louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03359109: Metallosis on Tissues and Serum Metal Levels in Children
Official title: Effect of Metallosis on Tissues and Serum Metal Levels in Children With Orthopedic Implants
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Orthopedic Disorder
Retained Metal Implant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing orthopedic surgery to remove or place metal implants.

Brief summary: Slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. This may have an impact on practice if children have high blood metal levels with routine orthopedic implants. If researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. Further work on this topic is needed.

Detailed description: Metal implants are routinely placed in children for treatment of fracture or deformity. Long-term effects of indwelling metal implants are not well-understood. Data from this study will provide guidances as to whether some metals are safer for children (stainless vs. titanium alloys). In addition, we will document the presence of serum ion concentration for children with metal implants in place and whether this resolves after implant removal. Tissues adjacent to implants will be evaluated for signs of metallosis and wear debris. Presence of metallosis will be correlated with serum ion concentration. In vivo studies will provide data on whether metal exposure to bone cells and fibroblasts affects their inflammatory cascade and function. Based on these findings, surgeons can better counsel patients whether routine implant removal is advisable or whether stainless steel implants are safer for long-term retention compared to titanium implants. Further, novel drug targets for treatment and prevention of metallosis will be developed. This project will foster collaboration and future partnerships between the Sanford Health and Mayo Clinic research teams

Eligibility criteria: Inclusion Criteria:

* Ages 4 years - 18 years
* Stainless steel, titanium or titanium-alloy based implants, scheduled for surgery
* De novo surgery where titanium implant placement

Exclusion Criteria:

* Concomitant infection

Primary outcomes:
measure: Mechanistic responses of bone repair cells upon Ti exposure
timeFrame: 3-6 months
Secondary outcomes:
measure: Evaluate serum levels of metal ions
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
Study officials:
affiliation: Mayo Clinic
name: A.Noelle Larson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02251509: Rate Control in Atrial Fibrillation
Official title: Rate Control in Atrial Fibrillation: A Randomized, Double-Blind, Crossover Comparison of Carvedilol and Metoprolol Tartrate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of metoprolol tartrate compared to carvedilol on heart rate control in patients with atrial fibrillation and a rapid ventricular rate.


Eligibility criteria: Inclusion Criteria:

* Permanent atrial fibrillation
* Baseline ventricular rate (prior to treatment) \> 110 bpm

Exclusion Criteria:

* History of accessory tract re-entry tachycardia
* Ejection fraction \< 35% or history of NYHA Class III/IV stage C/D heart failure
* Acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery in the past 2 months
* Child-Pugh class B or C hepatic dysfunction
* Uncontrolled hypertension
* Thyroid disease
* Intolerance to beta-blockers
* History of lung disease resulting in hospitalization in the past year

Primary outcomes:
measure: Resting heart rate
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Pallavi Bellamkonda, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545009: Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity
Official title: Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disease
Obesity
Exercise
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Additionally, we will determine if the ergogenic health benefits of beetroot juice is due to the nitric oxide compound within the product, the antioxidant compound within the product, or a combination of the two compounds.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30 kg/m2
* Able to perform exercise testing on a cycle ergometer

Exclusion Criteria:

* Currently taking medications know to affect cardiovascular or respiratory function
* Currently supplementing with an antioxidant compound
* Current smoker
* Currently taking antibiotics
* Not willing to abstain from mouthwash use
* Currently participating in regular physical activity

Primary outcomes:
measure: Time to Exhaustion
timeFrame: A Time to Exhaustion Test will be conducted on each participant a total of four times throughout their participation in the study. This will take place approximately 2.5 hours post ingestion of the dietary supplement they are randomized to at each visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gordon Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139009: Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Heart Transplantation
Keywords: intracellular concentration
cyclosporine A
renal biopsies
heart biopsies
Renal transplant recipients
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 30
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 primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Detailed description: The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Secondary objectives are to investigate associations between intralymphocyte concentrations and whole-blood concentrations of CsA, renal tissue concentrations and nephrotoxicity, heart tissue concentrations and cardiotoxicity with CsA based immunosuppressive therapy in transplanted patients. In addition, this study aims to validate the use of quinine as a probe for determination of CYP3A4 activity in transplanted patients as well as proteomic-based urine analyses as a screening tool for acute rejection episodes in transplanted patients.

Eligibility criteria: Inclusion Criteria:

1. Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation.
2. 18 years of age or older.
3. Signed informed consent.

Exclusion Criteria:

1. Known contraindications for renal or heart biopsies, respectively, at the time of inclusion.
2. Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.

Primary outcomes:
measure: rejection
measure: pharmacokinetics
Secondary outcomes:
measure: toxicity
measure: genotypes
measure: metabolites
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Section of Nephrology
Study officials:
affiliation: University of Oslo
name: Anders Åsberg, MSc
role: STUDY_DIRECTOR
References:
citation: Loftheim H, Midtvedt K, Hartmann A, Reisaeter AV, Falck P, Holdaas H, Jenssen T, Reubsaet L, Asberg A. Urinary proteomic shotgun approach for identification of potential acute rejection biomarkers in renal transplant recipients. Transplant Res. 2012 Aug 31;1(1):9. doi: 10.1186/2047-1440-1-9.
Clinical trial NCT02443909: Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nephrolithiasis
Keywords: Holmium Laser
Kidney Stones
RIRS
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).


Eligibility criteria: Inclusion Criteria:

* patients who have 2-3 cm kidney stones
* patients who are between 18-90 years old

Exclusion Criteria:

* patients who have congenital urogenital abnormalities
* patients who have previous surgery history for urinary stones

Primary outcomes:
measure: Safety (Complications according to clavien system)
timeFrame: 1 day
measure: Efficiency (visual analog score)
timeFrame: 1 Day
Secondary outcomes:
measure: Efficiency (stone free rate)
timeFrame: 3 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: S.B.Dıskapı Yıldırım Beyazıt Training and Research Hospital
Study officials:
affiliation: Ministry of Health, Turkey
name: Nihat Karakoyunlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redondo C, Ramon de Fata F, Gimbernat H, Meilan E, Andres G, Angulo JC. Retrograde intrarenal surgery with holmium-YAG laser lithotripsy in the primary treatment of renal lithiasis. Actas Urol Esp. 2015 Jun;39(5):320-6. doi: 10.1016/j.acuro.2014.06.004. Epub 2014 Oct 25. English, Spanish.
Clinical trial NCT05339009: Bio-ADM as a Biomarker of Refilling in Chronic Hemodialysis Patient
Official title: Bio-adrenomedullin (Bio-ADM) as a Biomarker of Refilling in Chronic Hemodialysis Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease 5D
Keywords: Chronic kidney disease
Extracorporeal purification
Bio-ADM
Vascular refilling rate
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients issued from dialysis units (non profit dialysis centers)

Brief summary: Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.


Eligibility criteria: Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
* Anuric patient

Exclusion criteria:

* Patient protected by law
* Patient under guardianship ou curatorship
* Patient deprived of liberty

Primary outcomes:
measure: Relationship between bio-ADM level and vascular refilling rate
timeFrame: Day 1
Secondary outcomes:
measure: Bio-ADM value according to comorbidity factors
timeFrame: Day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospital Center of Montpellier, FRANCE
name: Jean-Paul CRISTOL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02823509: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing.
* Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been dianoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01518309: An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
Official title: An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease Psychosis
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).


Eligibility criteria: Inclusion Criteria-

* Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin
* Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin
* Patient is willing and able to provide consent

Exclusion Criteria-

* Female patient of childbearing potential
* Patient has a clinically significant concurrent medical illness
* Patient is judged by the treating physician to be inappropriate for the study.

Primary outcomes:
measure: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
timeFrame: From first to last study drug dose plus 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Danbury
country: United States
state: Connecticut
Study officials:
References:
Clinical trial NCT05952609: A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Posterior Cavities
Official title: A 2-year Clinical Performance of Two Different Ion-releasing Bulk-fill Restorative Materials Placed in Posterior Cavities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Caries
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate and compare the clinical performance of 2 ion-releasing bulk-fill restorative materials in comparison with a bulk-fill resin composite restoration in posterior cavities.


Eligibility criteria: Inclusion Criteria:

* Criteria for patient's inclusion in the study will be the presence of at least 3 occlusal or proximal carious lesion in posterior teeth, favourable and stable occlusion between the remaining teeth, the patients must be older than 18 years old with permanent dentition, moderate oral hygiene, asymptomatic vital teeth with no sensitivity to percussion, and the presence of contact with adjacent teeth

Exclusion Criteria:

* Exclusion criteria will be, sever bruxism, patients with known unavailability to attend recall visits, patients with known allergy to any component of the study materials, pulp exposure during caries excavation, patients with unstable medical conditions and pregnant or lactating individuals.

Primary outcomes:
measure: Evaluating surface and marginal staining
timeFrame: 2 years
measure: Evaluating fracture and retention of the materials
timeFrame: 2-years
measure: Evaluating marginal adaptation and discoloration of the materials
timeFrame: 2-years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlyia
Study officials:
References:
Clinical trial NCT06117709: Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing
Official title: Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Cancer
Pain
Keywords: Advanced Cancer
Pain management
Opioid pain management
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.

Detailed description: The goal of this study is to develop and refine I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), an electronic health record-integrated mobile health (mHealth) application designed to support advanced cancer patients and care teams in pain management.

The research study procedures include screening for eligibility, surveys, and interviews. It is expected that up to 73 participants will take part in this research study. Activities 1-3 are non-interventional and will be used to collect data for application development.

Activity 4: This activity will be interventional and will be added with a future amendment.

Eligibility criteria: Inclusion Criteria for Participants (Activities 1a, 2a, 3a):

* Age ≥ 21 years
* Current or previous diagnosis of advanced cancer
* Current or previous experience with cancer pain

Exclusion Criteria for Participants (Activities 1a, 2a, 3a):

* Inability to understand, speak, or read English
* Any condition that would impede the patient's ability to complete study procedures such as visual impairment or significant cognitive impairment as determined by the participant's treating provider.

Primary outcomes:
measure: Usability
timeFrame: 2 weeks
measure: E-scale Acceptability
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrea Enzinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05874609: Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine
Official title: Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuraxial Ultrasonography
Keywords: ultrasound-guided
neuraxial anesthesia
virtual reality
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: As one of the most extensively practiced regional block, neuraxial anesthesia is the basic skill for anesthesiologist to acquire. Recently, virtual reality (VR) has been proposed as a new simulation training method to enhance medical education. The aim of our study is to evaluate the practical skills of ultrasound scan and the satisfaction of students who undergo training using VR versus traditional didactic lecture.

Detailed description: This is a prospective, single-center, randomized control trial to evaluate the performance of spine ultrasound scan after different training methods. Participants were randomly divided into two groups receiving different training methods: VR spine simulator or traditional didactic teaching. After the training, participants were required to perform a preprocedural spine ultrasound scan on healthy volunteers using the stepwise technique taught in the didactic teaching session. The participants needed to acquire three key ultrasound views during the scan and recognize the anatomic structures in three ultrasound views.

Eligibility criteria: Inclusion Criteria:

* anesthesia residents in our department

Exclusion Criteria:

* having previous experience of spine ultrasonography training
* having previous experience of spine ultrasound scan.

Primary outcomes:
measure: Composite learning score
timeFrame: Up to 12 hours after ultrasound scan is finished
Secondary outcomes:
measure: Time of scan
timeFrame: Up to 1 hour after ultrasound scan begins
measure: Rate of anatomic structures recognition
timeFrame: Up to 12 hours after ultrasound scan is finished
measure: Accuracy of depth measurement to the posterior complex
timeFrame: Up to 12 hours after ultrasound scan is finished
Other outcomes:
Locations:
Study officials:
References: