cyrilzakka/clinical-trials huggingface dataset:
Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Hospitalised Elderly Patients

The study population will consist of all elderly (65 and older) patients hospitalized at the Centre hospitalier universitaire de Sherbrooke. The patients who present a pharmacotherapeutic problem will be randomly allocated between intervention and control groups. Practically, the relevant data will be extracted from the Electronic Medical Record (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in geriatrics to determine their clinical relevance and the modifications that can be made. Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and treating physician to establish the changes needed to optimize drug therapy. A geriatrician will also be available to assist the pharmacist in his initial assessment for particularly complex cases. For control patients, a CAS analysis will be conducted to identify patients with a pharmacotherapeutic problem but there will not be a formal discussion amongst the health care providers (usual care) and the physicians of the control group will provide usual care to their patients. The investigators believe that it is ethical to provide usual care to the control group since the beneficial impact on patients outcomes of the investigators' intervention has not been demonstrated.

Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication committee and are based on the Beers criteria with an emphasis on drugs involved in the development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active at the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older: i) taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase inhibitor or memantine are frailty indicators.


Eligibility Criteria:
Inclusion Criteria:

* Patients 65 and older admitted at the Centre hospitalier universitaire de Sherbrooke

Exclusion Criteria:

* Patients admitted in psychiatry and intensive care
* Patients seen only in the emergency room
National Collaborative to Improve Care of Children With Complex Congenital Heart Disease

The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.

The purpose of this initiative is to improve care and outcomes for infants with HLHS by: 1) expanding the established NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, 2) improving implementation of consensus standards, tested by teams, into everyday practice across pediatric cardiology centers, and 3) engaging parents as partners in improving care and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Fetuses or newborns diagnosed with HLHS or other univentricular condition
* Intended to undergo Norwood procedure

Exclusion Criteria:

* None
Community Surveillance of Congestive Heart Failure

To conduct a surveillance study of congestive heart failure (CHF).

DESIGN NARRATIVE:

Systematic surveillance was conducted of CHF among residents, 35-84 years old, of the Minneapolis-St.Paul metropolitan area (population 2.45 million, 1995 estimate) in two complementary domains: 1) hospitalization for CHF in two calendar years, five years apart (1995 and the year 2000); and 2) newly diagnosed CHF over a 9-year period (1993-2001) among members of a large Health Maintenance Organization (HMO). The magnitude and characteristics of hospitalized CHF were assessed in all 21 acute care hospitals of the metropolitan area. One-third of all discharges with ICD-9 CHF codes were sampled randomly (n about 5,000 per surveillance year), abstracted by trained nurses, and classified according to clinical criteria and the results of diagnostic tests. Newly diagnosed CHF was distinguished from recurrent episodes of decompensated CHF by thorough review of the hospital record. A complementary perspective on CHF, including the outpatient setting, was provided by a systematic study of members of HealthPartners, one of the largest HMOs in Minneapolis-St. Paul. Using the HealthPartners database, all newly diagnosed CHF cases between January 1, 1993 and December 31, 2001 (n about 1,900) were identified and the diagnosis validated. Beginning in January 1, 1999, newly diagnosed CHF cases were identified on an ongoing basis (n about 600), surveyed by mail, and followed for one-year from the original diagnosis. Surveillance of the HealthPartners population supplemented hospital surveillance and contributed data on incidence, prevalence, treatment, use of resources, and patient outcomes.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Physiological Magnetic Resonance Imaging (MRI) to Improve Carotid Endarterectomy Outcomes

The carotid arteries are blood vessels in the neck that supply blood to the brain. Carotid stenosis disease is defined as a narrowing of these arteries due to the build up of plaque. The plaque material can also break off and move into the brain. The resulting blockage of blood supply to a portion of the brain is what causes 80% of all strokes. One treatment option is to have surgery on the carotid artery and remove the plaque. This procedure is called a carotid endarterectomy (CEA). There is evidence that proves CEA reduces the risk of stroke. The objective of this research project is to determine who is most likely to benefit from CEA surgery.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 30 years of age
* Greater than grade 9 education level
* Mini-mental state exam (MMSE) greater than 19 for carotid stenosis patients

Exclusion Criteria:

* History of acute stroke
* History of current psychiatric disorder, such as depression or movement disorder
* Diagnosed Alzheimer's Disease or dementia
Relationship Between Bladder Distention and Hysteroscopy Application

The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.

Women who should have diagnostic hysteroscopy procedure will be randomly allocated into two groups. In the first group hysteroscopy will be performed with a filled bladder and in the second group procedure will be performed with an empty bladder. The women will be assigned into groups randomly. The duration of the procedure, feasibility of the procedure and tolerability of procedure will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Women who are at reproductive age
* Women who are not pregnant at the time of presentation
* Women who are not nulliparous

Exclusion Criteria:

* Women who have previous cervical surgery or cervical incompetence.
* Women who have genitourinary infection
* Women who have profuse uterine bleeding or recent uterine perforation
* Women who have neurological disorders affecting evaluation of pain.
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve

Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient from 45 to 90 years old
* Patient agreeing freely to participate in the study
* Aortic surface area suspected to be \< 1 cm² or \< 0.6 cms²/m²
* Low aortic gradient defined by a mean pressure gradient \< 40 mmHg
* Aortic low flow defined by: a stroke volume indexed \< 35 ml/m2
* Any contra-indication for the realization of the MRI

Exclusion Criteria:

* Heart rhythm disorders
* Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L)
* Presence of a concomitant valvular heart disease with stenosis or regurgitation \> moderated
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Non-motor Symptoms and Brain Dopamine Transporter Binding

This project aims to clarify the role non-motor symptoms in the development of Parkinson's disease (PD) and to improve diagnostics at very early stages of PD. The project involves multidimensional measures of disease biomarkers together with brain dopamine transporter (DAT) imaging with \[123I\]FP-CIT single photon emission computed tomography (SPECT).


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 18-100 years
* Referred for clinical DAT SPECT in Turku or Helsinki
Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer

Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.

OBJECTIVES:

I. Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin.

II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic or unresectable carcinoma of the stomach
* Measurable disease
* No brain metastasis
* Performance status - Karnofsky 70-100%
* More than 3 months
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
* No history of any bleeding disorders
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 2 times normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No history of peptic ulceration or gastrointestinal bleeding
* No active infection
* No seizure disorder
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No other serious concurrent illness that would preclude study entry
* No medical, social, or psychological factors that would preclude study entry
* No prior chemotherapy
* No prior radiotherapy
* More than 4 weeks since prior major surgery
* Prior incomplete resection allowed
* No other prior antitumor treatment
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

Generate real-world evidence in the use of the da Vinci Surgical Systems for gynecological indications within the German health care system.

A prospective, non-interventional, multi-center, post market clinical study.

Eligibility Criteria:
Key Inclusion Criteria:

* Woman with 18 years of age or older
* Patient is willing to participate and to comply with the study procedures as demonstrated by signing the informed consent
* Patient is a candidate for a gynecological procedure to be performed with the Intuitive Surgical System

Key Exclusion Criteria:

* Life expectancy of less than 1 year
* Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women
* Current participation in a clinical study, if not pre-approved by Intuitive
* Individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliation
Study to Evaluate the Natural History of Osteoporosis in Children and Adolescents With Systemic Lupus Erythematosus

This is a study to determine if people with Lupus have weak bones.

Test which is a better method for detecting bone changes:

* Dual energy X-ray absorptiometry (DXA)
* Single energy quantitative computed tomography (SEQCT)

Evaluate whether weak bones are associated with things like medications or amount of fat and muscle.

This is a longitudinal cohort study to evaluate the natural history of osteoporosis in children and adolescents with Systemic Lupus Erythematosus.

The specific Aims are:

* To compare the BMD of children and adolescents with Systemic Lupus Erythematosus to healthy controls utilizing Dual energy X-ray absorptiometry (DXA) and Single energy quantitative computed tomography (SEQCT). The following questions will be addressed at baseline:

What is the variation of BMD seen among subjects with Systemic Lupus Erythematosus? Is the BMD of children with Systemic Lupus Erythematosus diminished relative to healthy controls? If BMD is diminished, what is the severity of the reduction?

* To characterize the annual change in BMD for children and adolescents with Systemic Lupus Erythematosus over a five year period in a longitudinal cohort study utilizing arial and volumetric densitometry methods of both trabecular- and cortical-rich regions of bone.
* To compare the use of DXA and SEQCT for measuring BMD in children and adolescents with Systemic Lupus Erythematosus.
* To characterize the determinants of BMD and corresponding markers of bone metabolism in a longitudinal cohort of pediatric Systemic Lupus Erythematosus subjects.
* To bank Systemic Lupus Erythematosus subject blood and urine specimens for future analysis. Future analysis will focus on newly developed bone metabolism markers, as this is a currently evolving area.
* To evaluate body composition in Systemic Lupus Erythematosus utilizing whole body DXA and to determine the contribution of body composition abnormalities to BMD.

Research Design and Method: This study includes a baseline cross-sectional component comparing Systemic Lupus Erythematosus subjects to normal healthy controls followed by a longitudinal follow up study of Systemic Lupus Erythematosus subjects. Systemic Lupus Erythematosus subjects and controls will be evaluated in a single-day visit to the University of California, San Francisco Pediatric Clinical Research Center for clinical assessment and phlebotomy followed by a radiologic evaluation at the Department of Radiology.

Eligibility Criteria:
Inclusion criteria:

* Systemic Lupus Erythematosus subjects 4/11 of the American College of Rheumatology criteria for SLE (23), age less than 22 years.

Exclusion Criteria:

* Neonatal SLE or drug-induced Systemic Lupus Erythematosus
* Subjects who are pregnant, and subjects weighing over 300 pounds, as the densitometry techniques are not reliable above this weight.
* Subjects receiving calcium or vitamin D supplementation will not be excluded but this information will be recorded and evaluated further in the dietary/nutritional assessment.
A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients

This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
* Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
* Patients with refractory lupus nephritis
* Proteinuria ≥ 0.5 g/day
* Patients who took steroid ≥ 20 mg/day over one month prior to the study
* Patients who failed a first-line therapy (non-responders to steroid monotherapy)

Exclusion Criteria:

* Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
* Patients who received tacrolimus in the past (excluding drugs for external use)
* Patients who used other immunosuppressants within 4 weeks before initiation of the study
* Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
* Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
* Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
* Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
* Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis
Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity

There is a correlation between endothelial progenitor cells (stem cells) and stenosis of the aortic valve.

Degenerative aortic valve (AV) stenosis (AS) is the most common valvular disease and increases in prevalence with age. Severe aortic valve stenosis accounts for considerable disease and death, especially in older patients. Aortic valve stenosis is the primary indication for valve replacement in western countries, and the number will only increase as elderly people are a growing subpopulation. Measures to identify AV disease earlier, to identify factors that influence disease progression and treat AV disease pharmacologically or with less invasive approaches would be a significant improvement over the current standard of care. These advances will only be possible with a better understanding the mechanisms underlying valve development and disease. Preliminary data suggest a novel pathophysiological concept for impaired valvular endothelial cells regeneration, leading to the progression of age-associated calcific AV disease and a potential treatment target is the disrupted endothelial cell layer of the valve leaflet.

The research objectives are:

1. To assess the number and function of endothelial progenitor cellss and apoptotic endothelial progenitor cellss in patients with mild, moderate and severe aortic stenosis.
2. To study the association between aortic stenosis progression, severity, symptoms and left ventricular function and the number and function of circulating endothelia progenitor cells. By understanding the correlation between valve severity, left ventricular longitudinal function and endothelial progenitor cells we will indentify high risk patients population that need early intervention. We hope to add new information on the pathogenesis of aortic stenosis and to indentify factors that predict disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Aortic stenosis
* Control with aortic stenosis

Exclusion Criteria:

* No
Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System

Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.

Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF safety-net system and access to care may be limited, novel models of health care delivery are warranted. The overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. Barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy.

Design: To rigorously examine the benefit of the centralized panel management to improve uptake of CRC screening with mailed FIT, the electronic health system will be used to identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed FIT kits + usual care versus usual care alone. The cost-effectiveness of no screening, usual care, and centralized management with mailed FIT outreach will be compared using mathematical simulation models.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic men and women
* 50 to 75 years of age

Exclusion Criteria:

* Personal history of polyps requiring colonoscopic surveillance
* Homeless
* Severe co-morbidities limiting life expectancy e.g., advanced stage cancer
OSTEOPATHY IN THE TREATMENT OF IBS SYMPTOMS IN ADULTS

Osteopathy is chosen by patients as a treatment for IBS but the evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.

a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group: active osteopathic treatment. Control group: sham osteopathic treatment. Randomization: allocation ratio 1:1. Assessment times: inclusion and baseline assessment (Day-1; Initial visit V0), Day 8, Day 15 and follow-up (1 month and 3 months), treatments (Day 0, Day 8, Day 15). Primary endpoint: Effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint: Effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size: 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 ans
* IBS patients (defined according to the Rome IV Criteria)
* Moderate symptom severity score on the IBS Symptom Severity Scale (IBS-SSS) (values ranging from 175 to 300).
* Negative colonoscopy within the last 5 years.
* Psychologically fit to provide signed informed consent.
* Agreed to undergo the procedures associated with the study
* Medical insurance

Exclusion Criteria:

* Have not received any osteopathic treatment in the last 12 months
* Chronic inflammatory bowel disease or digestive cancer (even if the disease is in remission)
* Pregnancy
* Planned or expected elective surgery during the study
* Dietary and lifestyle changes in the previous month.
* Use of prohibited concomitant medications in the previous month.
* Inability to understand or cooperate during the study.
* No current participation in a biomedical research trial.