable with capnography respiration rate (RRcap).


Eligibility Criteria:
Inclusion Criteria:

* Subjects weighing up to 10kg
* Subjects will be inpatients and/or outpatients admitted to the NICU (Neonatal Intensive Care Unit) or PICU (Pediatric Intensive Care Unit) or PACU (Post-Anaesthesia Care Unit)
* The parent/legal guardian has given written informed consent/assent to participate in the study.

Exclusion Criteria:

* Subjects with underdeveloped skin
* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator.
Temperature, Heart and Respiratory Rate Investigation Along With Variability Evaluation and Serum Biomarkers (THRRIVES)

The purpose of this study is to find a way of detecting infection earlier in patients receiving bone marrow transplant. This is accomplished by continuous individualized monitoring of heart rate, respiratory rate and temperature variability in this patient population. The investigators are collecting data to determine whether or not subtle differences in heart rate, respiratory rate and temperature will help physicians to detect infection earlier in order to begin faster treatment before a patient's condition deteriorates. Blood tests will also be performed to check for certain biomarkers that may indicate infection

In this prospective observational study, patients receiving bone marrow transplant are selected for continuous monitoring of heart rate, respiratory and temperate variability. Data is collected as per standard practice using the Zephyr Biopatch device, a highly compact wireless monitor with two small gel electrodes, that is much more comfortable than previous belt/strap-based monitoring devices.

The patient is asked to wear the Zephyr Biopatch device for approximately 23 hours a day, beginning the day before he/she begins bone marrow transplant. The patient is asked to continue wearing the device for a period of up to 10 days or until he/she is no longer experiencing any fever. The Zephyr Biopatch device records heart rate, respiratory rate and temperature for calculation of heart rate variability (HRV), respiratory rate variability (RRV) and temperature variability (TV) using the Continuous Multiorgan Individualized Variability Analysis (CIMVATM) software engine. The variability outcomes will look at the presence, rapidity and severity of change in variability prior to the onset, diagnosis and treatment of infection. Bloodwork will also be performed to check for certain biomarkers that may indicate infection.

Eligibility Criteria:
Inclusion Criteria:

An expected prolonged period of neutropenia

* Completing bone marrow;
* Allogeneic and/or autologous transplants OR
* Induction chemotherapy

Exclusion Criteria:

* Inability to obtain written informed consent from patient or legally authorized representative
* Ongoing treatment for active infection (not prophylaxis)
* Preexisting severe cardiopulmonary disease (defined as an EF 40%, FEV 40%,or interstitial lung disease with pulmonary fibrosis)
* On betablockers or calcium channel blockers
* Preexisting arrhythmia
* Permanent pacemaker
* Inability to speak neither English nor French
Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer

This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.


Eligibility Criteria:
Main Inclusion Criteria:

* Signed and dated written informed consent
* Male or female ≥18 years of age at the time of informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy \>3 months assessed during Screening
* Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC

Main Exclusion Criteria:

* Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
* Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment
* Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment
* Active Central Nervous System (CNS) metastases or carcinomatous meningitis
* Women who are pregnant
* Women who are breastfeeding
Optimization of Obesity for Total Knee Replacement with Glucagon-like Peptide-1 Receptor Agonist

Studies have shown that obese patients undergoing total knee replacement (TKR) surgery face a higher risk of perioperative issues such as increased use of pain medication, surgical site infections, and the need for revision surgeries compared to non-obese patients. Obesity is also linked to more significant preoperative pain and lingering symptoms post-surgery. Consequently, there's a growing interest in weight loss interventions prior to TKR to enhance perioperative care and outcomes. Recent retrospective studies have indicated that such interventions can improve physical function post-TKR.

Research focusing on weight loss interventions before joint replacement surgery is limited.

There is currently a gap in research regarding RCTs on weight loss interventions using anti-obesity drugs before TKR, particularly in Asian populations.

One promising avenue under exploration involves the use of glucagon-like peptide 1 receptor agonists (GLP-1RAs) as anti-obesity medication before total knee replacement (TKR) surgery. However, there are currently no randomized controlled trials (RCTs) examining the effects of GLP-1RAs on knee arthroplasty outcomes. Large database studies have indicated that GLP-1RAs may decrease the likelihood of certain post-surgery complications but increase the risk of others.

In summary, addressing obesity through weight loss interventions, particularly with GLP-1RAs, holds promise for improving outcomes in TKR patients. However, further research, including randomized controlled trials, is necessary to fully understand the effects of GLP-1RAs on perioperative outcomes and patient health.

2.1 Hypothesis Hypothesis for this pilot trial is conducting trial of GLP-1RA for perioperative optimization for TKR feasible. The null hypothesis for the full trial is that clinical, functional and quality of life (QoL) outcomes in obese patients undergoing TKR will not be improved if this is preceded by GLP-1 RA induced weight loss.

3. Study objective The primary aims of this pilot study are 1) estimate adherence, tolerability and follow-up rates, 2) recruitment and management challenges.

The secondary aims are to assess the effect of semaglutide for perioperative optimization in TKR and gather data to estimate the feasibility like tolerability and sample size for a future trial.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 80 years old
* BMI ≥27 kg/m2
* On the surgical waiting list for primary TKR
* Willing and able to cooperate in a weight management programme.
* Meeting indication for semaglutide

Exclusion Criteria:

* Revision surgery or surgery for neoplastic disease
* A medical condition which in the opinion of the investigators makes the patient unsuitable for participation in the trial
* Contraindication to GLP-1RA, like history of pancreatitis, severe gastrointestinal diseases such as gastroparesis, thyroid cancer, and inflammatory bowel disease
* Lack of acceptance of the randomisation process.
Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers

The COVID-19 pandemic is an exceptional and particularly anxiety-provoking health situation. In particular, for healthcare professionals who come into contact with patients who are contaminated or suspected of contamination, such as emergency rooms. The management of these patients requires reinforced protective equipment. However, in the context of this pandemic, data is currently non-existent on the objective measurement of the stress of these professionals. Sinus variability of heart rate is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc.).

This is an observational study. In the emergency room, each participant will wear a heart rate monitor and a consumer watch throughout the working day (there will be no measurement on duty at night, nor measurement at home). The days will be notified as being in the "COVID sector", "non-COVID sector" or "Trauma Room".

Each participant will complete a questionnaire comprising visual analog scales on the feeling (health concern, stress, fatigue, quality of sleep, anxiety, morale, burnout, decisional latitude, psychological demand, support, self-esteem), time of start and end of work, and socio-demographic data (sex, age, weight, height, smoking)

Eligibility Criteria:
Inclusion Criteria:

* Emergency health care worker

Exclusion Criteria:

* refusal to participate
Effectiveness of a Culinary Class on Food Literacy and Eating Behaviours of Francophone High School Students

As the frequency of meals taken outside the home increases, children and youth have less opportunities to develop their food and cooking skills. Consequently, poor food literacy can increase dependence on highly processed foods which generally contain high amounts of calories, fat, sugar and sodium. Past studies have shown positive impacts of culinary-based interventions on adolescents' nutrition knowledge, attitudes, eating behaviours and cooking skills. However, most of these interventions were led outside of the school context, which limits their reach. Since adolescents spend most of their waking hours in school, providing culinary classes in school may be an effective way of promoting adolescents' food literacy. Therefore, the aim of this quasi-experimental study was to assess the effectiveness of an optional culinary class on high school students' food literacy and eating behaviours. Specifically, data were collected among students from five francophone high schools who were enrolled in a culinary class. These students were compared to those who were enrolled in a social studies class. Both classes were 55-70 minutes in duration and were provided five times per week over a full 18-week semester. Data on students' food literacy and eating behaviours were collected via questionnaires during the first and last week of the semester.

This study used a quasi-experimental design. Students from five francophone high schools in the province of New Brunswick, Canada, who were enrolled in an optional culinary class were compared to students from those same schools who were enrolled in a social studies class. The culinary class is a hands-on course which teaches students how to measure and weigh ingredients, read and follow recipes, apply various food preparation, cooking and assembly techniques, as well as prepare meals. In contrast, the social studies class is a mandatory theory-based course which teaches students how to maintain positive relationships, how to become a productive member of society and how to make responsible and informed choices related to their health. Both classes are 55-70 minutes in duration and are provided daily over an 18-week semester.

A questionnaire was developed based on two previously validated food literacy questionnaires and assessed food and cooking skills, as well as eating behaviours. This pen and paper questionnaire was completed by students in both the culinary class and the social studies class during the first and last week of the semester (September 2019 and January 2020). Multilevel regressions will be used to assess the effectiveness of the culinary class on students' food literacy and eating behaviours as compared to the social studies class.

Eligibility Criteria:
Inclusion Criteria:

* Be enrolled in either the culinary class or social studies class in the fall semester of 2019

Exclusion Criteria:

* None
Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm

Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years;
* Definite diagnosis of rectal NET less than 10mm;
* Patients plan to receive either EMR-C or ESD treatment.

Exclusion Criteria:

* Serious comorbid diseases such as advanced malignant tumor and organ failure;
* Patients received conventional EMR, snare electrotomy and no treatment;
* Rectal NET with metastasis;
* Pregnant patient;
* Poor compliance
Acupoint Stimulation and Cranial Endovascular Treatment

In this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (TEAS) and group control (no intervention). The postoperative outcomes including NIHSS (National Institute of Health stroke scale) score, morbidity and mortality will be evaluated during hospital stay and by one year after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years
2. patients scheduled for cranial endovascular treatment

Exclusion Criteria:

1. American Society of Anesthesiologists class Ⅲ or higher
2. Hunt-Hess class Ⅲ or higher
3. body mass index (BMI) \< 18 kg/㎡ or \> 30kg/㎡
4. large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm
5. posterior circulation infarction
6. recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping
7. severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure
8. injury or infection of the skin around the acupoint area
9. participate in other clinical researchers within 3 months
10. history of neurological or psychiatric diseases
11. patients with implanted electrophysiological device
12. use of sedative or analgesics before surgery
13. patients with difficulty in communication
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.


Eligibility Criteria:
Inclusion Criteria:

* Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
* Moderate to severe lower-limb spasticity
* Able to give informed consent and willing to comply with protocol

Exclusion Criteria:

* Pregnancy
* History of seizures
* Existing or history of frequent Urinary Tract Infections
* History of drug or alcohol abuse
* Allergy to pyridine-containing substances
* Received a botox injection 4 months prior to study
* Received an investigational drug within 30 days
* Previously treated with 4-aminopyridine (4-AP)
* Not on stable medication dosing in 3 weeks prior to study
* Abnormal ECG or laboratory value at screening