louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01510535: Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis
Official title: An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Osteoartritis
Knee
LBSA0103
Hyruan Plus Inj.
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-01-16
Enrollment: 287
Sex: ALL
Minimum age (years): 40
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 compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* Over 40 years of age
* Kellgren \& Lawrence grade I-III
* If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS
* Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study

Exclusion Criteria:

* Body mass index \> 32
* Have rheumarthritis
* Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS
* Have Sudek's atrophy, Paget's disease, Spinal disc herniation
* Kellgren \& Lawrence Grade IV

Primary outcomes:
measure: Weight-bearing pain
timeFrame: 12 weeks after the last injection
Secondary outcomes:
measure: Weight-bearing pain
timeFrame: 1,6 weeks after the last injection
measure: WOMAC-likert assessment
timeFrame: 1,6,12 weeks after the last injection
measure: Patient Global Assessment
timeFrame: 1,6,12 weeks after the last injection
measure: Investigator Global Assessment
timeFrame: 1,6,12 weeks after the last injection
Other outcomes:
Locations:
city: Jongno-gu
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul
Study officials:
References:
citation: Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4.
Clinical trial NCT03359135: Compression Garments on Hypermobility Type of Ehlers-Danlos Syndrome (CGhEDS)
Official title: Compression Garments Effects on Postural Balance of Patients With Hypermobility Type of Ehlers-danlos Syndrome, a Prospective Study on 40 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypermobility Type Ehlers-Danlos Syndrome
Keywords: Compression garment
Lead sponsor: Hôpital Raymond Poincaré
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hypermobility type of Ehlers-Danlos syndrome

Brief summary: This study evaluates the effects of wearing a compression garment on the postural balance of patients with hypermobility type of Ehlers-Danlos syndrome, in randomised controlled study.


Eligibility criteria: Inclusion Criteria:

* Age ≥16 years
* hEDS with the 2017 diagnostic criteria .
* A normal neurological examination with no sensory disorders, no cerebellar syndrome or vestibular syndrome.
* An optimal balanced analgesic treatment before inclusion
* Patients who have not modified their physical treatment (physiotherapy) since 6 months.

Exclusion Criteria:

* Surgery of the lower limb (hip, knee or ankle)
* Patient having already wear compression garments in the year preceding.
* Neurological history of sensory , vestibular or cerebellar disorders.

Primary outcomes:
measure: Centre of pression speed
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Gader Nadra
Study officials:
References:
Clinical trial NCT01771835: Retinal Venous Pressure and ET-1 in Patients With Diabetes Mellitus
Official title: Measurement of Retinal Venous Pressure and Endothelin-1 in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
retinal venous pressure
endothelin-1
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabets mellitus type I or II, without diabetic retinopathy

Brief summary: Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.

Detailed description: Diabetic retinopathy and maculopathy are the main causes of visual loss. Hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. These in turn lead to hypoxia in the tissue and promote the release of VEGF (vascular endothelial growth factor) , which in turn increases the vascular pathology. Simultaneously, there is an increased expression of endothelin (ET-1). Endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling.

In ocular blood flow perfusion pressure plays an important role. While in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. An increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. A measurement of the retinal venous pressure and the hormone ET-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.

Eligibility criteria: Inclusion Criteria:

* diabetes mellitus type I or II
* no diabetic retinopathy

Exclusion Criteria:

* known diabetic retinopathy
* acute or chronic inflammation of the eyes
* narrow angle glaucoma
* minority

Primary outcomes:
measure: Quantification of retinal venous pressure (RVP)
timeFrame: 30 minutes
Secondary outcomes:
measure: Quantification of ET-1 in correlation with RVP
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Dept. of Ophthalmology
Study officials:
affiliation: University of Basel, Dept. of Ophthalmology
name: Josef Flammer, MD
role: STUDY_DIRECTOR
References:
citation: Cybulska-Heinrich AK, Baertschi M, Loesche CC, Schoetzau A, Konieczka K, Josifova T, Flammer J. Patients with diabetic retinopathy have high retinal venous pressure. EPMA J. 2015 Feb 24;6(1):5. doi: 10.1186/s13167-015-0027-1. eCollection 2015.
Clinical trial NCT06444035: Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome
Official title: 35kDa Hyaluronan Fragment Injection Treatment Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Wound
Myofascial Pain Syndrome
Lead sponsor: Nakhia Impex LLC
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 10
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: To verify the efficacy and safety of HA35 in chronic pain management and to further supplement effective treatments for chronic pain, we designed a proof-of-concept clinical study. This study aims to evaluate the 15-day treatment of HA35 on patients with myofascial pain syndrome and to observe the effects for up to 3 months.


Eligibility criteria: Inclusion Criteria:

* Male and female, aged 18-65 years old ;
* suffering from muscle strain, sprain, fall, wind and other diagnosed as myofascitis in patients with chronic back pain;
* the pain reported by the subject should reach level 3 or higher on the digital rating scale of 0-10 ( 0 means no pain, 10 represents the strongest pain imaginable );
* the mental state is good, and the pain level can be evaluated independently;
* be able to cooperate with the treatment independently and sign a written consent.

Exclusion Criteria:

* Previous severe trauma with permanent musculoskeletal dysfunction;
* symptomatic lumbar disc herniation with neurological deficits;
* specific spinal diseases, including rheumatoid arthritis, ankylosing spondylitis, and osteoporosis;
* diagnosed with mental illness;
* agree not to sign the written consent;
* pregnant, lactating or fertile women;
* currently participating ( or participating in the past 30 days ) in research-based treatment or equipment trials.

Primary outcomes:
measure: Chronic myofascial pain score
timeFrame: after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days
Secondary outcomes:
measure: Overall pain assessment during injection therapy and follow-up
timeFrame: after treatment 15 days, 30 days, 60 days, 90 days
measure: Satisfaction survey of injection treatment
timeFrame: after treatment 90 days
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Nahia Impex Llc
Study officials:
References:
Clinical trial NCT05001035: Effect of Different Biomimetic Materials on White Spot Lesions in Enamel
Official title: Effect of Different Biomimetic Materials on White Spot Lesions in Enamel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 21
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split mouth technique
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy of these agents on disappearance of these white spots.


Eligibility criteria: Inclusion Criteria:

* Total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment.
* These patients will be selected according to age groups between 15-25 years old
* good oral hygiene
* free of destroying habits for dental tissues

Exclusion Criteria:

* Bruxism
* soft drinks consumption
* acid regurgitation, etc.).
* Selected teeth having any cracks, malformations, dysplasia or caries.

Primary outcomes:
measure: change in remineralization from base line to time limit
timeFrame: Immediate and one month and two months
measure: changes of appearance from base line photograph to time limit
timeFrame: Immediate and one month and two months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine for girls branch of Alazhar University
Study officials:
References:
Clinical trial NCT05158335: Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of MBX 2109 in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single and Multiple Ascending Doses of MBX 2109 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: MBX Biosciences
Sponsor class: INDUSTRY
First posted: 2021-12-15
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers.

This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women (of nonchildbearing potential) between 20 and 60 years of age, inclusive.
2. Body mass index between 20.0 and 32.0 kg/m2, inclusive.
3. No clinically meaningful findings on physical examination, electrocardiogram, laboratory tests or vital signs
4. Subject has been given signed informed consent

Exclusion Criteria:

1. History of any significant illness or disorder
2. Acute illness within 30 days of administration of first dose of study drug
3. Positive screening result for HIV, hepatitis B or hepatitis C
4. History of or current substance abuse (drug or alcohol) within past 1 year or positive test for drugs of abuse during screening
5. Use of nicotine-containing or vaping products within 3 months prior to screening or check-in
6. Use of cannabis within 45 days prior to check-in
7. Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening or platelets within 6 weeks prior to screening
8. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within past 30 days

Primary outcomes:
measure: Primary Outcome Measures
timeFrame: Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary outcomes:
measure: Secondary Outcome Measures 1
timeFrame: Baseline through Day 40 (part A) or Day 60 (Part B)
measure: Secondary Outcome Measures 2
timeFrame: Baseline through Day 40 (part A) or Day 60 (Part B)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Labcorp Drug Development: Clinical Research Unit
state: Texas
city: Madison
country: United States
facility: Labcorp Drug Development: Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: MBX Biosciences
name: Mary Jane Geiger, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00688558: Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Official title: A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Simvastatin 40 mg in Patients With Low HDL Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low HDL


Eligibility criteria: Inclusion Criteria:

* Patients having lipid values as indicated below:
* HDL-C ≤ 1.0 mmol/L (40 mg/dL)
* TG ≤4.5 mmol/L (400 mg/dL)
* Patients with CHD or CHD risk equivalent
* Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index of ≥ 35 kg/m2
* Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
* Concomitant use of medications identified in the protocol

Primary outcomes:
measure: % change from baseline in HDL-C; inhibition of CETP activity
timeFrame: 4-weeks
Secondary outcomes:
measure: % change from baseline in LDL-C and TC/HDL-C
timeFrame: 4-weeks
measure: Plasma concentration of JTT-705
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
Study officials:
References:
Clinical trial NCT06262958: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence in Adolescent
Official title: REAL-SMART: Recognition and Early Intervention for Alcohol and Substance Abuse in Adolescence, REAL/Systemic Metabolic Alterations Related to Different Psychiatric Disease Categories in Adolescent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcoholism
Substance Abuse
Alcohol Dependence
Alcohol-Related Disorders
Substance Use Disorders
Adolescent Behavior
Adolescent Problem Behavior
Keywords: alcohol
substance
abuse
mini-intervention
adolescent
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 800
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clients are randomized into two groups: 1) those receiving TAU and 2) those receiving a mini-intervention for substance and alcohol use an add-on treatment.
Primary purpose: TREATMENT

Brief summary: ASSIST mini-intervention is applied in an electric form in adolescent outpatients to see if it

Detailed description: All 14-20-year-old patients admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during 2017-2028 are requested to participate. At admission (baseline), the patients are interviewed by the research nurse and asked to fill out questionnaires. The interview includes a semi-structured diagnostic interview (SCID). The participants are interviewed again in six months (follow-up), and the interview is identical to the one conducted in the admission phase.

Eligibility criteria: Inclusion Criteria: Admitted to the Kuopio University Hospital (KUH) adolescent psychiatric outpatient clinic during the years 2016-2019

Exclusion Criteria: Unable to understand the questionnaires

Primary outcomes:
measure: Decreased consumption of alcohol, tobacco or substances
timeFrame: 6 months
Secondary outcomes:
measure: BDI scores
timeFrame: 6 months
measure: GAD scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Professor
name: Tommi T Tolmunen, Docent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01293058: Randomized Trial of Intranasal Versus Intravenous Naloxone in Level of Consciousness in Suspected Opioid Overdose
Official title: Study of Routs of Naloxone Administration for Opioid Overdosed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Morphinan Opioid Overdose
Keywords: opioid
overdose
naloxone
intranasal
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which route of administration is better for treatment of opioid overdosed patients

Detailed description: In intravenous drug abusers (IDUs), as a result of previous intravenous substance abuse, the predictable difficult cannulate exist and cause the delay administration of antidote therapy. Additionally, IDUs are also at increased risk of carrying blood borne infections that could be transmitted to healthcare workers through needle stick injuries. The investigators aimed to compare intranasal administration of naloxone with intravenous route.

Eligibility criteria: Inclusion Criteria:

* Patients with the range of 15-50 years old

  * Who were suspicious to opioid overdoses based on history and having clinical appearance such as miotic pupils with loss of consciousness
  * Give response to naloxone with increasing the level of consciousness

Exclusion Criteria:

* Not giving response to naloxone and suspicious to have another reason for loss of consciousness

Primary outcomes:
measure: level of consciousness
timeFrame: 4 min after naloxone administration
Secondary outcomes:
measure: blood pressure
timeFrame: at 4 min after naloxone administration
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Noor university hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Nastaran Izadi, A.Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056858: Study of a Candidate Gene Involved in Goldenhar Syndrome.
Official title: Identification and Investigation of a Gene Involved in Monogenic Forms of Goldenhar Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Goldenhar Syndrome
Oculoauriculovertebral Dysplasia
Keywords: array-CGH
exome sequencing
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 248
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of 120 patients affected with Goldenhar/spectrum of oculoauriculovertebral dysplasia , whose phenotype is finely characterized, and that were analyzed using an oligonucleotide array-CGH pangenomic approach

Brief summary: The aim of this study is to identify of the first gene involved in the Goldenhar syndrome in a cohort of 120 affected patients.

Detailed description: Goldenhar syndrome belongs to the heterogeneous spectrum of oculoauriculovertebral dysplasia. Several chromosomal abnormalities have been described associated with this spectrum, and furthermore mutations in different genes of development cause abnormalities of the jaw or facial asymmetries in human or mouse. To date, no gene has been identified as formally involved in the genesis of the OAVS, despite evidence of familial cases, mostly with autosomal dominant inheritance.

The aim of this study is to identify of the first gene involved in the Goldenhar syndrome in a cohort of 120 affected patients.

Eligibility criteria: Inclusion Criteria:

* Spectrum of oculoauriculovertebral dysplasia minimal features include unilateral microtia and hemifacial microsomia

Exclusion Criteria:

* Absence of minimal spectrum of oculoauriculovertebral dysplasia features, molecular anomaly identified, other diagnosis

Primary outcomes:
measure: presence of sequence variation
timeFrame: At the screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bordeaux Universitu Hospital
name: Caroline ROORYCK THAMBO, Dr
role: PRINCIPAL_INVESTIGATOR
References: