cyrilzakka/clinical-trials huggingface dataset:
Safety of Lumiracoxib in Patients With Osteoarthritis

This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator


Eligibility Criteria:
Inclusion Criteria:

* Age \>=50 years old
* Primary osteoarthritis in hip, hand, knee or spine for at least 3 month
* Pain in the target joint of moderate intensity
* Written informed consent

Exclusion Criteria:

* Secondary osteoarthritis
* Active upper gastro intestinal tract ulceration
* Inflammatory joint disease
* Gout
* Clinically significant hepatic or renal disease

Other in and exclusion criteria may apply
Total Tumor Mapping (TTM) for Resectable Pancreatic Cancer

At present there is no validated prognostic tool for patients with resectable pancreatic cancer (RPC) to determine how best to tailor individual therapy. This study is to see if tumor features in blood and imaging prior to surgery correspond with tumor heterogeneity in the specimen after surgery.

This study is to prospectively determine whether there is a predictive relationship in RPC between pre-operative radiomic imaging features and pathologic tumor heterogeneity, delineated by gene-expression-based RSI and histologic measures of hypoxia measured by Glut-1 and CA-IX as well as the degree of pimonidazole staining.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older who have biopsy-proven resectable pancreatic cancer
* Participants must have a histological diagnosis of pancreatic head ductal adenocarcinoma at least ≥ 1 cm from ampula.
* Participants must be able to undergo all 3 imaging modalities.
* Participants' medical statuses must be considered appropriate for surgery and for general anesthesia.
* Female participants and female partners of male participants undergoing optional PET-CT or CT pancreatic protocol scan cannot be pregnant or nursing, as confirmed by serum pregnancy test if the patient is a woman of child-bearing potential.
* All female participants of child-bearing potential must agree to use birth control, including oral, injectable, or mechanical contraception, abstinence, or vasectomy for 30 days following pimonidazole administration.
* Adequate kidney and liver function as assessed by laboratory studies. Laboratory studies must be completed within 28 days prior to pimonidazole administration;
* Must be capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visits;
* Must be able to undergo MRI scans without having a pacemaker or other indwelling metal, which would contraindicate the scan.
* Have an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Participants who are contraindicated for MRI or gadolinium contrast agents.
* If the patient has an iodine contrast allergy, they must be able to take standard pre-medications so they can safely undergo a CT scan.
* Participants with a known active cancer with a prognosis that would contraindicate a curative intent pancreatic resection.
* Participants with depressed liver function, as assessed with a screening liver function test yielding serum ALT or AST greater than the IULN or total bilirubin greater than 2 mg/dL.
* Presence of any other co-existing condition, which, in the judgment of the investigator, might increase the risk to the patient.
Multidisciplinary Integrated Platform for a Technological Innvovative Approach to Oncotherapies

This is multicentric, observational, and retro- prospective study.

The project aims to develop a regional platform for innovative disease treatment oncology. In particular, an integrated platform will be created with several complementary skills among them, which have as their common objective to increase knowledge and the possibilities of surgery for certain types of cancer.

The actions implemented in this project will be as follows:

* Improvement of primary and secondary prevention strategies with precocious diagnostic devices;
* Optimization of therapeutic treatments by custom drawing of the scheme therapeutic;
* Improved therapeutic efficacy for high social impact resistant neoplasms development of innovative treatments such as personalized therapeutic vaccines and small molecules;
* Improving patient compliance and quality of life accompanied by less need of hospitalization of the patient himself with consequent decongestion of hospital admissions;
* Reduction of health costs as a result of early diagnosis and new therapies more effective and less invasive;
* Increasing regional health and technological attractiveness in a high bio-medical sector social and health impact.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any of the following diseases:

  1. breast cancer;
  2. melanoma;
  3. hepatocarcinoma;
  4. gynecological cancer;
  5. colorectal cancer;
  6. lung cancer.
  7. sarcoma;
  8. pancreatic tumor;
  9. tumor of endocrine glands (thyroid);
  10. digestive system tumor (classifying rare ones);
  11. urological and/or male genital tumor (classifying rare ones);
  12. female genital tumor (classifying rare ones);
  13. rare skin tumor;
* Signature of the informed consent for the study.
* Age 18 years
* Biological material leftover from biopsy or surgery, and the residual to the activities of clinical assistance analysis.
* No ongoing treatment for oncological diseases at the time of collection.

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for the present study:

* Patients aged \< 18 years;
* Patients who have not signed the informed consent;
* Positive history of previous neoplasms (only for "naive" patients);
* Positive history of synchronous/metachronous oncological pathologies different from those specified for recruitment (only for "naive" patients);
* Ongoing immunosuppressive therapy (only for "naive" patients).
Estimation of Pain During Epidural Analgesia During Labor

Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.

Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).

The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.

There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).


Eligibility Criteria:
Inclusion Criteria:

* Obstetrical Labor
* Able to rate their pain using VAS
* dilatation of the cervix under 6 centimeters
* Written consent

Exclusion Criteria:

* - Not having a anesthesia consultation during the 48 hours before delivery
* With a contra-indication for an epidural
* To which an incident occurred during a previous epidural using a medication used in the study
* Operated a unilateral or bilateral ocular surgery modifying the possibilities of variation of pupil diameter
* general anesthesia in the seven days preceding delivery
* Carry a pacemaker or heart grafted
* Having Parkinson's disease history, insulin or non-insulin diabetes or chronic alcoholism
* Having cardiac arrhythmia (atrial fibrillation or frequent extrasystoles)
* Treated for hypertension by receptor antagonists of angiotensin type 2
* anti-arrhythmic treatment or blocker,
* Refusing to participate in the study
* With a contra-indication for the use of ropivacaine and sufentanil.
Flax Lignans and Heart Health

Purpose: To demonstrate the efficacy of Beneflax™ flaxseed lignan (SDG) concentrate to lower serum cholesterol levels.

Background: Flaxseed has been studied for various health benefits in humans, including prostate health, glucose control, and cardiovascular health. Cholesterol levels and high blood pressure are known to be risk factors for cardiovascular disease. Whole flaxseed has had variable effects on serum lipid levels, perhaps a consequence of variations in the amounts of secoisolariciresinol diglucoside (SDG) found in different flax cultivars, making the study of this bioactive compound difficult.

Hypothesis: Flaxseed lignan (SDG) extract (Beneflax) significantly lowers total and LDL cholesterol. Flaxseed lignans also lower blood pressure and fasting glucose levels.


Eligibility Criteria:
Inclusion Criteria:

* Men, 40-65 yrs/old, postmenopausal women 50-65 yrs/old not \> 5 yrs post menopause. All subjects were hypercholesterolemic with either total cholesterol \>240 mg/dl and \< 320 mg/dL or LDL cholesterol \>140 mg/dl and \<190 mg/dl at the screening visit.

Exclusion Criteria:

* Excluded subjects included diabetics, people being actively treated with niacins, fibrates, statins, insulin, ACE inhibitors or other cholesterol/ blood pressure pharmaceutical treatments, people who consumed large amounts of soy, flax, rye breads, pumpkin seeds, hydrolyzed milk products, sterols, and/or berries (strawberries/blueberries) or supplements aimed at cholesterol reduction such as spruce lignans, sytrinol (poly methoxylated flavanols), polycosinols, people consuming flaxseed on a regular basis.
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury

To determine whether functional electrical stimulation (FES) promotes neurological and physical recovery in patients with spinal cord injury (SCI).

The researchers will investigate the extent of functional recovery in patients with spinal cord injury who receive functional electrical stimulation in the upper extremities compared with patients who do not receive FES.

A randomized, controlled, single-blinded, in-subject controlled (A-B type) trial will be performed in patients with SCI receiving an upper extremities non-FES assisted exercise protocol compared with patients receiving upper extremities ergometry in combination with FES. Neurological and functional outcome measures will be obtained at baseline (time 0), after 1st 4 months of intervention (4 months), after 1 month washout (5 months),after 2nd 4 months intervention (9 months), and 3 month after completing the last intervention (12 months).

Eligibility Criteria:
Inclusion Criteria:

* Male, Female, age 18-55, all ethnic groups
* Spinal Cord Injury, traumatic and non-traumatic
* C1-C6 neurological level
* ASIA class A-B
* Chronic injury \> 12 months and \< 20 years from the injury
* No upper-extremity electrical stimulation in the previous 4 weeks
* Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
* Baseline physical activity is kept stable
* Pain and antispasticity medications dose are kept stable
* Subjects are legally able to make their own health care decisions

Exclusion Criteria:

* Associated lower motor neuron/peripheral nerve injury in the C1-C6 levels
* Presence of pacemaker
* Presence of cancer
* History of seizures
* Women who are pregnant
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.

This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female patients minimum 18 years of age
2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
3. Target lesion is 20mm in length (visual estimate);
4. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria:

1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
2. Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
3. Documented Left ventricular ejection fraction 25%;
4. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.

The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.

Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.


Eligibility Criteria:
Population:

All patients already scheduled for biopsy because of a raised Prostate-Specific Antigen (PSA) and/ or abnormal Digital Rectal Examination (DRE) in the Academic Medical Centre (AMC), excluding patients who do meet the exclusion criteria.

Inclusion criteria:

* age ≥ 18 years
* signed informed consent

Exclusion criteria:

* Has documented acute prostatitis or urinary tract infections.
* History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts.
* Has had severe cardiac rhythm disorders within the last 7 days.
* Has severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
* Has received a biopsy procedure within 30 days before admission into this study
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
* Is incapable of understanding the language in which the information for the patient is given.
Premedication by Clonidine Intranasal in Pediatric Surgery

There are few studies using intra nasal way to dispense premedication in pediatrics.

This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.

Two groups, randomized,

Total of 150 patients (75 in each group) :

Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)


Eligibility Criteria:
Inclusion Criteria:

1. Child from 1 to 5 years
2. Weight between 10 to 25 kgs
3. Scheduled minor surgery
4. Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s).
5. ASA score 1 or 2
6. Patient with social care insurance

Exclusion Criteria:

1. Refusal of one of the parental authority or legal representing
2. Concomitant participation to a clinical trial with use of a drug
3. Known hypersensitivity or contraindication to Clonidine or one of its excipients
4. Airway infection within 3 weeks before inclusion
5. Intravenous induction of anesthesia
6. Antecedent of arrhythmia or congenital heart disease
7. Mental disorder or current psychoactive medication
Detecting Diabetes Sooner With a Risk Survey for the Family Doctor:Comparing Internet and Traditional Methods of Communication for Patients and Doctors

This pilot RCT study aims to develop and evaluate the uptake, feasibility, and potential value of a strategy for web-diabetes risk assessment versus paper-based methods in an undiagnosed diabetes population over 40 years of age from all listed FHT provided through an electronic medical record database. Following randomization, intervention participants will have the option to decide to use web-based self-screening and the control group will receive only a paper-based method. There will be two options for web-based screening; one involves completion of the CAN-RISK screening tool as part of a personal health record self-management program (MyOscar) versus a one off online risk-assessment. The intervention and control group will be compared with respect to risk-assessment uptake. Educational sessions and further assessment of diabetes conducted by the clinical health care team will be offered to all participants who scored a high risk of diabetes in accordance with the CAN-RISK results. Actual numbers of diabetes cases in those with a high risk score will be compared between the intervention and control groups as well as compared to the usual method of diabetes screening in a randomly chosen non-identifiable sample from the same clinical setting in the same one year period. The assessment of patient acceptability in feasibility of the implementation of the self-screening tool will be accomplished through surveys designed to be completed by patients and staff.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 and over who did not have diagnosis of diabetes and no previous use of personal health record (MyOscar)

Exclusion Criteria:

* People with diabetes, and those who are already registered as MyOSCAR (personal e-health record) users
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia

To determine the effect of Pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia (TG ≥500 to ≤2000 mg/dL) after 26 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥22 years
* Willing to enter a medication/lifestyle stabilization period during the screening period, which means maintaining those stable medication, eating, and exercise habits for the duration of the study
* Subjects should be on stable background Lipid Modifying Therapy (LMT) to manage ASCVD for a minimum of 4 weeks prior to first qualifying TG

Exclusion Criteria:

* Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Uncontrolled or newly diagnosed (≤3 months since diagnosis) Type 2 diabetes mellitus as determined by the Principal Investigator. Subjects must have HbA1c level ≤9.5% at Screening. Medications for glucose management must be stable for at least 4 weeks prior to Screening
* Type 1 diabetes mellitus
* A history of symptomatic gallstone disease, gallstone pancreatitis (unless treated with cholecystectomy), or any other ongoing symptomatic biliary disease
* Acute pancreatitis within 6 months prior to Screening
* Subjects with chronic pancreatitis
* Known or suspected familial chylomicronemia syndrome (FCS) (Type 1 hyperlipoproteinemia)

Other inclusion and exclusion criteria may apply.
Digital Literacy Promotion

This study evaluates the effects of digital versus standard literacy promotion, as well as dialogic language behaviors and reading comprehension among infants when comparing the use of e-books to standard board books. Around half of the participants will receive standard board books at the 6, 9, and 12 month well visits, while the other half will receive digital e-books.

This study has three main objectives. The first is to test the effects of digital versus standard literacy promotion by way of a randomized controlled trial design. The second aim is to explore the reading behaviors and reading activities between parents and their infants when comparing the use of e-books to standard board books. The third aim is to identify themes regarding dialogical reading behaviors among parents participating in the video sub-study.

Participants will be stratified by clinic site and randomized to receive literacy promotion using 1) standard early reader board books or 2) digital electronic early reader e-books. We will recruit and consent one hundred eligible parent-infant dyads, with the infant being between 5 and 7 months of age at enrollment.

In this intervention, parent-infant dyads randomized to the digital arm will receive developmentally appropriate e-books. Those randomized to the standard arm will receive developmentally appropriate board books. Participants will receive either the e-book or board book at the time of their 6, 9 and 12 month well visits. In addition to the books, parent-infant dyads in both arms will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.

The main outcome will be differences in Bayley-3 Composite scores between groups. Secondary aims include differences in StimQ Reading Subscale Scores and Edinburgh Postnatal Depression Scale Scores between groups.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Parents ≥ 15 years of age at start of study
* Child born ≥ 35 weeks estimated gestational age
* Child 5 to 7 months
* Medicaid Insurance
* Access to a smart phone and/or tablet

Exclusion Criteria:

* Child has neurodevelopmental disabilities or congenital malformation
Air Purifier to Improve Endothelial Function and Carotid Intima Thickness

Background: There is epidemiological evidence or link ambient air pollution exposure to the incidence of dementia.

Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air purification improves endothelial function and carotid intima thickness in older diabetic people with cognitive impairment.

Subjects and method: People with clinically diagnosis mild cognitive impairment or early dementia will be recruited. After obtaining written consent, the subjects will be assessed cognitive function and arterial health. After baseline measurements, the subjects are randomly assigned to have either filter or no filter installed in the air purifier. The air purifier will be placed in living room of the household of the subject for one year. At one year, the measurements will be repeated.

Statistical analysis: Intention to treat analysis will be adopted.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic people
* Mild cognitive impairment or early dementia

Exclusion Criteria:

* Current smoker
* The presence of a smoker in the household
* The absence of a reliable family caregiver
* The lack of mental capacity to give informed consent