louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04777227: Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma
Official title: Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma: A Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intractable Plantar Keratoma
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2021-03-02
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: An intractable plantar keratoma (IPK) is a conical thickening of the epidermis' stratum corneum and a common cause of foot pain which can have a significant, detrimental impact on the mobility, quality of life and independence of individuals. Conservative treatments are currently offered to patients with IPK, but they are unsatisfactory since they do not offer a sufficient or permanent reduction of symptoms. The purpose of this study was the evaluation of the feasibility, safety and effectiveness of innovative treatments for intractable plantar keratoma (IPK)


Eligibility criteria: Inclusion Criteria:

• Having a painful IPK for at least 3 months

Exclusion Criteria:

* Ongoing pregnancy or breastfeeding
* Severe cardiovascular or neurological disease
* Immunosuppressed status
* Presence of a plantar ulcer
* Allergy to lidocaine
* History of keloid or hypertrophic scar
* Simultaneous painful plantar syndrome unrelated to the presence of an IPK

Primary outcomes:
measure: Change from baseline in pain (visual analogue scale)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months
measure: Change from baseline in Foot-Function-Index-Revised (FFI-R)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline in size of Intractable plantar keratoma
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Clinique podiatrique de l'Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Vincent Cantin, PhD
role: STUDY_DIRECTOR
References:
citation: Mercier MP, Blanchette V, Cantin V, Brousseau-Foley M. Effectiveness of saline water and lidocaine injection treatment of intractable plantar keratoma: a randomised feasibility study. J Foot Ankle Res. 2021 Apr 13;14(1):30. doi: 10.1186/s13047-021-00467-7.
Clinical trial NCT06779227: Implementation and Evaluation of Hospital-to-Home Transitional Care Intervention in Patients with Chronic Heart Failure
Official title: Implementation Ond Evaluation of Hospital-to-Home Transitional Care Intervention in Patients with Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: Henan University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study lasted for a total of three months. The purpose is to build a hospital-family transitional nursing intervention program for patients with chronic heart failure, and to explore the effectiveness of the program on the self-management of patients with chronic heart failure, in order to provide certain empirical research for the clinical intervention of transitional nursing for patients with chronic heart failure. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and nursing. The purpose of this study is to improve your self-care level and prevent your re-admission. It will not harm your physical and mental health and will not have a negative impact on the relationship between patients and nursing. You participate in this study and The personal data in the study is confidential, and any public report on the results of this study will not disclose your personal identity.


Eligibility criteria: Inclusion Criteria:

* It meets the diagnostic criteria of the New York Heart Association (NYHA) for CHF, and the heart function level is II to III;
* Age ≥18 years old;
* The condition is stable and meets the standard of being discharged from the hospital;
* Clear consciousness, no communication barriers, able to understand and fill in the questionnaire correctly;
* Informed consent and voluntary participation in this study.

Exclusion Criteria:

* Patients with hepato-renal disfunction, sequelae of stroke, dementia;
* Patients with a history of mental disorders or already having mental disorders, critically ill patients.

Primary outcomes:
measure: Self-efficacy management indicators
timeFrame: Baseline, one month, three months
Secondary outcomes:
measure: Self-care indicators
timeFrame: Baseline, one month, three months
measure: Disease-related indicators
timeFrame: Baseline, one month, three months
measure: Transitional nursing evaluation indicators
timeFrame: Baseline, one month, three months
Other outcomes:
measure: Re-hospitalisation indicators
timeFrame: Baseline, one month, three months
Locations:
city: Kaifeng
country: China
facility: Institute of Nursing and Health, School of Nursing and Health, Henan University
state: Henan
Study officials:
References:
Clinical trial NCT00431327: Facilitators to Keeping Colonoscopy Appointments
Official title: Peer Coach Intervention to Improve Attendance to Scheduled Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: patient navigator
peer support
colonoscopy
adherence
None: have to be scheduled for screening or diagnostic colonoscopy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2007-02-05
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To identify patients at risk for nonattendance to their first scheduled colonoscopy and to conduct a randomized trial of a theory-based, peer coach intervention on completing the scheduled colonoscopy.

Detailed description: The potential to reduce the morbidity and mortality from colorectal cancer, the second most common cause of cancer death in the U.S. has been compromised because only about half of eligible patients have been appropriately screened. Patients contribute to inadequate colorectal cancer screening by failing to complete ordered tests. Several studies have reported low rates of attendance to scheduled sigmoidoscopy and colonoscopy studies. Because physicians offer limited counseling when ordering these tests, approaches are needed to address patient concerns and to promote adherence to scheduled colon studies. Therefore, we conducted a trial of a theory-based telephone intervention by patient 'peer coach' who was trained to address barriers to colonoscopy attendance versus a mailed professional brochure. The support was targeted to those at greatest risk of non-attendance.

Eligibility criteria: Inclusion Criteria:

* Age 50
* No prior colonoscopy in our health system records
* Patient in one of four primary care clinics within the University of Pennsylvania Health System
* Attended \<75 of their primary care physicians visits within the past year

Exclusion Criteria:

* Colonoscopy not ordered by a primary care physician in a study clinic
* High readiness for the procedure
* A health care professional
* Had a prior colonoscopy outside of our health care system

Primary outcomes:
measure: Attending the colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Barbara J Turner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00866827: Airway Vascular Lesions
Official title: Airway Vascular Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemangiomas
Venous Malformations
Lymphatic Malformations
Keywords: Airway
Hemangiomas
Venous Malformations
Lymphatic Malformations
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2009-03-23
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the ACH database that have been treated in the last ten years for airway vascular lesions.

Brief summary: Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various lasers, to open removal, none of which have proven to be a gold standard. Venous malformations of the airway are difficult to treat and also require laser therapy or open removal and often repeated treatments are required. Similarly airway lymphatic malformations can require multiple treatment modalities as well as multiple procedures and are infrequently eradicated when extensive. New uses for various lasers and differing treatment protocols are frequently developed. Review of the treatment modalities and efficacy of these methods is required. The goal of this research is to determine protocols for treatment of airway vascular malformation and to evaluate our results from treatment of these lesions.


Eligibility criteria: Inclusion Criteria:

* Airway Vascular Lesion

Exclusion Criteria:

* None at this time

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UAMS, ACH, Central Arkansas Veterans Healthcare System
name: Gresham T Richter, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UAMS, ACH, Central Arkansas Veterans Healthcare System
name: Jessica L Boswell, BS, CRS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03397927: The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes
Official title: The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ballet Dancers
Keywords: ballet shoe
orthosis
pain
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: An orthosis in the ballet shoe to see if pain reduction during dancing on pointes will decrease.

One group of pre-preprofessional ballet dancers will receive an orthosis and will train during four weeks with it. The other group without a orthosis will be the control group.


Eligibility criteria: Inclusion Criteria:

* girls on preprofessional ballet schools with a minimum of 30 minutes professional training a week;
* 12 to 18 years old
* pain during dancing on pointes

Exclusion Criteria:

* experience with wearing a orthosis in their ballet shoe

Primary outcomes:
measure: VAS-score
timeFrame: four weeks
Secondary outcomes:
measure: lower extremities muscle ratio
timeFrame: four weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
state: Limburg
Study officials:
References:
Clinical trial NCT00735527: Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
Official title: Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Status Epilepticus
Seizures
Keywords: seizures
status epilepticus
lorazepam
intra-nasal
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.


Eligibility criteria: Inclusion Criteria:

* Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
* Age 6-14 years

Exclusion Criteria:

* Known hypersensitivity to any benzodiazepine
* Child has received any parenteral anti-convulsant within 1 hr prior to enrollment
* Presence of severe cardio-respiratory compromise or cardiac arrhythmias
* Presence of upper respiratory tract infection
* Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea

Primary outcomes:
measure: Cessation of all clinical seizure activity within 10 min of drug administration
timeFrame: 10 min
Secondary outcomes:
measure: Persistent cessation of seizure activity for 1 hr
timeFrame: 1 hr
measure: Patients requiring rescue medication within 1 hr
timeFrame: 1 hr
measure: Time to achieve intra-venous access after arrival in casualty
timeFrame: minutes
measure: Time from drug administration to termination of seizure(s)
timeFrame: minutes
measure: Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration
timeFrame: 1 hr
measure: Development of significant respiratory depression requiring assisted ventilation
timeFrame: 1 hr
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
References:
citation: Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Intranasal versus intravenous lorazepam for control of acute seizures in children: a randomized open-label study. Epilepsia. 2011 Apr;52(4):788-93. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28.
Clinical trial NCT05297227: Non-surgical Periodontal Therapy: Efficacy of re Treatment for Non-responding Sites.
Official title: Non-surgical Periodontal Therapy: Efficacy of Repeated Subgingival Instrumentation for Non-responding Sites. A Quasi-experimental Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Therapy
Non Responding Sites
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with a Diagnosis of Periodontitis were recruited consecutively after a full mouth clinical examination and radiographic evaluation. The screening and periodontal chart were performed at the Department of Medical Biotechnologies, Unit of Periodontology, University Hospital of Siena, Siena (Italy).

Brief summary: The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. After 3 months they will be re-evaluated, and non-responding sites (Ppd\>=4mm and bop+) will be scheduled for the second session of PMPR and SI. After 2 months they will be re-evaluated and clinical efficacy will be defined.

Detailed description: The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. Once included, individuals will receive, by a calibrated examiner, a full-mouth periodontal chart, and accordingly, they will be treated in a multi-step approach, in accordance with the recent clinical guidelines. The treatment will consist of oral hygiene instruction and motivation, risk factor control, professional mechanical plaque removal (PMPR), and subgingival instrumentation (SI): it will be performed by two experienced operators. Thereafter, after 3 months, patients will be evaluated and a new periodontal chart will be performed. The presence of non-responding sites (Ppd\>4 and bop+) will be treated with the second session of PMPR plus Subgingival Instrumentation. After 2 months patients will be clinically evaluated and a full periodontal chart will be completed.

Eligibility criteria: Inclusion Criteria:

* unremarkable general health; age 18-80; minimum of 20 teeth; Periodontitis (Stage 1-4); no antibiotic intake in the previous 6 months;

Exclusion Criteria:

* Subgingival instrumentation in the previous 12 months
* No antibiotic intake in the previous 3 months
* A compromised medical condition requiring prophylactic antibiotic coverage
* Pregnant/nursing
* Ongoing drug therapy that might alter the clinical signs and symptoms of periodontitis

Primary outcomes:
measure: Number of pocket closures
timeFrame: through study completition, 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02727127: Brain Ion Homeostasis, Lithium and Bipolar Disorder
Official title: Brain Ion Homeostasis, Lithium and Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Bipolar Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of New York City and surrounding areas

Brief summary: In this project, investigators intend to carry out the first simultaneous, in vivo, imaging study of lithium content and sodium ion homeostasis in the brain of Bipolar Disorder (BPD) patients under Lithium therapy.

Detailed description: The purpose of this study is to validate a new method for the measurement of the amount of lithium (also known as lithium concentration) in the brain of subjects undergoing lithium treatment for bipolar disorder. The method involves the use of Magnetic Resonance Imaging (MRI) and Spectroscopy (MRS) techniques. These are non-invasive techniques, with no known harmful effects, that allow investigators to measure the amount of lithium in an individual's brain. There will be no contrast dye used in this study.

Eligibility criteria: Inclusion Criteria:

* Psychiatrically stable patients (diagnosed according to the Diagnostic and Statistical Manual, DSM-IV, criteria)
* On steady state serum lithium levels (0.8-1.2mEq/L)

Exclusion Criteria:

* Subjects who have a history of head trauma
* Subjects who have a contraindication for an MRI exam, including a claustrophobia, surgical or vascular implants, pregnancy, pacemakers, neurostimulators, history of metal in the eyes, and orthodontia or extensive bridgework (with have a particular impact on gradient echo imaging).

Primary outcomes:
measure: Study the relationship between BLC and brain sodium ion homeostasis, as measured by concurrent Single / Triple quantum sodium MRI in BPD patients
timeFrame: 1 Hour
Secondary outcomes:
measure: To investigate the measurement of sodium ion homeostasis in the brain of BPD patients, at clinical magnetic field strengths (3 Tesla), as a non-invasive surrogate marker of BLC during Lithium Carbonate therapy
timeFrame: 1 Hour
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Fernando Boada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06181227: A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema
Official title: A Phase 2 Study to Evaluate the Safety and Treatment Effect of Intravitreal AVD-104 in Participants With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
Lead sponsor: Aviceda Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 2 study to determine the safety and preliminary efficacy of intravitreal injections of AVD-104, a novel glyco-mimetic nanoparticle, in reducing macular edema associated with diabetic retinopathy.

Detailed description: The primary objective is to evaluate the tolerability and treatment effect of intravitreal injections (IVT) of AVD-104 in participants with diabetic macular edema (DME). Participants will receive either three intravitreal injections of low-dose AVD-104 (1.0 mg) each 28 days apart or two intravitreal injections of AVD-104 at a high-dose (2.0 mg) 56 days apart. Serial optical coherence tomography (OCT), ultra wide-field fluorescein angiography, and OCT-angiography (OCT-A) will be performed to evaluate the treatment effect on central subfield thickness (CST) and areas of non-perfusion. All participants will be followed-up for safety until day 84.

There will be a planned enrollment up to 30 participants.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus (type 1 or 2), as defined by the World Health Organization and/or American Diabetes Association
* Decreased visual acuity (VA) due to DME, with BCVA letter score of 75-20 letters on ETDRS-like charts (20/32-20/320 Snellen equivalent)
* DME represented by macular thickening on SD-OCT involving the center of the macula: CST ≥325 μm

Exclusion Criteria:

* Any IVT anti-vascular endothelial growth factor (VEGF) treatment within 3 months before randomization
* Any history of pan-retinal photocoagulation (PRP) treatment
* Any use of Iluvien® (Alimera Sciences, Inc., Alpharetta, GA) in the last 3 years; or Ozurdex® (Abbvie, Chicago, IL) or Xipere (Bausch \& Lomb, Vaughan, Ontario, Canada) in the last 6 months
* History of macular laser photocoagulation
* Any signs of high-risk proliferative diabetic retinopathy (PDR)

Primary outcomes:
measure: Safety of AVD-104
timeFrame: 3 months
Secondary outcomes:
measure: Treatment effect
timeFrame: 3 months
measure: Treatment effect - vision
timeFrame: 3 months
Other outcomes:
Locations:
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Wichita Falls
country: United States
facility: West Texas Retina Consultants
state: Texas
Study officials:
References: