louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02017834: Does the Harmonic Scalpel Reduce Blood Loss and OR Time in Major Head and Neck Cancer Surgery Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma?
Official title: Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cavity Squamous Cell Carcinoma, Treated With Surgery
Keywords: oral cavity squamous cell carcinoma
head and neck cancer
oral cancer
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 36
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 harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* oral cavity scc
* primary surgery including either uni or bilateral neck dissection (levels I-IV)

Exclusion Criteria:

* previous treatment for head and neck cancer
* unable or unwilling to give informed consent
* history of bleeding disorder
* other contraindications to surgery

Primary outcomes:
measure: blood loss
timeFrame: intraoperative
Secondary outcomes:
measure: operating time
timeFrame: intraoperative
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Joseph Dort, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fritz DK, Matthews TW, Chandarana SP, Nakoneshny SC, Dort JC. Harmonic scalpel impact on blood loss and operating time in major head and neck surgery: a randomized clinical trial. J Otolaryngol Head Neck Surg. 2016 Nov 8;45(1):58. doi: 10.1186/s40463-016-0173-z.
Clinical trial NCT01319734: Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus
Official title: Phase 1 Study of Randomized Clinical Trial Comparing Vitamin C Supplementation Plus Oral Hypoglycemic Drugs Versus Hypoglycemic Drugs Alone on Serum Selenium, Zinc, Copper and Malondialdehyde Levels in Type 2 Diabetes Mellitus and Its Microvascular Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Vitamin C
Oxidative stress
Type 2DM
Lead sponsor: Al-Neelain University
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Null hypothesis:

No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM).

Alternative hypothesis:

There is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of type 2DM
* patients in good health
* receiving oral hypoglycemic drugs

Exclusion Criteria:

* Insulin dependent diabetes
* receiving vitamin complex
* smoking
* renal disease
* liver disease

Primary outcomes:
measure: improving the renal function
timeFrame: the renal function will be measure at day 1 and after one month
Secondary outcomes:
measure: Vitamin C can improve the visual fields
timeFrame: the visual field will be assesed at day 1 and after one month
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Jaber abo aliz
Study officials:
affiliation: Al-Neelain University
name: Hamdan Z Hamdan, MBBS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06999434: Exploring the Utility of [18F]3F4AP for Demyelination Imaging
Official title: Exploring the Utility of [18F]3F4AP for Demyelination Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Demyelinating Disorders
MCI
Alzheimer's Disease (AD)
MS (Multiple Sclerosis)
SCI - Spinal Cord Injury
Spinal Radiculopathy
Keywords: 3F4AP
Demyelinating Disorders
MS
SCI
AD
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: National Institute on Aging (NIA)
First posted: 2025-05-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).


Eligibility criteria: Inclusion:

1. Male and Female subjects must be ≥18 and \<90 years of age;
2. Able to understand and provide informed consent prior to study procedures
3. Must be in good health

Exclusion:

1. Less than 18 years of age;
2. Pregnant or breastfeeding;
3. Any significant systemic illness or unstable medical condition;
4. Pre-existing medical conditions or claustrophobic reactions;
5. Research-related radiation exposure exceeds current PET Center guidelines (i.e. 50 mSv in the prior 12 months);
6. History of a bleeding disorder or are currently taking anticoagulants.

Primary outcomes:
measure: Tracers volume of distribution (VT)
timeFrame: 5 years
measure: Distribution volume ratio (DVR)
timeFrame: 5 years
measure: Binding potential (BPND)
timeFrame: 5 years
measure: Demyelination
timeFrame: 5 years
measure: Tau burden
timeFrame: 5 years
measure: Amyloid burden
timeFrame: 5 years
measure: Tracer rate constant
timeFrame: 5 years
measure: Associations between imaging modalities and biomarkers.
timeFrame: 5 years
Secondary outcomes:
measure: Measure of brain atrophy
timeFrame: 5 years
measure: Measure of cerebrovascular burden
timeFrame: 5 years
measure: Measure of White matter lesions (WML)
timeFrame: 5 years
measure: MR/MRSI images
timeFrame: 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University PET Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Georges El Fakhri, PhD, DABR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278834: NMES and Pelvic Fracture Rehabilitation
Official title: The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Rehabilitation
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Treatment and intervention group
Primary purpose: TREATMENT

Brief summary: Objectives: The acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. Patients have long periods of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has proven to minimise muscle loss. However, this has not previously been investigated within this patient population.

Design: Double blind, randomised, feasibility study.

Setting: NHS trust hospital setting.

Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at six weeks post fracture.

Interventions: The intervention group completed six weeks of NMES. The placebo group used transcutaneous electrical nerve stimulation (TENS).

Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using the non-operated limb as a baseline. Compliance and intensity levels were recorded. Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six and 12 weeks using a visual analogue scale (VAS).


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were any patient with a pelvic fracture that was surgically fixed with no associated injuries and able to give written informed consent.
* Pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (ORIF) were considered.

Exclusion Criteria:

* Exclusion criteria were patients who could not comply with the NMES or who had previous mental health diagnosis.
* Patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.

Primary outcomes:
measure: Muscle Strength
timeFrame: 12 weeks post operation
Secondary outcomes:
measure: Feasibility questionnaire
timeFrame: 12 weeks post operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03433534: Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
Official title: Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Lung Cancer
Keywords: nivolumab
monoclonal antibody
Opdivo
antineoplastic agent
ELISA
pharmacokinetic
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 64
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 treated with nivolumab at CHRU of Tours for squamous or non squamous non small cell lung cancer stage IV or renal cell carcinoma stage IV

Brief summary: To assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration.

Collection of standard data prospectively.

Detailed description: Nivolumab is a monoclonal antibody used for the treatment of non small cell lung carcinoma and renal cell carcinoma. Huge variability exists between patients treated by nivolumab in terms of efficacy and side effects. Like others monoclonal antibodies, a relation between concentration and effects of nivolumab may exist.

The aim of this study is to assess the relationship between blood concentration of nivolumab and progression free survival, overall survival and side effects on the one hand, and on the other to describe pharmacokinetic of nivolumab

Eligibility criteria: Inclusion Criteria:

* Patient with squamous or non squamous non small cell lung cancer stage IV or patient with renal cell carcinoma stage IV
* Patient receiving nivolumab or who will receive nivolumab
* Age ⩾ 18 years old
* OMS stage ≤ 2
* Evaluable disease

Exclusion Criteria:

* Active brain metastasis not treated before by surgery or radiotherapy
* Autoimmune disease
* Patient having objected to the processing of his data

Primary outcomes:
measure: Progression free survival
timeFrame: Up to one year
Secondary outcomes:
measure: Overall survival
timeFrame: Up to one year
measure: Target concentration
timeFrame: 14 days
measure: Side effects
timeFrame: 14 days
measure: Nivolumab PK parameters : distribution volume
timeFrame: Baseline up to one year
measure: Nivolumab PK parameters : clearance
timeFrame: Baseline up to one year
Other outcomes:
Locations:
city: Tours
country: France
facility: Medical oncology department, University Hospital, Tours
city: Tours
country: France
facility: Pneumology department, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Claude Linassier
role: STUDY_DIRECTOR
References:
Clinical trial NCT00379834: 12-Month Stability of Diurnal IOP Control on Cosopt
Official title: 12-Month Stability of Diurnal IOP Control on Cosopt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: glaucoma
diurnal
intraocular pressure
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2006-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Detailed description: Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.

Eligibility criteria: Inclusion Criteria:

* bilateral open-angle glaucoma

Exclusion Criteria:

* contraindications to Cosopt
* pathology affecting tonometry

Primary outcomes:
measure: Diurnal Intraocular Pressure Control
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West Virginia University
name: Anthony D Realini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490334: Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer
Official title: Assessment and Rehabilitation of Cognitive Impairments in Pediatric Survivors of Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Carcinomas
Squamous Cel
Adenocarcinoma
Acute Lymphocytic Leukemia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2007-06-22
Enrollment: 72
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric cancer patients 8 to 16 years of age, with age- and gender-matched control group.

Brief summary: This research involves assessment of cognitive outcome in childhood cancer as well as evaluation of a cognitive rehabilitation program for improving learning and problem solving difficulties in children with cancer.

Detailed description: The purpose of this study is to help determine specific cognitive-behavioral and neurobiologic impairments associated with chemotherapy treatments in children with cancer and to assess the efficacy of a cognitive intervention program for improving cognitive impairments in these children.

Eligibility criteria: INCLUSION

Everyone:

* At least 9 years of age and less than 17 years

Patients

* Diagnosis of brain tumor or acute lymphocytic leukemia (ALL)
* Completed all anti-cancer treatment(s) including chemotherapy, radiation and/or surgery

Control group

* Typical for age

EXCLUSION

Everyone:

* Non-English speaking (translated cognitive testing and MRI assessments unavailable)
* MRI contraindication, including but not limited to orthodontia, metal implants, and/or pacemaker
* Major sensory deficit disorders, including but not limited to blindness or deafness

Patients

* Shunt placement
* Received bone marrow transplant
* History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes) NOT related to cancer
* Participation in any concurrent cognitive rehabilitation study

Control group

* History of neurologic, psychiatric, developmental or major medical condition (eg, diabetes)

Primary outcomes:
measure: Performance on neuropsychological testing and brain activation patterns measured by functional MRI
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Shelli Kesler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616234: Exercise-induced Changes in Exosomes
Official title: Exercise-induced Changes in Exosomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exosomes
Connective Tissue
Exercise
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study aims to shed light on the function/importance/relevance of exercise-induced changes in exosomes to connective tissues. Exosomes are known to increase robustly in response to exercise. We have previously shown that serum isolated from subjects after they lift heavy weights increases human engineered ligament collagen content and mechanics more than serum from before they lift weight. Further, we showed that exercise-induced changes in hormones could not explain the change in ligament structure or function. These data indicate that there is a significant gap in our understanding of muscle-connective tissue crosstalk. To address this gap, the current proposal seeks to: i) isolate and sequence exosomal RNA (long non-coding, miR, and mRNA) and ii) determine whether exosomes isolated from serum after exercise increase engineered ligament mechanics and collagen content.


Eligibility criteria: Inclusion Criteria:

* Young healthy adults (18-35 y)
* Experience with exercise (\>1y)

Exclusion Criteria:

* Pregnancy
* Smoking
* Receiving any medication that may interfere with the study outcomes

Primary outcomes:
measure: Collagen content of ligament constructs
timeFrame: 15 min post-exercise
Secondary outcomes:
measure: Ultimate tensile stress and modulus of ligament constructs
timeFrame: 15 min post-exercise
measure: Exosomal RNA
timeFrame: 15 min post-exercise
Other outcomes:
Locations:
city: Davis
country: United States
facility: Hickey Laboratory
state: California
Study officials:
affiliation: University of California, Davis
name: Keith Baar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04391634: Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
Official title: Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Respiratory Failure
Premature Birth
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 25
Sex: ALL
Minimum age (years): 24
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective crossover study
Primary purpose: TREATMENT

Brief summary: The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.

Detailed description: Prospective, cross-over trial enrolling neonates \<28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters).

Eligibility criteria: Inclusion Criteria:

* premature infants born \<28 weeks of gestation
* respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
* stable condition with pH (acidity of blood)\> 7.2 and pCO2 (carbon dioxide partial pressure) \<60 mmHg in the blood gas analysis
* no identified genetic syndromes and serious congenital malformations

Exclusion Criteria:

* lack of written consent of patients' parents

Primary outcomes:
measure: StO2
timeFrame: 6 hours
measure: Stroke volume
timeFrame: 6 hours
measure: Cardiac output
timeFrame: 6 hours
measure: Stroke index
timeFrame: 6 hours
measure: Cardiac index
timeFrame: 6 hours
measure: Stroke volume variation (SVV)
timeFrame: 6 hours
measure: Index of contractility
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Neonatology at Poznań University of Medical Sciences
Study officials:
affiliation: Poznan University of Medical Sciences
name: Tomasz Szczapa, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04755634: Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
Official title: Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Micropenis
Lead sponsor: Shafer Clinic Fifth Avenue
Sponsor class: NETWORK
First posted: 2021-02-16
Enrollment: 20
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.


Eligibility criteria: Inclusion Criteria:

* Healthy males,
* 21 to 65 years of age,
* Seeking enhancement of their penile width and girth.

Exclusion Criteria:

* Patient with a history of psychological or psychiatric illness,
* Congenital or acquired penile malformation,
* Previous plastic surgery or non-invasive treatments of their penis,
* Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy.
* Patients with a history of allergic reactions to hyaluronic acid derivatives
* Individuals with penises measured less than 6 cm in length in the flaccid position
* Individuals with penises greater than 12.5 cm in length in the flaccid position.
* Individuals with uncircumcised penises

Primary outcomes:
measure: Increase in penile width and girth
timeFrame: 1 year
Secondary outcomes:
measure: Duration of increase in penile width and girth
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Shafer Clinic Fifth Avenue
state: New York
Study officials:
affiliation: Shafer Clinic Fifth Avenue
name: David Shafer, MD
role: PRINCIPAL_INVESTIGATOR
References: