louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04583475: Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria
Official title: Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Urticaria, Chronic
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with SUC, for whom the indication for AOM treatment has been selected.

Brief summary: This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months.


Eligibility criteria: Inclusion Criteria:

* Patient having expressed non-opposition
* Affiliation to a social protection scheme (beneficiary or entitled person)
* Decision by the investigator to initiate, independently of the study, an AOM treatment for Spontaneous Chronic Urticaria that may or may not be associated with an inducible component.

Exclusion Criteria:

* Patients \< 18 years of age
* Patient who had previously received AOM treatment prior to the inclusion visit
* Patients under guardianship or curatorship
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Proportion of patients benefiting from an intensification of OMA treatment at 3 months,
timeFrame: At 3 months
Secondary outcomes:
measure: Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects.
timeFrame: at baseline
measure: Proportion of patients benefiting from an intensification of OMA treatment
timeFrame: Baseline, at 6 months and at 9 months
measure: Activity of urticaria (score UCT) composite
timeFrame: at 3, 6 and 9 months
measure: Proportion of patients with side effect during follow-up (number and percentage of the total patients)
timeFrame: at 3, 6 and 9 months
measure: Life Quality
timeFrame: at 3, 6 and 9 months
measure: Life Quality
timeFrame: at 3, 6 and 9 months
measure: The angioedema activity
timeFrame: at 3, 6 and 9 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Delphine Staumont-Salle, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05518175: Patient-centered Outcomes After Permanent Female Sterilization Procedure(POPS Trial)
Official title: Patient-centered Outcomes After Permanent Female Sterilization Procedure: A Randomized Controlled Trial Comparing Three Surgical Routes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sterility, Female
Keywords: laparoscopy
quality of recovery
vaginal natural orifice transluminal endoscopic surgery
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity
* non-prolapsed uterus
* Patients should able to provide written consent

Exclusion Criteria:

* Women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy
* Postpartum (immediate) tubal sterilization
* Tubal sterilization during a cesarean section

Primary outcomes:
measure: Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Cosmesis as assessed by the Body Image Questionnaire
timeFrame: 2 weeks post surgery
measure: Cosmesis as assessed by the Body Image Questionnaire
timeFrame: 6 weeks post surgery
measure: Cosmesis as assessed by the Body Image Questionnaire
timeFrame: 3 months post surgery
measure: Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)
timeFrame: Baseline, 3 months post surgery
measure: Pain as assessed by the Resting Visual Analog Scale (VAS)
timeFrame: 24 hours post surgery
measure: Pain as assessed by the Resting Visual Analog Scale (VAS)
timeFrame: 2 weeks post surgery
measure: Pain as assessed by the Resting Visual Analog Scale (VAS)
timeFrame: 6 weeks post surgery
measure: Pain as assessed by the Resting Visual Analog Scale (VAS)
timeFrame: 3 months post surgery
measure: Pain as assessed by the Dynamic Visual Analog Scale (VAS)
timeFrame: 3 months post surgery
measure: Patient satisfaction as assessed by the satisfaction scale
timeFrame: 3 months post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Randa J Jalloul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171275: Fluvastatin in the Therapy of Acute Coronary Syndrome
Official title: Fluvastatin in the Therapy of Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Disease
Myocardial Infarction
Keywords: Coronary disease
Myocardial infarction
Statins
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Health, Czech Republic
First posted: 2005-09-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety and efficacy of fluvastatin versus placebo, dosed shortly after or immediately when the coronary event occurs.


Eligibility criteria: Inclusion Criteria:

* Acute coronary syndrome
* Adults, 18 years and older

Exclusion Criteria:

* History of lipid lowering therapy less than 30 days before index event
* Pregnancy and nursing
* Subject younger than 18 years

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in circulating markers of inflammation after 4 weeks and after 52 weeks
Secondary outcomes:
measure: Occurrence of death, nonfatal myocardial infarction, cardiac arrest with resuscitation, recurrent symptomatic ischemia, and urgent revascularization after 4 weeks and after 52 weeks
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ostadal P, Alan D, Vejvoda J, Kukacka J, Macek M, Hajek P, Mates M, Kvapil M, Kettner J, Wiendl M, Aschermann O, Slaby J, Holm F, Telekes P, Horak D, Blasko P, Zemanek D, Veselka J, Cepova J. Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial). Trials. 2010 May 25;11:61. doi: 10.1186/1745-6215-11-61.
Clinical trial NCT04904887: Clinical Outcomes With a New Monofocal IOL Enhanced for Intermediate Vision
Official title: Clinical Outcomes With a New Monofocal Intraocular Lens Enhanced for Intermediate Vision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Presbyopia
Lead sponsor: Dar Al Shifa Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients undergoing cataract surgery are managed with phacoemulsification and insertion of Eyehance intraocular lens in order to improve their intermediate vision.
Primary purpose: TREATMENT

Brief summary: phacoemulsification with insertion of EYHANCE IOL to improve near and intermediate vision

Detailed description: insertion of new intraocular lens enhanced for intermediate vision

Eligibility criteria: Inclusion Criteria:

* normal ocular examination apart from cataract.

Exclusion Criteria:

* previous ocular surgery.
* ocular pathology or corneal abnormalities.
* endothelial cell count below 2000 cells/mm2.
* corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).

Primary outcomes:
measure: intermediate vision assessment
timeFrame: 6 months postoperatively
measure: near vision assessment
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: defocus curve
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Daralshifa hospital
Study officials:
References:
Clinical trial NCT04183387: Simvastatin in Uveitis
Official title: Open-label Randomized Study of Efficacy and Safety of Simvastatin in Uveitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uveitis
Lead sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates anti-inflammatory effects and safety of simvastatin in non-infectious uveitis.

Detailed description: 3-Hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors (statins) have been shown to reduce local and systemic inflammation in animal models of various autoimmune disorders including uveitis. In this open-label, randomized study clinical efficacy and tolerability of simvastatin 40 mg/day for 8 weeks is evaluated.

Eligibility criteria: Inclusion Criteria:

- diagnosis of active non-infectious uveitis

Exclusion Criteria:

* serious liver or kidney disease
* increased transaminase levels of \>1.5 ULN
* planned or active pregnancy
* use of fibrates, nicotinic acid, cyclosporine A, antifungal drugs, macrolide antibiotics, verapamil, and grapefruit juice (\>1 L/day).

Primary outcomes:
measure: Incidence of corticosteroid sparing control of ocular inflammation
timeFrame: 8 weeks
Secondary outcomes:
measure: Visual acuity
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Anterior chamber cells
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Anterior chamber flare
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Vitreous haze
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Intraocular pressure
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in tear IL-6
timeFrame: Baseline, 8 weeks
measure: Changes in tear IL-8
timeFrame: Baseline, 8 weeks
measure: Changes in tear IL-10
timeFrame: Baseline, 8 weeks
measure: Changes in tear TNFα
timeFrame: Baseline, 8 weeks
measure: Changes in tear IFN-γ
timeFrame: Baseline, 8 weeks
measure: Incidence of corticosteroid sparing control of ocular inflammation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Laboratory of Clinical Immunopharmacology
Study officials:
References:
citation: Shirinsky IV, Biryukova AA, Kalinovskaya NY, Shirinsky VS. Tear cytokines as potential biomarkers in non-infectious uveitis: post hoc analysis of a randomised clinical trial. Graefes Arch Clin Exp Ophthalmol. 2020 Aug;258(8):1813-1819. doi: 10.1007/s00417-020-04707-7. Epub 2020 May 6.
Clinical trial NCT02251587: The $Ensible Weight Program: An Intervention Tailored for Low Income Women
Official title: The $Ensible Weight Program: An Intervention Tailored for Low Income Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn if a weight loss program especially designed to address food insecurity is more effective compared to a standard weight loss program.

Detailed description: Low income women are at greater risk of both obesity and food insecurity (not having consistent access to nutritious and adequate amounts of food). Most weight loss programs targeted at low income women do not focus on gaining skills and knowledge to reduce food insecurity.

Eligible participants will be randomized into one of two groups. The two groups will follow different weight management programs. One group will follow a standard weight management program. The other group with follow the investigations program, the $ensible Weigh Program. Participation in the study will last about 9 months.

Eligibility criteria: Inclusion Criteria:

* Documented low income
* Body Mass Index (BMI) \>25.0 kg/m2
* Must speak and understand English
* Able to attend intervention sessions and have access to telephone

Exclusion Criteria:

* Report serious medical risk such as insulin-dependent diabetes, cancer, recent cardiac event
* Currently or planning to become pregnant during the intervention
* Have no control over food purchases or choices
* Report participation in a weight reduction program involving diet or PA within past 6 months
* Report symptomology of an eating disorder
* Report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, Atkins, macrobiotic, etc.

Primary outcomes:
measure: Feasibility of implementing weight management program
timeFrame: 9 Months
Secondary outcomes:
measure: Change in weight
timeFrame: Change from Baseline to Month 3
measure: Change in weight
timeFrame: Change from Month 3 to Month 9
measure: Change in diet quality
timeFrame: Change from Baseline to Month 3
measure: Change in diet quality
timeFrame: Change from Month 3 to Month 9
measure: Change in food security status
timeFrame: Change from Baseline to Month 3
measure: Change in food security status
timeFrame: Change from Month 3 to Month 9
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeannine Goetz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04946487: Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery
Official title: Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spinal Stenosis
Keywords: Adjacent Segment Degeneration
lumbar posterior ligamentous complex
posterior lumbar interbody fusion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2010 to December 2014

Brief summary: To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)

Detailed description: Purpose: To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF).

Methods: This retrospective study was performed in patients who received L5/S1 PLIF with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. They were divided into the total laminectomy group, which had destruction of the PLC of the adjacent segment, or partial laminectomy group, which did not. Vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (LF) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (MRI). Disc degeneration and spinal stenosis on MRI scans were categorized. The incidence of ASD and clinical outcome were compared between the groups.

Eligibility criteria: Inclusion Criteria:

* typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to ≥6 months of strict conservative treatment; and L5/S1 single-level PLIF with pedicle screw instrumentation.

Exclusion Criteria:

* previous spine surgery, acute spinal fracture, infection, and tumor.

Primary outcomes:
measure: the Incidences of adjacent segment degeneration
timeFrame: From the end of treatment to more than 8 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Weishi Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06683287: Effects of Low-Level Red Light and Distant-Image Screen for Myopia Control in Children
Official title: Effects of Low-Level Red Light and Distant-Image Screen for Myopia Control in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia
red-light
distant-image screen
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficacy and safety of daily exposure to 650-nm low-level red light (RL) and distant-image therapy (DIT) for myopia treatment.

Detailed description: This was a randomized clinical trial. Children aged 8 to 10 years with a spherical equivalent error (SER) ranging from -1 to -1.5 diopters (D) were enrolled, and were randomly allocated to the following treatment group: RL, DIT, RL plus DIT, and control in a 1:1:1:1 ratio. The primary outcomes were one-year change in SER and axial length.

Eligibility criteria: Inclusion Criteria:

* 1. Age between 8 and 10 years old. 2. The spherical equivalent error after pupil dilation was between -1.0 D and -1.5D.

  3. Corneal astigmatism ≤ 1.25D. 4. Interocular refraction discrepancy ≤ 1.5D. 5. Near-distance exophoria \< 10 prism diopters (△) and far-distance exophoria \< 6 prism diopters (△).

  6. Willingness to participate in the study and signed informed consent.

Exclusion Criteria:

* 1. Intraocular pressure was below 10 mmHg or higher than 22 mm Hg. 2. Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders.

  3. Children currently using atropine or orthokeratology for myopia control. 4. Patients with systemic and immune disorders such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes, etc.

  5. Individuals with conditions like Tourette's syndrome or epilepsy.

Primary outcomes:
measure: Changes in axial length
timeFrame: one year
measure: Changes in spherical equivalent error
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References:
Clinical trial NCT04757987: An Observational Study of Distress, Immune Function, and Pain in HIV.
Official title: An Observational Study of Shared Variation and Reciprocal Influences: Distress, Immune Function and Pain in HIV.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
HIV
Distress, Emotional
Immune System and Related Disorders
Central Sensitisation
Keywords: Chronic pain
HIV
Innate Immune Response
Mental health
Hyperalgesia, secondary
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Brigham and Women's Hospital
name: University of Adelaide
name: University of Michigan
First posted: 2021-02-17
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic in South Africa.

Brief summary: This case-control study focuses on pain in HIV, which is common despite antiretroviral therapy and compromises quality of life, mental health and daily functioning. Specifically, it will investigate the relationships between psychosocial distress, inflammation and pain in HIV.

Detailed description: We plan to recruit 100 people and follow them for 6 months, taking repeated measures. Participants who report persistent pain at enrolment will be assessed at 0 (baseline), 2, 4, and 6 months. Participants who report no pain at enrolment will be assessed at 0 (baseline) and 6 months. All participants will also be invited to participate in weekly remote assessment of selected self-reported outcomes.

Eligibility criteria: Inclusion Criteria:

* HIV-positive with viral suppression
* report either persistent pain or no pain at enrolment

Exclusion Criteria:

* pregnancy
* acute psychiatric condition requiring urgent care
* cognitive impairment preventing full participation

Primary outcomes:
measure: Hopkins Symptom Checklist 25-item questionnaire
timeFrame: Baseline
measure: Provoked inflammatory response
timeFrame: Baseline
measure: Brief Pain Inventory
timeFrame: Baseline
Secondary outcomes:
measure: Secondary hyperalgesia (surface area)
timeFrame: Baseline assessment only
measure: Brief Pain Inventory
timeFrame: Baseline
Other outcomes:
Locations:
city: [City Withheld Due To Risk To Participants]
country: South Africa
facility: Community Health Clinic [name withheld due to risk to participants]
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Victoria J Madden, PhD
role: PRINCIPAL_INVESTIGATOR
References: