louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02745639: Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer
Official title: Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer: a Phase II Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Keywords: rectal cancer
radiotherapy
chemotherapy
VMAT
toxicity
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 18
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: This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).

Detailed description: This was a prospective phase II study on patients with LARC or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).

The primary aim was to asses the pathological response rate. Key secondary aim was the acute toxicity. Secondary aims were local control, disease-free survival (DFS) and overall survival (OS).

The follow-up period of each subjects started at the end of combined treatment and concluded after a period of maximum 60 months or until death.

Eligibility criteria: Inclusion Criteria: i) histologically proven rectal adenocarcinoma (cT3-4N0-2 or cT2N1-2 or locally recurrent) beginning within 12 cm from the anal verge; ii) age ≥ 18 years; iii) Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria: i) history of chemotherapy and/or pelvic radiotherapy; ii) previous treatment with immunotherapy; iii) metastatic patient; iv) presence of active intestinal inflammation or uncontrolled pelvic inflammation; v) pregnant and/or breastfeeding patient.

Primary outcomes:
measure: Pathological response rate
timeFrame: 6-8 weeks after chemoradiotherapy
Secondary outcomes:
measure: Acute Toxicity
timeFrame: During radiation treatment and at the first follow-up visit (4 weeks after RT).
Other outcomes:
Locations:
Study officials:
affiliation: Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06100939: Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
Official title: A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus (APRICITY-A)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Keratoconus
Lead sponsor: Epion Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 400
Sex: ALL
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus


Eligibility criteria: Inclusion Criteria:

* Diagnosis of keratoconus

Exclusion Criteria:

* Minimal corneal thickness \< 350 microns
* Non-keratoconic ectatic disease
* Contraindications or hypersensitivities to any required study medications
* Pregnancy or breastfeeding
* Certain concomitant ocular conditions

Primary outcomes:
measure: Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Rowland Heights
country: United States
facility: Nvision Eye Centers Rowland Heights
state: California
city: San Francisco
country: United States
facility: Goodman Eye Center
state: California
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Brookline
country: United States
facility: Boston Vision
state: Massachusetts
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: East Syracuse
country: United States
facility: The Eye Doctors at CNY Eye Care
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Vision Institute
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Epion Therapeutics
name: Michael Belin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06333639: Implementing Virtual Reality in the Operating Room
Official title: Implementing Virtual Reality in the Operating Room : Patient Satisfaction During Long Orthopaedic Surgery Under Locoregional Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Surgery
Orthopedic Procedures
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patients admitted for total hip or knee replacement surgery and whose anaesthetic management is by loco-regional anaesthesia

Brief summary: "Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing.

However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics.

The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.

The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour."


Eligibility criteria: Inclusion Criteria:

* Patient 18 years of age or older
* Patient admitted for total hip or knee replacement surgery.
* Patient undergoing anaesthetic management by loco-regional anaesthesia
* Affiliation to a French health insurance scheme or equivalent
* Patient who has given his non-opposition agreement

Exclusion Criteria:

* Patient with a neurological disorder (coma, dementia, confusion, photosensitive epilepsy)
* Patient with a severe psychiatric disorder
* Patients with severe deafness or visual impairment
* Language barrier
* Pregnant or breast-feeding women of childbearing age
* Refusal of patient involvement

Primary outcomes:
measure: To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset.
timeFrame: Immediate post-operative
Secondary outcomes:
measure: 1. To demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on the doses of premedication, compared with the same surgeries without headset.
timeFrame: Immediate post-operative
measure: Evaluate the Virtual Reality device in terms of comfort when wearing the headset, visual comfort and image and scenario quality, and auditory quality
timeFrame: Immediate post-operative
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NiICE
state: Alpes Maritimes
Study officials:
References:
Clinical trial NCT03539939: The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
Official title: The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Smoking
Keywords: Gingival crevicular fluid
Gingival recession
Saliva
Smoking
Wound healing
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: University of Louisville
First posted: 2018-05-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cigarette smoking is a patient-related factor that can affect healing of periodontal tissues and the success rate of root-coverage procedures. Neither the nature nor the mechanisms of action of cigarette smoking on root coverage are fully understood. Therefore, the hypothesis that cigarette smoking has negative impacts on the outcomes of root coverage after CAF surgery in systemically healthy individuals with an initial gingival thickness of at least 0.8 mm and who practice optimal oral hygiene was tested. It was also hypothesized that baseline analysis of disease-related biomarkers would shed light on the underlying mechanisms of a possible effect.


Eligibility criteria: Inclusion Criteria:

* Maxillary central and lateral incisors, canines, and premolars and mandibular premolars with isolated buccal recessions classified as Miller Class I or II
* Study tooth should present tooth vitality, identifiable cemento-enamel junction (CEJ) and absence of caries, restorations or extensive non-carious cervical lesion.

Exclusion Criteria:

* Medical disorders such as diabetes mellitus, immunologic disorders, hepatitis
* History of previous mucogingival surgery at the gingival recession site
* Medications known to affect gingival tissues
* Antibiotic treatment in the past 6 months
* Pregnancy or lactation

Primary outcomes:
measure: Change in the percentage of root coverage
timeFrame: 1-month, 3-month and 6-month after coronally advanced flap (CAF)
Secondary outcomes:
measure: Change in the percentage of complete root coverage
timeFrame: 1-month, 3-month and 6-month after coronally advanced flap (CAF)
measure: Change in gingival thickness
timeFrame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
measure: Changing of the gingival crevicular fluid (GCF) biomarkers
timeFrame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
measure: Changing of the salivary biomarkers
timeFrame: Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
measure: Change in the visual analog scale (VAS) values
timeFrame: 1 to 7 day after coronally advanced flap (CAF)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00481039: Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel
Official title: Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel- An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease
Sickle cell thalassemia
Population screening
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients diagnosed with abnormal hemoglobin in the bedouin arab village

Brief summary: Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab population. The purpose of this study is to assess the clinical characteristics of the patients in one arab village and the laboratory characteristics in the carriers of this gene based in the screening for pregnant women that is carried out in the population of northern Israel.

The results can be useful in order to institute universal screening for sickle cell anemia in northern Israel.


Eligibility criteria: Inclusion Criteria:

* All the patients that were diagnosed as having sickle cell disease in the specific village and all the population screened for hemoglobinopathies in the same location

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - HaEmek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit, Ha'Emek Medical Center
name: Ariel Koren, MD
role: STUDY_DIRECTOR
affiliation: Hematology Laboratory - HaEmek Medical Center
name: luci Zalman, Phd
role: STUDY_CHAIR
affiliation: Pediatric Dpt B - Ha'Emek Medical Center
name: Tania Flaishman, Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05900739: Fruit and Vegetable Intake Promotion. "The UVa Community Eats Healthy" Study Protocol (University of Valladolid)
Official title: Social Media for Nutrition Education. Fruit and Vegetable Intake Promotion in a University Setting: "The UVa Community Eats Healthy" Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fruit and Vegetable Consumption
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized controlled trial is to increase the consumption of fruit and vegetables of the University of Valladolid (UVa) community employing three different online methodologies: facebook (FB), virtual campus (VC) and, instagram (IG).

Detailed description: In order to use different methodologies, the sample was randomly divided in four groups, three took the nutrition educational program and the other one was a control group.

All four groups had access to the virtual campus of the UVa which uses the teaching platform Moodle Learning Management System (LMS). In this platform, a course entitled "The UVa community eats healthy" was created with four sections. Each of the sections corresponded to one of the four groups, the names of the sections were: I-campus (VC group), C-campus (control group), F-campus (FB group), and G-campus (IG group).

To make the intervention more effective, this program was theory-based designed, based on the theory of planned behaviour (TPB).

In order to assess the effectivity of social media use for nutrition education compared to more traditional interventions, the program was adapted to three platforms: virtual campus, private account of IG and private group of FB. The topics of the intervention groups were the same but with adapted activities.

Eligibility criteria: Inclusion Criteria:

* being part of the UVa community at the time of recruitment
* having IG and/or FB account
* having made the self-registration to the Moodle virtual campus of each group during the enrolment period

Exclusion Criteria:

* not meeting inclusion criteria

Primary outcomes:
measure: Fruit and vegetable consumption
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Fruit and vegetable consumption of the different groups
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: University of Valladolid
Study officials:
References:
Clinical trial NCT02154139: Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
Official title: Leuplin SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 651
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer

Brief summary: The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).

Detailed description: This survey was designed to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate 3 months depot for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).

For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Eligibility criteria: Inclusion Criteria:

* Premenopausal breast cancer patients (patients with advanced or recurrent breast cancer and patients who received adjuvant therapy).

Exclusion Criteria:

* Patients with a history of treatment with Leuplin SR 11.25 mg for Injection

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to 96 weeks
measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions
timeFrame: Baseline up to 96 weeks
Secondary outcomes:
measure: Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)
timeFrame: Week 24, 48,96
measure: Percentage of Participants With Progression Free Survival
timeFrame: Baseline up to 96 weeks
measure: Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy
timeFrame: Baseline up to 96 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT04600739: Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis
Official title: Entscheidungsunterstützung Bei Herzklappenerkrankungen Anhand Funktionaler Und Morphologischer Eigenschaften Mittels Methoden Der Mathematischen Modellierung Und Des Maschinellen Lernens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2020-10-23
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - retrospective acquisition of patients that receive TAVI

Brief summary: A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.

Detailed description: Using temporally resolved computed tomography images, the patient-specific geometry of the stenosed aortic valve during peak systole is reconstructed. Using this geometry, the projected area of the aortic valve's orifice (AVA) is calculated. Additionally, the left ventricular geometry is reconstructed for the complete heart cycle. Using the information of the left ventricular volume change, the patient-specific flow profile and peak-systolic flow (Q)is calculated. Using this information, the pressure gradient is calculated using a power law estimation of the form PG = a \* AVA\^b \* Q\^c. The model generation and parameter fit is described in \[1\].

To validate this model, retrospective data of patients receiving a catheter-based replacement of the aortic valve (TAVI) is collected. For those patients, CT images are already acquired for treatment planning and the invasive pressure measurements are performed during replacement of the aortic valve. Therefore, no additionally steps are required. Using the CT images the patient-specific aortic valve area ad flow rate are calculated. This information is then used for estimation of the pressure gradient using the power law model. The catheter-based pressure gradient is calculated as the difference between the peak-systolic pressure in the left ventricle and the ascending aorta before implantation of the prosthesis.

\[1\] Franke et al.; Towards improving the accuracy of aortic transvalvular pressure gradients: rethinking Bernoulli; Medical \& Biological Engineering \& Computing (2020); https://doi.org/10.1007/s11517-020-02186-w

Eligibility criteria: Inclusion Criteria:

* aortic valve stenosis
* treatment via TAVI

Primary outcomes:
measure: predicted vs. cather-measured pressure gradient across the aortic valv
timeFrame: 1 week up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzemtrum Berlin
state: Deutschland
Study officials:
References: