cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers

To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in healthy volunteers with calcium citrate as a positive control.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Ages: 18-75 years
* Serum Calcium level 8.6-10.2 mg/dL
* 25 vitamin D level 20-100 ng/mL
* 1, 25 dihydroxy vitamin D level 6-62 pg/mL
* Fasting glucose level of 65-99 mg/dL (min 8 hr fast)
* iPTH level of 10-65 pg/mL
* Serum phosphorous level of 2.5-4.5 mg/dL
* Albumin level of 3.6-5.1 g/dL
* Sodium level of 135-146 mEq/L
* Potassium level of 3.5-5.3 mEq/L
* Negative pregnancy test (at screening and prior to dosing) for women of childbearing potential and subjects must agree to use adequate contraception (hormonal or double barrier method) during the study
* No clinically significant abnormalities on electrocardiogram (ECG) reading as determined by the INVESTIGATOR
* No clinically significant abnormalities on liver function tests
* No clinically significant abnormalities on CBC and coagulation studies
* No clinically significant abnormalities on kidney function (eGFR using serum creatinine)
* BMI between 18.5-30
* Subjects must agree not to consume alcohol while in the treatment phase of the study

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Malignancy except squamous cell carcinoma of the skin
* Documented current acute or chronic disease
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Myocardial infarction within 6 months of study Day 0
* Parathyroidectomy within 6 months of study Day 0
* Gastrointestinal disorder associated with impaired absorption of oral medications
* Inability to swallow tablets or tolerate calcium acetate oral solution
* Hormonal therapy (except for contraceptives), immunotherapy or corticoid therapy
* Concurrent antibiotic treatment
* Any concurrent investigational treatment within 30 days of screening
* Unable or unwilling to comply fully with the protocol
* Diuretic therapy such as Thiazides, Furosemide (INN) or frusemide (former BAN) within one month before screening
* Subjects taking over-the-counter (OTC) or prescribed phosphorous or calcium containing supplements
* Subjects testing positive for drugs of abuse
Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis

Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed chronic coronary syndrome CCS ≥ 2.
2. Evidence of myocardial ischemia (positive result of non-invasive stress test).
3. Informed consent.
4. Age at least 18 years.

Exclusion Criteria:
Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood

Each year, 450,000 Canadian women become pregnant and, as a result of their participation in prenatal screening for Down syndrome, approximately 10,000 of them will have an amniocentesis (i.e. sampling of liquid surrounding the fetus) and of those, 315 will be found to carry a baby with Down syndrome and 70 normal pregnancies will be lost from complications of the procedure. It has been discovered recently that, during pregnancy, there is fetal DNA in maternal blood in sufficient quantities to be analysed and methods have been proposed to detect the presence or not of a fetus with Down syndrome using maternal blood. The introduction of genomic blood testing as proposed in the context of this project could lead to increased detection of Down syndrome, less invasive screening with 9700 amniocentesis avoided each year in Canada, improving the peace of mind of pregnant women, and preventing the accidental loss of 70 normal fetuses, at a lower overall cost than current practice. However, these methods still need to be validated before being appropriately introduced in routine care.

The study hypothesis is that new genomics-based non-invasive methods using fetal-DNA in maternal blood during pregnancy can be more effective than current prenatal screening methods for fetal aneuploidy.

This project will carry out an independent study that will validate the performance and utility of different new genomic technologies for screening in pregnant women using maternal blood. The team of researchers will compare the real-life performance of different non-invasive assays and strategies to screen for fetal aneuploidy, and identify an evidence-based cost-effective approach for implementation of this new technology in the Canadian health care system. The deliverables of this project will enable decision makers, pregnant women and their partner to make informed choices pertaining to prenatal genetic screening and diagnosis, such as screening for Down syndrome, and reduce the risk to pregnancies associated with amniocentesis.

The present study is a real life comparative effectiveness study that will compare the performances and costs of several prenatal screening modalities for fetal aneuploidy (see interventions).

Eligibility Criteria:
Inclusion Criteria (High risk arm):

* women 19 years or older between 10 weeks and 23 weeks 6 days gestation undergoing amniocentesis or CVS for:
* positive prenatal screen;
* abnormal ultrasound
* previous pregnancy with trisomy
* patient or partner carrier of Robertsonian translocation involving chr 21
* positive NIPT result
* Maternal age 40 or more

Inclusion Criteria (Low risk arm):

* women 19 years and older who are 10 and 13 weeks 6 days gestation based on dating ultrasound (CRL) and are undergoing screening for Down syndrome (first trimester combined, SIPS or IPS)

Exclusion Criteria:

* women with multiple gestations
* women with twin demise (spontaneous or elective) at any gestational age
* women with active or history of malignancy
Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion

Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.

This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.

Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.

Eligibility Criteria:
Inclusion Criteria:

* Full thickness rotator cuff tear
* Pre operative MRI
* Patients who are medically stable to undergo the surgery
* Patients who consent to involvement in the study

Exclusion Criteria:

* Prior surgery on the involved shoulder
* Preoperative MRI suggesting that the rotator cuff tear is unrepairable
* Patients with known allergies to oxycodone, bupivacaine or a similar drug
* Workman's compensation patients
* Patients who do not fill out their visual analog scores or their medication diaries.
The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects

The purpose of this study is to determine if the drug orlistat (Alli, Xenical) decreases the taste for fat in humans.

One screening visit and Testing Visits 1 and 2: Approximately 1-2 hours (Fasting - You will have nothing to eat or drink (except water or medications) after midnight before the test visit.) If you qualify for the study, you will return to Pennington Biomedical Research Center for the test visit

* You will be given a questionnaire to screen for allergies or cold symptoms.
* Women will answer a questionnaire based on their menstrual cycle.
* Before eating, you will be given instructions on how to use the study medication. You will swish about 2 teaspoons of a solution in your mouth for 30 seconds and then spit it out (like mouthwash).
* Just before eating, you will be given another brief questionnaire judging your appetite.
* You will be given the test meal. You will be allowed to eat as much or as little as you like during a 20-minute eating period.
* 30 minutes after starting your meal you will be given the brief questionnaire again to judge your appetite.
* You will return in 1 month to complete test visit 2.

Eligibility Criteria:
Inclusion Criteria:

* Are a healthy male or female,
* Are between 18 to 70 years of age,
* Have a body mass index between 25-35 kg/m2

Exclusion Criteria:

* Are a female who is pregnant or nursing,
* Are a restrained eater (determined using a questionnaire),
* Have any current illnesses such as an infection,
* Have any serious medical problems including kidney, liver, heart or lung disease,

  * Use medications known to increase appetite,
  * Are taking any medication that has not been on the same dose for at least 30 days,
  * Dislike the test food.
Effects of Monounsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin Resistant Subjects (MUFA )

The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins à (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with insulin-resistance. In this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (SFAs) by monounsaturated fatty acids (MUFAs) reduces CVD risk in the general population. Although the beneficial impact of PUFAs on CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels, recent data suggest that chronic MUFA consumption may also exert beneficial effects on CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by MUFAs on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal TRLs represent a large proportion of the atherogenic lipoproteins. The general objective of the proposed research is to investigate how dietary MUFAs in place of SFAs modify intestinal lipoprotein metabolism in men and women with dyslipidemia associated with insulin-resistance. The investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins will be lower following a diet rich in MUFAs than after consuming a diet rich in SFAs. The investigators also hypothesize that substitution of SFAs by MUFAs will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18-60 years
* Waist circumference \> 102 cm (men) and \> 88 cm (women)
* HDL-cholesterol \< 1.1 mmol/L (men) and \< 1.3 mmol/L (women)
* Triglycerides \> 1.7 mmol/L
* Fasting blood glucose \> 6.1 mmol/L
* Normal blood pressure (\<130/85)

Exclusion Criteria:

* Men and women \< 18 or \> 60 years
* Smokers (\> 1 cigarette/day)
* Body weight variation \> 10% during the last 6 months prior to the study baseline
* Subjects with a previous history of cardiovascular disease
* Subjects with type 2 diabetes
* Subjects with a monogenic dyslipidemia
* Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
* Subjects with endocrine or gastrointestinal disorders
* History of alcohol or drug abuse within the past 2 years
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients

The purpose of this study is to demonstrate that orally administered itraconazole, a commonly used antifungal medication, can inhibit Hedgehog pathway signaling in patients with esophageal cancer, including adenocarcinoma (EAC) and squamous cell carcinoma (ESCC).


Eligibility Criteria:
Inclusion Criteria:

• Clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer

Exclusion Criteria:

* Patients unwilling or unable to provide informed consent
* Coagulopathy that precludes safe endoscopic/surgical procedure (platelet count \<100,000/mm3, INR\>1.5)
* Esophageal varices
* Comorbidity (e.g. pulmonary, cardiac, renal, or liver disease) that precludes safe participation in the study
* QTc\>450 ms
* LFT's\>3xULN
* Pregnancy
* Allergy to itraconazole
* History of symptomatic congestive heart failure
Drainage or Not for Laparoscopic Cholecystetomy

Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.

The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.

Compare complications as below betwwen drainage and no drainage groups.

1. VAS
2. Nause and vomiting
3. infection
4. bleeding
5. bile leakage
6. puncture drainage
7. readmission
8. reoperation
9. hospital stay
10. hospital expense

Eligibility Criteria:
Inclusion Criteria:

* age:18-75 years old
* indicated and planed to receive laparoscopic cholecystectomy

Exclusion Criteria:

* cirrohosis Child Grading B and C
* upper abdominal surgery history
* adjustment of surgical name intraoperative
Evaluation of Periodontal Distractor in Acceleration of Canine Retraction

evaluate the effect of periodontal distractor with and without interseptal bone cuts on the displacement of the maxillary canines, to assess the effect of two approaches on the pain intensity and on the pulp vitality of the retracted canines.

The sample of the study consisted of 32 canines in 16 female patients (16- 21 years old) requiring extraction of bilateral maxillary first premolars and canine retraction. They were divided into two groups: canine retraction was done by buccal periodontal distractor with distal interseptal bone cuts (Group I), canine retraction was done by buccal periodontal distractor without distal interseptal bone cuts (Group II). After bilateral maxillary premolar extraction in both groups inter septal bone cuts was done in group I only. Then the periodontal distractor was cemented and activated twice per day in both groups. Rate of canine retraction was evaluated before and after complete canine retraction direct in patient's mouth with digital caliper. Pain intensity was evaluated at 1st ,2nd ,4th and 7th days after activation through visual analog scale (VAS). An electrical vitality test was evaluated before and after the distraction procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient age: 16-21 years.
* patients required bilateral extraction of maxillary first premolars followed by maxillary canine retraction (class I malocclusion as excessive overjet, bimaxillary protrusion, class II malocclusion).
* The dentition didn't exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
* No systemic disease that may affects the bone.
* No periodontal disease.
* Good oral hygiene.
* Very good patient compliance.
* Absence of any previous orthodontic treatment.

Exclusion Criteria:

* The dentition exhibit any gross anatomic root anomalies as assessed from panoramic radiographs.
* Cases with deep carious lesions or endodontic lesions involving the maxillary canines and buccal segments.
* Cases with severly rotated or grossly malpositioned canines.
* Systemic disease that may affects the bone.
* Periodontal disease and poor oral hygiene.
* Presence of previous orthodontic treatment.
Behavioral Economic Analysis of Demand for Marijuana

This laboratory study will employ a multi-session experimental design to examine the behavioral economic demand for marijuana, by studying effect of marijuana administration (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.

This laboratory study will employ a multi-session experimental design to examine craving for marijuana, the effect of marijuana administration (High THC) on behavioral economic demand for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly. The relationship between hypothetical and actual demand for marijuana will be examined. We will also investigate relationship between demand for marijuana and indices of marijuana smoking topography. The study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly to obtain a final sample of 85 with complete data (15% of attrition). Participants will be tested at a baseline session and during two experimental sessions (an ad libitum marijuana smoking session and a marijuana smoking topography session). This study will confirm the utility of the hypothetical marijuana purchase task as a reliable and valid tool for assessing behavioral economic marijuana demand.

Eligibility Criteria:
Inclusion Criteria:

* marijuana use at least 8 times in the past month on average and at least monthly for the past 6 months
* English-speaking
* negative urine toxicology screen for drugs other than marijuana
* non-treatment seeking
* purchase of marijuana at least twice in the past 6 months to confirm familiarity with the construct to be measured

Exclusion Criteria:

* positive pregnancy test
* nursing
* inability to use contraception during the study
* poor physical health
* positive breath alcohol concentration
* diagnosis of a current affective disorder, psychosis, and panic disorder
* self-report of past serious adverse reaction to marijuana
* current psychotropic drug use
* smoking more than 20 tobacco cigarettes per day
* inability to abstain from marijuana for 15 hours
* body mass index outside 18.5-30 kg/m2 range
Heart Rate Variability as a Clinical Marker in a Population of Anxio-depressive Patients

The heart rate (HR) is regulated by the autonomic nervous system (ANS) and results from a balance between the sympathetic nervous system (SNS) that accelerates the heart rate and the parasympathetic nervous system that slows the HR via the vagus nerve.

Low HRV is linked to poor emotional and cognitive regulation. Values for HRV are generally lower in depressed patients.

The aim of this study is to determine how HRV could be a clinical marker that can be used in routine psychiatry practice in patients with anxio-depressive disorders, to determine the severity of symptoms and the degree of response to treatment.


Eligibility Criteria:
Inclusion Criteria:

- Patients of the CHU Brugmann Hospital with an anxious or depressive disorder

Exclusion Criteria:

- None
Direct Application of Selective Laser Trabeculoplasty in Open Angle Glaucoma

The trial objectives are to establish the safety \& efficacy of using a DLTP laser to perform laser trabeculoplasty to reduce Intraocular Pressure (IOP) in patients with open angle glaucoma (Including Pigmentary \& Exfoliative Glaucoma), that did not achieve adequate IOP control by conventional therapy.

This is a single site outpatient feasibility study assessing the safety \& efficacy of the DLTP laser in the ability to reduce IOP in patients with open angle glaucoma (OAG). The investigational site will accrue patients with uncontrolled OAG. These eyes will be treated with the direct application of Direct Laser Trabeculoplasty (DLTP)/ Direct Selective Laser Trabeculoplasty automated device (DSLT).

Only one eye per patient is to be treated with the investigational device during the study.

The laser parameters used will be like these used in the Selective trabeculoplasty (SLT) device (CE/FDA approved), but all laser beams will be applied in about one-second, through the peri-limbal.

Subjects will be evaluated preoperatively and postoperatively at 1 hour, 2 hours (and hourly to 4 hours in the event of an IOP elevation in the immediate postop course), 1 day, 1 week, and 1, 3, 6 months.

Patients will be followed out to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient is aged 18 years or older, with 2 sighted eyes.
* Eye to be treated have average IOP \*22 mmHg, measured at 2 pretreatment visits.
* Eye to be treated either exhibits:
* poorly controlled open angle glaucoma including Pigmentary \& Exfoliative Glaucoma
* Patient would be considered eligible for conventional laser trabeculoplasty.
* Patient is willing to participate in the 6-month study and to adhere to the follow-up schedule.
* Patient is willing to review and sign a consent form.

Exclusion Criteria:

* evidence of glaucoma other than open-angle glaucoma;
* severe para-central or generalized field defect;
* Any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
* Prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.
* Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
* Patient is pregnant.
* Patient might require other ocular surgery within the 6-month follow-up period.
* Patient has a medical history that suggested the potential for complications from Direct Selective Trabeculoplasty (DSLT)
* Having concurrent treatment with systemic steroids.
* Patient is under 18 years old