louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05794854: Spot Reduction in Male Adults
Official title: The Assessment of Spot Reduction in Adults Males Following Endurance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: endurance exercise
subcutaneous tissue utilization
Lead sponsor: Molde University College
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2023-04-03
Enrollment: 16
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Spot reduction, referring to local body fat reduction, pertains to subcutaneous adipose tissue utilization from specific body parts during exercise. Its existence has been keenly debated, although generally accepted not to occur during exercise. However, it is based on not only equivocal data - commonly the training protocol typically applied is based on strength rather than endurance training. The investigators sought to test this assumption by utilizing endurance based exercise controlling for energy expenditure and using dual x-ray absorptiometric measures to assess body composition before and after training.


Eligibility criteria: Inclusion Criteria:

* males
* ≥ 30 years old
* classified as overweight (Body mass index ≥ 25 kg ∙ m-2)
* not participating in regular physical training

Exclusion Criteria:

* \< 30 years old
* Body mass index \< 25 kg ∙ m-2
* participating in regular physical training

Primary outcomes:
measure: Trunk fat mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
Secondary outcomes:
measure: Lower extremity fat mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Upper extremity fat mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Total fat mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Body weight change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Body mass index change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Waist circumference (cm) change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Hip circumference (cm) change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
Other outcomes:
measure: Trunk lean mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Lower extremity lean mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Upper extremity lean mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Total lean mass change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Maximal oxygen uptake change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
measure: Maximal muscle strength change
timeFrame: Change from pre (baseline) to post test (after 10 weeks)
Locations:
Study officials:
References:
Clinical trial NCT04419454: Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite
Official title: Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cellulite
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sample size will be a result of available charts from a 16-month retrospective review January 2018 - May 2019. The sample will not include any vulnerable populations (pregnant women, minors, or prisoners)

Brief summary: Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Detailed description: The purpose of this preliminary report is to retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18years of age at the time of procedure

  * patients with localized lipodystrophy in the medial or lateral thigh, and visible cellulite of laxity in the lower extremity or buttocks
  * BodyTite treatments performed from January 2018 - May 2019 for Cellulite indication

Exclusion Criteria:

* active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scaring. o BodyTite treatments performed from March 2018 - May 2019 for lipodystrophy and cellulite of laxity

Primary outcomes:
measure: Photonumeric Cellulite Severity Score
timeFrame: [ Time Frame: Baseline to 6 months posttreatment]
Secondary outcomes:
Other outcomes:
Locations:
city: Germantown
country: United States
facility: Dr. Mark Peters
state: Tennessee
Study officials:
name: Mark Petrs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02212951: Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500
Official title: A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin R U-500 and Humalog Mix 75/25 in Subjects With Type 2 Diabetes Mellitus Who Are Treated With 50-200 Units of Insulin Per Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2014-08-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* BMI \> 25 kg/m2
* Type 2 Diabetes Mellitus
* HbA1c \< 10.0%
* Subject uses 50-200 units of insulin/day

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* History of bariatric surgery
* Corticosteroid therapy
* Significant cardiovascular or other major organ disease
* Females who are breast feeding or pregnant
* A sexually active person not using adequate contraceptive methods

Primary outcomes:
measure: Post-standardized meal glucose exposure (AUC)
timeFrame: 0-120 minutes after meal
Secondary outcomes:
measure: Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
timeFrame: 0-720 minutes
measure: Insulin exposure (AUC)
timeFrame: Various time frames over 720 minutes
measure: Maximal insulin concentration
timeFrame: 0-720 minutes
measure: Post breakfast and post-lunch glucose exposure (AUC)
timeFrame: Various times frames over 720 minutes
measure: Post-breakfast and post-lunch maximal glucose concentrations
timeFrame: 0-720 minutes
measure: Injection site toleration (VAS and severity scales)
timeFrame: 30 minutes post injection
measure: Draize injection site erythema and edema scoring
timeFrame: 0-720 minutes
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research
state: California
Study officials:
References:
Clinical trial NCT02658851: Cold Plasma for the Reduction of Lymphoceles Following PLND
Official title: Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoceles Following Pelvic Lymph Node Dissection
Keywords: lymphocele
pelvic lymph node dissection
robotic assisted radical prostatectomy
PLND
RARP
prostatectomy
Patel
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
Collaborators: name: AdventHealth
First posted: 2016-01-20
Enrollment: 100
Sex: MALE
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: PREVENTION

Brief summary: This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.

Detailed description: Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.

Eligibility criteria: Inclusion Criteria:

1. Primary diagnosis of Prostate Cancer (ICD-10:C61)
2. Prostate Specific Antigen (PSA) level =/\> 10ng/mL
3. Gleason score =/\> 7
4. Planned Elective Robotic Assisted Radical Prostatectomy with planned pelvic lymph node dissection.
5. Willing and able to return to clinic for standard of care abdominal ultrasound within 12 weeks post operatively.
6. Able to provide informed consent

Exclusion Criteria:

Must answer no to all:

1. Patient is unwilling or unable to sign or understand informed consent
2. Patient resides outside of the United States
3. Performance of Lymph node dissection was aborted.

Primary outcomes:
measure: Number of Participants With Incidence of Lymphocele Formation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Hospital Global Robotics Institute
state: Florida
Study officials:
affiliation: Florida Hospital Global Robotics Institute
name: Vipul R Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03687151: Population-based Cancer Observatory
Official title: Population-based Cancer Observatory of the French Region Sud-Provence-Alpes-Côte d'Azur Recruiting Incident Cases of Cancer Since 2005
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-09-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with cancer

Brief summary: Cancer is the leading cause of death in Western countries. In France cancer control plans (National screening programmes) and recommendations for the management of cancer patients (multidisciplinary team meetings), have been implemented. Evaluating the effectiveness of these policies aiming for improved prevention and management is essential. However to conduct such an evaluation, a baseline reference requiring ongoing, reliable and complete data collection is necessary and can be used for epidemiological research.

There is no cancer registry in the French Region Sud-Provence-Alpes-Côte d'Azur. In view of this situation, the regional Health Agency appointed the public health department of the Nice Côte d'Azur University and the Centre for computerized pathology data collection (CRISAP-PACA) to develop a Cancer Observatory. Since 2005, the public health department collects data concerning invasive and in situ cancers from all the histopathology labs in the French Region Sud-Provence-Alpes-Côte d'Azur, gathered in the CRISAP-PACA, and transmits incidence cancer rates to the regional Health Agency. In 2007, a quality control procedure, comparing a random sample of data collected by the Cancer Observatory with pathology lab reports, confirmed the validity of the collected data with fewer than 3% in disagreement with the report's conclusions. In 2008, the estimated completeness of cancer records collected from histopathology laboratories was higher than 90% for new cases of breast and colorectal cancer within the age range concerned by the screening programme. Since 2012, public and private hospitals treating cancer patients as well as the regional cancer network ONCOPACA, coordinating multiple team meetings, have been contacted to transmit to the public health department cases of cancer without histological diagnosis. In addition, patients with cancer have been geolocated to study the influence of environmental exposures on the occurrence of cancers (patients living near of waste incinerator, highways).


Eligibility criteria: Inclusion Criteria:

* All subjects with a diagnosis of invasive or in situ cancer living in the French Region Sud-Provence-Alpes-Côte d'Azur.

Exclusion Criteria:

-

Primary outcomes:
measure: number of each cancer of the French Region Sud-Provence-Alpes-Côte d'Azur
timeFrame: 50 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT00626951: Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway
Official title: The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paralysis
Keywords: LMA Supreme
LMA ProSeal
Laryngeal mask airway
Ventilation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients

Detailed description: The LMA Supreme is a new extraglottic airway device which brings together features of both the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use - prevention of disease transmission). The new features are that the airway tube incorporates a drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been strengthened to prevent airway obstruction from infolding and epiglottic fins have been added to prevent airway obstruction from epiglottic downfolding. In the following randomized, crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed, anesthetized patients

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology physical status grade I-II
* Age 18-80 yr
* Elective gynecological surgery
* Supine position

Exclusion Criteria:

* Known or predicted difficult airway
* Body mass index \>35 kg m-2
* Risk of aspiration

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 5 min
Secondary outcomes:
measure: Ease of insertion
timeFrame: 1 min
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: Christian Keller, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544151: Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter
Official title: Swan-Ganz CCOmbo V for Obtaining an Optimal Depth of Right Internal Jugular Venous Catheter : A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insertion Depth of Central Venous Catheter
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac surgery were studied

Brief summary: The investigators will perform a study to create formula for the optimal insertion depth of right internal jugular vein catheter.

Detailed description: Patients scheduled for cardiac surgery were studied.Determine the optimal insertion depth of right internal jugular vein catheter using Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V).The investigators measure the distance between the insertion point and the junction between right atrium and superior vena cava using Swan-Ganz CCOmbo V.

Eligibility criteria: Inclusion Criteria:

* Adult patient over 18 years of age undergoing mitral valve or/and tricuspid valve
* Surgery under general anesthesia, requiring Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) insertion through the right internal jugular vein.

Exclusion Criteria:

* A change in the mediastinal structure from previous neck surgery,thoracic surgery or cardiac surgery
* Extracardiac vascular anomaly
* Anatomical abnormality in neck and thorax
* Refusal to enrol

Primary outcomes:
measure: The distance
timeFrame: After insertion of the Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V) and during operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Diansan Su
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
name: qi lu, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05286151: Network Connectivity and Temporal Processing in Adolescents Who Stutter
Official title: Subcortical Network Connectivity and Temporal Processing in Children with Persistent and Recovered Stuttering
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stuttering, Childhood
Stuttering
Keywords: Rhythm
Temporal processing
Healthy children
Speech disorders
Timing
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-03-18
Enrollment: 500
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The specific purpose of this clinical trial is to compare performance on rhythm perception and production tasks between children who stutter and children who do not stutter. The overall project also aims to investigate how performance on rhythm tasks may be related to brain activity (non-clinical trial).

Detailed description: Participants in the clinical trial portion of this study will complete rhythm discrimination and finger tapping experiments once a year for 3 years. The study team will compare performance between groups. Participants will also participate in the non-trial portion of the project that includes having magnetic resonance imaging (MRI) each year for 3 years.

Eligibility criteria: Inclusion Criteria Children who stutter:

* English as primary language
* Current or past stuttering diagnosis

Inclusion Criteria Children who do not stutter:

* English as primary language

Exclusion Criteria Children who stutter:

* Diagnosed/under treatment for any neurological or psychiatric conditions
* Head trauma with loss of consciousness
* Major medical illness
* Hearing loss- Language/motor delay (below -2 standard deviations on standardized assessments)
* Face, motor, or reflex abnormalities

Exclusion Criteria Children who do not stutter:

* Personal or family history of stuttering
* Diagnosed/under treatment for any neurological or psychiatric conditions
* Head trauma with loss of consciousness
* Major medical illness
* Hearing loss
* Language/motor delay (below -2 standard deviations on standardized assessments
* Face, motor, or reflex abnormalities

Primary outcomes:
measure: Rhythm discrimination (d')
timeFrame: Year 1
measure: Rhythm discrimination (d')
timeFrame: Year 2
measure: Rhythm discrimination (d')
timeFrame: Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Soo-Eun Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05442151: Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
Official title: Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Lead sponsor: Osaka University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PET / CT examination using \[18F\] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.

Detailed description: Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and \[68Ga\] FAPI-04 and \[18F\] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using \[18F\] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.

Eligibility criteria: Inclusion Criteria:

Patients who meet any of the following conditions.

1. Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
2. Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
3. Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor

Exclusion Criteria:

1. Pregnant women or patients who may be pregnant
2. Pediatric patients requiring sedation
3. Those who are judged to be inappropriate as subjects.

Primary outcomes:
measure: Comparison of the uptake on FAPI-PET with conventional imaging
timeFrame: Within 2 hours after administration of [F-18]FAPI-74 injection
measure: Comparison with pathological specimens
timeFrame: Within one month after FAPI-PET
measure: Time course of uptake on FAPI-PET
timeFrame: Approximately 6 months after initial FAPI-PET
Secondary outcomes:
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
References:
citation: Naka S, Watabe T, Lindner T, Cardinale J, Kurimoto K, Moore M, Tatsumi M, Mori Y, Shimosegawa E, Valla F Jr, Kato H, Giesel FL. One-pot and one-step automated radio-synthesis of [18F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z.