louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05730946: Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate
Official title: Understanding The Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate: A Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Lip and Palate
Keywords: Cleft Lip and Palate
Challenges
Concerns
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian parents of CLP patients presented to cleft lip \& palate clinic at Ain Shams university.

Brief summary: Cleft lip and/or palate (CLP) are the most common oro-facial congenital anomalies. These anomalies have an impact on feeding, speech and speech development, facial aesthetics \& oral health, all of which are factors that heavily impact the quality of life of CLP patients. CLP also has an effect on the families' social and psychological health.

Qualitative research helps understand the perspectives of the participants by exploring the psycho-social aspects of care. Phenomenological approach is a qualitative research method that aims to borrow participants' lived experiences to better understand a specific phenomenon. Currently, there is no clear understanding of the fears, anxieties, and challenges faced by parents of CLP patients in Egypt.


Eligibility criteria: Inclusion Criteria:

* Parents of Patients with non-syndromic CLP.

Exclusion Criteria:

* Parents of Patients presenting with dental pain.

Primary outcomes:
measure: Challenges & concerns faced by the parents of CLP patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Nagwa Mohamed Ali, Prof of PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johansson B, Ringsberg KC. Parents' experiences of having a child with cleft lip and palate. J Adv Nurs. 2004 Jul;47(2):165-73. doi: 10.1111/j.1365-2648.2004.03075.x.
citation: Ghirotto L, De Panfilis L, Di Leo S. Health professionals learning qualitative research in their workplace: a focused ethnography. BMC Med Educ. 2020 Aug 17;20(1):269. doi: 10.1186/s12909-020-02191-5.
citation: Baker C, Wuest J, Stern PN. Method slurring: the grounded theory/phenomenology example. J Adv Nurs. 1992 Nov;17(11):1355-60. doi: 10.1111/j.1365-2648.1992.tb01859.x.
citation: Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.
citation: Turner DW. Qualitative interview design: A practical guide for novice investigators. Qual Rep. 2010;15(3):754-60.
citation: Elmouden L, Elgasmi F, Ousehal L. Quality of Life in Adolescents with Cleft Lip and Palate. In: Gülşen A, editor. Current Treatment of Cleft Lip and Palate. 2020.
Clinical trial NCT02370446: Testing a Personalize Medication Log for Patients With Lymphoma
Official title: Testing a Personalize Medication Log for Patients With Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Medication Log
15-008
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 5
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 will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to see if using the MedLog is helpful to patients. Since the investigators do not yet know if this MedLog is helpful, some patients will receive it and some will receive our standard of care. The investigators want to know whether providing patients with this additional information is helpful and if having this additional information about their treatment schedule has an effect on their quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of lymphoma
* No prior treatment for lymphoma
* Scheduled to receive CHOP14 +/- Rituximab, CEOP 21, CHOPE or EPOCH +/- Rituximab
* Age 18 or older
* Able to speak and read English

Exclusion Criteria:

* Documented major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.

Primary outcomes:
measure: patient satisfaction with medication log ( identified qualitatively through the process of cognitive interviewing and further measured with the satisfaction question on the Patient Satisfaction and Treatment Data Sheet)
timeFrame: 1 year
Secondary outcomes:
measure: changes in quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kimberly Anselmi, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04334746: The Discriminative Ability of the Four Balance Measures for Fall History
Official title: The Discriminative Ability of the Four Balance Measures for.the Previous Fall Experience in Türkish Community-dwelling Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Older People--Abuse of
Balance; Distorted
Fall
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Giresun University
First posted: 2020-04-06
Enrollment: 351
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community-dwelling older adults

Brief summary: The fall rate is increased parallel to the aging process. The early determination and management of falls in older adults are quite crucial to preserve the independence of older adults. In the literature, there are used many measurement tools for predicting fall status. The discriminative ability of these measures is important for the accuracy of the assessment. In this study, four of the most commonly used balance measurement tools will be investigated in terms of the discriminative ability for fall status in the Turkish community-dwelling older adults.


Eligibility criteria: Inclusion Criteria:

* being aged 65 or above,
* having a score of 21 or more from the Mini-Mental State Examination (MMSE) \[20,23\],
* able to ambulate independently or with an assistive device.

Exclusion Criteria:

* having visual and hearing problems that may cause restrictions in communication and also balance impairments,
* drug use (benzodiazepine, psychotropic drugs, etc.) with adverse effects on balance and walking,
* having any serious neurological, cardiopulmonary, or orthopedic disorders that adversely affected balance conditions.

Primary outcomes:
measure: Fall History
timeFrame: 2 minutes
Secondary outcomes:
measure: One-leg Stance test
timeFrame: 1 minute
measure: Berg Balance Scale
timeFrame: 20 minutes
measure: Timed Up and Go Test
timeFrame: 3 minutes
measure: Functional Reach Test
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sevim ACARÖZ CANDAN
state: Altinordu
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: Sevim Acaröz Candan, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05792046: IMOvifa Perimeter Reference Database
Official title: IMOvifa Perimeter Reference Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Eyes
Lead sponsor: New View Optometric Center
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 376
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with normal visual function

Brief summary: This study will collect data to establish a reference database for the IMOvifa perimeter.

Detailed description: This study will collect data from a reference population to be used as inputs to the calculation of age corrected significance limits for expected visual function sensitivity to establish reference limits for key output parameters for select test patterns of the IMOvifa perimeter device.

Eligibility criteria: Inclusion Criteria:

* 22 years of age or older on the date of informed consent
* Able to understand the written informed consent and willing to participate
* IOP ≤ 21 mmHg (each eye)
* BCVA 20/40 or better (each eye)
* Both eyes free of ocular conditions that may affect visual function (at doctor's discretion)

Exclusion Criteria:

* Unable to tolerate ophthalmic imaging and/or VF testing
* History of conditions known to adversely affect visual function (at doctor discretion)
* Spherical Equivalent refractive error outside the range from +6 Diopters
* Cylindrical refractive error outside the range +2.5 Diopters

Primary outcomes:
measure: Reference limit for mean deviation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Topcon Healthcare Innovation Center
state: California
city: La Mesa
country: United States
facility: New View Optometric Center
state: California
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
Study officials:
References:
Clinical trial NCT02483169: PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study
Official title: Double Blind Placebo Controlled Multicenter Trial for Prevention of IMT Progression in the Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage With Cilostazol and Probucol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Brain Ischemia
Intracranial Hemorrhages
Keywords: ischemic stroke
intracranial hemorrhage
cilostazol
probucol
intima media thickness
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2015-06-26
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.

The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ischemic stroke within 120 days
* Adult aged 20 years or older
* High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage)
* Informed consent

Exclusion Criteria:

* Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks
* Bleeding tendency
* Pregnant or breast-feeding woman
* Hemorrhagic stroke within 6 months
* Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication
* Severe cardiovascular disease such as cardiomyopathy or congestive heart failure
* Life expectancy less than one year
* Contraindication to long term aspirin use
* Enrolled in other clinical trial within 30 days

Primary outcomes:
measure: mean carotid IMT progression
timeFrame: one year
Secondary outcomes:
measure: maximum carotid IMT progression
timeFrame: one year
measure: carotid plaque score
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurology, Asan Medical Center
name: Sun U Kwon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855269: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study
Official title: A Prospective Randomized Controlled Study: Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crying
Keywords: probiotic
infantile colic
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 74
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.

Detailed description: Infantile colic ıs one of the most common problems within the first 3 months of life, affecting as many as 3% to 28% of newborn children. It consists of a behavioral syndrome characterized by paroxysmal, excessive, inconsolable crying without identifiable cause. Lactobacillus reuteri, one of the few endogenous lactobacillus species in the human gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement in adults, and recent data demonstrated safety after long-term dietary supplementation for newborn infants. The positive effects of this probiotic on intestinal disorders such as constipation and diarrhea and in protection from infection,as well as its capacity to modulate immune responses.

The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.

Eligibility criteria: Inclusion Criteria:

* infants three weeks to three months
* infants with colic three hours of crying on three days in the week
* infants feeding with breast milk
* infants weighing 2500 to 4000 gram

Exclusion Criteria:

* chronic illness
* gastrointestinal disorders
* infants received either antibiotics or probiotics in the previous week

Primary outcomes:
measure: Crying time
timeFrame: 3 weeks
Secondary outcomes:
measure: postpartum depression
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sami Ulus CH
Study officials:
affiliation: MD, Sami Ulus CH
name: Nilgün Karadağ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222.
Clinical trial NCT04453969: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a
Official title: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2
Breastmilk
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Sinai Health System
First posted: 2020-07-01
Enrollment: 59
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: Community sample

Brief summary: The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown. This study seeks to address this public health issue. Breastmilk will be collected from mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding breastfeeding to protect the health of infants.


Eligibility criteria: Inclusion Criteria:

* Current COVID-19 positive status or COVID-19 positive status during pregnancy
* Intent to breastfeed or currently breastfeeding

Exclusion Criteria:

- None

Primary outcomes:
measure: Presence of SARS-CoV-2 in breastmilk
timeFrame: 2-6 months
measure: SARS-CoV-2 antibody in breastmilk
timeFrame: 2-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References:
citation: Ismail S, Unger S, Budylowski P, Poutanen S, Yau Y, Jenkins C, Anwer S, Christie-Holmes N, Kiss A, Mazzulli T, Johnstone J, McGeer A, Whittle W, Parvez B, Gray-Owen SD, Stone D, O'Connor DL. SARS-CoV-2 antibodies and their neutralizing capacity against live virus in human milk after COVID-19 infection and vaccination: prospective cohort studies. Am J Clin Nutr. 2024 Feb;119(2):485-495. doi: 10.1016/j.ajcnut.2023.10.008. Epub 2023 Dec 14.
Clinical trial NCT01395069: Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
Official title: Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema
Keywords: Post-cataract surgery
macular edema
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 162
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: Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).


Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent
* Age 18 years and older

Exclusion Criteria:

* Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)
* Previous uveitis
* Previous intraocular surgery
* Allergy or hypersensitivity to NSAIDs
* Complicated cataract surgery

Primary outcomes:
measure: Change in macular volume (as quantified by OCT) at one month (compared to baseline)
timeFrame: baseline and one month after surgery
Secondary outcomes:
measure: COMTOL health-related quality-of-life
timeFrame: one month after surgery
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Sherif El-Defrawy, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05508269: Genetics of Ischemic Cardiomyopathy
Official title: Quantitative Polymerase Chain Reaction of Four Genes in Coronary Artery Disease, Myocardial Infarction and Ischemic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Cardiomyopathy
Keywords: Ischemic Cardiomyopathy
qrt-pcr
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects were categorized into three control cases who were diagonosed as healthy subjects after diagnostic catheterization, three patients with stable coronary artery disease undergoing elective PCI who were diagnozed with coronary lesion/s and underwent stent implantation without previous history of myocardial infarction, four patients with history of myocardial infarction or with acute myocardial infarction undergoing primary PCI and three patients with ischaemic cardiomyopathy diagnosed by ejection fraction less than 35% with history of coronary artery disease or myocardial infarction or those with acute myocardial infarction with reduced ejection fraction.

Brief summary: Background:Ischemic heart disease is one of the heaviest health-related burdens worldwide.We aimed to identify the common hub mRNA and pathways that are involved in pathological progression of ischemic cardiomyopathy. Methods: To explore potential differentially expressed genes (DEGs) of all ischemic heart disease stages, we used chipster and GEO2R tools to analyze of retrieved eight high throughput RNA datasets obtained from GEO database. Gene Ontology functional annotation and Pathways enrichment analyses were used to obtain the common functional enriched DEGs which were visualized in protein-protein interactions (PPI) network to explore the hub mRNA according to the interaction scores. Validation qRT-PCR was carried out for blood and cardiac biopsies compared with controls to validate the determined four hub mRNAs and subsequently reviewed inside comprehensive published meta-analysis database. The validated mRNAs were visualized in two interaction modules. Finally screening of approved drugs was applied.


Eligibility criteria: Inclusion criteria The enrolled patients aged 20-80 years with stable coronary artery disease undergoing elective PCI or patients with unstable angina or myocardial infarction undergoing rescue PCI and admitted to the cardiology hospital (Asyut University, Asyut, Egypt) were recruited in this study.

Exclusion criteria Patients with dilated cardiomyopathy were execluded from this study.

Primary outcomes:
measure: Genetic pathway of pathological progression from stable coronary artery disease to myocardial infarction and finally to ischaemic cardiomyopathy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Asyūţ
country: Egypt
facility: cardiology hospital (Asyut University, Asyut, Egypt)
Study officials:
References:
Clinical trial NCT00681369: Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France
Official title: Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
fulvestrant
longitudinal study
France
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 217
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital sample

Brief summary: the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile


Eligibility criteria: Inclusion Criteria:

* Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007

Primary outcomes:
measure: Evaluate Faslodex therapeutic strategy and treatment duration
timeFrame: At the end of the study
measure: Describe the characteristics of patients treated with Faslodex
timeFrame: At the end of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TNS Healthcare - France138, avenue Marx Dormoy92120 Montrouge
name: Alain FLINOIS
role: PRINCIPAL_INVESTIGATOR
References: