louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06186115: Intraarticular Gold Microparticles for Hip Osteoarthritis
Official title: Intraarticular Gold Microparticles for Hip Osteoarthritis - a 2-year Follow-up Pilot Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis, Hip
Keywords: Hip osteoarthritis
Intra articular gold
Outcome
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2023-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiographically confirmed moderate hip OA .

Brief summary: In a pilot study, the investigators recently showed that intraarticular metallic gold microparticles reduce knee osteoarthritis pain for up to two years and found associated significant proteomic changes in serum and synovial fluid within eight weeks. This study aim to evaluate the outcome after intra-articular injection of gold microparticles for hip osteoarthritis.

Detailed description: A cohort of 20 patients, aged ≥ 18 years, with pain ≥ 3 months, and Kellgren-Lawrence OA grade 2-4, will beincluded. Metallic gold 20 mg, 72.000 pieces, 20-40 µ-meter (Berlock-Micro-Implants, HumanGoldInject) (1) were injected into the hip joint using hyaluronic acid as the carrier. In total, we treated 24 hip joints. The primary outcome was the Western Ontario and McMaster Universities Arthritis Index (WOMAC).

Eligibility criteria: Inclusion Criteria:

* confirmed moderate hip OA (Kellgren-Lawrence grade ≥ 2), pain for more than 3 months, and maximal pain intensity VAS (Visual Analogue Scale, 0-10) ≥ 5 during the last week

Exclusion Criteria:

* exclusion criteria were 1) malignancy, 2) active infection and antibiotic treatment, 3) active treatment with steroids, biological or other anti-rheumatic medication, 4) history of chronic pain condition, 5) inability to comply with the protocol, and 6) inadequacy in written and spoken national language.

Primary outcomes:
measure: WOMAC
timeFrame: 2 year
Secondary outcomes:
measure: PainDetect
timeFrame: 2 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Northern Jutland
Study officials:
affiliation: Northern ODD
name: Sten Rasmussen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen S, Kjaer Petersen K, Kristiansen MK, Skallerup J, Aboo C, Thomsen ME, Skjoldemose E, Jorgensen NK, Stensballe A, Arendt-Nielsen L. Gold micro-particles for knee osteoarthritis. Eur J Pain. 2022 Apr;26(4):811-824. doi: 10.1002/ejp.1909. Epub 2022 Feb 1.
citation: Danscher G, Rasmussen S. nanoGold and microGold inhibit autoimmune inflammation: a review. Histochem Cell Biol. 2023 Mar;159(3):225-232. doi: 10.1007/s00418-023-02182-9. Epub 2023 Mar 2.
citation: Rasmussen S, Frederickson C, Danscher G. Inhibition of Local Inflammation by Implanted Gold: A Narrative Review of the History and Use of Gold. J Rheumatol. 2023 May;50(5):704-705. doi: 10.3899/jrheum.221150. Epub 2023 Mar 15. No abstract available.
Clinical trial NCT05395715: Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome
Official title: Conditioning Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cubital Tunnel Syndrome
Electrical Stimulation
Keywords: Cubital tunnel syndrome
Nerve regeneration
Electrical stimulation
Functional outcomes
Randomized control trial
Surgery
Peripheral nerve regeneration
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomized controlled study
Primary purpose: TREATMENT

Brief summary: Cubital tunnel syndrome is the second most common compression neuropathy. In severe cases, functional recovery, even with surgery, is often poor. Therefore, alternative adjunct treatments capable of increasing the speed of nerve regeneration are much needed.

Detailed description: The effect of brief conditioning electrical stimulation on nerve regeneration has been showed to be efficacy in animal studies. In this double-blind, randomized, controlled study, the investigators will compare the physiological and functional improvements post surgery compared with the controls who received surgery alone. Because electrical stimulation is reasonably well-tolerated and the treatment only takes an hour, it is a potentially feasible clinical tool for patients with severe nerve injury.

Eligibility criteria: Inclusion Criteria:

1. Patients aged \>18 yr,
2. If signs and symptoms of severe CuTS (ie, McGowan-Goldberg grade 3) were observed,
3. If needle EMG examination showed evidence of chronic motor axonal loss and reduced recruitment in the ulnar-innervated intrinsic hand muscles, and
4. If electrophysiologic evidence of severe motor axonal loss with motor unit number estimation (MUNE) greater than 2 standard deviations below the normative mean.

Exclusion Criteria:

1) Patients were excluded if they had concurrent nerve injury, prior surgery for CuTS or coexisting neurologic conditions

Primary outcomes:
measure: Motor unit number estimation
timeFrame: 3 years
Secondary outcomes:
measure: Key pinch strength
timeFrame: 3 years
measure: Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: 3 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT03231215: The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery
Official title: The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy of dexamethasone when added to epidural bupivacaine on the duration of postoperative analgesia in patients underwent total knee replacement surgery.

Detailed description: Fifty patients underwent total knee replacement were included in the study. The patients (11 male and 39 female) were classified into two equal groups:- The patients received 15 mL plain bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups was 17 ml.

Postoperative records:

1. Pain score (NRS) at base line, then every 4 hrs for 24 hrs.
2. Frequency of rescue analgesia.
3. Postoperative side effects like nausea, vomiting, and over sedation.

Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for total knee replacement surgery.
2. ASA Physical status I,II,III.

Exclusion Criteria

1. Patients' refusal.
2. Uncooperative patients / Not able to understand pain assessment test.
3. Patients with history of allergy to the used drugs.
4. Significant liver disease.
5. Pregnancy.
6. Any contraindication for epidural anesthesia
7. Failed technique.

Primary outcomes:
measure: duration of postoperative analgesia (NRS)
timeFrame: 24 hrs postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00090415: Early Characteristics of Autism
Official title: UW STAART Center of Excellence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism
Autistic Disorder
Keywords: Autism
Developmental Delay Disorders
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-08-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.

Detailed description: Children with autism often suffer from social, educational, and functional problems. By understanding the social, linguistic, psychological, and physiological differences that distinguish between autistic children, developmentally delayed children, and children with typical development, researchers may be able to recognize autism early in life so that children with autism can be helped as early as possible and their long-term outcome can be improved.

Children in this study will be enrolled for 2 years. They will receive annual evaluations throughout the two-year period. They will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study. Communication and social behavior scales, an early development interview, observations of parent/child interaction, and neuropsychological, cognitive, and adaptive behavioral measures will be used to assess participants.

Eligibility criteria: Inclusion Criteria for Autistic Participants:

* Diagnosis of autism

Inclusion Criteria for Developmentally Delayed Participants:

* Exhibiting current delays in development

Inclusion Criteria for Participants with Normal Development:

* Exhibiting normal development

Inclusion Criteria for All Participants:

* Overall good health

Primary outcomes:
measure: Communication and social behavior scales; an early development interview; observations of parent/child interaction; and neuropsychological, cognitive, and adaptive behavioral measures
timeFrame: Measured at Year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Elizabeth Aylward, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.
Clinical trial NCT01478815: Contingency Management for Persons With Severe Mental Illness
Official title: Contingency Management for Persons With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-11-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Contingency management is efficacious for treating cocaine abuse, but contingency management interventions have rarely been applied to patients with severe and persistent mental health problems. This pilot project will estimate effect sizes of contingency management for reducing cocaine use in patients receiving psychiatric care at a large community based mental health program. In total, 30 cocaine abusing patients will be randomized to one of two 8-week treatment conditions: standard care or standard care with contingency management. Patients in both conditions will provide breath and urine samples for toxicology testing twice per week. In the contingency management condition, patients will receive the opportunity to win prizes for submitting cocaine negative urine samples. The investigators expect that patients receiving contingency management will evidence reductions in cocaine use and may show improvements in psychiatric symptoms and psychosocial functioning relative to patients in standard care. Effect size estimates obtained from this study will be used to guide larger scale and longer duration evaluations of contingency management for dually diagnosed patients.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* meet DSM-IV criteria for cocaine abuse or dependence
* English speaking
* pass a brief quiz regarding study procedures to ensure understanding of the informed consent process.

Exclusion Criteria:

* dementia
* in recovery from pathological gambling

Primary outcomes:
measure: longest continuous period of cocaine abstinence
timeFrame: Week 8
Secondary outcomes:
measure: other drug use and psychosocial problems
timeFrame: Week 8
Other outcomes:
Locations:
city: New Britain
country: United States
facility: Community Mental Health Affiliates, Inc.
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petry NM, Alessi SM, Rash CJ. A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. Drug Alcohol Depend. 2013 Jun 1;130(1-3):234-7. doi: 10.1016/j.drugalcdep.2012.10.017. Epub 2012 Nov 20.
Clinical trial NCT03792815: Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)
Official title: Open-labelled, Multicenter Phase II Clinical Trial of Intravenous Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation in Patients With Poor-risk, Refractory or Relapsed Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Transplantation Conditioning
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators developed a protocol utilizing once-daily intravenous busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).

Detailed description: Treatment:

busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2

Eligibility criteria: Inclusion criteria

1. Histologically confirmed aggressive NHL
2. Mantle cell lymphoma
3. salvage chemotherapy sensitive relapse/refractory NHL
4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
5. Age; 18-65
6. Adequate renal function: serum creatinine ≤ 1.5mg/dL
7. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value

Exclusion criteria

1. low grade NHL
2. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
3. Other serious illness or medical conditions

   * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
   * History of significant neurological or psychiatric disorders
   * Active uncontrolled infection (viral, bacterial or fungal infection)
4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
5. HIV (+)
6. Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period

Primary outcomes:
measure: rate of event free survival
timeFrame: from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years
Secondary outcomes:
measure: rate of event free survival
timeFrame: at least 2 years
measure: rate of regimen related toxicity
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jong-Ho Won, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814515: Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
Official title: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Dry Eye Syndrome
Keywords: Moderate
Severe
Dry
Eye
Ciclosporin
Cyclosporine
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2008-12-25
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome


Eligibility criteria: Inclusion Criteria:

* Males or females 18 years of age or greater.
* At baseline, moderate to severe dry eye condition persisting despite conventional management.

Exclusion Criteria:

* Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
* Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
* Any other ocular diseases requiring topical ocular treatment during the study period.
* Patient who has participated in a clinical trial with a new active substance during the past month before study entry.
* Participation in another clinical study at the same time as the present study.

Primary outcomes:
measure: Corneal fluorescein staining (on modified Oxford scale)
timeFrame: Approximately 26 weeks
measure: Patient's global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%-100%
timeFrame: Approximately 26 weeks
Secondary outcomes:
measure: • Ocular Symptom Disease Index© (OSDI©) questionnaire • Percentage of complete responder to corneal fluorescein staining (on modified Oxford scale), i.e. with corneal staining score =0 • Patient's score of each symptom of ocular discomfort unrelated to
timeFrame: Approximately 26 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital des XV-XX
state: Île-de-France
Study officials:
References:
Clinical trial NCT01972815: Reproducibility and Reliability of Epstein-Barr Virus (EBV) DNA/RNA Measures in Nasopharyngeal Swabs
Official title: Reproducibility and Reliability of Epstein-Barr Virus (EBV) DNA/RNA Measures in Nasopharyngeal Swabs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suspect NPC Patients
NPC Multiplex Families
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: suspect NPC patients

Brief summary: Nasopharyngeal carcinoma (NPC) is a virus-associated cancer that is rare among Caucasians but occurs at an elevated rate among Southern Asians. Rates of NPC are particularly high among individuals with a family history of this disease, but no specific genetic factors have been identified that can serve to guide clinical management of this high-risk population to ensure early detection and treatment of this life-threatening condition.


Eligibility criteria: Inclusion Criteria:

* suspect NPC patients

Exclusion Criteria:

-

Primary outcomes:
measure: positive agreement among the positives, coefficient of variation
timeFrame: Four years
measure: positive agreement among the positives, coefficient of variation
timeFrame: four years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Nation Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Jen Lou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00866385: AZD8566 Food Effect/Microtracer Study
Official title: An Open, Randomised, Phase I, 2-Period Crossover Trial to Investigate the Absolute Bioavailability and the Effect of Food on the Oral Bioavailability of AZD8566 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Keywords: Healthy Volunteer
AZD8566
Food Effect
Microtracer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
* Females who are permanently or surgically sterile or post-menopausal and males

Exclusion Criteria:

* History of any convulsions or seizures
* History of infection or risk of infection due to recent surgery or trauma
* History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the study drug

Primary outcomes:
measure: Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food
timeFrame: Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose
Secondary outcomes:
measure: Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events
timeFrame: Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events.
measure: Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose
timeFrame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
measure: Intravenous pharmacokinetics
timeFrame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS
name: Jo Collier, Dr,MB, ChB
role: PRINCIPAL_INVESTIGATOR
References: