cyrilzakka/clinical-trials huggingface dataset:
Tolerance and Utilization of Agave Inulin in Healthy Adults

The objective of this study is to assess the tolerance and utilization of agave inulin. This will be accomplished through analyses of breath and fecal samples to quantify fermentation end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial populations will also be measured in fecal samples.

The objective of this study is to assess the tolerance and utilization of agave inulin. This will be accomplished through analyses of breath and fecal samples to quantify fermentation end-products- hydrogen, carbon dioxide, and methane will be measured in the breath, and short-chain fatty acids, ammonia, phenol, and indole will be measured in feces. Microbial populations will also be measured in fecal samples.

Eligibility Criteria:
Inclusion Criteria:

* have body mass index (BMI) between 18.5 and 29.5 kg/m2
* free of metabolic and gastrointestinal diseases

Exclusion Criteria:

* BMI less than 18.5 or greater than 29.5 kg/m2
* presence of metabolic and gastrointestinal diseases
* pregnant or lactating
* taking medications that impact bowel function
Lexiscan(TM) Rb-82 Myocardial Perfusion PET: A Comparison With Dipyridamole Stress

Lexiscan(TM) has ideal properties for Rb-82 PET imaging and the stress response it invokes may offer multiple advantages for the diagnosis of coronary disease and functional abnormalities. The goal of this investigation is to establish quantitative equivalence of Lexiscan(TM) rest/stress Rb-82 PET images to dipyridamole rest/stress images.


Eligibility Criteria:
Inclusion Criteria:

* BMI \<35
* No intervention or change in management between dipyridamole and Lexiscan(TM) PET

Exclusion Criteria:

* BMI \>35
* An intervention or change in management between dipyridamole and Lexiscan(TM) PET
Assessing Repeatability and Intra-individual Variability in [O15]H2O-PET Myocardial Perfusion Imaging

This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI.

Myocardial perfusion imaging (MPI) using \[O15\]H2O-PET-CT represents a validated technique for quantitatively assessing myocardial blood flow (MBF) and myocardial flow reserve (MFR).

With advancements in scanner and software technology, it is now possible to accurately quantify both global and regional MBF in clinical PET-MPI studies. Reduced stress MBF or MFR, as determined by \[O15\]H2O-PET-MPI, is a reliable indicator for detecting hemodynamically significant coronary artery stenosis. Additionally, MBF and MFR offer valuable prognostic insights into mortality and the risk of myocardial infarction. Clinical experience suggests that implementing \[O15\]H2O-PET-MPI for coronary artery disease evaluation is not only feasible but also aids in making informed decisions regarding revascularization.

This study wish to assess the reproducibility of baseline and hyperemic myocardial blood flow as well as myocardial blood flow reserve measurements with \[O15\]H2O-PET-MPI.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 50 years of age referred for \[O15\]H2O-PET-MPI by the dept. of cardiology on clinical indication with symptoms suggestive of myocardial ischemia, primarily angina.
* Willing to repeat the \[O15\]H2O-PET-MPI
* Normal left ventricular ejection fraction (EF \> 45), as assessed from recent (max 1 year old) echocardiography description in medical journal.

Exclusion Criteria:

* Cardiovascular event in between scans (defined as hospitalization for cardiovascular event).
* History of myocardial infarction
* Regional perfusion deficits on the primary \[O15\]H2O-PET-MPI clinically suspected as a sign of significant coronary stenosis.
* Unstable angina
* Severe Chronic Obstructive Pulmonary Disease (COPD)
* Severe asthma
* Claustrophobia
* Acute illness
* Significant language barrier, estimated by the investigator not being able to understand the study information sufficiently.
Teledermatology and Modulation of Antibiotic Dose in Acne Vulgaris

To see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris

The investigators are going to ascertain if antibiotic burden can be reduced with tele dermatology use.

There are two arms of the study:

1. Feedback group
2. Non feedback group

All subjects will be randomised to either group, all subjects will take photos of their face and answer questions at baseline, visit 2 (1 month), visit 3 (2 months), visit 4 (3 months).

The investigators will then use measurements of acne grading (patient grading, investigator global assessment, lesion counting, global acne grading) to reduce/taper antibiotics in the feedback group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 15 years and older
* Subjects who have been prescribed doxycycline or minocycline by their physician for acne vulgaris but have not initiated treatment yet.

Exclusion Criteria:

* Subjects who have used isotretinoin in the last 6 weeks
* Those who have used oral antibiotics within the last 4 weeks
* Those who have been initiated or changed brand of oral contraceptive pill within the last one month.
* Those subjects who cannot engage with the teledermatology platform
* Prisoners
* Adults unable to consent
Spinal Cord Injury Program in Exercise

The purpose of this study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with spinal cord injury. Enrolled participants will be randomized into one of three groups: a) M2M, b) SET, and c) attention control (AC).

The purpose of the Spinal Cord Injury Program in Exercise (SCIPE) study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with SCI. The primary aim is to examine change in physical activity level after the 8-week M2M and SET interventions. We hypothesize that participants in M2M and SET will have significant increase in physical activity compared to an Attention Control (AC) group after the 8-week intervention. The secondary aim is to examine effects of the M2M and SET interventions on health and quality of life outcomes. We hypothesize that participants in M2M and SET will have significant increases in sleep quality and quality of life and decreases in pain and fatigue compared to AC after the 8-week intervention. Exercise enjoyment in M2M and SET participants will also be explored. The tertiary aim is to evaluate the demographic (age, race, sex), clinical (level of injury, type of injury), and psychosocial (social support, outcome expectations, self-efficacy, self-regulation) variables of two participant groups: 1) compliant participants who completed ≥ 50% of the intervention, and 2) noncompliant participants who completed post-testing but \< 50% of the intervention or who did not complete post-testing.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with a SCI resulting in incomplete or complete (C5 and below) paraplegia or tetraplegia;
2. Demonstrate readiness to physical activity by completing the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
3. Obtain medical clearance if required by PAR-Q+;
4. Converse in and read English.

Exclusion Criteria:

1. No broadband internet access;
2. Significant visual impairment that prevents seeing a computer screen to follow a home exercise program;
3. Currently pregnant.
The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.

The study will be carried on children undergoing lower abdominal surgeries. Patients will be randomly categorized into two study groups. Group A will include patients who will receive bupivacaine intrathecal injection without adjuvant. Group B will include patients who will receive bupivacaine and preservative-free midazolam.


Eligibility Criteria:
Inclusion Criteria:

* All children aged 3-12 years, assigned for lower abdominal and pelvic surgeries and will be ASA grade I after obtaining written fully informed parental consent.

Exclusion Criteria:

* Patients with congenital anomalies especially of the spine, infections in the skin of the back, had coagulopathy, or allergy to the study drugs and those whose parents refused to give the consent .
Comparison of Intubation Rate of Macintosh Size 2 and 3 Blades in Asian Female: a Randomised Controlled Trial

Direct laryngoscope is a standard equipment for endotracheal intubation. To identify the differences between Macintosh size 3 and 2 blades, we will analysis the data collected from airway and intubation condition.

Selection the most appropriate size of laryngoscope blade size could not only increased intubation successful rate at the first time but also decrease the incidence of tissue trauma. Laryngoscope blade used in daily practice is usually Macintosh 3. However, compared with Caucasian people, Asian people are smaller and thinner especially in women. This study aims to confirm that the Macintosh 2 blade is not inferior to size 3 blade in laryngeal view and intubation rate.

Female patients without known difficult airway will be enrolled and allocated into Macintosh blade size 2 and size 3 groups. The age, body weight, body height, Mallampati classification, mouth opening, thyromental distance, neck circumference, intubation time, Cormack-Lehane grade, intubation difficulty scale scores and associated teeth or tissue traumas will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* with American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3
* undergo elective surgery
* receive endotracheal intubation

Exclusion Criteria:

* with known difficult airway (i.e. pathology of the neck, upper airway or alimentary tracts)
* with risks of pulmonary aspiration (i.e. emergent operation, pregnancy or inadequate nil per os)
* with previous difficult intubation history
* intubation attempts more than three times
* patient refusal
Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy

The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.

After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.

Eligibility Criteria:
Inclusion Criteria:

- Elective admission for laparoscopic cholecystectomy

Exclusion Criteria:

* Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
* previous GI surgeries, except bariatric and anti-reflux surgeries
* Currently on immunosuppressant agents
* Pregnancy
* Breastfeeding
* Currently diagnosed with drug addiction
* American Society of Anesthesiologists (ASA) score 3 and more
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors

This is a first-in-human (FIH), phase 1/2, multi center, open-label, dose escalation and cohort expansion study designed to determine the safety and tolerability of PRS-344/S095012 in patients with advanced and/or metastatic solid tumors.

The trial is an open-label, multi-center safety trial of PRS-344/S095012. The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2)). The expansion part of the trial will be initiated once the optimal biological dose (OBD) has been determined.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years on the day the consent is signed.
2. Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
3. Patient should have a documented disease progression on prior therapy before entry into this study.
4. Patients must have at least one measurable target lesion as per RECIST 1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Patient with no available archived material must have one or more tumor lesions amenable to biopsy.
7. Adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab.
8. A female patient must use a highly effective method of birth control during study treatment and for 120 days after last dose of PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest.

Exclusion Criteria:

1. Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid \<10 mg/day prednisone or equivalent) is allowed.
2. Patients who have received prior:

   1. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
   2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter.
   3. Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter.
3. Patients who have received 4-1BB agonists in the past.
4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.
5. History of progressive multifocal leukoencephalopathy.
6. Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients

Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. The study aim to investigate the possible effects of ketogenic diet on intra- and peri-operative complications of right laparoscopic adrenalectomy in obese patients; researchers will analyze intra- and peri-operative outcomes among obese patients who underwent laparoscopic right adrenalectomy, comparing the two arms with and without ketogenic diet.

Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. Due to a standard trans abdominal laparoscopic right adrenalectomy is performed with the patient in left lateral position, it is necessary to retract liver in order to expose the right adrenal gland and the cava vein. It is therefore evident how a reduced size liver may allow a faster, easier and safer surgery. Finding a normal size liver is uncommon in patients presenting with a body mass index above 30 Kg/m2. According to this, patients scheduled to right laparoscopic adrenalectomy and belonging to the case arm, will be administered a standard 21 days ketogenic diet before surgery. Conversely this will not be prescribed to patients belonging to control group. Ketogenic diet is based on a standard diet plus a ketogenic product to be taken once daily for 21 days. In both groups patients will undergo abdominal ultrasound before surgery.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 Kg/m2
* Planned for laparoscopic right adrenalectomy
* Age \> 18y.o.
* No contraindications for ketogenic diet

Exclusion Criteria:

* Diabetes
* Patients requiring conversion to open surgery
* BMI \< 30 Kg/m2
* Age \< 18 y.o.
Primary Care Audit of Global Risk Management

1. Assessing the perception of Canadian Primary Care Physicians towards global cardiovascular risk assessment.
2. Correlating physician perceptions to actual practice data, gathered via a retrospective chart audit.
3. Evaluating the impact of a prospective educational and peer-practice pattern intervention on future assessment o cardiovascular risk and
4. Assessing the role of carotid atherosclerosis assessment(Carotid IMT and plaque) as an adjunct to global risk prediction.

The majority of cardiovascular events occur in people with low to intermediate Framingham Risk Score. Despite evidence-based guidelines, the appropriate use of lipid-lowering therapies in this population remains limited and controversial. Strategies to refine risk stratification in primary prevention have been poorly adopted. Dissemination of practice-changing trials and closing the care gap in primary care remain a priority and a challenge. Considerable confusion remains regarding the optimal application of lipid-lowering therapy in primary prevention. Importantly, it remains largely unknown which tools or techniques are used by Canadian primary care physicians to identify global vascular risk, and what barriers exist to implementing risk reduction therapies in such individuals.

For primary prevention of patients with normal levels of LDL-Cholesterol who are at increased risk on the basis of elevated hsCRP, it remains unproven whether statin therapy will effectively reduce vascular event rates. The JUPITER trial was launched in 2003 comparing rosuvastatin with placebo in 18,000 primary prevention patients with LDL-cholesterol of less than 3.36mM who also have an hsCRP of greater than 2 mg/L. This trial has been stopped early due to unequivocal morbidity and mortality benefits in favor of the treatment strategy, and the final results will be available in early November, 2008. JUPITER, once published, will require a major change in physician behavior with respect to screening and treating cardiovascular risk.

Eligibility Criteria:
Inclusion Criteria:

1. Men more than or equal to 40 yrs old and women more than or equal to 50 yrs old;
2. No previous history of atherosclerosis( angina, TIA, myocardial infarction, stroke, peripheral arterial disease);
3. Non-diabetic;
4. Absence of lipid lowering treatment (current or past).

Exclusion Criteria:

1. Known history of atherosclerosis or diabetes;
2. Use of lipid lowering therapies (statins, ezetimibe, fibrates, niacin, fish oil);
3. Use of postmenopausal hormone replacement therapy;
4. Use of immunosuppressant's or steroids;
5. Active liver disease or hepatic dysfunction(ALT\>2times the ULN);
6. Active renal disease (baseline Creatinine \>170 umol/L);
7. History of malignancy within the past 5-years;
8. Chronic inflammatory conditions such as arthritis, lupus or inflammatory bowel disease;
9. Known alcohol or drug abuse;
10. Failure to provide informed consent.
Early Prevention of Conduct Problems

The purpose of this study is to examine the immediate and long-term effects of a prevention program in children at risk for developing conduct problems and antisocial behavior.

Participants are randomly assigned to a year-long family-based intervention or to a no contact control group. The intervention focuses on improving parenting practices, parent-child interactions, and child social competence.

Children are assessed at the beginning of the study and again after one year. The development of conduct problems, social competence, and school functioning is assessed from second through fifth grade. Assessments are made through observations, parent and teacher ratings, and diagnostic interviews.

Eligibility Criteria:
Inclusion Criteria:

* Sibling of youth adjudicated in Family Court
Timing of Start of systemIc Treatment for Asymptomatic Metastasized Pancreatic Cancer

Since patients with metastatic pancreatic cancer have a limited life expectancy, it is important to determine the timing of when to start chemotherapy in order to optimize the benefits of chemotherapy relative to the side effects. Therefore, two treatment strategies can be considered: chemotherapy started immediately at diagnosis, or delayed until disease-related symptoms occur.


Eligibility Criteria:
Inclusion Criteria:

* Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
* Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
* Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
* Eastern Cooperative Oncology Group Performance Status of 0-1
* Life expectancy ≥ 3 months.
* Age ≥ 18 years.
* A negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential.
* Screening clinical laboratory values as follows:

  1. Absolute neutrophil count \> 1.5 x 109 /L
  2. Total bilirubin ≤ 1.5 times upper limit of normal (ULN).
  3. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed).
  4. Serum creatinine \< 1.5 x ULN or creatinine clearance \>50 mL/min/1.73 m2
  5. Prothrombin time/international normalized ratio within normal limits (± 15%) or within therapeutic range if subject takes warfarin. Partial thromboplastin time (PTT) within normal limits (± 15%).
  6. Platelet count \> 100,000 x 109 /L
* No symptoms related to advanced disease, specified as:

  1. no pain requiring regular narcotic analgesics;
  2. no weight loss over 5 kg (unless related to surgery or other illness);
  3. no persistent nausea requiring medication;
  4. no obstructive bowel symptoms;
  5. no persistent fever related to metastatic cancer;
  6. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer.
* No prior chemotherapy for metastatic disease (patients might have received adjuvant treatment more than 6 months before the development of metastatic disease, or neoadjuvant treatment before surgery for resectable disease)

Exclusion Criteria:

* Known central nervous system involvement or brain metastases.
* New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months
* Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
* Inability to comply with study and follow-up procedures as judged by the Investigator.
* Women currently pregnant or breastfeeding.
Impact of Using an Hemodynamic Monitoring System on Anesthetic Consumption During Abdominal Surgery

In this study investigators will study the association between the use of an hemodynamic monitoring system and the anesthetic consumption in patients following major abdominal surgery. Investigators will randomise patients for a control group and an intervention group. Patients belonging to intervention group will be monitored with a non-invasively continue system (Acumen IQ cuff sensor), while the control group will be monitored with a non-invasive intermittent pressure system. The total amount of mL of Sevoflurane will be registered in both groups and the difference will be considered as the aim of our study


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* signature of informed medical consent

Exclusion Criteria:

* BMI\> 30
* eGFR\<30
* NYHA III-IV
* severe cardiac valvular diseases
* absence of informed medical consent