cyrilzakka/clinical-trials huggingface dataset:
SPARK Symptom Screening and Feedback to Providers

Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component. This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care

Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days. This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse). Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. We will enroll 345 participants over 4 years from 7 Canadian centers

Eligibility Criteria:
Inclusion Criteria:

* 8 to 18 years of age
* Diagnosis of cancer or have received or about to receive HSCT
* Understand English
* Expected to be in hospital or clinic for 5 day

Exclusion Criteria:

* illness severity
* cognitive disability
* visual impairment
European, Open-label, Prospective, Multinational, Multicenter Study in Adult Subjects With Type 1 or Type 2 Diabetes Previously on MDI or CSII Therapy. Subjects Home Setting is Considered Routine Practice.

Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects will receive training in the preparation, programming and daily use of the Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more training in order to be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years old
* Diagnosed at least for 12 months with Type 1 or 2 Diabetes requiring insulin therapy
* Intensive insulin therapy by MDI or CSII at least 6 months
* Willing to self monitor blood glucose 4 times daily

Exclusion Criteria:

* Significantly impaired awareness of hypoglycemia
* Unstable chronic disease other than diabetes
* Acute illness or inability to recognize pump signals or alarms as determined by the investigator
* Pregnancy
Body Surface Gastric Mapping in Patients on Semaglutide

Glucagon-like receptor-1 agonists (GLP-1 RAs), such as Semaglutide (Ozempic), are a class of drugs used for glycemic control in diabetes, and for weight loss and management in obesity. It has been shown to delay gastric emptying and lead to gastrointestinal symptoms. However, the exact mechanisms are unknown. Alterations in gastric function, including myoelectrical activity, may be a likely mechanism of gastrointestinal side effects.

Body Surface Gastric Mapping (BSGM) using the FDA-approved medical device Gastric Alimetry is a novel non-invasive diagnostic tool to assess gastric myoelectrical activity and patient-reported symptoms to achieve accurate non-invasive biomarkers of gastric dysfunction. A proof-of-principle case study of Ozempic using Gastric Alimetry showed abnormal gastric myoelectrical activity along with the development of severe bloating following the meal after 5 weeks of Ozempic use.

This study will extend on this initial finding by conducting an exploratory pilot study to investigate the effects on gastric motility in patients with and without diabetes before and after Ozempic. It is hypothesized that Gastric Alimetry will show changes in gastric myoelectrical activity and symptoms in patients after being on the weekly injectable Ozempic compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* No gastrointestinal symptoms based on Rome IV criteria
* For diabetics: Diagnosed T2DM (defined as HbA1c levels \> 7%)
* For diabetics: Fasting blood glucose level \< 15 mmol/L

Exclusion Criteria:

* Current use of Ozempic, similar GLP-1 RAs or regular insulin in the last 3 months
* Confirmed gastroparesis on gastric emptying scintigraphy
* Pregnant or breast-feeding
* Inability to perform a BSGM test according to Indications for Use: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); unable to remain in a relaxed reclined position for the test duration.
Nutrition Day in Hospitals, Nursing Homes and Community. Israel January 2010

This study is a one-day international cross-sectional nutritional audit in one ward. The purpose of this study is to generate a risk and level of nutritional intervention profile for an individual unit/ward based on case-mix, structures and social environment.


Eligibility Criteria:
Inclusion Criteria:

* A adult patients within the unit from 7H00 to 7H00

Exclusion Criteria:

* Patients younger than 18 years
* Patients admitted and discharged during same calendar day
Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy

This study will examine the clinical effectiveness of Tafamidis in patients with Mixed Phenotype Transthyretin Amyloidosis using data that already exist in patients' medical records


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at diagnosis.
* Diagnosed with ATTRv-CM or ATTRwt-CM, mixed phenotype.
* Treated with tafamidis, as VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily for ≥12 months or started on tafamidis 20 mg then switched to VYNDAMAX 61 mg for ≥12 months
* Have had ≥1 pre- and ≥1 post-treatment neurologic assessments.

Exclusion Criteria:

* History of any organ transplant.
* Individuals who are non-ambulatory.
* Prior or current treatment with any disease-modifying therapy (investigational or approved) alone or in combination, except tafamidis, as VYNDAQEL 80 mg \[four 20-mg tafamidis meglumine capsules\] orally once daily or VYNDAMAX 61 mg \[one 61-mg tafamidis capsule\] orally once daily.
* Peripheral neuropathy attributed to causes other than ATTR amyloidosis (eg, diabetes mellitus, B12 deficiency, hypothyroidism, shingles,Lyme disease, HIV infection, secondary to injury, chronic kidney disease).
* Patient's data fails to pass data quality checks.
Bone Marrow Clot for Posterior Lumbar Fusion

Bone marrow aspirate (BMA) in association to graft substitutes has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, BMA use is limited by the absence of a standardized technique, of a physical texture and by the possibility of dispersion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. A prospective pilot clinical study designed to assessing the safety and efficacy of autologous vertebral BMA (vBMA) clot as multifunctional bio-scaffold in instrumental posterior lumbar fusion will be performed.


Eligibility Criteria:
Inclusion Criteria:

* patients over the age of 18 at the time of surgery
* symptomatic degenerative spine disease needing posterior fusion at the lumbar tract

Exclusion Criteria:

* any form of local or systemic infections, inflammatory or autoimmune disease
* coagulation disorders
* tumor diseases
* alcohol or drug abuse
* pregnancy
* chemotherapeutic drugs that might interfere with bone regeneration processes
* revision surgery
Evaluation of Electronic Prescribing in Hospital Ambulatory Care Clinics

All reliably evaluated POE systems to date have been desktop computer based, but now there is widespread use and acceptance among physicians of PDA devices for a variety of purposes. Clinicians report that drug information on a PDA improved their access to information and efficiency while reducing their self perceived error rates6. The use of these devices for information retrieval in clinical settings is expected to grow as wireless communication becomes more ubiquitous and as more applications become available6,7. During the past decade there has been a growing awareness of several issues aimed at promoting safer health care for our patients - point of care information technology is one of the keys.

To this end we have worked with a Canadian company, Drugmagnet, to develop and implement PDA-based electronic prescribing system within a major Canadian academic health centre. This is a cluster randomised trial, in which access to and use of the e-prescribing system is switched on and off for randomly chosen weeks, thus time serves as the randomized element.


Eligibility Criteria:
Inclusion Criteria:

* active staff physician at Sunnybrook \& Women's College HSC

Exclusion Criteria:

* inadequate prescribing practice (minimum number)
SNV1521 in Participants with Advanced Solid Tumors

This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.


Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumor malignancy
* Evaluable or Measurable disease (RECIST 1.1 Criteria).
* ECOG Performance Status 0 or 1.
* Life expectancy \> 3 months

Exclusion Criteria:

* History of other malignancy within the past 2 years
* Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
* Significant cardiovascular disease within 6 months
* Significant gastrointestinal disease
* HIV infection with a CD4+ T-cell count \< 200 cells/μL and/or a detectable viral load
* Liver dysfunction
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.

This is a prospective, interventional, double-blinded placebo-controlled study of up to 40 participants to evaluate the effect of a botanical formulation on inflammatory biomarkers and epigenetic age.

The objective of this study is to understand the impact of a multi-botanical formulation on measurements of protein markers, with a focus on inflammation over a 60-day period. The primary objective of this study is to assess the effect of the formulation, LLP-01, on inflammatory proteomic biomarkers and epigenetic changes. Adverse events will be self-monitored by participants and will be reported. Changes in weight/calculated BMI and grip strength, as well as changes in well-being through a self-reported questionnaire will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Age: 50-75 years of age
* Any sex / gender
* All ethnicities
* Able to participate in a 2 month trial
* Able to provide informed consent
* Participant must be able to comply with treatment plan and laboratory tests
* Can swallow 00 size capsules

Exclusion Criteria:

* Any clinically diagnosed medical disease or disorder that requires prescribed medication(s)
* Currently on any anticoagulant medicines, such as warfarin
* Planned surgical procedure during study period
* Consumption of any supplements within the last 30 days that include the following botanicals/ingredients: green tea extract, Ashwagandha, Fisetin, Curcumin/Turmeric extract, Rosemary extract, Cordyceps, Ginseng
* Allergy or other sensitivity to any of the botanicals in the investigated product
* Currently or have been sick (bacterial or viral infection) in the last 14 days
* Alcoholism or drug addiction
* Participation in a clinical research trial within 30 days prior to enrollment in this trial
* Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent
* Unable or unwilling to provide required blood sample for testing and for use in a scientific publication (personal information undisclosed)
* Participants with any condition that may preclude venipuncture/ venous blood draw
Hidden Slow Conduction Ablation for Recurrent Atrial Fibrillation: Unmasking the Arrhythmogenic Substrate (Unmask-AF)

Over recent years, pulmonary vein isolation (PVI) procedures have demonstrated progressively enhanced efficacy and safety, resulting in a substantial increase in the number of atrial fibrillation ablations, not only as a first-line treatment but also for repeat procedures. However, there is still a notable lack of randomized evidence in this area, which limits guidance and decision-making in clinical practice. Recently, the investigators found that employing short-coupled atrial extrastimuli revealed highly fragmented or double atrial evoked electrograms (EGMs) in AF patients, termed as hidden slow conduction (HSC). Identifying HSC sites may provide insight into the early identification of the arrhythmogenic substrate, offering a potential target for ablation This multi-center, prospective, randomized, controlled trial will include two arms: one investigational (PV reconnection + HSC) and one control (PV reconnection). All the subjects will be followed for 12 months after the ablation procedure.

The aim of our study is to investigate the impact of ablating HSC sites on arrhythmia recurrence in repeat ablation procedures. The hypothesis is that the additional ablation of HSC zones may improve the freedom from atrial arrhythmia recurrence after repeat ablation procedure.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent paroxysmal AF (continuous AF episode lasting longer than 30 s but terminating spontaneously or with intervention within 7 days of onset), recurrent persistent AF (continuous AF episode lasting longer than 7 days but \< 1 year) and recurrent long standing persistent AF (continuous AF ≥1 year in duration, in patients where rhythm control management is being pursued)
* Previous PVI procedure
* Age \> 40 years
* Willing and capable of providing consent
* Able and willing to comply with all follow-up testing and requirements

Exclusion Criteria:

* Additional left atrial ablations during the previous procedures (es. posterior wall isolation, anterior line, roof line, CFAE and others)
* Acute illness, active systemic infection, or sepsis
* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
* Severe mitral regurgitation
* Women who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
Brimonidine Eye Drops for Treatment of Ocular Graft-vs-Host Disease (oGVHD)

The objective of this study is to establish whether patients with dry eye disease (DED) are able to tolerate receiving Brimonidine: 0.15% eye drops two times a day for twelve weeks (primary tolerability objective) and to investigate the preliminary efficacy of Brimonidine 0.15% topical eye drop solution in treating Meibomian Gland Dysfunction (MGD) (primary efficacy objective).

Meibomian Gland dysfunction can happen with numerous conditions such as Rosacea, Sjögren's syndrome, and oGVHD. In order to limit the influence of differing etiologies on the outcome of this trial, the investigator has limited the screening to MGD that accompanies oGVHD.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older.
2. Capable of giving informed consent and does provide informed consent.
3. Diagnosis of Meibomian Gland Disease
4. Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 7 days of the participant receiving first dose of study drug along with definite evidence of contraceptive use during the duration of the study. Women of reproductive age should use a method of birth control that is acceptable to the participant and the study doctor. This may include oral contraceptive pills, birth control implants, barrier methods or abstinence. If a participant suspects pregnancy after being enrolled, another pregnancy test will be administered. If the test is positive, the participant will be discontinued from the study immediately.

Exclusion Criteria:

1. Allergic to Brimonidine or any similar products, or excipients of Brimonidine
2. Currently receiving any Brimonidine preparation as a part of glaucoma management
3. Receiving or have received within 30 days any experimental systemic medication.
4. Active ocular infection or ocular allergies.
5. Any history of eyelid surgery or ocular surgery within the past 3 months.
6. Corneal epithelial defect larger than 1 mm2 in either eye.
7. Have active drug/alcohol dependence or abuse history.
8. Vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.
Studies of Neuroendocrine and Energy Metabolism in Patients With Eating Disorders

This study aims to investigate neuroendocrine, autonomic functioning, and energy metabolism in patients with eating disorder and their relationships with psychopathology of eating disorders (eating patterns, depression, and personality) in these patients.

The study subjects include female patients with DSM-IV diagnosis of AN (n = 30), BN (n = 60) and age-controled normal subjects (n = 30). They will receive a clinical interview and are asked to complete several self-administered questionnaires which included eating-related questionnaires, general psychological functioning scales and personality scales. After overnight fast, each subject undergoes a blood sample collection for neuroendocrine examination, body composition examination using BIA method, basal metabolic rate measurement by indirect calorimetry, and ECG in the morning between 0800 and 0900. Clinical patients would be asked to repeat filling the self-rating scales, weight and body fat measurement, as well as blood drawing again 2 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who fulfilled DSM-IV diagnosis of anorexia nervosa or bulimia nervosa
* Normal controls

Exclusion Criteria:

* Any major psychiatric disorders
* Use of psychoactive medications
* Drug and alcohol abuse
* Medical problems (cardiovascular condition and endocrine disorders)
Observational Study for the Cytofluorimetric Analysis of Cerebrospinal Fluid in Non-Hodgkin's Lymphoma Patients

The purpose of this study is to define if flow cytometry has more sensitivity for detecting neoplastic cells in cerebrospinal fluid versus conventional cytology.

Aggressive B-cell non-Hodgkin's lymphoma (B-NHL), Lymphoblastic Lymphoma and Burkitt's Lymphoma are at high risk of CNS relapse. For this reason is recommended a prophylaxis therapy. This suggests that negative leptomeningeal localization patients at diagnosis are really positive and that would be a very high risk of CNS relapse subtype patients. It's very important detecting neoplastic cells in cerebrospinal fluid as soon as possible. This study will evaluate only patients that have been flow cytometry and cytology at diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of

   * Diffuse large cell lymphoma HIV positive,
   * Lymphoblastic lymphoma,
   * Burkitt's lymphoma,
   * Mantle cell lymphoma blastoid type.
2. DLCL patients who presented one risk factor for leptomeningeal involvement as:

   * testis, bone marrow, orbit, palate, paranasal cavity or peridural disease localization,
   * 2-3 age-adjusted IPI score with more than 1 extranodal site and LDH \> normal.
3. Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis.

Exclusion Criteria:

1. Patients with clinical or strumental evidence of meningeal localization disease.
Sex Hormone and Vascular Function in Women With CKD

The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in the field of nephrology focuses on male patients, and studies on women's vascular health are limited. Moreover, endogenous sex hormones, particularly estradiol, are well-documented to be cardioprotective in women without CKD; however, the role of sex hormones on vascular function in women with CKD remains unclear. The goals of the proposed project are: 1) to evaluate vasuclar function in pre- and post-menopausal women with CKD vs. age-matched healthy women; 2) to evaluate sex hormone concentrations and determine whether they associate with vascular function in the proposed cohort; and 3) to gain mechanistic insight on the association between sex hormones and vascular dysfunction in the proposed cohort.


Eligibility Criteria:
Inclusion Criteria:

1. Pre- (18-44 y) and post-menopausal (55-75 y) women
2. Individuals with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation AND/OR urinary albumin-creatinine ratio (UACR) ≥ 30.
3. Controls must be healthy (free from hypertension, kidney disease, cardiovascular disease, diabetes, and other chronic disease as assessed by self-report, medical history, and screening labs). Premenopausal healthy women must have a regular menstrual cycle (25-35 d).

Exclusion Criteria:

1. Perimenopausal (45-54 y) women
2. Pregnancy, lactation, or less than one year post-partum
3. Use of hormonal birth control methods, hormone replacement therapy, or a levonorgestrel intrauterine device (IUD) insertion for a duration less than 6 months
4. Advanced CKD requiring dialysis
5. History of kidney transplant
6. Use of immunosuppressant medications (unless taking a stable dosage for a quiescent disease in CKD group)
7. Antioxidant and/or omega-3 fatty acid use within the 2 weeks prior to testing
8. Current tobacco or nicotine use or history of use in the last 12 months
9. Marijuana use within 2 weeks prior to testing
10. Uncontrolled hypertension in CKD group (BP \>140/90 mmHg)
11. Atrial fibrillation
12. Active infection or antibiotic therapy
13. Hospitalization in the last month
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma

AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.


Eligibility Criteria:
Inclusion Criteria:

* Inoperable cancer of the pancreas.
* Blood cell counts and blood chemistries in or near normal range.
* Able to perform the activities of daily living.
* A projected life expectancy of at least 2 months.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No current other drug therapy for the cancer or steroid therapy.
* Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.

Exclusion Criteria:

* Prior chemotherapy for metastatic disease.
* Brain metastases