louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06504667: To Validate Point Mini User Needs
Official title: To Validate Point Mini User Needs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation; Traumatic, Hand
Amputation, Congenital
Lead sponsor: Point Designs
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Denver
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-07-17
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.


Eligibility criteria: Inclusion Criteria:

* Partial hand loss with at least index and/or middle fingers loss at the MCP level
* Intact thumb with full range of motion
* Fluent in English
* Between the ages of 5 and 15 years

Exclusion Criteria:

* Patients with a residual limb that is unhealed from the amputation surgery
* Unhealed wounds
* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
* Serious uncontrolled medical problems as judged by the project therapist

Primary outcomes:
measure: VAL-1
timeFrame: Day 1 (8 hours)
measure: VAL-2
timeFrame: Day 1 (10 minutes)
measure: VAL-3.1
timeFrame: Day 1 (10 minutes)
measure: VAL-3.2
timeFrame: Day 1 (10 minutes)
measure: VAL-4
timeFrame: Day 1 (10 minutes)
measure: VAL-5
timeFrame: Day 1 (10 minutes)
measure: VAL-6
timeFrame: Day 1 (10 minutes)
measure: VAL-7
timeFrame: Day 1 (10 minutes)
measure: VAL-8
timeFrame: Day 1 (10 minutes)
measure: VAL-9
timeFrame: Day 1 (8 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver | Anschutz Medical Campus
state: Colorado
city: Lafayette
country: United States
facility: Point Designs
state: Colorado
Study officials:
affiliation: CEO, Point Designs
name: Levin Sliker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05389267: Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
Official title: Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study purpose is to evaluate the safety of T4090.


Eligibility criteria: Inclusion Criteria:

* Informed consent dated and signed.
* Both eyes diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* History of trauma, infection, clinically significant inflammation within the previous 6 months
* Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
* Pregnancy or breast-feeding

Primary outcomes:
measure: Ocular and systemic adverse events
timeFrame: up to 22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Dr EL-HARAZI
state: California
Study officials:
References:
Clinical trial NCT03081767: Standard PET/CT vs. Digital PET/CT
Official title: Comparison of Standard PET/CT vs. Digital PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: PET/CT
digital PET/CT
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 199
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: The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.

Detailed description: There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.

Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the scan
* Patient provides written informed consent
* Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)

Exclusion Criteria:

* Patient is pregnant or nursing

Primary outcomes:
measure: Diagnostic Image Quality
timeFrame: an expected average of 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrei Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan H, Baratto L, Hatami N, Liang T, Mari Aparici C, Davidzon GA, Iagaru A. 68Ga-PSMA11 PET/CT for biochemically recurrent prostate cancer: Influence of dual-time and PMT- vs SiPM-based detectors. Transl Oncol. 2022 Jan;15(1):101293. doi: 10.1016/j.tranon.2021.101293. Epub 2021 Nov 22.
citation: Baratto L, Toriihara A, Hatami N, Aparici CM, Davidzon G, Levin CS, Iagaru A. Results of a Prospective Trial to Compare 68Ga-DOTA-TATE with SiPM-Based PET/CT vs. Conventional PET/CT in Patients with Neuroendocrine Tumors. Diagnostics (Basel). 2021 May 30;11(6):992. doi: 10.3390/diagnostics11060992.
Clinical trial NCT01447667: Magnetic Resonance Elastography (MRE) as a Predictor of HCC Recurrence After Radiofrequency Ablation (RFA)
Official title: Magnetic Resonance Elastography Score Reflecting Hepatic Fibrosis as an Independent Predictor for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Fibrosis
Hepatocellular Carcinoma
Keywords: Hepatic fibrosis
Magnetic resonance elastography
Hepatocellular carcinoma
Recurrence
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine:

* The efficacy of MRE score as a predictor of HCC recurrence within 2 years after RFA treatment
* The efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis

Detailed description: To evaluate whether MRE score reflecting hepatic fibrosis can predict the recurrence of HCC within 2 years after RFA treatment

* Local recurrence/intrahepatic distant recurrence
* Multivariable analysis including several related factors to find whether MRE score is an independent predictor of HCC recurrence even after adjusting other factors (etiology of liver disease, size of HCC, vessel invasion, HBsAg titer, etc.)

To find the efficacy of each indicator (MRE score, non-invasive serum markers) compared to the gold-standard histology score predicting hepatic fibrosis.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as single hypervascular hepatocellular carcinoma initially
* AJCC stage I HCC
* Child-Pugh class A
* Planning radiofrequency ablation for HCC
* Voluntary agreement for this study

Exclusion Criteria:

* Decreased kidney function (GFR \< 70 mL/min/kg)
* Contraindication to MRI (pacemaker, defibrillator)
* Contrast media hypersensitivity
* Other primary malignancy
* Acute viral hepatitis
* Prior history of liver transplantation
* Thrombosis in splenic vein or portal vein
* Patients who were enrolled to other clinical trials within 4 weeks
* Other severe chronic disease or psychiatric disease
* Pregnant or milk-feeding women
* Patients with coagulopathy, high risk of bleeding for the liver biopsy
* Patients who disagree to participate in this study

Primary outcomes:
measure: Number of patients who experienced HCC recurrence after RFA
timeFrame: within 2 years after RFA procedure
Secondary outcomes:
measure: Sensitivity and specificity of each indicator of hepatic fibrosis compared to the gold-standard histology score
timeFrame: 2 years after RFA
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung-Hwan Yoon, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01318967: Measurement of Kidney Blood Flow and Oxygen Levels by MRI
Official title: MRI for the Non-invasive Determination of Renal Blood Flow and Renal Oxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Renal blood flow
Regional renal blood flow
MRI
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of renal blood flow measurements by PAH clearance and MRI

Detailed description: The traditional measurement of renal blood flow in ml/min involves the collection of multiple blood and urine samples after an infusion of a drug called para-aminohippurate (PAH) is given. In this study, the investigators determine the ability of MRI to estimate renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as estimated by MRI. The measurements by PAH clearance and MRI are both performed on the same day.

Eligibility criteria: Inclusion Criteria:

In this study, the investigators will enroll 16 men and women aged ≥ 18 years with Stage II - V chronic kidney disease (CKD). In addition, the investigators will enroll 4 subjects with a glomerular filtration rate (GFR) of greater than 60 ml/min who do not have any evidence of CKD.

Exclusion Criteria:

This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.

Primary outcomes:
measure: Measurement of Renal Blood Flow of the Kidney by the PAH Method
timeFrame: Renal blood flow is estimated over 1 hour by PAH
Secondary outcomes:
measure: Measurement of Regional Blood Oxygenation by MRI
timeFrame: One measure after furosemide (day 1)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Rocco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104167: Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Official title: An Open-Label Clinical Study of the Safety and Efficacy of the ROI-C Anterior Cervical Interbody Fusion Device Using the VerteBRIDGE Plating System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Keywords: DDD
degenerative disc disease
cervical spine
fusion rate
Lead sponsor: LDR Spine USA
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be drawn from community surgeon practices in which the subjects have already received the device and who meet the Inclusion/Exclusion criteria

Brief summary: The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.


Eligibility criteria: Inclusion Criteria:

* Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T1.
* The subject can have the ROI-C device at only one level.
* Autograft must have been used with the ROI-C device.
* Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery.
* Subject must be at least 21 years of age at the time of surgery

Exclusion Criteria:

* No BMP was used in the interbody cage
* Subject was a prisoner at the time of surgery
* Subject was pregnant at the time of surgery
* Subject had an active infection or sepsis at the time of surgery

Primary outcomes:
measure: Percentage of Participants With Fusion
timeFrame: 12 months or more after device implantation; mean follow up 20.7 months
Secondary outcomes:
measure: Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain
timeFrame: 12 months (Last available visit) post surgery
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange County Neurological Associates
state: California
city: Munster
country: United States
facility: Orthpedic Specialists of Northwest Indiana
state: Indiana
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: New England Orthopedic Surgeons
state: Massachusetts
city: Greenville
country: United States
facility: St Francis Hospital
state: South Carolina
city: Tacoma
country: United States
facility: Franciscan Neurosurgery Associates
state: Washington
Study officials:
affiliation: Orange County Neurosurgical Associates
name: Robert J Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00883467: The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
Official title: The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia
Keywords: Ischemic Preconditioning
functional MRI
BOLD
Reperfusion
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal is acquired from calf muscles.

A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different MR measurement methods (BOLD imaging and high energy phosphates) are planned.


Eligibility criteria: Inclusion Criteria:

* Men aged between 18 and 45 years
* Nonsmoker for more than 3 months
* Body mass index between 18 and 25 kg/m2
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
* Treatment in the previous 3 weeks with any drug including over-the-counter drugs
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Blood donation during the previous 3 weeks
* Any metallic, electric, electronic or magnetic device or object not removable
* Claustrophobia

Primary outcomes:
measure: Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
timeFrame: during and 30 min after ischemia
measure: Main outcome variables: Change in cellular oxygen saturation for BOLD MRI
timeFrame: during and 30 minutes after ischemia
measure: Serum markers of myocellular injury (myoglobin, creatine-kinase)
timeFrame: prior to, directly and 24 hours after ischemia
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
affiliation: MUV, Department of Clinical Pharmacology
name: Michael Wolzt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreas M, Schmid AI, Keilani M, Doberer D, Bartko J, Crevenna R, Moser E, Wolzt M. Effect of ischemic preconditioning in skeletal muscle measured by functional magnetic resonance imaging and spectroscopy: a randomized crossover trial. J Cardiovasc Magn Reson. 2011 Jun 30;13(1):32. doi: 10.1186/1532-429X-13-32.
Clinical trial NCT01474967: Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
Official title: Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
lipid profile
metformin
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this study was to assess the effects of metformin on menstrual disorders and lipid profile in women with PCOS in bandarabbas.

Detailed description: Poly cystic ovarian syndrome (PCOS) is a common hormonal disorder in women that affecting of 6.6-6.8% of women o f reproductive age. PCOS associated with a broad range of clinical, hormonal and metabolic disorders consist of hirsutism, Obesity, Acne and elevated male hormones, anovulatory cycles, dyslipidemia and infertility.

Metformin is an oral hyperglycemic agent witch by decrease insulin resistance and improving serum glucose level in diabetic patients and anovulatory cyle in women with PCOS. The goal of this study is to evaluate the efficacy of different dosage of metformin on menstruation and lipid profile in women with PCOS in banda-abbas.

Eligibility criteria: Inclusion Criteria:

* Women with PCOS

Exclusion Criteria:

* avoiding to participate in the study

Primary outcomes:
measure: Lipid profile
timeFrame: 6 month
Secondary outcomes:
measure: Hormone levels
timeFrame: 6 month
Other outcomes:
Locations:
city: Bandarabbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences (HUMS)
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences (HUMS)
name: Nazanin Abdi, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02396667: Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies : A Pilot Study
Official title: Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Macrosomia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 37 and 42 weeks with macrosomic fetuses.

Brief summary: 5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight.


Eligibility criteria: Inclusion Criteria:

* 37 to 42 weeks gestation
* macrosomic fetuses
* maternal diabetes

Exclusion Criteria:

* intrauterine fetal death
* multiple pregnancy
* congenital anomaly
* nonvisualized fetal parts

Primary outcomes:
measure: Accuracy of 5D ultrasound in predicting actual birth weight in comparison to 2D ultrasound. (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
timeFrame: 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References: