louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00959920: Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy
Official title: Study of Obstetric Foley Therapy (SOFT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Keywords: Indwelling bladder catheter
Intermittent straight catheterization
Labor and Delivery
Time to delivery during labor
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2009-08-17
Enrollment: 139
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: The goal of this study is to compare two clinically-relevant bladder drainage techniques. This is a randomized controlled trial with a single primary outcome of time to delivery. The results will inform clinical decisions about method of catheterization during labor.

Detailed description: Urinary catheterization is a common practice during labor following placement of an epidural for pain control, as this form of anesthesia is known to inhibit normal bladder emptying. There is insufficient evidence to guide clinicians in selection of an indwelling catheter versus intermittent straight catheterization during the course of labor.

The goal of this randomized control trial is to compare two clinically-relevant bladder drainage techniques.

Eligibility criteria: Inclusion Criteria:

* Women who present to either Loyola University Medical Center or Loyola at Gottlieb Hospital in active labor or for induction of labor with a singleton pregnancy and who are anticipated to undergo vaginal delivery during the current admission

Exclusion Criteria:

* Women who are undergoing a scheduled cesarean delivery
* Women with a contraindication to either of the 2 study interventions
* Multi-fetal gestations
* Current or planned tocolysis
* Women who are on magnesium prophylaxis

Primary outcomes:
measure: Time to Delivery (by Any Route)
timeFrame: 1 day
Secondary outcomes:
measure: Difference in Cost Between the Two Interventions
timeFrame: End of study.
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Health System
state: Illinois
Study officials:
affiliation: Loyola University
name: Sarita Massey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rivard C, Awad M, Liebermann M, Dejong M, Massey SM, Sinacore J, Brubaker L. Bladder drainage during labor: a randomized controlled trial. J Obstet Gynaecol Res. 2012 Aug;38(8):1046-51. doi: 10.1111/j.1447-0756.2011.01837.x. Epub 2012 Apr 30.
Clinical trial NCT05352620: Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.
Official title: Smart Box Accompanied With OT Equator Attachment in Retaining Immediately Loaded Inclined Implant Assisted Overdenture for Atrophic Maxilla
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Maxilla
Edentulous Jaw
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT Equator attachment and inclined implants with smart box attachment radiographically using CBCT


Eligibility criteria: Inclusion Criteria:

* Male patients with comparable age (30- 65 years).
* All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region.
* Opposing mandibular dentate arch including bilateral posterior teeth.
* All patients should have an adequate zone of keratinized mucosa.
* All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants.
* All patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants.

Exclusion Criteria:

* Patients with flabby maxillary ridges.
* Patients who are unwilling to accept implant overdentures as a treatment modality.
* Patients with temporomandibular and neuromuscular disorders.

Primary outcomes:
measure: change in peri-implant probing depth
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in Clinical Attachment level
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in Implant Stability
timeFrame: at baseline and 9 months
measure: Change in alveolar bone level
timeFrame: at baseline and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT06743620: Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Official title: Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of Cook Myosite, Inc. Sponsored CELLEBRATE Clinical Study in Patients With Persistent or Recurrent Stress Urinary Incontinence (SUI) Following Surgical Treatment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Stress Urinary Incontinence
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects who have received iltamiocel as part of participation in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment will be considered for enrollment.

Brief summary: The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.


Eligibility criteria: Inclusion Criteria:

* Has completed participation within 15 months in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study).
* Has received at least one dose of iltamiocel as part of the CLBT study.
* Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
* Has access to a phone or electronic device to allow completion of electronic documents

Exclusion Criteria:

* Has only received placebo as part of the CLBT study.
* Unable or unwilling to provide informed consent.

Primary outcomes:
measure: Long term safety
timeFrame: 5 years
measure: Long term effectiveness
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Harvard
country: United States
facility: Virtual Site
state: Massachusetts
Study officials:
affiliation: Cook MyoSite, Inc.
name: Ron Jankowski, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02295020: Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
Official title: Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Cropper Medical
Sponsor class: INDUSTRY
First posted: 2014-11-19
Enrollment: 40
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: The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.

Detailed description: Once consented, the patient is assigned to either Group A or Group B. Group A patients will receive standard treatment only and will not be prescribed a knee brace. Group B patients will receive standard treatment and the Bioskin Ten-7 knee brace. On Day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. VAS, WOMAC, Oxford Knee Score, KOOS questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. All patients will record use of NSAIDs and for Group B, the start and end time of brace use will be recorded. All patients will return in 8 weeks to assess efficacy of treatment. All patients will return their diaries, complete the same validated outcome measures as Day 0 and undergo a repeat synovial fluid analysis.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis.
* Must have telephone access.

Exclusion Criteria:

-

Primary outcomes:
measure: KOOS - Pain
timeFrame: Week 8- Day 0
measure: KOOS - Symptoms
timeFrame: Week 8 - Day 0
measure: KOOS - ADL
timeFrame: week 8 - day 0
measure: KOOS - Sport/Rec
timeFrame: Week 8 - day 0
measure: KOOS - QOL
timeFrame: Week 8 - day 0
measure: Synovial Fluid Analysis (IL-6)
timeFrame: Week 8 - day 0
measure: Synovial Fluid Analysis (IL-8)
timeFrame: Week 8 - day 0
measure: Synovial Fluid Analysis (TNF-alpha)
timeFrame: Week 8 - day 0
measure: Synovial Fluid Analysis (MIP - 1alpha)
timeFrame: Week 8 - day 0
measure: Synovial Fluid Analysis (MCP - 1)
timeFrame: Week 8 -day 0
measure: Oxford Knee Score
timeFrame: Day 0 and Week 8
measure: WOMAC
timeFrame: Day 0 and Week 8
measure: Visual Analog Scale
timeFrame: Day 0 and Week 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LSUHSC-NO, Orthopaedic Department
name: Vinod Dasa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070420: Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Myocardial Ischemia
Keywords: Adenosine
Fractional flow reserve, Hyperemia
Fractional Flow Reserve, Myocardial
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV continuous infusion without the insertion of central venous vascular access method in the achievement of steady-state maximal coronary hyperemia compared with the central IV continuous infusion method.


Eligibility criteria: Inclusion Criteria:

* non -infarct related, patients with moderate coronary artery stenosis
* normal ejection fraction on echocardiogram

Exclusion Criteria:

* infarct-related arteries or clinically unstable state
* collateral blood flow to the target vessel is shown
* atrioventricular block on electrocardiogram
* reduced ejection fraction(\<50%) or left ventricular hypertrophy on echocardiography
* contraindication of adenosine

Primary outcomes:
measure: compare fractional flow reserve at maximal hyperemia
timeFrame: interval of 10 minutes
Secondary outcomes:
measure: compare the time to maximal hyperemia and changes in heart rate
timeFrame: interval of 10 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiovascular Center, Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
name: Bon- Kwon Koo, MD, PhD
role: STUDY_CHAIR
References:
citation: Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Her SH, Hur SH, Park JS, Kim MK, Choi YS, Kim HS, Cho JH, Lee SG, Park YW, Jeong MH, Lee BK, Lee NH, Lim DS, Yoon J, Seung KB, Shin WY, Rha SW, Kim KS, Tahk SJ, Park BE, Ahn T, Yang JY, Jeong YS, Rhew JH, Park SJ; IRIS-DES Investigators. Outcomes after unrestricted use of everolimus-eluting and sirolimus-eluting stents in routine clinical practice: a multicenter, prospective cohort study. Circ Cardiovasc Interv. 2012 Jun;5(3):365-71. doi: 10.1161/CIRCINTERVENTIONS.111.966549. Epub 2012 Jun 12.
citation: Seo MK, Koo BK, Kim JH, Shin DH, Yang HM, Park KW, Lee HY, Kang HJ, Kim HS, Oh BH, Park YB. Comparison of hyperemic efficacy between central and peripheral venous adenosine infusion for fractional flow reserve measurement. Circ Cardiovasc Interv. 2012 Jun;5(3):401-5. doi: 10.1161/CIRCINTERVENTIONS.111.965392. Epub 2012 May 29.
Clinical trial NCT04254120: Integrating Motivational Interviewing With Cognitive-behavioral Therapy
Official title: Integrating Motivational Interviewing With Cognitive-behavioral Therapy for Anxiety Disorders, Depression, and Unhealthy Lifestyle Behaviors: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Depression
Life Style
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive-behavioral therapy (CBT) is efficacious for anxiety disorders and depression, but not all patients achieve remission, and dropout is considerable. Motivational interviewing (MI) may strengthen motivation to change, and influence non-response and dropout. Research shows that MI as a pretreatment to CBT produces moderate effects compared to CBT alone. Studies integrating MI with CBT (MI-CBT) throughout treatment are scarce. The present study explored the feasibility of MI-CBT in routine psychiatric care, and compared CBT alone to MI-CBT for anxiety disorders, depression, and unhealthy lifestyle behaviors. The Anxiety, Depression, Diet, Alcohol, Physical activity, and Tobacco (ADDAPT) feasibility study had a randomized controlled design, and data were analyzed using hierarchical regression.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* A principal diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) of panic disorder, social anxiety disorder, obsessive-compulsive disorder, generalized anxiety disorder, posttraumatic stress disorder, or major depressive disorder
* At least one of the following unhealthy lifestyle behaviors: unhealthy eating habits, hazardous use of alcohol, insufficient physical activity, or tobacco use, according to screening criteria suggested by the National Board of Health and Welfare

Exclusion Criteria:

* Psychotic symptoms
* DSM-IV-TR criteria for substance abuse other than alcohol
* DSM-IV-TR criteria for substance dependence including alcohol
* Moderate to severe suicide risk according to the Mini-International Neuropsychiatric Interview or a score of 2 or above on item 9 on the Patient Health Questionnaire 9
* Another simultaneous psychological treatment

Primary outcomes:
measure: Index measure of aggregated psychiatric symptoms
timeFrame: 12 weeks
measure: Index measure of aggregated unhealthy lifestyle behaviors
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: WeMind Psykiatri AB
Study officials:
affiliation: Karolinska Institutet
name: Benjamin Bohman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06530420: The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment
Official title: The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retrospective Analysis of Material From the Hospital Database
Lead sponsor: Brothers Hospitallers Hospital in Cracow
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 1087
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with umbilical hernia operated in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022

Brief summary: The aim of the study is to assess the usefulness of the new classification of primary umbilical hernias in the choice of treatment of patients.

The study is conducted as a retrospective analysis of material from the hospital database

Detailed description: A retrospective analysis will include patients operated on in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022. The incidence of recurrence will be assessed based on outpatient records and a telephone survey. Hernias will be classified according to the EHS/AHS guidelines as small, medium and large. The qualification will take into account the old and new classification of hernias.

Eligibility criteria: Inclusion Criteria:

* Repair surgery for primary umbilical hernia

Exclusion Criteria:

* Repair surgery for recurrent umbilical hernia

Primary outcomes:
measure: Incidence of umbilical hernia recurrence
timeFrame: 20.12.2025
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Hospital of the Brothers Hospitallers of Saint John of God
Study officials:
References:
Clinical trial NCT01353820: Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults
Official title: Proof of Concept -Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Midly hypercholesterolemic subjects
Probiotic
Cholesterol lowering
Dairy
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2011-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus control product.


Eligibility criteria: Inclusion Criteria:

* male and female aged 18-75 years;
* BMI between 19 and 30 kg/m2,
* LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy,
* stabilized hypercholesterolemia (since more than 3 months),
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
* used to consume dairy products,
* for female: effective contraceptive methods used,
* agreeing to a written informed consent

Exclusion Criteria:

* plasma triglycerides (TG) levels \> 350 mg/dL (4 mmol//L),
* any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months,
* known allergy or hypersensitivity to milk proteins,
* systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria,
* subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
* diabetic subjects (type I and type II),
* any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
* for female subject: pregnancy, breast feeding or intention to become pregnant during the study,
* for female subject: subject likely to change her contraceptive method during the study,
* active heavy cigarette smokers (reported more than 20 cigarettes / day),
* subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: AMED s.r.o (Poliklinika Budějovická)
Study officials:
References: