louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01097447: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)
Official title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Keratoconus
Ectasia
Degeneration
Keywords: Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
Lead sponsor: Cxlusa
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 2619
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication


Eligibility criteria: Inclusion Criteria:

* 8 years of age or older
* Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
* Diagnosis of FFKC
* History of Radial Keratotomy with fluctuating vision.
* Ability to provide written informed consent
* Likely to complete all study visits
* Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

Exclusion Criteria:

* Severe corneal scarring that markedly affects vision
* Contraindications to any study medications or their components
* Pregnancy or breast feeding
* Active Herpes Corneal Disease

Primary outcomes:
measure: Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
timeFrame: 1 year
Secondary outcomes:
measure: increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clear View Eye & Laser Medical Center
state: California
city: Littleton
country: United States
facility: Corneal Consultants of Colorado, P.C
state: Colorado
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, LTD
state: Illinois
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, P.A.
state: Minnesota
city: Dallas
country: United States
facility: Cornea Associates of Texas
state: Texas
Study officials:
affiliation: Chicago Cornea Consultants, LTD
name: Parag Majmudar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corneal Consultants of Colorado, P.C
name: Lance Forstot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornea Associates of Texas
name: Bradley Bowman, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Clear View Eye & Laser Medical Center
name: Sandy Feldman, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Eye Consultants, P.A.
name: Sherman Reeves, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04671147: Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis
Official title: Short-Term Preoperative Traction Method for Rigid and Severe Scoliosis: A Comparison Between Skull Tongs-Femoral Traction and Cotrel Longitudinal Traction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis Idiopathic
Lead sponsor: Indonesian Orthopaedic Association
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severe (\>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018

Brief summary: The investigators collected retrospective data of severe (\>80o) and rigid scoliosis patients who underwent preoperative traction before correction surgery from 2016 to 2018. The first group consisted of patients who underwent Cotrel traction exercises and second group underwent continuous-progressively increasing Skull Tongs Femoral Traction (STFT) traction. Posterior fusion was performed in all patients. Intraoperative parameters (blood loss, operation time and level instrumented) and radiologic change (initial, post-traction and postoperative Cobb Angle) was evaluated and analyzed


Eligibility criteria: Inclusion Criteria:

* adolescence/adult idiopathic scoliosis;
* severe and rigid scoliosis (defined as Cobb angle more than 80° and flexibility index less than 25%);
* either skull tongs-femoral traction or Cotrel longitudinal traction used in the preoperative time period

Exclusion Criteria:

* other types of scoliosis (neuromuscular scoliosis, congenital scoliosis, etc.)
* intradural abnormalities (diastomatomyelia, tethered cord, etc)
* history of previous spine surgery

Primary outcomes:
measure: Radiologic change
timeFrame: - Baseline - Immediately after 2 weeks of preoperative traction - immediately after the correction surgery
Secondary outcomes:
measure: Blood loss
timeFrame: Intraoperative
measure: Duration of surgery
timeFrame: Intraoperative
measure: Number of instrumented levels
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04268147: Instrumented Data Exchange for Ataxia Study
Official title: APDM Instrumented Data Exchange for Ataxia (IDEA) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinocerebellar Ataxia Type 1
Spinocerebellar Ataxia Type 2
Spinocerebellar Ataxia Type 3
Spinocerebellar Ataxia Type 6
Friedreich Ataxia
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Biogen
name: APDM Wearable Technologies
First posted: 2020-02-13
Enrollment: 128
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ataxia clinics

Brief summary: This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of ataxia.


Eligibility criteria: Inclusion Criteria:

* SCA 1, 2, 3, 6, and FA with mutations in the pathogenic range confirmed from genetic testing
* SCA: aged 18-75 years
* FA: aged 12-30, diagnosed between ages 5-25
* community dwelling
* physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement
* able to walk independently 10 yards without an assistive device
* able to sit or stand unassisted for 30 seconds
* no other neurological or musculoskeletal disorder that could affect mobility
* no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility
* willing and able to participate in a 2-year study
* consent to be video recorded while performing study assessments

Exclusion Criteria:

* dementia that limits subjects' ability to follow directions
* pain that limits mobility
* SCA: enrolled in a clinical drug trial

Primary outcomes:
measure: iSARA
timeFrame: 2 years
measure: SARA
timeFrame: 2 years
measure: mFARS
timeFrame: 2 years
measure: Daily Life (UChicago site ONLY)
timeFrame: 2 weeks
measure: Ataxia App on Watch/iPhone
timeFrame: 2 years
measure: Patient-Reported Questionnaires of Health
timeFrame: 2 years
measure: Falls Questionnaire
timeFrame: 2 years
measure: Functional Staging
timeFrame: 2 years
measure: Timed 25 Foot Walk
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California-Los Angeles
state: California
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Boston
country: United States
facility: Mass General Hospital
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT05149547: mNGS Versus Blood Culture in FN
Official title: The Comparison of mNGS Versus Blood Culture for Early Diagnosis of Blood Stream Infection During the Febrile Neutropenia in Patients With Hematological Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infections
Hematologic Diseases
Febrile Neutropenia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University International Hospital
name: Hebei Yanda Ludaopei Hospital
First posted: 2021-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with hematologic disease during febrile neutropenia

Brief summary: Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.


Eligibility criteria: Inclusion Criteria:

* hematologic disease
* febrile neutropenia

Exclusion Criteria:

* refuse to consent
* age\<=14
* not caused by infection

Primary outcomes:
measure: diagnosis performance
timeFrame: 14 days after sapmpling
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yuqian Sun
Study officials:
affiliation: Peiking University People's Hospital
name: YUQIAN SUN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03122847: Glucocorticoids and Bone in Graves' Ophthalmopathy
Official title: The Effect of 4.5 Gram Methylprednisolone Administered Once Weekly for 12 Weeks on Bone Metabolism in Graves´ Ophthalmopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Ophthalmopathy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2017-04-21
Enrollment: 39
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: 30 adult patients with Graves' Ophthalopathy

Brief summary: Continuous use of systemic glucocorticoids decreases bone mineral density and increases fracture risk. Graves' orbitopathy is treated with weekly infusion of high-dose intravenous glucocorticoid. The investigators aim at investigating whether this treatment regimen also affects bone metabolism.

Detailed description: Systemic glucocorticoid increases bone resorption and decreases bone formation and thereby decreases bone mineral density and increases fracture risk. This effect is evident with a daily dose of 5 mg for three months or an accumulated dose of 450mg. There is, however, less evidence that intermittent use of glucocorticoids is harmful to bone.

Graves orbitopathy is treated with a weekly infusion of the glucocorticoid methylprednisolone and the accumulated dose over a 12-week course sums up to 4,500mg.

The investigators therefore want to investigate if that treatment regimen affects bone turnover, bone mineral density, or bone structure in 30 patients with Graves' orbitopathy.

Eligibility criteria: Inclusion Criteria:

* Graves Ophthalmopathy that requires treatment with intra-venous methylprednisolone

Exclusion Criteria:

* Treatment with osteoporosis medication
* Primary hyperparathyroidism
* Hypoparathyroidism
* Vitamin D \< 20mmol/L
* Estimated glomerular filtration rate \< 30 mL/min
* Liver disease
* Peroral treatment with glucocorticoids within last three months prior to inclusion

Primary outcomes:
measure: Percent Change Lumbar Spine Bone Mineral Density
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Change Femoral Neck Bone Mineral Density
timeFrame: 12 weeks
measure: Percent Change Total Hip Bone Mineral Density
timeFrame: 12 weeks
measure: Bone Resorption
timeFrame: 12 weeks
measure: Bone Formation
timeFrame: 12 weeks
measure: Percent Change in Bone Structure at the Radius
timeFrame: 12 weeks
measure: Percent Change in Bone Structure at the Tibia
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Aarhus
name: Torben Harsløf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410747: A Study to Evaluate the Safety and Efficacy of Tacrolimus for Lupus Nephritis Under Actual Use Situations
Official title: Specified Drug Use-Results Survey on Long-Term Treatment for Prograf® Capsules 0.5 mg, 1 mg Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Nephritis
Keywords: long-term treatment
tacrolimus
renal failure
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 1484
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: patients receiving tacrolimus for the treatment of lupus nephritis

Brief summary: To evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use.

Detailed description: The objectives of the survey are to evaluate the safety and efficacy of tacrolimus for lupus nephritis under actual-use situations, and to identify factors that might affect the safety and efficacy of tacrolimus. In addition, long-term renal outcome will be evaluated.

Eligibility criteria: patients receiving tacrolimus for the treatment of lupus nephritis

Primary outcomes:
measure: Incidence of renal events (renal failure and progression to dialysis)
timeFrame: Up to 10 years
Secondary outcomes:
measure: 24-hour urinary protein
timeFrame: Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year
measure: Urinary red blood cell (RBC) count
timeFrame: Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year
measure: Serum creatinine
timeFrame: Baseline, 4 week, 8 week, 12 week, 1 year, 2 year, 3 year, 4 year, 5 year, 6 year, 7 year, 8 year, 9 year, 10 year
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Shagoku
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Suzuki K, Uno S, Wakasugi N. Tacrolimus use and renal function in pregnancy with lupus nephritis: Analysis of post-marketing surveillance data in Japan. Mod Rheumatol. 2023 Aug 25;33(5):944-952. doi: 10.1093/mr/roac094.
citation: Takeuchi T, Wakasugi N, Uno S, Makino H. Long-term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis: 5-year Interim Postmarketing Surveillance Study in Japan (TRUST). J Rheumatol. 2021 Jan 1;48(1):74-81. doi: 10.3899/jrheum.191008. Epub 2020 Apr 1.
Clinical trial NCT01497847: Post-Infectious Irritable Bowel Syndrome (PI-IBS)
Official title: Post-Infectious Irritable Bowel Syndrome (PI-IBS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: Post-Infectious Irritable Bowel Syndrome
PI-IBS
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Travelers to tropical destinations visiting the outpatient clinic for vaccinations in a tertiary care hospital.

Brief summary: Purpose:

* identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome (PI-IBS) development after an episode of traveler's diarrhea
* identification of systemic (serum) and local (biopsy) changes in infectious and immunological activity during infection and correlation with Irritable Bowel Syndrome (IBS) symptoms, persisting after traveler's diarrhea

Design:

* 4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12 months after traveling
* at each study visit following investigations: blood collection, stool collection, questionnaires, rectal biopsy


Eligibility criteria: Inclusion Criteria:

* traveling to South-America, Africa, South-East Asia
* 18-70 years
* traveling for 1-10 weeks

Exclusion Criteria:

* Chronic diarrhea
* Pregnant
* Colitis Ulcerosa
* Morbus Chrohn
* IBS
* Coeliakie
* Gastrointestinal malabsorption
* microscopic colitis
* diverticulitis
* immune deficiency
* use of antibiotics/corticosteroids 2 weeks before travelling

Primary outcomes:
measure: postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode
timeFrame: 1 year after traveling
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Catholic University Leuven
name: Guy Boeckxstaens, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wouters MM, Van Wanrooy S, Nguyen A, Dooley J, Aguilera-Lizarraga J, Van Brabant W, Garcia-Perez JE, Van Oudenhove L, Van Ranst M, Verhaegen J, Liston A, Boeckxstaens G. Psychological comorbidity increases the risk for postinfectious IBS partly by enhanced susceptibility to develop infectious gastroenteritis. Gut. 2016 Aug;65(8):1279-88. doi: 10.1136/gutjnl-2015-309460. Epub 2015 Jun 12.
Clinical trial NCT02996747: Low Grade Chondrosarcoma Versus Enchondroma
Official title: Low Grade Chondrosarcoma Versus Enchondroma: Challenges in Diagnosis and Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chondroma
Chondrosarcoma
Keywords: bone tumors
chondroma
chondrosarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chondroma or low grade chondrosarcoma of bone treated in a single Institution

Brief summary: The purpose of this project is to verify possible clinical and radiological findings with regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In addition, this study presents the outcome of patients with enchondroma and low grade chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).

Detailed description: The investigators retrospectively review the records of 65 patients with enchondroma and 37 patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and 2014 in a single Institution.

Eligibility criteria: Inclusion Criteria:

* chondroma or low grade chondrosarcoma of long bones

Exclusion Criteria:

* chondroma or low grade chondrosarcoma of spine and pelvis

Primary outcomes:
measure: Local recurrence rate of patients with chondroma or low grade chondrosarcoma treated by curettage (intralesional surgery)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Davide Donati, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06731647: Non-steroidal Anti-inflammatory Drugs in Pleurodesis
Official title: Non-steroidal Anti-inflammatory Drugs in Pleurodesis Surgery for Pneumothorax
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-steroidal Anti-inflammatory Drugs
Pleurodesis
Pneumothorax
Pain Management
Keywords: non-steroidal anti-inflammatory drugs
pleurodesis
pneumothorax
pain management
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier VALENCIENNES
name: Clinique Victor Pauchet
name: University Hospital, Rouen
First posted: 2024-12-12
Enrollment: 358
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: Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended in a multimodal pain management to reduce pain intensity and to spare opioid use. However, there is a controversy in its use in pleurodesis surgery as it could block the process of pleurodesis in surgical pneumothorax. In addition, NSAIDs could increase the risk of pneumothorax recurrence.

The investigators hypothesized that NSAIDs are safe during pleurodesis with a better pain management without increasing the risk of pneumothorax reccurence.


Eligibility criteria: Inclusion Criteria:

* Age≥18-year-old
* pneumothorax with an indication of pleurodesis
* with or without minimal lung resection
* via thoracotomy or thoracoscopy

Exclusion Criteria:

* Minor patient
* Pregnant, parturient or breast-feeding patient
* Severe polytrauma (associated with the presence of a Vittel criterion)
* Purulent pleurisy
* Hemopneumothorax
* Lactose hyper sensibility
* Contraindications to NSAID
* Contraindications to tramadol
* Contraindications to paracetamol
* Curative anticoagulation
* Patients under guardians or deprived of their liberty
* Patient refusal

Primary outcomes:
measure: duration of pleural drainage
timeFrame: from the time of orotracheal extubation to the time of pleural tube remove
Secondary outcomes:
measure: postoperative pain
timeFrame: at 72 hours
measure: cumulative postoperative opioid equivalent dose
timeFrame: at 72 hours
measure: Postoperative pneumonia occurence
timeFrame: From enrollment to the end of hospital stay, up to 6 months
measure: Length of hospital stay
timeFrame: From enrollment to the end of hospital stay, up to 6 months
measure: homolateral or contralateral recurrence in spontaneous pneumothorax
timeFrame: at 1month
measure: homolateral or contralateral recurrence in spontaneous pneumothorax
timeFrame: at 6 months
measure: homolateral or contralateral recurrence in spontaneous pneumothorax
timeFrame: at 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
Study officials:
References: