cyrilzakka/clinical-trials huggingface dataset:
Enhancing COVID Rehabilitation With Technology

In March 2020, the World Health Organization (WHO) declared the novel coronavirus (COVID-19) a global pandemic. Ontario has confirmed more than 547,000 cases of COVID-19 since testing began. For many of these patients, symptoms resolve within 4 weeks of onset. However, it is becoming apparent that a significant number of individuals are experiencing symptoms that persist long after the acute infection, known as Long COVID. These individuals have a wide constellation of presenting symptoms, often varying from initial presentation. For this study, we will be enrolling individuals receiving care at The Ottawa Hospital for Long COVID. This study aims to determine the following four things: 1) will adding electronic case management improve quality of life three months after coming to hospital with Long COVID; 2) is the electronic case management platform cost effective; 3) is there any factors that predict outcomes at 3 months; 4) to determine how a personalized rehabilitation program supported by a digital platform could be implemented for individuals with Long COVID. We will enroll individuals from The Ottawa Hospital who will then be randomly assigned to receive either usual care or usual care plus electronic case management, through a platform called NexJ Connected Wellness. Participants will also complete questionnaires every 4 weeks for 3 months. We will be looking at quality of life, mental and physical health, cognitive symptoms, fatigue and pain.


Eligibility Criteria:
Inclusion Criteria

Participants must:

1. Be 18 years of age or older
2. Have a confirmed diagnosis of COVID-19 with a PCR test at least 12 weeks prior OR a confirmed Rapid Antigen Test at least 12-weeks prior OR meet Ottawa Public Health guidance for a suspected COVID-19 case
3. Have at least one ongoing symptom consistent with Long COVID as measured by the WHO Post COVID Case Report Form (CRF)
4. Have a minimum WHODAS (36 item) sum score of 15
5. Be willing to use email for study activities
6. Be able and willing to use a smart phone application for the duration of the trial
7. Be able to read and understand English or French.
8. Be willing and able to provide informed consent.

Exclusion Criteria

Participants must not:

1. Have any significant functional impairment (for example. advanced dementia, heart or lung disease) as judged by the assessing clinician
2. Participate in another long-COVID trial where treatment is required in the protocol (pharmacological or behavioural). Observational studies will be allowed.
3. Have symptoms consistent with Long COVID that are better explained by an alternative diagnosis
Impact of Methylation Alterations in Colon Cancer: Epidemiology and Prognosis

We conducted a preliminary study in 2010 using the innovative Illumina GoldenGate (methylation assay) which has enabled us to characterize the level of methylation of 807 potential markers on a series of 200 adenocarcinomas of the colon (C18) and rectosigmoid junction (C19) resected between 1998 and 2001. The results, validated by pyrosequencing, allowed us to establish a panel of 12 markers to assess the level of methylation. The aim of this project is to validate the prognostic value of this panel in a second cohort of patients with adenocarcinomas (stage I to IV) resected between 2002 and 2006 in public and private hospitals (n=685).

This study relies on an original collection of surgical specimens of colorectal cancers resected in public and private hospitals among patients resident in the département of Côte-d'Or and followed by the cancer registry of Burgundy. Samples obtained from each cancer and from adjacent normal mucosa are stored in liquid nitrogen in the Ferdinand Cabane Biological Resources Centre(certified S 96900). Annotations are collected by the cancer registry staff from multiple sources (pathologists, gastroenterologists, oncologists and radiotherapists).

Pyrosequencing will be used to quantify the level of methylation. The percentage of methylated allele for each marker on cancerous DNA and the ratio of methylated markers to the number of markers analyzed will be determined. The molecular status of MSI, BRAF, KRAS, and PI3K will be taken into consideration.

To study the prognosis, relative and relapse free-survival will be calculated. A multivariate relative survival analysis will be performed to determine independent prognostic factors taking into account the characteristics of patients and tumours and epigenetic and molecular alterations. Epigenetic alterations will be described according to age group, sex and subsite. The epigenetic phenotypes will be evaluated according to already known molecular status using logistic regression models.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinomas of the colon (C18) and rectosigmoid junction (C19)
* Resident in Côte-d'Or
* Treated by surgical resection

Exclusion Criteria:

* Rectal cancer
* Cancer on Crohn's disease and ulcerate colitis
* Hereditary colon cancer (HNPCC, familial polyposis)
Patient Outcomes in Simulation Education (POISE) Intravenous (IV) and Lumbar Puncture (LP) Multi-institution Protocol

This study aims to compare the clinical efficacy of multimedia audiovisual training to hands on "practice till perfect" training for pediatric and emergency medicine residents' procedural skills. This initial study will explore the success rates on infant lumbar puncture and child intravenous access skills in post-graduate year one pediatric residents.


Eligibility Criteria:
Inclusion Criteria:

Pediatric interns at POISE network hospitals
Lexical Priming by Music in Alzheimer's Disease and Healthy Aging

While verbal memory is quickly reached in the wake of Alzheimer's disease, the musical memory remains preserved until a late stage of the disease. This observation encouraged the development of music-based therapies in the management of neurocognitive and behavioral disorders that characterize Alzheimer's disease. In order to develop rehabilitation programs that effectively target cognitive functions to stimulate, it is necessary to understand the mechanisms underlying this beneficial effect of music on cognition.

The investigators study the stimulation by the song, material integrating language and music, and having an autobiographical value. The investigators measure the lexical priming capacity of the song, that is, its ability to activate and maintain lexical and semantic representations, which are threatened with alteration in the course of the disease.

This lexical priming effect by song is measured in patients with mild Alzheimer's disease and healthy volunteers during a single test session. In the first phase of the session, participants are exposed to familiar songs, presented in sung, spoken or instrumental form, whose popularity they evaluate. In the second phase, they perform two implicit memory tasks: a trigram completion task and a lexical decision task. These tests measure the facilitation of the processing of words evoked by songs in relation to words unrelated to songs, reflecting a "long-term" memory update of mnemic traces of primed words.

Eligibility Criteria:
Inclusion Criteria for patients :

* Presence of diagnostic criteria for Alzheimer's disease
* Age ≥ 65 years
* MMSE (Mini-mental state Examination) ≥ 20

Exclusion Criteria for patient :

* Unstable clinical presentation or language presentation in the foreground
* Cognitive disorder of etiology different from that of Alzheimer's disease

Inclusion Criteria for volunteers :

* Age ≥ 18 years
* Absence of neurological or psychiatric antecedents
* For those aged 65 or over: MMSE (Mini-mental state Examination) greater than or equal to 27; non-pathological performance against the 5 words of Dubois and the verbal fluency test.

Exclusion Criteria for volunteers :

* Visual or auditory disorders insufficiently corrected
* Oral or written expression in French insufficient to carry out tests
* Consumption of psychotropic drugs not stabilized
Long-term Outcomes of Critical Illness Survivors

The goal of this study is to assess the Long-term Outcomes of Critical Illness Survivors,including physical, psychological, and cognitive sequelae.

An increasing number of patients survive critical illness; however, the evidence reveals that over the same period the number of patients being sent to rehabilitation settings have tripled . For those who do survive, the latest data indicate that 50-70% of ICU "survivors" will suffer cognitive impairment and 60-80% of "survivors" will suffer functional impairment or ICU-acquired weakness (ICU-AW).Still,there is a lack valid data on the long-term impact on morbidity from prospective observational studies. Therefore, the investigators designed an observational cohort which cover a broader range of outcomes to quantify long-term physical, psychological, and cognitive impairment after intensive care unit (ICU).Intensive Care Unit patients survive from critical illness will be approached for study recruitment and participation.Survival rate,Quality of life,Cognitive impairments,Depression and anxiety,PTSD,Physical activity,Neuromuscular impairment will be assessed 3 or 6 months after ICU discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>17 years
* Patients in intensive care unit(ICU) with at least one organ or system dysfunction,such as respiratory failure, cardiogenic shock,or septic shock.

Exclusion Criteria:

* Refuse to participate
* Death before ICU discharge
* pre-existing cognitive impairment, malignant tumor
Maxolon to Improve Breastmilk Supply in Diabetic Women: a Randomised Controlled Trial

Early use of oral maxalon can hasten and improve the establishment of breastfeeding in diabetic mothers after preterm and term deliveries.

Maxolon promotes breastfeeding by working on the central nervous system which increases the milk producing hormone, prolactin which in turn helps to increase the milk supply for breastfeeding. Successful early breastfeeding establishment is important for continued breastfeeding.

The study aims to determine the breastfeeding initiation and duration rate of a cohort of pregnant women with gestational diabetes(diet-controlled) and insulin dependent and pre-existing diabetes, assess the impact of a post natally administered galactogogue, metoclopramide on the milk volume production and timing of lactogenesis II in diabetic women on diet control and insulin and determine the prolactin response to lactation among diabetic women on diet control and insulin.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women with pregestational or gestational diabetes under diet or insulin control

Exclusion Criteria:

* Patient who have epilepsy or on anti-seizure medications,
* Patients who have a history of significant depression or are on antidepressant drugs
* Patients who have pheochromocytoma or uncontrolled hypertension
* Patients who have intestinal bleeding or obstruction
* Patient with known allergy or prior reaction to metoclopramide
* Patient with HIV infection
* Current pregnancy complicated by fetal congenital anomalies and multiple fetuses
Pilot Study on the Submental Area

The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.


Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects \> 18 years of age and \< 65 years of age.
2. Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
3. No weight change exceeding 10 pounds in the preceding month.
4. Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
5. Subject has signed a written informed consent form.

Exclusion Criteria

1. Skin laxity in the neck or chin area for which reduction in submental fat may.
2. Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
3. Enlargement on the anterior neck that may prevent the proper placement of the applicator.
4. Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
5. Botulinum toxin injections within the neck or chin area.
6. History of a fat reduction procedure in the area of intended treatment.
7. History of prior surgery in the area of intended treatment.
8. Current dental infection.
9. Known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
10. Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
11. Impaired skin sensation or thermal sensitivity in the intended treatment area.
12. Open or infected wounds in the intended treatment area.
13. Currently taking or has taken diet pills or weight control supplements within the past month.
14. Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
15. Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
16. Pregnant or intending to become pregnant in the next 5 months.
17. Lactating or has been lactating in the past 6 months.
18. Unable or unwilling to comply with the study requirements.
19. Currently enrolled in a clinical study of any other unapproved investigational drug or device.
20. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients

The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis of blood samples.

This is a historically-controlled, multicenter, open label Phase 3 study to determine the safety and efficacy of 25 mg/kg/day of Defibrotide (DF) for the treatment of severe VOD in hematopoietic stem cell transplantation (HSCT) patients.

In this study, the term "severe VOD" is defined as those patients who meet the Baltimore diagnostic criteria for VOD (total bilirubin \>/= 2.0 mg/dL plus two of the following: ascites, \>/=5% weight gain and hepatomegaly), who also have multi-organ failure (i.e., pulmonary and/or renal dysfunction). This represents a group of patients in whom mortality at Day+100 has been estimated to be \>80%.

Comparisons: The primary parameter is Complete Response at 100 days following stem cell transplant, utilizing historical controls as a comparator. The historical control database will be generated through a retrospective medical chart review performed at participating centers; the survival outcome of patients who would otherwise have met eligibility criteria for this trial will be compared to the survival observed in patients prospectively treated with Defibrotide. Secondary parameters include survival rate at 100 days and 6 months post stem cell transplantation (SCT), and special studies of endothelial and serum markers for VOD. This study will assess safety of the dose and schedule in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of VOD, defined by jaundice (bilirubin \>/= 2 mg/dL) and at least 2 of the following clinical findings, by Day+21 post stem cell transplant: ascites; weight gain \>/= 5% above baseline weight; hepatomegaly.
* Severe VOD, defined as VOD with multi-organ failure, i.e., presence of one or both of the following, by Day+28 post stem cell transplant: renal or pulmonary dysfunction.
* Provide voluntary written informed consent.

Exclusion Criteria:

* Pre-existing (prior to SCT) cirrhosis
* An alternative diagnosis for weight gain, ascites and jaundice
* Graft-versus-host disease (GVHD) grade B or higher involving liver or gut or grade C or higher involving skin
* Prior solid organ transplant
* Dependent on dialysis prior to and/or at the time of SCT
* Dependent on oxygen supplementation prior to SCT
* Significant acute bleeding or hemodynamic instability
* Requirement for the use of any medications that increase risk of hemorrhage will be excluded from the treatment group
Effect of Ramadan Fasting on Ovulation and Insuline Resistance in Patients With PCOS

Polycystic ovary syndrome (PCOS) has a heterogeneous clinical presentation comprising reproductive (hyperandrogenism, menstrual irregularity, anovulation, infertility, pregnancy complications), metabolic \[insulin resistance (IR), increased type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) risk factors\] and psychological features (worsened quality of life and increased anxiety and depression) Whether prolonged fasting during Ramadan breaks the insulin resistance state of polycystic ovarian syndrome and subsequently improve the ovulation and spontaneous pregnancy will happen without ovarian stimulation.

Question of the study:

The question is raised whether prolonged fasting during Ramadan breaks the insulin resistance state of polycystic ovarian syndrome and improve the metabolic syndrome does prolonged fasting decrease glucose level, insulin level, insulin resistance markers such as adipokines and subsequently improve ovarian function and causes spontaneous ovulation.

Eligibility Criteria:
Inclusion Criteria:

* Females with PCO in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital, and welling to fast for 30 days from 5 am until 7 pm and do not plan to induce her ovulation in the next 4 months to get pregnant.
* Does not have any other medical illnesses other than PCO.
* Welling not to start any ovulation induction in the next 4 months after the first blood sample was taken and after fasting month.

Exclusion Criteria:

* Known androgen secreting tumor.
* PCO on ovarian stimulation medications
* PCO with any other medical illness.
* Non-compliance with fasting 30 days from 5 am- 7 pm.
Biomarkers and Functional Imaging in Predicting Response of Esophageal Cancer

The purpose of this study is to determine whether combination of molecular and biomarkers with functional imaging can predict pathologic response and clinical outcomes in squamous esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant chemoradiotherapy and surgery

The recommended care for the management of locally advanced esophageal cancers is neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy based on the NCCN guideline. The rate of pathologic complete response (pCR) after nCRT was around 25-30%, reflecting potential cure of unresectable esophageal cancer receiving CRT. Since esophagectomy might have substantial morbidity and mortality rate, establishing the model for predicting nCRT response and survival will guide neoadjuvant treatment decisions and personalized treatment. Thus surgery might be spared in some patients with complete responses after nCRT, and surgery could be selectively reserved for those with only partial or no response to CRT. However, reported models yield unsatisfactory results due to small sample size and low accuracy, and most cases were adenocarcinoma and few models were used to predict survival. This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, detect CRT resistance biomarkers, assess the SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients.The investigators will also establish a model for survival prediction. This model might possibly guide the personalized treatment for esophageal squamous cell carcinoma patients in China.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must have histologic documentation of squamous carcinoma of the esophagus at Xijing Hospital.
2. Newly diagnosed Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at Xijing Hospital and are considered appropriate candidates for and are willing to undergo chemoradiotherapy followed by surgery at Xijing Hospital.
3. Patient must have undergone a baseline esophageal-gastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at Xijing, with tissue available for biomarker analysis.
4. Patient must be willing to undergo this research and must provide written informed consent.

Exclusion Criteria:

1. Patient is unable or unwilling to comply with the requirements of the protocol.
2. History of prior malignancy within the past 3 years.
3. Patients with second primary tumors.
4. Patients who received endoscopical therapy or induction chemotherapy prior to chemoradiation therapy are excluded.
5. Patient is not a candidate for chemoradiation followed by surgery.
A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects

This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening.
2. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.

Exclusion Criteria:

1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure.
3. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.
A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.

Sites will identify patients who meet the entry criteria during the conduct of their normal practice. Patients meeting these criteria will be offered participation in the study after reading and completing an informed consent document.

Eligibility Criteria:
Inclusion Criteria:

* Male aged ≥45 years;
* Experienced abrupt visual change in only 1 eye

Exclusion Criteria:

* Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
* History of NAION or optic neuritis.
* Participation in other studies within 60 days prior to entry in the study.