louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02886143: Effect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention
Official title: Effect of Active vs. Passive Voiding Trials on Time to Patient Discharge, Rate of Urinary Tract Infection, and Rate of Urinary Retention: a Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Retention
Urinary Tract Infections
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urinary retention is a common problem, particularly in hospitalized patients. When a Foley catheter is removed, a patient must be monitored for urinary retention. The usual method is a passive voiding trial where the catheter is removed, the bladder fills with urine and the patient is monitored for voiding over approximately 6 hours. Another option is an active voiding trial where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted to void. This study seeks to determine the effect of active vs passive voiding trials on time to hospital discharge, rate of urinary tract infections, and rate or urinary retention in the general hospitalized population.

Detailed description: The intervention to be tested is an active voiding trial, where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted to void.

Eligibility criteria: Inclusion Criteria:

* Admission to one of three hospital units at the University of Virginia (5 Central, 6 West, or the Short Stay Unit)
* Patient has a Foley urethral catheter in place
* The physician has ordered the Foley urethral catheter to be discontinued
* 18 years of age and older

Exclusion Criteria:

* Age less than 18 years
* Prisoners
* Women who are pregnant

Primary outcomes:
measure: time from removal of Foley catheter until hospital discharge
timeFrame: approximately one day
Secondary outcomes:
measure: urinary tract infection
timeFrame: within 2 weeks of hospital discharge
measure: Urinary retention
timeFrame: within 2 weeks of hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Tracey L Krupski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills JT, Rapp DE, Shaw NM, Hougen HY, Agard HE, Case RM Jr, McMurry TL, Schenkman NS, Krupski TL. Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial. World J Urol. 2020 Sep;38(9):2247-2252. doi: 10.1007/s00345-019-03005-0. Epub 2019 Nov 15.
Clinical trial NCT02619643: Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation
Official title: Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Following brain injury (e.g. stroke), application of non-invasive brain stimulation may improve rehabilitative efforts. However, the most effective method of non-invasive brain stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus to the head. This method can be applied in a manner that increases (facilitates) or decreases (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions within minutes of each other (called primed PAS) may augment changes in excitability more than a single PAS session alone.

Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS) to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 and ≤ 30 years of age
* Elicitable motor evoked potential from the motor cortex contralateral to the dominant hand
* Elicitable N20 sensory evoked potential

Exclusion Criteria:

* History of neurological disease
* Seizure within the past 2 years
* Currently taking epileptogenic medication
* Peripheral neuropathy
* Cognitive impairment and/or major psychiatric disorder
* Metal in the head (dental permitted)
* Pacemaker or other indwelling devices
* Pregnancy

Primary outcomes:
measure: Change from baseline peak-to-peak amplitude of motor evoked potential
timeFrame: Immediately before and within 60 minutes following intervention
measure: Change from baseline resting motor threshold
timeFrame: Immediately before and within 60 minutes following intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Kate Frost, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06436443: SMS Counseling on Gestational Diabetes
Official title: The Effect of SMS Counseling for Gestational Diabetes on Self-Efficacy and Knowledge Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational diabetes mellitus,
Self-Efficacy,
SMS Counseling.
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The use of technology-based education and counseling services in the self-management of gestational diabetes contributes to better control of blood sugar levels, motivation and increased self-efficacy in women. Therefore, this study was planned as interventional research to determine the effect of SMS counseling given to individuals with gestational diabetes on self-efficacy and knowledge levels. This study was conducted descriptively with 95 patients with gestational diabetes who were treated in the endocrine service of a university hospital between August 15, 2021 and April 24, 2022. Personal information form created by the researchers, The Self-Efficacy Scale in Gestational Diabetes, and Diabetes Knowledge Scale were used to collect data.


Eligibility criteria: Inclusion Criteria:

* diagnosed with gestational diabetes,
* being in the 30th week of pregnancy,
* having a smartphone,
* volunteering to participate in the study,
* having no communication problems,
* having no psychiatric problems

Exclusion Criteria:

* being non-literate,
* having communication problems (hearing or sight),
* not volunteering to participate in the research

Primary outcomes:
measure: Diabetes Knowledge Scale
timeFrame: 5 Minute
measure: The Self-Efficacy Scale in Gestational Diabetes
timeFrame: 5 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
References:
citation: Hemmati Maslakpak M, Razmara S, Niazkhani Z. Effects of Face-to-Face and Telephone-Based Family-Oriented Education on Self-Care Behavior and Patient Outcomes in Type 2 Diabetes: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:8404328. doi: 10.1155/2017/8404328. Epub 2017 Nov 22.
citation: Guo Y, Zhou L, Sun B, Wang C, Zhang J. Application of online-offline integrated medical care management in patients with gestational diabetes. Ginekol Pol. 2021;92(10):720-725. doi: 10.5603/GP.a2021.0054. Epub 2021 Apr 29.
citation: Miremberg H, Ben-Ari T, Betzer T, Raphaeli H, Gasnier R, Barda G, Bar J, Weiner E. The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial. Am J Obstet Gynecol. 2018 Apr;218(4):453.e1-453.e7. doi: 10.1016/j.ajog.2018.01.044. Epub 2018 Feb 7.
Clinical trial NCT03367143: Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL
Official title: A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma Refractory
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.


Eligibility criteria: Inclusion Criteria:

1. Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment.
2. No history of stem cell transplantation.
3. Age between 16-75.
4. ECOG\<3.
5. At least 1 measurable tumor mass.
6. Minimum life expectancy of 3 months.
7. Written informed consent.
8. No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
9. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.

Exclusion Criteria:

1. Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
2. Clinically significant active infection.
3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
6. Patients who are pregnant or breast-feeding.
7. HIV infection.

Primary outcomes:
measure: Complete response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Progression free survival rate
timeFrame: 1 year
measure: Overall survival rate
timeFrame: 1 year
measure: Overall response rate
timeFrame: 12 weeks
measure: Safety as assessed using CTCAE v4.0
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Weili Zhao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666743: Safety and Efficacy Study of Ceftaroline in Elderly Subjects With Community-Acquired Bacterial Pneumonia
Official title: A Multicenter Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Elderly Subjects With Community-Acquired Bacterial Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Community-Acquired Bacterial Pneumonia (CABP)
Keywords: Community-Acquired Pneumonia
Lung
Adult
Infections
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of ceftaroline fosamil in elderly subjects with community-acquired bacterial pneumonia (CABP) receiving antibiotic therapy in the hospital.

Detailed description: This is a multicenter study of ceftaroline fosamil in elderly subjects (≥ 65 years of age) with CABP. Adjunctive macrolide therapy is to be used at the Investigator's discretion. A switch to oral treatment may be allowed at the discretion of the Investigator. The total duration of therapy is 5 to 7 days; a minimum of 48 hours of study drug is required.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 65 years of age.
2. Presence of CABP warranting hospitalization.
3. Acute illness with ≥ 2 clinical signs or symptoms of lower respiratory tract infection.
4. Radiographically confirmed pneumonia.

Exclusion Criteria:

1. History of any hypersensitivity or allergic reaction to any β-lactam or macrolide antibacterial agent.
2. Confirmed or suspected respiratory tract infection due solely to an atypical bacterial, mycobacterial, viral, or fungal pathogen.
3. More than 24 hours of potentially effective antibacterial therapy within 96 hours prior to enrollment.
4. Life expectancy of \< 30 days or presence of an order of Do Not Resuscitate (DNR).
5. Evidence of significant hematologic, hepatic, or immunologic impairment.

Primary outcomes:
measure: Evaluate the safety of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
timeFrame: Between 3 and 33-37 days
Secondary outcomes:
measure: Evaluate the efficacy of ceftaroline fosamil in elderly subjects (≥ 65 years) with community-acquired bacterial pneumonia (CABP)
timeFrame: 30 days following discharge from the hospital, anticipated between 33 to 37 days.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01008943: Autologous Cell Therapy for Female Stress Urinary Incontinence
Official title: A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.


Eligibility criteria: Inclusion Criteria:

* SUI with normal detrusor activity confirmed with urodynamics
* Bladder capacity \>200 ml
* Incontinence has not shown any improvement for at least -6 months
* Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion Criteria:

* Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
* Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
* Uncontrolled diabetes
* Pregnant, lactating, or plans to become pregnant during course of the study
* Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
* Current or acute conditions involving cystitis or urethritis
* Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures

Primary outcomes:
measure: Number of Participants That Experienced Biopsy Procedure-related Adverse Events
timeFrame: at biopsy or between biopsy and treatment, approximately 6 weeks
measure: Number of Participants That Experienced Injection Procedure-related Adverse Events
timeFrame: 30 days
measure: Injection Procedure-related Adverse Events
timeFrame: 30 days
measure: Number of Participants That Experienced AMDC Product-related Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Center
name: Lesley K. Carr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05772143: Percutaneous Discectomy to Treat Symptomatic Lumbar Disc Herniation : Evaluation of Clinical Efficiency, Patient Reported Outcomes and Economical Impact by Assessing Time Before Return to Work and Duration of Hospitalization Stay
Official title: Percutaneous Lumbar Discectomy : Evaluation of Patient Reported Outcomes, Aconomical Impact and Return to Work
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 87
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: Patient over 18 years of age suffering from radiculalgia related to lumbar disc herniation visualized on MRI with radio-clinical concordance, failure of conservative treatment and nerve root infiltrations ; consulting in interventionnal radiology care unit,

Brief summary: This study aims to evaluate the clinical (pain) and functional (patient reported outcomes) efficacy of percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.

The aim is also to evaluate the economic impact of the procedure, mainly through the length of hospitalization and the time to return to work.

Patients were evaluated initially before surgery and then at 1, 3 and 6 months.


Eligibility criteria: Inclusion Criteria:

* radiculalgia related to lumbar disc herniation with clinical radiological concordance
* age \> 18
* resistance to conservative treatment and nerve root infiltrations

Exclusion Criteria:

* prior discal surgery at the same level,
* lumbar canal stenosis,
* extruded discal herniation,
* neurological deficit,
* no capacity to answer to follow-up calls

Primary outcomes:
measure: Oswestry disability index
timeFrame: before treatment
measure: Oswestry disability index
timeFrame: At 1 month after treatment
measure: Oswestry disability index
timeFrame: At 3 month after treatment
measure: Oswestry disability index
timeFrame: At 6 month after treatment
Secondary outcomes:
measure: Visual analogic scale
timeFrame: Initially and at 1 month, 3 month and 6 month after the procedure
measure: Off work duration
timeFrame: Initially and at 1 month, 3 month and 6 month after the procedure
measure: Hospitalization duration
timeFrame: Initially and at 1 month, 3 month and 6 month after the procedure
measure: use of pain killers
timeFrame: Initially and at 1 month, 3 month and 6 month after the procedure
Other outcomes:
Locations:
city: Nice
country: France
facility: Chu de Nice
Study officials:
References:
Clinical trial NCT01487343: Patient Factors Impacting Adherence to Oral Chemotherapy
Official title: A Pilot Study to Identify Patient Factors Impacting Adherence to Oral Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Gastrointestinal Cancer
Keywords: Oral Chemotherapy
capecitabine
questionnaire
breast
gastric
11-194
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 79
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

Brief summary: The purpose of this study is to identify what makes it easier and what makes it harder to take oral chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary breast cancer or gastrointestinal cancer
* Currently prescribed capecitabine
* Age 21 years or older
* Able to understand written and oral English

Exclusion Criteria:

* Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.

Primary outcomes:
measure: adherence to oral chemotherapy
timeFrame: 1 year
Secondary outcomes:
measure: improve the care of patients
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Pamela Ginex, EdD, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04511143: The Correlation Between Ultrasonography Based Muscle Architecture Parameters and Voluntary Isometric Muscle Strength
Official title: Investigation of the Correlation Between Ultrasonography Based Muscle Architecture Parameters and Maximum Voluntary Isometric Knee Flexor Muscle Strength
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Imaging
Lead sponsor: Istanbul Kültür University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2020-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty healthy participants (22.15 ± 2.41 y.o; 1.72 ± 0.09 m; 66.5 ± 11.50 kg; 8 female, 12 male) participated in the study.

Brief summary: The goal of this study is to investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals. IKFS was measured for twenty participants (22.15±2.41 y.o; 8 females, 12 males) by a hand-held dynamometer. Investigated parameters were total and individual cross-sectional areas (CSA), Muscle-Thickness (MT), and pennation-angle (PA) for Biceps Femoris-long head (LBF), Semitendinosus (ST) and Semimembranosus (SM) muscles at 25%, 50% and 75% length of the thigh.

Detailed description: The images of hamstring muscles were taken by a US device (Toshiba Aplio 500, Japan) with a linear probe (10-12 MHz, with a footprint of 52 mm).

For each participant, maximum voluntary IKFS was measured from the non-dominant side in the prone position with foot and ankle stayed outside of the bed. Maximum IKFS (20 limbs) was measured by an HHD (A Lafayette Model 01165) (Lafayette, IN) at 15° knee flexion in prone lying position

Eligibility criteria: Inclusion Criteria:

* being healthy young

Exclusion Criteria:

-

Primary outcomes:
measure: The association between IKFS and ultrasound-based muscle architecture in this study will investigate potential relations of ultrasound-based muscle architecture parameters and isometric knee flexor muscle strength (IKFS) in healthy individuals.
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Kultur University
state: E5 Highway Bakırköy, İstanbul
Study officials:
affiliation: Istanbul Kültür University
name: Nazıf E Akalan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Bulent Bayraktar, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Sergen Devran, Researcher
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Omer B Gozubuyuk, M.D.,M.Sc.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Kültür University
name: Gulsah Karaca, Researcher
role: PRINCIPAL_INVESTIGATOR
References: