louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05037994: Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Frozen Shoulder
Official title: Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Shoulder
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The patients will be randomly allocated into two equal groups (each 20 patients) using sealed opaque numbered envelopes:

Control Group (C Group) : Patients receive continuous US suprascapular nerve block only.

Gabapentin Group (G Group) : Patients receive continuous US suprascapular nerve block with oral gabapentin 300 mg once daily at bed time.

Both groups compared as regard:

Visual Analogue Scale Range of passive and active movements Patients satisfaction complication related to block The total dose of diclofenac sodium


Eligibility criteria: Inclusion Criteria:

* Body mass index ≥ 18 Kg/m2 ≤ 30Kg/m2
* ASA I, II or III.
* Cooperative patients.

Exclusion Criteria:

* local infection at site of injection.
* coagulopathy
* previous history of mental disorders or chronic drug abuse (opioids, tranquilizers)
* known hypersensitivity to any of the drugs used in the study.

Primary outcomes:
measure: Visual analogue scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Range of passive and active movements
timeFrame: 6 weeks
measure: Patients satisfaction
timeFrame: 6 weeks
Other outcomes:
measure: The total dose of diclofenac sodium
timeFrame: 6 weeks
Locations:
city: Zagazig
country: Egypt
facility: Amr Shaaban Elshafei
Study officials:
affiliation: Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University
name: AHMAD S HEGAB, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01358994: Metformin Treatment, Renal Function and Lactic Acidosis
Official title: Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: metformin
type 2 diabetes
e-GFR
creatinine
lactic acidosis
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients irrespective of age prescribed metformin according to a registry for the city of Malmö

Brief summary: From a central registry at the National Board of Health and Welfare in Sweden collect all patients in the city of Malmö prescribed metformin during two years. Glomerular filtration rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU admission were also sought. The study hypothesis is that metformin is prescribed to patients with lower GFR than anticipated with very few cases of lactic acidosis registered.


Eligibility criteria: Inclusion Criteria:

* Patients in the city of Malmö prescribed metformin at least three times during two years
* Available at least one p-creatinine during the two years

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Dept of Nephrology
Study officials:
References:
Clinical trial NCT02447094: Quality of Life After Stroke Using a Telemedicine-based Stroke Network
Official title: Assessing the Impact of Care in A Telemedicine-based Stroke Network Using Patient-Centered Health Related Quality of Life Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: ischemic
tPA
tele-medicine
robot
tele-stroke
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2015-05-18
Enrollment: 300
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: This research will be performed only in AIS patients who are routinely admitted to our "Hub" and participating "spoke" centers.

Brief summary: To study the effect of a telemedicine model of stroke care on patient-based outcomes.

Detailed description: Approximately 750,000 patients suffer from ischemic stroke (AIS) annually in the United States. AIS is a a leading cause of long-term disability and the third-leading cause of mortality. Effective therapies exist to ameliorate the disability associated with AIS, but implementation of these therapies is time-sensitive. Currently, there is a shortage in health care professionals with expertise in the treatment of stroke and such expertise tends to be concentrated in large community-based or academic medical centers. To respond to this shortage, stroke networks are being organized in a "hub-and-spoke" model to facilitate the rapid delivery of time-sensitive interventions such as intravenous (i.v.) tissue plasminogen activator (tPA) or rapid evaluation for AIS. Some networks are also using telemedicine to facilitate this approach and bring the needed expertise via robotic tele-presence (RTP). Though the accuracy of stroke diagnosis and i.v. tPA utilization may be higher in RTP based networks, the impact of this model on patient's outcomes has been difficult to elucidate. To this end, meaningful validated outcome assessments are crucial to understand the impact of stroke interventions including telemedicine or RTP based networks. The objective of this study is to translate evidence-based practice of healthcare, patient-centered outcome assessments, and patient-family perceptions of delivery of care into meaningful data. This will aid in the validation of the role of interventions such as "hub-and-spoke" RTP based models in stroke care.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected acute ischemic stroke (AIS)
* Age \>17 years

Exclusion Criteria:

* Hemorrhagic strokes (ICH or SAH)
* Transient ischemic attacks (TIA)
* Trauma
* Inability to obtain informed consent
* Participation in another study

Primary outcomes:
measure: HRQoL
timeFrame: 6 months
Secondary outcomes:
measure: mRS
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00422994: A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
Official title: An Open-Label, Parallel-Group, Repeat-Dose Study to Investigate the Effects of End Stage Renal Disease and Haemodialysis on the Pharmacokinetics of Ropinirole (Study RRL103628)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Restless Legs Syndrome
Keywords: end stage renal impairment
tolerability
ropinirole
pharmacokinetics
hemodialysis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.


Eligibility criteria: Inclusion:

* Patients and subjects between 18-79 years old.
* End stage renal patients who are consistently receiving dialysis for a minimum of 3.5 hours, three times per week, with hemodialysis blood flow rates of \>200mL/min may be eligible to enter the study.
* Patients must also have systolic blood pressure 100-190mmHg and diastolic blood pressure \<120mmHg.
* Healthy subjects must have systolic blood pressure 100-150mmHg.

Exclusion:

* Female subjects who are pregnant and/or breast-feeding must not participate in this study.

Primary outcomes:
measure: SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.
measure: SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when "on dialysis" & "off dialysis" in patients.
Secondary outcomes:
measure: ECG: every other visit
measure: Vital Signs: Each visit
measure: Adverse Events: each visit
measure: Clinical laboratory: every other visit
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04702594: Music Therapy and Psycho-behavioral Disorders in the Elderly Population
Official title: Impact of Music Therapy on Psycho-behavioral Disorders of the Elderly Suffering From Neuro-cognitive Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavioral Disorder
Music Therapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Since the 1990s, neuroscience, with functional MRI, has made it possible to understand the beneficial neurophysiological effect of music on man and his brain. They have shown that music stimulates brain plasticity and contributes to the reorganization of the affected neural circuits. The concept of cerebral plasticity and cerebral symphony have thus been developed. In March 2008, the HAS (High Authority for Health) proposed in its recommendations good practices concerning the management of neurodegenerative diseases that "Music therapy, aromatherapy, multisensory stimulation ... could improve certain of behavior's aspects ". Music has shown that memory capacity can remain present in people with Alzheimer's disease even in the advanced stages. Music also improves the well-being of patients with Alzheimer's or mixed dementia living in institutions and reduces the suffering of caregivers. It improves communication with others, including those who have lost the usual codes of communication and improves the quality of sleep of elderly people living in institutions.

However, although musical interventions have recently gained popularity as a non-pharmacological treatment for dementia, the scientific evidence warrants further research.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 60 present in the reinforced hospital unit during the study period
* Patients over 60 years hospitalized in follow-up care and rehabilitation with behavioral disorders in the context of a neurocognitive disorder

Exclusion Criteria:

* Unpaired deafness
* Refusal to participate

Primary outcomes:
measure: Evolution of the NeuroPsychiatric Inventory (NPI) scale
timeFrame: Baseline, once a week during study participation and at the end of the patient's participation in the study (1 month after inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Pierre Garraud
Study officials:
References:
Clinical trial NCT06709794: Evaluating the Effect of Automatic Plan Assignment and Enhanced Outreach of Marketplace Take-up
Official title: Evaluating the Effect of Automatic Plan Assignment and Enhanced Outreach of Marketplace Take-up
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Outreach Intervention
Lead sponsor: Covered California
Sponsor class: OTHER_GOV
First posted: 2024-11-29
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Facilitated enrollment offers a potential solution to some administrative burdens and choice frictions that may produce incomplete take-up of marketplace coverage. Because Covered California, California's ACA individual marketplace, and Medi-Cal, California's Medicaid program, share an eligibility system, Covered California has the ability to identify individuals who are eligible for marketplace coverage upon losing Medicaid eligibility.

This evaluation will compare the effectiveness of facilitated enrollment strategies, including personalized plan pre-selection and personalized quotes of net premiums, to other enhanced, but general outreach tactics, on marketplace take-up among individuals losing Medi-Cal coverage.


Eligibility criteria: Inclusion Criteria:

* Individual in a single-member household
* Discontinued from Medi-Cal
* Eligible for Covered California program
* Ineligible for APTCs on initial application
* Did not attest to planning to file taxes within their Covered California application

Exclusion Criteria:

* Consumer case is no longer active within the application system
* Consumer is already actively enrolled in a marketplace plan
* Consumer has already restored Medi-Cal eligibility
* A consumer's Special Enrollment Period has ended
* Consumer is no longer listed as a single-member household
* Consumer was procedurally denied from Medi-Cal coverage due to no response
* Consumers has a MAGI Medi-Cal income less than 138% of the Federal Poverty Level (FPL)

Primary outcomes:
measure: Enrollment
timeFrame: within calendar year since the loss of Medicaid
Secondary outcomes:
measure: Tenure
timeFrame: within 1-2 years after treatment assignment
measure: Uninsured
timeFrame: within 1-2 years from the treatment assignment
measure: Consumer engagement
timeFrame: within 90 days from the treatment assignment
measure: Office visit
timeFrame: during 1-2 years since the treatment assignment
measure: Prescription filled
timeFrame: during 1-2 years since the treatment assignment
measure: Emergency room visit
timeFrame: during 1-2 years since the treatment assignment
measure: Hospital admission
timeFrame: 1-2 years before and during 1-2 years after the treatment assignment
measure: Out-of-pocket health care spending
timeFrame: during 1-2 years since the treatment assignment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Covered California
state: California
Study officials:
References:
Clinical trial NCT01084694: Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant
Official title: The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Fatigue
Distress
Keywords: HSCT
Caregiver
Caregiver Burden
Allogeneic Transplant
Autologous Transplant
Hematopoietic Stem Cell Transplantation
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be an autologous patient and their caregiver and an allogeneic patient and their caregiver

Brief summary: The purpose of this study is to examine the impact that serving as a caregiver for a patient undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and overall distress. It will also look at whether caregiver burden leads to an increase in hospitalization and overall outcome.


Eligibility criteria: Inclusion Criteria:

Patient:

* Any patient undergoing autologous or allogeneic HSCT at The Blood and Marrow Transplant Program at Northside Hospital
* Patients must have a single primary caregiver
* Patients must be willing to comply with all assessments as outlined in the protocol
* Patients must be willing to sign informed consent

Caregiver:

* Must be the primary caregiver for an autologous or allogenic HSCT patient at the Blood and Marrow Transplant Program at Northside Hospital
* Caregiver must be willing to comply will all assessments as outlined in the protocol
* Caregiver must be willing to sign consent

Primary outcomes:
measure: Brief Symptom Inventory and Burden Interview
timeFrame: Baseline, Day 30 & 1 year
Secondary outcomes:
measure: Patient Distress, Fatigue & Pain Scores
timeFrame: Baseline, Day 30 & 1 year
measure: Overall Patient Survival
timeFrame: Pre-transplant to 1 year post-transplant
measure: Common Characteristics of Caregivers
timeFrame: Baseline
measure: Length of Patient Hospitalization
timeFrame: pretransplant to 1 year post-transplant
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: Northside Hospital
name: Dawn Speckhart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06458894: Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.
Official title: Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study, based on the Internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides new ideas for other specialties。

Detailed description: This study using a randomized controlled trial, 100 patients that meet the inclusion criteria are divided into experimental group and control group, experimental group adopts routine nursing measures, intervention group for preoperative family rehabilitation training, intervention for 2 weeks, observe the first after surgery, lung function index, chest catheterization days, postoperative hospital stay and medical expenses.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years old; 2. A preliminary diagnosis of pulmonary结节 or lung tumor by chest CT; 3. Planning to undergo thoracoscopic lung resection surgery; 4. Voluntary participation of patients.

Exclusion Criteria:

1. Patients with severe condition who cannot tolerate pre-rehabilitation training; 2. Patients with consciousness disorder or mental abnormalities who cannot cooperate with pre-rehabilitation training; 3. Patients who cannot complete questionnaire filling out due to visual, auditory, or intellectual impairment, etc.

Primary outcomes:
measure: Time to the first ambulation after surgery
timeFrame: 3 Weeks after intervention
measure: Dwelling time of chest drain and chest drainage flow
timeFrame: Two days after the intervention
Secondary outcomes:
measure: Lung function index
timeFrame: 30 Days after intervention
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT04415294: Flicker App for Minimal Hepatic Encephalopathy
Official title: Evaluating a Novel, Self-administered Device ("Flicker-App") That Measures Critical Flicker Frequency as a Test for Minimal Hepatic Encephalopathy in Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatic Encephalopathy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-06-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhosis patients without Grade III or IV OHE

Brief summary: There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients

Detailed description: SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in clinic supervised by a research assistant and calculate the level of agreement between the CFF determined by the Flicker-App, the CFF determined by the "gold-standard" FFS device, and the test scores on the EncephalApp Stroop test.

SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these CFF measurements.

SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical Gastroenterologists/Hepatologists

Eligibility criteria: Inclusion Criteria:

* Cirrhosis (standard criteria)
* Chronic liver disease

Exclusion Criteria:

* Grade III or IV hepatic encephalopathy
* Mini-mental state examination score ≤25 (suggestive of dementia)
* alcohol or illicit drug use within 3 months
* current use of benzodiazepines
* antiepileptics or psychotropic drugs
* color blindness
* severe vision impairment (blindness, macular degeneration).

Primary outcomes:
measure: CFF Agreement
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: George N Ioannou, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: