cyrilzakka/clinical-trials huggingface dataset:
The Archimedes Biodegradable Biliary and Pancreatic Stents

This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.

On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.

The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication to position one ore more biliary plastic stents during ERCP
* Patients with an indication to position a pancreatic plastic stent during ERCP

Exclusion Criteria:

* Age \< 18 y
* Life expectancy \< 1 m,
* Inability to pass a guidewire through stricture
* Contra-indication for endoscopy or interventional radiology
* Presence of partial gastric resection
* Unsigned informing consent form, ICF
* Pregnancy
* Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
Wheelchair Maintenance Training Program

The objective of this research study is to assess the effectiveness of a remote wheelchair maintenance training program, and to determine methods which may increase overall success of an online training program.

Up to 100 individuals will be recruited for this research study. We will recruit individuals who use a wheelchair for the majority of their mobility (over 40 hours per week), and have a traumatic spinal cord injury (SCI). This study will be accessed entirely online and participation is expected to last approximately one year. Subjects will select to participate in one of three groups; one group that will receive maintenance training immediately with no follow up, one group that will receive the maintenance training immediately with 1 month and 6 month follow up, and one group that will be randomized to either receive the maintenance training immediately or after 6 months. The maintenance training program itself will take approximately 1-2 hours to complete.

After obtaining informed consent, participants in the first two groups will complete baseline questionnaires. They will then receive the maintenance training program.

Participants in the third group (a wait-list control group) will complete the baseline questionnaires and be contacted one month later to complete a wheelchair maintenance assessment questionnaire. They will then wait 5 months. After this period, participants will complete the baseline questionnaires a second time, and then receive the wheelchair maintenance training.

After completing the maintenance training, all groups will be contacted immediately post training to complete additional questionnaires to assess the effectiveness of the remote training program. Participants in the 2nd and 3rd group will be contacted 1 month and 6 months post-training to complete additional questionnaires. Participants may be compensated for their time.

Eligibility Criteria:
Inclusion Criteria:

* Have a traumatic spinal cord injury
* Use a wheelchair as a primary means of mobility (\>40 hours per week)

Exclusion Criteria:

* English is not a primary language
* Primary residence is not in the United States
Mindfulness-based Music Therapy in Blind Elderly Women

This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.


Eligibility Criteria:
Inclusion Criteria:

* female
* blind with visual acuity (the best eye) of 20/400 or below
* aged 65 years or above
* cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12
* able to speak Cantonese

Exclusion Criteria:

* none
Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
* Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
* Otherwise healthy

Exclusion Criteria:

* No active STIs and/or current UTI
* Previous exposure to SPL7013 Gel
* A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions \[HSIL\] on cytology or cervical intraepithelial neoplasia \[CIN\] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
Pilot Evaluation of Youth Chef Academy

This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based experiential culinary and nutrition literacy curriculum for middle-school students. The primary study hypothesis was that students assigned to YCA would demonstrate greater improvement in F/V and whole grain consumption compared to students in the control group. Eight classrooms in eight public K-8 schools participated in the project. Classrooms were assigned to intervention or control condition in a non-randomized manner. YCA was delivered by project staff to all of the students in the four intervention classrooms. Students completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum cohort).


Eligibility Criteria:
Inclusion Criteria:

* Student in intervention or control classroom

Exclusion Criteria:

-
Ranibizumab Plus Indomethacin

To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* provision of written informed consent and compliance with study assessments for the full duration of the study
* age \> 40 years
* presence of treatment-naïve neovascular AMD.

Exclusion Criteria:

* any previous intravitreal treatment
* previous laser treatment in the study eye
* myopia \> 7 diopters in the study eye
* concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
* concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
* known sensitivity to any component of the formulations being investigated.
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
* For participants not undergoing Gender-affirming care: Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or bone scan) and/or next-generation imaging \[NGI\] demonstrating greater than equal (\>=) 2 distinct extraprostatic sites of metastasis
* For participants undergoing Gender-affirming care: No evidence of metastasis by either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also acceptable
* For participants not undergoing gender-affirming care: testosterone levels \> 50 (ng/dL) nanograms per deciliter at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of (ADT) androgen-deprivation therapy prior to enrollment
* For participants undergoing Gender-affirming care: There is no testosterone level requirement for inclusion
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
* A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
* Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
* Assigned male at birth, inclusive of all gender identities

Exclusion Criteria:

* History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
* Pelvic lymph nodes as only site of metastasis
* Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
* Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
* Gastrointestinal disorder affecting absorption
* Participants who have undergone a bilateral orchiectomy with the exception of participants who completed this as part of their gender-affirming care or a result of a variation in physical sex development
Combination Iron Chelation Therapy

Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy. Compliance with the use of the only FDA-approved drug for removing excess iron from patients (Desferal) continues to be a major problem despite convincing evidence that it markedly reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be realized until an orally-effective drug is available. This small trial is testing the premise that a combination of drugs as a new approach to iron chelation therapy may reduce side effects and increase efficacy. If both drugs can be given orally, there may be a better chance of finding a suitable alternative to Desferal. Several combinations of experimental iron chelating drugs are being used in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Iron overload

Exclusion Criteria:

* Overt cardiac disease
Pharmacokinetics of Rocuronium for Deep Block (DeepRocu)

Rocuronium is a non-depolarising neuromuscular blocking agent. The compound has a rapid onset and an intermediate duration of action.

The rapid onset is of importance in patients at risk for pulmonary aspiration, for elective induction of anesthesia. Clinical studies simulating rapid sequence induction in elective patients indicate that rocuronium 0.9 mg kg-1 may be suitable for crash intubation.Also, rocuronium may be an alternative to succinylcholine for rapid sequence induction when high dose is injected (3x Effective Dose 95 %= 1mg/kg). But, pharmacokinetic of rocuronium at 1 mg/kg is not well establish.

The investigator investigate the onset and recovery of a single dose rocuronium (1 mg/kg) in consecutive patients (\>100) using adductor muscle monitoring (Train of Four and Post Tetanic Count)

In this study, pharmacokinetic of rocuronium at 1 mg/kg will be evaluated at each point of Train of Four Response (TOF) and Post Tetanic Count (when TOF=0) troughout the period of anesthesia and surgery.

Time 0 is the time of rocuronium injection, Time 1 is the time when post tetanic count is \> 5-7 and TOF=0, Time 3 when TOF \>0 response, Time 4 when 4 reponses of the TOF and Time 5 when TOF \> 90 %

Eligibility Criteria:
Inclusion Criteria:

* elective or emergency surgery under general anesthesia with deep block
* approval
* adult

Exclusion Criteria:

* contra indication to neuromuscular blockade (allergy, myopathy, hyperkaliemia)
* refusal
* \< 18 years olds
* Body mass index \> 50
* neuropathy
* regional anesthesia
Deep Learning Based Early Warning Score in Rapid Response Team Activation

The objective of this study is to evaluate the safety and clinical usefulness of the Deep learning based Early Warning Score (DEWS).

SPTTS is the representative trigger tracking system. In addition to the conventional SPTTS, DEWS will be calculated at each time point by the previously developed algorithm. SPTTS and DEWS will be shown simulataneously on the screening board. The rapid response team performs the rescue activity as before, using both SPTTS and DEWS simultaneously.

The alarm threshold setting of DEWS will be changed to 70 points, 75 points, and 80 points every month.

The primary and secondary outcomes will be evaluated to compare SPTTS and DEWS (based on each threshold).

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to general ward and monitored by in-hospital rapid response system

Exclusion Criteria:

* patients admitted to pediatric ward
* patients in emergency room, intensive care unit, and operating room
An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients

The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written inform consent.
* Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months.
* Established cardiovascular disease, such as CAD (CoronaryArtery Disease), previous TIA (Transient Ischemic Attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events

Exclusion Criteria:

* Need for concomitant treatment with a non-ASA NSAID (Nonsteroidal Antiinflammatory Drugs) including acyclooxygenase-2 (COX-2) selective NSAID. Occasional use of up to 1 day/week is allowed.
Fatty Liver Patient Registry

The purpose of the Non-Alcoholic Fatty Liver Disease (NAFLD) registry is to collect demographic and clinical data on patients being treated for NAFLD and to determine the factors affecting the progression of the disease as well as the success of different treatment strategies.

The NAFLD registry is a local database provided by the principal investigator, Dr. J. Allard, which will be stored on the Research Intranet at the University Health Network, Toronto. The database will be password protected. Only clinic personnel and members of Dr. Allard's research team involved in the study will have access to the database. A code and date of birth will be used to identify each patient. All patients entering the NAFLD clinic at Toronto General Hospital will be consented for the registry. Only data from their regular clinic visits will be used for entry into the registry. Data entered into the registry will include: 1) Patient demography: age, sex, ethnicity, medical history; 2) Anthropometry: weight, height, BMI, waist circumference; 3) Nutritional assessment: Food records and food frequency questionnaires are kept by the subjects and data will be analyzed to assess the intake of macro- and micronutrients. Amount of alcohol and number of cigarette smoked will also be recorded; 4) Physical Activity will be assessed using the Paffenbarger Physical Activity Questionnaire; 5) Medications: insulin, non-steroidal anti-inflammatory drugs, corticosteroids, statins, medications used to treat diabetes/obesity (e.g. metformin, thiazolidinediones, orlistat...), medication to treat liver disease (eg. urso, carnitine, choline...), antioxidant vitamin or fish oil supplementation; 6) Blood work, currently including: complete blood count, biochemistry including liver enzymes, total protein, albumin, glucose, insulin, and blood lipid profile; other diagnostic blood work done to exclude other causes of liver disease, e.g. ceruloplasmin, anti-smooth muscle antibodies,... One plasma sample will be stored for assessment of cytokeratin 18 (CK-18) fragments as a novel marker for NASH in patients with NAFLD; 7) Presence of metabolic syndrome; 8) Disease categorization: SS, NASH, cirrhosis; 9) Survival: alive, death: causes, NAFLD-related or not NAFLD-related; 10) Liver biopsy results, NAFLD fibrosis score, and elastography results.

Data will be entered after every clinic visit. Case report forms will be used to collect the data from the patient charts and facilitate data input into the registry database All patients will be followed prospectively until withdrawal from the clinic or death. Descriptive statistics will be performed. For the entire NAFLD population, probability of survival, cirrhosis, as well as liver and non-liver related morbidity will be calculated using the Kaplan Meier method.

Eligibility Criteria:
Inclusion Criteria:

- Patients being treated for NAFLD at the Toronto General Hospital NAFLD clinic

Exclusion Criteria:

* None
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.

To examine whether the number of euploid embryos following ovarian stimulation with micronized progesterone is equivalent as compared with the number of embryos after ovarian stimulation with the use of a GnRH antagonist in patients undergoing ovarian stimulation for IVF or intracytoplasmatic sperm injection (ICSI).

The pre-ovulatory surges of GnRH and LH are activated by increased concentrations of circulating estradiol, but ovulation is blocked when progesterone concentrations are elevated, due to a central inhibition of the GnRH surge. Although traditionally GnRH has been traditionally considered the drug of choice to control endogenous LH in controlled ovarian stimulation (COS) cycles, recently, micronized progesterone has been shown to be an effective oral alternative for preventing premature LH surges during COS in women undergoing IVF/ICSI treatments, with excellent results, whereas their safety during pregnancy is well-established. This novel protocol, has several advantages (good tolerance, user convenience, and cost reduction), that are very attractive when it comes to establishing a convenient user regimen in combination with a ''freeze all'' strategy. However, the comparative efficacy of this novel protocol with the more universal use of GnRH-antagonist protocol for the treatment of IVF patients in terms of embryo ploidy has never been evaluated up to date. The current study aims, for the first time, to examine whether the number of euploid embryos following ovarian stimulation with micronized progesterone is equivalent as compared with the number of embryos after ovarian stimulation with the use of a GnRH antagonist in patients undergoing ovarian stimulation for IVF/ICSI.

If efficacy would prove to be similar, with no impact on the chromosomal constitution of embryos, there will be obvious advantages for the preferential use of micronized progesterone over the antagonist protocol: oral administration is preferred over subcutaneous injection, and total cost of medication would be lower. This would be particularly interesting for the future in all "freeze all" protocols such as women undergoing ovarian stimulation for fertility preservation, preimplantation genetic screening and oocyte donation programs.

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients
* Age 36-40 years old
* BMI 18-30 kg/m2
* Undergoing preimplantation genetic screening cycles
* Planned to undergo at least two treatment cycles, to accumulate embryos to increase the chance of obtaining euploid embryos for transfer
* Willing to participate in the study

Exclusion Criteria:

* Age\> 41
* Severe male factor requiring TESE (testicular sperm extraction)
* Low ovarian reserve (AMH \< 1.2 ng/ml)
* Administration of any other drug potentially interfering with the treatment.
Prediction of Maternal Arterial Hypotension After Spinal Anesthesia by Passive Leg Raise Test.

Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.

The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.

Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia.

Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.

The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.

Patients will have a clinical hemodynamic and echocardiographic evaluation, before performing the spinal anesthesia, before and after the passive leg raise test.

Then, the patients will benefit from a clinical hemodynamic evaluation during the preparation of the parturient in the operating room and finally after the completion of the spinal anesthesia and until the clamping of the umbilical cord.

Eligibility Criteria:
Inclusion Criteria:

* Adult women admitted to Necker Enfants Malades hospital for scheduled cesarean section under spinal anesthesia
* Written informed consent

Exclusion Criteria:

* No health insurance
* Urgent cesarean
* Failure of spinal anesthesia
* Free and informed consent impossible to obtain (especially due to a language barrier)
* Severe cardiovascular or neurovascular comorbidities
* Contraindication to the PLR (intracranial hypertension, fractures of the pelvis and / or lower limbs, ...)
* Background of preeclampsia or eclampsia
* Severe fetal pathology