cyrilzakka/clinical-trials huggingface dataset:
A Study To Estimate The Effects Of Itraconazole On Pharmacokinetics Of Pf-06649751 In Healthy Adult Subjects

The purpose of this study is to evaluate the impact of CYP3A4 inhibitor, itraconazole, on plasma concentration of PF-06649751 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

* Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
* Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).

Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.

* Unwilling or unable to comply with the Lifestyle Requirements described in this protocol
* Subjects who had a history of allergy or intolerance to azole antifungal drugs
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients

The clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have recently been reported in two clinical trials. The SOLOIST reported the benefits of sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of Heart Failure (HF), while the SCORED involved T2DM patients with Chronic Kidney Disease (CKD). It is worth noting that not only did the event curves separate within the first week post-treatment, but the effects of sotagliflozin on HF-related outcomes were observed regardless of Left Ventricular Ejection Fraction (LVEF) values and did not seem to attenuate with increasing LVEF as seen with empagliflozin and sacubitril/valsartan. Despite the favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these benefits remains unclear.

The present study aims to investigate the potential (non-glucose dependent) "cardio-renal" pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind, placebo-control trial in HF patients with preserved ejection fraction (HFpEF). Comparisons between treatment groups will be made using cardiac MRI, CPET, 6-MWT and KCCQ-12.


Eligibility Criteria:
Inclusion Criteria: patients should meet all of the following criteria

* Ambulatory patients age ≥ 18 years
* Written informed consent prior to admission to the trial.
* No diabetes as confirmed by HbA1c \<6.5%, fasting serum glucose \<126 mg/dL, and review of concomitant medications and medical history
* Diagnosis of Heart failure (NYHA II to III)
* LVEF \> 50%
* On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥4 weeks prior to screening, except for diuretics which must have been stable for ≥2 weeks prior to screening
* Women of child-bearing potential must agree to use birth control measures with a failure rate of \<1% per year during the treatment period of the study

Exclusion Criteria:

* Type 1 and Type 2 diabetes
* Acute coronary syndrome (ACS) or cardiac surgery within the last week.
* Pregnant or lactating women,
* Acute decompensated HF or hospitalized for HF within 1 month from screening visit
* Glomerular Filtration Rate (GFR) \< 25 ml/ min/1.73m2,
* Patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, HIV medication and rifampin.
* Receiving SGLT2-I 3-months prior to randomization.
* non-MRI compatible PM or ICD and any other medical or physical condition considered unappropriated by a study physician.
Multicomponent Yoga Intervention for Major Depressive Disorder

The purpose of this study is to evaluate the efficacy of a multi-component yoga intervention featuring Sudarshan Kriya Yoga (SKY) as an adjunctive treatment for patients with Major Depressive Disorders with incomplete response to antidepressants.

According to the World Health Organization, compared to two hundred health conditions, depression is ranked as the second leading cause of disability worldwide. The annual prevalence of Major Depressive Disorder (MDD) in the United States is estimated at 7% and the lifetime risk approximately 17%. Depression is associated with approximately 75% of all deaths by suicide, resulting in immense suffering for families and society at large. 83 billion dollars are spent per year on treatment and lost productivity related to the disorder. Current treatments for MDD have remission rates between 35-50%. Patients who respond to treatment, but do not experience clinical remission are at markedly increased risk for relapse. Approximately 50% of patients treated with two trials of antidepressant interventions do not achieve clinical remission. Consequently, novel evidence-based treatment modalities that can further treat this devastating disorder are needed. Mind-body interventions constitute a large and diverse group of practices that reduce both stress and inflammation and are increasingly being evaluated in the treatment of MDD The 2007 NHIS concluded that 16.6% of U.S. adults, representing 34.1 million Americans, used at least one mind-body intervention in the past year. Initial studies with different mind-body interventions have been shown to improve outcomes in MDD. A recent meta-analysis gave a Grade B for current evidence for the use of yoga as an intervention for MDD. Sudarshan Kriya Yoga (SKY) is a advanced yogic breathing intervention that has been reported to relieve symptoms of major depressive disorder and generalized anxiety disorder. In MDD, SKY can correct the P300 amplitude, decrease plasma cortisol levels and increase plasma prolactin levels. In a small-scale randomized controlled trial, 45 consenting inpatients meeting criteria for DSM-IV severe, melancholic depression were randomized to receive SKY, electroconvulsive therapy (ECT) or imipramine treatment for four weeks (Janakiramaiah et al. 2000). Consequently, the rigorous evaluation of a multicomponent yogic intervention featuring SKY as an adjunctive treatment for adults with MDD warrants further study.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depressive Disorder
* Able to give informed consent
* Aged 18-67
* Currently in outpatient care for MDD
* On a stable antidepressant regimen for at least 2 months
* 17-item Hamilton Depression Score \>14 at screening \& baseline visit

Exclusion Criteria:

* Currently in crisis requiring inpatient treatment
* Bipolar Disorder, Psychotic Disorder, ADHD, Substance Use Disorder
* Pregnancy, Epilepsy
* Initiating psychotherapy or other yoga/meditation program
EEG Classification System for Dementia

The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups.

In the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. The categorization is performed during the data analysis.

The groups in the data analysis will initially be based on the following:

1. Healthy controls
2. Mild Cognitive Impairment
3. Alzheimers Disease (AD)
4. Lewy-body Dementia
5. Parkinsons Disease Dementia
6. Vascular Dementia (VaD)
7. Frontotemporal Dementia (FTD)
8. Depression

Other groups will be added if needed.


Eligibility Criteria:
Inclusion Criteria:

* Age of participant in the range of 50-90 years

Exclusion Criteria:

* Outside required age range
Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19

Food forms an integral part of diabetes management. As children mature into young adults, they must learn to adopt lifestyle behaviours critical for optimal diabetes care. The development of food preparation and cooking skills at a young age may help to facilitate healthy food choices in children and provide a solid foundation for young adulthood. Food skills workshops are effective interventions that have been shown to improve food literacy and healthy eating in the general pediatric population. However, food skills programs have not been adequately evaluated in children with type 1 diabetes. Further, virtual programs are not well assessed, which can increase the accessibility of food education during the pandemic and in the future.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for over one year

Exclusion Criteria:

* Type 1 diabetes for less than one year, non-English speaking, do not have access to a computer or internet
Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture

The aim of this study is to observe how the hemodynamic changes induced by spinal blockade affect cerebral oxygenation. Elderly patients are very frail. Hypotension is very frequent during spinal anaesthesia. Bradycardia is other side effect of regional anaesthesia affecting cardiac output and cerebral blood flow. These complications of spinal anaesthesia could decline cognitive function. In this way a non invasive monitoring technique as cerebral oximetry is useful for the safety of anesthetic procedure.

Patients aged 70 years old with hip fracture presenting for surgical repair under intrathecal anaesthesia performed with bupivacaine or L bupivacaine (dose 7 - 9 mg). Preoperative haemoglobin and drugs consumption are registered. All patients receive supplemental oxygen during surgery. Cerebral oximetry, blood pressure, heart rate and oxygen arterial saturation are measured. Level and duration of sensory and motor block are registered. The study observes if there is any correlation between cerebral oximetry and these hemodynamic parameters.

The investigators also observe if there is any correlation between cerebral oximetry and cognitive function evaluated pre and postoperatively by SPMSQ test.

Postoperative SPMSQ test will be performed on the 5th postoperative day and the complications registered.Patients will be followed for the duration of acute hospital stay.

Eligibility Criteria:
Inclusion criteria:

* Patients aged \>70 years old with hip fracture.
* No contraindication for spinal anaesthesia.

Exclusion Criteria:

* Allergic reaction to local anesthetics.
* Severe aortic stenosis.
* Local infection.
* SPMSQ test \>7 errors.
* Patient refusal
Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects

Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat foot. Little is known about the effectiveness of their interaction on managing flatfoot.

The study aims to evaluate the effect of insoles and short foot exercise on the height and area of the medial longitudinal arch of flexible flatfoot participants as well as the force and pressure.

Study design: A parallel, active-control study design was used to conduct a single-blinded randomized controlled trial.

Method: The toe rising test, the "too many toes" sign, and the navicular drop test was used to select 30 participants with flexible flatfoot. Participants was randomly assigned either to an experimental group (n = 15) or a control group (n = 15). The experimental group received short foot exercises (SFE) and insoles, and the control group received only insoles. SFE was implemented 30 times for a duration of three minutes each day over the course of six weeks. The exercise progressed from sitting to standing and finally to one leg stance position within every two weeks. The participants wore shoes containing orthotic insoles for eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure distribution (force, area, and pressure) at baseline and at two-week intervals throughout the six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate restriction in participants' functional abilities, and the navicular drop test (NDT) was used to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline and at the sixth week.

Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two groups across time and within-subject observations of the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Females and males aged between 18 and 36
* Bilateral symptomatic flexible flatfoot, with symptoms including foot pain and lower limb fatigue
* Participants must show positive physical examination findings, including a positive result for the "too many toes" sign, the navicular drop test, and the foot toe raising test (Carr et al., 2016). A positive result for the "too many toes" sign occurs when more toes can be seen on the lateral side of each foot due to external rotation and abduction of the feet, and the positive result for the toe rising test is the reconstruction of the medial longitudinal arch secondary to the tightness of the plantar fascia (Carr et al., 2016). A positive result for the navicular drop test is an arch height more than or equal to 10 mm(Aenumulapalli et al., 2017)

Exclusion Criteria:

* An anatomical discrepancy in leg length
* Pathologic or neurologic disorders of the feet
* A history of traumatic foot injury or surgery within the last six months
* History of wearing foot orthoses within the past two years
A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults

The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of Calcipotriene/Betamethasone Dipropionate (CAL/BDP) PAD cream in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (greater than or equal to \[\>=\] 18 years) male or female participants with mild-to-moderate plaque psoriasis of the scalp (defined as scalp-PGA score of 2 or 3 at baseline) with or without involvement of the trunk and limbs, and who may or may not have been previously treated (treatment-naive participants) with other anti-psoriatic therapies.
2. Participants who have been prescribed CAL/BDP PAD cream (Wynzora®) treatment to manage plaque psoriasis of the scalp according to SmPC in routine clinical practice.
3. Willingness and ability to participate in the study; participants must give their written consent to participate.

Exclusion Criteria:

1. Participants with severe plaque psoriasis, per physician global assessment.
2. Participants with erythrodermic, exfoliative or pustular psoriasis.
3. Participants previously treated with systemic drugs for psoriasis (conventional or biologic) within the last 12 weeks prior to inclusion.
4. Concomitant systemic treatment with anti-psoriatic drugs.
5. Concomitant treatment of any type for plaque psoriasis of the scalp.
6. Hypersensitivity to the active substances or to any of the excipients of CAL/BDP PAD cream (Wynzora®).
7. Participants with known disorders of calcium metabolism.
8. Participants with viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.
9. Pregnant or breastfeeding women, except when the potential benefit justifies the potential risk.
10. Participants unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
11. Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
Effect of Combined Exercise Training in Patients With Multiple Sclerosis

The aim of this clinical trial is exercise in sarcopenic MS patients to demonstrate the effectiveness of education. The main questions it aims to answer are: -Can exercise training make a change in muscle thickness in sarcopenic MS patients?

--Does exercise training have an effect on balance in sarcopenic MS patients?

- Does exercise training have an effect on the risk of falling in sarcopenic MS patients?

Participants will:

They will continue combined exercise applications 3 days a week for 8 weeks. Evaluations will be made before the application and at the end of the 8 weeks. The data will be analyzed afterwards.

A significant decrease in physical performance is observed in MS patients. The reasons for this can be changes in muscle contractile structures and symptoms such as sarcopenia. Sarcopenia is a disorder characterized by loss of skeletal muscle mass and decrease in muscle strength and physical performance. Loss of muscle mass seen outside of old age is defined as secondary sarcopenia. In recent years, studies on neurological disorders and their relationship with sarcopenia have increased. Early diagnosis of sarcopenia in neurological patients and implementation of applications aimed at this are important from an early stage. The aim of this study is to examine the effect of exercise training in sarcopenic MS patients. In the study, participants will be applied a combined exercise program 3 days a week for 8 weeks. Parameters such as muscle thickness, balance, and fall risk will be evaluated before and after physiotherapy application including aerobic exercise, balance exercises, and strengthening exercises.

Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with MS by a neurologist
* People with ambulation whose EDSS is 4.5 or below
* People between the ages of 18-50
* People who do not exercise regularly and are not included in an exercise program

Exclusion Criteria:

* Having been diagnosed with sarcopenia before MS diagnosis
* Having had an MS attack within the last 30 days
* Having any musculoskeletal problems that may affect walking and balance
* Having a diagnosed psychiatric disease that may affect cognitive status
* Having a neurological disease other than MS
Moringa Supplementation for Improved Milk Output

The overall objective is to obtain preliminary data on the effect of Moringa oleifera leaf supplementation (moringa) at 4g daily for four weeks compared to placebo to improve human milk quantity and quality and infant health. Hypothesis: Four grams of moringa daily by mouth compared to placebo will increase breastmilk output and percent of mother's own milk consumed by infant.


Eligibility Criteria:
Mom

YES:

* willing to breastfeed or pump for one week
* willing to complete study activities (at minimum measure 24 hour pumped volume at start and end of capsules, take capsules daily, and answer questions)
* has access to breastpump (in hospital and/or home)
* English speaking
* 18 years or older
* Gave birth between 2-6 weeks prior to study start

NO:

* taking metoclopramide (trade name Reglan) currently or within 2 weeks of enrollment
* taking moringa regularly or within 2 weeks of enrollment
* breast surgery (amplification, reduction, or other)
* breast condition: Insufficient Glandular tissue
* unprescribed or street drug use at any point in pregnancy, or enrolled in rehab program or receiving addiction therapy
* refuses to take 4 capsules twice daily within 2 days of study start
* wishes to withdraw within 2 days of study start

Infant

YES:

* 28-36 and 7 weeks gestation (ie 37 weeks is too old)
* 2-6 weeks old
* singleton birth

NO:

· any condition where breastmilk is clinically contraindicated
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea

To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

In this Phase 3, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 18 years of age and older.
3. Participants must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
5. Have 2 nodules or less.

Exclusion Criteria:

1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

Chronic rhinosinusitis (CRS) is one of the most common chronic diseases, affecting the quality of life of patients who suffer. Despite medical and surgical treatments available, there are a significant number of people suffering from CRS refractory to these standard treatments.

A preliminary clinical trial conducted at CHUM Hôtel-Dieu, has allowed us to evaluate the therapeutic potential of intranasal irrigation of probiotics in patients with CRS. This treatment administered twice daily for 14 days was well tolerated and resulted in improved chronic rhinosinusitis symptoms.

Prior to deployment on a larger scale, the safety of this therapy must be confirmed in a healthy population, free of sinus disease. Therefore, this study aims to assess the safety of the use of probiotic intranasal irrigation in healthy volunteers.

If the participant (healthy volunteer) agrees to participate in the study, and after signing the information consent form, her/his participation in this project will consist to receive the experimental treatment of probiotics, to come to four (4) medical assessment visits at CHUM, over a period of time of four (4) weeks, and answer to one (1) phone call.

This study will include five (5) periods :

1. Determination of eligibility period (Day 0)
2. Saline irrigation period (Day 0 to Day 7)
3. Elimination of saline period (Day 8 to Day 14)
4. Probiotic treatment period (Day 15 to Day 21)
5. Telephone follow-up period (Day 22 to Day 28)

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 and older.
* Participant in general good health.
* Absence of nasal and ear signs or symptoms.

Exclusion Criteria:

* Participant suffering from acute rhinosinusitis, chronic rhinosinusitis, symptomatic allergic rhinitis, or other sinus disease.
* Participant with diseases of the middle ear causing impairment of the eardrum or middle ear, or have had surgery of the middle ear previously, except myringotomy with insertion tube.
* Primary or acquired immunodeficiencies documented.
* Antibiotic intake within 30 days before enrollment.
* Unable to do nasal rinse.
* Pregnant woman.
* Smell score from UPSIT-40 under normal smell threshold (\<34).