cyrilzakka/clinical-trials huggingface dataset:
APIXABAN App Study

The aim of this clinical trial is to evaluate whether the medication reminder app and video call can improve medication adherence to apixaban in patients with AF and comorbidities.

Patients with AF and comorbid heart disease taking apixaban who meet the inclusion criteria will be randomised 1:1 to a treatment arm using a medication reminder app and bi-weekly video education and a control arm using the medication reminder app alone to compare medication adherence.

Patients in both groups will use the medication app, but only the treatment group will receive additional education and feedback via video call every two weeks to reinforce the use of the medication app and medication reminders with video education.

The study aims to assess the change in adherence between the two groups at week 8.


Eligibility Criteria:
Participants must meet all of the following criteria:

Adults aged 19 years or older with a diagnosis of atrial fibrillation (AF)

Presence of at least one of the following cardiovascular or metabolic comorbidities:

A. Heart failure

B. Hypertension

C. Coronary artery disease

D. Peripheral arterial disease

E. Diabetes mellitus

F. Stroke

G. Other cardiac diseases requiring treatment

Currently taking or planning to initiate oral anticoagulation therapy with apixaban

Able to use a smartphone with an Android operating system

Voluntarily provided written informed consent to participate in the clinical trial after being adequately informed of its purpose, procedures, and potential risks

2. Exclusion Criteria

Participants will be excluded if any of the following conditions apply:

Creatinine clearance (CCr) \< 15 mL/min

Presence of moderate to severe mitral stenosis

History of mitral valve repair or replacement

Clinically significant history of alcohol or substance abuse

Deemed by the investigator to be legally or psychologically unsuitable for participation in the clinical trial

Participation in another clinical trial involving investigational drugs within 4 weeks prior to screening

Declines or is unwilling to provide informed consent for participation in this study
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.


Eligibility Criteria:
Inclusion criteria:

* Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
* Recipients of a kidney with a cold ischemia time \< 30 hours.
* Recipients of a kidney from a donor 10 - 65 years old.

Exclusion criteria:

* Multi-organ transplant recipients.
* Recipients of an organ from an non-heart beating donor.
* Patients receiving a second kidney allograft if the first allograft was
* Functional for less than three years
* Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment.

Other protocol-defined inclusion/exclusion criteria may apply
Brain SPECT Following Cialis (Tadalafil ) Administration

The study will be an open label one and will include 30 patients who underwent ischemic stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients in the age range of 35-75 years.

Exclusion Criteria:

1. known allergic reaction to TF
2. Medical contraindication to use TF
3. Hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage
4. Acute stroke or cardiac ischemic event up to 3 month prior to study.
5. Other neurological brain diseases including degenerative diseases, multiple sclerosis, brain tumors, post severe brain injury (TBI) and migraine headache.
6. Sensory aphasia.
7. Cognitive impairment with disability to sign a consent form.Patients' Assessment
Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening

The goal of this cross-sectional, multicentric and descriptive epidemiological study is to assess the prevalence of chronic urinary retention (CUR) in elderly living in residential care for dependent elderly people in order to determine if there is an interest in offering them a bladder scan screening.

The main goal of this study is to assess the prevalence of CUR in elderly living in homes for the aged, the secondary ones are to evaluate the risk factors and complications of CUR.

We will carry out this prevalence study in 5 centres whit a draw of 40 residents per centre. Following an information and a non-opposition of the patients, we will collect datas in their medical file (age, medical history and comorbidities, current treatments, anticholinergic score according to the ADS (Anticholinergic Drug Scale), GIR score according to the AGGIR scale (Autonomie Gérontologique Groupes Iso Ressources), FAC modified score (Functional Ambulation Classification modified), MMSE score (Mini Mental State Examination), communicative capacity, notion of fall and date of last fall, knowledge of urinary incontinence, knowledge of constipation, knowledge of previous urinary screening by bladder scan and previous urological consulting, last urinalysis and its results, last analysis of creatinemia and creatinine clearance according to CKD-EPI) and we will perform up to 3 measurements of vesical volume by bladder scan.

The expected results are a prevalence of CUR between 10 and 20 % among people living in homes for the aged with more urinary tract infections, renal insufficiency and falls in the CUR group showing the interest of screening for CUR by bladder scan in elderly people living in nursing homes according to risk groups based on the risk factors found.

Eligibility Criteria:
Inclusion Criteria:

* Adult people
* Residents in a participating nursing home

Exclusion Criteria:

* Resident with indwelling urinary catheter or regular urinary catheterisation
* Resident or legal representative opposing participation
An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients

This is an observational, prospective, non-interventional, non-randomised, open label multicentric study planned to be conducted in 1000 subjects with mild to moderate primary hypertension in approximately 20 centres in Thailand. The purpose of this study is to examine the beneficial effects of combination of bisoprolol with hydrochlorothiazide available as Lodoz in treatment of Thai subjects with mild to moderate hypertension. The outcome of the study would also provide information on the optimal daily dosage schedule as well as adherence of Lodoz.

Essential hypertension is a heterogenous multifactorial disease affecting large number of population. Monotherapy treatment in hypertension is often unable to achieve the desired blood pressure (BP) goals and subjects even remain at significant risk for developing cardiovascular disease. The use of combination therapy as first line treatment for hypertension provides a solution to the management problems related to hypertension. Among combination drugs, low dose combinations are useful tools in treating large segments of hypertensive subjects because of their several advantages, such as simplified dosage regimens, improve compliance and hypertensive control, decrease dose dependent side effects as well as reduce costs.

OBJECTIVES

Primary objective:

* To evaluate the efficacy of Lodoz therapy when used in routine clinical practice in subjects with mild to moderate essential hypertension.

Secondary objective:

* To evaluate the discontinuation rate of Lodoz therapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Subjects diagnosed with mild to moderate essential hypertension
* Subjects foreseen for Lodoz treatment for hypertension
* Age ≥ 18 years

Exclusion Criteria:

* Subjects treated with Lodoz before study initiation
* Subjects who are pregnant
* Subjects with any known contraindications to Lodoz based on local label
The Impact of Watermelon Juice on Blood Pressure

L-citrulline is found naturally in watermelon. Recently interest has increased for this amino acid due to potential health benefits. Notably, L-citrulline has the potential to lead to dilation of blood vessels due to its involvement in the production of nitric oxide.

The study will be an acute single blind, randomised controlled, crossover intervention study in healthy, young volunteers. Participants receive either the test watermelon drink or control drink (water). Blood samples and vascular measures (by a single-cuff based method) will be measured at baseline. Vascular measures will be repeated at 15-minute intervals between 0-2 hours and a second blood sample will be drawn at 1.5 hours to coincide with the estimated peak plasma L-citrulline. Citrulline, arginine and nitric oxide metabolites will be measured in the blood samples.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 18-30 years
* Healthy (as per exclusion criteria)
* Able to understand information sheet
* Willing to comply with the study protocol
* Able to give informed consent.

Exclusion Criteria:

* Medical history of myocardial infarction
* Medical history of angina
* Medical history of thrombosis
* Medical history of stroke
* Medical history of cancer
* Medical history of high cholesterol
* Medical history of liver diseases
* Medical history of renal diseases
* Medical history of respiratory diseases
* Medical history of bowel diseases
* Medical history of diabetes
* Medical history of other endocrine disorders
* BMI \<18.5 kg/m2 or \>25 kg/m2
* Blood pressure \<90/60 or \> 140/90 mmHg
* Current use of antihypertensive medication
* Pregnant or lactating
* Alcohol intake \> 14 units/week
* Cigarette smoker (or quit within the last 6 months)
* Vigorous exercise \> 3 times/ week
Apixaban Discontinuation Prior to Major Surgery

The ADIOS study is a prospective, observational study will evaluate one hundred and thirty (130) patients with non-valvular atrial fibrillation who are currently receiving treatment with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who require an elective major surgical or invasive procedure will be included in the study. The purpose of the study is to evaluate the efficacy of the recommended pre-procedure washout period of 48 hours.

This study will estimate for what proportion of patients a 48 hour pre-procedure apixaban discontinuation is sufficient to achieve minimal apixaban plasma levels (less than 30 ng/mL) prior to surgery. The investigators hypothesize that this portion will be 80-95%.

All patients will have a blood draw at 48 hours prior to procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-Xa levels. Patients will also receive a follow-up phone call at 30 days to collect information on clinical events.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* On long term anticoagulation with apixaban for treatment of non-valvular atrial fibrillation or venous thromboembolism
* Undergoing elective major surgery or invasive procedure

Exclusion Criteria:

* Inability to obtain informed consent for the blood sample draws
* Any condition precluding collection of follow-up information
* Participation in another clinical trial
* Apixaban Package Insert Recommendations and Cautions
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
* Women must not be breastfeeding
* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of study drug apixaban (approximately 3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post- treatment completion.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of the study drug (approximately 3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion.
* Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However WOCBP must still undergo pregnancy testing as described.
* The safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves. Therefore, use is not recommended in these patients.
INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus

The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.

There is not sampling method

Eligibility Criteria:
Inclusion Criteria:

Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.

Exclusion Criteria:

Patients that do not have a minimum (pre-specified) of data in their clinical record.
Impact of Skin to Skin Contact on Maternal Satisfaction, Pain Scores, and Narcotic Usage After Cesarean Delivery

Early skin to skin contact has beneficial effects and is part of the Healthy Birth Initiative. Positive effects on breast feeding, cardiorespiratory status, blood glucose control, and temperature has been demonstrated. It is the standard of care for vaginal deliveries but surgery is a barrier in its initiation in the operating room. This study is evaluating initiating skin to skin contact as soon as feasible in the operating room. Informed consent will be obtained from scheduled/non emergent cesarean sections who are of EGA.37 weeks who are ASA I-II and receiving the standard spinal anesthetic. Skin to skin contact will be initiated after delivery as soon as apgars and newborn assessment has been completed. Goal is a minimum of 60 minutes of skin to skin contact between the mother and the newborn, with the only interruption being upon movement from the OR table to the stretcher when leaving the OR. Subjects seen post delivery day 1 for assessments of pain and maternal satisfaction utilizing a sliding 100mm VAS assessment tool.

Initiation of skin to skin contact between the mother and the baby will be done in the operating room during surgery rather than waiting until the recovery room as is our standard of care. After assurance that both mom and newborn are stable, the newborn will be placed across the mother's chest and covered with a blanket to help maintain body temperature. The skin to skin contact is maintained throughout the remaining surgical time and then continued into the recovery room. The subjects are seen post delivery day 1 for evaluation of their pain and satisfaction with care using a 0-100mm sliding VAS scale, with 0=not satisfied at all or no pain at all through 100 = total satisfaction and most severe pain ever.

Eligibility Criteria:
Inclusion Criteria:

* non emergent cesarean deliveries term gestation age ASA I or II spinal anesthetic

Exclusion Criteria:

* contraindication to spinal anesthetic or to medications utilized emergence cesarean delivery under age 18 less than 37 weeks gestational age
Text-message Support to Improve Oral Antibiotic Adherence After ED Discharge

The investigators are testing the hypothesis that patients who are exposed to daily text-message (TM) assessments with feedback will have better adherence to prescription than those patients not exposed to TM-based queries with feedback.

Short course, oral antibiotics are frequently prescribed to patients treated/discharged from the Emergency Department. Medication adherence involves the patient taking the proper daily dosing of prescribed medication for the entire length of time it is prescribed. Previous studies have shown that prescription non-filling rates range from 5 to 20%. Other studies have shown that even if patients fill their prescription, as low as 30-40% will properly take the medication. The purpose of this study is to determine if the proportion of patients discharged from the Emergency Department that are adherent with antibiotics is higher in patients that are provided TM support using self-report.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and older
* Planned discharge form the ED on oral antibiotics

Exclusion Criteria:

* non-English speaking
* Prisoner
* No personal mobile phone with text message features
Effect of an Apple Polyphenol Extract on Brachial Artery Flow-mediated Vasodilatory Function

Effect of apple polyphenols on FMD.

The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Borderline hypertension
* Otherwise healthy
* Aged 40-65 years (inclusive)
* Not consuming high amounts (over 20 mg daily) of flavonoids

Exclusion Criteria:

* BMI \>32 kg/m2
* Total serum cholesterol ≥ 8 mmol/l
* Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant
* Coronary artery disease
* Pregnancy or lactating
* Alcohol abuse as evaluated by medical history
* Regular smoking/using nicotine products
* Diabetes mellitus
* Apple allergy
* Use of lipid lowering medications
* Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction
* Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject
* High consumption of vitamin products, herbal remedies or products containing flavonoids
Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health

This study evaluates the addition of a mouth rinse containing sea salt, xylitol and lysozyme to standardized oral health practices on biofilm formation and gingival health in a group of young adults.

The purpose of this study is to evaluate a new sea salt mouth rinse containing xylitol and the antibacterial enzyme, lysozyme on biofilm formation and gingival health in a group of young adults. Xylitol is a well-established non-sugar sweetener and an anti-caries agent. The use of this polyol results in loosely adherent biofilms by reducing the amount of extracellular lipopolysaccharides and lipoteichoic acids, facilitating its easy removal by mechanical means. Lysozymes are antibacterial proteins that hydrolyze the linkage between N-acetylmuramic acid and N-acetylglucosamine of peptidoglycan in the cell wall of Gram + bacteria effectively limiting growth.

Eligibility Criteria:
Inclusion Criteria:

* Dentate
* Medically healthy
* No orthodontic bands
* An anticipated ability to attend the two scheduled visits

Exclusion Criteria:

* Significant medical condition (including but not limited to, poorly controlled diabetes mellitus, rheumatic heart disease or clinically significant heart murmur)
* Pregnancy
* Recent history of, or ongoing, antibiotic therapy
A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery

It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.

During neurosurgical procedures intubation, insertion of the head pins, extubation and the early postoperative period are the time lines in which cerebral autoregulation can be impaired by changes in heart rate and blood pressure. Several anesthetic regimens have been implied to overcome this problem. Remifentanil is used in neurosurgery since it allows early recovery and neurologic evaluation. Esmolol on the other hand is also very short acting, effective to blunt cardiovascular responses during surgery and has no significant effect on intracranial pressure and cerebral blood flow. In addition esmolol is addressed to reduce perioperative ischemia during noncardiac surgery.

It was hypothesized that the use of esmolol as an alternative to remifentanil with sevoflurane inhalation anesthesia during intracranial surgery, could provide better hemodynamic conditions and cause lesser side effects in the perioperative period. It was the main objective of this study to compare the effect of esmolol and remifentanil on the incidence of tachycardia and hypertension and the intraoperative fentanyl consumption. The comparison of postoperative troponine I and creatine phosphokinase levels and EKG changes were the secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* Intracranial surgery

Exclusion Criteria:

* heart rate ≤ 50,
* atrioventricular block,
* sick sinus syndrome,
* heart failure,
* history of asthma,
* hypertension,
* impaired renal or hepatic function,
* patients receiving beta blockers or calcium channel blockers,
* emergency surgery.
Impact of E-cigarette Use on the Body

This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.

PRIMARY OBJECTIVE:

Examine the short-term impacts of vaping on pulmonary and respiratory outcomes.

OUTLINE:

Current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. Before and after the 30 minute vaping \[video\] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will also undergo collection of blood.

Eligibility Criteria:
Inclusion Criteria:

* 75 e-cig users and 75 never-users
* No self-reported diagnosis of lung disease (e.g., coronavirus disease-2019 \[COVID-19\], pneumonia, cystic fibrosis)
* No history of cardiac event or distress
* Not currently breastfeeding, pregnant, or planning to become pregnant (e-cig users only; will be confirmed via pregnancy test)