louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02873455: Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer
Official title: Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Video Information
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery. The investigators aim to evaluate the effect of video information on preoperative anxiety level in patients with colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Age: 20-75
* Elective surgery

Exclusion Criteria:

* History of previous any surgery
* emergency surgery
* dementia
* psychological disease

Primary outcomes:
measure: Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video.
timeFrame: baseline and 1 minute after watching video.
Secondary outcomes:
measure: Change of HADS (Hospital Anxiety and Depression Scale) from baseline HADS to watching video.
timeFrame: baseline and 1 minute after watching video.
measure: Postoperative hospital stay
timeFrame: through study completion and an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Heung-Kwon Oh, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01784055: NeoChord TACT Post-Market Surveillance Registry
Official title: Post-Market Surveillance Registry for the NeoChord DS1000
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Keywords: NeoChord
DS1000
Mitral Valve
Mitral Valve Regurgitation
MR
Mitral Valve Repair
Mitral Valve Prolapse
Artificial Chordae
Lead sponsor: NeoChord
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement

Brief summary: To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System


Eligibility criteria: Inclusion Criteria:

* Grade 3+ or 4+ mitral valve regurgitation

Exclusion Criteria:

* Heavily calcified valves
* Valvular retraction with severely reduced mobility
* Active bacterial endocarditis
* Complex mechanism of MR (leaflet perforation, etc.)
* Significant tethering of leaflets
* Inflammatory valve disease

Primary outcomes:
measure: Procedure Success
timeFrame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux Heart University Hospital (CHU)
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Hamburg
country: Germany
facility: Asklepios Hospital St. Georg
city: Hamburg
country: Germany
facility: University Medical Center Hamburg
city: Padova
country: Italy
facility: University of Padova Medical School
city: Vilnius
country: Lithuania
facility: Vilniaus Universiteto ligonines Santariskiu
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: Leipzig University
name: Joerg Seeberger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02314455: Esophageal Absorption in EoE
Official title: Esophageal Absorption in Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis
EoE
dysphagia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To determine how the esophagus in active and inactive stages of eosinophilic esophagitis tranmit fluids.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study
* endoscopy with esophageal and duodenal biopsies within two weeks of performance of this study
* Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study, and are now in histologic remission( \<15phf) by the use of steroids or the six food elimination diet.
* Volunteers will be selected for not having any history of esophageal symptoms

Exclusion Criteria:

* Vulnerable populations, such as those with diminished mental acuity, will be excluded.
* Patients taking Nsaids within 48 hours of the d-xylose testing
* artificial sweeteners within 48 hours of the d-xylose testing
* History of IBD
* Currently smoking or history of smoking
* History of Celiac disease
* Bacterial overgrowth,
* motility disorders
* other diffuse small bowel diseases.

Primary outcomes:
measure: Reliability of the d-xylose testing defined by the serum levels
timeFrame: 1 year
Secondary outcomes:
measure: D-xylose testing compared to endoscopy/biopsy findings.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Katzka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00409955: Lamellar Transplant With Lyophilized Corneas
Official title: Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconus
Keywords: Lamellar transplant
Lyophilization
Corneas storage
Keratoconus patients
Best corrected visual acuity < 20/60
Signed the consent inform
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Sorocaba Eye Bank
First posted: 2006-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: - The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas

Detailed description: * After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of \< 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas.
* Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy.
* Results are going to be statistically analysed by SPSS program.

Eligibility criteria: Inclusion Criteria:

* Keratoconus patient
* BCVA \< 20/60
* No systemic diseases
* Who signed the inform consent

Exclusion Criteria:

* BCVA \> 20/60
* Presence of deep opacities
* Systemic diseases

Primary outcomes:
measure: Topography
measure: Orbscan
measure: Pachmetry
measure: Ultrasound Biomicroscopy
measure: Confocal Microscopy
measure: Masked Examiner to evaluate transparency and quality of the transplant
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Roberta JM Farias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06751355: Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial
Official title: Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kaposi Sarcoma
Keywords: Kaposi
Imaging
Photography
3D
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Pensievision
First posted: 2024-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will enroll at Siteman Cancer Center at Washington University School of Medicine.

Brief summary: While tremendous progress has been made against HIV, both in preventing the infection and in treating AIDS, the disease it causes, AIDS-related malignancies like Kaposi sarcoma (KS) remain a significant health burden, in both the U.S. and especially the developing world. In many cases, multiple KS lesions develop simultaneously, and may progress and regress independently. Photographs are an essential part of the evaluation for KS, as reflected in their formal usage described in the KS Tumor Assessment Manual of Procedures. However, acquiring a clear, informative photo is not trivial, since anatomy is 3D and conventional imaging is 2D. The importance of accurate, quantitative 3D information is especially pronounced for the treatment of KS because when a tumor responds positively to treatment, the initial change is usually a flattening of the lesion, without any significant change in the projected 2D area. To evaluate the vertical space, along with other characteristics of a KS lesion, we have created an innovative imaging system, SkinScan3D, utilizing new commercial liquid lens technologies and AI based image analysis software, with strategies borrowed from astronomical imaging techniques previously used on NASA space telescopes. In this study, the investigators will develop and demonstrate a protocol for recording measurable 3D parameters, which may be used in a longitudinal study to rigorously monitor therapeutic responses of KS and statistically compare with that of the conventional AMC criteria.


Eligibility criteria: Eligibility Criteria:

* Have been diagnosed with histologically or cytologically proven Kaposi sarcoma (KS).
* Has at least 3 cutaneous Kaposi sarcoma lesions.
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Primary outcomes:
measure: Feasibility of capturing 3D images of cutaneous KS lesions
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lee Ratner, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669655: Plasma Profile of Exclusively Breastfed Infants
Official title: Plasma Profile of Exclusively Breastfed Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Fed Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breastfeeding infants and their mothers

Brief summary: To characterize nutrient levels in breastfeeding infants and their mothers.

Detailed description: The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.

Eligibility criteria: Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth.
* Infant's birth weight was \> 2490 g.
* Infant is between 6 weeks and 16 weeks (42 to 112 days).
* Infant must have been exclusively breastfed at enrollment.
* Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day.
* Mother is a non-smoker.
* Mother is in good health.
* Mother confirms her intention to continue breastfeeding.

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development.
* Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment.
* Infants who have consumed any solid or liquid foods or juices prior to enrollment.
* Infants who have received any supplements containing carotenoids prior to enrollment.
* Mother who is consuming dietary supplements containing carotenoids.
* Participation in another study that has not been approved as a concomitant study.

Primary outcomes:
measure: Plasma carotenoids in breastfed infants
timeFrame: At visit 1 (enrollment)
Secondary outcomes:
measure: Plasma carotenoids in mothers of breastfed infants
timeFrame: At visit 1 (enrollment)
measure: Dietary carotenoid intake of mothers of breastfed infants
timeFrame: At visit 1 (enrollment) and visit 2 (14 days)
measure: Carotenoid levels in breastmilk
timeFrame: At visit 1 (enrollment) and visit 2 (14 days)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University of Shanghai
state: Shanghai
Study officials:
affiliation: Abbott Nutrition, R&D China
name: Xianfeng Zhao, MD, PhD
role: STUDY_CHAIR
References:
citation: Xu X, Zhao X, Berde Y, Low YL, Kuchan MJ. Milk and Plasma Lutein and Zeaxanthin Concentrations in Chinese Breast-Feeding Mother-Infant Dyads With Healthy Maternal Fruit and Vegetable Intake. J Am Coll Nutr. 2019 Feb;38(2):179-184. doi: 10.1080/07315724.2018.1490934. Epub 2018 Sep 11.
Clinical trial NCT00733655: Study of Histological Samples From Patients With Hereditary Haemorrhagic Telangiectasia
Official title: Histological Samples From Patients With Hereditary Haemorrhagic Telangiectasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telangiectasia, Hereditary Hemorrhagic
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hereditary hemorrhagic telangiectasia (HHT)

Brief summary: In this study the investigators will obtain histological samples from people with hereditary haemorrhagic telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome).

Detailed description: HHT is an inherited condition that leads to the development of dilated and fragile blood vessels. We propose to obtain small skin samples from patients with HHT in order to analyze the samples using histological methods, and study the properties of vascular endothelial cells derived from patients. We hypothesize that these cells will show differences when compared to normal endothelial cells, which may be confirmed in single time point analyses in histological samples. We anticipate that that these findings may help to explain aspects of the HHT disease phenotype.

Eligibility criteria: Inclusion Criteria:

* Patients with Hereditary Haemorrhagic Telangiectasia

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Hammersmith Campus
Study officials:
affiliation: Imperial College London
name: Claire L Shovlin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shovlin CL, Gilson C, Busbridge M, Patel D, Shi C, Dina R, Abdulla FN, Awan I. Can Iron Treatments Aggravate Epistaxis in Some Patients With Hereditary Hemorrhagic Telangiectasia? Laryngoscope. 2016 Nov;126(11):2468-2474. doi: 10.1002/lary.25959. Epub 2016 Apr 23.
Clinical trial NCT06590155: Erythropoietin in HIE Neonate
Official title: Role of Erythropoietin in Neonates With Hypoxic Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Neonatal Hypoxic Ischemic Encephalopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: this study is aim to delineate the role of erythropoietin in improving neonatal hypoxic ischemic encephalopathy the study is conducted to answer the question : is erythropoietin will improve neonatal hypoxic ischemic encephalopathy?

Detailed description: Hypoxic-ischemic encephalopathy (HIE) remains a major cause of morbidity and mortality. HIE causes 23% of neonatal deaths . Erythropoietin is a 34kDa glycoprotein that was originally identified because of its role in erythropoiesis. In the fetus, EPO is produced in the liver, and, following the neonatal period, EPO is produced in the kidney and the liver. EPO is a cytokine with pleiotropic functions including erythropoiesis, modulation of inflammatory and immune responses. EPO and the EPO receptor (EPO-R) are expressed by a variety of cell types in the brain including neuronal progenitor cells. EPO transport across the blood-brain barrier is limited by its large size. Only 1% to 2% of circulating EPO crosses the blood-brain barrier under normal circumstances, most likely via passive diffusion . EPO provides a mechanism to maintain or re-establish the function of all other cells in challenging physiological conditions (e.g., hypoxia) . EPO's main role is to prevent apoptosis of erythroid progenitor cells and to enhance their maturation and proliferation . The use of EPO reduces the need for blood transfusions in premature infants. To cross the blood-brain barrier, high doses at 2000 to 5000 IU/kg body weight are administered either early or late for prolonged periods of time. These high doses are well tolerated in preterm infants (i.e., EPO is safe and devoid of untoward complications in this context . In previos studies , The first dose of r-Hu-EPO was administered at 1 to 48 h after birth, followed by doses every other day for 2 weeks. At 18 months-of-age neurodevelopmental outcomes were assessed. Improved long-term outcomes in the r-Hu-EPO-treated infants were evident after moderate HIE, but not in those with severe HIE. There were no side-effects from r-HuEPO treatment .

Eligibility criteria: Inclusion Criteria:

- neonates who less than 1 month suffer from hypoxic ischemic encephalopathy

Exclusion Criteria:

* neonates who more than 1 month
* neonates who suffer from brain insults other than HIE

Primary outcomes:
measure: oxygen saturation in neonates hypoxic ischemic encephalopathy after treatment byerythropoietin
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university children hospital
Study officials:
References:
Clinical trial NCT06302855: Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care
Official title: Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test).

Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it.

The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes

Exclusion Criteria:

* last dental visit\<1 year
* patient unable to give consent

Primary outcomes:
measure: adherence of diabetic patients to periodontal
timeFrame: 1 month
Secondary outcomes:
measure: calculate the prevalence of periodontitis
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00175955: Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia
Official title: An 8-week Exploratory, Double-blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-induced Tardive Dyskinesia in Subjects With Stable Axis I Psychiatric Disorder, Aged From at Least 18 Years to 80 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyskinesia, Medication-induced
Keywords: Neuroleptic-induced tardive dyskinesia
Keppra, Levetiracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia


Eligibility criteria: Inclusion Criteria:

* Subjects between ages 18 and 80 years
* Subjects must have a diagnosis of stable axis I psychiatric disorder at least 6 months prior to screening
* Subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria
* Subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening

Exclusion Criteria:

* Presence of any axis II condition within 6 months prior to screening
* Huntington´s disease, idiopathic dystonia, Wilson´s disease, Sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia
* Start of drugs-other than neuroleptics- that can cause dyskinesia
* Presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness

Primary outcomes:
measure: Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
Secondary outcomes:
measure: Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
measure: Effect on the primary psychiatric disorder
measure: Safety
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Bourgois
country: Belgium
city: Gonce
country: Belgium
city: Hulselmans
country: Belgium
city: Liège
country: Belgium
city: Roeselare
country: Belgium
city: Haralanov
country: Bulgaria
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: