louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05487729: Low Back Pain Prevalence
Official title: Low Back Pain Prevalence in Young Adults.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Local Stabilizers
ODI
Keywords: low back pain
local stabilizers
ODI
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Brief Summery: Low back pain is a significant, serious and widespread problem in our world today, both in terms of social and economic burdens. It should be emphasized that even the young adult age group is very often affected by non-specific, low back pain without proven pathoanatomical changes.

The aim of our current study is to assess the prevalence of low back pain among young adults, and we would like to examine the musculoskeletal and psychosocial factors associated with low back pain that can be justified as risk factors. Our further goal is to assess and compare lumbar sensorimotor control in young people without complaints and with low back pain.


Eligibility criteria: Inclusion Criteria:

* in case of patients with low back pain: chronic pain
* in case of asymptomatic individuals: no symptomes

Exclusion Criteria:

* serious neurologycal symptomes
* serious scoliosis
* previous surgery which affected the local stabilizers
* serious pulmonar disease

Primary outcomes:
measure: DIAGNOSTICAL ULTRASOUND - MUSCULOSKELETAL ULTRASOUND
timeFrame: 12 minutes
measure: NEUROCOM BASIC BALANCE MASTER
timeFrame: 20 minutes
measure: STABILIZER PRESSURE BIOFEEDBACK
timeFrame: 5 minutes
measure: ZEBRIS CMS-10 ULTRASOUND SYSTEM
timeFrame: 10 minutes
measure: The Functional Movement Screen (FMS)
timeFrame: 10 minutes
measure: STABILITY LIMIT TESTS
timeFrame: 12 minutes
Secondary outcomes:
measure: VISUAL ANALOG SCALE
timeFrame: 1 minute
measure: MEDICAL HISTORY RECORD SHEET
timeFrame: 3 minutes
measure: OSWESTRY DISABILITY INDEX
timeFrame: 3 minutes
measure: ROLAND-MORRIS QUESTIONNAIRE
timeFrame: 2 minutes
measure: THE QUEBEC BACK PAIN DISABILITY SCALE (QBPDS)
timeFrame: 2 minutes
measure: SHORT FORM-36 HEALTH SURVEY
timeFrame: 4 minutes
measure: THE STATE-TRAIT ANXIETY INVENTORY (STAI Y-1,2 form))
timeFrame: 4 minutes
measure: THE PERCEIVED STRESS SCALE (PSS)
timeFrame: 2 minutes
measure: THE BECK DEPRESSION INVENTORY (BDI, BDI-1A, BDI-II)
timeFrame: 4 minutes
measure: LOW BACK PAIN KNOWLEDGE QUESTIONNAIRE (LKQ)
timeFrame: 2 minutes
measure: COMI
timeFrame: 2 minutes
measure: ZUNG
timeFrame: 1 minute
measure: PISQ-IR
timeFrame: 2 minutes
measure: FSFI
timeFrame: 3 minutes
measure: GAUDENZ
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged
state: Csongrád-Csanád
Study officials:
References:
Clinical trial NCT04228029: Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
Official title: Does Carboxytherapy Play a Role in Alopecia Areata Either Solely or in Combination? Comparative Study for Treatment of Alopecia Areata Using Carboxytherapy and Intralesional Steroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alopecia Areata
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Patients with three lesions of alopecia areata are randomly recruited in this study. Each lesion is randomized in to receiving either carboxytherapy in one lesion, intralesional steroids in another lesion and combination of both in the third lesion.

Treatment period is 3 months followed by a follow-up period of 2 months.


Eligibility criteria: Inclusion Criteria:

* early localized scalp alopecia areata
* patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent.

Exclusion Criteria:

* pregnant, and lactating females and those with unrealistic expectation.
* Alopecia totalis or universalis or ophiasis or cicatrising alopecia
* Usage of systemic treatment of alopecia areata 2 months prior to the study.
* Any scalp lesion within the treated area
* Bleeding diathesis, severe anemia or platelet disorders
* Medical conditions such as autoimmune diseases.

Primary outcomes:
measure: Severity of Alopecia Tool (SALT) score
timeFrame: 6months-1 year
measure: Dermoscopy
timeFrame: 6months-1 year
measure: blinded observer evaluation by use of photography
timeFrame: 6months-1 year
measure: patient satisfaction rate
timeFrame: 6months-1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr ElAiny Hospital, Cairo university
state: El Manial
Study officials:
References:
citation: Metwally D, Abdel-Fattah R, Hilal RF. Comparative study for treatment of alopecia areata using carboxy therapy, intralesional corticosteroids, and a combination of both. Arch Dermatol Res. 2022 Mar;314(2):167-182. doi: 10.1007/s00403-021-02201-6. Epub 2021 Mar 19.
Clinical trial NCT06926829: A Long-term Trial of EB-1020 in Adult Patients With ADHD
Official title: A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan


Eligibility criteria: Inclusion Criteria:

* Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).
* Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.

Exclusion Criteria:

* Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.
* Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.
* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:

  * Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or
  * Reported suicidal behavior
* Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.
* Participants who test positive for drugs or alcohol in a urine test on baseline visit.

Primary outcomes:
measure: Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline, week52
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Maynds Tower Mental Clinic
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Nobuhito Sanada
role: STUDY_DIRECTOR
References:
Clinical trial NCT01396629: Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
Official title: Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cartridge IOL
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with senile cataract or Nuclear Sclerosis grade I and grade II and age between 40-60

Brief summary: The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.

Detailed description: Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This cartridge is used as lens delivery system for foldable lens implantation while doing cataract surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating would be useful for smooth delivery of intraocular lens.

Eligibility criteria: Inclusion Criteria:

* Age 40 to 60
* Senile cataract
* Nuclear Sclerosis grade I and grade II

Exclusion Criteria:

* Inherent zonular weakness
* Shallow anterior chamber
* PXF
* Traumatic cataract
* Uveitis and Complicated cataract
* Dense PSCC and PPC

Primary outcomes:
measure: intra operative complication
timeFrame: post operative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamilnadu
Study officials:
affiliation: HOD of IOL & Cataract clinic, Aravind Eye Hospital, Madurai
name: Dr. Haripriya Aravind, MBBS., MS.,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00043329: Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis
Official title: Post-Marketing Surveillance Study of Actimmune (Interferon Gamma-1b) in Patients With Severe Malignant Osteopetrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopetrosis
Keywords: Registry
Actimmune
osteopetrosis
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2002-08-20
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Osteopetrosis patients receiving Actimmune therapy

Brief summary: The purpose of this study is to establish a registry of all children with severe, malignant osteopetrosis who are treated with Actimmune (IFN-g 1b or Interferon gamma-1b) to monitor the effects of IFN-g 1b on preventing progression of this disease and to follow the safety of patients receiving it on a long-term basis. In addition, evaluation of the possible effect of Actimmune therapy on the humoral response to normal childhood vaccinations in this same patient population will be examined.Interferon gamma is a substance that the body makes naturally.

Detailed description: It is made by white blood cells and appears to be involved in regulating the body's ability to fight off infection. Actimmune is a synthetic form of Interferon gamma which is similar to that normally made by white blood cells.

IFN-g 1b (Actimmune®) is currently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with chronic granulomatous disease (CGD) to reduce the frequency and severity of serious infections. It is also approved in patients with severe, malignant osteopetrosis to delay the time to disease progression. In research trials, IFN-g 1b has been given to over 2,000 patients in diseases such as CGD, osteopetrosis, atopic dermatitis, pulmonary fibrosis, atypical mycobacteria and various cancers.

Eligibility criteria: * Male or female
* Diagnosis of severe, malignant osteopetrosis
* Currently receiving or planning to initiate therapy with Actimmune (Interferon gamma-1b)
* Willing to attend follow-up appointments every 6 months following enrollment into the study, if clinically indicated

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: InterMune, Inc.
state: California
Study officials:
affiliation: InterMune
name: Steven Porter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03518229: Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors
Official title: Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Melanoma (Skin)
Keywords: cancer prevention
sunburn
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Melanoma Research Alliance
First posted: 2018-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. The use of wearable technology devices has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. The investigators will pilot test the technology device versus a similar control device in 80 melanoma survivors and compare sunburns between the two groups after the three month intervention.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* Diagnosed with stage I-III cutaneous invasive melanoma between 2009 and 2017 and treated at the University of Minnesota
* Able to read/write in English
* Own a smartphone
* Able to provide voluntary informed consent

Exclusion Criteria:

-Patients currently undergoing adjuvant therapy.

Primary outcomes:
measure: Sunburn
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05816629: Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules
Official title: Multiparameter Ultrasound Based-AI for the Diagnosis of Thyroid Nodules: an International Multi-center Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Thyroid Nodule
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with thyroid nodule

Brief summary: The cases that fulfill the inclusion criteria will be enrolled with written informed consent. Images and videos will be collected in accordance with the procedure, uploaded to Ruiying Cloud, followed up, and registered with basic case information, such as thyroid function, FNA/surgical pathology results, etc.


Eligibility criteria: Inclusion Criteria:

* 18\~80 years old;
* Thyroid nodules (ACR-TI RADS category 3-5，category 3 nodules ≥1cm submitted for FNA) or clustered micro-calcifications;
* The patients schedule to perform FNA/surgery within 1 month;
* Without any history of invasive procedure of thyroid before (such as FNA,CNB, ablation, radiation, or surgery).

Exclusion Criteria:

* Incomplete data;
* Contraindications of CEUS

Primary outcomes:
measure: Number of Participants with 1827 Nodule Classification
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZJU
state: Zhejiang
Study officials:
References:
Clinical trial NCT01117129: A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)
Official title: Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab \[MabThera/Rituxan\] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is \<50 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age
* active rheumatoid arthritis (DAS28-CRP\>3.2)
* refractory to one or more anti-TNF
* on stable treatment for RA for \>/=4 weeks
* evidence of erosive disease and/or synovitis in wrist and/or knuckles

Exclusion Criteria:

* active systemic or local infection
* previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
* signs of immunodeficiency, HIV infection or tuberculosis
* contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent

Primary outcomes:
measure: Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)
timeFrame: 6 months
Secondary outcomes:
measure: Synovitis score on MRI using RAMRIS
timeFrame: months 6, 12 and 24
measure: Bone edema score on MRI using RAMRIS
timeFrame: months 6, 12 and 24
measure: Bone erosion score on MRI using RAMRIS
timeFrame: months 12 and 24
measure: Disease activity according to DAS28-CRP
timeFrame: months 12 and 24
measure: Tender or swollen joint count (ACR criteria)
timeFrame: months 12 and 24
measure: Health assessment questionnaire (HAQ)
timeFrame: months 12 and 24
Other outcomes:
Locations:
city: Barcelona
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03542929: Acute Whole Body Vibration Change the Glycemic and Lactate Levels
Official title: Acute Whole Body Vibration Decrease the Glucose Levels in Elderly Diabetic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 29
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The type II diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels. The Whole body vibration session may improve the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. Ten healthy elderly women and eight diabetic elderly women were allocated into two groups, and have made an acute whole body session.


Eligibility criteria: Inclusion Criteria:

* elderly between 60 to 74 years,
* sedentary according the International Physical Activity Questionnaire (IPAQ- short form)
* For diabetic group, were considered who those medical diagnoses of type II diabetes for at least 02 complete years, who had used only oral hypoglycemic agents of biguanides class (Metformin extended release - XR) in dosage between 500 to 850 mg.
* For healthy elderly group were considered elderly women without self-reported diseases

Exclusion Criteria:

* diabetic volunteers who have ingested the breakfast less than 02 hours or more than 03 hours and those who have taken Metformin less than 02 hours before the intervention.

For all volunteers, the complementary exclusion criteria were:

* the current or past smoking or alcoholic habits;
* the cardiovascular, liver or neuromuscular diseases;
* subjects with prior labyrinthitis or embolic events;
* who have had any surgery in last year;
* volunteers with metallic prosthesis as pacemaker, pins or plates;
* volunteers with advanced osteoporosis;
* which had difficulties during the evaluation or acute protocol.

Primary outcomes:
measure: Changes in glucose levels
timeFrame: before and immediately after the 10 minute intervention
measure: Changes in lactate levels
timeFrame: before and immediately after the 10 minute intervention
Secondary outcomes:
measure: peripheral oxygen saturation (SpO2)
timeFrame: before and immediately after the 10 minute intervention
measure: heart rate (HR)
timeFrame: before and immediately after the 10 minute intervention
measure: Borg's Rating of Perceived Exertion Scale (RPE) or Modified Borg Scale
timeFrame: before and immediately after the 10 minute intervention
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Maíra F Pessoa
state: Pernambuco
Study officials:
References: