louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05754450: An Extension Study Assessing the Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II
Official title: A Phase 3, Open-Label, Extension Study to Assess the Long-term Safety and Efficacy of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Leukocyte Adhesion Deficiency
Lead sponsor: AUG Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-03-03
Enrollment: 2
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this extension study is to assess the long-term safety and efficacy of AVTX-803 in subjects with LAD II (SLC35C1-CDG).


Eligibility criteria: Inclusion Criteria:

* Subject must have completed protocol AVTX-803-LAD-301
* Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)

Exclusion Criteria:

* Subject has severe anemia defined as hemoglobin \<8.0 g/dL (\<4.9 mmol/L)
* Subject has impaired renal function as defined by an eGFR \<90 mL/min
* Subject has known or suspected intolerance or hypersensitivity to fucose or any ingredients of the investigational product
* In the investigator's opinion, subject has a history of failure to respond to fucose at adequate dosing

Primary outcomes:
measure: Incidence of treatment emergent adverse events reported during the study attributable to AVTX-803.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Sialyl-Lewis X antigen expression on leukocytes
timeFrame: At 6 months
measure: Change from Baseline in the composite Nijmegen Pediatric Congenital Disorders of Glycosylation (CDG) Rating Scale (NPCRS)
timeFrame: Through study completion, an average of 1 year.
measure: Change from Baseline in the individual parameters of the Nijmegen Pediatric Congenital Disorders of Glycosylation (CDG) Rating Scale (NPCRS)
timeFrame: Through study completion, an average of 1 year.
measure: Goal Attainment Score (GAS)
timeFrame: Through study completion, an average of 1 year.
measure: Clinician Global Impression of Severity (CGI-S)
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Deyle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06833450: Reliability of IUS in Crohn's Disease
Official title: Reliability of IUS in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease (CD)
Keywords: Crohn's disease
intestinal ultrasound
bowel wall thickness
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Transabdominal intestinal ultrasound (IUS) is gaining acceptance as a point-of-care test to objectively assess disease activity in Crohn's disease (CD).

In order to incorporate individual parameters in a future definition of transmural healing, and for the consistent application of IUS as a modality to assess treatment outcomes and establish therapeutic targets to ensure comparability between future studies, the inter-observer agreement should be determined for all relevant parameters.


Eligibility criteria: Inclusion Criteria:

* Crohn's disease evolving for at least 1 months
* Patient older than 18 years
* Patient covered by French national health insurance
* Written informed consent

Exclusion Criteria:

* Pregnant women or breastfeeding
* Minor
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

Primary outcomes:
measure: Number of different IUS parameters between two operators
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
Study officials:
References:
Clinical trial NCT03613350: Prevalence Rates of USI, BO, DO and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
Official title: Prevalence Rates of Urodynamic Stress Incontinence, Bladder Oversensitivity/Detrusor Overactivity or Both and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptom in Severe Cystocele Women
Keywords: Cystocele
Urodynamic stress incontinence
Detrusor overactivity
Pad test
Urodynamic study
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 480
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with ≥stage II cystocele.

Brief summary: Prevalence rates of urodynamic stress incontinence (USI), bladder oversensitivity (BO) /detrusor overactivity (DO) or both and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Detailed description: Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction. BO was defined as \<300 mL of the volume at strong desire to void during filling cystometry. Those women without USI, BO or DO were allocated into the no demonstrated USI+BO/DO group.

Eligibility criteria: Inclusion Criteria:

1. Age \>20y/o
2. Severe cystocele, ie, more than stage 2
3. Complete pad test and urodynamic study

Exclusion Criteria:

1. Pregnancy
2. Urinary tract infection
3. Had received pelvic reconstruction

Primary outcomes:
measure: USI
timeFrame: Between November 2011 and January 2017
measure: BO/DO
timeFrame: Between November 2011 and January 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00952250: Targeted Feedback Reports to Improve Acute Coronary Syndromes (ACS) Care
Official title: Personalized and Targeted Feedback in the ACTION-Registry-GWTG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: quality improvement
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2009-08-06
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project is designed to examine the impact of tailored feedback on site performance.

The investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback.

The investigators hypothesize that a site-specific report with centrally identified targets for improvement paired with target specific interventions will enable sites to quickly identify and prioritize salient problem areas, have ready access to an analysis of factors that underlie problems, and formulate an effective action plan. The investigators also hypothesize that those hospitals randomized to receive intervention will be more likely to improve their overall performance, as well as their target specific performance, during the period of observation in direct response to activated QI processes.

Outcomes:

The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.

The secondary outcome is improvement in the composite of targeted metrics.

Outcomes will be assessed in all participating sites, and in among relevant performance subgroups (low performers, academic centers, full service, and among medication versus process metrics).


Eligibility criteria: Inclusion Criteria:

* hospitals participating in the ACTION Registry GWTG

Exclusion Criteria:

* sites with low volume of data submission (\< 10 data forms in the past year)

Primary outcomes:
measure: The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.
timeFrame: 12 months
Secondary outcomes:
measure: The secondary outcome is improvement in the composite of targeted metrics.
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Karen P Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexander KP, Wang TY, Li S, Lytle BL, Slattery LE, Calhoun S, Poteat J, Roe MT, Rumsfeld JS, Cannon CP, Peterson ED. Randomized trial of targeted performance feedback to facilitate quality improvement in acute myocardial infarction care. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):129-35. doi: 10.1161/CIRCOUTCOMES.110.958470.
Clinical trial NCT06773650: Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation for Lactose Intolerance
Official title: Lactose Intolerance: a Guide to Proper Dietary Management, Follow-up, and Lactase Enzyme Supplementation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lactose Intolerant
Lactose Malabsorption
Lactose Intolerance
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The online survey aims to reach a representative sample of the Italian population to identify their knowledge regarding Lactose Intolerance

Brief summary: Lactose intolerance (LI) is considered the clinical syndrome caused by lactose malabsorption (LM).

It is possible to identify four causes of lactase deficiency defining four different types of LM: primary (genetic), secondary (acquired), congenital (alactasia), and developmental (in premature infants, so reversible).

The aim of this protocol is to investigate through an anonymous online survey the knowledge of the Italian population on clinical, pathophysiological, diagnostic and therapeutic issues of lactose intolerance. Data collected will be divulgated through a publication for both people with IL and nutritionists, enriched with tables and flow charts, to improve the knowledge on lactose intolerance and to support people suffering from this condition. The results of this survey will guide subjects suspected of suffering from lactose intolerance towards a correct diagnosis and a better management.


Eligibility criteria: Inclusion Criteria:

* Subjects must be adults (≥18 years of age)
* Willingness to complete the online survey

Exclusion Criteria:

* Subjects \<18 years of age
* Subjects not available to answer the online survey

Primary outcomes:
measure: Evaluation of knowledge of the Italian population on lactose intolerance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
References:
Clinical trial NCT01646450: First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
Official title: An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
EGFR Mutation
Elder patients
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 35
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

Detailed description: A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

* Primary endpoint to assess progression-free survival
* Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.

Eligibility criteria: Inclusion Criteria:

* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
* Positive EGFR Mutation.
* No previous systemic anticancer therapy.
* Male and female patients aged over 70 years.
* Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
* Provision of written informed consent.

Exclusion Criteria:

* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Objective response rate
timeFrame: 3-6 months
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
name: Han Baohui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02245555: Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia
Official title: Observational Study About the Use of Tamsulosin in Patients With Benign Prostatic Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 1060
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with benign prostatic hyperplasia (BPH), who require pharmacological treatment

Brief summary: Study to describe Tamsulosin prescription characteristics in a representative population of patients on treatment for benign prostatic hyperplasia


Eligibility criteria: Inclusion Criteria:

* Patients older than 21 years old diagnosed with benign prostatic hyperplasia (BPH), who require pharmacological treatment to relieve symptoms and improve their quality of life, according to physician's judgment. The study will include naïve patients and patients not responding to previous therapy who receive Secotex as alternative or complementary treatment. The decision to treat a patient with Tamsulosin must be based on the best standard accepted in the clinical practice and must be carried out following Secotex (Tamsulosin) prescription information

Exclusion Criteria:

* Patients with known hypersensitivity to Tamsulosin or any of its ingredients, history of orthostatic hypotension or severe liver failure, or with any missing data required to complete the questionnaire are excluded

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 21 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05251155: Accuracy of Mobile-Based Vision Charts.
Official title: Accuracy of Mobile-Based Vision Charts in Clinical Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Spatial Processing
Keywords: Visual acuity
Mobile-based chart
Snellen's chart
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 288
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aimed to asses their best corrected visual acuity or seek spectacles prescription at ophthalmology clinic at Al-Nil Hospital, Banha, EGYPT.

Brief summary: Analyzing the accuracy of mobile-based distant vision charts in clinical practice as an economic alternative for standard vision charts.

Detailed description: Accuracy of mobile-based visual acuity testing in clinical practice is still debatable. The aim of this study was to analyze the accuracy of mobile-based distant vision chart in comparison to standard chart projector.

Eligibility criteria: Inclusion Criteria:

* Subjects visited ophthalmology clinic at Al-Nil Hospital, Banha, EGYPT for visual acuity assessment.
* Subjects that their best corrected visual acuity was ranged from 0.1 to 1.0 in decimal form measured on snellen's chart.

Exclusion Criteria:

* Subjects that refuse to measure visual acuity twice during the same visit.
* Subjects that their best corrected visual acuity is less than 0.1 in decimal form by the standard chart projector.

Primary outcomes:
measure: Accuracy of mobile based "snellen chart" in measuring distant visual acuity.
timeFrame: Immediately after visual acuity testing using the standard chart projector.
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Al-Nil Hospital
state: QA
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05387343: COVID Vaccine Immunity in Kidney Transplant Recipients
Official title: COVID Vaccine Immunity in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: End Stage Renal Disease
Kidney Transplant; Complications
Keywords: COVID-19
kidney
kidney transplant
end stage renal disease
mRNA vaccine
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: ViraCor Laboratories
First posted: 2022-05-24
Enrollment: 0
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: patients planning on having a renal transplant at the University of Alabama at Birmingham

Brief summary: 50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

Detailed description: 50 ESRD patients on peritoneal dialysis or hemodialysis or not on immunosuppression, no prior transplant, no known history of COVID infection, whom have had at least 2 doses of mRNA vaccine, and undergoing transplantation at UAB will be enrolled, after signing the informed consent. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.

Eligibility criteria: Inclusion Criteria:

* End Stage Renal Disease patients on peritoneal dialysis or hemodialysis or not on immunosuppression
* no prior transplant
* no known history of COVID infection
* had at least 2 doses of mRNA COVID vaccine
* undergoing transplantation at the University of Alabama at Birmingham
* multi-organ transplant allowed

Exclusion Criteria:

* active COVID infection
* participant is not vaccinated against COVID

Primary outcomes:
measure: COVID spike protein Immunoglobulin G (IgG) and Tcell assay
timeFrame: pre-transplant
measure: COVID spike protein IgG and Tcell assay
timeFrame: month 1
measure: COVID spike protein IgG and Tcell assay
timeFrame: month 3
measure: COVID spike protein IgG and Tcell assay
timeFrame: month 4
measure: COVID spike protein IgG and Tcell assay
timeFrame: month 6
measure: COVID spike protein IgG and Tcell assay
timeFrame: month 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Graham C Towns, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03394443: Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ?
Official title: Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? A Qualitative Study in Besancon University Hospital.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Birth
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 20
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of a premature new-born baby (\< 37 SA)

Brief summary: This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.

Detailed description: * From parents collected during semi-structured interviews.
* To highlight the social, environmental and economic difficulties that parents have encountered in the context of the premature birth of their child (before birth, during hospitalization and return home).
* Determine the possible help they need in the psychosocial and environmental field.
* Difficulties of the parents we expected:

  * Pre-existing child birth: poor socio-economic environment, unstable social, family and / or occupational status, poorly followed pregnancy, etc.
  * After the birth: professional break-up, custody of other children of the siblings, balance of the couple, financial loss, isolation, transportation problems to get to the hospital, etc.
* Needs we expected :

  * Before birth: measures to prevent prematurity, social and/or psychological support, information, etc.
  * After the birth: support of the entourage, interview with a social worker, help to come in hospital, help to live near the hospital, parental leave, project and long-term support, doctor referred, relationship with professionals in ambulatory (psychologist, Infant and Maternal Protection ...), preparation of the arrival of the child at home +/- home improvement, etc.

Eligibility criteria: Inclusion Criteria:

* Parents (father or mother ) of a premature new-born baby (\< 37 SA) hospitalised in Besancon University Hospital at birth.

Exclusion Criteria:

* Parents \< 18 years old
* Refusing to participate

Primary outcomes:
measure: Social, environmental and economic difficulties encountered by parents
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References: