louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05590520: Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Official title: A Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure :A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fissure in Ano
Keywords: Fissure, botulinum toxin, Gtn ointment
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomized to receive treatment with either a total of 20 U of botulinum toxin(diluted in saline to a concentration of 50 U per milliliter.

Detailed description: Lateral internal sphincterotomy, the most common treatment for chronic anal fissure, may cause permanent injury to the anal sphincter, which can lead to fecal incontinence. We compared two nonsurgical treatments that avert the risk of fecal incontinence.treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis: evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter
* symptoms (post-defecatory or nocturnal pain, bleeding, or both) lasting for more than two months.

Exclusion Criteria:

* Patients with acute fissure
* fissure associated with other conditions (i.e., inflammatory bowel diseases, HIV infection, hemorrhoids, fistula in ano, anal abscesses, or anal or perianal cancer)
* those who had undergone previous surgical procedures in the anal canal.
* known hypersensitivity to component of the formulations of type A BTX
* pregnant or breast-feeding women 6-refusal of consent

Primary outcomes:
measure: Healing of fissure
timeFrame: Within 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pak-Emirates Military Hospital
state: Punjab
Study officials:
affiliation: Resident
name: Mubashra Badar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100020: Implementing Physical Activity Guidelines for Adults With MS
Official title: A Community-based Randomized Controlled Trial Testing Implementation of the New Canadian Physical Activity Guidelines for Adults With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: physical activity
exercise guidelines
multiple sclerosis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The proposed project will evaluate two methods of implementation of the new Physical Activity Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities. The investigators will also determine if following the PAGs will improve aspects of fitness, function, quality of life and risk for cardiometabolic disease in this population. The investigators hypothesize that adherence to the PAGs will be higher in people who have been referred directly to a community-based exercise program, and that this greater adherence to physical activity will be associated with greater improvements in fitness, function and quality of life.

This randomized controlled trial will provide important information on how best to implement physical activity recommendations within the community setting; this information will be translated to key stakeholders during the final stages of the project.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS with mild-moderate disability (EDSS 1-7)
* Aged 18-60
* Medical clearance to participate in physical activity

Exclusion Criteria:

* current participation in regular physical activity (at least twice-weekly)
* other serious medical condition that might impair ability to participate in strength or aerobic exercise

Primary outcomes:
measure: Adherence to the Physical Activity Guidelines
timeFrame: 3 years
Secondary outcomes:
measure: Physical Fitness
timeFrame: At baseline and after the 16 week intervention
measure: Perceived Quality of Life
timeFrame: At baseline and after the 16 week intervention
measure: Fatigue
timeFrame: At baseline and after the 16 week intervention
measure: Mobility
timeFrame: At baseline and after the 16 week intervention
measure: Blood markers of cardiovascular disease risk
timeFrame: At baseline and after the 16 week intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University, Physical Activity Centre for Excellence
state: Ontario
city: Kingston
country: Canada
facility: Queens University
state: Ontario
Study officials:
affiliation: McMaster University
name: Audrey L Hicks, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canning KL, Hicks AL. Physician referral improves adherence to the physical activity guidelines for adults with MS: A randomized controlled trial. Mult Scler Relat Disord. 2020 Jan;37:101441. doi: 10.1016/j.msard.2019.101441. Epub 2019 Oct 22.
Clinical trial NCT01981720: Extension Study of PRX-102 for up to 60 Months
Official title: A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fabry Disease
Keywords: PRX-102
pegunigalsidase alfa
Fabry Disease
Lead sponsor: Protalix
Sponsor class: INDUSTRY
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2013-11-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.

Detailed description: An open-label study to evaluate the ongoing safety, tolerability and efficacy parameters of PRX-102 in adult Fabry patients (≥18 years of age). Patients enrolled received 1.0 mg/kg of PRX-102 as an intravenous infusion every 2 weeks (+/- 3 days) for up to 60 months and no less than 36 months.

Eligibility criteria: Inclusion Criteria:

* Completion of study PB-102-F02
* The patient signs informed consent
* Female patients and male patients whose co-partners were of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used throughout the duration of the study and for 3 months after termination of treatment.

Exclusion Criteria:

* Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
timeFrame: Every two weeks up to 60 months
Secondary outcomes:
Other outcomes:
measure: Plasma Lyso-Gb3 Concentration
timeFrame: Baseline and month 60
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline and Month 60
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Dallas
country: United States
facility: Institute of Metabolic Disease
state: Texas
city: Fairfax
country: United States
facility: O & O Alpan
state: Virginia
city: Asunción
country: Paraguay
facility: Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C)
city: Zaragoza
country: Spain
facility: Hospital de Dia Quiron Zaragoza
city: London
country: United Kingdom
facility: The Royal Free Hospital
Study officials:
References:
Clinical trial NCT00579020: A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
Official title: An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Corneal Infiltrates
Keywords: cornea
inflammation
blepharitis
lid infection
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-21
Enrollment: 144
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Age related.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)
timeFrame: Day 10
Secondary outcomes:
measure: Percentage of patients with eradication of pre-therapy pathogens from the lid of the study eye at TOC Visit (Day 10)
timeFrame: Day 10
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center at 1-888-451-3937
state: Texas
Study officials:
References:
Clinical trial NCT06136520: The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression
Official title: The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Baby Massage
Postpartum Depression
Keywords: Postpartum Depression
baby massage
attachment
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The research to be conducted within the scope of the project will be randomized controlled, and the population of the research will be primiparous pregnant women reached through social media. Primiparous pregnant women in the 32nd - 40th weeks of pregnancy will be included in the study, and the sample size is determined by using the G\*Power (3.1.9.2) program, considering a margin of error of 0.05 and data loss, with a power of 95% and a medium effect size; 27 people should be included in the experimental (baby massage) group and 27 people in the control group. In determining the groups, participants will be assigned to experimental and control groups using the "Randomizer.org" program. Pregnant women included in the research will be informed about the study and will be presented with an "Informed Consent Form" and "Voluntary Consent Form". Baby massage training will be given to the experimental group, and a reminder training will be given 2 weeks later. "Personal Information Form", "Prenatal Attachment Inventory" and "Beck Depression Inventory" will be applied to both groups at the beginning of the study, and postpartum 30-42 weeks. and 60-72. "Maternal Attachment Scale" and "Edinburg Postpartum Depression Scale" will be administered between days.


Eligibility criteria: Inclusion Criteria:

Being between the ages of 18-35, Being primiparous and having a singleton pregnancy,

* No high-risk pregnancy,
* Being in the 32nd to 40th week of pregnancy,
* Being literate and knowing and understanding Turkish,
* Pregnant women who have internet access and knowledge of internet usage.

Exclusion Criteria:

* ● Presence of chronic disease,

  * Pregnancy with congenital malformation,
  * Unwanted pregnancy,
  * Having attended a pregnancy school,
  * Women who become pregnant as a result of assisted reproductive technology,
  * Those with hearing and vision problems,
  * Having a known serious psychiatric disease diagnosis.

Primary outcomes:
measure: the Maternal Attachment Scale (mother-baby bonding scale)
timeFrame: 3 months
measure: The Edinburgh Postpartum Depression Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Betül Uncu
Study officials:
References:
Clinical trial NCT00237120: Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Official title: Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Myelogenous Leukemia in Chronic Phase
Keywords: Chronic Myelogenous Leukemia
Imatinib
CML
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
* Previously untreated with Interferon-alpha
* Performance status is normal or capable of only limited self-care

Exclusion Criteria:

* Patients who are pregnant or possibly pregnant
* Significant hepatic diseases
* Chronic Myelogenous Leukemia in advanced phase

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: 3 years overall survival
measure: Duration of remaining in chronic phase
Secondary outcomes:
measure: Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
measure: Adverse event
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT02842320: Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)
Official title: Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic myelogenous leukemia (CML).

Its effectiveness in controlling the progression of the disease is such that it is possible today to consider stopping treatment in patients with deep molecular response (\> RM4.0).

Only in about 50% of cases, patients relapse. It has been shown in these patients that hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These cells are probably at the origin of relapse. It is therefore necessary to develop complementary therapies to cure the disease and consider discontinuation iTKs The development of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The membrane expression of the IL-1-RAP protein could be an interesting target.


Eligibility criteria: Inclusion Criteria:

* patients for whom there is a strong suspicion of CML diagnosed as part of routine activity.
* written informed consent

Exclusion Criteria:

* patient with atypical CML
* patient with a non SMP CML
* patients previously treated with interferon
* patient enrolled in another study therapy or within the exclusion period thereof
* pregnant or breast-feeding women
* patient under guardianship, curator or under the protection of justice.

Primary outcomes:
measure: IL1RAP protein expression on the surface of cells detected by flow cytometry
timeFrame: up to 2 years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hôpital Nord Franche-Comté
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Dijon
country: France
facility: CHU de Dijon
city: Vesoul
country: France
facility: CHI de Haute-Saône
Study officials:
References:
Clinical trial NCT00547820: Urinary Sensor for Cystourethrography
Official title: Urinary Sensor for Cystourethrography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dose During VCUG
Keywords: radiation dose
VCUG
pediatric patients
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients

Detailed description: It is of immense importance to perform fluoroscopy during voiding phase of VCUG (Voiding Cystourethrogram) procedures in order to rule out vesicourethral reflux. It is difficult to know exactly when a child will start voiding, so the child is intermittently imaged by fluoroscopy. Fluoroscopy involves radiation, and this we try to diminish as much as possible. We suggest application of small urinary sensor in the perineum of the patient, that will signal the beginning of urination, and only then fluoroscopy will begin. This urinary sensor should cut down substantially radiation dose to the patient.

Eligibility criteria: Inclusion Criteria:

* children referred for VCUG procedure at out department

Exclusion Criteria:

* children with pacemakers
* decline to participate

Primary outcomes:
measure: Radiation dose during VCUG procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Diagnostic Imaging, Rambam Health Care Campus
Study officials:
affiliation: Department of Diagnostic Imaging, Rambam Health Care Campus
name: Olga R Brook, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545920: To Assess Ear Blood Flow During Dialysis
Official title: Pilot Study to Assess the Effects of Haemodialysis Treatments on Blood Flow to the Ear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Failure
Keywords: haemodialysis
hypotension
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic kidney failure attending for regular dialysis treatment

Brief summary: This is a prospective observational pilot study of patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular thrice weekly haemodialysis treatments in a dialysis centre,to measure the changes in blood flow in the ear during haemodialysis.

Detailed description: 10 patients, attending for thrice weekly outpatient haemodiafiltration shall be studied during a dialysis session using a CE marked commercially available digital otoscope capable of recording digital videos of the tympanic membrane and ear canal.

Patients will receive standard clinical care and monitoring of their dialysis session, which includes recording of blood pressure and changes in haematocrit and volume status during dialysis and noting patient symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients age 18 years and older up to 80 years
* Under the care of the Royal Free Hospital with chronic kidney disease and established on regular thrice weekly haemodiafiltration.
* Able to provide written informed consent obtained

Exclusion Criteria:

* Patients unable to provide written informed consent
* Patients using hearing aids
* Patients who have had previous middle ear surgery
* Patients not fulfilling inclusion criteria

Primary outcomes:
measure: change in ear blood flow
timeFrame: day 1 dialysis session
Secondary outcomes:
measure: change in blood pressure
timeFrame: day 1 dialysis session
measure: change in haematocrit volume status
timeFrame: day 1 dialysis session
measure: record of hypotensive episodes during dialysis
timeFrame: day 1 dialysis session
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: UCL Centre for Nephrology, Royal Free Hospital
name: andrew davenport
role: PRINCIPAL_INVESTIGATOR
References: