cyrilzakka/clinical-trials huggingface dataset:
Adverse Drug Event Prevention Using Structured Pharmacist Review

The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the Unites States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem.

A recently described approach to hospitalised older patients' medication optimisation is that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. Whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. At discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and GP. The intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. In an RCT comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (MAI), Beers' criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist review of older peoples' medication in hospital is a proven intervention in term of reducing inappropriateness of medication.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 65 years and over presenting to CUH Accident and Emergency Departments with acute illness for admission under a medical team will be eligible for the study.

Exclusion Criteria:

1. Age less than 65 years.
2. Patient to be admitted under the care of a Geriatrician Psychiatrist of Old Age or Clinical Pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (These doctor groups are likely to minimise inappropriate medications in this population).
3. Terminally ill patient attended by palliative care team.
4. Critically ill patient e.g. admitted to Intensive Care Unit.
5. Patients who do not wish to participate in the study.
6. Patients whose hospital physician does not wish to participate in the study ver, its efficacy in terms of ADE prevention is not yet demonstrated.
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.


Eligibility Criteria:
Inclusion criteria Inclusion criteria

1. Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
2. Patients who had additional risk factor for thromboembolism; one or more of the following conditions/events:

   * Hypertension
   * Diabetes mellitus
   * Left-side heart failure
   * A previous ischemic stroke or transient ischemic attack
   * Age 75 years or older
   * A history of coronary artery diseases

Exclusion criteria Exclusion criteria

1. Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
2. Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
3. Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
4. Patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent
5. Patients with atrial myxoma or left ventricular thrombosis
6. Patients with contraindication to anticoagulant therapies
7. Patients scheduled for major surgery or invasive procedure
8. Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
9. Patients with uncontrolled hypertension
A Multicenter Retrospective Review of Management Strategies in Small Bowel Obstruction

The objective of the study is to review performance of water soluble contrast study in patients admitted with Small Bowel Obstruction(SBO), will improve quality and safety, and decrease length of stay and morbidity.

Performance of contrast study has been a part of the protocols at multiple institutions of the southwestern surgical congress. Plan to perform a retrospective review of management protocols at these institutions. Wish to know whether the implementation of a standardized, protocol-driven pattern of practice involving the performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.

The objective of the study is to review performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.

Performance of contrast study has been a part of the protocols at multiple institutions of the southwestern surgical congress.

Hypothesize that implementation of a standardized, protocol-driven pattern of practice involving the performance of water soluble contrast study in patients admitted with SBO, will improve quality and safety, and decrease length of stay and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* • Adults aged 18-89 years of age

  * Patients presenting with SBO

Exclusion Criteria:

* • Prisoners

  * Pregnant women
Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients

The aim of the current study is to compare the effects of ventilator hyperinflation and vibrocompression on lung compliance in mechanically ventilated patients.

Lower respiratory infections remained the world's most deadly communicable disease, ranked as the 4th leading cause of death.

The aim of mechanical ventilation is to reduce the ventilatory work and maintain gas exchange, but it also has deleterious effects on mucociliary transport and coughing ability. These effects provoke the stasis of secretions in the airways and bronchial obstruction, with hypoventilation, atelectasis, and consequent hypoxemia. This set of factors also favors microorganism multiplication and, thus, an increased incidence of ventilator-associated pneumonia (VAP), impaired gas exchange, pulmonary infection and fibrosis, and progressive reduction of lung compliance. To reverse or reduce these deleterious effects, bronchial hygiene techniques are used by physical therapists in several ICUs around the world. Among these techniques, tracheal aspiration, vibrocompression (VB), and hyperinflation with mechanical ventilation are commonly employed.

Lung compliance is inversely proportional to elastance. This elastic resistance is due to the elastic property of lung tissue or parenchyma and the surface elastic force. Any changes occurring to these forces could lead to changes in compliance. Compliance determines 65% of the work of breathing. If the lung has low compliance, it requires more work from breathing muscles to inflate the lungs. In specific pathologies, continuous monitoring of the lung compliance curve is useful to understand the condition's progression and to decide on therapeutic settings needed for ventilator management So, the current study will help to determine the effects of ventilator hyperinflation and vibrocompression on lung compliance and sputum production in mechanically ventilated patients.

Eligibility Criteria:
Inclusion Criteria:

* Eighty-one mechanically ventilated patients more than 48 hours up to 7 days
* Their ages range from 35 to 55 years old.
* Medical stability (mean arterial pressure \> 60 \< 110, systolic blood pressure \> 80, diastolic blood pressure \> 60, fraction of inspired oxygen \< 60, positive end expiratory pressure (PEEP) \<10)

Exclusion Criteria:

Patients will be excluded if they have the following conditions or diseases:

* Unstable hemodynamics
* Fraction of inspired oxygen (FiO2) ≥ 0.6
* PEEP ≥ 10 cmH2O
* undrained pneumothorax and hemothorax or subcutaneous emphysema
* Pulmonary pathology (e.g., acute respiratory distress syndrome, exacerbation of chronic obstructive pulmonary disease, and acute pulmonary edema)
* Unstable neurological problems (raised intracranial pressure).
* Lung Cancer
* Recent/unhealed rib fracture
* Any disease obstructs our study.
A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

Study to compare 2 different chemical forms of GSK1363089.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of solid tumor malignancy.
* 18 years old with ECOG of 0-1.
* female subject who is not pregnant
* Male subjects must agree to use contraception methods
* Able to swallow and retain oral medication.
* The subject will refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
* QTcB or QTcF \< 470 msec.
* Bilirubin = 1.5mg/dl, AST, ALT, ALP \<2X ULN in absence of malignant disease in the liver or \<5X ULN in case of liver involvement by the tumor.
* Serum Creatinine \<1.5mg/dL

Exclusion Inclusion:

* The subject has received anticancer treatment.
* The subject has participated in a clinical trial and has received an investigational product within 21 days.
* The subject has known brain metastases.
* The subject has uncontrolled intercurrent illness.
* History of sensitivity to any of the study medications, or components.
* The subject is known to be positive for the human immunodeficiency virus (HIV).
* Subjects who have had partial or complete gastrectomy.
* Pregnant females as determined by positive ß-hCG test at screening or prior to dosing.
* Lactating females.
* Unwillingness or inability to follow the procedures outlined in the protocol.
Family Lifestyles, Actions, and Risk Education Intervention: Version 2

The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.

Enrollment

After parent-child dyads complete screening and informed consent/assent procedures, participants will be invited to complete an online baseline assessment. Following the baseline assessment, dyads will be randomized to receive either the FLARE intervention or standard education. After randomization, each dyad will receive a unique log-in to a secure study website that will be used to review didactic materials prior to each intervention session.

Intervention Sessions

Dyads will meet with an interventionist via remotely-delivered live session for their three intervention sessions. Intervention sessions will be scheduled every two weeks. After completion of the last remotely-delivered session, all parents will receive quarterly booster messages via text or email.

Study Assessments

Dyads will be asked to complete online assessments after consent is given (baseline) and within the 4 days prior to Session 3. A first post-intervention assessment will occur 4 weeks after the last intervention session is held. A second post-intervention assessment will occur 4 weeks later. The long-term follow-up assessment will take place 1-year post-baseline. Each assessment is expected to take 15-30 minutes. Parents will also receive a brief assessment via text or email (depending on parent preference) at monthly intervals between the second post-assessment and the 1-year post-baseline assessment, and in the summer months immediately following the 1-year post-baseline assessment. All assessments will be completed electronically.

Eligibility Criteria:
Inclusion Criteria:

Adults are eligible for this trial if they:

* Are at least 18 years old AND
* Have been diagnosed with melanoma at any time in their life AND
* Have at least one biological child between the ages of 8-17 years who is able to participate in the trial with them.

Children are eligible to participate with their parent if they:

* Are between the ages of 8-17 years AND
* Had at least 1 sunburn in the last 12 months AND
* Have at least one biological parent with a history of melanoma who can participate in the trial with them.

Exclusion Criteria:

Adults and children will be excluded from participation if they:

* Do not speak English OR
* Are unable to participate due to developmental delay OR
* Received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p16.
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction

Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether of organic, psychogenic or relational cause. In this case the pudendal nerve is addressed, since it has its origin in the sacral plexus, deriving from the S2, S3 and S4 nerve branches. Its fibers have different innervation, being the pudendal nerve a mixed nerve, and estimating that it has 30% of autonomic innervation, and 70% of somatic innervation (50% sensory and 20% motor). Peripheral percutaneous nerve stimulation (proposed treatment) is performed with a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings of the deeper tissues.

The study corresponds to an experimental, prospective, multicenter, randomized, prospective clinical trial. According to the Granmo program, it has been calculated to recruit 72 subjects with erectile dysfunction, recruited from different leading urology and andrology centers such as Clínica LYX (Instituto de Urología de Madrid). Patients will voluntarily accept to be part of the study, and will be able to ask the principal investigator any questions they may have at any time. The intervention will be performed at the LYX Clinic (Urology Institute).

Eligibility Criteria:
Inclusion Criteria:

* Men
* Ages 18-60 years old
* Primarily organic cause diagnosed by Doppler:

Peak-systolic velocities (PSV). Tele-diastolic velocity (DTV). Resistance Index (IR)

* Initial IIEF-EF questionnaire scores: 1-25 points (mild, moderate or severe erectile dysfunction).
* Active sex life (more than 4 attempts per month).

Exclusion Criteria:

* Pelvic surgeries
* History of Peyronie's disease
* Penile surgeries, except circumcision or frenuloplasty
* Priapism
* Pelvic radiation
* Women
Impact of Sourdough Bread Consumption on Long-term Energy Intake: A Pilot Study of Feasibility

The present study is a pilot study examining whether long-term sourdough bread consumption reduces energy intake and blood lipids levels over a period of 4 weeks in free-living normalweight and overweight participants.


Eligibility Criteria:
Inclusion Criteria:

* Female and male participants
* Age range 18 - 50
* BMI range \>20 kg/m2 at screening visit
* Regular eating pattern (3 meals per day on at least 5 days per week)
* Habitual brown bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
* Stable body weight for the last 6 months

Exclusion Criteria:

* Currently smoking or willingness to smoke during the study period
* Pregnancy, lactation or wish to become pregnant during the study period
* Previous or current gastrointestinal or endocrine disorders
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* Coeliac disease or gluten sensitivity
* Allergy/intolerance to milk, egg, nuts, soy or sesame
* Habitual sourdough bread consumption of at least 1 slice per day (assessed by The European Prospective Investigation into Cancer (EPIC) Norfolk FFQ)
* Excessive concern about eating habits or body weight as evidenced from scores \< 18 on the restraint and disinhibition subscales of the Three-Factor Eating Questionnaire (Stunkard \& Messick, 1985)
Effects of Contact Lens Wear on Children's Self-Perceptions

The purpose of the study is to determine whether contact lens wear will improve children's self-perceptions more than spectacle wear.

Eight to eleven year old children will be randomly assigned to wear spectacles or soft contact lenses. The children's self-perceptions will be measured at baseline and every six months. We will compare the change in self-perception between spectacle and soft contact lens wearers over three years. We will also examine the effect of how much children initially like or dislike to wear glasses on the change in self-perception over three years.

Eligibility Criteria:
Inclusion Criteria:

* 1.00 to 6.00 D spherical component myopia, based on cycloplegic autorefraction
* 1.00 DC or less astigmatism, based on cycloplegic autorefraction
* 20/20 or better best-corrected visual acuity in each eye
* Global stereoacuity of 250 seconds of arc or better based on Randot stereoacuity

Exclusion Criteria:

* Contact lens wear within the past month
* Ocular health problems that could affect vision, eye development, or contact lens wear
* Systemic health problems that could affect understanding of surveys or contact lens wear
* Participation in other eye or vision studies that prescribed a treatment
Effectiveness Study of New Generation Bednets in the Context of Conventional Insecticide Resistance in the Democratic Republic of the Congo

Despite the mass distribution of LLINs (long-lasting insecticidal nets) as a Malaria control strategy, populations are still continuously exposed to a high frequency of malarial inoculation in some countries. The situation can be explained by a swift increase in the resistance of Anopheles to common insecticides. To preserve the gains of insecticides and improve their effectiveness, a new generation of bednets treated with piperonyl butoxide combination insectides have emerged.But more evidence is needed to plead for scale up of their usage. The lack of information relating to the additional impact of that combination on the transmission of Malaria, its relative efficacy in real-life setting and its safety in users are the rationale for more investigation.This will be a randomized controlled study on a dynamic cohort of households with 1680, 0-10 years-old subjects in 30 villages will be recruited to compute the effectiveness of this new tool.

The findings will be useful information for decision-making by national malaria control programs, their partners, the international community and the bednet manufacturers with regard to the effectiveness of the new combination of insecticides in real-life context. The results will also enable a better design of the tool in the future and a broader understanding of long-term dynamics for sustainability, as well as identification of some factors with negative impacts on the benefits of the strategy.


Eligibility Criteria:
Inclusion Criteria : -households where there are one or more children below the age of 10 years;

* Ability and willingness of the head of the household to participate based on signed informed consent (or fingerprint) and with the assistance of an impartial witness (if the head of the household is illiterate)

Exclusion Criteria :

* refusal of the head of household to participate
* known allergy to insecticides
Lifting and Tightening of the Face and Neck Utilizing the Ulthera® System

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with a non-invasive treatment to obtain lift and tightening of facial and neck tissue utilizing the Ulthera® System to deliver ultrasound energy in a focused manner below the surface of the skin.

The primary objective of this clinical trial is to demonstrate the effectiveness of the Ulthera® System to obtain improvement in overall lifting and tightening of skin.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Subject in good health.
* Skin laxity in the lower face and neck.
* Willingness and ability to comply with protocol requirements and return for follow-up visits.
* Provides written informed consent and HIPAA authorization.

Exclusion Criteria:

* Pregnant or lactating.
* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face and lower neck.
* Excessive skin laxity on the face and neck.
* Significant scarring in areas to be treated.
* Significant open facial wounds or lesions.
* Severe or cystic acne on the face.
* Presence of a metal stent or implant in the facial area to be treated.
Circulating PRCP in STEMI Patients Undergoing Primary PCI

Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on circulating prolylcarboxypeptidase (PRCP) level and activity.


Eligibility Criteria:
Inclusion Criteria:

* Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
* Age ≥18 years;
* Informed consent from subject or next of kin.

Exclusion Criteria:

* Nonischaemic Cardiomyopathy;
* Cardiac surgery planed in the 6 months;
* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
* Renal or hepatic failure;
* Malignancy, HIV, or central nervous system disorder;
* Cardiopulmonary resuscitation \>15 min and compromised level of consciousness;
* Cardiogenic shock;
* Current participation in any research study involving investigational drugs or devices;
* No written consensus;
* Previous myocardial infarction.