louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00189267: A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients
Official title: Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream Applied Once Daily 3 Days Per Week for the Treatment of Actinic Keratoses in Immunosuppressed Organ Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Aldara
Actinic Keratosis
Graft Recipients
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 45
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 purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.


Eligibility criteria: Inclusion Criteria:

* Have a total of 4-10 actinic keratosis (AK) lesions located on either face or scalp
* If female and of childbearing potential, have a negative urine pregnancy test at treatment initiation, and willing to use a medically acceptable method of contraception during the treatment period
* Renal, liver or heart transplant recipients

Exclusion Criteria:

* Graft rejection with loss of the graft in the medical history
* Unstable status of organ transplant disease during the last 12 months
* Known to be pregnant or lactating

Primary outcomes:
measure: Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.
Secondary outcomes:
measure: Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates.
Other outcomes:
Locations:
Study officials:
affiliation: Universitaetsklinikum Charite
name: Study Coordinator
role: STUDY_CHAIR
References:
Clinical trial NCT00702767: Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants
Official title: Tolerance of Increased Infusion Rates of Intravenous Fat Emulsions in Very Low Birth Weight Infants During the First Week of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Birth Weight
Keywords: This study was completed in October 2006
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 110
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was completed in October 2006. No further participates are being recruited.


Eligibility criteria: Inclusion Criteria:

* All infants who are Appropriate for Gestational Age at Birth and who have a birthweight between 750-1500 grams will be enrolled in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Drenckpohl D, McConnell C, Gaffney S, Niehaus M, Macwan KS. Randomized trial of very low birth weight infants receiving higher rates of infusion of intravenous fat emulsions during the first week of life. Pediatrics. 2008 Oct;122(4):743-51. doi: 10.1542/peds.2007-2282.
Clinical trial NCT05369767: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
Official title: A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Prevention of Arterial and Venous Thrombosis
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-2004 injection compared with placebo
Primary purpose: OTHER

Brief summary: The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004 injection in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. males or females, aged 18-55;
2. body mass index (BMI) between 19 kg/m2 to 28 kg/m2, and a total body weight: male ≥50.0 kg and \<90.0 kg; female ≥45.0 kg and \<90.0 kg.

Exclusion Criteria:

1. previous medical history of coagulation or bleeding disorders;
2. known risks of bleeding or thrombosis, such as recurrent gingival bleeding, spontaneous bleeding, haemorrhoids, gastrointestinal ulcers, or other high-risk bleeding diseases.

Primary outcomes:
measure: To assess the number of subjects with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: up to day 113
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital of Nanjing University Medical school
state: Jiangsu
Study officials:
References:
Clinical trial NCT01749267: Digital Subtraction Radiography Evaluation of SMART Restoration With Partial Caries Removal in Primary Teeth
Official title: Clinical and Digital Subtraction Radiography Evaluation of Partial Caries Removal in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries Extending Into Dentine
Keywords: dentin remineralization
caries regression
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to analyze the radiographic density of digital subtraction radiographs after SMART restoration with partial caries removal in primary molars at 6 and 12 months.

Detailed description: In management of deep caries in primary teeth, the partial caries removal approach favored the arrest of dentin carious lesions, reduced cariogenic micro-organisms and the risk of pulp exposure. The carious tissue at the lateral walls of the cavity at the enamel dentin junction (EDJ) was removed by a spoon excavator without carious tissue removal at the pulpal site. After caries removal, restoration using glass ionomer cement (GIC)(GC Fuji IX™GP extra) was completed. Such an approach is called SMART restoration. The serial radiographs of each restoration consisted of three radiographs; immediately after restoration, at the 6-month follow-up and at the 12-month follow-ups. Digital subtraction radiography(DSR) was used to evaluate dentin remineralization following partial caries removal. Image-Pro Plus software was used to evaluate DSR. For evaluating the changes in DSR, areas with increase density show higher radiopacity, whereas areas with decreased density show higher radiolucency. The 6-month and 12-month follow-up radiographs were subtracted from the baseline radiograph.

Eligibility criteria: Inclusion Criteria:

* Presence of teeth with dentinal caries limited to the occlusal and proximal surfaces without clinical signs and symptoms of irreversible pulpitis (spontaneous pain, sinus opening, or abnormal tooth mobility
* The radiographic examination showing dental caries involving not less than half of the dentin without any pathologic findings (external root resorption, internal root resorption, abnormality of root resorption, or radiolucency area at furcation /periapical regions).

Exclusion Criteria:

* Teeth with caries exposure to pulp

Primary outcomes:
measure: dentin remineralization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol University
Study officials:
name: Araya Phonghanyudh, PhD
role: STUDY_DIRECTOR
References:
citation: Phonghanyudh A, Phantumvanit P, Songpaisan Y, Petersen PE. Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. Community Dent Health. 2012 Jun;29(2):173-8.
Clinical trial NCT01495767: Quality of Life in Juvenile Patients With Uveitis
Official title: The Impact of Uveitis on Health-related Quality of Life in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Keywords: childhood uveitis
health-related quality of life
gender
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2011-12-20
Enrollment: 37
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with uveitis, aged 11-18 years

Brief summary: Data about psychodynamics in uveitis patients are scare. A negative impact of disease is described not only in adult patients with active, but also with quiescent disease. During adolescence even less is known about psychodynamics although this is an especially sensible and challenging stage of life. Given the assumption that juvenile patients with quiescent disease still could suffer from emotional distress, this would require special attention.

In this study the investigators evaluate the impact of juvenile uveitis on HRQoL and attempted to identify clinical and demographic factors contributing to an impaired health status. The investigators limit the study to patients with quiescent uveitis and good visual function in at least one eye to exclude additional negative stressors. As there are no validated uveitis-specific psychometric questionnaires evaluating QoL available yet, the investigators use age-appropriate generic instruments. This should allow obtaining an overview about the adolescents' general Health-related Quality of Life (HRQoL) and whether psychological interventions should be offered to this sensitive patient group.


Eligibility criteria: Inclusion Criteria:

* Patients with uveitis
* aged 11-18 years
* willing to participate
* parent or legal guardian agrees with participation of adolescent

Exclusion Criteria:

* not willing to participate
* parent or legal guardian does not agree with participation of adolescent

Primary outcomes:
measure: Quality of life as assessed with the "Inventory for Assessing the Quality of Life in Children and Adolescents"
timeFrame: One day
Secondary outcomes:
measure: Quality of life as assessed with the "Children Quality of Life Questionnaire"
timeFrame: One day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Hospital Hietzing, Vienna + Medical University of Vienna, Vienna
name: Saskia M Maca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02521467: Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series
Official title: Adjunctive Role of Platelets Rich Fibrin in Palatal Wound Healing After Free Gingival Graft Harvesting - Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Platelets Rich Fibrin, Palatal Donor Tissue
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.

Detailed description: Introduction:

Free gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.

Materials and methods:

Ten patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.

Eligibility criteria: Inclusion Criteria:

* Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation

Exclusion Criteria:

* High arched palate, medically compromised

Primary outcomes:
measure: Pain Assessment by Visual Analog Scale (VAS)
timeFrame: 1 week postoperative
measure: Clinical healing of the palate
timeFrame: 2 weeks postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05566067: Survey of Anesthesiology Residents' Perceptions of Critical Care Medicine as a Career
Official title: Survey of Anesthesiology Residents' Perceptions of Critical Care Medicine as a Career at One Academic Center
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anesthesia
Keywords: critical care medicine
fellowship
anesthesiology residency
perception
anesthesia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 100
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: Anesthesiology residents at Stanford

Brief summary: This study's goal is to investigate the reasons behind the decline in interest in critical care fellowships among anesthesia residents.

Detailed description: Anesthesia-based critical care medicine (CCM) is at a crossroads at the turn of the millennium. Although anesthesiologists were pioneers in the field of critical care, their surgical and pulmonary medicine counterparts have now eclipsed them in terms of both numbers and influence. In the United States, anesthesia-based CCM is a niche specialization of anesthesiology, while in Europe, anesthesiologists play a central role in critical care. Anesthesia-based critical care physician production has remained low on an annual basis. Some medical students join anesthesiology residencies with an interest in critical care training, but this enthusiasm appears to diminish as the number of years of residency grows. In the United States, anesthesiology residents have been unable to fill many critical care fellowship spots consistently. This survey aims to investigate the factors that influence residents' decision to pursue a career as a critical care physician, as it is essential to comprehend the underlying reasons for such a decline.

Eligibility criteria: Inclusion Criteria:

* Anesthesiology residents at Stanford

Exclusion Criteria:

* Non-anesthesiology residents at Stanford

Primary outcomes:
measure: Decline in applying to CCM fellowships
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Ban CH Tsui, MD
role: STUDY_DIRECTOR
References:
citation: Hanson CW 3rd, Durbin CG Jr, Maccioli GA, Deutschman CS, Sladen RN, Pronovost PJ, Gattinoni L. The anesthesiologist in critical care medicine: past, present, and future. Anesthesiology. 2001 Sep;95(3):781-8. doi: 10.1097/00000542-200109000-00034. No abstract available.
Clinical trial NCT00037167: Effects of Exercise Poles on Older Adults During Exercise Walking
Official title: Impact of Running Poles on Older Adult Exercise Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Movement Disorders
Aging
Keywords: Fall-Prevention
Balance
Musculoskeletal Systems
Protective Devices
Gait
Equilibrium
Accidental Falls
Frail Elderly
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor class: NIH
Collaborators: name: Ball State University
First posted: 2002-05-17
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study uses a patented type of exercise poles, developed to assist runners rehabilitating from lower body injuries. These poles may offer older adults improved stability, reduced fear of falling, and lessened lower body pain when exercise walking.

Detailed description: Phase 1 (being concluded as of Feb 2002) used 18 older adults to investigate prototype versions of the running poles. Preliminary results, after 3 months of testing, indicate the poles are safe and effective. Phase 2 will use improved versions of the poles, which are currently in development, with a group of around 125-150 subjects over a longer length of time (12 months). Changes in walking gait quality, balance, strength, body composition, exercise adherence, and subjective perceptions of wellness will be assessed before, during, and after the 12 month exercise session.

Eligibility criteria: Inclusion Criteria:

* Age 65-80
* Normal gait

Exclusion Criteria:

* Inability to walk continuously for 5 minutes
* Contraindication from a personal physician
* Height over 6'2" or weight over 200 lbs (due to limitations of existing pole design)
* Mild to severe cognitive impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muncie
country: United States
facility: School of Physical Education, Biomechanics Lab
state: Indiana
Study officials:
affiliation: Martinus Van Breems, Inc.
name: Martin van Breems
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03601767: Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission
Official title: Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
score
Lead sponsor: Azienda Ospedaliera San Paolo
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 600
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: subjects presenting to the accident and emergency department and admitted to hospital for any infection

Brief summary: The aim of the present study is to develop a prognostic tool to assess the risk of dead and major complications in patient admitted to hospital for infection. A detailed database of clinical, biochemical and microbiological data is recorded and each item is analyzed and compared with clinical outcomes to develop a prognostic score.


Eligibility criteria: Inclusion Criteria:

* al least 18 years old
* admission to hospital for any infection for more than 72 hours

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: mortality
timeFrame: at 28 days
Secondary outcomes:
measure: major complications
timeFrame: at 28 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Paolo Polo Univesitario - ASST Santi Paolo e Carlo
Study officials:
References:
Clinical trial NCT00187967: Cardiopulmonary Bypass (CPB) Pumps and Blood Activation
Official title: Blood Activation During Cardiopulmonary Bypass Using Roller or Centrifugal Pumps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiopulmonary Bypass
Coronary Artery Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Blood activation induced by cardiopulmonary bypass may compromise the postoperative outcome. The goal of this study is to compare blood activation induced by cardiopulmonary bypass performed with centrifugal pump or roller pump in patients undergoing coronary artery surgery.


Eligibility criteria: Inclusion Criteria:

* Men undergoing coronary artery bypass grafting using cardiopulmonary bypass
* Aspirin therapy

Exclusion Criteria:

* Redo surgery
* Acute coronary syndrome requiring urgent surgery
* Oral anticoagulant therapy
* Organ dysfunction or chronic inflammatory disease
* Surgery other than coronary artery bypass grafting

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
Study officials:
affiliation: University Hospital of Angers, France
name: Christophe Baufreton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05295667: Doppler and AFV for Outcome Prediction ın FGR
Official title: Combination of Doppler Measurements With Amniotic Fluid Volume for the Predicition of Perinatal Outcome in FGR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Retardation
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A pregnant womens between 18-40 years of age with singleton pregnancy after 37 weeks of gestational age with FGR

Brief summary: The investigator contrived a prospective study of AUCR to compare its association to adverse perinatal outcomes with other established doppler parameters, such as CPR and UCR within a population of suspected FGR fetuses at term.


Eligibility criteria: Inclusion Criteria:

* SİNGLETON PREGNANCİES WİTH FGR FETUSES
* AFTER 37th GESTATİONAL WEEKS

Exclusion Criteria:

* SİNGLE OR MUTİPL FETAL ANOMALİES
* EVİDENCE OF İNTRAUTERİNE ENFECTİON

Primary outcomes:
measure: the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
citation: Stumpfe FM, Faschingbauer F, Kehl S, Pretscher J, Emons J, Gass P, Mayr A, Schmid M, Beckmann MW, Stelzl P. Amniotic-Umbilical-to-Cerebral Ratio - A Novel Ratio Combining Doppler Parameters and Amniotic Fluid Volume to Predict Adverse Perinatal Outcome in SGA Fetuses At Term. Ultraschall Med. 2022 Apr;43(2):159-167. doi: 10.1055/a-1205-0161. Epub 2020 Jul 28.