cyrilzakka/clinical-trials huggingface dataset:
Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer

Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner.

The investigators have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. The investigators are conducting a multi-center trial at Princess Margaret Cancer Centre and Kingston General Hospital to compare STEP with usual symptom screening in medical oncology clinics.

Randomized controlled trials have shown that when patients with advanced cancer were referred early to specialized palliative care teams, they had improved QOL, symptom control, and greater satisfaction with their cancer care. Such routine specialized palliative care intervention, while effective, may be challenging to enact broadly with widespread shortages of palliative care physicians. STEP systematically identifies patients with the greatest need, using symptom screening at every outpatient visit, with triage and targeted referral to palliative care. This could reduce resource use while directing care to the most vulnerable.

Consenting patients from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics will be assigned randomly either to receive STEP or to follow usual symptom screening. All patients will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The investigators will measure the impact of STEP on these outcomes, compared to screening alone.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of stage IV cancer (advanced); hormone-refractory for breast or prostate cancer; stage III or IV for lung cancer and pancreatic cancer; patients with stage III cancer and poor clinical prognosis, e.g. ovarian or esophageal cancer, will be included at the discretion of the oncologist
* ECOG performance status ≤ 2 (estimated by primary oncologist)
* Prognosis of 6-36 months (estimated by primary oncologist)
* Patient completes symptom screening in outpatient clinic electronically

Exclusion Criteria:

* Insufficient English literacy to complete questionnaires
* Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score \<20 or \>10 errors)
* Receiving specialized palliative care within the last 6 months prior to screening, per chart and patient statement.
Shared Interactive Book Reading in Preschool Children with Neurodevelopmental Disorders: Effects on Language Development and Reading Habits

The goal of this observational retrospective study is to explore the effects of a parent-based book reading intervention on children with neurodevelopmental disorders. The project consisted of interactive lessons for parents and shared reading experiences. It took place between May 2021 and June 2022 in Rome and at the time children were receiving neuropsychomotor and speech therapy sessions based on the developmental profile.

The investigators'primary goal is to investigate lexical quotients of children who participated in the project to explore whether it had an impact on their language development. The secondary goal is to assess shared reading habits.

For both outcome measures, researchers will compare the group who partecipated in the study with a cohort of children with the same characteristics who also attended Fondazione Don Carlo Gnocchi for rehabilitation purposes.

Patients and their family will not be asked for any further engagement because all data will be taken from medical records.


Eligibility Criteria:
Inclusion criteria for the study group:

* age between 1 and 6 years old
* having attended at least 2 out of 5 parent training meetings and 2 out of 9 reading aloud sessions
* at least one caregiver with a good command of the Italian language,
* having given written consent to participate

Exclusion Criteria for both groups:

* cerebral palsy or severe sensory disorder (deafness, blindness)
* limited command of the italian language
* lack of informed consent
Research on the Sources of Noise in Post Anesthesia Care Unit and the Impact of Noise on Medical Staff

The study aims to clarify the sources and influencing factors of noise in the post anesthesia care unit, as well as the perception of noise by medical staff through survey table, in order to improve the noise environment, optimize noise management, protect medical staff, and enhance medical quality.


Eligibility Criteria:
Inclusion Criteria:

* Currently working as nurses, doctors, or technicians in the Post Anesthesia Care Unit;
* Have at least continuous 6 months of work experience in the Post Anesthesia Care Unit;
* Able to read and answer questionnaires in Chinese fluently.

Exclusion Criteria:

* Have hearing impairments or other conditions affecting auditory perception;
* Have participated in similar studies and completed related surveys within the past 6 months.
Evaluation of Illinois Agility Performance With Smartphone Applications: A Validity and Reliability Study

Due to the impracticality of accessing the gold standard test devices, researchers have developed easy-to-use and cost-effective smartphone applications that do not require expert knowledge, and these applications have been used to measure different motor abilities. Smartphone applications such as CODtimer, Stopwatch Movie watch, and Seconds Count are used to evaluate the ability to change direction within these biomotor features. However, the validity and reliability of these applications are the subjects of research.

The athletic performance level is one of the main factors that determine the success of an athlete. However, the athletic performance level of an athlete is determined by many motor abilities. One of these motor abilities is agility.

Because agility has been seen as a complex physical skill, valid and reliable tests and test devices are needed to determine the level of agility. Therefore, researchers have developed many test devices using technology and they have aimed to reach gold standards to measure agility ability through these devices. In this context, manual timers were first used to measure agility performance, then devices such as fully automatic test devices, photocell types, video timers, and radar systems were accepted as a test tool for the measurement of agility performance. Although fully automatic test devices are accepted as the gold standard in the measurement of velocity-based parameters, they cannot be preferred by everyone due to obstacles such as the need for expert knowledge and being economically costly for their use.

Due to the impracticality of accessing the gold standard test devices, researchers have developed easy-to-use and cost-effective smartphone applications that do not require expert knowledge, and these applications have been used to measure different motor abilities. Among these motor features, CODTimer App is the smartphone application that is frequently preferred in the evaluation of agility ability and whose validity-reliability studies are conducted.

In the previous studies on the validity and reliability of the CODTimer App, a very strong correlation was found between the CODTimer App and the gold standard automatic timing gates according to the 5+5 and 505 agility test protocols. However, many mobile applications have validity and reliability unexplored. It is necessary to investigate different test protocols and devices to spread the use of mobile applications and prove that they are valid and reliable measurement tools.

This study aimed to determine the validity, reliability, and usefulness of the CODTimer, Second Count, and Stopwatch Moviewatch App with an iPhone 11 compared to gold standard timing gates for the evaluation of Illinois agility performance in college athletes.

Eligibility Criteria:
Inclusion Criteria:

* Athletes who have not experienced an injury in the last 1 year and have a training history of at least one year.

Exclusion Criteria:

* Participants who do not meet the inclusion criteria
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.

The primary goal of the study is to determine the success rate of Twin A external Cephalic Version in our obstetric clinic and to determine new favorable sonographic criteria associated with a successful attempt that have not been investigated before.

Eligibility Criteria:
Inclusion Criteria:

* Presence of the written consent of the patients.
* The patients must be over 18 years old .
* No limit in the ability to consent.

Exclusion Criteria:

* Age under 18
* Limited ability to consent
* Placenta previa
* Fetal abnormalities
Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium

The purpose of the present study is to assess the influence of the administration of low dose hCG on the endometrium. The study is a randomised trial where 2 groups of patients, undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization, are studied. In addition to the histological findings, by analysing the correlation of the morphological pattern and gene expression profile of human endometrium on the day of oocyte retrieval in patients of both treatment groups, the investigators want to study the implantation potential.


Eligibility Criteria:
Inclusion Criteria:

* \< 36 years on day of randomisation
* FSH \< 12 in the early follicular phase
* Normal ultrasound scan
* BMI between 18 and 29 (both inclusive)
* Randomisation at outpatient clinic

Exclusion Criteria:

* Endometriosis ≥ grade 3
* PCO syndrome
* Poor responder
* Endocrine or metabolic abnormalities
Surgery or Clincial Follow up, in Patients With Bell' s Palsy

The purpose of this study is to investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Bell´s Palsy
2. Men and women aged 18-55 y
3. Score \< 70 according to Sunny Brook scale (SB)
4. Signed informed consent

Exclusion Criteria:

1. High bloodpressure
2. Diabetes
3. Pregnancy
4. Currently on immunodepressive treatment
5. Smoker
6. Psychiatric disorder
7. Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery
A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC

The purpose of this study is is to assess the safety and tolerability of curcumin in combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR NSCLC.

This is a phase 1 open prospective cohort study to assess the safety and feasibility of using curcumin in conjunction with an EGFR-TKI in patients with advanced NSCLC. The investigators will use an enhanced bioavailable formulation of curcumin (CURCUViva TM at 80 mg/ 1 capsule per day) approved and licensed by Health Canada (NPN 80027414) that has been shown to have 2-3 times higher curcumin concentration in the blood as compared to previous clinical trials. As primary objective, the investigators will recruit 20 patients for a duration of 8 weeks to monitor adverse effects according to the the National Cancer Institute Common Terminology Criteria.Exploratory objectives would include assessing changes in health-related quality of life using the standardized FACT-L questionnaire and evaluating anti-inflammatory properties of curcumin by measuring CRP. If tolerable safety data is obtained, an expanded phase II trial will be designed.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or patients on treatment for histologically confirmed advanced EGFR-mutant NSCLC defined as unresectable stage 3A, stage 3B or stage 4.
* The EGFR mutation analysis must be performed prior to enrolment into the trial (i.e., before a patient is consented). Any EGFR mutation-positive result must be documented and the analysis for the mutation will be performed using the JGH local testing methodology.
* Receiving concurrent EGFR-TKI therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Score 0-3

Exclusion Criteria:

* Symptomatic brain metastases.
* Patients who are receiving any other investigational agents.
* Patients using other non-vitamin or mineral regular natural health product, which includes Chinese Herbs.
* Incapacity to understand and sign a written informed consent document in English/French.
* Pregnancy
An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia

This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.

This is an open-label extension study of IMR-687 in adult patients with SCA who were previously participants in the Phase 2a study titled "A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study of IMR-687 in Adult Patients with Sickle Cell Anaemia (Homozygous HbSS or Sickle-β0 Thalassemia)."

This open-label extension study with IMR-687 will evaluate the long-term safety and tolerability of IMR 687 in adult SCA patients. Exploratory long-term PD parameters will also be examined.

Eligibility Criteria:
Inclusion Criteria:

1. Completed Study IMR-SCD-102.
2. Female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.
3. Subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them
4. Subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.

Exclusion Criteria:

1. Subjects with Hb \>12.5 g/dL or \<6 g/dL
2. Subjects with known active hepatitis B or hepatitis C, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (HIV)
3. eGFR \<50 mL/min
4. AST/ALT \> 3x the upper limit of normal
Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal

Based on stereoelectroencephalography model in the treatment of epilepsy patients, this study conducted language-related experimental studies without interfering with normal monitoring treatment. Meanwhile, voice data and intracranial electrophysiological data were collected for analysis. To study the mechanism related to the language function of patients, try to establish a model to decode the intracranial electrophysiological data related to language.


Eligibility Criteria:
Inclusion Criteria:

* Patients with focal refractory epilepsy also need preoperative evaluation with SEEG

Exclusion Criteria:

* History of major depression or psychiatric disorders and medication that causes symptoms of psychiatric disorders
* Patients with severe cognitive impairment (MMSE score ≤15), unable to complete the language function test
Aurora Test for Patients Treated With Recombinant Gonadotropins

This is an observational study. The main aim is to determine the expression of potential biomarker genes in the cumulus cells isolated from individual oocytes in two patient cohorts: recombinant human Follicle Stimulating Hormone(hFSH) and recombinant hFSH:human Luteinizing Hormone(r-hLH) ratio 2:1. Algorithms from gene combinations will be identified that predict embryo quality and pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients are between 22-38 years old
* BMI between 17-33
* provide written informed consent
* Patients undergoing a first or second ICSI treatment cycle.
* Patients will be treated by ICSI (intracytoplasmic sperm injection)
* Patients agree that the oocytes will be denuded for cumulus testing and agree to the single blastocyst transfer.
* Patients must be predicted good ovarian responders (AMH 1-4,7 ng/ml) with 7-18 follicles of minimum 10-11 mm on trigger day (oocyte retrieval minus 2 days (OR -2)) by ultrasound following ovarian stimulation with r-hFSH or r-hFSH with r-hLH in a Gonadotropin-releasing hormone (GnRH) antagonist protocol (starting dose recombinant Follicle Stimulating Hormone (rFSH) between 150-225 IU)
* HCG trigger after stimulation (r-hCG)

Exclusion Criteria:

* Women with less than 7 or more than 18 follicles at Day -2 or -3 measured by ultrasound
* Women with history of poor oocyte maturation or known maturation defect
* Irregular menstrual cycle (\< 24 or \> 35 days)
* BMI \< 17 or \> 33
* Smoking \> 10 cigarettes per day.
* Known low ovarian response based on Bologna criteria
* Combined use of urinary and recombinant gonadotropins in the current cycle
* Patients with severe endometriosis ≥ III (AFS classification)
* Polycystic ovary syndrome (PCOS), defined by revised criteria American Society for Reproductive Medicine (ASRM) European Society of Human Reproduction and Embryology (ESHRE) 2018
* Patient included in any other study
* Patient scheduled for preimplantation genetic testing (PGT)
* Testicular sperm extraction (TESE) or extreme oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml.
Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen

Oocyte retrieval is an outpatient procedure that is a routine surgical intervention in the process of assisted reproductive technologies and oocyte banking. The perioperative pain control is achieved with multidrug regimen including intraoperative opioid medication and perioperative administration of oral or intravenous acetaminophen. This medication is more commonly known as Tylenol. Intravenous formulation of this medication is several fold more expensive and the data for perioperative pain control is mixed on the equivalence of pain control with intravenous versus oral acetaminophen in other fields. Currently there is no accepted standard of care and the two formulations are used interchangeably depending on primary physician's preference. We are conducting an equivalence placebo controlled randomized clinical trial to assess the difference in efficacy of these two formulations

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Female, aged 18-45
4. Ability to take oral medication and be willing to adhere to the study intervention regimen

Exclusion Criteria:

1. Known clinically significant liver disfunction
2. Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other
3. Known current substance use disorder
4. Chronic pain syndrome
5. Weight less than 50 kg
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer

This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.

PRIMARY OBJECTIVE:

I. Define the feasibility of the current photoacoustic imaging (PAI) technology in head and neck (H\&N) cancer patients.

SECONDARY OBJECTIVE:

I. Define the utility of the current PAI in H\&N cancer patients.

OUTLINE:

PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.

PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* No restriction on race or ethnic background
* Subject must understand the investigational nature of the study and sign an independent ethics committee/institutional review board approved written informed consent prior to receiving any study related procedure
* FOR CANCER PATIENTS IN THE H\&N RADIATION GROUP (PART I):
* Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) getting chemoradiation therapy
* Presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (PA-US)
* FOR ALTENS PATIENTS (PART II):
* History of prior radiation therapy with xerostomia requiring ALTENS

Exclusion Criteria:

* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Unwilling or unable to follow protocol requirements or provide consent
* Any condition which in the Investigator?s opinion deems the subject an unsuitable candidate to undergo imaging procedure
Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.

The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of heterozygous familial hypercholesterolemia
* Ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects
* Calculated LDL-C level greater than or equal to 100 mg/dL (or 2.5 mmol/L) and triglycerides less than 500 mg/dL (5.65 mmol/L) while on usual and stable lipid-lowering therapy

Exclusion Criteria:

* Breast feeding or lactating women
* Previous organ transplantation
* High-grade stenosis (\>75%) or the occlusion of any segment of either carotid artery
* History of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures