louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04329039: Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Official title: Randomized Control Trial Comparing Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pancreatic Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial comparing somatostatin analogues with perioperative antibiotics versus prolonged antibiotics
Primary purpose: TREATMENT

Brief summary: Researchers are trying to determine how the length of antibiotic treatment in addition to octreotide after pancreatic surgery affects the amount of time subjects are hospitalized as well as how many subjects develop pancreatic fistulas.


Eligibility criteria: Inclusion Criteria

* Patients undergoing a Whipple procedure for various diagnoses (neuroendocrine tumors, adenocarcinoma, benign cystic neoplasms, duodenal and ampullary malignancies, etc) who are deemed intermediate-high risk as per our institutional protocol as shown above.
* Patients \> 18 years of age

Exclusion Criteria

* Negligible and low risk patients
* All patients undergoing arterial resection.
* Age \<18 years
* Currently pregnant

Primary outcomes:
measure: This study aims to determine whether duration of antibiotic therapy coupled with octreotide leads to reduction of the severity or occurrence of pancreatic fistula.
timeFrame: During operative time plus 2 to 5 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael L Kendrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00963339: Age-Related Macular Degeneration (AMD) - Usability Study
Official title: Age-Related Macular Degeneration (AMD) - Usability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: AMD
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intermediate AMD

Brief summary: The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

Detailed description: The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.

Eligibility criteria: Inclusion criteria

* Subjects diagnosed as intermediate AMD in at least one eye
* Visual Acuity (VA) with habitual correction \<20/60 in the study eye
* Qualified in the clinic to use the device
* Ability to speak, read and understand instructions in English
* Subjects with ability to comprehend and sign the informed consent/authorization

Exclusion criteria

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

Primary outcomes:
measure: Successful unpacking and installation
timeFrame: 3 months
measure: Successful self tutorial performance
timeFrame: 3 months
measure: Ability of the subjects to operate the device as define by a successful test completion
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate the success rate of the interactive tutorial as defined by a reliable test result.
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Vitreos retina center - NJ
name: Daniel Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00568139: Evaluation of Side Effects of Mitotane
Official title: Evaluierung Von Nebenwirkungen Einer Therapie Mit Mitotane Beim Nebennierenkarzinom- Evaluation of Side Effects of Mitotane in Adrenocortical Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adrenocortical Carcinoma
Keywords: adrenal cancer
mitotane (Lysodren)
adverse events
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with adrenocortical carcinoma treated in our center or other ENSAT centers

Brief summary: Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many adverse effects are not well documented. Therefore, we are aiming at collecting data about adverse effects in patients treated with mitotane


Eligibility criteria: Inclusion Criteria:

* Adrenocortical carcinoma
* Treatment with mitotane monotherapy as first-line therapy (in adjuvant setting or advanced disease)

Primary outcomes:
measure: Documentation of adverse effects
timeFrame: from starting mitotane until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years) or start of additional other medical therapies
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital
Study officials:
affiliation: University of Wuerzburg
name: Martin Fassnacht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00786539: Mitochondria Inborn Errors of Metabolism and ANT Defects in Mitochondria Diseases
Official title: Investigation of the Nature and Prevalence of Mitochondria Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitochondrial Disease
Keywords: mitochondrial
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-11-06
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population with mitochondrial disorder and/or their relatives will be referred to MITOMED by Primary Care Physicians or by Clinical Specialists.

Brief summary: The objective of this research protocol is to continue investigation of the nature and prevalence of mitochondria disease and to aid patients and health care providers in the understanding of these complex disorders.

This research study brings together many clinical sub-specialists to address the etiology of these disorders and to develop more effective approaches for their diagnoses and more reliable prognoses.

Detailed description: The non-invasive device named Diffuse Optical Spectroscopy developed at the Beckman Laser Institute is to be used to measure various physiological parameters. Since mitochondria produce most of the energy necessary for cellular function, their efficacy is most important for systems with a high energy demand like the brain, heart, skeletal muscle, kidney, liver, and endocrine tissues. As a result, mitochondria diseases usually manifest as complex, multi-organ disorders, requiring multispecialty investigations.

Eligibility criteria: Inclusion Criteria:

* Male or female all ages group with diagnosis of mitochondrial disorder

Exclusion Criteria:

* Subjects with visual, auditory and/or neurological problems known to result from toxic or environmental effects

Primary outcomes:
measure: Symptoms of Mitochondrial diseases
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Bruce J Tromberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCIMC Pediatrics
name: Virginia Kimonis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636739: Special Drug Use Investigation for ROTARIX®
Official title: Special Drug Use Investigation for ROTARIX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Intussusceptions
Special Drug Use Investigation
Rotavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 10982
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis.

Brief summary: This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.

Detailed description: This is non-interventional study conducted in one group received Oral Rotarix®.

Eligibility criteria: Inclusion Criteria:

* Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.

Exclusion Criteria:

* All infants included in the drug use investigation of Oral Rotarix will be excluded.

Primary outcomes:
measure: Determination of the incidence of IS
timeFrame: During the 31-day (Day 0 -Day 30) observation period after each vaccination
measure: Determination of the incidence of IS
timeFrame: On the 1 year birthday of the subject
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05428839: The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Official title: The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: OSA
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.

Detailed description: The objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (CCC) at the soft palate

Eligibility criteria: Inclusion Criteria:

* Patient meets the indications for the Inspire Upper Airway Stimulation
* Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery.

Exclusion Criteria:

* Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement
* Any other reason the investigator deems that the patient is unfit for participation in the study.

Primary outcomes:
measure: Measurement of pharyngeal width to determine if there is correlation between pharyngeal width and presence or absence of complete concentric collapse at the soft palate during drug induced sleep endoscopy
timeFrame: Baseline, prior to routine diagnostic drug induced sleep endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Valley ENT
state: Arizona
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Mason City
country: United States
facility: Mason City Clinic
state: Iowa
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Saint Louis Park
country: United States
facility: ENT Specialty Care of MN
state: Minnesota
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT06683339: Functional Capacity in Children with Chronic Kidney Disease
Official title: Assessment of Functional Capacity in Children with Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease(CKD)
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with chronic kidney disease will be included in the study.

Brief summary: The aim of our study is to assess the functional capacity of children with chronic kidney disease using various tests.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with chronic kidney disease
* Being clinically stable
* Being between 6-18 years old
* Volunteering to participate in the research

Exclusion Criteria:

* Having a musculoskelatal disease that may affect functional capacity measurement
* Having a cognitive problem

Primary outcomes:
measure: Exercise capacity
timeFrame: 1st day
measure: Exercise capacity
timeFrame: 1st day
measure: Exercise capacity
timeFrame: 1st day
Secondary outcomes:
measure: Muscle strength
timeFrame: 1st day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Merve Firat
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Naciye Vardar-Yagli
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Bora Gulhan
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Melda Saglam
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Aydan Asli Aksel-Uylar
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Rezan Topaloglu
role: STUDY_CHAIR
References:
Clinical trial NCT01774539: Diffusion MRI and Growth Plate Injuries: Pilot Study
Official title: Diffusion MRI as a Prognostic Tool in Growth Plate Injuries: A Pilot Study to Assess Feasibility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture
Keywords: Fracture
Physeal injury
Diffusion MRI
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Pediatric Orthopaedic Society of North America
First posted: 2013-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be selected from the Orthopaedic Trauma Clinic at BC Children's Hospital

Brief summary: Children who suffer fractures to the growth plates (physes) of their bones are at risk for premature growth arrest which can lead to long term complications. There is currently no technique to predict who is at risk of growth arrest following a physeal injury. The investigators aim to determine if diffusion MRI (an imaging method to analyze tissue properties) can effectively pick up differences between a healthy growth plate and an injured one. This would allow orthopaedics surgeons to predict which injuries are at a higher risk of growth arrest, so earlier interventions can be done in the orthopaedic clinic.

Detailed description: The purpose of this study is to determine if diffusion MRI can be used for tissue characterization in childhood and adolescent growth plate injuries, and to get a better understanding of the physiologic disturbance of an injured physis

Eligibility criteria: Inclusion Criteria:

* Salter-Harris Type II, III, or IV fracture through the distal radius
* Growth plates are open
* Ages 8-12
* Able to consent in English

Exclusion Criteria:

* All fractures not sustained to distal radius
* SH Type I or V fracture
* Injury to contralateral limb
* Previous injury to distal radius
* Diseases known to alter bone healing or growth\]
* Contraindications to undergoing an MRI scan

Primary outcomes:
measure: Tissue characterization of growth plate using diffusion MRI
timeFrame: 4-6 weeks following injury
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Firoz Miyanji, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073639: The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction
Official title: The Clinical Effect of Autogenous Dentin Graft in Mandibular Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontal Pocket
Swelling Lips & Face
Trismus
Pain, Acute
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. The primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. The investigators also measured periodontal healing of distal aspect of the adjacent second molar up to 2 year after the surgery.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Symmetry mandibular third molars
* Symmetry maxillary third molars with no caries or periodontal disease
* Mandibular second molars are available

Exclusion Criteria:

* Systematic health has contraindication for surgery
* Pregnant or breastfeeding women
* Allergy with Lidocaine
* Abnormal signs surrounding mandibular third molars

Primary outcomes:
measure: Rate of self-reported pain
timeFrame: 3 days, 7 days
measure: Self-reported swelling
timeFrame: 3 days, 7 days
measure: Trismus
timeFrame: 3 days, 7 days
measure: Soft tissue healing score
timeFrame: 3 days, 7 days, 30 days
measure: Aveolar height
timeFrame: 7 days, 2 months, 6 months, 2 years
measure: Swelling measured by facial dimension
timeFrame: 3 days, 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Son Hoang Le
state: District 5
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Son H Le
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06637839: Optimal Dosing of High-Intensity Locomotor Training for Step Attainment and Locomotor Outcomes in Stroke Patients Undergoing Acute Inpatient Rehabilitation
Official title: A Randomized, Double-blind Study Comparing the Effects of Three Distinct High Intensity Locomotor Training Protocols on Locomotor Outcomes in Subacute Stroke Patients Undergoing Adult Inpatient Rehabilitation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-10-15
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery.

This is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.


Eligibility criteria: Inclusion Criteria:

• Primary diagnosis of stroke

Exclusion Criteria:

* Weightbearing restrictions, uncontrolled cardiopulmonary, metabolic, infectious, or psychiatric disorders, which would preclude aerobic locomotor training
* Estimated length of stay of less than 14 days
* Non-ambulatory status prior to admission (unable to walk \>50 meters)
* Pregnant

Primary outcomes:
measure: Berg Balance Scale (BBS) Score
timeFrame: Discharge Assessment (Day 13-14)
measure: Ten Meter Walk Test (10mWT) Time
timeFrame: Discharge Assessment (Day 13-14)
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: Discharge Assessment (Day 13-14)
measure: Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers
timeFrame: Discharge Assessment (Day 13-14)
measure: IRF-PAI - Admission QI Score: Cumulative Ambulation
timeFrame: Discharge Assessment (Day 13-14)
measure: IRF-PAI - Admission QI Score: Cumulative Stairs
timeFrame: Discharge Assessment (Day 13-14)
Secondary outcomes:
measure: Number of Patients Discharged at Home
timeFrame: Discharge Assessment (Day 13-14)
measure: Number of Patients Discharged at Subacute Rehabilitation Facility
timeFrame: Discharge Assessment (Day 13-14)
measure: Number of Steps of Locomotor Training
timeFrame: Discharge Assessment (Day 13-14)
measure: Time Spent in Locomotor Training
timeFrame: Discharge Assessment (Day 13-14)
measure: Number of Minutes Spent in Target HR Zone
timeFrame: Discharge Assessment (Day 13-14)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Susan Camillieri
role: PRINCIPAL_INVESTIGATOR
References: