louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05214586: Conservative Treatment of Ingrown Toenail
Official title: Conservative Treatment of Ingrown Toenail in Stages I or IIa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ingrown Nail
Nails, Abnormal
Keywords: Ingrown toenail
Conservative treatment
Recurrence
Podiatry
Nail remodelling
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2022-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for consultation in podiatry clinics. In the initial stages of the pathology, conservative treatments are the first choice of therapy. The aim was therefore, to analyze and compare the efficacy of the technique of nail re-education with gauze bandage and nail remodelling for the conservative treatment of onychocryptosis in stage I and IIA, A prospective, longitudinal, randomised clinical trial-type analytical study is proposed. A sample of 20 subjects with stage I and IIA onychocryptosis will be selected. Of these, 10 cases were part of the gauze bandage nail re-education group and the remaining 10 cases were part of the nail remodelling group.


Eligibility criteria: Inclusion Criteria:

* Ingrown toenail in stage I or IIa (Mozena Classification)

Exclusion Criteria:

* Patients not allowed for clinical follow-up of the evolution of the pathology.
* Patients presented with deforming pathologies
* Pattens had been surgically operated for ingrown toenail

Primary outcomes:
measure: Recurrence of the disease
timeFrame: 3 months
Secondary outcomes:
measure: Reported pain
timeFrame: Every clinic visit of the patient until 3 months
measure: Infection
timeFrame: Every clinic visit of the patient until 3 months
measure: Swelling
timeFrame: Every clinic visit of the patient until 3 months
measure: Patient satisfaction
timeFrame: Every clinic visit of the patient until 3 months
Other outcomes:
Locations:
city: Plasencia
country: Spain
facility: Alfonso Martínez Nova
state: Cáceres
Study officials:
References:
Clinical trial NCT00646386: Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
Official title: Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis
Psoriatic
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 315
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: Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis


Eligibility criteria: Inclusion Criteria:

* Moderate to severe PsA
* Inadequate response to DMARD therapy
* Corticosteroid stable dose \<= 10 mg QD
* DMARDs must have been taken for 3 months and stable dose for 4 weeks
* MTX maximum dose = \<= 30 mg/week
* Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria:

* No other active skin disease

Primary outcomes:
measure: ACR20
timeFrame: Week 12
measure: Adverse Events
timeFrame: Throughout study participation
measure: Sharp Score
timeFrame: Week 24
Secondary outcomes:
measure: ACR20, 50, 70
timeFrame: Weeks 12, 24
measure: Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI
timeFrame: Weeks 12 and 24
Other outcomes:
Locations:
Study officials:
References:
citation: Landewe R, Ritchlin CT, Aletaha D, Zhang Y, Ganz F, Hojnik M, Coates LC. Inhibition of radiographic progression in psoriatic arthritis by adalimumab independent of the control of clinical disease activity. Rheumatology (Oxford). 2019 Jun 1;58(6):1025-1033. doi: 10.1093/rheumatology/key417.
citation: Mease PJ, Heckaman M, Kary S, Kupper H. Application and modifications of minimal disease activity measures for patients with psoriatic arthritis treated with adalimumab: subanalyses of ADEPT. J Rheumatol. 2013 May;40(5):647-52. doi: 10.3899/jrheum.120970. Epub 2013 Mar 15.
Clinical trial NCT00925886: Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Official title: Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Astigmatism
Keywords: Astigmatism
Cataract
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate neutralization of keratometric astigmatism in patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the implantation of a toric intraocular lens.

Detailed description: Patients with Cataract are treated with phacoemulsification of the lens with an implantation of an intraocular lens. Besides cataract, almost 25% of these patients have some degree of Astigmatism; when it is higher than 1 diopter, it is possible to neutralize it with an implantation of a toric intraocular lens.

Eligibility criteria: Inclusion Criteria:

* Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.

Exclusion Criteria:

* Irregular astigmatism,
* Keratoconus,
* Previous Refractive Surgery.

Primary outcomes:
measure: Neutralization of Astigmatism
timeFrame: 3 months after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociacion Para Evitar la Ceguera en Mexico
state: D.f.
Study officials:
References:
citation: Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
Clinical trial NCT03024086: Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia
Official title: Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Dyspepsia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 124
Sex: ALL
Minimum age (years): 19
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 the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.


Eligibility criteria: Inclusion Criteria:

* Male of female of at least 19 years old
* Patient with functional dyspepsia met the ROME III criteria

Exclusion Criteria:

* Patients with previous gastrointestinal surgery
* Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
* Patients with history of gastrointestinal cancer

Primary outcomes:
measure: The change from baseline in GIS (Gastrointestinal Symptom Score)
timeFrame: At 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
References:
Clinical trial NCT00845286: Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial
Official title: Investigation of Myocardial Function and Vascular Adaptation in Association With Genotype in Marathon Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Sudden Cardiac Death
Keywords: exercise, myocardial dysfunction, endothelial dysfunction,
polymorphism
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 162
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with genotype/polymorphisms. We aim to investigate the effects of extreme endurance exercise on the cardiovascular system. Furthermore, the role of the inflammatory response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.

Detailed description: Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

Diagnostic tools include measurements of augmentation index (AIx), arteriolar-venular ratio (AVR) and, for the first time, 2D and 3D echocardiographic measurements such as TDI-imaging and speckle tracking. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor. Additionally, cardiovascular markers are measured. All variations are analysed on the basis of genotype characteristics/polymorphisms.

Eligibility criteria: Inclusion Criteria:

* men aged 30-60 years

Exclusion Criteria:

* manifested heart disease
* insulin dependent diabetes mellitus
* multi drug therapy
* GFR\<60ml/min.

Primary outcomes:
measure: E/A ratio
timeFrame: pre-, post-, one day follow-up
Secondary outcomes:
measure: LV twist
timeFrame: pre-, post-, one day follow-up
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Prevention and Sports medicine
state: Bavaria
Study officials:
References:
Clinical trial NCT04455386: Diagnostic Study of Lateral Ligament Complex Injury of Ankle
Official title: Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Ligament Complex Injury of Ankle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Instability of Ankle Joint
Lateral Ligament Complex Injury of Ankle
Keywords: Lateral Ligament complex
Ankle
Diagnostic Methods
Chronic Lateral Instability of Ankle
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic lateral ligament complex injury of the ankle were divided into 3 groups and each group with 25 cases, according to the anterior drawer test and talar tilt test.

Brief summary: Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle

Detailed description: Background: The lateral ligament complex of ankle joint consisting of the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain, swelling and other symptoms, but also can lead to chronic lateral ankle instability, and osteoarthritis, which could seriously affect the joint motor function.

Method and objective: This study is a prospective diagnostic test. By comparing the sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and characteristics of different diagnostic methods of lateral chronic ankle instability, We aim to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.

Eligibility criteria: Inclusion Criteria:

* Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.

Exclusion Criteria:

* Acute and subacute injury of the lateral ligament complex of the ankle joint (less than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage IV).

Primary outcomes:
measure: anterior talar translation and talar tilt
timeFrame: before operation
measure: length of ATFL and CFL in relax and stress position
timeFrame: before operation
measure: Morphology of ATFL and CFL
timeFrame: before operation
measure: status of ATFL and CFL
timeFrame: during operation
Secondary outcomes:
measure: avulsion fracture
timeFrame: before operation
measure: osteophyte
timeFrame: before operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qinwei Guo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06736886: Effect of Light Color Temperature Applied During Breastfeeding on Mother's Stress, Anxiety, Peace and Breastfeeding Motivation
Official title: Effect of Light Color Temperature Applied During Breastfeeding on Mother's Stress, Anxiety, Peace and Breastfeeding Motivation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Light
Stress
Anxiety
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breastfeeding is an important condition for the health of the mother and the baby, which is the most difficult for mothers after birth. Since it is an important practice for both the mother and the baby, the evaluation and reduction of the mother's stress factors can help the hospital to regulate the lighting of the breastfeeding room. In addition, setting the light color temperature to a more appropriate kelvin can make a positive contribution to the hospital in terms of costs. For this purpose, when researchers look at the literature, we have not come across a randomized controlled study examining the effect of the light color temperature applied during breastfeeding on the mother's stress, anxiety, peace and breastfeeding motivation. Researchers' purpose is to determine the effect of the light color temperature applied during breastfeeding on the mother's stress, anxiety, peace and breastfeeding motivation.


Eligibility criteria: Inclusion Criteria:

* Mothers who have given birth for the first time,
* being 18 years of age and older,
* volunteering.

Exclusion Criteria:

* Being a mother who has given birth to more than one child,
* having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding disorders),
* receiving psychiatric treatment (pharmacotherapy or psychotherapy),
* having a disease that prevents vision.

Primary outcomes:
measure: stress scale
timeFrame: 2 minutes
measure: anxiety scale
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05318586: Individualized rTMS Based on fNIRS to Spasticity
Official title: Effect of Individualized rTMS Based on fNIRS on the Upper Limb Spasticity After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Spasticity, Muscle
Rehabilitation
Keywords: Stroke
Spasticity, Muscle
Rehabilitation
fNIRS
rTMS
Activation
Brain network
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is of high morbidity and mortality, and surviving patients are often unable to take care of themselves because of severe motor dysfunction. The brain has plasticity, and makes adaptive changes after stroke, resulting in the reorganization and compensation of neural networks. However, the muscle tone of some patients will significantly increase during the recovery process, which affects the rehabilitation effect. Neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been widely used to promote brain network remodeling after stroke. The investigators attempted to evaluate the motor brain network characteristics of spastic patients by fNIRS, and used the most active brain regions as rTMS stimulation regions to evaluate the improvement effect of this individualized treatment on post-stroke spasticity.


Eligibility criteria: Inclusion Criteria:

* Aged 40-79 years;
* Patients with first-onset stroke within 1 to 3 months after onset;
* Consciousness, sitting balance level 1 or above, can cooperate with fNIRS assessment;
* The patient or its authorized agent signs the informed consent form.

Exclusion Criteria:

* Previous seizures;
* Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;
* Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.

Primary outcomes:
measure: modified Ashworth scale
timeFrame: 1 month
Secondary outcomes:
measure: Fugl-Meyer Assessment of upper limb motor function
timeFrame: 1 month
measure: Barthel index
timeFrame: 1 month
measure: average weighted clustering coefficient
timeFrame: 1 month
measure: global efficiency
timeFrame: 1 month
measure: inter-density
timeFrame: 1 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
Clinical trial NCT02877186: Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
Official title: Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This pilot study is being conducted to evaluate whether consumption of diet soda sweetened with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a one week run-in period, healthy, young adults are randomized to consume either diet soda or carbonated water (control) three times per day for one week. Stool and urine samples are collected at baseline, following the run-in, and after the one-week intervention.


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18-35 years
* Consume less than 1 food/beverage with non-nutritive sweeteners per month
* Able and willing to consume diet soda three times daily for 1 week

Exclusion Criteria:

* Recent diet or significant weight change
* Antibiotic use in the past 3 months
* Diarrhea in the past two weeks
* Use of medications known to affect metabolism or weight
* Weight \< 50 kg (110 lbs.)
* History of metabolic complications including high blood sugar, elevated cholesterol, or liver disease

Primary outcomes:
measure: Taxa abundance before and after one-week of three times daily diet soda consumption
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sylvetsky AC, Walter PJ, Garraffo HM, Robien K, Rother KI. Widespread sucralose exposure in a randomized clinical trial in healthy young adults. Am J Clin Nutr. 2017 Apr;105(4):820-823. doi: 10.3945/ajcn.116.144402. Epub 2017 Feb 22.
Clinical trial NCT02985086: Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis
Official title: The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Infection During Pregnancy (Diagnosis)
Neonatal Infection
Keywords: term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection
Lead sponsor: Hospital de Santa Maria, Portugal
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 568
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.

Detailed description: In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).

Eligibility criteria: Inclusion Criteria:

* term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.

Exclusion Criteria:

* active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery

Primary outcomes:
measure: Maternal and neonatal infection rate
timeFrame: intrapartum and immediate postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria, CHLN, EPE
Study officials:
References: