louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06675357: Using FAPI PET/MRI to Evaluate Prostate Cancer
Official title: Novel FAP-targeted Approach to Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer Metastatic Disease
Prostate Cancers
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 30
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 goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer.

Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Able and willing to provide informed consent
* Known diagnosis of prostate cancer with established or suspected non-osseous, non-nodal metastases
* Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET
* Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.
* Willing and able to undergo PET/MRI as part of this research

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Contraindication(s) to or inability to undergo PET/MRI
* Participants for whom PET/MRI will delay timely delivery of treatment
* Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
* Have their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of this medication
* Come to the research visit with a driver

Primary outcomes:
measure: Performance of FAPI for lesion detection
timeFrame: Duration of scan, up to 80 minutes
measure: Lesion FAPI uptake on PET
timeFrame: Duration of scan, up to 80 minutes
measure: Total FAPI-positive tumor volume change
timeFrame: Duration of scan, up to 80 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ali Pirasteh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05227157: GOUTMETALSAIN: Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers
Official title: Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Taste Disorders
Sensation Disorders
Taste, Metallic
Taste Disorder, Glossopharyngeal Nerve
Keywords: Taste, Metallic
Lead sponsor: Centre Hospitalier de Valence
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volonteers without olfactory and gustatory disorder

Brief summary: This is a mono center , observational study carried out within otorhinolaryngology department in CH Valence.

This is a descriptive and exploratory study in healthy volunteers. Based on the hypothesis that Metallic taste is imperfectly assessed, this study will provide a better understanding of the Metallic Taste.

Detailed description: The study consists of the application of a swab soaked in iron sulfate at a concentration of 10g/l.

each patient will rate the intensity he/she perceives (on a numerical scale from 1 to 5) at each of the 4 predefined lingual locations

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Healthy volunteers
* Read, write and understand the French language
* Patient affiliated to a social security system
* Written and signed informed consent

Exclusion Criteria:

* head and Neck cancer history
* olfactory and gustatory disorder
* Refusal to participate in research
* Patient under guardianship, deprived of liberty, safeguard of justice

Primary outcomes:
measure: evaluation of the intensity of metallic taste
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Valence
country: France
facility: Ch Valence
state: Drome
Study officials:
References:
Clinical trial NCT03963557: Cognitive Function and Body Mass Index in Children and Adolescents
Official title: Cognitive Function and Body Mass Index in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Childhood
Obesity, Adolescent
Cognitive Orientation
Lead sponsor: Imperial College London Diabetes Centre
Sponsor class: OTHER
Collaborators: name: Georgetown University
First posted: 2019-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Local population; children and adolescents

Brief summary: The child will complete computerized tasks and paper-pencil test, and will be presented with symbols, letters, or numbers on a computer screen and asked to respond by pressing a button on the computer. Before each task a researcher will explain the instructions of the task and assess if the child needs a break before completing the next task. While the child is completing computerized tasks, the parent/guardian will be asked to fill out paper-pencil questionnaires about the child and to sign a release of medical information form so that we can study how physical markers of health effect cognition.


Eligibility criteria: Inclusion Criteria:

* Local population (based on ethnicity)
* Healthy or overweight/obese

Exclusion Criteria:

* History of developmental delay or disorders
* History of any medical conditions ( that may impact the development)

Primary outcomes:
measure: Perceptual organization index- Matrix reasoning subtest
timeFrame: 10-15 minutes
measure: Perceptual organization index- Block design subtest
timeFrame: 15-20 minutes
measure: Processing speed index- Coding subtest
timeFrame: 2-3 minutes
measure: Working memory index- Digit span subtest
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
Study officials:
References:
Clinical trial NCT02564757: Does Pregnancy Increase Risk of Ventral Hernia Recurrence?
Official title: Does Pregnancy Increase Risk of Ventral Hernia Recurrence?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Hernia of Anterior Abdominal Wall
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2015-10-01
Enrollment: 3578
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fertile female patients who have undergone ventral hernia repair

Brief summary: The investigators will examine if pregnancy increases risk of ventral hernia recurrence

Detailed description: The investigators will establish a cohort of female fertile patients who underwent ventral hernia repair (Umbilical, Epigastric and Incisional hernia repair) registered in the Danish Hernia Database. The investigators will link these data at an individual level with the Danish National Patient Registry (DNPR), Danish Medical Birth Registry (DMBR) and the Danish Civil Registry (CPR).

From DMBR, subsequent pregnancies in the study cohort will be noted. From DNPR, ventral hernia recurrence, defined as clinical recurrence and/or reoperation for recurrence will be noted. Cases registered with both clinical recurrence and reoperation for recurrence, the date of the earliest registration will be defined as the date of ventral hernia recurrence.

From CPR, date of death or emigration will be noted.

Through an extended Cox regression analysis, handling pregnancy as a time-dependent variable, the investigators will examine whether pregnancy is associated with an increased risk of ventral hernia recurrence.

Eligibility criteria: Inclusion Criteria:

* Fertile female patient

Exclusion Criteria:

* non-Danish citizen

Primary outcomes:
measure: Clinical Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence
timeFrame: 0-7 years
measure: Ventral Hernia (Epigastric, Umbilical and Incisional Hernia) Recurrence Repair
timeFrame: 0-8 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital, University of Copenhagen
name: Lars N Jorgensen, MD, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT01055457: Vistakon Investigational Multi-purpose Contact Lens Care Solution.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 315
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: This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.


Eligibility criteria: Inclusion Criteria:

* must be an adapted contact lens wearer
* best corrected distance visual acuity must be 20/25 or better in each eye
* must be wearing their habitual lenses on a daily wear basis
* must be willing to refrain from swimming during the study

Exclusion Criteria:

* any systemic diseases that may interfere with contact lens wear
* any clinically significant ocular disease
* any ocular infection
* use of certain medications
* any grade 2 or greater slit lamp findings
* any know sensitivity to marketed contact lens care solutions
* currently pregnant or lactating
* monovision corrected

Primary outcomes:
measure: Slit Lamp Findings (SLF)
timeFrame: Up to 3 months Post Lens Wear
measure: Distance Visual Acuity (LogMAR)
timeFrame: Up to 3 Months Post Lens Wear
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Bloomington
country: United States
state: Illinois
city: Pittsburg
country: United States
state: Kansas
city: Jamestown
country: United States
state: New York
city: Vestal
country: United States
state: New York
city: Athens
country: United States
state: Ohio
city: Moon
country: United States
state: Pennsylvania
city: State College
country: United States
state: Pennsylvania
city: Amarillo
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT05249257: Durability and Safety of CCH With Two Different Injection Techniques in Cellulite With Laxity
Official title: A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cellulite
Laxity; Skin
Edematous Fibrosclerotic Panniculopathy
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Safety Population is defined as all participants who meet the inclusion/exclusion criteria at Day 360. All Safety analyses will be based on this population.

The Full Analysis Set (FAS) is defined as all participants in the Safety Population who have at least 1 I-GAIS assessment. All efficacy analyses will be based on this population.

Brief summary: All participants who completed the EN3835-224 study will be invited to participate in this observational study to evaluate long term durability of response and safety.


Eligibility criteria: Inclusion Criteria:

1. Have participated in and completed study EN3835-224 (parent study).
2. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Has received any collagenase treatments (eg, Santyl® Ointment) at any time since
2. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-224 study since the completion of that study.
3. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study

Primary outcomes:
measure: Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
timeFrame: Day 360
measure: Proportion of 1-level responders (+1 or better score) on the I-GAIS for either buttock or either thigh
timeFrame: Day 540
Secondary outcomes:
measure: I-GAIS ratings
timeFrame: Day 360 and Day 540
measure: Proportion of 1-level responders (+1 or better score) on the S-GAIS for either buttock or either thigh
timeFrame: Day 360 and Day 540
measure: Change from Day 1 (pre-treatment) of the parent study and each study visit in Subsection D of the Hexsel CSS
timeFrame: Day 360 and Day 540
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #2
state: Florida
city: Metairie
country: United States
facility: Endo Clinical Trial Site #3
state: Louisiana
city: New York
country: United States
facility: Endo Clinical Trial Site #1
state: New York
Study officials:
affiliation: Endo Pharmaceuticals
name: Karen Chajko
role: STUDY_DIRECTOR
References:
Clinical trial NCT04800757: VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers (LDL) Injury Disparities
Official title: VALES+Tú: Targeting Psychosocial Stressors to Reduce Latino Day Laborers Injury Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Work-related Injury
Keywords: latino day laborers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-03-16
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the efficacy of VALES+Tú in reducing hazardous exposures at work and to determine the mediating effect of psychosocial stressors on VALES+Tú primary outcomes


Eligibility criteria: Inclusion Criteria:

* self-identify as Hispanic or Latino
* be present at the corner for the purpose of looking for work

Exclusion Criteria:

* have not been previously hired to work at a corner
* symptoms of COVID-19 in the previous 48 hours

Primary outcomes:
measure: Change in Work Hazard Exposure as Assessed by a Survey
timeFrame: Baseline, 4 weeks post intervention
measure: Change in Work Conditions as Assessed by a Survey
timeFrame: Baseline, 4 weeks post intervention
Secondary outcomes:
measure: Change in Safety Practices as Assessed by a Survey
timeFrame: Baseline, 4 weeks post intervention
measure: Number of Participants That Implemented the Safety Plan as Assessed by a Survey
timeFrame: 4 weeks post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Maria Eugenia Fernandez-Esquer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05939557: Effects of Kinesio Taping vs Jones Technique on Myofascial Trigger Points in Cervicalgia.
Official title: Effects of Kinesio Taping vs Jones Technique on Myofascial Trigger Points in Cervicalgia: a Pilot Study of a Randomised Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicalgia
Keywords: Cervicalgia
cinta de kinesio
Técnica de Jones
fisioterapia
puntos de activación.
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A large number of workers in different sectors suffer from musculoskeletal neck disorders, which are the most common work-related illness in Europe. A multitude of combinations of techniques can be used to treat these conditions, including recorded film and the Jones technique. This pilot study examines the efficacy of Kinesio taping and the Jones technique in improving pain, joint range of motion and muscle tension in active subjects with latent myofascial trigger points. A clinical trial was conducted with 38 patients with neck pain. The sample was randomly distributed into three groups: a Jones technique group, a kinesio taping group and a combined therapy group in which both techniques were performed. The duration of treatment was 4 weeks, with a follow-up of 2 weeks. Cervical spine joint range of motion, pain and functional disability were assessed with the goniometer, the visual analogue scale, the pressure algometer and the cervical disability index.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of latent PGM in the upper trapezius
* Have been working for more than 6 months in the center or company
* Work more than 4 hours a day with the computer
* Be over 18 years of age and under 64 years of age

Exclusion Criteria:

* Diagnosis of fibromyalgia
* Having suffered a cervical sprain
* Diagnosis of radiculopathy, cervical spine surgery
* Medical contraindications to neuromuscular bandaging or Jones technique
* Diseases such as diabetes and cancer, pregnancy, and any other pathology that produces neck pain other than that specified in the objective of the study

Primary outcomes:
measure: Change from Baseline VAS at 4 weeks of treatment and at the 2-week follow-up
timeFrame: time 0, after 4 weeks of treatment, and at the 2-week follow-up
measure: Change from Baseline UDP at 4 weeks of treatment and at the 2-week follow-up
timeFrame: time 0, after 4 weeks of treatment, and at the 2-week follow-up
measure: Change from Baseline NDI at 4 weeks of treatment and at the 2-week follow-up
timeFrame: time 0, after 4 weeks of treatment, and at the 2-week follow-up
measure: Change from Baseline GONIOMETER at 4 weeks of treatment and at the 2-week follow-up
timeFrame: time 0, after 4 weeks of treatment, and at the 2-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01364948: Effect of Coconut Oil Application in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)
Official title: Effect of Topical Oil Application on Trans-epidermal Water Loss (TEWL) in Preterm Very Low Birth Weight (VLBW) Infants - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trans Epidermal Water Loss (TEWL)
Keywords: Preterm
VLBW
Coconut Oil application
Trans epidermal water loss
Weight gain
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 168
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Oil application on the skin can act as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut oil, often used for traditional massage of babies by Indian communities, is culturally acceptable and Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application


Eligibility criteria: Inclusion Criteria:

All preterm babies born at the study center with birth weight \< 1500gms were eligible for inclusion in the study.

Exclusion Criteria:

1. Babies with birth weight less than 750 gms at birth
2. Babies with major congenital malformations.
3. Babies with severe asphyxia, hydrops and shock.
4. Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
5. Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area

Primary outcomes:
measure: Trans Epidermal Water Loss(TEWL)
timeFrame: first 7 days of life
Secondary outcomes:
measure: Weight
timeFrame: Weight first 7 days of life and 40 weeks postmenstrual age
measure: Skin condition Score
timeFrame: Skin condition Score at day 7 of life
measure: Skin colonization pattern
timeFrame: Skin colonization pattern at day 7 of life
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute Of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Dr Sushma Nangia, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346748: The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Official title: The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: vasospasm prevention
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in the last years. Phase II randomized clinical trials have demonstrated that statin decreases the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage. Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though some articles have shown that statins provide better prognosis, some issues remain in debate, e.g., treatment duration and the choice of the statin.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years old, Hunt-hess scale \< 3

Exclusion Criteria:

* Liver disfunction, previous use of statin, hunt-hess scale 4 or 5.

Primary outcomes:
measure: The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas
Study officials:
affiliation: University of Sao Paulo
name: Eberval Figueiredo, PhD
role: PRINCIPAL_INVESTIGATOR
References: