louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03785262: Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters
Official title: Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurogenic Bladder
Urinary Tract Infections
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.


Eligibility criteria: Inclusion Criteria:

1. \>18 years of age
2. Spinal cord injury (\>1 year), multiple sclerosis (\>1 year), spina bifida, parkinsons (\>1 year)
3. Indwelling catheter (urethral or suprapubic) for \>3 months, and used as primary bladder management mechanism
4. \>1 urinary tract infection in the last 12 months

Exclusion Criteria:

1. Intravesical botox in the last 6 months
2. Chronic antibiotic suppressive therapy
3. Active symptomatic UTI on day of randomization
4. Unable to understand written and spoken English
5. Prior/current utilization of the Uroshield device

Primary outcomes:
measure: Bacteriuria
timeFrame: 30 days
Secondary outcomes:
measure: Neurogenic bladder symptom score (NBSS)
timeFrame: 30 days
measure: Patient subjective rating of amount of sediment/debris at the end of the 30 days
timeFrame: 30 days
measure: Total bacterial cell counts
timeFrame: 30 days
measure: Microbiome comparison of biofilms
timeFrame: 30 days
measure: Scanning electron microscopy of biofilms
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: Canada
facility: St Josephs Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT04683562: Netrin-1 and Placenta Accreta
Official title: The Implication of Placental Netrin-1 Receptor DCC in the Pathophysiology of Placenta Accreta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 34
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Netrin-1 is a secreted protein, which was first identified as a neuronal guidance factor. It is expressed in a multitude of tissues as pancreas, lung, breast, and placenta. Netrin-1 is a multifunctional protein, involved in cell polarity, adhesion, angiogenesis, apoptosis, migration, morphogenesis, and differentiation of various cell types. Most of netrin-1 activity occur through signaling pathways induced by its two main receptors, DCC (deleted in colorectal cancer) and UNC5H (uncoordinated-5 homolog). Its receptors have been linked to the processes of apoptosis and angiogenesis. In absence of netrin-1, DCC and UNC5H receptors lead to apoptosis. In contrary, in presence of netrin-1, receptors transduce molecular cascades leading to proliferation, differentiation and migration of the cells. Netrin-1 has been involved in the pathogenesis of multiple diseases, as diabetes, cardiovascular diseases, and cancer. Serum Netrin-1 levels were high in preeclamptic patients.


Eligibility criteria: Inclusion Criteria:

* Age between 20-40 years.
* Singleton pregnancy.
* Women with suspicion of PA by two-dimensional (2D) gray scale imaging and color Doppler flow mapping

Exclusion Criteria:

* Multiple pregnancy,
* Fetal anomalies,
* Preterm premature rupture of membranes, or infection
* Any medical disorders, such as thyroid dysfunction, hypertension, and gestational diabetes
* Patients with known bleeding disorders or on anticoagulant therapy.

Primary outcomes:
measure: Placental Netrin-1 level
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health Hospital
Study officials:
References:
Clinical trial NCT03653962: Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content
Official title: Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: Multimedia
informed consent
metabolic surgery
Roux-en-Y gastric bypass
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.


Eligibility criteria: Inclusion Criteria:

* being a being bariatric metabolic surgery candidate according to international guidelines

Exclusion Criteria:

* illiterate
* previous bariatric surgery
* age \<18

Primary outcomes:
measure: Questionnaire
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04743362: A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions
Official title: Noninvasive Assessment of Muco-cutaneous Lesions In Vivo
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Lesion
Mucosal Lesion
Keywords: muco-cutaneous lesion
skin lesion
mucosal lesion
Memorial Sloan Kettering Cancer Center
21-019
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 5010
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study, we anticipate to recruit \~5000 participants over a period of 7 years. Of this, \~4000 will be patients with a muco-cutaneous lesion and \~1000 will be volunteers.

Patients in the Dermatology, Clinical Immunology Services, Pediatrics, Bone Marrow Transplant, Dental, and Radiation Oncology departments who have a muco-cutaneous lesion/process amenable to imaging with one or more of the available noninvasive devices will be offered the opportunity to participate in the study. In addition to patients and volunteers, MSK clinicians will be recruited to the study via clinician verbal informed consent.

Brief summary: The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.The High-resolution OCT (Apollo Medical Optics) device ApolloVue® S100 Image System (medical device Class II) can provide both cross-sectional and en-face images with cellular information.


Eligibility criteria: Inclusion Criteria:

* All ages
* Patients with a muco-cutaneous lesion(s) amenable to imaging by non-invasive tools
* Healthy volunteer subjects
* Ability to give informed consent or in the case of pediatric patients, assent and consent from the parent/guardian

Exclusion Criteria:

* Allergy or intolerance to ultrasound gel or mineral oil used for imaging
* Patients who are not able to comply with imaging procedure

Primary outcomes:
measure: Collect images of untreated and treated neoplastic and non-neoplastic muco-cutaneous conditions
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Manu Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03400462: Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients
Official title: Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: Dry needling, occlusal splint, NSAID, nimesulide
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effectiveness of myofascial pain treatment methods.

Detailed description: Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.

Eligibility criteria: Inclusion Criteria:

* pain localized in the TMJ or in the preauricular area.
* no other analgesic treatment in the area of head and neck during last 12 months

Exclusion Criteria:

* inflammation in the oral cavity that emerge as a myofascial pain
* earlier splint therapy
* pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants
* systemic diseases e.g. rheumatic, metabolic
* lack of stability in the masticatory organ motor system
* masticatory organ injury

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pomeranian Medical University
name: Bartosz Dalewski, DMD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06304662: Yoga for Physical and Mental Health
Official title: Physical and Mental Health. Effects of Yoga as a Therapeutic Tool.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future.


Eligibility criteria: Inclusion Criteria:

* University students who do not participate in any physical exercise program
* Sufficient physical autonomy to participate in the physical activities required by the study
* That they are able to understand the instructions, programs and protocols of this project.

Exclusion Criteria:- University students who have serious physical or mental conditions

* Lack of commitment to regular attendance
* Extensive previous experience in yoga

Primary outcomes:
measure: Stress level
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: D2 test
timeFrame: Up to twelve weeks
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Up to twelve weeks
measure: Handgrip Strength
timeFrame: Up to twelve weeks
measure: Anxiety and Depression
timeFrame: Up to twelve weeks
measure: Sleep quality
timeFrame: Up to twelve weeks
measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
timeFrame: Up to twelve weeks
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Agustín Aibar Almazán
Study officials:
References:
Clinical trial NCT01840462: Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]
Official title: A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from cervical dystonia

Brief summary: The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.


Eligibility criteria: Inclusion Criteria:

* Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
* Naïve to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis for at least 2 years prior to inclusion and last injection with Dysport® and last injection between 3 and 6 months prior to inclusion
* With the intention to be treated with Dysport®

Exclusion Criteria:

* The subject has already been included in this study
* Participation in an interventional trial
* Suffering from anterocollis or retrocollis as primary component

Primary outcomes:
measure: Change in Tsui scores
timeFrame: Baseline and 12 weeks post-injection Cycle 2
Secondary outcomes:
measure: Change in Tsui scores
timeFrame: Baseline and 12 weeks post-injection Cycle 1
measure: Change in Tsui scores
timeFrame: Baseline and 12 weeks post-injection Cycle 3
measure: Change in Tsui scores
timeFrame: Baseline and 12 weeks post-injection Cycle 4
Other outcomes:
Locations:
city: Graz
country: Austria
city: Wiesbaden
country: Germany
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00831662: The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 490
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 purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Have best corrected visual acuity in both eyes of at least +0.7 or better
* Central corneal staining of 3 on the NEI scale
* If female, are non-pregnant or non-lactating
* Have a history of dry eye disease in both eyes
* Have normal lid anatomy

Exclusion Criteria:

* Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study
* Have had ocular surface surgery within the past year
* Are considered legally blind in one eye
* Have a serious medical condition which could confound study assessments

Primary outcomes:
measure: Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders.
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale)
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medical Monitor, Inspire
name: Reza Haque, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Tauber J, Davitt WF, Bokosky JE, Nichols KK, Yerxa BR, Schaberg AE, LaVange LM, Mills-Wilson MC, Kellerman DJ. Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye. Cornea. 2004 Nov;23(8):784-92. doi: 10.1097/01.ico.0000133993.14768.a9.
Clinical trial NCT01334762: Efficacy of Letrozole and CC Alone in an IUI Program in Cases With Surgically Treated Minimal to Mild Endometriosis
Official title: Letrozole and CC Alone in an IUI Program in Women With Surgically Treated Minimal to Mild Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: minimal to mild endometriosis
letrozole
clomiphene citrate
IUI
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-04-13
Enrollment: 136
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate pregnancy rates with letrozole and CC alone in an IUI program for women with recently surgically treated minimal to mild endometriosis.


Eligibility criteria: Inclusion Criteria:

* Patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure
* No other infertility factors.
* Normal serum basal hormone levels as well as documented ovulation

Exclusion Criteria:

* Moderate or severe endometriosis
* Dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery
* Age more than 36 years, BMI more than 30 kg/m2
* women with a previous pregnancy

Primary outcomes:
measure: Clinical pregnancy rate per cycle
timeFrame: 6-7 weeks gestation
Secondary outcomes:
measure: Miscarriage rate.
timeFrame: Up to 20 weeks gestation
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals,OB/GYN department
state: Dakahlia Governorate
Study officials:
affiliation: Mansoura University Hospital
name: Hatem Abu Hashim, MD MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Hospital
name: Mohamed El Rakhawy, MD
role: STUDY_CHAIR
affiliation: Mansoura University Hospital
name: Ibrahim Abd Elaal
role: STUDY_DIRECTOR
References:
citation: Dmowski WP, Pry M, Ding J, Rana N. Cycle-specific and cumulative fecundity in patients with endometriosis who are undergoing controlled ovarian hyperstimulation-intrauterine insemination or in vitro fertilization-embryo transfer. Fertil Steril. 2002 Oct;78(4):750-6. doi: 10.1016/s0015-0282(02)03343-5.
citation: Werbrouck E, Spiessens C, Meuleman C, D'Hooghe T. No difference in cycle pregnancy rate and in cumulative live-birth rate between women with surgically treated minimal to mild endometriosis and women with unexplained infertility after controlled ovarian hyperstimulation and intrauterine insemination. Fertil Steril. 2006 Sep;86(3):566-71. doi: 10.1016/j.fertnstert.2006.01.044.
citation: Abu Hashim H, El Rakhawy M, Abd Elaal I. Randomized comparison of superovulation with letrozole vs. clomiphene citrate in an IUI program for women with recently surgically treated minimal to mild endometriosis. Acta Obstet Gynecol Scand. 2012 Mar;91(3):338-45. doi: 10.1111/j.1600-0412.2011.01346.x. Epub 2012 Jan 26.
Clinical trial NCT02634762: Acute Congestive Heart Failure Urgent Care Evaluation
Official title: Acute Congestive Heart Failure Urgent Care Evaluation: Prospective Validation of the Emergency Heart Failure Mortality Risk Grade 7-day and 30-day Algorithms in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Institute for Clinical Evaluative Sciences
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 1983
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: Patients presenting to the emergency department diagnosed with heart failure at 8 centers in Ontario, Canada

Brief summary: This prospective validation study evaluates the ability of a risk algorithm, which can simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart failure presenting to the emergency department. The risk algorithms for prediction of 7-day (Emergency Heart failure Mortality Risk Grade \[EHMRG\]) and 30-day mortality (EHMRG30-ST) have been previously derived.


Eligibility criteria: Inclusion Criteria:

* Patients with acute heart failure diagnosed in the emergency department

Exclusion Criteria:

* Palliative or do-not-resuscitate (DNR) directive
* Dialysis dependent

Primary outcomes:
measure: Mortality
timeFrame: 7 days
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Institute for Clinical Evaluative Sciences
name: Douglas Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee DS, Lee JS, Schull MJ, Borgundvaag B, Edmonds ML, Ivankovic M, McLeod SL, Dreyer JF, Sabbah S, Levy PD, O'Neill T, Chong A, Stukel TA, Austin PC, Tu JV. Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure. Circulation. 2019 Feb 26;139(9):1146-1156. doi: 10.1161/CIRCULATIONAHA.118.035509.