louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06905743: Isometric Contraction-Based Pain Modulation Versus Eccentric Strengthening in Treating Achilles Tendinopathy
Official title: Isometric Contraction-Based Pain Modulation Versus Eccentric Strengthening in Treating Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Achilles Tendinopathy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Achilles tendinopathy is a common overuse injury that leads to pain and functional limitations. Traditional rehabilitation focuses on eccentric strengthening, which has been widely studied for its benefits in promoting tendon remodeling and improving strength. However, recent research suggests that isometric contractions may offer superior pain modulation effects, especially in the early stages of rehabilitation.

Detailed description: This study aims to compare the effectiveness of isometric contraction-based pain modulation versus eccentric strengthening in treating Achilles tendinopathy. Isometric exercises involve maintaining a static muscle contraction, which has been shown to reduce pain through neuromuscular mechanisms, potentially making it a valuable alternative or complement to eccentric loading.

Eligibility criteria: Inclusion Criteria:

* Clinically Diagnosed with Achilles Tendinopathy using MRI
* At least 3 months incidence period of Achilles Tendinopathy
* Must be able to attend all treatment sessions and follow-up assessments.
* Ability to walk independently without any assistive devices.

Exclusion Criteria:

* Severely restricted ROM of ankle
* Patients who underwent surgery for Achilles tendinopathy
* Patients who had undergone previous surgery of lower limb extremity
* Those using ankle orthosis
* Patients with systemic diseases affecting ankle (osteoarthritis, rheumatoid arthritis, and osteoporosis)
* Individuals with neurological disorders affecting the lower limbs.
* Systemic Conditions like diabetes, cardiovascular diseases.

Primary outcomes:
measure: NUMERIC PAIN RATING SCALE (NPRS):
timeFrame: 12 Months
measure: PRESSURE ALGOMETRY:
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Punjab Social Security Health Management Hospital Manga Raiwind
state: Punjab
Study officials:
References:
Clinical trial NCT02329743: Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
Official title: A Multicenter, Double-Masked, Parallel-Group, Vehicle-Controlled Study to Assess the Efficacy and Safety of RX-10045 Nanomicellar Ophthalmic Solution for Treatment of Ocular Inflammation and Pain in Subjects Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation
Pain
Cataract
Lead sponsor: A.T. Resolve SARL
Sponsor class: INDUSTRY
First posted: 2015-01-01
Enrollment: 256
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 primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag.

Exclusion Criteria:

* Any additional surgical procedures at the time of the cataract surgery
* Refractive surgery in the study eye within the past 2 years
* History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye
* Intraocular pressure of \> 21 mm Hg in either eye
* Proliferative or severe nonproliferative diabetic retinopathy in either eye
* Neovascular/wet age-related macular degeneration in either eye

Primary outcomes:
measure: Proportion of Subjects With Clearing of Anterior Inflammation
timeFrame: Day 8
Secondary outcomes:
measure: Proportion of Subjects Reporting no Ocular Pain
timeFrame: Day 3
Other outcomes:
Locations:
city: Murray Hill
country: United States
facility: Auven Therapeutics
state: New Jersey
Study officials:
affiliation: Auven Therapeutics
name: Tomasz Sablinski, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05035043: Economic Burden of NAFLD
Official title: The Economic Burden of Non-Alcoholic Fatty Liver Disease Patients in Flanders, Belgium
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
NAFLD
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine the economic burden of NAFLD (Non-Alcoholic-Fatty-Liver Disease) patients in Belgium, Flanders by means of a bottom-up approach.


Eligibility criteria: Inclusion Criteria:

* having NAFLD as was diagnosed by FibroScan®,
* 18 years or older
* BMI ≥ 25 kg/m²

Exclusion Criteria:

* unable to give informed consent
* \>70 years

Primary outcomes:
measure: iMTA MCQ
timeFrame: baseline
Secondary outcomes:
measure: iMTA MCQ
timeFrame: Baseline
measure: EuroQol-5D-5L
timeFrame: baseline
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Geert Robaeys, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Leen Heyens
role: STUDY_CHAIR
References:
Clinical trial NCT05283343: Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision
Official title: Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Thickness
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing pachymetry measurement

Brief summary: Agreement and Precision of corneal thickness measurement (pachymetry) function of the test device TRK-3 and the predicate device SP-1P will be evaluated in volunteers, and safety will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Individuals who gave written informed consent to participate in the clinical trial by their free will.
2. Individuals who aged 20 years or older at the time of informed consent
3. Individuals who were deemed eligible for the study by the investigator for screening prior to enrollment.
4. Subjects who are able to comply with compliance items during participation in the clinical trial, undergo medical examination and examination specified in the protocol, and report subjective symptoms, etc.

Exclusion Criteria:

1. Individuals with ocular diseases that may affect corneal thickness measurement (blindness, corneal perforation, bullous keratopathy, nystagmus, etc.) or who have a history of ocular diseases and are considered by the investigator to be ineligible for participation in the study.
2. Individuals who have or are suspected of suffering from ocular or systemic infections.
3. Other persons who are judged by the investigator to be unfavorable candidates for the study.

Primary outcomes:
measure: Corneal thickness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Samoncho Clinic
Study officials:
References:
Clinical trial NCT01744743: Preconceptional Thyroid Screening and Childhood Nerocognitive Function
Official title: Preconceptional Thyroid Screening and Childhood Nerocognitive Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothyroidism
Keywords: preconception
hypothyroidism
neurocognitive development
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Science and Technology Commission
name: Shanghai Municipal Health Bureau
First posted: 2012-12-07
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.

Detailed description: Epidemic evidence and animal studies suggested that hypothyroidism is related with maternal pregnancy outcome, offspring cognitive ability. Negro's study found improved maternal health in those screened in early trimester; while Lazarus et al. reported no significant offspring IQ score at 3yrs in universal screening in early trimester. Currently, it lacks evidence of universal pre-conception screening for maternal pregnancy outcome and offspring cognitive development, motivation ability, attention. China Governmental Health Department has included thyroid function screening into preconception in 2011. The investigators hypothesize that pre-conception effective treatment may be helpful for decrease possible negative effects on maternal and offspring health, instead of early trimester.

Eligibility criteria: Inclusion Criteria:

1. Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
2. age: 18-55
3. those who can obey the rules of this study and assign the consent

Exclusion Criteria:

1. age: less than 18 or more than 55
2. multiple pregnancy
3. thyroid tumor disease history
4. those who cannot obey the rules of this study

Primary outcomes:
measure: Offspring neurocognitive assessment at 0-3 yrs
timeFrame: 3 months, 6 months, 1 year, 2 years, 3 years
measure: Offspring IQ assessment at 0-3 yrs
timeFrame: 3 months, 6 months, 1 year, 2 years, 3 years
Secondary outcomes:
measure: Incidence of neonatal hypothyroid and complications
timeFrame: up to 28 days of birth
Other outcomes:
measure: Incidence of maternal complications
timeFrame: up to 42 days postpartumn
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Obstetrics and Gynecology Hospital, Fudan University
name: Xiaotian Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou Q, Wang C, Xu H, Li X. Impact of Preconception Treatment Initiation for Hypothyroidism on Neurocognitive Function in Children. J Clin Endocrinol Metab. 2020 Nov 1;105(11):dgaa565. doi: 10.1210/clinem/dgaa565.
Clinical trial NCT05311943: Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
Official title: Treatment With Olverembatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Failed to at Least Two Previously Administered Second-generation Tyrosine Kinase Inhibitors: a Prospective, Single-arm Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Olverembatinib
Chronic Myeloid Leukemia, Chronic Phase
Tyrosine Kinase Inhibitors
Keywords: olverembatinib, CML-CP
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤75 years.
* Diagnosis of CML-CP.
* ECOG performance of 0-2.
* Adequate end organ function defined as the following: total bilirubin \<1.5xULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
* Resistance and/or intolerance of at least two second-generation TKIs.
* Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

* Known to be allergic to study drug ingredients or their analogues.
* History of undergone major surgery within 4 weeks.
* Patients unwilling or unable to comply with the protocol.
* Pregnant or breast-feeding patients.
* patients with other malignant tumor.

Primary outcomes:
measure: The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of patients with MMR at 3, 6, 9 months.
timeFrame: 3, 6, 9 months.
measure: The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
timeFrame: 3, 6, 9, 12 months.
measure: Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
timeFrame: 3, 6, 9, 12 months.
measure: Progression free survival (PFS)
timeFrame: 12 months
measure: Overall survive (OS)
timeFrame: 12 months
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.
timeFrame: 12 months.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Xin Du, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT06047743: Comparison of Upper and Lower Extremity Isometrics on Cognition in Healthy Adolescents
Official title: Comparison of Upper and Lower Extremity Isometrics on Cognition in Healthy Adolescents: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adolescents
Keywords: Cognition
Isometrics
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effects of upper and lower-extremity isometrics on cognition in healthy adolescents.

Detailed description: The literature suggests a positive impact of isometrics on cognition. Identifying how cognitive results would differ in upper vs. lower extremity isometric groups is the main objective of the study. for cognitive assessment, different aspects of cognition will be measured by all computer-based tools (except for Trail making A and B).

Eligibility criteria: Inclusion Criteria:

* School-going adolescents
* Both male and female students with a minimum age of 12 and a maximum of 18yrs
* Students with good school attendance
* Subjects who are willing to commit to the time commitments required by the program

Exclusion Criteria:

* Students with Physical or mental disabilities
* Those who suffered a fracture before
* Students with any morbidity

Primary outcomes:
measure: Corsi Block Test
timeFrame: Baseline
measure: Corsi Block Test
timeFrame: After 4 weeks
measure: Corsi Block Test
timeFrame: After 8 weeks
measure: Free and delayed recall test
timeFrame: Baseline
measure: Free and delayed recall test
timeFrame: After 4 weeks
measure: Free and delayed recall test
timeFrame: After 8 weeks
measure: Go/ No Go task
timeFrame: Baseline
measure: Go/ No Go task
timeFrame: After 4 week
measure: Go/ No Go task
timeFrame: After 8 weeks
measure: Stroop test
timeFrame: Baseline
measure: Stroop test
timeFrame: After 4 weeks
measure: Stroop test
timeFrame: After 8 weeks
measure: Trail making A
timeFrame: Baseline
measure: Trail making B
timeFrame: Baseline
measure: Trail making A
timeFrame: After 4 weeks
measure: Trail making B
timeFrame: After 4 weeks
measure: Trail making A
timeFrame: After 8 weeks
measure: Trail making B
timeFrame: After 8 weeks
Secondary outcomes:
measure: Borg Category-Ratio scale (CR)-10 Scale
timeFrame: Baseline
measure: Borg Category-Ratio scale (CR)-10 Scale
timeFrame: After 4 weeks
measure: Borg Category-Ratio scale (CR)-10 Scale
timeFrame: After 8 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Academy of Islamic and Modern Studies (AIMS)
state: Punjab
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01506843: Sublingual Immunotherapy in Children With Allergic Rhinitis
Official title: Clinical Efficacy and Mucosal/Systemic Antibody Response Changes After Sublingual Immunotherapy in Mite-allergic Children in a Randomized Double-blind, Placebo-controlled Study in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Keywords: IgA antibody
IgE antibody
IgG1/IgG4 subclasses
Mite allergy
Sublingual immunotherapy
Saliva
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-01-10
Enrollment: 122
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.

Detailed description: Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of allergic rhinitis
* Positive skin test to Dermatophagoides pteronyssinus total extract
* Positive serum levels of specific IgE to D. pteronyssinus extract

Exclusion Criteria:

* Previous allergen immunotherapy
* Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test
* Long term use of systemic corticosteroid.
* Airway infection 30 days prior to the selection.
* Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy.
* Users of cigarette smoke
* Presence of severe skin lesions

Primary outcomes:
measure: Change from Baseline in Symptom and Medication Scores at 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change from Baseline in Specific Antibody Levels.
timeFrame: Baseline, 12 months and 18 Months
Other outcomes:
Locations:
city: Itumbiara
country: Brazil
facility: Asthma and Rhinitis Control Program
state: Goias
Study officials:
affiliation: Federal University of Uberlandia
name: Ernesto A Taketomi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03468543: Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects
Official title: A Study Designed to Determine the Gastro-Retentive and Modified Release Properties of Memantine Hydrochloride (HCl) Prototype Capsule Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Gastric Retention
Healthy
Lead sponsor: Lyndra Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).

Detailed description: This is a single center, open-label, single dose, 5-period study in 24 healthy male and female subjects, with an optional Period 6, if required. It is expected the study will be executed in 3 cohorts of 8 subjects, with each cohort participating in up to 2 study periods (total of up to 6 study periods). Cohort 3 may be conducted in parallel with Cohort 2.

Subjects will be dosed in a sequential manner, as appropriate. Each subject will be administered up to 2 regimens (2 different prototype capsule formulations) across 2 study periods. There will be a minimum 35-day interval between each dose administration.

Subjects will have an MRI scan performed on Days 2, 4, 7, 10 and 14 of each period to assess the gastric retentive properties of the formulation.

Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects.
2. Body mass index of 18.0 to 32.0 kg/m2.
3. Subjects must demonstrate their ability to swallow a test capsule at screening.
4. Must provide written informed consent.

Exclusion Criteria:

1. Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.
2. Subjects who have previously been enrolled in this study.
3. History of any drug or alcohol abuse in the past 2 years.
4. Current smokers and those who have smoked within the last 12 months.
5. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential for complications, thereof
6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
7. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
8. Individuals with contraindication to MRI imaging.

Other protocol defined criteria may apply.

Primary outcomes:
measure: Gastric Retention by Magnetic Resonance Imaging (MRI)
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences (formerly Quotient Clinical)
state: Nottingham
Study officials:
affiliation: Quotient Clinical
name: Stuart Mair, MBChB, DRCOG
role: STUDY_DIRECTOR
References: