louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01580774: Effect of Post-discharge Phone Calls on Patient Outcomes
Official title: Effect of Post-discharge Phone Calls on Patient Outcomes for General Internal Medicine Patients Discharged From a Teaching Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transition
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population is patients admitted to a general internal medicine ward.

Brief summary: The purpose of this study is to determine whether a post-discharge telephone call to general medical patients discharged home will improve quality of care and adherence, and reduce hospital readmission.

Detailed description: Currently, discharge from hospital in many institutions is a confusing process for patients filled with uncertainty and potential for harm. For instance, 1 in 5 discharges results in a post discharge adverse event, many of which are related to medication errors. These may lead to serious harm and possibly require readmission to hospital. Telephone follow-up calls after discharge has been studied in small single-center trials and as a part of a coordinated, multi-layered discharge process but its direct effectiveness is not known. Understanding the impact of this simple intervention on patient outcomes is an important step towards improving patients' discharge from hospital.

Eligibility criteria: Inclusion Criteria:

* Admission to internal medicine ward
* Discharged to home
* Must have telephone access

Exclusion Criteria:

* Discharged to care facility
* Lack of telephone access

Primary outcomes:
measure: Care Transition Measure-3 score (CTM-3)
timeFrame: 30-days post discharge
Secondary outcomes:
measure: Hospital readmission
timeFrame: 30-day post discharge
measure: Emergency department visit
timeFrame: 30-days post discharge
measure: Patient satisfaction
timeFrame: 30-days post discharge
measure: Treatment plan adherence
timeFrame: 30-days post discharge
measure: Outpatient provider follow-up rates
timeFrame: 30-days post discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Christine Soong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soong C, Kurabi B, Wells D, Caines L, Morgan MW, Ramsden R, Bell CM. Do post discharge phone calls improve care transitions? A cluster-randomized trial. PLoS One. 2014 Nov 11;9(11):e112230. doi: 10.1371/journal.pone.0112230. eCollection 2014.
Clinical trial NCT05362474: Targeting Leukotrienes in Kidney Disease
Official title: Targeting Leukotrienes in Kidney Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Kidney Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diabetic kidney disease (DKD) is associated with significant morbidity and mortality. Identifying new treatments for DKD to be used alone or in combination with other therapies is a high priority. Inflammation plays a key role in DKD and targeting pro-inflammatory lipid mediators called leukotrienes may represent a promising therapy for DKD. The current proposal will investigate whether montelukast, a leukotriene antagonist, reduces proteinuria and improves vascular function and arterial stiffness in patients with DKD.


Eligibility criteria: Inclusion Criteria:

* CKD stage 3
* urine albumin to creatinine ratio 200-5000 mg/g
* blood pressure \<140/90 mmHg
* use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
* history of diabetes type 1 or 2
* BMI \<40 kg/m2
* Stable antihypertensive regimen for at least one month prior to enrollment
* Stable diabetes regimen for at least one month prior to enrollment
* Sedentary or recreationally active (\<2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)
* Able to provide consent

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Uncontrolled hypertension
* Factors judged to limit adherence to interventions (e.g. history of medication noncompliance, noncompliance with follow up visits, significant cognitive impairment, etc.)
* Anticipated initiation of dialysis or kidney transplantation within 3 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Allergy to aspirin
* Severe hepatic impairment (Child-Pugh Class C)
* History of major psychiatric disorder
* Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)
* Current use of SGLT2 inhibitor
* Current use of phenobarbital, rifampin or carbamazepine.

Primary outcomes:
measure: Change in Albuminuria at 3 Months
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Jessica Kendrick
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02037074: Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics
Official title: A Double-Blind, Escalating Dose Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Repeat Doses of EVP-6308 or Placebo in Subjects With Schizophrenia on a Stable Antipsychotic Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Phosphodiesterase 10 inhibitor
Lead sponsor: FORUM Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2014-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308 administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic regimen.


Eligibility criteria: Inclusion Criteria:

• Diagnosed with schizophrenia, male or female subjects, 18 to 60 years of age

Exclusion Criteria:

* Clinically significant abnormalities on physical examination, medical history, ECG, vital signs, laboratory values, or unstable medical or psychiatric illness
* Any disorder that may interfere with drug absorption
* Clinically significant allergy or sensitivity to medications Positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C antibody
* Pregnant or breast feeding

Primary outcomes:
measure: Safety and tolerability of EVP-6308 in subjects with schizophrenia currently receiving stable treatment with up to 2 atypical antipsychotics
timeFrame: Baseline to Day 21 or Early Termination
Secondary outcomes:
measure: Pharmacokinetics of EVP-6308 in subjects with schizophrenia and the potential for EVP-6308 to affect the pharmacokinetic properties of the antipsychotic regimen
timeFrame: Day -1 through Day 16
measure: Potential pharmacodynamics effects of EVP-6308
timeFrame: Baseline to Day 21 or Early Termination
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
Study officials:
References:
Clinical trial NCT03619174: LIBERATE International
Official title: LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: incontinence
urine
urinary
pee
leak
SUI
Lead sponsor: Viveve Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.

Detailed description: Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.

Eligibility criteria: Key Inclusion Criteria:

* Signed and dated ICF
* Pre-menopausal females
* Documented diagnosis of SUI

Exclusion Criteria:

* Pregnant or planning to become pregnant within the year
* Undergone other SUI treatments (excluding Kegels)

Primary outcomes:
measure: CFB in 1-hour Pad Weight Test
timeFrame: 6 months post-treatment
Secondary outcomes:
measure: Safety and Adverse Event Reporting
timeFrame: 6 months post-treatment
Other outcomes:
measure: UDI-6
timeFrame: 6 months post-treatment
measure: ICIQ-UI-SF
timeFrame: 6 months post-treatment
measure: I-QOL
timeFrame: 6 months post-treatment
measure: FSFI
timeFrame: 6 months post-treatment
measure: Voiding Episodes Per Day
timeFrame: 6 months post-treatment
Locations:
city: Vancouver
country: Canada
facility: LIBERATE In't Site
state: British Columbia
city: Pointe-Claire
country: Canada
facility: LIBERATE Int'l Site
state: Montreal
city: Burlington
country: Canada
facility: LIBERATE Int'l Site
state: Ontario
city: London
country: Canada
facility: LIBERATE Int'l Site
state: Ontario
city: Sarnia
country: Canada
facility: LIBERATE Int'l Site
state: Ontario
city: Toronto
country: Canada
facility: LIBERATE Int'l Site
state: Ontario
Study officials:
affiliation: Viveve Inc.
name: Stacie Bell, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04261374: Microcirculation in Dehydrated Older Patients
Official title: The Analysis of the Sublingual Microvascular Terminal Circuit Improves the Diagnostic and Therapeutic Algorithms in Dehydrated Older Patients- a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dehydration
Keywords: Microcirculation
dehydration
risk stratification
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who clinically dehydrated

Brief summary: This proof-of-concept study examines whether 1) sublingual measurement in dehydrated old patients is feasible, 2) frailty and incompliance in old, awake patients affects video-quality, 3) dehydration impacts microcirculation This prospective observational study includes clinically dehydrated patients aged ≥ 65 years, who have spontaneous circulation and access to the sublingual mucosa, immediately after admission. Dehydration will be assessed clinically. A sidestream dark field camera (SDF) will be used for measurement. Video-quality will be evaluated with MIQS (microcirculation image quality score). Both AVA 4.3C- and AVA POEM-software analyzed the videos. Seventeen patients ≥ 65 years not showing dehydration served as control.


Eligibility criteria: Inclusion Criteria:

* 65 years old or older
* diagnosed with dehydration according to the clinical impression of the treating physician
* informed consent
* the sublingual mucosa had to be accessible.

Exclusion Criteria:

* \<65 years
* Lacking informed consent
* time-critical disease
* previous resuscitation
* inaccessibility of sublingual area

Primary outcomes:
measure: Change from Baseline of Percentage of Perfusion Vessels [%]
timeFrame: at Baseline and after 24 hours
Secondary outcomes:
measure: Microcirculatory quality score (MIQS)
timeFrame: at Baseline
measure: Clinical Frailty Scale
timeFrame: at Baseline
measure: Barthel scoring
timeFrame: at Baseline
measure: Mini-Mental-Test scoring
timeFrame: at Baseline
measure: Rate of mortality
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References:
Clinical trial NCT03499574: Feasibility Study of Biofeedback in Dysphagia Therapy Post Stroke
Official title: A Randomised Controlled Feasibility Trial of Dysphagia Therapy Using Biofeedback in Patients With Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Dysphagia, Oropharyngeal
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2018-04-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study will investigate the feasibility of delivering swallowing therapy using surface electromyography as a means of biofeedback to patients with dysphagia in the acute stroke setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual care. The results will inform future dosing and efficacy studies.


Eligibility criteria: Inclusion Criteria:

* New diagnosis stroke, new dysphagia, medically stable, adequate trunk strength for videofluoroscopy.

Exclusion Criteria:

* Severe cognitive impairment, previous dysphagia, previous neurological condition, severe visual impairment

Primary outcomes:
measure: Number of participants recruited
timeFrame: 2 weeks
measure: Number of participants completing the treatment
timeFrame: 2 weeks
measure: Average number of sessions completed
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Swallow function - severity
timeFrame: Pre and post 3 week intervention intervention and at 90 days
measure: Change in Swallow function - intake
timeFrame: Pre and post 3 week intervention intervention and at 90 days
measure: Change in Swallow physiology - PAS
timeFrame: Pre and post 2 week intervention
measure: Change in swallow physiology - timing
timeFrame: Pre and post 2 week intervention
measure: Quality of life
timeFrame: Pre and post 2 week intervention and at 90 days
measure: Change in Clinical outcomes - disability
timeFrame: Pre and post 2 week intervention and at 90 days.
measure: Change in Clinical outcomes - stroke severity
timeFrame: Pre and post 2 week intervention
measure: Change in Clinical outcomes - tube status
timeFrame: Pre and post 2 week intervention and at 90 days.
measure: Change in Clinical outcomes - mortality
timeFrame: Pre and post 2 week intervention and at 90 days.
measure: Change in Clinical outcomes - pneumonia
timeFrame: Pre and post 2 week intervention and at 90 days.
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: Timothy England, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06583174: Evaluation of the Relationship Between Breastfeeding Attitudes and Nutrition Knowledge Levels
Official title: Evaluation of the Relationship Between Breastfeeding Attitudes and Nutrition Knowledge Levels of Mothers with 0-6 Months Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breastfeeding
Keywords: Breast milk
breastfeeding
nutrition
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: breastfeeding mothers

Brief summary: The importance of breast milk, whose physiological nutritional properties for an infant are not equal to any other food, has been the subject of many studies. In this study, it is aimed to evaluate the relationship between breastfeeding attitude and nutritional knowledge levels of mothers who have 0-6 months infants.


Eligibility criteria: Inclusion Criteria:

* volunteering
* Having a baby 0-6 months

Exclusion Criteria:

* not breastfeeding
* Being a pregnant

Primary outcomes:
measure: Nutrition Knowledge
timeFrame: Baseline
measure: Breastfeeding Attitude
timeFrame: Baseline
measure: Descriptive assessment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nigde
country: Turkey
facility: Nigde Omer Halisdemir University
state: Bor
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Elif Gökçe İnbaşı, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03975374: To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
Official title: Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Blepharo Conjunctivitis
Lead sponsor: Sutphin Drugs
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In group one, patients will be instructed to instill 2 gtt of Tobradex ophthalmic solution for 10 days.

In group two, patients will be instructed to instill 2 gtt of Tobramycin/dexamethasone solution for 10 days .
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare and describe efficacy and safety of Tobradex ophthalmic suspension versus generic Tobramycin/dexamethasone Suspension in treatment of Blepharoconjuctivitis through clinical parameters

Detailed description: Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter; Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.

Eligibility criteria: Inclusion Criteria:

* All potential subjects with symptomatic blepharitis examined to have blepharitis with healthy mental status, able to give consent, with/without co-existing medical conditions will be considered

Exclusion Criteria:

* All subjects with history and/or probable history of allergic reaction to tobramycin/dexamethasone and all subjects who have mental disability and are unable to give direct consent will be excluded

Primary outcomes:
measure: Sign and symptoms composite score
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jamaica
country: United States
facility: Sutphin Drugs
state: New York
Study officials:
affiliation: Sutphin Drugs
name: Ajai Prakash
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684574: Nordic Walking on Knee Osteoarthritis
Official title: Effects of Covid-19 and Nordic Walking on Older People with Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Keywords: Knee osteoarthritis
Quality of life
Covid-19
Exercise therapy
Nordic walking
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 71
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention is a program of nordic walking and strengtheining exercises
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to improve osteoarthritis symptoms and quality of life in older people with knee osteoarthritis from a primary care center. The main question it aims to answer is:

* To participate in a Nordic walking reduces pain measured on WOMAC pain dimension?
* To participate in a Nordic walking improves mobility measured on WOMAC physical activitiy dimension? Researchers will compare pain and physical activity outcomes between intervention and control arm (randomly allocated).

Detailed description: Osteoarthritis is one of the clinical circumstances that produces the most disability in terms of disability-adjusted life years (DALYs), its main localization is in the knees and hips, the most disabling joints. Ten percent of the adult Spanish population has knee osteoarthritis , which is accompanied by symptoms of pain, mechanical alterations, stiffness, and decreased functionality, constituting one of the most common causes of disability in older people.. Decreased muscle mass and strength of knee extensor-flexor muscles are associated with symptomatic progression of oseoarthritis and lower general health status.

Eligibility criteria: Inclusion Criteria:

* Aged of 60 years or older
* Knee osteoarthritis
* Body mass index less than 35 kg/m2

Exclusion Criteria:

* People who had a knee prostheses
* To have any contraindication for physical activity
* To have an acute exacerbation of any chronic condition at enrollment

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: From enrollment to the end of treatment at 10 weeks
Secondary outcomes:
measure: 36-Item Short Form Survey Instrument (SF-36)
timeFrame: From enrollment to the end of treatment at 10 weeks
Other outcomes:
measure: Time up and go
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: Sit to stand
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: 6-minute walk test
timeFrame: From enrollment to the end of treatment at 10 weeks
Locations:
city: Vic
country: Spain
facility: Health and Welfare Sciences School
state: Barcelona
Study officials:
affiliation: Vic Hospital Consortium
name: Pere Roura-Poch, PhD
role: PRINCIPAL_INVESTIGATOR
References: