cyrilzakka/clinical-trials huggingface dataset:
Lentils as a Functional Food to Improve Glucose and Decrease Cardiovascular Risk

Compared to control foods, consumption of 3 cups of cooked lentils given weekly for 12 weeks will significantly improve glucose tolerance and lower LDL-cholesterol in individuals with high cholesterol and obesity.

This is a multi-site, randomized, controlled, parallel group food study designed to examine the health benefits, specifically glucose tolerance, insulin sensitivity and LDL-cholesterol in overweight individuals with a high waist circumference and elevated LDL-cholesterol. Recruitment will consist of approximately 102 overweight participants (n= 51 participants per site, at 2 sites located in Winnipeg and Toronto) with high waist circumference and elevated LDL-cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females aged 30 to 75 years;
* Body Mass Index of ≤40 kg/m2 and ≥23 kg/m2 if Asian or ≥25 kg/m2 if non-Asian;
* Waist circumference ≥94 cm for males and ≥80 cm for females of Asian ethnicity,and ≥102 cm for males and ≥88 cm of non-Asian ethnicity;
* Fasting plasma glucose \<7 mmol/L;
* Fasting triglycerides \<4.00 mmol/L and LDL-cholesterol \>2.50 mmol/L and \<5.00 mmol/L;
* Must be on a stable regime for the past 3 months if taking medications to treat hypertension or if taking vitamin and mineral/dietary/herbal supplements;
* Stable body weight (±3 kg) for the past 3 months

Exclusion Criteria:

* Previous diagnosis of type 2 diabetes;
* High pulse consumption (≥2 servings per week);
* Presence of liver disease (aspartate transaminase \>2 times Upper Normal Limit), renal insufficiency (creatinine \>1.5 times Upper Normal Limit); inflammatory bowel disease or other gastrointestinal disorders influencing gastrointestinal motility or nutrient absorption;
* Use of medication which influence carbohydrate metabolism (i.e., steroids), or medications used to treat diabetes or to lower blood lipids, or any active medical or surgical conditions within the past 3 months;
* Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;
* History of gastrointestinal reactions or allergies to lentils or potato-based foods, or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed.
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis.
* Age of the participant at the time of migraine onset \<50 years.

Exclusion Criteria:

* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine.
* Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy.
* History of an inadequate response to \>4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder

The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.

The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score =\> 30

Exclusion Criteria:

* Patient is at immediate risk for suicidal behavior
* Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
* Patients with a current depressive episode secondary to a general medical disorder
* Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
* Patients with severe or unstable concomitant medical conditions
* Pregnant, breastfeeding, or likely to become pregnant during the study
* Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram

The investigator will evaluate whether there are other reasons why a patient may not participate.
Pilot Study of New Computer-based Neuropsychological Tool: Visual Tests, Touch Responses

This study is aimed at investigating three new tests that will form part of a computerized tool designed to test brain/cognitive functioning. The system will be evaluated along with the tests' usability on samples of healthy controls and neurologically impaired patient participants. These new tests will be assessed with regard to reliability and validity. Reliability will be addressed through investigation of internal consistency of the test items. Validity will be evaluated relative to traditional paper-and-pencil tests and differentiation between patient and healthy participants.Each participant will complete both the computerized and paper and pencil-based tests. The results will be analyzed to see how performances on the two test types compare. The overall aim of this project is to determine if these new computerized tasks are an improvement over standard paper and pencil-based neuropsychological measures.


Eligibility Criteria:
Inclusion Criteria:

Individuals without positive cerebral findings on neuroimaging (Non-PCF)

* Participants can be male or female and between the ages of 21 and 65 years old.
* Participants will have adequate perceptual and motor capabilities to participate in testing.

Neuroimaging-positive cerebral findings (PCF)

* Patients at NYULMC identified to have significant cerebral findings on neuroimaging.
* Participants will be male or female and between the ages of 21 and 65 years old.
* Participants will have adequate perceptual and motor capabilities to participate in testing.

Exclusion Criteria:

* Participants without adequate perceptual and motor capacities preventing them from participation in the testing.
* Participants with severe dysfunction at the level of dementia that can interfere with informed consent.
Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery

for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.

For patients with Crohn's disease(CD), whether exclusive enteral nutrition(EEN) following bowel resection and anastomosis could delay the disease recurrence remains unkown. In this study， CD patients after surgery will be divided into two groups: one group is treated with 3 months' EEN and then turn to normal diet after 3 months; the other group is given with normal diet all through. All patients will be adminstrated with oral azathioprine after surgery. Then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

* patients who had administered with immunomodulators or biological agents patients who were created stoma
Study of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With Rivaroxaban

Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older.
* Patients with diagnosis of NVAF.
* Patients treated with rivaroxaban from at least six months prior to the study inclusion.
* Patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Patients who initiate treatment with rivaroxaban after the start of the study inclusion period.
* Prosthetic heart valves or the presence of any severe valvulopathies.
* Patients with severe cognitive impairment.
* Patients with chronic infections (HIV infection, hepatitis C virus, hepatitis B virus) or systemic autoimmune diseases.
* Patients with active cancer.
* Patients with liver insufficiency (eg. cirrhosis).
Coronary Sinus Reducer in Coronary Microvascular Disease

Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (CS). By augmenting CS pressure, CSR implantation was shown to improve myocardial perfusion, potentially providing a novel treatment for patients with CMD. REDUCE CMD is a placebo-controlled study of CSR in 50 patients with CMD. The main study endpoints are the change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm, and the difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.


Eligibility Criteria:
Inclusion Criteria:

1. Coronary microvascular dysfunction as expressed by abnormal absolute coronary flow reserve (CFR\<2.5) confirmed during the index study procedure using the continuous thermodilution technique and saline-induced coronary hyperemia.
2. No hemodynamically significant epicardial stenoses based on both non-hyperemic pressure ratio (NHPR; iFR\&gt;0.89, or RFR\&gt;0.89, or dFR\&gt;0.89) and fractional flow reserve (FFR\&gt;0.80) assessments.
3. Angina - Canadian Cardiovascular Society Class II-IV on maximal medical therapy.
4. Negative acetylcholine provocation testing with respect to epicardial or microvascular vasospasm (as such, patients with equivocal acetylcholine provocation test results are not eligible for enrolment).
5. Patient understands the nature of the procedure and provides written informed consent prior to enrolment.
6. Patient is willing to comply with specified follow-up evaluation.

Exclusion Criteria:

1. Age ≤ 40 years.
2. Pregnancy.
3. Recent acute coronary syndrome (within 3 months).
4. Recent revascularization with PCI (within 6 months).
5. Severe arrhythmias, including chronic atrial fibrillation.
6. Severe left ventricular impairment (left ventricular ejection fraction \&lt;25%).
7. Permanent pacemaker or defibrillator leads in the right ventricle or atrium.
8. Indication for cardiac resynchronization therapy.
9. Severe valvular heart disease.
10. History of tricuspid valve replacement or repair.
11. Mean right atrial pressure ≥15 mm Hg.
12. Known allergy to stainless steel or nickel.
13. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava).
14. CS diameter at the site of planned implantation greater than 13mm or less than 9.5mm as measured on the venogram.
15. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
16. Life expectancy \<1 year.
Study to Evaluate the Efficacy and Safety of Camrelizumab and Famitinib in Patients With Advanced Solid Tumor

This is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically- or cytologically-confirmed diagnosis of advanced solid tumor.
2. Willing to provide tumor tissue for PD-L1 biomarker analysis.
3. At least one measurable lesion according to RECIST 1.1.
4. ECOG performance status of 0 to 1.
5. Life expectancy of more than 12 weeks.
6. Signing the informed consent forms.
7. Adequate bone marrow, liver and renal function.

Exclusion Criteria:

1. Subjects with untreated central nervous system (CNS) metastases.
2. Subjects with an active, known or suspected autoimmune disease.
3. Subjects with clinically significant cardiovascular and cerebrovascular diseases.
4. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
5. Subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
6. Subjects with arterial / venous thrombosis events occurred within 6 months of the first dose.
7. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
Effect of Calcium Silicate-Based Root Canal Medicament After Retreatment

Calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. A new calcium silicate-based root canal medicament has been developed as an alternative to calcium hydroxide-based medicaments.

The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on antibacterial, antifungal activity, and postoperative pain in root canal-treated teeth with periapical lesions.

Sixty patients were randomly divided into two groups using a web-based program according to the selected medicament (calcium silicate-based root canal medicament or calcium hydroxide-based root canal medicament).

After the removal of gutta-percha from the root canals, the first samples were collected using paper points to evaluate antibacterial and antifungal effects. The root canals were then chemomechanically prepared, followed by final irrigation activation, and the second samples were collected. The selected root canal medicament was placed in the canals, and the patients were given a form to record their postoperative pain levels over one week.

At the second appointment, the medicaments were removed, and third samples were collected using paper points to assess antibacterial and antifungal effects. The root canal treatments of the patients were then completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.

Eligibility Criteria:
Inclusion Criteria:

* healthy patients with aged between 18-60.
* Incisor, canine, and premolar teeth that had previously undergone root canal treatment
* Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
* teeth with only 1 root canal
* the patients had not used any antibiotics for 3 months before treatment

Exclusion Criteria:

* the presence of a root fracture
* teeth with any swelling
* ankyloses,
* periodontal pockets deeper than 4 mm.
* teeth which a rubber dam could not be performed
* patients with allergy to ibuprofen or ciprofloxacin were also excluded.
Pilot Study Evaluating Sulforaphane in Atypical Nevi-Precursor Lesions

This is a pilot study to see if oral administration of freeze dried, powdered broccoli sprouts have any effect on whether moles end up becoming melanoma.

This study is designed as a pilot evaluation of sulforaphane as a candidate natural nutritional chemopreventive agent able to modulate key steps in melanoma progression and the expression of STAT proteins in melanocytic and stromal elements of atypical nevi, which are precursor lesions and risk markers of melanoma. Eighteen individuals in total will receive oral broccoli sprout extract rich in sulforaphane (BSE-SFN) standardized for 3 different concentrations of actual sulforaphane content which will be utilized in our study. Three groups of six patients will be randomly assigned to receive oral BSE-SFN at SFN dosages of 50 µmol, 100 µmol, or 200 µmol daily. Due to the established safety of SFN at all of the proposed dosage levels, there is no plan to complete a lower dosage level prior to escalating to the next higher dosage level; i.e., subjects will be randomized across all of the proposed SFN dosage levels. However, the safety of BSE-SFN administration will continue to be evaluated through laboratory studies (CBC, chemistry) performed before and following 28 days of administration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have at least two atypical nevi of ≥ 4 mm diameter and prior diagnosis of melanoma.
* Subjects must be ≥ age 18.
* Subjects must not have received any form of systemic antineoplastic treatment for melanoma within the last year from day 1.
* Subjects should not have known allergies to cruciferous vegetables.
* Subjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study (28 days). Participants will be asked to keep a food diary. A list of food and supplements to abstain from is provided in Appendix A. Patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs 7 or more times.
* Female subjects must not be pregnant or breast feeding within 6 months prior to and during course of study.
* CBC including diff \& platelets - without clinically significant abnormalities
* CMP (Na, K, Cl, CO2, glucose, BUN, creatinine, calcium, total protein, albumin, AST, ALT, ALK phos, total bilirubin) - within 2x ULN

Exclusion Criteria:

N/A
Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

The feasibility and impact of respiratory rehabilitation (RR) in patients with advanced or metastatic (EGF-R WT or mutated) non-small cell lung cancer treated with oral targeted therapy including Inhibitors of EGF-R tyrosine kinases (TKI) and ALK inhibitors.

These patients will benefit, at the beginning of the chemotherapy whatever the treatment line, of a respiratory rehabilitation. The respiratory rehabilitation takes place at the patient's home with the HAD's cooperation 3 hours per week, divided into 2 or 3 sessions. There is associated educational, nutritional and psychological support for a total duration of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patient with advanced or metastatic lung cancer
* In the course of treatment by oral chemotherapy of oral targeted therapy (tyrosine kinase inhibitor) in 1st, 2nd, 3rd line or more at the time of their inclusion
* Diagnosis of CP retained after multidisciplinary discussion of patient records

Exclusion Criteria:

* Any residual toxicity of a previous antineoplastic treatment, grade\> 2.
* Cardio-respiratory contraindications to exercise re-training:
* Angina unstable
* Recent infarct
* Tight aortic stenosis
* Unsteady heart failure
* Pericarditis, endocarditis, myocarditis
* Evolutionary thromboembolic disease
* Ventricular aneurysm
* Intra ventricular thrombus
* Uncontrolled rhythm disorders
* Instability of the respiratory state defined by uncompensated respiratory acidosis
* Carcinological contraindications:
* Bone metastases at risk of fracture and / or algae despite optimal analgesic treatment, symptomatic central nervous system metastases
* Presence of anemia (Hb \<8g / dl or \<10g / dl if patient with previous cardiac history), thrombocytopenia (\<100,000 platelets / mm3)
* Chimio toxicity (neurological, cardiac) according to the investigator's assessment
* Neuromuscular contraindications:
* Neuromuscular and / or osteo-articular disease making it impossible to re-train
* Severe cognitive impairment
* Patient under tutorship or curatorship
Age-Related Changes in Proliferation and Differentiation Capacity of Human Preadipocytes From Periorbital Fat.

Periorbital rejuvenation has been an issue of great interest in plastic surgery. Adipose tissue plays an important role in the periorbital anatomy, and has a great impact on the aging process of the region. We believe age-related atrophy of the facial adipose tissue may be related to the decreased proliferation and differentiation capability of the preadipocytes (adipose precursor cells).

Understanding the age-related changes in periorbital adipose tissue is crucial for improving current rejuvenation techniques, or developing new ones. However, no such study has been reported in the literature.

Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral pretarsal fat can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes of the preadipocytes in human periorbital adipose tissue regarding their proliferation and differentiation capability.

The adipose samples taken during the surgery are sent to the lab immediately to separate the preadipocytes from the specimens. Their number is estimated under the microscope, and then the cells are cultured in vitro to evaluate their proliferation and differentiation capability. Proliferation is assessed by counting the number of preadipocyte everyday for 7 days, and differentiation is assessed by Glycerol-3-phosphate dehydrogenase (GPDH) assay.

A linear regression analysis is used to analyze correlations of the parameters with age. Moreover, by dividing the subjects who had their periorbital fat sampled during upper blepharoplasty operation into three age groups, the parameters are compared with ANOVA test. Therefore, the age-related changes of the proliferation and differentiation capability of the preadipocytes in human periorbital adipose tissue can be concluded.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving lower blepharoplasty

Exclusion Criteria:

* patients who do not require fat removal