louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01045109: Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen.
Official title: Vitamin D and Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate
cancer
vitamin D3
early stage
active surveillance
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.


Eligibility criteria: Inclusion Criteria:

* lowgrade prostate cancer
* serum PSA less than/equal to 10 ng/ml
* Gleason score less than/equal to 6
* referred from their treating physician with treatment plan of active surveillance for one year
* serum creatinine less than/equal to 2.0 mg/dL
* serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL
* serum calcium greater than 8.5 and less than 10.5 mg/dL

Exclusion Criteria:

* concurrent malignancy, except non-melanoma skin cancer
* history of sarcoidosis
* history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation
* history of hypercalcemia
* treatment with lithium medication

Primary outcomes:
measure: Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.
timeFrame: 48 weeks
Secondary outcomes:
measure: Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily.
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: MUSC Department of Radiation Oncology
name: Sebastiano Gattoni-Celli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garrett-Mayer E, Wagner CL, Hollis BW, Kindy MS, Gattoni-Celli S. Vitamin D3 supplementation (4000 IU/d for 1 y) eliminates differences in circulating 25-hydroxyvitamin D between African American and white men. Am J Clin Nutr. 2012 Aug;96(2):332-6. doi: 10.3945/ajcn.112.034256. Epub 2012 Jul 3.
Clinical trial NCT01614509: Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Branch Retinal Vein Occlusion
Keywords: branch retinal vein occlusion
bevacizumab
triamcinolone acetonide
Lead sponsor: Yeungnam University College of Medicine
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the treatment of macular edema associated with branch retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

1. The participant must have macular edema associated branch retinal vein occlusion.
2. The participant has retinal photographs, optical coherence tomography (OCT) and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice.
3. The participant must be willing and able to comply with the protocol.

Exclusion Criteria:

1. The participant has BRVO with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc.
2. The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
3. The participant has a history of treatment for BRVO in the study eye with focal laser photocoagulation, intravitreal triamcinolone acetonide injection or intravitreal Bevacizumab injection
4. The participant has a history of intraocular surgery (including lens replacement surgery).
5. The participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).

Primary outcomes:
measure: Changes of Central Retinal Thickness
timeFrame: baseline, 1, 3, 6 months after injection
Secondary outcomes:
measure: Additional Intravitreal Bevacizumab Injection
timeFrame: 6 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University College of Medicine
Study officials:
References:
Clinical trial NCT06102109: Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
Official title: Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lens Luxation
IOL Subluxation
IOL Opacification
Aphakia - No Lens Capsule
Keywords: Scleral fixated IOL
Yamane
4 flanged technique
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral IOL fixation techniques: Yamane technique versus the 4-flanged technique.

The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.


Eligibility criteria: Inclusion Criteria:

* - Necessity for IOL (re)fixation in the absence of capsular support
* willing to give informed consent and follow-up the duration of study

Exclusion Criteria:

* Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia
* active inflammatory diseases of the eye

Primary outcomes:
measure: IOL tilt
timeFrame: 3 years
measure: IOL decentration
timeFrame: 3 years
Secondary outcomes:
measure: Best corrected visual outcome
timeFrame: 12 weeks
measure: Flange erosion and intrusion
timeFrame: 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01500109: Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
Official title: Analgesic Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair; a Randomized, Double, Blinded, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Keywords: cleft palate surgery
post-operative pain management
Acetaminophen
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.


Eligibility criteria: Inclusion Criteria:

* Children 5 months to five years of age
* ASA physical status I or II
* primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?

Exclusion Criteria:

* Repeat/revision cleft palate repair
* Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)
* Chronic pain medications
* Diagnosis of chronic pain syndrome
* Contraindications to morphine (renal impairment, allergy)
* Seizure disorders and/or taking anti-seizure medications
* Contraindications to oral midazolam (liver dysfunction, allergy)
* Allergy to local anesthetics

Primary outcomes:
measure: Opioid (Fentanyl and Morphine) Consumption
timeFrame: intraoperative period and first postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Chelan Nour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06672809: Effects of Core Stability Training on the Function and Control of Deep Stabilizing Muscles
Official title: Effects of Core Stability Training on the Function and Control of Deep Stabilizing Muscles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Core Stability
Keywords: Core Stability
Deep Stabilizing Muscles
Muscle Activation
Rehabilitation
Lead sponsor: Kyungdong University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of core stability training on the functionality and control of deep stabilizing muscles in healthy adults. Core stability exercises focus on strengthening the transversus abdominis and related core muscles to prevent and manage low back pain. Participants are randomly assigned to either the experimental group, performing core stability exercises on unstable surfaces such as a reformer, or the control group, performing aerobic exercises. Outcomes are measured by changes in muscle thickness and contraction time using rehabilitative ultrasound imaging, aiming to demonstrate the potential of core stabilization for enhancing spine support and reducing lower back pain.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 29 years
* Healthy adults who can understand and complete the planned training program
* Individuals who have signed informed consent to participate in the study

Exclusion Criteria:

* Individuals with balance disorders due to orthopedic or neurological conditions
* Those with cardiopulmonary diseases
* Individuals who have undergone surgery within the past 6 months
* Persons with other physical disabilities that could interfere with the study
* Individuals who have participated in similar studies recently
* Pregnant individuals

Primary outcomes:
measure: Thickness of Deep Stabilizing Muscles
timeFrame: Baseline and 8 weeks after the intervention
measure: Contraction Time of Deep Stabilizing Muscles
timeFrame: Baseline and 8 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Department of Physical Therapy, Kyungdong University
state: Gangwon-do
Study officials:
References:
Clinical trial NCT05072509: Assessment of the Endovascular Aortic Aneurysm Repair's (EVAR) Main Body Lateral Movement Impact on the Rate of Reintervention After AAA's Treatment
Official title: Endoprothesis Long-term Behavior After Subrenal Abdominal Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abdominal Aortic Aneurysm
Keywords: aortic
endovascular
aneurysm
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Association Le Don du Souffle
First posted: 2021-10-11
Enrollment: 180
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 patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)

Brief summary: The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.


Eligibility criteria: Inclusion Criteria:

* Male or female \> 18 years old
* All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)

Exclusion Criteria:

* Patient in emergency situation (ruptured abdominal aortic aneurysm)
* Life expectancy supposed to be inferior to 1 year
* Legal incapacity or limited capacity
* Pregnant female
* Patient unlikely to cooperate with the study
* Patient without health insurance

Primary outcomes:
measure: Reintervention rate
timeFrame: through study completion, an average of 5 years
measure: Lateral movement of the EVAR
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: EVAR's movements: other than lateral.
timeFrame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
measure: Moving
timeFrame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
measure: Compliance
timeFrame: 1 month post-op, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years.
Other outcomes:
Locations:
city: Besançon
country: France
facility: Vascular Surgery Department
Study officials:
References:
Clinical trial NCT05275309: Determination of Optimal Positive End-expiratory Pressure Using Electrical Impedance Tomography in Children Under General Anesthesia: Comparison Between Supine and Prone Positions
Official title: Determination of Optimal Positive End-expiratory Pressure Using Electrical Impedance Tomography in Children Under General Anesthesia: Comparison Between Supine and Prone Positions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 33
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to determine the appropriate positive end-expiratory pressure (PEEP) using electrical impedance tomography (EIT) in children under general anesthesia and to investigate whether there is a difference between the supine and prone positions.


Eligibility criteria: Inclusion Criteria:

* Children \<= years of age who are scheduled for surgery in the prone position under general anesthesia

Exclusion Criteria:

* Respiratory distress, bronchopulmonary dysplasia
* Pneumothorax
* Increased intracranial pressure
* History of airway surgery
* Cervical or thoracic surgery
* Pulmonary hypertension

Primary outcomes:
measure: Optimal PEEP level at spine position
timeFrame: 10 minutes after intubation (supine)
measure: Optimal PEEP level at prone position
timeFrame: 1 hour after prone positioning (prone)
Secondary outcomes:
measure: Dynamic compliance measured using Electrical impedance tomography
timeFrame: until 1 hour after prone positioning
measure: regional ventilation delay measured using Electrical impedance tomography
timeFrame: until 1 hour after prone positioning
measure: pulmonary opening pressure measured using Electrical impedance tomography
timeFrame: until 1 hour after prone positioning
measure: atelectasis/overdistension ratio measured using Electrical impedance tomography
timeFrame: until 1 hour after prone positioning
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04702607: Functional Lung Imaging With DECT and 4DCT
Official title: Pilot Study to Assess Lung Function Using Perfusion Blood Volume Dual Energy CT and 4DCT Derived Lung Ventilation Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 40
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: * Patients have histologic diagnosis of non-small cell lung cancer
* Patients have AJCC stage II, III or IV disease were the plan is to receive definitive concurrent chemoradiation to 60 Gy or higher
* Age \> 18 years of age

Brief summary: The basic premise of this pilot study is to enroll 40 patients over 3 years who have Stage II, III, or IV non-small cell lung cancer and are planned for definitive treatment with concurrent chemoradiation where a contrast enhanced 4DCT is planned.


Eligibility criteria: Inclusion criteria:

* Patients have histologic diagnosis of non-small cell lung cancer
* Patients have AJCC stage II, III or IV disease were the plan is to receive definitive concurrent chemoradiation to 60 Gy or higher
* Age \> 18 years of age
* Patients are able to provide informed consent
* No additional lung radiation is planned until after the 2nd CT on this study (i.e. patient does not have a solitary pulmonary nodule or second primary that the plan is to undergo SBRT)
* Patient must have adequate kidney function to receive IV contrast (following institutional policy supplied by radiology). The cutoff level for serum creatinine is 1.6 mg/dL
* Negative urine pregnancy test before every CT scan

Exclusion criteria:

* Allergy to IV iodine contrast
* Severe claustrophobia
* Further thoracic radiation therapy is planned.

Primary outcomes:
measure: evaluate the reproducibility of PBV DECT imaging and 4DCT derived lung ventilation for evaluating lung function
timeFrame: 3 years
measure: correlate changes of PBV DECT and 4DCT lung function images seen at ~6 months with radiation dose and with patient reported outcome quality of life
timeFrame: 3 years
Secondary outcomes:
measure: • To propose a novel biologic (i.e. functional) dose volume algorithm to reduce PBV and 4DCT lung function changes
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abamson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Steven Feigenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01357707: Clinical-genetic Investigations in Children With Early Infantile Epilepsies
Official title: Clinical-genetic Investigations in Children With Early Infantile Epilepsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Seizures, Infantile
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Mainz University
name: University of Ulm
name: Ludwig-Maximilians - University of Munich
name: University of Kiel
First posted: 2011-05-23
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with infantile seizures without brain malformations, metabolic disorders of lissencephaly who had a good outcome and are seizure free (with or without AEDs) after the age of 5 years.

Brief summary: The project strives to discover novel genetic defects that cause monogenic epilepsy or that genetically modify a preexisting epileptic phenotype. Our main aim is to find genetic causes for the idiopathic West Syndrome (infantile seizures) that are not caused by known cerebral malformation, lissencephaly or metabolic disorders and which have a comparatively benign prognosis.

The investigators hypothesize that mutations in genes coding for ion channels or genes that modify the action of ion channels might be causative.

For that the investigators will perform a sequence analysis of the coding exons of a large set of genes in all recruited patients and verify found mutations in their parents.


Eligibility criteria: Inclusion Criteria:

* Hypsarrhythmia in the first year of life
* Infantile seizures in the first year of life
* Freedom of seizures at the age of 5 years

Exclusion Criteria:

* brain malformation
* metabolic disorder
* intracranial hemorrhage
* lissencephaly

Primary outcomes:
measure: Discovery of a pathogenic mutation in an ion channel gene
timeFrame: 4 weeks after taking of the DNA specimen
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin
Study officials:
References: