louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06470490: Effect of Psycho-Educational Program and Relaxation Training on Resilience Among Women With Breast Cancer
Official title: Effect of Psycho-Educational Program and Relaxation Training on Resilience, Self- Esteem and Psychological Distress Among Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women With Breast Cancer
Keywords: Self-esteem
Psychological Distress
Breast Cancer
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim: To evaluate the effect of psycho-educational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer.

Design: Randomized controlled trials used a pretest and posttest design to determine the effect of psychoeducational program and relaxation training on resilience, self-esteem, and psychological distress among women with breast cancer presenting to breast clinics in Assiut, Egypt. The women were randomly allocated to the intervention group and control group.

Method: Data collection took place at the outpatient clinic at the Assiut University in South Egypt Cancer Institute. The study involved a total of 100 participants diagnosed with breast cancer recruited using a purposive sampling method, who were categorized into two groups, each comprising 50 women. Group 1 received a psychoeducational program and relaxation training, while Group 2 received only routine care without the psychoeducational program. Inclusion criteria were age ranging from 20 to 60 years, consent to research participation, and nonmetastatic breast cancer diagnosis. The investigators excluded failing to engage regularly in the psychoeducational program, suffering from a significant illness other than breast cancer, having a history of persistent psychological illnesses, and using psychiatric medications.

Detailed description: Breast cancer is the most frequent kind of cancer among women in developed as well as developing nations, and it is the leading malignancy among females in Egypt

Eligibility criteria: Inclusion Criteria:

* Age ranging from 20 to 60 years
* Consent to research participation
* Nonmetastatic breast cancer diagnosis

Exclusion Criteria:

* Failing to engage regularly in the psychoeducational programme
* Suffering from a significant illness other than breast cancer
* Having a history of persistent psychological illnesses
* Using psychiatric medications.

Primary outcomes:
measure: Measurement tool: questionnaire The psychoeducational intervention employed was effective in enhancing resilience and self-esteem while changing psychological distress among women diagnosed with breast cancer
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Assiut
name: Saleh O Abdullah, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00832390: Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)
Official title: Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After 24 weeks of treatment evaluate the efficacy and security.


Eligibility criteria: Inclusion Criteria:

* Patients Being Treated With Metformin
* Patients With Hba1c Between 6.5 % And 12.0%.
* Type 2 DM

Primary outcomes:
measure: Change From Baseline in A1C at Week 24
timeFrame: Baseline and 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06380790: Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding
Official title: Effect of Laser-aided Circumferential Supracrestal Fiberotomy on the Rate of Leveling and Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontics
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment


Eligibility criteria: Inclusion Criteria:

* Patients indicated for orthodontic treatment 18-25 years
* full permanent dentition (not necessarily third molars)
* mandibular anterior crowding
* no visible anomaly of enamel
* good oral hygiene

Exclusion Criteria:

* patients with mandibular anterior teeth with advanced caries, prosthetic restorations or dental anomalies
* patients with dentofacial deformities or medical problems
* patients indicated for extractions as a part of orthodontic treatment
* patients with severe mandibular gingival inflammation/periodontitis
* pregnant female patients
* patients with previous orthodontic treatment
* patients with previous mandibular extractions except third molars
* patients taking medications that could alter orthodontic treatment
* patients with clefts,syndromes, systemic diseases

Primary outcomes:
measure: Rate of tooth movement
timeFrame: 4 months
Secondary outcomes:
measure: Pain level
timeFrame: 1 week
measure: Periodontal health
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry cairo university
Study officials:
References:
Clinical trial NCT00181090: Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Keywords: Epilepsy
Ketosis
Atkins
seizures
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution. In this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.


Eligibility criteria: Inclusion Criteria:

* Ages 3-18
* Daily seizures or 7 per week
* Failed at least 2 anticonvulsants

Exclusion Criteria:

* Prior use of the Atkins diet for over 1 week
* Significant heart, liver, or kidney disease

Primary outcomes:
measure: Seizure control
timeFrame: 6 months
measure: Ketosis
timeFrame: 6 months
Secondary outcomes:
measure: Tolerability
timeFrame: 6 months
measure: Safety - cholesterol, kidney function, weight
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric H Kossoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. doi: 10.1212/01.wnl.0000098889.35155.72.
Clinical trial NCT02433990: Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease
Official title: Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: Congenital Heart Disease
Acquired Cardiovascular Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with Moderate or Complex Congenital Heart Disease

Brief summary: This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

Detailed description: Advances in surgical and clinical management of patients with congenital heart disease has made survival to adulthood an expectation. Today there are more than 1 million adult survivors of congenital heart disease, but increasing age brings additional concerns for this patient population. Although the literature remains scarce, existing evidence suggests that inactivity, obesity, diabetes, cancer, and acquired cardiovascular disease may be at least as prevalent in patients with congenital heart disease, if not more so, than in an age-matched general population. Acquired cardiovascular disease is likely to impact substantially on long-term survival and quality of life in these patients with palliated and already fragile hearts. This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

Eligibility criteria: Inclusion Criteria:

* Male or Female over 18 years of age
* Moderate or Complex Congenital Heart Disease
* Willingness to Consent

Exclusion Criteria:

* Pregnancy
* Surgery within 6 months
* Unrepaired cyanotic heart disease
* Patients with Eisenmenger Syndrome physiology

Primary outcomes:
measure: Risk factors for acquired cardiovascular disease in adults with congenital heart disease
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
affiliation: Stanford Hospital
name: Susan Fernandes, PA-C, LP.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054690: Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)
Official title: A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Catheterization
Urinary Tract Infection
Elective Surgery
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Bactiguard AB, Sweden
First posted: 2010-01-22
Enrollment: 511
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: This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).


Eligibility criteria: Inclusion Criteria:

* Adults in elective surgery requiring urinary catheterization

Exclusion Criteria:

* Patients who has or recently (within 3 weeks) had a urinary catheter
* Signs of urinary tracts infection
* Previous radiation therapy in lower pelvis
* Latex allergy
* Cognitive impaired
* Do not understand Swedish language.

Primary outcomes:
measure: To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.
timeFrame: At catheter withdrawal (normally 1-3 days after catheter insertion).
Secondary outcomes:
measure: Patient´s evaluation of the catheterization and overall satisfaction.
timeFrame: At catheter withdrawal and 7-10 days after catheter withdrawal.
Other outcomes:
Locations:
city: Hässleholm
country: Sweden
facility: Ortopedkliniken, Hässleholms Sjukhus
city: Lund
country: Sweden
facility: Ortopedklinien, Lunds Hospital
city: Trelleborg
country: Sweden
facility: Ortopedkliniken Lasarettet i Trelleborg
Study officials:
affiliation: Department Urology, University Hospital in Lund, Sweden
name: Karin Stenzelius, PhD Nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217890: the Relationship Between Cleft Lip and / or Palate (Different Types) and ABO Blood Groups.
Official title: Distribution Of ABO Blood Groups In Relation To Cleft Lip And/or Palate .
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 376
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 376 Egyptian cleft lip and/or palate patients (Age ranged from 2 days to 15 years ) With no syndrome .

Brief summary: Direct benefit of the research to assess the relationship between cleft lip and / or palate (different types) and ABO blood groups.

Detailed description: 376 Egyptian cleft lip and/or palate patients ( age ranged from 2 days to 15 years ) With no syndrome. Blood group from records will be collected an d then assess the relationship between cleft lip and / or palate (different types) and ABO blood groups.

Eligibility criteria: Inclusion Criteria:

* Egyptian Patients with cleft or/and palate
* The children's age ranged between 2 days and 15 years.

Exclusion Criteria:

* syndromic patients

Primary outcomes:
measure: Distribution of ABO blood group in relation to different types of cleft lip and/or palate .
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05503290: The Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy
Official title: A Pilot Study for the Lullaby Project as a Musical Intervention for Pregnant Individuals With Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Pregnancy Related
Keywords: Music
Empowerment
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized-controlled pilot study where enrolled subjects (primiparous individuals with epilepsy) will be randomized 1:1 to the control or intervention group (participation in the Lullaby Project). Outcomes of interest will be measured in each participant at day of consent, 3 weeks after, 7 weeks after, and 10 weeks after. A follow-up via email will be conducted for intervention participants 6 months after their last workshop.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study's proposed intervention is the randomized participation of pregnant individuals with epilepsy in the Lullaby Project coordinated by a musical institution in Toronto. The purpose of this present study is to investigate the potential benefits of the Lullaby Project on pregnant individuals with epilepsy. Namely, effects on quality of life-related to epilepsy, symptoms of depression and anxiety, perceived stress, and feelings of empowerment.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* currently pregnant and primiparous
* able to provide informed consent
* able to have internet access
* have a confirmed diagnosis of epilepsy based on EEG or clinical evidence

Exclusion Criteria:

* need of a language interpreter to provide informed consent and/or communicate with the MH-RTH musician
* prior involvement in the Lullaby Project

Primary outcomes:
measure: Quality of Life in Epilepsy
timeFrame: 6 months
Secondary outcomes:
measure: Depression and Anxiety
timeFrame: 6 months
measure: Pregnancy-related Empowerment
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT00838890: A Study of BMS-863233 in Patients With Hematologic Cancer
Official title: A Phase 1/2, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Refractory Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Refractory Hematologic Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Exelixis
First posted: 2009-02-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine safety, tolerability and maximum tolerated dose of BMS-63233/XL413 in subjects with Refractory Hematologic Cancer


Eligibility criteria: Inclusion Criteria:

* AML by current WHO diagnostic criteria, any FAB type (except APML), Refractory ALL, Accelerated/blast phase CML and Refractory MDS with total IPSS score of 2 or higher
* ECOG performance status \<= 2
* Accessible for treatment, PK sample collection and required study follow-up
* Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 3 x ULN

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Subjects with Acute Promyelocytic leukemia disease or CNS leukemia disease)
* Hyperleukocytosis (defined as peripheral WBC \>50,000/uL)
* Treatment with any other investigational agent for any indication within 30 days of protocol enrollment
* Subjects a history of gastrointestinal disease
* Subjects less than four weeks from allogenic or autologous stem cell transplant infusion

Primary outcomes:
measure: To determine maximum tolerated dose and anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
timeFrame: Every 21 or 28 days until maximum tolerated dose is reached
Secondary outcomes:
measure: To determine the safety of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
timeFrame: Every 21 or 28 days until the MTD is reached
measure: To determine the pharmacokinetics of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
timeFrame: Every 21 or 28 days until the MTD is reached
measure: To determine the anti-tumor activity of BMS-863233/XL413 when administered to subjects with refractory Hematologic Cancer
timeFrame: Every 21 or 28 days until the MTD is reached
Other outcomes:
Locations:
city: Miami
country: United States
facility: University Of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park
state: New York
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03811990: Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
Official title: Does a Phone-based Meditation Application Improve Mental Wellness in Emergency Medicine Personnel?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burnout, Professional
Depression
Anxiety
Stress
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, non-blinded, control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emergency medicine is notorious for its high rate of burnout and mental health issues. The emergency department (ED) is a high paced work environment dealing with life and death issues. Employees in the ED work shift times that are not conducive to a natural circadian rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with their career choice. These are known downsides of a career in emergency medicine, but little effort is put into addressing this issue in everyday EDs.

Cell phones offer an easy and convenient means to participate in meditation. There are multiple evidence-based meditation apps available to cell phone users free of charge. Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We hypothesize that weekly use of a meditation-based cell phone application will improve the mental health of emergency department employees as measured on various wellness inventories.


Eligibility criteria: Inclusion Criteria:

* Employment in the Emergency Department (with at least 8 shifts a month at Dell Seton Medical Center or Seton Medical Center) as either an attending physician, resident physician, or nurse
* Age greater than/equal to 18 years old and younger than 75 years old
* Must own a mobile phone operating on the iOS system

Exclusion Criteria:

* Already use a phone-based meditation app on a weekly basis
* Currently undergoing psychological treatment in the form of weekly therapy or psychotropic medications

Primary outcomes:
measure: Change in depression score
timeFrame: 90 and 180 days
measure: Change in anxiety score
timeFrame: 90 and 180 days
measure: Change in stress levels
timeFrame: 90 and 180 days
measure: Change in burnout level
timeFrame: 90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Keith Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coulon SM, Monroe CM, West DS. A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Am J Prev Med. 2016 Jul;51(1):95-105. doi: 10.1016/j.amepre.2016.01.026. Epub 2016 Mar 15.