louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01405729: Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome
Official title: Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Medial Patellofemoral Ligament Reconstruction
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A single surgeon experience beginning in 2005 with patient's undergoing MPFL reconstruction using intra-operative fluoroscopy for proper placement of the femoral tunnel.

Brief summary: The purpose of this retrospective study was to determine the accuracy of femoral tunnel placement utilizing Redfern et al's radiographic method for anatomic femoral attachment during MPFL reconstruction in addition to the resultant outcome.

Detailed description: Reconstruction of the medial patellofemoral ligament (MPFL) has been shown to be an effective treatment for recurrent patellar instability, There has been some concern in the literature about the accuracy of femoral tunnel placement and the effect that it might have on patient outcomes.

The investigators evaluated the accuracy of MPFL placement using an intraopetative fluoroscopy technique and to assess subsequent patient outcomes.

All patients undergoing MPFL reconstruction using an intraoperative fluoroscopically guided technique between 2005 and 2010 were identified. A retrospective review of their charts and radiographs were performed and the subjects were brought back for a follow up exam, radiographic series, and Kujala questionaire.

Eligibility criteria: Inclusion Criteria:

* Patients having undergone the MPFL procedure, starting January 1, 2005 through February 3, 2010
* Minimum follow up of 24 months

Exclusion Criteria:

* Pregnant women
* Under 18 years of age
* Previously undergone prior MPFL surgery
* Participated in any previous research studies involving the use of ionizing radiation (either radioisotopes or diagnostic x-rays during the past 12 months.
* The participant should not volunteer for other research studies involving the use of ionizing radiation within 12 months of completing the current study.

Primary outcomes:
measure: Radiograph measurements
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopedics Center
state: Utah
Study officials:
affiliation: University of Utah Orthopaedic Center
name: Robert T Burks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04934280: Diagnostic Yield of Transvaginal Ultrasonography Versus Sonohysterography in Detection of Ceserean Section Niche
Official title: Diagnostic Yield of Transvaginal Ultrasonography Versus Sonohysterography in the Evaluation of Ceserean Section Niche.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Niche Evaluation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 2
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the identification of CS scar niche between 2D transvaginal ultrasonography alone and with the use of saline infusion as a contrast. Does it differ in the measurements and identification or not.

Detailed description: Cesarean section (CS) rate is increasing in recent practice with a corresponding increase in associated complication. One of these complications is the CS scar defect or 'niche'. A niche forms after CS at the site of hysterotomy of the anterior uterine wall. Recently, it has been demonstrated that niche may be the causative factor for abnormal uterine bleeding, dysmenorrhea, obstetric complications in subsequent pregnancies and possibly subfertility. Therefore, the accurate measurement and description of a niche is becoming increasingly important, for the clinical assessment of gynecological symptoms and for the planning of possible surgical treatment.A niche can be examined using two- (2D) or three- (3D) dimensional transvaginal sonography (TVS), with or without saline or gel contrast, magnetic resonance imaging and hysteroscopy. We will examine about 30 patients of non pregnant women with previous CS having gynecological complications or seeking fertility. All participants will be subjected to 2D vaginal examination to exclude uterine pathology followed by 2D transvaginal ultrasonography with saline infusion using 10-20 ml of sterile Na Cl 0.9% solution injected through the cervix using a 2 mm sterile disposable catheter or IOL Foley catheter. The procedure will be done postmenstrually.

Eligibility criteria: Inclusion Criteria:

* women with previous CS section scar seeking pregnancy or having gynecological complications

Exclusion Criteria:

* women having other gynecological pathology other than niche

Primary outcomes:
measure: accurate evaluation of CS section niche
timeFrame: 6 months from the date of approval
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01738880: Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported to cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to insufficient fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid accumulation. However, the guideline for perioperative fluid management has not been yet established. The investigators hypothesized that intraoperative fluid management according to SVV(Stroke Volume Variation)could reduce perioperative metabolic acidosis compared to those by CVP(Central Venous Pressure). Therefore, the study is trying to determine if intraoperative fluid administration based on SVV could reduce metabolic acidosis when compared with CVP in patients undergoing craniotomy due to brain tumor who receive 0.9% normal saline as main fluid regimen.


Eligibility criteria: Inclusion Criteria:

* patients undergoing craniotomy due to brain tumor
* American Society of Anesthesiologists physical status I or II
* aged from 20 to 65

Exclusion Criteria:

* compromised cardiopulmonary function
* diabetes mellitus
* symptom or sign with increased intracranial pressure
* liver or renal disease
* pre-existing metabolic acidosis
* pregnant or breast-feeding
* patients who cannot understand the statements for subjects

Primary outcomes:
measure: Standard base excess point
timeFrame: at the suturing of scalp
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT01601080: An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
Official title: REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Keywords: Adherence
Multiple Sclerosis
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Limited, UK
First posted: 2012-05-17
Enrollment: 230
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Relapsing Multiple Sclerosis who have been prescribed Rebif® (22mcg or 44mcg)

Brief summary: This is an observational, retrospective, UK \& Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.


Eligibility criteria: Inclusion Criteria:

* Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland
* Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device
* Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care
* Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland)
* Be willing to give consent for their adherence data to be captured in the audit

Exclusion Criteria:

Patients who do not fulfill entirely the inclusion criteria as well as the following:

* Discontinued Rebif before 24 months of treatment
* Unable or unwilling to give consent for their adherence data to be captured in the audit

Primary outcomes:
measure: Patient Adherence
timeFrame: 24 months
Secondary outcomes:
measure: Patient Adherence
timeFrame: 1 month
measure: Patient Adherence
timeFrame: 3 months
measure: Patient Adherence
timeFrame: 6 months
measure: Patient Adherence
timeFrame: 12 months
measure: Difference in patient adherence over time
timeFrame: 12 months
measure: Medication Possession Ratio
timeFrame: 12 months
measure: Medication Possession Ratio
timeFrame: 24 months
measure: Adherence of patient subgroups
timeFrame: 12 months
measure: Adherence of patient subgroups
timeFrame: 24 months
measure: Patient Adherence in the UK versus Ireland
timeFrame: 12 months
measure: Patient Adherence in the UK versus Ireland
timeFrame: 24 months
measure: Device Comfort Settings
timeFrame: 12 months
Other outcomes:
Locations:
city: Merck KGaA Communication Center for recruiting locations
country: United Kingdom
facility: Please contact the
Study officials:
References:
Clinical trial NCT04285580: A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-02-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension


Eligibility criteria: Inclusion Criteria:

* Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment
* Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months

Exclusion Criteria:

* Current or anticipated enrollment in another investigational drug or device study
* Females who are pregnant, nursing, or planning a pregnancy during the study

Primary outcomes:
measure: Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes
timeFrame: 8 weeks
measure: Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group /ID# 232749
state: Alabama
city: Newport Beach
country: United States
facility: The Eye Research Foundation /ID# 232694
state: California
city: Roswell
country: United States
facility: Coastal Research Associates /ID# 232798
state: Georgia
city: Winston-Salem
country: United States
facility: James D Branch MD /ID# 232718
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott and Christie and Associates /ID# 232747
state: Pennsylvania
city: Austin
country: United States
facility: Keystone Research LTD /ID# 232665
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01164280: Effect of Pulse Rate Changes on Clinical Outcome
Official title: The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder Syndrome
Chronic Urinary Retention
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: To evaluate the effect of pulse rate changes on the clinical response and stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.

Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates (5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation was kept off for 24 hours between consecutive test periods. The last 3 days of every test period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical response and pain symptoms were compared between the four pulse-rates using multivariate analysis.

Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD 12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic non-obstructive urinary retention. No significant difference was found regarding clinical outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the four pulse rates was significantly related to the occurrence of SNM-related pain. However, on individual basis, patients appear to benefit from changing the pulse rate concerning both treatment efficacy and stimulation related pain.

Conclusions: On group level, none of the four pulse rates in this study appears to have a significantly different effect on clinical outcome or SNM-related pain. However, a tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be useful.


Eligibility criteria: Inclusion Criteria:

* Patients who have been implanted with a neurostimulator for overactive bladder symptoms or urinary retention
* Patients with suboptimal effect of their neurostimulator

Exclusion Criteria:

* Patients with 100% effect of their neurostimulator

Primary outcomes:
measure: Improvement in voiding diary variables
Secondary outcomes:
measure: Improvement in subjective voiding symptoms
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Philip van Kerrebroeck, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05744180: A Study of Workflow-Integrated Artificial Intelligence for RPM Enrollment
Official title: Pragmatic Analysis of the Impact and Utilization of Workflow-Integrated Artificial Intelligence for RPM Enrollment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to evaluate effectiveness, usability and clinical utility of the remote patient monitoring (RPM) "fit" score when choosing patients to enter the RPM Program.


Eligibility criteria: Inclusion Criteria:

* The study participants will be nurses who are part of the RPM care team that cares for adult patients ≥18 years.
* A patient's data will be included in the analysis if the patient is ≥18 years old and receives care from a participating nurse.
* Patient data will only be collected if permitted (based on the use of the Minnesota Research Authorization Retrieval Tool).
* Patients who will be considered for this study will be assessed based on standard RPM program inclusion and exclusion criteria for the any of the chronic disease RPM programs (congestive heart failure, coronary artery disease, hypertension, type 2 diabetes, COPD, and general complex care).

Exclusion Criteria:

- \< 18 years old.

Primary outcomes:
measure: Evaluation of the effectiveness, usability, and clinical utility of the RPM "fit" score as displayed in the Acute Multipatient Viewer (AMP) and underlying AI models in the real-world setting
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of "fit" score overall effect on nursing efficiency and clinical workflows
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tufia Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04481880: Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity
Official title: Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Intra-Abdominal Hypertension
Bariatric Surgery Candidate
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult subjects with morbid obesity

Brief summary: The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed

Detailed description: Intra-abdominal pressure (IAP) affects cardio-respiratory hemodynamics and can be assessed either directly, or by measuring gastric or urinary bladder pressure. However, in patients with morbid obesity, the correlations between gastric and urinary bladder pressures with IAP have not been addressed. The investigator's aim was to assess the correlations between IAP and gastric and urinary bladder pressure in patients with morbid obesity, at normal and elevated levels of IAP, and to examine the effects of increasing IAP and patient position on hemodynamic and respiratory parameters.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* Morbid Obesity
* candidate for bariatric surgery

Exclusion Criteria:

* Contraindication to laparoscopy
* Advanced COPD
* Advanced CHF

Primary outcomes:
measure: correlation between intra-abdominal pressure and gastric pressure
timeFrame: Early post-operative- up to 1 week post operation
measure: Intra-abdominal pressure
timeFrame: 0-7 days post bariatric surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03731780: Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults
Official title: Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: caries, prevention, personalized medicine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. This is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.

Detailed description: Aim of the study: is to conduct an RCT to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients

Hypothesis: This project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures

Primary objective: is to measure the incidence of new caries lesions

Eligibility criteria: Inclusion Criteria:

1. High caries risk patients
2. 18-25 years
3. Males or Females
4. Patients approving to participate in the study -

Exclusion Criteria:

* Patients with systemic conditions
* Current periodontitis (sites of probing pocket depth ≥ 5 mm)
* Allergy to any of the ingredients of the study products
* Evidence of parafunctional habits
* Dysfunction of temporomandibular joint
* Use of antibiotics in the previous 30 days
* Patients with developmental dental anomalies
* Patients with removable prosthesis
* Patients with Orthodontic appliance
* Periapical Abscess or Fistula and exposed pulps.

Primary outcomes:
measure: incidence of new caries lesions
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Fawzi, PhD
role: STUDY_CHAIR
References: