cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females

To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in breast milk of healthy lactating women after an oral administration of 10 mg once daily over a period of 8 days.


Eligibility Criteria:
Inclusion Criteria:

* Women, age ≥18 and ≤50 years
* Stopped with breast feeding their baby
* Provided breast milk samples over a period of 10 days (including day -1)
* Have been breast feeding for at least 14 days
* Complied with the requirements of the protocol (e.g complete a diary)
* Body Mass Index (BMI) ≤ 35 kg/m2
* Medically acceptable method of contraception \[i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive) or intrauterine device
* Signed and dated a written informed consent prior to any study procedures study in accordance with Good Clinical practice (GCP) and the local legislation

Exclusion Criteria:

* Findings during medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance
* Evidence of clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency, myocardial infarction, other known cardiovascular disease including hypertension
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, that may interfere with the safety of the subject
* Surgery of the gastrointestinal tract (except appendectomy) in the last 2 years
* Metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that would interfere with participation in the study
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections (e.g. HIV, Hepatitis)
* Participated in another study with an investigational product within 1 month prior to enrolment into this study or during the study
* Eating disorder
* Hypersensitivity to bisacodyl, sodium picosulfate or any of the inactive ingredients
* Any concomitant medication except for paracetamol or hormonal therapy.
* Abnormal electrolyte values at the screening visit. The electrolyte values should be within the normal ranges
* Alcohol abuse; subjects who report regular consumption of 40g/day = 5 units/day or more alcoholic drinks per day were excluded
* Smoker (\>10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Drug abuse
* Any laboratory value outside the reference range that is of clinical relevance
* Mastitis
* Less than 200 ml daily (24 hours) production of breast milk on day -1
* A positive pregnancy test at screening
Adult Primary and Preventive Practice (APPP) Study

The study is a pre-post two round, randomized controlled study design of PCPs randomly assigned to a control or 1 of 2 intervention arms.


Eligibility Criteria:
Inclusion Criteria:

* 1. Provide consent to participate in the study 2. Board-certified physician currently practicing in the following areas: 3. Internal medicine 4. Family medicine 5. Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. 6. English-speaking 7. Community / non-academic based practice setting 8. ≥ 40 patients under care weekly 9. Access to the internet

Exclusion Criteria:

* 1. Not board certified in their respective area of care 2. Academic-based practice 3. Have practiced as a board-certified physician for less than 2 or greater than 30 years 4. Follow \<40 patients weekly 5. Non-English speaking 6. Unable to access the internet
Fat Effects in Women With Metabolic Syndrome

Among 10 premenopausal women with Metabolic Syndrome:

Specific Aim 1: Compare the effects of acute fat feeding on flow mediated dilation (FMD) as measured by brachial artery reactivity among three fat challenges (saturated fat vs. monounsaturated fat (MUFA) vs. polyunsaturated fat (PUFA)at 4 hours post feeding. Hypothesis Saturated fat feeding will impair FMD but MUFA and PUFA feeding will not.

Specific Aim 2: Compare the effects of acute feeding on vascular inflammation as measured by VCAM and sICAM among three fat challenges at 3 1/2 hours post feeding.

Hypothesis: Saturated fat feeding will increase vascular inflammation but MUFA and PUFA will not.


Eligibility Criteria:
Inclusion Criteria:

* Female,
* 18-50 years of age,
* Pre-menopausal,
* Weight stable for at least 3 months,
* Not planning to lose or gain weight for 3 months,
* Meets the following 3/5 criteria for metabolic syndrome:

  * increased blood sugar
  * increased blood fats (triglycerides),
  * increased blood pressure,
  * decreased good cholesterol (HDL-C).
  * increased waist circumference,

Exclusion Criteria:

* History of diabetes mellitus
* Fasting glucose ≥ 126 mg/dL
* History of cardiovascular disease (peripheral vascular disease, coronary artery disease, cerebrovascular disease)
* Pregnant or planning a pregnancy within the study period
* Fasting triglycerides \> 500 mg/dL
* Currently taking lipid lowering medications\*\*
* Oral or patch hormone contraception\*\*
* Currently taking vaso-active (blood pressure) medications\*\*
* SBP ≥ 140 and/or DBP ≥90 mm Hg or taking blood pressure lowering Rx
* Chronic use of aspirin (prn use is allowed)
* Chronic use of non-steroidal anti-inflammatory medications (prn use is allowed)
* Tobacco use within 6 months of starting study
* Participation in another clinical trial within the last 30 days
* History of active gall bladder disease
* History of digestive or malabsorptive disease requiring treatment or surgery
* Moderate to severe lactose intolerance
* Milk Allergy
* Walnut Allergy or Nut Allergy
* Coconut allergy

(\*\*) Drugs within the following classifications are exclusionary: Lipid lowering, beta blockers, ACE inhibitors, angiotensin receptor blockers, diuretics, calcium channel blockers, alpha blockers, nitrates, hormone contraception includes patch or oral hormone contraception (Hormone containing IUDs or vaginal rings are okay)
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

The purpose of this study is to collect acute confirmatory data to evaluate technical success and acute safety of the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system.


Eligibility Criteria:
Inclusion Criteria:

* Has stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts),
* or occluded lesion(s) located in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) suitable for primary stenting.

Exclusion Criteria:

* Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel.
Biological Specifications for Denture Designs

The primary term goal of these research efforts has been to enhance the functional status, comfort and quality of life of edentulous patients by evaluating clinical procedures, denture designs and adjunctive therapies based upon a clear understanding of: (1) oral functional impairments caused by the loss of teeth and subsequent tissue changes; (2) neurophysiological mechanisms associated with oral functions; (3) metabolism of oral tissues; and (4) interactions between biological and psychological processes and denture characteristics. The primary purpose of the proposed clinical outcome study is to compare the relative efficacies of three different combinations of implant-supported maxillary and mandibular prostheses with traditional complete dentures for edentulous patients. Completion of this study will determine the relative cost-effectiveness of the implant-supported denture treatments for use in the general population of edentulous patients.


Eligibility Criteria:
Inclusion criteria:

* Completely edentulous veterans with clinically acceptable conventional dentures.
* Both male and female applicants will be accepted and the prospective participants will be from 35 to 80 years of age.
* Patients who have been completely edentulous for at least two years and have clinically acceptable conventional dentures, which have been worn for at least 6 months.

Exclusion criteria:

* Verified history of medical conditions such as connective tissue disorders, blood dyscrasias, uncontrolled endocrine disorders, active tuberculosis, AIDS, leukemias, Hodgkins, liver disfunction, osteoporosis, chronic nephritis, any chronic condition with life expectancy of less than five years as well as patients on long-term steroids, anticoagulants, and radiation therapy.
* Extremely poor oral hygiene. Oral hygiene condition will be assessed from the amount of food debris, plaque and calculus in their present dentures.
* Insufficient mandibular or maxillary bone height to accommodate 10 mm long implants in potential implant sites.
* Presence of temporomandibular joint dysfunction and evidence of severe bruxism.
* Physician determines a contraindication for oral surgery.
* Candidate expresses reservations about participating for at least three years.
Effects of Breast Milk Simulated Infant Formula

Objective：The aim of this trial is to assess effects of Kieember and Yashili infant formula on body growth, behavior development, intestinal comfort, infectious diseases, allergic diseases, the absorption of nutrients and gut microbiota as compared to breast-milk in term infants aged 0-3 months.

Participants：144 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial.

Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I).

Intervention Duration: 90 days.

Visits: 1month and 3month old.

Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Term infant: Born at 37-42 gestation weeks
* Birth weight: 2500-4000g (appropriate for gestational age)
* The infant is in good health and Apgar after 5 minutes \>7
* The mother had unequivocally decided not to breastfeed (for formula fed infants) or to breastfeed (for human milk fed infants)
* age at the enrollment: less than 30 days

Exclusion Criteria:

* The mother is unable to take care of her infant on account of health condition (psychological or physical) or socioeconomic problems
* The infant is born with a congenital malformation or chromosome abnormality with a clinical significance
* The infant suffers from a disease requiring mechanical ventilation or medication in the first week of life (not including applying phototherapy of blue to cure neonatal jaundice)
* The infant whose feeding or normal metabolism is affected by any suspected or unknown metabolic factors or physical limitations
* The infant has been breastfed for more than 2 weeks (for formula fed infants)
* Twins or multiple births
Caffeine Intake Inrelation to Perioperative Analgesic Consumption

Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood.

We designed this prospective observational study to determine if caffeine consumption would influence intraoperative analgesic consumption

Caffeine is a well-known natural compound present in various plant products. Caffeine is an integral component of several daily drinks, including tea, coffee, soft drinks, and energy drinks \[1\]. (e consumption habits of these caffeinated drinks have facilitated the wide distribution of and dependence on caffeine. For instance, 89% of the US adult population has an average caffeine intake of 200 mg/day \[2\]. Among the multiple effects and side effects, caffeine also has an analgesic action and is used to reduce pain in several pharmaceutical forms as an adjuvant \[1\]. Several studies have reported a role for caffeine in controlling pain and suggested that caffeine may block the central processing of pain signals in the brain and enhance the body's natural pain resistance pathways \[3\]. In addition, Overstreet et al. found that habitual caffeine consumption diminishes pain sensitivity in a laboratory setting \[4\]

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective laparoscopic surgery

Exclusion Criteria:

* Patients converted to an open surgery, postoperative complications that increased postoperative pain, and those with psychological or nervous system diseases were also excluded. Liver disease
Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of the negative symptoms of schizophrenia


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, between 18 and 55 years of age
2. A clinical diagnosis of schizophrenia with a minimum duration of 1 year
3. Has predominant negative symptoms according to predefined study criteria
4. The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

   * Aripiprazole
   * Aripiprazole long-acting injectables:

     * Abilify Maintena®
     * Aristada®
   * Risperidone
   * Risperidone long-acting injection
   * Olanzapine
   * Lurasidone
   * Cariprazine
   * Brexpiprazole
   * Asenapine

Exclusion Criteria:

1. Patient has a psychiatric disorder other than schizophrenia
2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

   a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
3. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
4. Patient has had a myocardial infarction in the last six months
5. Patient has a family or personal history or symptoms of long QT syndrome
6. Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
A 56-Week Extension to a Clinical Study to Assess the Efficacy and Safety of Vildagliptin Compared to Placebo in Drug Naive Patients With Type 2 Diabetes and Mild Hyperglycemia

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to gather data on the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.


Eligibility Criteria:
Inclusion Criteria:

* Completion of study CLAF237A2307 within 4 weeks of entering into the extension
* Written informed consent
* Ability to comply with all study requirements
* Blood glucose criteria must be met

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2307
Efficacy and Safety of Ursodeoxycholic Acid (UDCA) Added to the DPP-4 Inhibitor in People With Type 2 Diabetes and Chronic Liver Diseases

1. Objectives

1. To test whether Ursodeoxycholic Acid (UDCA) increases Glucagon-like peptide-1 (GLP-1) response to nutrients and improves glycemic control in people with type 2 diabetes.
2. To test whether sitagliptin enhances UDCA-induced beneficial effect in GLP-1 levels and glycemic control.
3. To test safety of combination therapy of sitagliptin and UDCA in people with type 2 diabetes.

2. Clinical hypothesis.

1. UDCA increases GLP-1 response to nutrients via provoking bile acids excretion from the liver to the intestine/colon.
2. UDCA improves glycemic control in people with type 2 diabetes.
3. Sitagliptin enhances UDCA-induced response of GLP-1 to nutrients.
4. Sitagliptin has additive beneficial effects with UDCA in glycemic control in people with type 2 diabetes.
5. Combination therapy of sitagliptin and UDCA is safe and well-tolerated in people with type 2 diabetes.
6. The combination therapy may loose weight by unique mechanisms of each agent; GLP-1 inhibits appetite by acting on CNS and gastrointestinal motility, whereas UDCA-enhanced circulating primary bile acids increases energy expenditure through the pathway involving G protein-coupled bile acid receptor 1 (Gpbar1, or M-Bar, TGR-5) and subsequent activation of type 2 iodothyronine deiodinase (D2) in brown adipose and muscle tissues, as reported previously.


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. HbA1c \>=6.5% during 8 weeks prior to the study
3. Treated with none or single oral hypoglycemic agent(OHA: sulfonyl ureas, biguanides, or thiazolidinediones) over 12 weeks prior to the study

Exclusion Criteria:

1. Non-Type 2 diabetes
2. Medical history and/or complication of diabetic ketoacidosis
3. Medical history and/or complication of severe hypoglycemia
4. Insulin treatment within 16 weeks prior to the study
5. Treatment with alpha-glucosidase inhibitors or sitagliptin within 12 weeks prior to the study
6. Treatment with glucocorticoid
7. Unstable glycemic control
8. Hypersensitivity to or contraindication of sitagliptin and voglibose
9. Aspartate transaminase (AST) or alanine transaminase (ALT) \>=2.5 time of institutional upper normal limit
10. Uncontrolled hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
11. Severe health problems not suitable for the study
12. Pregnant or lactating women
13. Hepatitis B or C
Myocardial Infarction Prescription Duration Adherence Study

Quasi-experimental, controlled interrupted time series design, evaluating the impact of the intervention at Hamilton Health Sciences (HHS) where standardized prescriptions and education will be provided and St Joseph's Hospital (SJH) and Niagara Health Services (NHS) where education alone will be provided, with remaining Ontario cardiac sites as a concurrent control group.

The overarching goal of this study is to reduce the morbidity and mortality of post-MI patients through improved long-term cardiac medication adherence.

The specific objectives include: 1. Assess the impact on long-term cardiac medication adherence following the implementation of a standardized increase in discharge prescription length to 90-days with 3 repeats in post-MI patients as compared to education alone and usual care; 2. Assess the cost implications of the intervention as compared to usual care; 3. Compare clinical outcomes between longer (\>60 days) versus shorter prescription durations; 4. Collect baseline information to inform a multi-centre interventional study (i.e., simple monthly proportions of 1-year adherence by hospitals in Ontario).

Intervention:1. Policy Change implementing a standardized discharge prescription form available on all wards where MI patients are managed at HHS that includes a 90-day supply with 3 repeats for all cardiac medications, and education alone provided at SJH and NHS 2. Educational materials will be disseminated to all involved health care providers (e.g., physicians, residents, nurses) at the start of the intervention period to ensure the new discharge prescriptions are understood and used. Furthermore, extensive outreach to community pharmacies in LHIN IV will be undertaken with help from Ontario Pharmacists' Association (OPA) and Ontario Pharmacy Evidence Network (OPEN).

3. Education (e.g., emails, mail-outs, site visits) will recur every 3-4 months during the intervention period. Furthermore, monthly monitoring will ensure standardized prescription forms and point of care reminders are implemented at all intervention sites.

The intervention group will be exposed to this intervention post-MI and include all eligible patients at HHS/SJH/NHS in the 6-months post-intervention implementation.

Eligibility Criteria:
Inclusion Criteria:

* Use of Ontario Drug Benefits (ODB-Age \>65 years, social assistance, and disability);
* Cardiac catheterization during an index admission with an MI;
* Evidence of obstructive coronary artery disease;
* Discharged alive
* Ontario Residents (Ontario, Canada)

Exclusion Criteria:

* None
Effect of OC000459 on Moderate to Severe Atopic Dermatitis

The purpose of this study is to determine whether OC000459 is in reducing disease severity and preventing flares in people with moderate to severe atopic dermatitis (AD).

The study will include patients with a Th2 high eosinophilic phenotype who typically have more severe disease and are prone to flare.

Eligibility Criteria:
Inclusion Criteria:

1. Atopic dermatitis as defined by a score of at least 9 on the Nottingham Eczema Severity Score, stratified into moderate (score 9 to 11 inclusive) and severe (score 12 to 15 inclusive) disease.
2. Fully documented history of the use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI). Subjects without a fully documented history will be excluded from the study.
3. Male and female subjects with moderate to severe atopic dermatitis treated with by TCS and/or TCI (with or without emollients) at the time of screening and over the previous month.
4. Subjects must have had at least 1 AD flare in the previous 6 months.

Exclusion Criteria:

1. Receipt of any forbidden medication including over the counter preparations and herbal medicines within 14 days of the first dosing day with the exception of paracetamol up to a maximum of 2g daily.
2. Use of systemic steroids within 4 weeks of the screening visit, light therapy or immunosuppressants within 2 months of the screening visit.
3. Use of NSAIDs.
4. Subjects initially diagnosed with AD aged 2 years or over will be excluded unless they have either coexisting or a history of asthma and/or allergic rhinoconjunctivitis.
5. Subjects with contact dermatitis will be excluded.
6. Subjects with acute skin infection or acute disease flares. Subjects with active flares during the screening to randomisation period (visits 1 to 2) may be managed according to normal clinical practice and be rescreened once their flares are no longer active.

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