louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06513507: A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.
Official title: A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Inflammatory Disease
Keywords: Arthritis Treatment
Cannabinoid Therapy
Anti-CCP
Lead sponsor: Raphael Pharma
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-group study with an exploratory longitudinal prospective design aimed at measuring the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis.
Primary purpose: TREATMENT

Brief summary: This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.


Eligibility criteria: Inclusion Criteria:

* Male or female, over 25 years of age
* Positive anti-CCP blood test
* Active RA-related inflammation with at least 2 swollen joints
* University graduate
* Generally healthy with no uncontrolled chronic disease
* Able to read, understand, and sign informed consent
* Resides in the USA
* Willing to comply with study requirements and avoid other cannabis products during the study period

Exclusion Criteria:

* Pre-existing chronic conditions preventing adherence
* Severe allergic reactions requiring an Epi-pen
* Use of opiates in the last 4 weeks or cannabis in the last 8 weeks
* Pregnant or breastfeeding women
* Recent invasive medical procedure or surgery
* Active malignancy or ongoing oncology treatment
* Use of cytochrome P450 or 3A4 inhibitors
* History of substance abuse

Primary outcomes:
measure: Change in inflammatory markers from Baseline to Week 8
timeFrame: Baseline, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes:
measure: Change in self-reported symptoms and quality of life from Baseline to Week 8
timeFrame: Baseline, Week 4, and Week 8
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT05940207: A Study of Hydrogen Peroxide-Generating E-bandage Safety
Official title: Safety Testing of Hydrogen Peroxide-Generating e-Bandage on Normal Human Skin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A novel hydrogen peroxide-generating electrochemical bandage for wound infection treatment and prevention, and wound healing has been developed. The purpose of this research is to gather information on the safety and to confirm lack of toxicity of small hydrogen peroxide-generating e-bandages on normal human skin.


Eligibility criteria: Inclusion Criteria:

* Healthy.
* Intact skin on arms.
* Able to provide appropriate consent.

Exclusion Criteria:

* Vulnerable study population.
* Pregnancy.
* Children.
* Skin disease.
* Non-intact skin on arms.

Primary outcomes:
measure: e-Bandage Discomfort
timeFrame: Approximately 3 - 24 hours
measure: Skin irritation/dermatitis
timeFrame: Approximately 3 - 24 hours
measure: Allergic Reaction
timeFrame: Approximately 3 - 24 hours
measure: Skin Discoloration
timeFrame: Approximately 3 - 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robin Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284907: Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
Official title: Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Asthma therapy
Randomized controlled trial
children
Lead sponsor: United Arab Emirates University
Sponsor class: OTHER
Collaborators: name: Roma Paediatrics
First posted: 2011-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma

Detailed description: The proposed interventional study will clarify the role of vitamin D in preventing asthma exacerbations and in achieving better chronic asthma control in children with moderate to severe asthma.

Eligibility criteria: Inclusion Criteria:

* Physician diagnosed asthmatics and they should fulfill at least two of the following three criteria:

  * A minimum of three clinic visits for acute asthma within 1 year
  * Two or more asthma-related hospital admissions within 1 year, or
  * Steroid dependency, as defined by either 6 months of oral or 1 year of inhaled corticosteroid use
* Age: 6-14 years old. The age group of 6 to 14 years old was chosen for two reasons:

  1. Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded.
  2. Child should be able to use a peak flow meter and perform spirometry tests.
* A positive specific IgE or a positive skin prick test for at least one airborne allergen.

Exclusion Criteria:

* Children with mild intermittent and mild persistent asthma.
* Asthmatic children who are currently on immunotherapy or anti IgE.
* Asthmatic children with concomitant other medical problems.
* Children who are younger than 6 yrs or older than 14 yrs.
* Children with history of early life injury to airways like premature birth (\< 36 weeks) or home use of oxygen.
* Children with vitamin D deficiency. Since these children may be randomized to the control group, they will be excluded for ethical reasons.

Primary outcomes:
measure: A change from baseline in Peak expiratory flow rate
timeFrame: up to six months
Secondary outcomes:
measure: A change from baseline in lung function test
timeFrame: up to six months
Other outcomes:
Locations:
city: Al Ain
country: United Arab Emirates
facility: Tawam Hospital
city: Al Ain
country: United Arab Emirates
facility: Al Ain Hospital
Study officials:
affiliation: Roma Paediatrics
name: Mariam Elremeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05526807: Ursodeoxycholic Acid in C. Difficile Infection
Official title: Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Clostridioides Difficile Infection
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid


Eligibility criteria: Inclusion Criteria:

* Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days

Exclusion Criteria:

* • Pregnant or Breast-feeding

  * Gall bladder inflammation
  * Frequent episodes of biliary colic
  * Occlusion of the common bile duct or cystic duct
  * Active small intestinal inflammation
  * Previous resection of distal small intestine
  * Treatment with bile salt binding agents, ciclosporin or ciprofloxacin
  * Diarrhoea (from any cause) at study initiation
  * hypersensitivity to bile acids or any excipient of the formulation
  * Life expectancy less than 6 months

Primary outcomes:
measure: To assess tolerability to oral ursodeoxycholic acid
timeFrame: 6 weeks
Secondary outcomes:
measure: To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT04134507: Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-Lasik Patients With Monofocal IOLs
Official title: Multivariate Regression Analysis of Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-LASIK Patients With Monofocal IOLs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction
Keywords: Post-LASIK
Presbyopia-correcting IOL
Monofocal IOL
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-LASIK patients, male and female, aged 40 and older, who have undergone cataract surgery or clear lens exchange

Brief summary: Compare functional visual outcomes and patient satisfaction of post-LASIK patients having received presbyopia-correcting IOLs versus post-LASIK patients having received monofocal IOLs


Eligibility criteria: Inclusion Criteria:

* Post-LASIK
* Post cataract surgery
* Implantation of ZLB00, ZXR or ZXT, ZCB00, or AO60 intraocular lenses
* Spherical values greater than ± 0.50 and/or cylinder magnitude greater than 0.75D

Exclusion Criteria:

* Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
* Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
* Max sphere no greater than ± 0.50D and cylinder less than and/or equal to 0.75D

Primary outcomes:
measure: Patient Satisfaction: subjective questionnaire
timeFrame: Measured 3 months to 4 years after cataract surgery
Secondary outcomes:
measure: Visual Acuity at Distance
timeFrame: Measured 3 months to 4 years after cataract surgery
measure: Visual Acuity at Intermediate
timeFrame: Measured 3 months to 4 years after cataract surgery
measure: Visual Acuity at Near
timeFrame: Measured 3 months to 4 years; after cataract surgery
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03572907: Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact.
Official title: Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate: Aesthetic and Functional Impact. TROPIC (Titanium RhinOPlasty ImpaCt)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cleft Lip
Cleft Palate
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cleft lip and palate who underwent secondary rhinoplasty using a titanium columelar strut between March 1, 2016 and March 1, 2018.

Brief summary: The patients in this study are all born with a cleft lip and palate. They underwent several interventions in childhood to take care of it.

Professor Gleizal offered them a secondary rhinoplasty aimed at normalizing the appearance of their nose.

In this malformative and multioperated context, typical nasal deformities affect the tip of the nose, which appears to be sagging and asymmetrical. Scarred soft tissues exert an important retractile force against which conventional rhinoplasty techniques often remain insufficient.

The use of columellar struts makes it possible to give again projection to the tip of the nose but when this strut is made from cartilage or bone, it is absorbed with the time. Moreover, these interventions require a remote removal of the site of interest (costal cartilage, tibial crest, calvaria) which generates additional morbidity.

The investigators propose an alternative using a synthetic graft of titanium. This material has been used for many years for its excellent biocompatibility and trauma resistance.

28 patients were able to benefit from this technique between March 1, 2016 and March 1, 2018.

The investigators wish to evaluate the aesthetic and functional results from the patient's point of view by submitting them to one validated rhinoplasty questionnaire after the end of the patient's inclusion.


Eligibility criteria: Inclusion Criteria:

* patient over 12 years
* patients with cleft lip and palate operated by Pr Gleizal of a secondary rhinoplasty using a titanium columellar strut
* between January 1, 2016 and March 1, 2018
* patient not having opposed their participation

Exclusion Criteria:

* patient not mastering the French language
* patient participating in interventional research

Primary outcomes:
measure: Rhinoplasty Outcome Evaluation scores
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de chirurgie maxillo-faciale - Hôpital de la Croix Rousse - Groupement Hospitalier Nord - Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT04859907: Bone Flap Fixation Systems For Craniotomy Procedures
Official title: Bone Flap Fixation Systems For Craniotomy Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniotomy
Lead sponsor: NEOS Surgery
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.


Eligibility criteria: Inclusion Criteria:

* The subject is 18 years or older.
* The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
* At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
* Life expectancy higher than 6 months.
* The subject is willing to give his/her informed consent and to comply with the required follow-up.

Exclusion Criteria:

* The subject presents any of the contraindications of the assigned craniotomy closure system.
* Orbitozygomatic or mastoid craniotomies.
* Posterior fossa (skull base) surgeries.
* Combined used of craniotomy systems (plates and clamps).
* The subject is currently participating in an investigational drug or device study.

Primary outcomes:
measure: Bone flap alignment score
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of adverse effects and device deficiencies (device safety)
timeFrame: 6 months
measure: Bone-flap alignment score
timeFrame: 0-7 days after surgery (before discharge)
measure: Surgeon usability questionnaire
timeFrame: 0 days after surgery
measure: Device related artefacts in neuroimaging
timeFrame: 6 months
measure: Device-related bulges or visible offsets
timeFrame: 6 months
measure: Post-craniotomy headache
timeFrame: 6 months
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: Maribor University Medical Center
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
Study officials:
References:
Clinical trial NCT06271707: Stellate Ganglion Block
Official title: Left Sided Stellate Ganglion Blocks Impact on the Rate of Post-operative Atrial Fibrillation in Patients Undergoing Thoracic Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Esophagectomy
Pneumonectomy
Lobectomy
Keywords: Esophagectomy
Pneumonectomy
Lobectomy
Stellate Ganglion Block
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing esophagectomy, pneumonectomy, or lobectomy aged 18-85.

Exclusion Criteria:

* Patients who have an exclusion to regional anesthesia.
* Patients who have exclusion to stellate blockade.
* Patients who are pregnant assessed via self-report or pregnancy test if they have taken one

Primary outcomes:
measure: an ultrasound guided left stellate ganglion block with 5 mL of saline.
timeFrame: 168 hours after surgery
measure: Atrial fibrillation; Other arrhythmias; Adverse events.
timeFrame: 168 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Jacob Hutchins
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564807: Testing an Online Insomnia Intervention
Official title: Testing an Online Insomnia Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Insomnia
Keywords: sleep
cognitive behavioral therapy
CBT
electronic
alcohol
non-pharmacological
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.


Eligibility criteria: Inclusion Criteria:

* engage in weekly alcohol binge episodes
* moderate to severe insomnia

Exclusion Criteria:

* history of severe alcohol or other substance use disorder
* obstructive sleep apnea
* schizophrenia
* bipolar disorder
* psychotic spectrum disorder
* lack of internet access
* lack of English fluency
* pregnant or nursing

Primary outcomes:
measure: Change in Alcohol Use
timeFrame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
measure: Change in Insomnia
timeFrame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
measure: Change in Sleep Quality
timeFrame: 12 months (at baseline, 9 weeks, 3 months post-intervention, and 6 months post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University Of Kentucky Psychology Research Lab
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jessica Weafer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00875407: Feasibility of 123I-IBZM Scintigraphy (a D2 Agonist) in Patients With Pheochromocytoma (PHEO) and/or Paraganglioma (PGL) : Study Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chromaffin-tissue Derived Tumors
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor D2 isoforms has been found in endocrine tumors.

Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.


Eligibility criteria: Inclusion Criteria:

* Age + 18 years. The women in ages to procreate have to have an effective contraception or a negative pregnancy test (in the absence of effective contraception) Having a radiological and functional imaging (balance sheet(assessment) pré--IBZM) considered adapted and complete for the pathology.
* Having a phéochromocytome or a paragangliome proving a surgical operation in view of the data of the balance sheet(assessment) pré--IBZM.
* With or without allergy in the iodine.

Exclusion Criteria:

* NEM2A or 2B.
* Malignant Forms which do not recover from an even partial, surgical gesture(movement).
* Pregnant Women or in the course of feeding.
* Women in age to procreate without effective contraception, with positive pregnancy test.
* Renal insufficiency

Primary outcomes:
measure: The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique-Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: DAVID TAIEB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saveanu A, Sebag F, Guillet B, Archange C, Essamet W, Barlier A, Palazzo FF, Taieb D. Targeting dopamine receptors subtype 2 (D2DR) in pheochromocytomas: head-to-head comparison between in vitro and in vivo findings. J Clin Endocrinol Metab. 2013 Dec;98(12):E1951-5. doi: 10.1210/jc.2013-2269. Epub 2013 Sep 5.