louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00343070: Functional Neuroimaging in Depression
Official title: Functional Neuroimaging in Depression: Longitudinal Study of PET Metabolism in Correlation With Changes in Attentional Bias, Autobiographical Memory, Future Fluency and Facial Recognition in Depressed Patients Treated With Escitalopram.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depression
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: H. Lundbeck A/S
First posted: 2006-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oral administration of escitalopram during 8 weeks; PET scan with 18F-FDG at inclusion and after 8 weeks


Eligibility criteria: Inclusion Criteria:

* Major Depression, Depressive episode, following DSM-IV criteria
* MADRS-score \> 25
* Age: 18-65 yrs
* Medication-free or anti-depressant wash-out 7 days (for fluoxetine: 6 weeks)
* Lorazepam 1mg or zolpidem 10mg are allowed

Exclusion Criteria:

* Suicidality
* Bipolar disorder, following DSM-IV criteria
* Psychotic symptoms
* Substance abuse
* Personality disorder, following DSM-IV criteria
* Cognitive dysfunction due to trauma capitis or dementia
* Diabetes mellitus
* Women without contraceptive protection, with pregnancy or breast feeding
* Pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion
* IQ below 80
* Conditions not compatible with SPC

Primary outcomes:
measure: Brain metabolism
Secondary outcomes:
measure: Cognitive functions
measure: Efficacy scales (mood, anxiety, anger and hopelessness)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Kortrijk
country: Belgium
facility: AZ Groeninge campus Sint Maarten
Study officials:
affiliation: University Hospital, Ghent
name: Kurt Audenaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04404270: Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)
Official title: Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 1146
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: The eligible population is composed of all civilian and military personnel working on the Creil Air Force Base (BA110) or having worked on BA110 as a permanent personnel since February 1st 2020, including the people working in satellite units such as the "Groupement de soutien de base de Défense" de Creil ("Creil Defence Base Support Group") or the 3/60 Esterel squadron.

Brief summary: In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible.

The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.


Eligibility criteria: Inclusion Criteria:

* Active military or civilian defence personnel working on the Creil Air Force Base (BA110) during the period of interest (from February 1st 2020 to the end of the study)

Exclusion Criteria:

* Contraindication to blood sampling
* Pregnant, parturient, breastfeeding woman

Primary outcomes:
measure: Proportion anti-SARS-CoV2 seropositive
timeFrame: Day 0
Secondary outcomes:
measure: Proportion of asymptomatic anti-SARS-CoV2 seropositive participants
timeFrame: Day 0
measure: Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)
timeFrame: Day 0
measure: Proportion of serum neutralization positive
timeFrame: Day 0
measure: Change of antibody level over time
timeFrame: 3 months and 9 months after Day 0
Other outcomes:
Locations:
city: Creil
country: France
facility: 24e antenne médicale de Creil
Study officials:
References:
Clinical trial NCT02140970: Randomized Trial of NSAID vs Placebo Prior to Ureteral Stent Removal
Official title: Double-blind, Placebo-controlled Randomized Controlled Trial of NSAID Prior to Ureteral Stent Removal in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Urinary Stent
Ureteral Spasm
Ureteropelvic Junction Obstruction
Urolithiasis
Keywords: ureteral stent
stent pain
ureteral spasm
NSAID
ibuprofen
placebo
ureteropelvic junction obstruction
urolithiasis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2014-05-16
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study plans to learn more about whether ibuprofen can reduce pain after removal of a ureteral stent more than a placebo. Some patients experience pain after removal of a ureteral stent. The investigators plan to learn how often this occurs and whether it can be prevented.

The investigators hypothesize that children who have a temporary, indwelling ureteral stent will experience a significantly less post-operative pain if given a non-steroidal anti-inflammatory (NSAID) prior to removal of the ureteral stent when compared to placebo. The investigators hypothesize that the incidence of severe post-stent removal pain is similar to an adult population.


Eligibility criteria: Inclusion Criteria:

* ages 4-17
* unilateral ureteral stent placed after ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis

Exclusion Criteria:

* bilateral stents
* undergoing other concomitant procedure at time of planned ureteral stent removal
* indication for stent other than ureteropelvic junction obstruction repair or treatment of upper tract urolithiasis
* pregnant
* developmental delay
* allergy to ibuprofen or non-steroidal anti-inflammatory medication class
* chronic kidney disease
* prior renal transplant
* history of nasal polyps
* history of asthma

Primary outcomes:
measure: Incidence of Post-operative Severe Pain (Pain Score ≥ 7)
timeFrame: 24 hours after stent removal
Secondary outcomes:
measure: Incidence of "Significantly Worsening" Pain
timeFrame: 24 hours after stent removal
measure: Change in Pre- and Post-operative Pain Score
timeFrame: 24 hours after stent removal
measure: Opioid Usage Post-operatively
timeFrame: 24 hours after stent removal
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jeffrey Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tadros NN, Bland L, Legg E, Olyaei A, Conlin MJ. A single dose of a non-steroidal anti-inflammatory drug (NSAID) prevents severe pain after ureteric stent removal: a prospective, randomised, double-blind, placebo-controlled trial. BJU Int. 2013 Jan;111(1):101-5. doi: 10.1111/j.1464-410X.2012.11214.x. Epub 2012 May 11.
Clinical trial NCT00948870: Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Traditional Chinese Medicine
Keywords: alternative medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 200
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Shugan decoction on irritable bowel syndrome（diarrhea type）.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of irritable bowel syndrome（diarrhea type）
* Male of female patients between 18-65 years old
* Written informed consent

Exclusion Criteria:

* Discrepancy of irritable bowel syndrome
* Diarrhea-type of irritable bowel syndrome combine with intestinal disease
* Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
* Pregnancy or breast feeding women, or unwilling to have contraception.

Primary outcomes:
measure: Symptoms and conditions of tongue and pulse
timeFrame: 4 weeks
Secondary outcomes:
measure: Indicates of liver and renal function
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua hospital
state: Shanghai
Study officials:
affiliation: Shanghai University of Chinese Medicine
name: Xie Jianqun, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT06000670: Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions
Official title: Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
knee chondromalacia
Lead sponsor: Dubai Health Authority
Sponsor class: OTHER_GOV
First posted: 2023-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: clinical efficacy of autologous stromal vascular fraction SVF,for inflammatory and degenerative conditions of the knees

Detailed description: to evaluate the clinical effectiveness of point of care autologous adipose derived stromal vascular fraction (SVF) alone or in combination with exosomes,for inflammatory and degenerative conditions of the knees.

Eligibility criteria: Inclusion Criteria:

* knee osteoarthritis any grade

  * knee chondromalacia grade 2 and above

Exclusion Criteria:

* active HIV
* pregnant women
* Mental disease
* severe cardio vascular disease
* severe coagulation disorders
* infected tissues
* patients on other experimental studies within 3 months

Primary outcomes:
measure: change in pain level
timeFrame: 2 years
Secondary outcomes:
measure: percentage cartilage thickness change
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: dubai health autority
name: DHA DHA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03531970: Effect of Lidocaine/Dexamethasone on the Success of IANB
Official title: Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Local Anesthesia
Keywords: inferior alveolar nerve block
irreversible pulpitis
local anesthesia
dexamethasone
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this prospective, randomized, double-blind study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Detailed description: Several investigations have been carried out to demonstrate the effect of dexamethasone added to local anesthetics in regional block injections. These investigations shown that the addition of dexamethasone to local anaesthetics may prolong the duration of anesthesia and also results in a faster onset. It is hypothesized that dexamethasone added to lidocaine may affect the success rate of inferior alveolar nerve block

Eligibility criteria: Inclusion Criteria:

* vital mandibular molar tooth
* diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

* younger than 18 years old
* history of significant medical conditions
* allergies to local anesthetics or sulfites
* pregnancy
* taking any medications that might influence anesthetic assessment
* active sites of pathosis in area of injection
* inability to give informed consent

Primary outcomes:
measure: success of IAN Block anesthesia for the Dexamethasone group
timeFrame: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
measure: success of IAN Block anesthesia for the Non-dexamethasone group
timeFrame: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
Secondary outcomes:
measure: initial pain
timeFrame: Baseline
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Masoud Saatchi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00349570: Xtract™ Aspiration Catheter Registry Study
Official title: Xtract™ Aspiration Catheter Registry Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fresh Soft Emboli or Thrombi in the Arteries.
Keywords: thrombus
aspiration catheter
Lead sponsor: Lumen Biomedical
Sponsor class: INDUSTRY
First posted: 2006-07-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous coronary and other vascular interventional techniques. The Xtract™ Aspiration Catheter is a single use device designed to remove fresh, soft emboli and thrombi from the arterial system using standard catheter techniques, compatible with 6 Fr guide catheters and 0.014 guidewires. The purpose of this registry study is to validate the design and demonstrate the performance of the Xtract Aspiration Catheter as a thrombectomy catheter during percutaneous intervention of vessels in the arterial system. Subjects will be enrolled during percutaneous intervention when the Interventional Physician decides a thrombectomy catheter is needed to remove thrombus during the procedure.


Eligibility criteria: Inclusion Criteria:

* Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion
* Angiographic evidence of thrombus.

Primary outcomes:
measure: The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter.
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: ChristChurch
country: New Zealand
facility: ChristChurch Hospital
Study officials:
affiliation: Auckland City Hospital
name: Mark Webster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03606070: Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study
Official title: Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NSCLC
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2018-07-30
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: DIAGNOSTIC

Brief summary: To estimate the intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping in locally advanced and trace mestastatic non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

1. Locally advanced NSCLC (stages IIB, IIIA or IIIB of the TNM classification 7th edition) or trace metastatic stage IV (\</=5 mestastasis, \</= 3 organ reached)
2. Exclusive therapeutic management by concomitant radio-chemotherapy administered in accordance with international recommendations (dual therapy with platinum salts)
3. Signed consent
4. Patients affiliated with the social security scheme or beneficiary of a similar scheme.

Exclusion Criteria:

1. Minor
2. Pregnant / lactating woman
3. Person deprived of liberty by judicial or administrative decision, adults who are the subject of a legal protection measure or unable to express their consent
4. Previous cancer in the 2 years prior to registration
5. Previousradiotherapy / thoracic surgery
6. Patients under experimental treatment or for whom the administration of an experimental treatment is planned
7. Claustrophobic patients
8. Severe Renal Insufficiency (Clearance MDRD Cockroft \<30ml / min)
9. Uncontrolled diabetes, hyperglycemia\> 1.8g / L
10. Patient with metallic implants not compatible with MRI or any immovable implanted electronic medical device (eg pacemaker, neurostimulator, cochlear implants, etc.)

Primary outcomes:
measure: Measurement of intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping performed before and under treatment.
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT02680470: Virtual Observed Therapy for Patients With Tuberculosis
Official title: Virtual Observed Therapy for Patients With Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Tuberculosis
Management
Observed therapy
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2016-02-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Using modern technology, investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment.

Detailed description: Using modern technology, the investigators will observe participants taking their TB tablets three times per week using a mobile phone, iPod or computer with camera facilities in the participants home environment.

Investigators will connect to the participants mobile phone, iPod or computer at a mutually convenient time three times per week who will observe participants taking their TB medication.

The Virtual Observed Therapy will be carried out using NHS Lothian approved software (mobile app called POLYCOM) three times per week. This is software similar to Skype but POLYCOM is the approved software we use in NHS Lothian.

Eligibility criteria: Inclusion Criteria:

Any patient requiring Tuberculosis treatment

Exclusion Criteria:

Those refusing consent; the healthcare professional deems the patient that will not be able to comply with VOT

Primary outcomes:
measure: Treatment completion rates using VOT compared with historical completion rates.
timeFrame: length of TB treatment (usually 6-12 months)
Secondary outcomes:
measure: % Cure from TB treatment
timeFrame: length of TB treatment (usually 6-12 months)
measure: number of VOT actually observed divided by the expected VOT observed
timeFrame: length of TB treatment (usually 6-12 months)
measure: patient satisfaction questionnaire at end of treatment
timeFrame: length of TB treatment (usually 6-12 months)
measure: Mortality
timeFrame: length of TB treatment (usually 6-12 months)
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
References:
Clinical trial NCT05845970: An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
Official title: An Investigation Into the Efficacy of a Botanical Supplement to Provide Period Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menstrual Pain
Premenstrual Syndrome
Lead sponsor: Focus Consumer Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-05-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Women often experience significant pain during their periods which can significantly impact on quality of life. In this study, two products that are used to alleviate period pain will be examined. One test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. The trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. Participants will use the botanical product alongside a traditional over-the-counter period product during their second period. Participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial.


Eligibility criteria: Inclusion Criteria:

* Female between 18-40 years of age.
* Must be in good health with no significant chronic conditions and a BMI under 35.
* Must experience period pain and other PMS symptoms.
* Must have a regular menstrual cycle with a bleed week.
* If using hormonal contraception, must do so for at least three months
* If using oral contraception, must allow for bleed week.
* Must be able to predict their bleed week.
* Willing to abstain from strenuous exercise 24 hours before each of the three blood draws in this trial.

Exclusion Criteria:

* Suffers from pre-existing conditions that would prevent them from adhering to the protocol.
* Anyone with known severe allergic reactions.
* Anyone with a previous negative experience with acetaminophen.
* Unwilling to follow the study protocol.
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
* Anyone who uses other supplements for period pain and PMS symptoms.
* Current use of an extended activity hormonal contraception (examples include Depo-provera or Nexplanon.

Primary outcomes:
measure: Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)]
timeFrame: 60 days
Secondary outcomes:
measure: Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)]
timeFrame: 60 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: