cyrilzakka/clinical-trials huggingface dataset:
Vascular Effect of CIMICIFUGA RACEMOSA

Postmenopausal women with vascular symptoms will use Cimifuga Racemosa or Placebo and the effects will be evaluated using Flow-Mediated Dilatation of the brachial artery.

The interruption of the secretion of ovarian steroids after menopause, determines a change in the vascular pattern in several levels. Thus, several vascular effects might interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies, the investigators observed the effects of hormonal replacement therapy in improving such effects in postmenopausal women. The aim of the present study is to evaluate the effects of CIMICIFUGA RACEMOSA on the Flow-Mediated Dilatation of the brachial artery.

Eligibility Criteria:
Inclusion Criteria:

* Women with postmenopausal vascular symptoms
* Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH) \> 30 International Units(IU)/Litre
* Women that were not using drugs with potential vascular effect within the last 1 year
* Women that were not using hormone replacement therapy within the last 1 year

Exclusion Criteria:

* Smoking
* Blood Pressure \> 160/90 mm Hg.
* Breast and or endometrial cancer
* History of acute myocardial infarction
* Diabetes
* Vaginal bleeding of any origin
* Hepatic disease
* Thrombophlebitis or thromboembolic disorders
Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.

A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of infant formula with prebiotics and postbiotics in healthy term infants.


Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy, singleton, term infants (gestational age ≥37 weeks + 0 days and ≤41weeks + 6 days);

  2. Infants with age at screening ≤14 days;

  3. Birth weight within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards;

  4. Head circumference at screening within ±2 SD per age and sex according to WHO Child Growth Standards;

  5. a Randomised groups: Infants who are exclusively formula fed and/or whose mothers have autonomously decided to exclusively formula feed, i.e. not to breastfeed or have ended breastfeeding before screening, and who are intending to exclusively formula feed at least till their infant is 17 weeks of age; OR b Breastfed reference group: Infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed at least till their infant is 17 weeks of age;

  6. Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years at screening.

Exclusion Criteria:

* 1. Randomised groups: Infants who require a special diet other than non-hydrolysed, cow's milk based infant formula (e.g. due to known or suspected to have cow's milk allergy, soy allergy and/or lactose intolerance);

  2. Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters, such as but not limited to: GI malformations, congenital metabolic disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as per the clinical judgement of the Investigator;

  3. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products;

  4. Incapability of infants' parents to comply with study protocol as per the judgement of the Investigator;

  5. Infants born from mothers known to have (any) hepatitis or human immunodeficiency virus;

  6. Infants born from mothers with significant medical conditions during pregnancy that might interfere with the study or its outcome parameters or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, Type 1, 2 diabetes) as per clinical judgement of the Investigator;

  7. Infants born from mothers, who did participate in any clinical study involving investigational products during pregnancy, and for infants in Breastfed reference group: mothers who are currently participating or intend to participate in any clinical study involving investigational products during lactation.
Paratracheal Force Required for Occluding the Upper Esophagus

In this study, the median paratracheal force for occluding the upper esophagus are evaluated in anesthetized and paralyzed patients using the up-and-down technique.


Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus
* aspiration tendency
* history of carotid artery diseases or cerebrovascular diseases
* suspicious of thrombus in carotid artery on ultrasonographic examination
A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. The investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes.

Participants will test each meal strategy in random order, and each meal strategy will be 21 days long. For the duration of each meal strategy, participants will use an automated insulin delivery system or "artificial pancreas" with an ultra-rapid insulin called Lyumjev.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria.
* Insulin pump use for at least 3 months.
* Individuals of childbearing potential must agree to use a highly effective method of birth control.
* Willing to switch to Lyumjev insulin for the duration of the study.

Exclusion Criteria:

* Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin...); 1 month for GLP1-RA.
* Use of glucocorticoids (except low, stable doses and inhaled steroids).
* Use of hydroxyurea.
* Planned or ongoing pregnancy.
* Breastfeeding.
* Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission.
* Clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator.
* Recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
* Known hypersensitivity to the study drug or its excipients.
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator.
A Qualitative and Quantitative Analysis on the Living History of Survivors From Charcoal-burning Suicide

The current study aims to explore the risk factors, protective factors, resilient factors, and factors jeopardizing the recovery progress on survivors from charcoal-burning suicide. To this end, an in-depth individual interview and Mini-Mental State Examination(MMSE) will be used to acquire the first-hand information on the attempters. As well, a more comprehensive neuropsychological test, WAIS III, will be administered at 3-month, 6-month, and 12-month after the index suicide attempt.


Eligibility Criteria:
Inclusion Criteria:

* above 20 years old, survivors from charcoal-burning suicide.

Exclusion Criteria:

* under 20 years old
* survivors from other kind of suicide
* prisoner
* suffer from a serious illness
* foreigner/ can't speak Chinese
* the people who can't express themselves
* can not be interviewed in FEMH
* people with severe physical or psychological symptoms
Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission

In the 21st century, the incidence of inflammatory bowel disease (IBD) globally increases. Higher incidence of IBD development may implicate that environmental factors played essential roles in IBD pathogenesis. One of the environmental factors is a westernized diet that contains a high amount of animal protein and a low amount of dietary fiber. This kind of diet can lead to gut microbial dysbiosis and increase susceptibility to IBD. A microbial dysbiosis pattern in IBD is a decrease in microbial diversity and the inversed ratio of local protective and pathologic bacteria. High animal protein was associated with an increased risk of IBD and increased risk of disease relapse meanwhile dietary fiber was associated with IBD risk reduction. A semi-vegetarian diet is a diet with high fiber and low red meat and processed food that may reduce inflammatory activity in IBD. The study in the semi-vegetarian diet in IBD activity is still limited.

This study aimed to evaluate a semi-vegetarian diet's effect in maintaining IBD remission in disease quiescence patients.

This study is a prospective interventional cohort in clinically quiescence IBD patients in Siriraj Hospital, Mahidol University, Bangkok, Thailand. At enrollment, clinical information, dietary intake, inflammatory markers, and fecal microbiota will be recorded. Dietary intake will be assessed by an experienced nutritionist using pictures of food, a dietary questionnaire, and patient interviewing. The nutritionist advises the participants to consume a semi-vegetarian diet which includes high dietary fiber consumption and low red meat and processed food consumption. All patients will be required to send all pictures of food intake three days in 1 week before every visit, including two weekdays and one weekend. The dietary component will be analyzed using Nutrient calculation computer software INMUCAL-Nutrient V3 database NB1 (Institute of Nutrition, Mahidol University. Nakornpathom. 2013). The study will take 1 year including 6 visits (including baseline, 6th weeks, 18th week, 30th week, 42nd week, 54th week) for each patient. The primary outcome is the effect of increasing fiber diets and decreasing red meat and processed food on maintaining clinical remission in IBD. Secondary outcomes are the effect of modifying diet on change of inflammatory markers, microbiota, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Crohn's disease or Ulcerative colitis
2. Age ≥ 18 years old
3. Disease in remission at least 2weeks by following criteria Crohn's disease: Crohn's Disease Activity Index(CDAI) \< 150 Ulcerative colitis: Mayo Ulcerative Colitis Subscore ≤ 2
4. Prednisolone ≤ 15 mg/day for at least 1 month
5. Stable immunomodulator dosage at least 1 month
6. Stable biologic agent at least 2 months

Exclusion Criteria:

1. Patients with Ulcerative colitis with a history of proctocolectomy
2. Patients with Crohn's disease with bowel stricture
3. Patients with recently antibiotic usage within 1 month
4. Pregnant patients
RAK-PRIDE: Optimizing Proton Pump Inhibitor Use Through Education and Intervention

The goal of this study is to determine if a pharmacist-led educational intervention can reduce the inappropriate use of proton pump inhibitors (PPIs) among adult patients (≥18 years) with potentially inappropriate PPI prescriptions in Ras Al Khaimah.

The main questions it aims to answer are:

* Can a pharmacist-led education program reduce unnecessary PPI use?
* Does the intervention improve patients' quality of life and reduce healthcare costs? Researchers will compare the intervention group (receiving pharmacist-led education and materials) to the usual care group to see if the intervention reduces PPI use and improves patient outcomes.

Participants will:

* Receive educational materials from pharmacists, including a patient educational brochure, PPI patient decision aid, PPI deprescribing pamphlet, and PPI patient action plan.
* Physicians involved will also receive a pharmaceutical intervention, which includes a physician educational brochure, PPI evidence-based deprescribing guideline, PPI deprescribing algorithm, and whiteboard videos on PPI deprescribing.
* Patients will be followed up for 6 months to monitor changes in PPI use, symptoms, and quality of life.

The RAK-PRIDE Study aims to evaluate the impact of a pharmacist-led educational intervention on the inappropriate use of proton pump inhibitors (PPIs) among adult patients in Ras Al Khaimah. This intervention will focus on both patient education and physician guidance, promoting evidence-based deprescribing practices for PPIs.

Eligibility Criteria:
Inclusion Criteria:

Physicians will be eligible to participate if:

* They are prescribing PPIs in outpatient department of the study sites
* They have patients with potentially inappropriate PPI prescriptions

Patients will be eligible to participate if:

* They are ≥18 years
* They are presenting to out-patient departments of the study sites
* They have prescriptions of potentially inappropriate PPIs
* Their treating physicians are included in the study

Exclusion Criteria:

Physicians will be excluded if:

• They are involved in any other prescribing trial

Patients will be excluded if:

* They are unable to give informed consent, as judged by their physicians
* They have definitive indications for PPI use
The Online Mood Booster Challenge to Support Physical and Mental Health

Healthier Together Mood Booster Challenge - To improve mental and physical fitness, while providing participants with online education, tracking, social connectivity, and feedback.

An 8-week web-based health promotion program to learn strategies and use digital tools that will give participants a physical, mental, and emotional boost, with exercise remaining a key component of the mission.

Each week participants will learn and practice evidence-based strategies that they will master to improve their physical and mental health.

Techniques will be focused on: spending time exercising outdoors, practicing daily gratitude, practicing good posture, building social connection, deep breathing, listening to music, limiting time on social media and focusing on better sleep.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated with McGill University or family member

Exclusion Criteria: None
Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial

Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. A negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. Research has led to the recent development of computerized cognitive bias modification (CBM) techniques to augment such biases and it has been suggested that CBM techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St. Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to the existing iCBT modules offered through St. Vincent's Hospital and the University of New South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as indexed by a standardized clinical battery.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder,
* Internet access + printer access,
* Australian resident,
* Fluent in written and spoken English.

Exclusion Criteria:

* Current substance abuse/dependence,
* Psychotic mental illness (Bipolar or Schizophrenia),
* Current or planned psychological treatment during study duration,
* Change in medication during last 1 month or intended change during study duration,
* Use of Benzodiazepines,
* Suicidal.
Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

This is a single centre, open-label phase I trial to investigate the effects of moderate to severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy volunteers. Furthermore the short-term safety and tolerability of a single dose of prucalopride will be assessed.

In this phase I trial two groups of 6 to 8 hepatically impaired subjects will be evaluated. The first group are the moderate hepatic impairment (Grade B) subjects and the second group the severe hepatic impairment (grade C) subjects. Subjects for both groups will be recruited and treated in parallel. After all subjects with hepatic impairment completed the treatment a third group with matching healthy volunteers will be recruited. Eight healthy subjects will be selected matching for age, gender and weight (BMI based).

The subjects will receive a single dose of 2 mg prucalopride in the morning after overnight fasting followed by the consumption of a standard breakfast after 2 hours.

Pharmacokinetic evaluation of blood samples will be done immediately before and at a specific timepoint up to 120h post-dosing. Urine samples will be taken to determine prucalopride.

Adverse events, including serious adverse events, will be reported from signing the Informed Consent until the last visit. Safety blood samples and a urine sample for urinalysis will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Main inclusion criteria for hepatic impairment subjects:

  * Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to Child-Pugh classification; Hepatic impairment must be stable, both clinically and biochemically;
  * Within the normal range of body height and weight on the basis of the Body Mass Index.
* Main inclusion criteria for healthy subjects:

  * Matching on sex, age and weight(BMI based).

Exclusion Criteria:

* History or suspicion of barbiturate, amphetamine or narcotic abuse; Suspicion of current alcohol abuse;
* Clinical suspicion or laboratory evidence of unstable hepatic impairment or acute liver injury;
* Clinically relevant renal disease as judged by the investigator.
A Comparison of Two Initial Dosing Formulas

This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.

The current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 U, or a weight-based formulas, 0.1-0.2 U/kg. The estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 U/kg. Those many weeks of dosage upward titration are required. The investigators propose to compare the current recommended weight based, 0.1 U/kg to a correction factor derived formula. Starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 U/kg. Further, there would be no significant increase in overall reported hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. Age 18 years and above
3. Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides
4. A1c ≥ 7.0% but ≤ 10%
5. Capable of self monitoring glucose ≥4/day
6. Previously compliant with clinical recommendations
7. Fasting blood glucose ≥ 150 mg/dl
8. BMI ≤ 45 kg/m2

Exclusion Criteria:

1. Urinary ketosis
2. Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatinine \>1.5 mg/dl), glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistant of another)
3. Currently participating in another clinical trial
4. Known or suspected allergy to insulin determir
5. Using insulin
6. Pregnancy or nursing or the intention of becoming pregnant or not using adequate
7. Significant liver or heart failure.
Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision

The aim of this study is to compare aesthetic results of two different type of sutures (subcuticular versus synthetic glue) in post-thyroidectomy incisions. It is a randomized clinical trial (single blinded) designed as a superiority study, since in the authors' hypotheses glue can give better results compared with subcuticular suture in this particular district. Secondary objective is to investigate if other factors (like the use of cold/warm blade, the sex, the presence of diabetes, the lenght of incision) can influence aesthetic results.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent thyroidectomy, emithyroidectomy, parathyroidectomy

Exclusion Criteria:

* Former neck operations with external incisions
* Post-operative bleeding
* Cervical nodes involvement (with the necessity of widened incisions)
Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis

The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form and HIPAA document
* Willing and able to comply with all study procedures
* Be at least 18 years of age at the time of enrollment
* 20/40 vision, or better, in each eye
* History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

* Preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, glaucoma, diabetic retinopathy, clinically significant blepharitis, follicular conjunctivitis and iritis)
* Have had any ocular infection within the last 30 days
* A positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears)
* Any significant illness that could be expected to interfere with study parameters
* Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye
* Use of any investigational product or device within one month prior to Visit 1 or during the study period
* Concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial or within the washout period
* Any blood donation or significant loss of blood within 56 days of Visit 1
* Any history of autoimmune disease, immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant. Any known history of iritis/uveitis, glaucoma, or other chronic ophthalmologic disorder other than allergic conjunctivitis
* History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 3 months prior to Visit 1
* Known history of alcohol abuse and/or drug abuse