louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02221557: Case Series of New Alloplastic Bone Graft Material
Official title: Clinical and Histomorphometric Evaluation of Beta-tricalcium Phosphate/Polylactide Bone Substitute for Socket Preservation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontology
Oral Surgery
Lead sponsor: Sunstar Americas
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A case series to compare the handling and effectiveness of two different treatment approaches using a new alloplastic bone graft material in ridge preservation compared to allograft existing historical data.


Eligibility criteria: Inclusion Criteria:

* Must have read, understood and signed a consent form.
* 18-75 years of age
* Diagnosis with a need of extraction of single tooth (with intact extraction socket at the time of extraction) with adjacent teeth present.

Exclusion Criteria:

* Active caries or endodontic lesions in adjacent teeth
* Any systemic disease or condition that would compromise the normal healing. (e.g., uncontrolled diabetes)
* Taking any medication known for gingival hyperplasia for past 3 months.
* Any systemic contraindications to surgery
* Subject smokes \> 10 cigarettes per day.

Primary outcomes:
measure: Percentage Change in Radiographic Measurement of Alveolar Ridge Height
timeFrame: Change from baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
Study officials:
References:
Clinical trial NCT00684957: Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors
Official title: Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Growth Hormone Deficiency
Keywords: rhGH
rhIGF-1
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Tercica
First posted: 2008-05-28
Enrollment: 5
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if giving growth hormone or insulin-like growth factor-1 (IGF-1) to subjects with growth hormone deficiency effects cardiovascular risk factors differently.

Detailed description: Insulin-like growth factor-1 (IGF-1) in some circumstances acts as the mediator of the metabolic effects of growth hormone. However, there is some evidence to suggest that growth hormone (GH) and IGF-1 act differently in some metabolic pathways. We will study the differences between GH and IGF-1 when provided as therapy for growth hormone deficiency in adults. Specifically we will be assessing if either medication impacts cardiovascular risk factors and if so do they impact risk factors differently. Ten adult males ages 18-65 who are growth hormone deficient on stable medications and with stable magnetic resonance imaging (MRI) findings (in the event of a known pituitary mass) will be recruited for the study.

Eligibility criteria: Inclusion Criteria:

* Adult male age 25-65 with documented growth hormone deficiency on stable doses x 3 months (at least) of any hormone replacement therapies and with stable MRIs x 2 years in the setting of a known pituitary mass.

Exclusion Criteria:

* Female gender
* current GH use or GH use within three months of the study
* diabetes
* hypoglycemia
* liver or kidney disease
* use of drugs that could increase GH secretion (i.e. L-dopa)
* alcohol or substance abuse
* use of investigational drugs within four weeks of our study and use of supraphysiologic doses of steroids within the previous six months.

Primary outcomes:
measure: Cardiovascular Serum Risk Markers Including Lipids, IL-6, CRP and Homocysteine
timeFrame: 2 months
Secondary outcomes:
measure: Changes in Visceral Adiposity, Intrahepatic and Intramyocellular Lipids
timeFrame: 2 months
measure: Changes in Endothelial Cell Function
timeFrame: 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University, College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Pamela U. Freda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01922557: Thoracic Fluid Content and Acute Lung Injury
Official title: The Association of Thoracic Fluid Content and Acute Lung Injury in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: end stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital were enrolled.

Brief summary: To study the association of the thoracic fluid content and acute lung injury during liver transplantation.

Detailed description: Acute lung injury is not uncommon after liver transplantation. A new monitor non-invasive cardiac output monitor (NICOM) is designed to measure thoracic fluid content. The investigators attempt to use the parameter thoracic fluid content to investigate its relationship with acute lung injury in liver transplant recipients.

Eligibility criteria: Inclusion Criteria:

* end stage liver disease scheduled for liver transplantation in National Taiwna University Hospital.

Exclusion Criteria:

* allergic reaction
* history of aortic regurgitation
* pre-existing pulmonary disease

Primary outcomes:
measure: Cardiac index
timeFrame: one day
Secondary outcomes:
measure: Thoracic fluid content
timeFrame: one day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, NTUH
Study officials:
affiliation: Department of Anesthesiology, NTUH, Taipei, Taiwan
name: Kuang Cheng Chan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong SK, Hwang S, Lee SG, Lee LS, Ahn CS, Kim KH, Moon DB, Ha TY. Pulmonary complications following adult liver transplantation. Transplant Proc. 2006 Nov;38(9):2979-81. doi: 10.1016/j.transproceed.2006.08.090.
Clinical trial NCT04672057: Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
Official title: Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Keywords: Hemiparesis
Lateralization
Spatio-temporal analysis
Gait
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis.

Detailed description: A total of 108 individuals within the age range of 20-65 and 36 of whom are right hemiparetic (Group1; 16F, 20M), 36 of whom are left hemiparetic (Group2; 16F, 20M) and 36 of whom are healthy (Group3; 19F, 17M) have been included in the study. BTS G-Walk Gait Analysis System has been used to assess the spatio-temporal gait characteristics.

Eligibility criteria: Inclusion Criteria:

for the hemiparetic individuals

* Being between the ages of 20-65,
* Having a stroke for the first time and one-sidedly,
* Having a stable clinical state,
* Having no cognitive disorder (Hodkinson Mental Test ≥ 8),
* Having ≤ 3 from Modified Rankin Score,
* Having no problems with vision and hearing.

for the healthy control group;

* Being between the ages of 20-65
* Having no neurological, musculosceletal, cardiac and cognitive problems that was undergone before and may affect walking.

Exclusion Criteria:

* The existence of vision and hearing problems in both study and control groups,
* The existence of orthopedic, neurological and psychiatric problems that may affect walking.

Primary outcomes:
measure: assessment of gait between in right and left hemiparetics
timeFrame: Measurement time is 10 minutes. Only one measurement was made.
Secondary outcomes:
measure: assessment of gait between in hemiparetic and healthy individuals
timeFrame: Measurement time is 10 minutes. Only one measurement was made.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Gulsum Tikac, MSc Pt
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Filiz Altuğ, Prof Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06694857: A Prospective Evaluation of the Filler for Jaw Contouring
Official title: 3-Dimensional Volumetric Analysis of a Hyaluronic Filler Injection for Jaw Contouring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dermal Fillers
Keywords: Jaw
Hyaluronic Acid
HA Filler
Hyaluronic Acid Filler
Filler
Cosmetic
Face
Dermal Fillers
Chin
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this prospective study is to analyze volumetric changes in the lower face after hyaluronic acid filler injections over 90 days. The main question it aims to answer is:

To quantify volume change of the lower face area over time after injection of filler

* Participants will receive hyaluronic acid filler injections (Juvéderm Volux XC) for contouring of the jawline. Each patient will receive FDA approved dosages of filler to the lower face region to treat facial contour or asymmetry, as per FDA approved indications.
* Prior to injection patients will be imaged with 3-dimensional photogrammetry. Subjects will return post-injection in 2 weeks, 1 month, and 3 months for re-imaging.


Eligibility criteria: Inclusion Criteria:

1. Age 22-55
2. Patients interested in jaw contouring
3. Participants must sign the informed consent form.

Exclusion Criteria:

1Prior filler for facial contouring 2) Filler injection within the past 12 months or during duration of study 3) Prior facial cosmetic surgery (ie. facelift) 4) Prior facial trauma (ie. orbital fracture) 5) Pregnant or breastfeeding 6) Planned dental work within next 2 weeks 7) The following contraindications: patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies, gram-positive bacterial protein allergies and lidocaine allergies

Primary outcomes:
measure: Volume change of the lower face area at 30 days post-intervention
timeFrame: 30 days
Secondary outcomes:
measure: PRO
timeFrame: 90 Days
measure: Volume Change of the Lower Face 14 days Post-intervention
timeFrame: 14 days
measure: Volume changes of the lower face at 90 days post-intervention
timeFrame: 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02413957: Medication Reconciliation in Comparison to an Extensive Medication Safety Check
Official title: Pilot Project to Investigate the Influence of Medication Reconciliation and an Extensive Medication Safety Check on the Number of Adverse Drug Events in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Adverse Drug Event
Keywords: Elderly Patients
Medication Safety
Pharmaceutical Care
Medication Reconciliation
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Ärztliche Zentrum für Qualität in der Medizin
name: Universitätsklinikum Bonn - Institut für Patientensicherheit
First posted: 2015-04-10
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine wether an extensive medication safety check has a greater impact on the incidence of adverse drug events than medication reconciliation or no intervention.


Eligibility criteria: Inclusion Criteria:

* Patient 65 years and older
* written informed consent patient or the legal representative
* existing medication therapy at hospitalization
* admission to one of the project wards via emergency department (non elective)

Exclusion Criteria:

- patients included in the study previously

Primary outcomes:
measure: incidence of adverse drug events
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of the clinical relevance of medication related problems as determined by the French Society of Clinical Pharmacy
timeFrame: 1 year
measure: Assessment of the clinical relevance of discrepancies as determined by the French Society of Clinical Pharmacy
timeFrame: 1 year
measure: number of medication related problems
timeFrame: 1 year
measure: number of discrepancies
timeFrame: 1 year
measure: duration of taking the best possible medication history
timeFrame: 1 year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
References:
citation: Franzen K, Lenssen R, Jaehde U, Eisert A. [Medication Reconciliation-theory and practice]. Ther Umsch. 2014 Jun;71(6):335-42. doi: 10.1024/0040-5930/a000521. German.
Clinical trial NCT01099657: Virtual Reality Hypnosis for Chronic Pain Reduction
Official title: Virtual Reality Hypnosis for Chronic Pain Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2010-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We would like to determine how well hypnosis works when induced through virtual reality medium for patients who have suffered a major burn injury in the past two years and suffer from chronic pain. These patients are coming back to the outpatient burn and plastic clinic at Harborview Medical Center for routine follow-up. We think that patients will find VR-Hypnosis interesting, and it will help them relax and feel less pain.


Eligibility criteria: Inclusion Criteria:

* Age 13 - 75 years
* Able to complete subjective evaluations of pain
* English-speaking
* Able to communicate orally

Exclusion Criteria:

* Age less than 13 years or greater than 75 years
* Incapable of indicating subjective evaluation of pain
* Non-English-speaking (Virtual Reality Hypnosis only available in English)
* Demonstrating delirium, psychosis, or Organic Brain Disorder
* Unable to communicate verbally
* Significant developmental disability
* Extreme susceptibility to motion sickness
* Significant head/or neck injury
* Pregnant women

Primary outcomes:
measure: Pain and anxiety
timeFrame: pre and post VR and then up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT05597657: Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
Official title: Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Magnetic Resonance
T1 Mapping
Healthy Individuals
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cardiovascular Academy (DCA)
name: Eva og Henry Frænkels Mindefond
name: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
First posted: 2022-10-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine the normal variation of T1 values with cardiac magnetic resonance in healthy individuals with respect to reproducibility, changes over time, and dependency on hydration status.

Detailed description: T1 mapping with cardiac magnetic resonance (CMR) is a novel non-invasive technique to quantitatively characterize the myocardium. T1 mapping is a surrogate marker of myocardial edema and fibrosis, and has the potential to be implemented in the diagnosis and follow-up of various cardiac diseases. However, there is limited data on the natural variation of T1 mapping in healthy individuals.

The study comprises three substudies:

1. Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the same day .
2. Hydration changes: Participants will receive two liters of isotonic saline intravenously between two identical CMR with T1 mapping and echocardiographic examinations. The post-fluid order of CMR and echocardiography will be randomized.
3. Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months follow-up, and at 1-year follow-up.

Eligibility criteria: Inclusion Criteria:

* Age 18-89 years
* Healthy

Exclusion Criteria:

* Chronic disease (e.g. cardiovascular disease, rheumatological disease, lung disease)
* Medications affecting the cardiovascular system (e.g. antihypertensives, statins, anticoagulants)
* Contraindications for CMR (claustrophobia, pregnancy, magnetic metallic implants)

Primary outcomes:
measure: Change in T1 values (substudy 1)
timeFrame: Through study completion, an average of 1 year
measure: Change of T1 values (substudy 2)
timeFrame: Through study completion, an average of 1 year
measure: Change in T1 values (substudy 3)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Katrine A Myhr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04399057: Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction
Official title: a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Penile Diseases
Keywords: erectile dysfunction
elastosonography
penile diseases
International index of erectile function
erectile hardness score
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 322
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the population chosen is male, who goes to the clinics for andrological problems.

Brief summary: the study proposes the use of a new non-invasive ultrasound method for the diagnosis of erectile dysfunction. in particular, the shear Wave elastosonosgraphy of the corpora cavernosa will be used. this last method quantitatively measures the rigidity of the analyzed tissues.

Detailed description: erectile function is a complex mechanism in which the elasticity of the tissues that make up the corpora cavernosa is fundamental. indeed, anatomopathological studies have shown that in patients with erectile dysfunction the elastic fibers are replaced by inextensible collagen. the aim of the study is the correlation between penile stiffness measured with this new non-invasive diagnostic method - elastosonography of the corpora cavernosa - and the correlation with validated questionnaires. the international Index of Erectile Function (IIEF5) short form and the erectile Hardness Score (EHS) will be used.

Eligibility criteria: Inclusion Criteria:

male who came attended our general andrology clinic between January 2019 to January 2020.

Exclusion Criteria:

1. with: age \>80 years or \<18 years. , 2
2. diabetes,
3. spinal trauma,
4. treatment with continuous PDE5i,
5. ischemic heart disease for less than 6 months,
6. pelvic surgery for within less than 1 year,
7. hypotestosteronemia (\<8 nmol/L),
8. La Peyronie's disease.
9. penile trauma.

Primary outcomes:
measure: Shear Wave elastosonografy and Erectile tissues Stiffness.
timeFrame: 15 days
measure: Shear Wave Elastosonography and IIEF5 questionnaire
timeFrame: 15 days
measure: Shear Wave elastosonography and EHS questionnaire
timeFrame: 15 days
Secondary outcomes:
measure: cut-off value at elastosonography and erectile dysfunction
timeFrame: 15 days
Other outcomes:
Locations:
city: Terni
country: Italy
facility: Elisabetta Costantini
Study officials:
References:
Clinical trial NCT05324657: Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)
Official title: Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm Abdominal
Keywords: abdominal aortic aneurysm
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company).

The patients will be compared in order to detect possible significant differences in terms of perioperative risk factors that could affect the study. Risk adjustment or other statistical tools might be used to create comparable cohorts.

Brief summary: The aim was to determine, within the patient enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company) studies which are preoperative and postoperative anatomical risk factors associated to limb occlusion. In the three studies the total number of enrolled patients was 400, of whom 134 enrolled in the US


Eligibility criteria: Inclusion Criteria:

* Patients with abdominal aortic aneurysm, who have been treated with the INCRAFT® Grafting System (AAA Stent-Graft System).
* All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company)

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: limb occlusion
timeFrame: 30 days
measure: freedom from death
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
citation: De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.
citation: United Kingdom EVAR Trial Investigators; Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1863-71. doi: 10.1056/NEJMoa0909305. Epub 2010 Apr 11.