cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

The goal of this exploratory study is the characterization of the pharmacokinetic (PK) profile of paracetamol in older patients and the specific PK (pharmacokinetic) variables associated with plasma exposure in this population.

The goal of this exploratory study is the characterization of the pharmacokinetic profile of paracetamol in older patients and the specific PK variables associated with plasma exposure in this population. The primary endpoint is the identification of the pharmacokinetic parameters: area under the curve (AUC), peak plasma concentration after administration of paracetamol (Cmax) and the time at which the Cmax is observed (Tmax) of paracetamol. The secondary endpoint consists of 3 sub-endpoints:

1. The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
2. The association between the PK parameters and pathophysiological factors
3. The correlation between PK parameters and clinical parameters.

Eligibility Criteria:
Inclusion Criteria:

* a minimum age of 80 years
* admission to the acute geriatrics ward
* oral intake of paracetamol 1000 milligram (mg) in tablet form tid
* a steady state situation (defined as at least 4 consecutive intakes of paracetamol before sampling)

Exclusion Criteria:

* palliative care setting with downgrading of care
Simulation-Based Training Program Effect on Pediatric Nurses Regarding Heel-Prick Screening Test

This study aimed to assess the impact of simulation-based training on pediatric nurses' knowledge and performance regarding the heel-prick technique used during newborn blood screening tests in select hospitals in Saudi Arabia and Egypt. This study utilized an experimental pre-test and post-test design. The G\*Power Program® Version 3.1.9.4 was employed to determine the necessary sample size to fulfill the study's objectives. The sample consisted of 50 nurses recruited from the Maternity \& Children Hospital Bisha, Al-Namas General Hospital in the Kingdom of Saudi Arabia, and Pediatric Assiut University Hospital in Egypt. The current study's findings indicate that, following simulation-based training, pediatric nurses significantly improved their heel-prick knowledge and performance during the newborn blood screening test. This study provides strong evidence that the simulation-based training program improved nurses' knowledge and performance, and we advise all pediatric healthcare practitioners, physicians, and nurses employed in hospitals and healthcare facilities to undergo advanced simulation-based training. Nursing managers can target public hospitals with low scores by putting systematic methods into place to improve nurses' performance and knowledge in simulation-based training.

One of the best ways to impart important skills to trainees is through simulation-based training which is more reliable than the conventional method of doing clinical examinations. It is used in pediatric nursing training to allow nurses to practice and improve their clinical and conversational skills during an actual child encounter. A heel-prick is a complex psychomotor task that requires skill and knowledge on the part of the pediatric nurse who is performing the procedure while applying for the National Newborn Screening Program.

Eligibility Criteria:
Inclusion Criteria:The study's inclusion criteria encompassed nurses, regardless of their age, gender, education, experience, part-time status, or administrative responsibilities, who gave their consent to participate. Pediatric nurses in experimental and control groups had recently graduated, worked for less than 6 months, and did not have any training program by simulation-based training for using the Newborn Blood Spot Test Simulator regarding heel-pricks during newborn blood screening tests.

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Exclusion Criteria:The exclusion criteria included nursing experience for more than six months, as well as non-consenting participants.

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Tele-Pharmacy Intervention to Improve Treatment Adherence

The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment.

Long-term adherence to evidence-based medications remains exceptionally poor. Half of all patients become non-adherent within a year of treatment initiation. Interventions that improve medication adherence may have important clinical benefits across large populations, and may even be cost-saving by reducing rates of costly and morbid clinical outcomes such as myocardial infarction and stroke.

The Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC 2 IT) is a cluster randomized controlled trial (RCT) evaluating whether a novel tele-pharmacist-based intervention improves medication adherence and disease control among individuals with hyperlipidemia, hypertension, and diabetes who are nonadherent to their medications and who have poor or worsening disease control. The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. Potentially eligible patients will be identified using data from paid-prescription claims data and the electronic health record. The study is being conducted at 14 practice sites in a large multi-specialty group practice with approximately 250 primary care physicians. Practice sites will be randomized to intervention or control. In intervention sites, the primary care physicians of potentially eligible patients will be asked whether they would like patients to be enrolled in the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Filled and poorly adherent (defined as a PDC \< 80%) to medication for hyperlipidemia, hypertension, or diabetes
* Suboptimal average adherence to all of the qualifying medications that a patient has filled (defined as combined (average of averages) PDC \< 80%)
* For patients with hypertension or diabetes, poor or worsening disease control (according to relevant clinical targets)

Exclusion Criteria:

* Patients with \<6 months of continuous enrolment in the health plan
* Patients with no available contact information
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition

The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fed conditions

An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fed conditions

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).

Exclusion Criteria

1. Hypersensitivity to isotretinoin or related compounds.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
7. Regular tobacco use in the 3 months prior to study dosing.
Clinical Trial of Exercise in Patients With Spinal Muscular Atrophy (SMA)

This study is being conducted to test whether exercise can be effectively used as an intervention to treat Spinal Muscular Atrophy (SMA). In order to answer this question, the investigators will enroll 14 subjects with SMA between ages 8 and 50 and ask them to complete an 18 month training schedule. At some points subjects will be asked to closely follow a specific training regimen and at other points they may be asked to exercise in the same manner they do normally. The exercises they will be asked to perform include biking on a stationary cycle and lifting hand weights. Subjects will be asked to come in to the clinic seven times over the course of the study to perform tests. These tests include motor function measures, a physical exam, questionnaires, a exercise capacity test which involves riding a stationary bicycle, and test where the subject is asked to walk as far as they can in six minutes. The main goal of the study is to see if the subjects who participate in the exercise protocol have larger increases in the distance they can walk in six minutes than those who do not.


Eligibility Criteria:
Inclusion Criteria:

1. Weakness and hypotonia consistent with the clinical diagnosis of SMA type 3, i.e. having achieved the ability to walk independently
2. Laboratory documentation of homozygous absence of SMN1 exon 7
3. ability to walk at least 25 meters without assistance
4. Aged 8 to 50 years at the time of enrollment
5. Ability to tread the stationary cycle ergometer
6. Written informed consent of patient (if ≥ 18 years of age) or parents/guardian (if \< 18 years of age), and assent for participants who are of minor age.

Exclusion Criteria:

1. Inability to walk independently at least 25 meters
2. Any acute co-morbid condition interfering with study participation in the judgment of the investigators within 7 days of enrollment including bacterial infection, viral infectious process, food poisoning, temperature \> 99.0ºF, need for acute treatment or observation due to any other reason, as judged by the investigator; patient can be included after resolution of the acute event
3. Use of investigational medications intended for the treatment of SMA including riluzole, valproic acid, hydroxyurea, oral use of albuterol, sodium phenylbutyrate, butyrate derivatives, creatine, carnitine, growth hormone, anabolic steroids, or agents with known or presumed histone deacetylase (HDAC) inhibition, within 30 days prior to study entry. After signing informed consent, participants may discontinue prohibited medications and will then qualify for a screening visit after the 30 day wash-out period
4. Inability to meet study visit requirements, or cooperate reliably with functional testing and exercise protocol
5. Coexisting medical conditions that contraindicate travel, testing or moderate intensity exercise
6. Pregnant or breastfeeding women, or those intending to become pregnant during the course of the study.
Training Therapists in Motivational Interviewing

The purpose of this study is to test the efficacy of a Motivational Interviewing intervention on therapy participation as performed by physical and occupational therapists in an inpatient setting with patients with spinal cord injuries.

Physical and Occupational Therapists that work in the inpatient spinal cord injury unit will be trained in Motivational Interviewing and will use the communication style to determine whether it is an effective tool to increase participation in therapy as opposed to patients who will have Physical and Occupational Therapists that are not trained in Motivational Interviewing.

Eligibility Criteria:
Therapist Inclusion Criteria:

* Inpatient therapist specializing in spinal cord injury patients for at least 3 months
* Practicing on one of the two designated inpatient units
* Willing to collect Patient Rehabilitation Participation Scale (PRPS) daily on their patients
* Willing to audio record conversations with patients;
* Willing and able to participate in 16 hours of MI training
* Willing to receive feedback on MI skills

Therapist Exclusion Criteria:

* Inpatient therapist specializing in spinal cord injury patients for less than 3 months
* Unwilling or unable to follow the study protocol

Patient Inclusion Criteria:

* Inpatient in the spinal cord injury unit
* Has a physical or occupational therapist who is a participant in the study

Patient Exclusion Criteria:

* Unwilling to allow for therapy sessions to be recorded
Evaluation of Muscle Activation Efficiency in Challenging Subjects

The purpose of this study is to determine whether muscle activation can be accomplished more effectively and comfortably in challenging subjects using novel configurations of an activation device. A novel device will be compared side by side with a market leading device.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 (Wing 1 of study)
* Non-hospitalized with confirmed diagnosis of COPD (Wing 2 of study)

Exclusion Criteria:

* Age \< 18 years
* Subject has an implanted pacemaker/defibrillator
* Subject diagnosed with epilepsy
* Subject has implanted metallic femoral rods
* Subject is chair- or bed-bound
* Subject has neuromuscular disease or abnormalities
* Subject BMI \> 45
* Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study
The Predict H Trial

The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy affects tissue oxygenation and organ perfusion.

Background: Intraoperative arterial hypotension is associated with poor postoperative outcomes. The Hypotension Prediction Index developed from machine learning, predicts the occurrence of arterial hypotension from the analysis of the arterial pressure waveform. The use of this index can reduce the duration and severity of intraoperative hypotension in adults undergoing noncardiac surgery.

Methods: We will conduct a multicenter, randomized, controlled trial (N=80) in high-risk surgical patients scheduled for elective major abdominal surgery. All participants will be randomly assigned to a control or intervention group. Hemodynamic management in the control group will be based on standard hemodynamic parameters. Hemodynamic management of patients in the intervention group will be based on functional hemodynamic parameters provided by Hemosphere platform (Edwards Lifesciences Ltd), including dynamic arterial elastance, dP/dtmax and the Hypotension Prediction Index. Tissue oxygen saturation will be non-invasively and continuously recorded by using near-infrared spectroscopy technology. Biomarkers of acute kidney stress (cTIMP2 and IGFBP7) will be obtained before and after surgery. The primary outcome will be intraoperative time-weighted average with a mean arterial pressure \< 65mmHg.

Discussion: The aim of the study is to determine whether a goal-directed algorithm based on the prevention of arterial hypotension using the Hypotension Prediction Index reduces the duration and severity of intraoperative hypotension when compared with the recommended standard therapy and if this intraoperative strategy affects tissue oxygenation and organ perfusion.

Eligibility Criteria:
Enrolled patients will be at least 65 years old and/or American Society of Anesthesiologist (ASA) physical status III/IV, scheduled for elective major abdominal surgery (general surgery, urology, or gynecology, through laparoscopic or open approach), with general or combined anesthesia. Surgery will be considered to be major if the expected duration is \> 2 h, or the estimated blood loss is \> 15% of blood volume, or if the expected required transfusion is ≥ 2 packed red blood cells.

Exclusion criteria will be pregnancy, surgery performed only under regional anesthesia, preoperative glomerular filtrate \< 60 ml/min/1.73m2 according to the CKD-EPI 2009 formula, persistent atrial fibrillation, known cardiac shunts or if the patient received a kidney transplant, and refusal of the patient to participate in the study.
Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy

Investigators assess the gastric contents by ultrasonography in fasted patients undergoing cholecystectomy.

Investigators evaluate the gastric volume through cross sectional area and amount of clear fluid using Perlas grade by ultrasound in the supine and right lateral position of fasted patients undergoing cholecystectomy. Full stomach is regarded if solid gastric contents are detected or clear fluid is more than 1.5 ml/kg. The frequency of full stomach will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cholecystectomy

Exclusion Criteria:

* Presence of gastric anatomic abnormality or pathology
* A previous surgery of esophagus or stomach
* Current pregnancy
* Who could not lie in the right lateral decubitus (RLD) position
Genetic Study of Patients With Primary Ciliary Dyskinesia

OBJECTIVES:

I. Characterize the clinical presentation of patients with primary ciliary dyskinesia.

II. Identify the genetic mutations associated with this disease.

PROTOCOL OUTLINE:

Participants undergo a scrape biopsy acquisition of nasal cells for ciliary studies, a chest radiograph, sinus radiographs, lung function tests, sputum cultures, nitric oxide measurement, and an ear, nose and throat evaluation to screen for primary ciliary dyskinesia (PCD). Blood collection and/or a buccal scrape is also performed for genetic studies.

Genetic studies include molecular linkage analyses, genetic mapping, and gene mutation identification based on large deletions. Microsatellite markers are used to identify polymorphism.

Genetic counseling is provided to all participants.

Eligibility Criteria:
* Histologically or cytologically confirmed primary ciliary dyskinesia (PCD)
* Family members of patients with PCD
Using Pedometers for the Assessment and Enhancement of Mobility in Gynaecological and Oncological Patients Following Surgery.

This is a prospective cohort study, planned to study the effects of pedometers (digital step counters) on patient mobility following gynecology and gynecology oncology surgeries. The investigators plan to study the effect of personalized repeated feedback approach based on pedometer results in patients following gynecology and gynecology oncology surgeries.


Eligibility Criteria:
Inclusion Criteria:

Patients following gynecology and gynecology oncology surgery Consent to participation No medical recommendation for bed rest and limited mobility

Exclusion Criteria:

Refusal to participate Medical recommendation to limit mobility
VEGF Concentrations After Intravitreal Bevacizumab vs Ranibizumab as a Treatment for Type 1 ROP

The Retinopathy of Prematurity (ROP) is one of the leading causes of blindness on the pediatric age worldwide. This pathology is characterized for arrest of the normal vascular and neuronal retina that because of pathological compensatory mechanisms results in proliferation of vascular tissue that grow in the limit between the vascular retina and the avascular retina.

The ET-ROP group classified the ROP by those who need treatment immediately or those who doesn't need treatment, The classification is the following Type 1 ROP--\>ROP zone I any stage with plus, zone I stage 3 without plus, zone II stage 2 y 3 with plus Type 2 ROP --\> Zone 1, Stage 2 or 3 without plus, and Zone II, stage 3 without plus.

The treatment is begun on patient with type 1 ROP and type 2 ROP is maintained in observation.

It has been documented that de Vascular Endothelial Growth Factor (VEGF) is involved on the physiopathology of this disease.

The VEGF is a glucoprotein that regulates the angiogenesis and the vasculogenesis, it's presence is crucial on the growth and development of several tissues around the organism.

Nowadays the treatment of type 1 ROP it si focus on the disminution of the intravitreal VEGF after the intravitreal application of drugs like Bevacizumab and Ranibizumab.

However these drugs can pass through the hematorretinal barrier in to the blood stream where they can also decrease the systemic levels of VEGF.

We still don't know the long term effects of the intravitreal application of these drugs on premature babies, but there is the concern.

The objective of this study is to compare the serum VEGF concentrations after intravitreal application of Bevacizumab (0.500mg/0.02mL) versus Ranibizumab (0.25 mg/0.025mL) for the treatment of type 1 ROP.

HYPOTESIS: The serum VEGF concentrations after the intravitreal application of Bevacizumab will be smaller than the serum VEGF concentrations after the intravitreal application of Ranibizumab.

METHODOLOGY: Safety ECCA. Inclusion criteria, premature newborns who fulfill the criteria for type 1 ROP according to the ET-ROP classification.

The investigators will identify the patients that can be included The principal investigator will take a blood sample of 500 microliters and then the patients would receive intravitreal treatment assigned randomly (Bevacizumab 0.5mg/0.02mL or Ranibizumab 0.25mg/0.25 mL).

The principal investigator will take new blood samples a day, 2 weeks and 8 weeks after the application of the intravitreal treatment, these samples will be frozen to further analysis.

The analysis will be performed by ELISA kits.

The investigators are going to describe the results of the ELISA for the blood samples, and then make a comparison between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Premature newborns that fulfill the criteria for type 1 ROP, according to the Early Treatment of ROP classification on both eyes.

Exclusion Criteria:

* Patients that do not continue the required evaluations.