louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04376593: PET/CT Imaging in COVID-19 Patients
Official title: 18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: COVID-19
SARS-CoV-2 Infection
Keywords: COVID-19; SARS-CoV2 infection
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-05-06
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: DIAGNOSTIC

Brief summary: This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.

Detailed description: The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect lung damage.

Eligibility criteria: Inclusion Criteria:

* Men and women age ≥ 18 yrs
* Diagnosed with SARS CoV2
* Must have 2 sequential COVID negative tests prior to each scan
* Must have no previous lung disease prior to SARS CoV2 infection
* Lung image (Xray or CT) taken during infectious/ diagnosis period
* Will sign the IRB-approved consent form
* Able to remain motionless for up to 30-60 minutes per scan.

Exclusion Criteria:

* Life expectancy \<3 mo
* Women who are pregnant or breast-feeding
* Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
* Lack of availability for follow-up assessments
* Re-infection with SARS CoV2 between scan sessions
* Other active infectious respiratory illness

Primary outcomes:
measure: Administration of 18F-αvβ6-BP
timeFrame: baseline
measure: Administration of 18F-αvβ6-BP
timeFrame: 3 months
measure: Administration of 18F-αvβ6-BP
timeFrame: 6 months
Secondary outcomes:
measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
timeFrame: baseline
measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
timeFrame: 3 months
measure: Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage
timeFrame: 6 months
Other outcomes:
measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.
timeFrame: baseline
measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.
timeFrame: 3 months
measure: Determine whether 18F-αvβ6-BP accumulation in lung correlates to lung damage as indicated on CT.
timeFrame: 6 months
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
References:
Clinical trial NCT02371993: Asthma in the Elderly: A Study of Choline Supplementation
Official title: Asthma in the Elderly: A Study of Choline Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma in the Elderly
Lead sponsor: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Asthma in the elderly is poorly understood, as most studies have not included this patient group. In a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. The investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and homocysteine levels.


Eligibility criteria: Inclusion Criteria:

* Asthma

Exclusion Criteria:

* No history of smoking more than 10 pack/years,
* no gastrointestinal cancers,
* no liver or kidney disease,
* no bipolar disorder.

Primary outcomes:
measure: Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test
timeFrame: six weeks
measure: Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)
timeFrame: six weeks
Secondary outcomes:
measure: Effect of choline supplementation on peripheral blood eosinophils
timeFrame: six weeks
measure: Effect of choline supplementation on serum IgE
timeFrame: six weeks
measure: Effect of choline supplementation on serum homocysteine levels
timeFrame: six weeks
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
state: Pennsylvania
Study officials:
affiliation: Rohr and Columbo Asthma, Allergy and Immunology Specialists
name: Michele Columbo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Columbo M, Rohr AS. Asthma in the elderly: the effect of choline supplementation. Allergy Asthma Clin Immunol. 2016 Mar 11;12:15. doi: 10.1186/s13223-016-0121-5. eCollection 2016.
Clinical trial NCT02355093: Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically
Official title: Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia; Reaction
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare continuous femoral nerve block with adductor canal block after anterior cruciate ligament reconstruction arthroscopically，especially in the effect on quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients postoperatively.

Detailed description: Forty patients with American Society of Anesthesiologists（ASA） Ⅰ-Ⅲ（no limitation of age and gender）are randomized to receive either a continuous adductor canal block(ACB) or a femoral nerve block(FNB) via a catheter (a continuous infusion of 0.2% ropivacaine, 5 mL/h for 48 hours)in the PACU immediately after the anterior cruciate ligament reconstruction arthroscopically. Patients were under general anesthesia during the operation and received a femoral nerve block with 0.25% ropivacaine 10ml before the surgery.Both groups will receive postoperatively IV patient controlled analgesia (PCA) with morphine (bolus 0.8mg,lock-out time 15 minutes, background infusion 2ml/h)beside the continuous nerve block. Patients are going to be visited for follow-up on the day of surgery and in the following two days. Quadriceps strength is assessed with the displacement of patella.VAS at rest time、degree of knee flexion、VAS at 45°flexion of the knee、dose of opioids、whether the patient has sleep disturbance are also recorded.

Eligibility criteria: Inclusion Criteria:

* ASA Ⅰ-Ⅲ
* Anterior Cruciate Ligament Reconstruction

Exclusion Criteria:

* patient refusal
* chronic use of opioids
* coagulation disorders
* infection at the puncture site
* allergic to anaesthetic
* preexisting neurological disorders
* communication difficulties

Primary outcomes:
measure: quadriceps muscle strength, as measured by handheld dynamometer.
timeFrame: 3 days
Secondary outcomes:
measure: pain at rest time and during flexion of the knee, as measured by visual analog score(VAS).
timeFrame: 3 days
Other outcomes:
measure: Dose of opioids
timeFrame: 3 days
Locations:
Study officials:
affiliation: Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
name: Daqiang Zhao, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876093: Epilepsy-related Brain Tumors Register
Official title: Epilepsy-related Brain Tumors Register
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Epilepsy
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized following an epileptic seizure or seen in consultation in the neurology department of the GHPSJ, diagnosed with primary or secondary brain tumor from January 2013 to December 2023.

Brief summary: Epilepsy is defined by a cerebral disorder characterized by a lasting predisposition to generate epileptic seizures and by the neurobiological, cognitive, psychological and social consequences of this affection. The definition of epilepsy requires the occurrence of at least one epileptic seizure. 1% of the population suffers from epilepsy. The most common causes are genetic and vascular, 10% of epileptic syndromes are caused by a tumor.

The incidence of brain tumors in people with epilepsy is approximately 4%. Among patients with brain tumor (s), the frequency of epilepsy is 30% or more depending on type of tumeur. 30-50% of brain tumors are revealed by an epileptic seizure and 10 to 30% of patients with brain tumor (s) will develop seizures during their evolution.

The main objective is to evaluate the frequency of epileptic seizures according to the type of brain tumor.


Eligibility criteria: Inclusion Criteria:

* patient whose age ≥ 18 years
* Patient hospitalized or seen in consultation in the Department of Neurology within the Hospital Group Paris Saint-Joseph
* Diagnosis of primary or secondary brain tumor, radiologically and / or histologically
* Epilepsy revealing or occurring in a patient developing a brain tumor
* Francophone patient

Exclusion Criteria:

* Pre-existing and known epilepsy before the diagnosis of brain tumors
* Epilepsy occurring within 2 weeks postoperatively
* Anteriority of taking antiepileptic treatment
* Patient under tutorship or curatorship
* Patient deprived of liberty
* Patient with comprehension disorders making it impossible to understand the protocol
* Patient or relative opposing the use of his data

Primary outcomes:
measure: number of epileptic seizures
timeFrame: Day 1
Secondary outcomes:
measure: number of epileptic seizures
timeFrame: until 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Roubeau Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03826693: Efficacy of Nitrous Oxide in OCD: Pilot Study
Official title: Efficacy of Nitrous Oxide in OCD: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
nitrous oxide
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2019-02-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled 2:1 randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: This study investigates whether the commonly used and well-tolerated inhaled anesthetic nitrous oxide can rapidly improve symptoms of OCD.

Detailed description: Obsessive-compulsive disorder (OCD) is a chronic and disabling disorder characterized by recurrent intrusive thoughts and associated compulsive behaviors that is estimated to affect more than 3 million individuals in the US each year.

This study seeks to explore whether a single inhalation of nitrous oxide gas may bring about rapid symptom relief in OCD.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Primary diagnosis of OCD
* Sufficient severity of OCD symptoms
* Ability to tolerate a treatment-free period
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric or medical conditions that make participation unsafe
* Pregnant or nursing females
* Concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)

Primary outcomes:
measure: Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Univeristy
name: Peter J van Roessel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02968693: Drug Delivery Devices for Osteomyelitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteomyelitis
Lead sponsor: Yulin Orthopedics Hospital of Chinese and Western Medicine
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 51
Sex: ALL
Minimum age (years): 15
Maximum age (years): 68
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between April 2011 and April 2015, fifty-one patients requiring surgical treatment for chronic post-traumatic/postoperative osteomyelitis of the lower extremities were enrolled in a retrospective and control study in our hospital.

Brief summary: Fifty-one patients suffering from chronic post-traumatic or postoperative osteomyelitis of the lower extremities were included in the retrospective investigation. The patients were assigned to the study group of the combination therapy with antibiotic-loaded calcium sulfate and antibiotic-loaded PMMA or the control group of the antibiotic-loaded PMMA. Hematological parameters, eradication of infection, rate of infection recurrence and reoperation rate were evaluated during the follow-up.


Eligibility criteria: Inclusion Criteria:

* The retrospective study included patients with chronic post-traumatic or postoperative osteomyelitis and excluded patients suffering from hematogenous osteomyelitis or acute post-traumatic or postoperative osteomyelitis.

Exclusion Criteria:

* Other kinds of osteomyelitis.

Primary outcomes:
measure: complications after first-stage surgery.
timeFrame: through study completion, an average of 24 months.
measure: local infection recurrence after first-stage surgery.
timeFrame: through study completion, an average of 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Yulin
country: China
facility: Yulin Orthopedics Hospital of Chinese and Western Medicine
state: Guangxi
Study officials:
References:
citation: Luo S, Jiang T, Yang Y, Yang X, Zhao J. Combination therapy with vancomycin-loaded calcium sulfate and vancomycin-loaded PMMA in the treatment of chronic osteomyelitis. BMC Musculoskelet Disord. 2016 Dec 22;17(1):502. doi: 10.1186/s12891-016-1352-9.
Clinical trial NCT05010993: Establishing Czech Norms of Selected Standardized Tests
Official title: Establishing Czech Norms of Selected Standardized Tests for Use in Rehabilitation and Upper Limbs Functional Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Motor Activity
Keywords: standardized test
occupational therapy
fine motor skills
Nine Hole Peg Test
Purdue Pegboard Test
Box and Block Test
Czech language
norms
healthy population
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 540
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Czech healthy men and women

Brief summary: The main aim of the project is to establish Czech updated manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test to be used in rehabilitation to evaluate upper limb functions, including establishing norms for the Czech healthy population.

Detailed description: The main aim of the project is to establish Czech updated manuals for the Nine Hole Peg Test, Purdue Pegboard Test and Box and Block Test to be used in rehabilitation to evaluate upper limb functions, including establishing norms for the Czech healthy population.

The Czech updated manuals for those tests were made by back-translation method and updated for unification of recommended three trials of each subtest administration and interpretation of tested individuals performance.

At least 540 individuals (20-65 years old) will be tested by the updated Czech manuals till the end of 2023 by those three tests. The Czech norms will be established from acquired data.

Eligibility criteria: Inclusion Criteria:

* Czech language as a mother tongue
* age from 20 to 65 years

Exclusion Criteria:

* diagnosed pathology of the upper limbs or diseases that negatively affect the dexterity of their limbs
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete testing
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague

Primary outcomes:
measure: results from the Nine Hole Peg Test
timeFrame: 10 minutes
measure: results from the Purdue Pegboard Test
timeFrame: 25 minutes
measure: results from the Box and Block Test
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
References:
Clinical trial NCT04243993: Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment
Official title: Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Outcome
Endodontic Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the endodontic outcomes of Bio-MA and ProRoot MTA in pulpotomy, orthograde MTA apical barrier, root perforation repair, endodontic microsurgery.

Detailed description: The patients were recruited at the Endodontic clinic, Faculty of Dentistry, Mahidol University, Thailand. Each treatment was provided following the standard protocol. The calcium silicate based material (Bio-MA or ProRoot MTA) was randomly selected and used in the treatment. The patients were periodically recalled at 6 to 12 months. The outcome of the three treatments based on the clinical and radiographic criteria was assessed by the calibrated examiners and interpreted as ''healed/healing" or ''disease.''

Eligibility criteria: Inclusion Criteria:

* Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery

Exclusion Criteria:

* Teeth with un-restorable condition
* Teeth with crack or fracture
* Teeth with external or internal root resorption
* Teeth with chronic periodontitis with marginal bone loss more than 5 mm

Primary outcomes:
measure: Healed rate
timeFrame: At least 1 year recall
measure: Healing rate
timeFrame: At least 1 year recall
measure: Disease rate
timeFrame: At least 1 year recall
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Nuttida Tungsuksomboon
Study officials:
affiliation: Mahidol University
name: Supachai Sutimuntanakul, TBOD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01220193: Evaluation of RTVue in Corneal Measurement
Official title: Evaluation of RTVue in Corneal Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Cornea
Post Laser Refractive Surgery
Cornea Pathology
Cataract Surgery
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 196
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: Various ocular conditions to include normal, pathology, post refractive surgery and cataract.

Brief summary: The purpose of this study is to evaluate RTVue measurement of the cornea in various ocular conditions to include normal, pathology, post refractive surgery and cataract.


Eligibility criteria: Inclusion Criteria:

Normal cornea:

* 18 years of age or older
* No corneal pathology
* No prior ocular surgery and no prior laser refractive surgery

Post laser refractive surgery:

* 18 years of age or older
* No corneal pathology
* No prior ocular surgery except laser refractive surgery
* At least 1 week post laser refractive surgery without complication

Corneal pathology:

* 18 years of age or older
* Clinical diagnosis of one or more type of corneal pathologies, including corneal scar and keratoconus, etc., excluding eyes in which corneal power measurement are not clinically relevant (e.g., eyes requiring corneal transplant)
* No prior laser refractive surgery

Cataract surgery:

* 18 years of age or older
* No corneal pathology
* No prior ocular surgery, no prior laser refractive surgery, and no prior cataract surgery
* Post surgery visit shall only include eyes without complication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Gordon Binder & Weiss Vision Institute
state: California
city: Latham
country: United States
facility: Brass Eye Center
state: New York
Study officials:
References: