louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06767397: Factors Influencing Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and GA
Official title: Factors Influencing the Hemodynamic Stability and Its Management in Patients Undergoing Pelvic Surgery Under Spinal and General Anesthesia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Floor Disorders
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intraoperatively hemodunamic instability during spinal and general anesthesia was adressed and also evaluate its management.

Brief summary: Patients are at risk for hemodynamic instability both during and after surgery, as it is an independent predictor of long-term patient morbidity and length of hospital stay. The development of hemodynamic instability is caused by a number of factors. When these risk factors are prevented or treated, patients may experience less hemodynamic instability during pelvic surgery, as well as the morbidity and mortality that come with it in both spinal and general anesthesia.

Detailed description: The objective of this study was to evaluate the factors that affect the hemodynamic stability and evaluate the effectiveness of different management strategies employed to maintain hemodynamic stability during spinal and general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years and older.
* ASA (American Society of Anesthesiologists) physical status classification I and II.
* Patients scheduled for elective pelvic surgery.
* Can give informed consent or has a legal representative to give consent.
* There are no contraindications to spinal or general anesthesia based on preoperative assessment (e.g, severe cardiovascular disease, no previous history of adverse anesthetic reactions).

Exclusion Criteria:

* Age below 18 years.
* Emergency procedures or that require immediate intervention.
* Pregnancy or breastfeeding status.
* Conditions such as spinal cord disease and severe coagulopathy that are recognized contraindications to spinal or general anesthesia.
* ASA physical status classification III and above.
* History of severe adverse reactions to anesthesia or known allergy to anesthetic agents.
* Concurrent involvement in additional clinical trials that could have an impact on the treatment of anesthesia or hemodynamic results.
* Individuals with substantial comorbidities (such as uncontrolled hypertension or heart failure) that might complicate hemodynamic responses.

Primary outcomes:
measure: Hemodynamic instability
timeFrame: 12 Months
measure: Self-designed questionnaire
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Mardan
country: Pakistan
facility: Mardan Medical Complex
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT01290497: Efficacy and Safety of 3 Different Dosage Regimens of Hyaluronic Acid in Patients With Knee Osteoarthritis (OA)
Official title: Pilot, Unicentre, Randomized, Parallel, Controlled Study to Evaluate the Efficacy and Safety of Three Different Intraarticular Dosage Regimens of Adant® in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Lead sponsor: Tedec-Meiji Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* Outpatient\>45 years of age diagnosed with primary osteoarthritis according to ACR and Kellgren criteria
* Knee pain ≥ 55 mm and ≤90 mm measured by Visual Analogue Scale (VAS) 100 mm
* Ability to understand and follow study procedures
* Written informed consent

Exclusion Criteria:

* Patients with secondary osteoarthritis of the knee according to ACR criteria.
* Severe inflammation of the knee diagnosed by physical examination or a sedimentation speed rate \< 40 mm/h and serum rheumatoid factor titre \< 1:40
* Patients having previously received surgery, including arthroscopy
* Patients with joint inflammatory disease (spondilitis, systemic rheumatoid arthritis), microcrystalline arthropathies (chondrocalcinosis, gout, fibromyalgia) and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment
* Previous administration of any of the following treatments: hyaluronic acid ia (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study

Primary outcomes:
measure: The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee.
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the safety of the different dosage regimens
timeFrame: 1 year
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
state: Andalucia
Study officials:
name: Alejandro Escudero
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02931097: DBS of the MLR for Gait and Balance Disorders in PD Patients
Official title: Effects of Deep Brain Stimulation of the Mesencephalic Locomotor Region on Gait and Balance Disorders in Parkinson's Disease Patients : a Randomized, Double-blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Deep brain stimulation
Mesencephalic locomotor region
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2016-10-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Gait and balance disorders represent the main motor disability in advanced Parkinson's disease. These symptoms are less or unresponsive to levodopa treatment and are considered to be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and freezing of gait are responsible for high morbidity (fractures, residential health care) and increased significantly mortality. The pathophysiology of gait and balance disorders is still poorly understood, but recent data obtained in animals and humans suggest that a degeneration of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic locomotor region, could play a crucial role. In line with this hypothesis, low-frequency stimulation of the pedunculopontine area, thought to increase the activity of the remaining cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over, controlled study.


Eligibility criteria: Inclusion Criteria:

* age below 71 years
* severe form of Parkinson's Disease with disease duration \> 5 years
* presence of gait and/or balance disorders unresponsive to levodopa treatment,
* \> 40% decrease in others motor symptoms with levodopa treatment
* health insurance
* give signed informed written consent

Exclusion Criteria:

* dementia (Mattis Dementia Rating Scale \< 129, MDRS),
* ongoing psychiatric disturbances,
* surgical contraindications
* significant brain lesions detected on MRI.

Primary outcomes:
measure: Change in the anticipatory postural adjustments between each deep brain stimulation condition
timeFrame: 3, 5, 7 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Institut du Cerveau et de la Moelle Epiniere
Study officials:
affiliation: APHP
name: Marie-Laure Welter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010997: Foresee Home for Monitoring Age Related Macular Degeneration (AMD)
Official title: Foresee Home for Monitoring Age Related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: AMD, CNV
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: AMD subjects

Brief summary: The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

Detailed description: The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Eligibility criteria: Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
* Did not perform more then 10 anti- VEGF injections
* Age \>50 years
* VA with habitual correction \>6/45 in the study eye
* Computer users

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

Primary outcomes:
measure: To investigate the FORESEE HOME ability to diagnose AMD in different stages
timeFrame: 1 year
Secondary outcomes:
measure: To investigate the correlation between visual fields (VF) defects map generated by the FORESEE HOME and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).
timeFrame: 1 year
Other outcomes:
Locations:
city: Naharia
country: Israel
facility: Naharia Hospital
Study officials:
affiliation: Naharia Hospital
name: Eliezer Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01803997: Pink and Dude Chef
Official title: Pink and Dude Chef Afterschool Cooking Program: Improving Food Knowledge and Skills in Middle School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition
Fruit and Vegetable Intake
Healthy Food Choice
Healthy Food Preparation
Keywords: Child
Nutrition
resonance Raman spectroscopy
Fruit & Vegetable
Children Cooking
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: California Polytechnic State University-San Luis Obispo
First posted: 2013-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to evaluate an afterschool program to teach nutrition through basic cooking skills. This after school extracurricular program increases the students' confidence, knowledge, and skills for cooking as one of the first steps for dietary improvement. In addition to the life lessons students learn during this class, they gain self-confidence and become self-sufficient culinary experts that are capable of educating their siblings, parents, and social circles. This research project will test the impact this program has on nutritional knowledge, culinary efficacy, and nutritional choices made in and out of the home. The Pink and Dude Chef Afterschool Cooking Program was developed through STRIDE (Science through Translational Research in Diet and Exercise at California Polytechnic state University (Cal Poly) in San Luis Obispo, CA.

Hypothesis: Middle school students participating in the Pink and Dude Chef afterschool cooking program will increase nutritional knowledge, culinary efficacy, motivation to eat fruits and vegetables, and fruit and vegetable intake compared to an attention control group.


Eligibility criteria: Inclusion Criteria:

* Middle school aged child with parent willing to partcipate
* Ability to partipate in an afterschool program

Exclusion Criteria:

* Less or greater than middle school aged

Primary outcomes:
measure: Questionnaire on nutritional knowledge, culinary efficacy, and motivation to eat fruit and vegetables
timeFrame: 6 weeks
measure: Palm scans (resonance Raman spectroscopy) to measure cartenoids (indicator of vegetable and fruit intake).
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Research Nutrition Center
state: North Dakota
Study officials:
References:
citation: Casperson SL, Sieling J, Moon J, Johnson L, Roemmich JN, Whigham L. A mobile phone food record app to digitally capture dietary intake for adolescents in a free-living environment: usability study. JMIR Mhealth Uhealth. 2015 Mar 13;3(1):e30. doi: 10.2196/mhealth.3324.
Clinical trial NCT02834897: Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation
Obstetric Labor Complications
Pregnancy Complications
Keywords: EOS imagery
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus "Goldstandard current "that is the pelviscanner.


Eligibility criteria: Inclusion Criteria:

* pelviscanner indication in women

Exclusion Criteria:

* In the disqualification of another study or under the "national register of volunteers."

Primary outcomes:
measure: Measurement reliability index Magnin with EOS cab relative to the CT measurements
timeFrame: one months
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU de Besançon
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: sebastien AUBRY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06662097: A Study of Bevonescein in Patients Undergoing Abdominopelvic Surgery
Official title: Multicenter Open-Label Feasibility Study of Intraoperative Nerve and Ureter Visualization With Bevonescein in Patients Undergoing Minimally Invasive Abdominopelvic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Surgery
Nerve Injury
Imaging
Lead sponsor: Alume Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study will begin with a dose-defining stage in each surgical setting. Once dose defining is complete, the study will proceed to a dose expansion phase for each surgical setting.
Primary purpose: PREVENTION

Brief summary: Feasibility study of Bevonescein to highlight Nerves and Ureter in patients undergoing Minimally Invasive Surgery

Detailed description: This study will evaluate the safety, tolerability and efficacy of Bevonescein administered as an intravenous (IV) infusion to patients undergoing minimally invasive surgery. This study will also characterize the pharmacokinetic of Bevonescein in this subject population and determine the dose of Bevonescein needed to generate a fluorescence signal in nerve and ureter tissue to enable fluorescence recordings and image analysis with an imaging system.

Eligibility criteria: Inclusion Criteria:

* Must be a minimum of 18 years of age
* Study participant is planning to proceed with surgery
* Willing to provide informed consent
* Sexually active patients must be willing to use an acceptable form of contraceptive while participating and 30 days after.
* Females of childbearing potential must have a negative pregnancy test at screening and during the study.

Exclusion Criteria:

* Patient has had prior surgery at the intended surgical site.
* Patient has abnormal cardiac rhythm not controlled by medication.
* Patient has moderate to severe renal impairment.
* Patient has a history of fluorescein allergy.
* Patient has a history of drug-related anaphylactic.
* Presence of a concurrent disease or condition that may interfere with study participation.
* Presence or history of any condition that, in the view of the investigator, places the patient at high risk of treatment compliance.
* Use of any Investigational Product or investigational medial device within 30 days prior to screening.

Primary outcomes:
measure: Fluorescence System Survey
timeFrame: 28 (+5 days)
Secondary outcomes:
measure: To determine the optimal dose of Bevonescein in Minimally Invasive Surgery settings
timeFrame: 28 (+5 days)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
References:
Clinical trial NCT01683097: Patient Understanding of End of Life Care
Official title: Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Directives
Resuscitation Orders
Lead sponsor: Partners in Internal Medicine
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. Based on patient responses, factors that affect choices of code status would be analyzed. We will also evaluate if a standardized explanation improves patient understanding of end of life issues. This would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Admitted to regular nursing floor

Exclusion Criteria:

* altered mental status
* admitted in ICU
* positive screening for depression
* terminal illness defined as life expectancy\< 100 days
* inability to consent

Primary outcomes:
measure: Composite score of correct responses
timeFrame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
Secondary outcomes:
measure: Compare differences in demographic, medical, social and associated factors on patient choice of code status
timeFrame: Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Saint Vincent Hospital
state: Massachusetts
Study officials:
affiliation: Saint Vincent Hospital
name: George Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Vincent Hospital
name: Kriti Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558297: Internet Treatment for Weight Loss in Primary Care
Official title: Internet Treatment for Weight Loss in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-03-20
Enrollment: 89
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: This study will test the effectiveness of two distinct treatments for weight loss:

1. Motivational Interviewing
2. Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.


Eligibility criteria: Inclusion Criteria:

* BMI 25-55
* Daily access to internet and phone

Exclusion Criteria:

* Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
* Meets criteria for current substance abuse or dependence
* Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
* Pregnant, breastfeeding, or plans to become pregnant during the treatment period
* Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
* Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
* Uncontrolled diabetes, thyroid conditions, or hypertension

Primary outcomes:
measure: Body Weight in Pounds.
timeFrame: 1.5 months after treatment start (Baseline)
measure: Body Weight in Pounds.
timeFrame: 3 months after treatment start (Baseline)
measure: Body Weight in Pounds.
timeFrame: 6 months after treatment start (Baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Rachel Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes RD, White MA, Martino S, Grilo CM. A randomized controlled trial comparing scalable weight loss treatments in primary care. Obesity (Silver Spring). 2014 Dec;22(12):2508-16. doi: 10.1002/oby.20889. Epub 2014 Oct 9.
citation: Wiedemann AA, Baumgardt SS, Ivezaj V, Kerrigan SG, Lydecker JA, Grilo CM, Barnes RD. Getting a head start: identifying pretreatment correlates associated with early weight loss for individuals participating in weight loss treatment. Transl Behav Med. 2021 Feb 11;11(1):236-243. doi: 10.1093/tbm/ibz149.