louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03271333: Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.
Official title: Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma and Analysis of Associated Factors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with systemic sclerosis and Diffuse Infiltrating Pneumonia

Brief summary: Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.


Eligibility criteria: Inclusion Criteria:

* systemic sclerosis
* Diffuse Infiltrating Pneumonia

Exclusion Criteria:

* infection
* other lung diseases
* non French native

Primary outcomes:
measure: composite criteria: forced vital capacity and CO diffusing capacity
timeFrame: At 24 months
Secondary outcomes:
measure: composite criteria: forced vital capacity and CO diffusing capacity
timeFrame: At 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
city: Paris 12
country: France
facility: AH-HP, Hôpital Saint Antoine
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05213533: Kanagawa Intravenous and Endvascular Treatment Registry
Official title: Kanagawa Intravenous and Endovascular Treatment Registry for Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: acute stroke, mechanical thrombectomy, intravenous tPA
Lead sponsor: St. Marianna University Toyoko Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Kanagawa prefecture in Japan

Brief summary: The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.

Detailed description: Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion. There were no exclusion criteria. The local neurologists, neurosurgeons, and neurointerventionalists at each institution made the decision to perform EVT and intravenous tPA.

The primary outcome was good as defined by the modified Rankin Scale (mRS) of 0 to 2 at three months. We also determined a favorable outcome: mRS 0-2 or not worsening of the mRS score at three months. Secondary analyses included predicting a favorable outcome using multivariate logistic regression analysis.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion.

Exclusion Criteria:

There were no exclusion criteria. There are no upper or lower age limits for this study.

Primary outcomes:
measure: modified Rankin Scale
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kawasaki
country: Japan
facility: St.Marianna University Toyoko Hospital
state: Kanagawa
Study officials:
affiliation: St. Marianna University Toyoko Hospital
name: Toshihiro Ueda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04498533: Bracing or Kinesio Taping in The Management of Lateral Epicondylitis
Official title: Bracing or Kinesio Taping in The Management of Lateral Epicondylitis: a Randomized Single-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis (Tennis Elbow)
Keywords: Lateral epicondylitis
forearm counterforce brace
kinesio taping
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized and assessor-blinded study
Primary purpose: OTHER

Brief summary: Lateral epicondylitis is an overuse syndrome of the forearm, which is associated with pain and sensitivity in the lateral elbow region.

The aim of the study was to find out about is there any difference between the effects of traditional orthotic devices and adhesive taping, in the management of lateral epicondylitis. Therefore, the forearm counterforce brace, which was widely used in daily clinical practice for lateral epicondylitis, was compared with kinesio tape, a new technique of adhesive taping which has become increasingly popular. The study investigated and compared the effects of the two interventions (the forearm counterforce brace and kinesio tape) on pain severity, functional status and disability of patients with lateral epicondylitis.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 65 years
* presence of elbow pain lasting for less than three months

Exclusion Criteria:

* history of acute trauma or fracture on forearm
* congenital or acquired elbow deformities
* demyelinating diseases
* patients who had diagnosed as fibromyalgia
* presence of skin lesion on lateral aspect of the elbow
* presence of rheumatic disease
* presence of systemic infection
* presence of pregnancy
* presence of malignancy

Primary outcomes:
measure: Pain Pressure Threshold
timeFrame: Baseline to 3 week (İmmediately after treatment)
measure: Grip Strength
timeFrame: Baseline to 3 week (İmmediately after treatment)
Secondary outcomes:
measure: Patient-Rated Tennis Elbow Evaluation Questionnaire
timeFrame: 0 week (Baseline), 3 week (After treatment), 7 week (One month later after treatment)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University of Health Sciences, Istanbul Haseki Training and Research Hospital
Study officials:
affiliation: University of Health Sciences, Istanbul Haseki Training and Research Hospital
name: Öznur Çelik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Struijs PA, Smidt N, Arola H, Dijk vC, Buchbinder R, Assendelft WJ. Orthotic devices for the treatment of tennis elbow. Cochrane Database Syst Rev. 2002;(1):CD001821. doi: 10.1002/14651858.CD001821.
Clinical trial NCT02079233: Evaluation of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
Official title: Phase 1 Multiple Dose Trial to Assess the Safety, Tolerability and Efficacy of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Basic Science
Safety
Tolerability
Efficacy of CLP
Lead sponsor: Sorbent Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer is ≥ 18 years of age with BMI of 18-32
* Females could not be pregnant or breast feeding and had to be using birth control
* Must have regular bowel habits, typically producing at least 1 daily bowel movement

Exclusion Criteria:

* Screening 12-lead ECG demonstrating QTc interval \>430 msec for males and \>450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant
* History or presence of gastrointestinal conditions
* Positive drug screen for substances of abuse
* Positive results for HIV, hepatitis B, or hepatitis C

Primary outcomes:
measure: Change in fecal sodium content
timeFrame: Baseline (Days 3-6) vs. Treatment (Days 10-13)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jasper Clinic, Inc.
name: Shanthini A. Daniel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00221533: Relation Between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial Stiffness in Renal Transplant Recipients
Official title: Relation Between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial Stiffness in Renal Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Diseases
Arterial Stiffness
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Relation between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial Stiffness in Renal Transplant Recipients


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 80 years, extremes included
* Kidney transplants with or without other transplant organs
* Informed consent
* Stable clinical condition on the basis of a pre-trial physical examination, medical history, and the results of blood biochemistry and haematology tests

Exclusion Criteria:

* Pregnant, lactating females
* Recent (\< 4 weeks) change in antihypertensive drug medication
* Current or recent (\< 2 weeks) acute illness such as infection or bleeding
* Current treatment for malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Francis Verbeke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06955533: Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms
Official title: Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stent Related Symptoms
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a randomized clinical trial conducted on 64 Egyptian patients from the outpatient clinic at Ain Shams University Hospital over a six-month period from 3/2024 to 9/2024.The study population was randomized into 2 groups. Group A included 32 patients with stent related symptoms receiving double doses of tamsulosin (Tamsulin® 0.4 mg 2 capsules taken together per day) and Solifenacin 10mg (Sofenacin® 10mg tab taken once daily).Group B included 32 patients with stent related symptoms receiving a standard dose of tamsulosin (0.4 mg once daily) and solifenacin (5 mg once daily).


Eligibility criteria: Inclusion Criteria:

- We included patients older than18 years of age, with presence of a double-J (DJ) stent in place, suffering from lower urinary tract symptoms (LUTS).Patients younger than 18 years of age, patients with a history of prostate or bladder surgery, lower urinary tract procedures, cancer, neurological conditions, pelvic radiation, diabetes, kidney dysfunction (acute or chronic), a solitary kidney, congenital urinary anomalies, or those taking medications such as α-blockers, beta-blockers, calcium channel blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, anticholinergics, or nitrates were excluded. Additionally, patients with cardiac issues, residual stone fragments after surgery, multiple or bilateral ureteral stones, long-term or bilateral stents requiring frequent changes, interstitial cystitis, chronic cystitis, prostatitis, pregnant or breastfeeding women, and those unavailable for follow-up were also excluded from the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Improvement of ussq
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
Clinical trial NCT01593033: Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy
Official title: Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Enteropathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 225
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the therapeutic effectiveness of micronutrients (full RDA) and micronutrients + fish oil as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.


Eligibility criteria: Inclusion Criteria:

* 1-3 years of age
* Lives in study villages
* Will not move in next 6 months
* Caregiver willing to give intervention daily for 6 months

Exclusion Criteria:

* Unable to drink 20 mL of sugar water
* Demonstrating evidence of severe acute malnutrition, WHZ \< or = -3, presence of bi-pedal pitting edema
* Apparent need for acute medical treatment for an illness or injury
* Caregiver refusal to participate and return for 3 and 6 month follow-ups

Primary outcomes:
measure: Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: Changes in the expression of several fecal mRNAs
timeFrame: 3 months, 6 months
measure: Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested
timeFrame: 3 months, 6 months
measure: Change in height
timeFrame: 3 month, 6 month
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Saint Louis Nutrition Project
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith HE, Ryan KN, Stephenson KB, Westcott C, Thakwalakwa C, Maleta K, Cheng JY, Brenna JT, Shulman RJ, Trehan I, Manary MJ. Multiple micronutrient supplementation transiently ameliorates environmental enteropathy in Malawian children aged 12-35 months in a randomized controlled clinical trial. J Nutr. 2014 Dec;144(12):2059-65. doi: 10.3945/jn.114.201673. Epub 2014 Oct 1.
Clinical trial NCT06356233: Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy
Official title: Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: STXBP1 Encephalopathy With Epilepsy
Keywords: STXBP1
Lead sponsor: Fundación Iniciativa para las Neurociencias (FINCE)
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under 10 years of age with confirmed mutation for STXBP1 willing to collaborate in the study.

Brief summary: This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF).


Eligibility criteria: Inclusion Criteria:

* Patients under 10 years of age with confirmed mutation for STXBP1. In cases where the diagnostic technique for the mutation is not optimal, a trio exome will be performed to confirm the mutation.

Exclusion Criteria:

* Presence of functional disability that prevents the neuropsychological study from being carried out and absence of a reliable informant for the patient.

Primary outcomes:
measure: CSF biomarkers
timeFrame: Baseline, 1 year and 2 years
measure: EEG markers
timeFrame: Baseline, 1 year and 2 years
measure: MRI markers
timeFrame: Baseline, 1 year and 2 years
Secondary outcomes:
measure: Clinical phenotype
timeFrame: Baseline, 1 year and 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
Study officials:
References:
Clinical trial NCT01013233: Cognitive Training to Improve Cognitive Function Following Chemotherapy
Official title: Training of Cognitive Function of Patients After Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Dysfunction
Keywords: cognitive dysfunction chemotherapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Freie Universität Berlin
First posted: 2009-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to improve cognitive dysfunction following chemotherapy, the investigators investigated to see whether a cognitive training for memory and concentration skills can improve cognitive performance in patients following cancer treatment.

Detailed description: Patients following chemotherapy invited for a cognitive training. Before and after cognitive function will evaluate.

Eligibility criteria: Inclusion Criteria:

* patients with cancer 6 weeks after chemotherapy

Exclusion Criteria:

* patients with neurological or psychiatric disorders
* patients without compliance

Primary outcomes:
measure: several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3)
timeFrame: one weeks following the end of the cognitive training
Secondary outcomes:
measure: quality of life and subjective perception of cognitive problems
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Freie Universität Berlin
name: Michael Niedeggen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02252133: DAILIES TOTAL1® Lens Centration in a Japanese Population
Official title: Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Refractive Error
Keywords: Contact lenses
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-09-30
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.


Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent document.
* Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
* Symptoms of contact lens discomfort as defined by protocol.
* Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
* Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
* Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
* Acceptable contact lens fit with both study contact lenses.
* Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing DT1 or 1DAVTE.
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
* History of herpetic keratitis, ocular surgery or irregular cornea.
* Prior refractive surgery (e.g. LASIK, PRK, etc).
* Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
* Judged ineligible as a patient in this clinical study by the investigator.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Success Rate of Lens Centration After 7 ± 2 Days of Wear
timeFrame: Day 7, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Contact Alcon Japan Ltd. for Trial Locations
Study officials:
affiliation: Alcon Japan, Ltd.
name: Senior Manager, Clinical Development
role: STUDY_DIRECTOR
References: