louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04874142: Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A
Official title: Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemias
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-cohort, single-sequence, parallel, open label, multiple oral dosing study.
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A

Detailed description: Phase 1 to evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A. Which is designed as two cohort, single-sequence, paralle, open label, multiple oral dosing.

Eligibility criteria: Inclusion Criteria:

* Over 19 ages healty men
* Over 50.0kg, 18.0kg/m2 ≤ BMI ≤30.0kg/m2
* Men who dont have congenital disease and other cronic disease need to be cared etc.

Exclusion Criteria:

* Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
* Men who have drunken or eatten something including carffeine within 24 hours before etc.

Primary outcomes:
measure: Pharmacokietic parameters administration: Cmax
timeFrame: Until 48 hours
measure: Pharmacokietic parameters administration: AUC
timeFrame: Until 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: ChungBuk National University Hospital
Study officials:
affiliation: ChungBuk National Unviersity Hospital.
name: Min Kyu Park, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05237570: Minimally Invasive Sinus Lift Through the Interradicular Septum
Official title: Minimally Invasive Microsurgical Sinus-lift Through the Interradicular Septum. A Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Loss
Bone Loss, Age-related
Atrophy; Alveolar Process
Surgical Procedure, Unspecified
Keywords: maxillary sinus
sinus lift
xenograft
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2022-02-14
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: This study aims to describe a new approach for the reconstruction of the alveolar process in the sinus area. This minimally invasive approach will access the maxillary sinus through the alveolar process, elevating the sinus membrane in the area immediately above it. The regeneration may be achieved in the specific area required for dental implant placement, reducing the morbidity of the procedure.


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years.
* Plaque index and bleeding index less than 30%.
* Invagination of the sinus cavity in the interradicular area of the upper first molar.
* Upper first molar not restorable and with height of the interradicular remnant less than 5 mm.

Exclusion Criteria:

* Presence of systemic disease contraindicating the intervention.
* Pregnant women.

Primary outcomes:
measure: Bone height
timeFrame: 9 months
Secondary outcomes:
measure: Bucco-palatal bone width
timeFrame: 9 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Centro Odontologico Del Sureste Slp
Study officials:
References:
citation: Moreno Rodriguez JA, Pecci-Lloret M, Ortiz Ruiz E, Ortiz Ruiz AJ. Preliminary Results of a Minimally Invasive Microsurgical Approach to Sinus Floor Elevation and Bone Reconstruction Using a Palatal Septum Window. Int J Periodontics Restorative Dent. 2021 Nov-Dec;41(6):e255-e263. doi: 10.11607/prd.4810.
Clinical trial NCT04019470: Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors
Official title: Immunomodulation Analysis on Peripheral Blood Mononuclear Cells of Radiation Therapy in Pediatric Malignant Brain Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Brain Tumor, Pediatric
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The brain tumors patients between the ages of 3 year and 18 years who will be received radiation therapy evaluated and determined by their physician

Brief summary: To investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients.


Eligibility criteria: Inclusion Criteria:

* Age from 3 to 18
* To be diagnosed with malignant brain tumors
* To eligible for radiation therapy
* Karnofsky performance status ≥ 70
* No prior radiation exposure
* Informed consent signed for blood sample collection and used for research purpose

Exclusion Criteria:

* Patients had received radiotherapy previously.
* Patients who had no histological diagnosis
* Patients who do not wish to participate
* Patients with infections

Primary outcomes:
measure: The changes of peripheral blood immune cells
timeFrame: 6 weeks (prior and post the radiation therapy )
Secondary outcomes:
measure: Activation status of T cells
timeFrame: 6 weeks (prior and post the radiation therapy )
measure: The changs of inflammatory cytokines and chemokines
timeFrame: 6 weeks (prior and post the radiation therapy )
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital Cancer Center
Study officials:
References:
Clinical trial NCT00188370: Ultrasound Biomicroscopy - Apoptosis
Official title: Ultrasound Biomicroscopy for Monitoring Apoptosis in Lymphoma, Melanoma and Basal Cell Carcinoma Patients During Chemotherapy or Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lymphoma, Non-Hodgkin
Melanoma
Carcinoma, Basal Cell
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A group of researchers at the Ontario Cancer Institute/Princess Margaret Hospital have discovered that a very specific form of cell death 'apoptosis' can be detected using high-frequency ultrasound imaging. This type of cell death is recognized to occur in tumours in response to various different chemotherapeutic drugs and in response to radiation therapy. This group of researchers has confirmed that high-frequency ultrasound can detect apoptosis in response to tumour treatments experimentally using cell culture and experimental animal systems. The ultrasound approach is now being evaluated clinically in a 3-year clinical trial enrolling a target of 200 patients including Hodgkin's disease and non-Hodgkin's disease lymphoma patients, melanoma patients and patients with basal cell carcinoma. Our hope is to be able to use this type of imaging system in the future to clinically monitor the effects of therapy on tumours and rapidly detect tumours which are not responding so that changes in therapy can be made much quicker than presently possible.


Eligibility criteria: Inclusion Criteria:

* lymphoma patients with superficial lesions prior to starting chemotherapy or after relapse of disease
* patients with superficial melanoma lesions
* patients with superficial basal cell carcinoma lesions
* Informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Feasibility study of the use of Ultrasound Biomicroscopy for monitoring tumour response of lymphoma and melanoma patients to chemotheapy or radiation therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Richard Tsang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01936870: Drug Use Investigation for Toviaz
Official title: DRUG USE INVESTIGATION FOR TOVIAZ
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder (OAB)
Keywords: Toviaz
Fesoterodine
Post marketing surveillance
Japanese
Overactive Bladder
OAB
Good post marketing practice
Regulatory Post Marketing Commitment Plan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-06
Enrollment: 2521
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients prescribed fesoterodine (Toviaz) by investigators involved in protocol A0221096.

Brief summary: The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.


Eligibility criteria: Inclusion Criteria:

* Patients prescribed fesoterodine (Toviaz).

Exclusion Criteria:

* There are no exclustion criteria

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 12 Weeks
measure: Clinical Efficacy Rate
timeFrame: 12 Weeks
Secondary outcomes:
measure: Number of Participants With Treatment-Related Serious Adverse Events
timeFrame: 12 Weeks
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: 12 Weeks
measure: Number of Participants With Adverse Events Related to Cognitive Function Disorder
timeFrame: 12 Weeks
measure: Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks
timeFrame: Baseline, 12 Weeks
measure: Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors
timeFrame: 12 Weeks
measure: Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors
timeFrame: 12 Weeks
measure: Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg
timeFrame: 12 Weeks
measure: Satisfaction Rate
timeFrame: 12 Weeks
measure: Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks
timeFrame: Baseline, 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02832570: Sildenafil Efficacy Study on Time Walk From Peripheral Arterial Desease Patients (Stade II) With Arterial Claudication
Official title: Etude préliminaire Sur l'efficacité Aigue du Sildenafil Sur le Temps de Marche Chez Les Patients Atteints d'AOMI de Stade II présentant Une Claudication artérielle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-07-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication

Detailed description: Sildenafil 100mg or Placebo Oral intake 2 hours before the treadmill test Safety and security control throughout the period of drug efficacy (approx 4 hours) Evaluation of maximal walking distance for a constant load treadmill test (3.2 kml/h 10% slope)

Eligibility criteria: Inclusion Criteria:

* Patient with peripheral arterial desease stade II
* Patient with vascular claudication for at least 3 months
* Patient able to perform a treadmill walking test with time to walk \< 5min

Exclusion Criteria:

* Patient suffering from ischemia
* Previous angina or myocardial
* Patient treated with nitrates drugs
* Patient with severe renal insufficiency
* Patient with severe hepatic insufficiency
* Patient with hypotension

Primary outcomes:
measure: Walking duration on treadmill
timeFrame: 2 hours after treatment intake
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Angers
name: Loukman OMARJEE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omarjee L, Le Pabic E, Custaud MA, Fontaine C, Locher C, Renault A, Jaquinandi V, Azzola V, Barbeau-Terrier C, Laporte I, Ripoche M, Onillon Y, Chretien JM, Daniel V, Chao de la Barca JM, Homedan C, Reynier P, Abraham P, Mahe G. Effects of sildenafil on maximum walking time in patients with arterial claudication: The ARTERIOFIL study. Vascul Pharmacol. 2019 Jul-Aug;118-119:106563. doi: 10.1016/j.vph.2019.05.003. Epub 2019 May 30.
Clinical trial NCT03323970: Decision Making in Neonatology : a Qualitative Study
Official title: Decision Making in Neonatology : a Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns the situation of new born for whom a decision making regarding limiting or withdrawing treatments is emerging, but only the physicians are involved as subjects of the study and seen in interviews.

Brief summary: This study aimed to describe and understand the decision making process in neonatology in situations of limiting of withdraw life sustaining treatments, by conducting interviews with physicians from one neonatology unit.


Eligibility criteria: Inclusion Criteria:

* Physicians in charge of new born babies for whom a decision making regarding limiting or withdrawing treatments is emerging.
* physicians' informed consent to participate to an interview
* parents' informed consent to collect data concerning their new born.

Exclusion Criteria:

- Not fluent French speaker

Primary outcomes:
measure: semi-structured interviews
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06389370: Assessment of Oral Health Knowledge, Attitude and Behaviour of Dental Students in Cairo University
Official title: Assessment of Oral Health Knowledge, Attitude and Behaviour and Its Association With Sociodemographic Factors of Preclinical and Clinical Dental Students in Cairo University: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oral Health Knowledge, Attitude and Behaviour of Dental Students
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 535
Sex: ALL
Minimum age (years): 17
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dental Students from level 1 to level 5 in faculty of dentistry, Cairo university.

Brief summary: The knowledge, behaviour and attitude of oral health professionals reflects their awareness and understanding of oral preventive measures, which will have significant impact on their delivery of public oral health promotion in the future. They are expected to set an example for positive oral health behaviour among other college students, family members and their patients. Various external factors like sociodemographic factors like age, gender, marital state, occupation, and number of family members play a major role in oral hygiene. The relationships between various modifiable factors needs to be assesses in a vast manner.

There were some researches about oral health knowledge, behaviour and attitude in correlation to socio-demographic data, of dental students in other countries, but little was known in Egypt. Dental students are expected to play a critical role in instructing public oral health for improving their patient's, families, and friends. In addition, it may pave the way to develop new programs to encourage needful oral health practices.


Eligibility criteria: Inclusion Criteria:

* Preclinical and clinical dental students, Faculty of Dentistry, Cairo University through the academic year 2024-2025.

Exclusion Criteria:

* Dental students from other universities.
* Internship dental students.
* Post-graduate dental students.

Primary outcomes:
measure: Knowledge
timeFrame: 1 month
Secondary outcomes:
measure: Attitude and behaviour
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Alyaa IA Ahmed, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02865070: A Smart, "Always -On" Health Monitoring System
Official title: A Smart, "Always -On" Health Monitoring System, Sub-Study: No Strings Attached: Wireless Sensor Technology in the Prentice NICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: premature
wireless vitals
vitals monitor
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 38
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 110 premature babies in the Lurie Children's Hospital and Prentice Women's Hospital NICU within 1 week of birth that fall into one of the listed cohorts, fit inclusion and exclusion criteria

Brief summary: This is a pilot study is to test a wireless, skin-sensor device against current technology in the NICU to monitor vitals

Detailed description: This is a single center, prospective, observational study that will recruit subjects from Lurie Children's Hospital and Prentice Women's Hospital to test a new wireless vitals monitor against the current vitals monitors used in the NICU. Patients will be neonates in different age brackets.

Eligibility criteria: Inclusion Criteria:

* Neonates in different age cohorts from ages 25 weeks gestational age to fullterm infants or infants up to 6 months of age, selected with assistance of NICU staff
* Currently in NICU and requiring monitoring for heart rate, ECG, respiratory rate, temperature, and pulse oximetry
* Parents able to understand and provide informed consent for study
* Infants enrolled in the Pre-Vent study (sub-study only)

Exclusion Criteria:

* Over 6 months of age
* Hemodynamic or other instability precluding testing of new monitoring with concurrent standards
* Infants at imminent risk of death and neonates with a skin abnormality that precludes assessment

Primary outcomes:
measure: Correlation of vital parameters against current technology
timeFrame: 15 min, 3 hours, 24 hours, 1 week
Secondary outcomes:
measure: Adverse events from wireless monitoring sensor assessed through Neonatal Skin Condition Score (NSCS)-sub-study only
timeFrame: 24 hours, 1 week
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University, Lurie Children's Hospital Department of Dermatology
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192970: Bevacizumab Against Recurrent Retinal Detachment
Official title: Bevacizumab Against Recurrent Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinal Detachment
Proliferative Vitreoretinopathy
Keywords: Retinal detachment
Proliferative vitreoretinopathy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Eyes with rhegmatogenous retinal detachment

Exclusion Criteria:

* Presence of PVR
* Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy.
* Recent intravitreal injection of an anti-VEGF agent less than 3 months prior
* Secondary retinal detachment repair
* Use of silicone oil as tamponade agent
* Patients less than 18 years of age
* Pregnancy
* Known allergy or contraindication to intravitreal bevacizumab

Primary outcomes:
measure: Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
timeFrame: 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael Altaweel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pennock S, Kim D, Mukai S, Kuhnle M, Chun DW, Matsubara J, Cui J, Ma P, Maberley D, Samad A, Van Geest RJ, Oberstein SL, Schlingemann RO, Kazlauskas A. Ranibizumab is a potential prophylaxis for proliferative vitreoretinopathy, a nonangiogenic blinding disease. Am J Pathol. 2013 May;182(5):1659-70. doi: 10.1016/j.ajpath.2013.01.052. Epub 2013 Apr 9.
Clinical trial NCT06996470: The Relationship Between Cervical Endurance Time and Eye Gaze
Official title: The Relationship Between Cervical Endurance Time and Eye Gaze Dual Time in University Students
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endurance Time During Gazing
Lead sponsor: Al-Ahliyya Amman University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: normal students at university, level 3

Brief summary: 46 normal students will participate at the study; they will be randomly divided (male and female) into 2 groups (23 for each group) The study will be conducted in physical therapy lab and Speech and hearing center at Allied medical school.


Eligibility criteria: Inclusion Criteria:

* Normal students

Exclusion Criteria:

* subjects achieving less than 20 mmHg in the CCFT test
* Students with cervical pain within the last six months

Primary outcomes:
measure: Endurance time during gazing
timeFrame: at base line
measure: Endurance time without gazing gazing
timeFrame: at base line
measure: Attention Span Scale for Students
timeFrame: at base line
measure: Cervical Vestibular-Evoked Myogenic Potential (cVEMP)
timeFrame: at base line
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: