louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00607360: Integration of the Therapeutic Workplace in Drug Court
Official title: Integration of the Therapeutic Workplace in Drug Court
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Addiction
Keywords: cocaine addiction, treatment, contingency management, employment intervention
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2008-02-05
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug Courts were developed as a therapeutic alternative to incarceration of drug-involved offenders by providing 'judicially supervised' drug abuse treatment and probation for nonviolent offenders in lieu of criminal prosecution and incarceration. Outcome studies have shown that drug courts have modest effects on participation in drug abuse treatment, drug use, and employment. The Therapeutic Workplace intervention is an effective employment-based treatment that integrates abstinence reinforcement contingencies in a work setting, intended to treat individuals with histories of drug addiction and chronic unemployment. Under this intervention, drug abuse patients are hired and paid to work. To promote abstinence, patients are required to provide drug-free urine samples to gain and maintain daily access in the workplace. In this way, patients can work and earn salary, but only as long as they remain drug abstinent. Patients using drugs and lacking job skills participate in an initial training phase to initiate abstinence and establish computer data entry skills. Once abstinent and skilled, patients are hired into an income-producing Therapeutic Workplace data entry business. Given that many drug court participants suffer from long histories of drug addiction and unemployment, the Therapeutic Workplace could be ideal for this population. This proposes of this clinical trial is to evaluate the Therapeutic Workplace intervention in a Drug Court.


Eligibility criteria: Inclusion Criteria:

* Enrolled in Drug Court
* Report using any opiates and/or cocaine during 30 days prior to their arrest
* Unemployed

Exclusion Criteria:

Individuals are excluded if they:

* Are at imminent risk of suicide
* Have a psychotic disorder that may limit their workplace functioning or their ability to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06981260: The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers
Official title: The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Institute of Health and Resilience
Sponsor class: OTHER
Collaborators: name: Aegean College, Athens, Greece
name: Coventry University, United Kingdom
First posted: 2025-05-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A healthy volunteer pilot study.
Primary purpose: OTHER

Brief summary: Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* No history of TENS use

Exclusion Criteria:

* Current medication use
* Orthopedic, neurological, or systemic conditions
* Pregnancy (current and planned)

Primary outcomes:
measure: Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention.
timeFrame: From Baseliine to 5 minutes
Secondary outcomes:
measure: Effect of gender on placebo response
timeFrame: From Baseliine to 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05218460: Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects
Official title: Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Pathology
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.


Eligibility criteria: Inclusion Criteria for all subjects :

* to be over 18 year-old,
* to be enrolled in a social security plan,
* to have underwent a pre-inclusion medical examination,
* to give a written consent.

Inclusion Criteria for volunteers with pathology :

- person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).

Exclusion Criteria for all subjects :

* any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... ),
* subject under a measure of legal protection,
* Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.

Primary outcomes:
measure: Image quality based on standard imaging quality criteria
timeFrame: 6 months after the last inclusion
measure: Signal quality based on standard signal quality criteria
timeFrame: 6 months after the last inclusion
Secondary outcomes:
measure: Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation.
timeFrame: 6 months after the last inclusion
measure: Comparison of the Contrast to Noise Ratio obtained by the component of the MRI system under development and the reference situation.
timeFrame: 6 months after the last inclusion
measure: Comparison of blurring and artefacts obtained by the component of the MRI system under development and the reference situation.
timeFrame: 6 months after the last inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT02764060: The Effect of Tongue Cleaning in Periodontitis Patients
Official title: The Effect of Tongue Scraping Compared to Tongue Cleaning on the Tongue Coating of Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Periodontitis
Tongue Coating
Keywords: Periodontitis
Tongue coating
Tongue cleaning
Bacterial load
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue.

Detailed description: Volatile sulphur compounds (VSC's) are the most important causes of bad breath. Since the micro-organisms that produce VSC's are also periodopathogens, intuitively, one would think that there is a positive correlation between VSC levels in exhaled breath and periodontitis. However, not all periodontitis patients have bad breath. A possible explanation can be a positive relationship between tongue coating an bad breath. In the past, tongue cleaning was already researched in an oral healthy population. This research aimed to examine in periodontitis patients with visible tongue coating the changes in microbial load (aerobic and anaerobic) of the 14 day use of a tongue scraper versus the use of a regular toothbrush to clean the tongue. Additionally changes in tongue coating; and patient perception about tongue cleaning was researched.

Eligibility criteria: Inclusion Criteria:

* systemically healthy patients
* periodontitis patients

Exclusion Criteria:

* already using a tongue cleaning device
* use of antibiotics the previous 6 months
* rinsing with a chlorhexidine mouth rinse the past month
* smokers
* patients who underwent periodontal therapy the past three years were not included.

Primary outcomes:
measure: Extension of the tongue coating
timeFrame: 14 days
Secondary outcomes:
measure: Bacterial load measured by culturing methods
timeFrame: 14 days
measure: Bacterial load measured by means of qPCR
timeFrame: 14 days
measure: Bacterial composition of unstimulated saliva (measured with the aid of culturing methods)
timeFrame: 14 days
measure: Bacterial composition of unstimulated saliva (measured with qPCR)
timeFrame: 14 days
measure: Experience of the subject of tongue coating related factors measured using a questionnaire
timeFrame: 14 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: marc.quirynen@uzleuven.be
name: Marc Quirynen
role: STUDY_DIRECTOR
References:
citation: Quirynen M, Avontroodt P, Soers C, Zhao H, Pauwels M, van Steenberghe D. Impact of tongue cleansers on microbial load and taste. J Clin Periodontol. 2004 Jul;31(7):506-10. doi: 10.1111/j.0303-6979.2004.00507.x.
Clinical trial NCT06067360: Evaluation of Performance of New IFIS Sleeve
Official title: Hydrodissection Sleeve to Aid Cataract Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Lead sponsor: Medicel AG
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 20
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: A silicone sleeve will be used on the hydrodissection needle to avoid that the iris can prolaps through the gap between needle and incision wound.

Detailed description: Cataract surgey is a common operation approximately 25 million pocedures per year worldwide. An essential step of the procedure is hydrodissection where fluid is forced into the eye through a cannula to free the cataract from its capsule. A serious and potential sight threatening complication of hydrodissection is iris prolapse, where the iris comes out of the wound. The overall incidence of iris prolapse during cataract surgery is 0.9% and higher in patients with intraoperative floppy iris syndrome (IFIS) at 11.9% , small pupils and small eyes. Patients on Tamsulosin medication with a Full Set of Project Data IRAS Version 6.3.3 5 DRAFT pupil less than 7.5mm have a 79% risk of prolapse Iris prolapse most often occurs during hydrodissection because the hydrodissection cannula is smaller (approx.1mm) than the wound (2.2-2.7mm) it is introduced through. Therefore the iris can be forced out / prolapse through this gap by the forced injection of fluid.

Traditional methods such as phenylephrine injection into the eye have varying effects can be unlicensed and possibly increase the prolapse risk. Mechanical pupil stretching can permanently damage the iris with complications.

Phacosleeve hydrodissection where the wound is sealed by a phacosleeve and the hydrodissecting irrigation cannula introduced through the sleeve or from side port /incison. The phacosleeve is not designed for this. This study is to use a purpose made tapered sleeve by Medicel in the same fashion as the current phacosleeve.

Eligibility criteria: Inclusion Criteria:

* patient with planned cataract surgery

Exclusion Criteria:

* pregnant woman

Primary outcomes:
measure: performance of IFIS sleeve to prevent iris prolapse
timeFrame: The evaluation of the device is during cataract surgery, which typically is less than 10 minutes. No additional treatments or evaluations after the surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06055660: Moesin Expression in Clear Cell Renal Cell Carcinoma
Official title: Expression and Distribution of Membrane-Organizing Extension Spike Protein (Moesin/ MSN) is Associated With Epithelial-Mesenchymal Transition in Clear Cell Renal Cell Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma
Moesin
Epithelial-Mesenchymal Transition
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present work will be performed on archived formalin-fixed, paraffin-embedded renal cell carcinoma tissue blocks that were belonged to 55 patients who were admitted to Sohag University Hospital because of loin/ back pain, from January 1st,2017 to December 31st, 2021. Radiological evaluation revealed renal neoplasms and patients underwent radical nephrectomies.

Brief summary: Renal cell carcinoma (RCC) is the most frequently occurring primary renal neoplasm. There are several histological variants of RCC that are associated with variable prognostic outcomes. Epithelial-mesenchymal transition (EMT) is a phenomenon in which the epithelial cells acquire some mesenchymal criteria as enhanced invasive potential. There are several cell surface molecules that are implicated in EMT. Moesin is one of these molecules that is involved in EMT, which is associated with enhanced invasive potential and poor prognosis. Targeting Moesin by novel therapeutic agents may prevent EMT and improve prognosis of patients with RCC.


Eligibility criteria: Inclusion Criteria:

1. All cases of ccRCC.
2. Tissue blocks with material adequate for immunohistochemical evaluation.
3. All cases with accessible clinical data.

Exclusion Criteria:

1. Cases of renal neoplasms other than ccRCC.
2. Patients who received preoperative chemotherapy or radiotherapy.
3. Patients with ccRCC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
4. Cases with insufficient/destructed material.
5. Patients with inadequate clinical data.

Primary outcomes:
measure: Detection of Moesin in renal cell carcinoma
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06355960: Effect of Dexmedetomidine on Oxygenation and Lung Mechanics
Official title: Effect of Different Does of Dexmedetomidine on Oxygenation and Lung Mechanics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Drug Use
Dexmedetomidine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation


Eligibility criteria: Inclusion Criteria:

Morbidly obese patients with restrictive lung disease ASA I AND II laparoscopic sleeve gastrectomy

Exclusion Criteria:

history of heart failure history of cardiac arrhythmias severe liver or kidney impairment. Patients with forced expiratory volume in 1 sec (FEV1)/ FVC \< 70%

Primary outcomes:
measure: Oxygenation by the end study
timeFrame: UP TO 6 HOURE
Secondary outcomes:
measure: Intraoperative dynamic lung compliance
timeFrame: up to 6 hours
measure: Intraoperative static lung compliance
timeFrame: UP TO 6 HOURE
measure: Physiological dead space
timeFrame: UP TO 6HOURE
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo university , Cairo, Egypt
name: Amr s wahdan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04684160: Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Official title: Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Arthropathy of Knee
Joint Awareness
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.

Detailed description: Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with knee joint advanced osteoarthritis
* Age over 55 years old
* Scheduled to undergo primary total knee arthroplasty

Exclusion Criteria:

* Post-traumatic or inflammatory osteoarthritis
* Those who undertook previous ligamentous surgery
* Those who do not understand and give answers to a survey

Primary outcomes:
measure: Forgotten joint score
timeFrame: Postoperative 3 years
measure: Crepitus
timeFrame: Postoperative 3 years
Secondary outcomes:
measure: Forgotten joint score
timeFrame: Postoperative 5 years
measure: Crepitus
timeFrame: Postoperative 5 years
Other outcomes:
measure: Change from baseline Knee Society Score (KSS) at 3 and 5 years
timeFrame: Preoperative and Postoperative 3, 5 years
measure: Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 and 5 years
timeFrame: Preoperative and Postoperative 3, 5 years
measure: Central Sensitization Index (CSI)
timeFrame: Postoperative 3 years
measure: Central Sensitization Index (CSI)
timeFrame: Postoperative 5 years
measure: Radiological outcomes
timeFrame: Postoperative 3 years
measure: Radiological outcomes
timeFrame: Postoperative 5 years
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong In, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03921060: Markers of Osteoporosis in Cystic Fibrosis
Official title: Markers of Osteoporosis in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cystic Fibrosis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Main Study Up to 100 subjects, both non-CF volunteers and Cystic Fibrosis (CF) patients, will participate in a single study visit that will include a DEXA scan, micro CT, and blood collection.

Denosumab (Prolia) Sub study Approximately 10 adult subjects with CF who participated in the main study and have results indicating bone disease will receive treatment with Denosumab for up to 5 years. They will be asked to return annually for repeat DEXA scans, micro CT, and blood collection.


Eligibility criteria: Cystic Fibrosis Main Study Inclusion Criteria:

* Must have CF diagnosis confirmed by sweat test or genotype analysis
* Subjects (and parents/legal guardians as applicable) must have the ability to read and write in English

Sub-study Exclusion Criteria:

* No CF diagnosis
* Men or women without osteoporosis
* Less than 18 years of age
* Unwilling to return annually for study visits for up to 5 years
* Unwilling and/or medically unable to take denosumab

Primary outcomes:
measure: DEXA results
timeFrame: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
measure: Micro CT results
timeFrame: Looking at single timepoints and well as changes for up to 5 years for those in the sub-study
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT01275560: Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anal Incontinence
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence


Eligibility criteria: Inclusion Criteria:

* Gaz incontinence for more than 3 months
* Afflilied to national health security
* Having read and sign the information letter and consent form

Exclusion Criteria:

* Pregnancy
* use of antibiotics, probiotics, IPP for less tha n 3 months
* past of small intestinal bacterial overgrowth
* ischemic, inflammatory colitis,colo-rectal cancer
* diabetes
* allergy to metronidazole
* psychiatric disease
* patients who do not speak or read french

Primary outcomes:
measure: number of gaz incontinence episodes
timeFrame: 3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
Study officials:
References: