cyrilzakka/clinical-trials huggingface dataset:
Patient-Centered Pharmacist Care in the Hemodialysis Unit: A Quasi-Experimental Interrupted Time Series Study

Nonadherence to medications by patients requiring hemodialysis (HD) leads to unfavorable clinical outcomes.Limited data exist on the influence of pharmacists on pharmacoadherence by patients requiring HD. Therefore, we assessed the impact of patient-centered pharmacist care through the implementation of concepts of Medication Therapy Management (MTM) and motivational interview (MI) on pharmacoadherence and its outcomes in patients requiring HD.

Patients were assessed at baseline for baseline characteristics, dialysis-related factors, and medications records

1. Pharmacists conducted brief monthly interview for patients to assess the medications they are receiving
2. A comprehensive interview for patients occurred at month 3 and 5 including concepts of MTM and MI
3. MTM included a review of each participant's medications and personal medication record to identify the use of any over-the-counter medications, design of their medication-related action plan, formulation of specific therapeutic interventions, and referrals for discussion with their physician and subsequent documentation and follow-up. The therapeutic interventions accepted by the physician were further discussed with each patient/caregiver using the MI technique to encourage adherence and this discussion was documented in each patient's medication record.
4. MI incorporated the main components reported in the literature: rolling with resistance; expressing empathy; avoiding argumentative behavior; highlighting the discrepancy between patients' current attitudes compared with the desired therapeutic goals; and empowering patients' self-efficacy

Eligibility Criteria:
Inclusion Criteria:

* Patients (≥18 years of age)
* Outpatient HD for at least 3 months before the study period

Exclusion Criteria:

* Patients who refused to participate in the study
* Patients without the capacity to understand or take responsibility for their medications
GLP-1 Effects on Insulin and Glucagon in PTDM

Post-transplantation diabetes mellitus (PTDM) develops in 10-15 % of all renal transplant recipients within 10 weeks after transplantation, and has been associated with increased risk of cardiovascular disease and impaired patient survival. PTDM is primarily believed to be a variant of type 2 diabetes mellitus (T2DM), but the pathophysiology underlying the impaired glucose metabolism in renal transplant recipients with PTDM is unclear and some aspects are still poorly investigated. Hyperglycemic clamp investigations with concomitant infusion of glucagon-like peptide-1 (GLP-1) are warranted for a thorough characterization of the α-cell and β-cell function.

The primary objective of the present study is to investigate whether hyperglucagonemia is present in renal transplant recipients with PTDM. Furthermore, the investigators aim to examine the insulinotropic and glucagon suppressive effects of GLP-1 (compared to placebo) in PTDM patients during fasting glycemia and during hyperglycemic conditions (hyperglycemic clamp), respectively.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients more than 1 year post transplant with stable renal function (less than 20% deviation in serum creatinine within the last 2 months) and stable prednisolone dose (maximum 5 mg/day) the last three months before inclusion
* Diagnose of PTDM on standard clinical follow-up performed 8 weeks and 1 year post transplant at OUS-Rikshospitalet (fasting plasma glucose ≥ 7.0 mmol/l and/or 2-hour plasma glucose ≥ 11.1 mmol/l following an oral glucose tolerance test) OR
* Non-diabetic renal transplant recipients with a normal glucose tolerance test (control group)
* \> 18 years of age
* BMI 18.5-29.9 kg/m2
* Signed informed consent

Exclusion Criteria:

* Severe liver disease
* Pancreatitis (chronic or acute), previous bowel resection, inflammatory bowel disease, malignancy (previous or actual)
* Estimated GFR \< 25 ml/min/1.73 m2
* Pregnant or nursing mothers
A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers

The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.

The purpose of the investigation is to evaluate the safety and tolerability of an investigational new drug, PF-03049423, when dosed for two weeks in both healthy younger and healthy older subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy persons, male or female.
* For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive.
* For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive.
* Body Mass Index (BMI) of 18 to 35; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Subjects with clinically significant medical conditions.
* Women of non-child bearing potential.
* Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy.
* A positive urine drug screen.
Prospective Cohort Study of the Risk of Recurrent Atrial Fibrillation After Radiofrequency Ablation

In this study, the continuous inclusion of atrial fibrillation patients treated by catheter ablation in the Department of Cardiology, Peking University Third Hospital, through the collection of clinical data and outpatient follow-up, to explore the risk factors of atrial fibrillation recurrence after catheter ablation and the influencing factors of major clinical events in atrial fibrillation patients, and further guide the management mode of atrial fibrillation patients.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age \> 18
* 2) ECG or holter electrocardiogram confirmed atrial fibrillation

Exclusion Criteria:

* 1) Hematological diseases, autoimmune diseases and malignant tumors
* 2) Immobility caused by hemiplegia or severe trauma
* 3) The expected survival time is less than 2 years
* 4) Poor compliance and high risk of expected loss of follow-up
* 5) Disorders of consciousness or Alzheimer's disease
Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.

Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).

Eligibility Criteria:
Inclusion Criteria:

- Moderate papulopustular rosacea (IGA\>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia

Exclusion Criteria:

* Sensitivity to any of the treatments used
* Co-existing conditions that would unfavorably influence the course of the disease
* Pregnant or lactating women
* Severe rosacea
Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa

This study is to compare the effectiveness of three different antihypertensive treatment strategies for reaching a target blood pressure (clinic BP) of \</= 130/80 mmHg among patients \<65years of age and \</= 140/90 mmHg among patients \>/=65years of Age in HIV-positive and HIV-negative patients with uncomplicated arterial hypertension in rural Tanzania and Lesotho.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive and negative patients of African descent and black ethnicity with a documented uncomplicated, untreated arterial hypertension (blood pressure \>/=140/90 mmHg) diagnosed at one of the 2 study sites

Exclusion Criteria:

* Current hospitalization for any reason
* Not of African descent
* Refusal of an HIV-test or indeterminate HIV test result
* History of cardiovascular event in the last month (anginal pain, stroke, myocardial infarction or diagnosis by a doctor)
* Symptomatic arterial hypertension (blood pressure \>/=180/110 mmHg plus headache or chest pain) or acute cardiovascular event
* acute disease, (e.g. fever \>37.5°C or other signs of acute concomitant infection; Dyspnea/respiratory distress; Acute pain)
* Clinical signs of hypertension-mediated organ damage (heart failure, bilateral pitting edema, bilateral crackles or pleural effusion, distended jugular veins, ischemic heart disease (anginal pain on exertion), signs of current ischemic/hemorrhagic stroke (hemiparesis, loss of consciousness)
* Pregnancy (test required for females 18-45years of age)
* Non-consenting or inability to come for follow-up visits
* creatinine clearance \</=30ml/min by Chronic Kidney Disease Epidemiology Formula (CK-EPI) estimation and measurement with a point-of care creatinine from capillary blood
Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Evaluate the Malignancy Risk Value of Thyroid Nodules

The goal of this clinical trial is to explore the value of a multimodal ultrasound model based on Angio Planewave Ultrasensitive Imaging, Shear Wave Elastography and grayscale ultrasound in the differential diagnosis of benign and malignant thyroid nodules. The main questions it aims to answer are:

Can an innovative ultra-microvascular classification system based on Angio Planewave Ultrasensitive Imaging distinguish between benign and malignant thyroid nodules? How about the performance of multimodal ultrasound model to Guide the Fine-Needle Aspiration Management of Thyroid Lesions?

Participants will:

Undergo grayscale ultrasound, SWE, and Angio Planewave Ultrasensitive Imaging multimodal thyroid ultrasound examination within one week before surgery Undergo surgery and obtain the postoperative pathological diagnosis


Eligibility Criteria:
Inclusion Criteria:

1. age more than 18 years;
2. Voluntarily signed informed consent;
3. Have 1 or more thyroid nodules detectable by ultrasound;
4. participant underwent surgical procedure to confirm the pathologic results

Exclusion Criteria:

1. Nodules are accompanied by large calcifications followed by acoustic shadows
2. History of previous neck surgery or cancer, thyroid medications, radiation or surgical treatment;
3. Poor quality of retained images or non-standard operations (such as intermittent scanning and improper probe compression), and incomplete pathological results.
Acupuncture as a Complementary Treatment for Hypertension (ACT-HAS)

This is a randomized clinical trial with blinded, multi-center, involving the Federal University of in Rio de Janeiro(UFRJ), through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of in Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia of Vitoria, developed by building doctorate thesis as a final product of the research.

The objective of investigation is the effectiveness of acupuncture as a complementary health care to patients with primary hypertension drug therapy.

Methodological approach - Randomized Clinical Trial triple blind.

Population / sample - Patients with Primary Hypertension in drug treatment for over a year and no effective control of blood pressure levels, that is, regular saving measures above was over 140x90 mmHg.

How centers Participants Research, the study covers health units of the Municipal Health of Maricá in Rio de Janeiro, the Municipal of Victoria Health in Espirito Santo, beyond the scope of Integrated Project Research-Service (PIPA), linked to School Nursing Anna Nery /UFRJ.

Primary Objective - To evaluate the effectiveness of acupuncture as a complementary health practice associated with drug treatment used in adults with primary hypertension, based on nursing diagnoses.

Secondary objectives:

* Estimate blood pressure levels after exposure to acupuncture applied in adults with primary hypertension.
* Draw the profile of the most frequent nursing diagnoses in adults with primary hypertension.
* Analyze the effectiveness of acupuncture as a complementary health therapy associated with drug treatment used on these clients, based on nursing diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* Be suffering from essential hypertension;
* Be properly prescribed medication and have difficulty controlling blood pressure keeping regular measurement above was over 140x90 mmHg.

Exclusion Criteria:

* A woman in pregnancy;
* Be in possession of any type of cancer;
* being a smoker;
* be alcoholic;
* Be in drug treatment for other diseases including obesity;
* Not dieting for weight loss;
* practice regular physical activity.
Revealing Increased Axonal Loss in Treated HIV Patients

HIV patients may suffer sooner from aging than average population, including brain aging. Our hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in HIV patients, this loss could be detected earlier by a thinning down of retinal nerve fiber layer (RNFL), compared to non HIV patients of the same age.

The investigators aim to compare the thickness of the RNFL and the thickness of the RCGs measured by spectral domain OCT between patients infected by HIV and patients of same age non infected by HIV.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection known since at least 10 years
* viral load undetectable under ARV treatment since at least 5 years, whatever the type of ARV
* lymphocytes CD4 \> 350, whatever the CD4 nadir
* signed informed consent

Exclusion Criteria:

* History of ocular pathology, eye surgery, or intraocular injection
* Familial History of glaucoma
* ametropia (\>3 dioptres on the sphere and \>1,5 dioptres on the cylinder)
* known neurological pathology, active or former
* History of ethambutol or synthetic antimalarial drug consumption
* History of chemotherapy
* Active and regular use of drugs
* non-weaned chronic alcoholism
* contra indication to MRI
* diabetes
* cognitive disorders (MoCA\<26)
* non covered by health insurance
* patient under legal protection
* pregnant or breast-feeding woman
* Non inclusion criteria for control patients: known HIV infection
Association of Intravenous Ketamine With Thoracic Epidural Analgesia: Effects on Pain and Respiratory Function Following Thoracotomy.

Thoracotomy for lung resection is deemed painful. Ketamine is now a renewed interest in preventing acute postoperative pain. A previous study performed in the service testing the association ketamine/morphine versus morphine PCA, postoperative, for patients who do not benefit from postoperative epidural thoracic surgery, has demonstrated a reduction of postoperative pain associated with a reduction of nocturnal arterial desaturation following surgery when ketamine was added to morphine.

In this prospective double blind randomized study, intravenous administration of an analgesic dose of ketamine was started since the induction of general anesthesia and continued during the first 48 postoperative hours in association with epidural analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Subject between 18 and 85 years
* subject of both sexes
* subject operated in the service of thoracic surgery of a lobectomy by thoracotomie lateral or postlaterale subject
* subject operated in settled surgery

Exclusion Criteria:

* Against indication in the epidural insanity,
* confusionnel, patient psychotic
* treatment in the long price by medicine which can interfere on the pain (morphine, antidepressants, psychotropic treatment)
International Validation Study Of The Algoplus Scale In Five Languages

Acute pain is responsible for unnecessary suffering. Among elderly patients, acute pain is frequent and underestimated, especially when these patients have cognitive disorders. The expression of pain is then modified and the conventional tools for evaluating pain cannot be used. Thus the existence of pain must be detected on the basis of a behavioural assessment.

It is nonetheless necessary to have the assistance of standardised and validated tools. In France, the Doloplus Group has proposed a scale called Doloplus, validated in January 1999, and is now proposing a new scale for acute pain, Algoplus that has been validated in French (4). Doloplus has been recently translated and validated in 5 languages and an identical methodology will be used in this protocol.

Internationally, although several teams are working on the development of scales that can be used for non-communicating elderly subjects, there is as yet no validated tool for acute pain assessment.

Considering 1- the lack of tools at an international level and 2- the frequent request from many practitioners worldwide, the Doloplus group has offered to validate the Algoplus® scale in 5 foreign languages, English, German, Spanish, Italian, Portuguese. A rigorous methodology with the help of a statistician will be used in this validation process.

50 patients per language will be explored : t1 = time t Physician M Physician N t2 = time t+4 hours Physician M

The methodology of the validation of our translation procedure consists of studying the reliability of the scale in two major steps:

* Data from a sample of 50 patients will be used to explore the test-retest reliability of the scale administered by the same trained clinician, on two occasions four hours apart, without any treatment in between. The ALGOPLUS® scores obtained from the patients at a time t will be compared with their (t + 4 hours) scores to assess test-retest reliability.
* For a sample of at least 50 patients, two physicians trained for the use of ALGOPLUS, will assess pain independently. A statistical test will be used to compare the results for the inter-rater reliability.

Eligibility Criteria:
Inclusion Criteria:

* - males or females aged 65 or above 65, with communication disorders
* with or without suspected acute pain

Exclusion Criteria:

* - are too agitated,
* have acute pain needing immediate pain management,
* change of treatment between the two evaluations ( t and t+4 hours ),
* refuse to participate
Versius or Laparoscopic Abdominal Hernia REpair

This trial will compare laparoscopic and robotic-assisted abdominal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.

This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of abdominal hernias. The study will randomise 60 patients who require repair of an abdominal hernia and have been deemed suitable for a minimally invasive approach. Patients will be randomised to receive either laparoscopic or Versius® robotic assisted surgery but will be informed that it will be attempted via a minimally invasive approach that could include either of these two subtypes of minimally invasive surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Need for abdominal hernia repair surgery

  * Incisional
  * Congenital
* Deemed suitable for minimally invasive surgery

Exclusion Criteria:

* Patients who are unable to consent
* Prisoners
* Patients in need of emergency surgery
* Patients with a hernial defect size of over 7cm
An Oral Nutritional Supplement Study in Older Malnourished Spanish Population

Post-marketing observational study of a nutritional care plan, including a higher calorie, higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished. The objective is to assess the impact of the ONS on body weight, activities of daily living and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study.
* Considered malnourished, or is at risk for malnutrition based on NRS 2002 score ≥3.
* ≥65 years of age.
* Conforms to the requirements set forth on the study product label.
* Under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/d of the study ONS, orally, by their health care professional.
* Free living or residing in a nursing home.
* Estimated, or measured, glomerular filtration rate \>60ml/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) Study equation) within 60 days of beginning their nutritional care plan.
* Body mass index (BMI) is \<30 kg/m2.
* Study physician determines the subject is fit to participate.