louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06935851: Effect of Word Characteristics and Orthography on Vocabulary Learning
Official title: The Effect of Word Characteristics and Orthography on Vocabulary Learning
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Developmental Child Delay
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Arizona State University
First posted: 2025-04-20
Enrollment: 23
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: OTHER

Brief summary: The purpose of the study is to investigate how word characteristics (e.g., phonotactic probability) and orthography affect vocabulary by children with low oral language levels. The investigators will use a 2 x 2 within-subjects factorial design where every participant receives the treatment. This 12-week study aims to improve vocabulary learning efficiency for children with low oral language levels. The study's findings will uniquely contribute to the field in that this is the first research study using real words instead of nonwords while combining word learning research with vocabulary learning.

Detailed description: The investigators are proposing a vocabulary intervention that analyzes word sounds and sound segments. This analysis offers valuable insights into how children at risk for specific learning disabilities, such as dyslexia or speech and language impairments, learn words differently from typically developing children.

Eligibility criteria: Inclusion Criteria:

Score of 85 or lower on the Clinical Evaluation of Language Fundamentals - CELF (4) Enrolled in or just completed third grade.

Exclusion Criteria:

Any diagnosis of sensory impairments A diagnosis of autism or traumatic brain injury

Primary outcomes:
measure: Pre- and post test total correct scores
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Number of trials to criterion
timeFrame: up to 8 weeks
Other outcomes:
measure: Total number of words learned to criterion
timeFrame: 12 weeks
Locations:
city: Phoenix
country: United States
facility: Osborn District School Encanto
state: Arizona
Study officials:
References:
Clinical trial NCT05462951: Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Official title: Phase 0 Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Cervix Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: UK Radiopharma Alliance
First posted: 2022-07-18
Enrollment: 30
Sex: FEMALE
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: This is an unblinded phase 0 window-of-opportunity intervention clinical trial to study biomarkers of uterine cervix cancer biology and disease progression in women undergoing cisplatin-based radiochemotherapy for advanced-stage uterine cervix cancer.

Brief summary: This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.


Eligibility criteria: Inclusion Criteria:

- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (\> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.

Exclusion Criteria:

* Presence of another concurrent active invasive malignancy
* Prior invasive malignancy diagnosed within the last three years except for \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix
* prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.

Primary outcomes:
measure: Biomarker
timeFrame: 3 months posttherapy
measure: Biomarker
timeFrame: 3 months posttherapy
measure: Biomarker
timeFrame: 3 months posttherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Denise Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00928551: Comparative Formulation Study of Vabicaserin
Official title: A Randomized, Open-Label, Single-Dose, 3-Period Crossover, Comparative Study of a Modified Formulation of Vabicaserin (SCA-136) Versus the Reference Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare two different formulations of vabicaserin.


Eligibility criteria: Inclusion Criteria:

* Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

* Use of any investigational or prescription drug within 30 days before investigation product administration.
* Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1.
* Use of any over-the-counter drugs, including herbal supplements within 72 hours before study day 1.

Primary outcomes:
measure: Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC.
timeFrame: 2 months
Secondary outcomes:
measure: Safety assessment as measured by evaluating any reported adverse events, scheduled physical examinations, vital sign measurements, ECGs, and clinical laboratory results.
timeFrame: 2 months
Other outcomes:
Locations:
city: Brighton
country: United States
state: Massachusetts
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00919451: Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy
Official title: A Pilot Study Assessing the Efficacy and Safety of Ciclosporin as a Second -Line Drug in Patients With Type 1 Reactions Who Have Not Responded to a 12 Week Course of Prednisolone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leprosy
Keywords: Leprosy
Type 1 Reaction
Prednisolone
Ciclosporin
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Homes and Hospitals of St Giles
name: Alert Hospital, Ethiopia
name: Armauer Hansen Research Institute, Ethiopia
First posted: 2009-06-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy

Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.


Eligibility criteria: Inclusion Criteria:

* Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
* Aged 18-65
* Weigh more than 30Kg

Exclusion Criteria:

* Unwillingness to give informed consent
* Patients with severe active infections such as tuberculosis
* Pregnant or breastfeeding women (see Appendix II)
* Those with renal failure, abnormal renal function, hypertensive
* Patients taking thalidomide currently or within the last 3 months
* Patients not willing to return for follow-up
* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
* HIV positive

Primary outcomes:
measure: improvement in nerve function
timeFrame: at 24 weeks and 32 weeks
Secondary outcomes:
measure: incidence of adverse effects
timeFrame: throughout 32 weeks
measure: Skin lesion inflammation improvement
timeFrame: up to 36 weeks
measure: rate of improvement of reaction
timeFrame: up to 36 weeks
measure: Time to next reactional episode
timeFrame: up to 2 years
measure: extra prednisolone needed to control reaction
timeFrame: up to 36 weeks
Other outcomes:
Locations:
city: Addis Abeba
country: Ethiopia
facility: Alert Hospital
Study officials:
affiliation: London SHTM
name: Diana NJ Lockwood, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00157651: Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters
Official title: A Double-Blind, Placebo Controlled, Randomized Trial of Low-Intensity Adjusted-Dose Warfarin for the Prevention of Mechanical Malfunction of Double-Lumen Haemodialysis Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Thrombosis
Bleeding
Keywords: end stage renal disease
thrombosis
bleeding
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.

Detailed description: Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.

Eligibility criteria: Inclusion Criteria:

* Newly placed double-lumen hemodialysis catheter

Exclusion Criteria:

* Major bleed within last 3 months
* Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR \> 1.5, not due to warfarin)
* Active peptic ulcer disease
* Anticipated need for invasive intervention within next 2 weeks
* Taking warfarin for an indication other than access prophylaxis
* Allergic to, or intolerant of, warfarin
* Pregnant
* Woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study
* Catheter likely needed for 2 weeks or less
* Patient previously took part in the study
* Patient has known aortic aneurysm of 6cm or greater
* Patients nephrologist has refused consent
* Patient has refused consent

Primary outcomes:
measure: Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter.
timeFrame: monthly
Secondary outcomes:
measure: Blood flow rate and adequacy of dialysis.
timeFrame: monthly
measure: Major bleeding events.
timeFrame: monthly
measure: Death from any cause.
timeFrame: monthly
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: Associate Professor, Medicine
name: Alistair J Ingram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Medicine
name: Catherine M Clase, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02435251: Changes in Anthropometry Following Ambulatory Orthopaedic Surgery
Official title: Changes in Anthropometry Following Ambulatory Orthopaedic Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Knee Surgery
Shoulder Surgery
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo ambulatory orthopaedic surgery at our institution.

Brief summary: The purpose of this research is to study changes in weight, body mass index, and percentage of fat following orthopaedic knee or shoulder surgery.


Eligibility criteria: Inclusion Criteria:

* 18-70 years-old
* scheduled to undergo knee or shoulder ambulatory surgery

Exclusion Criteria:

* weighs greater than 350 pounds
* pregnancy
* history of bariatric surgery
* dieting or engaged in a weight loss program
* taking weight loss supplements
* undergoing other types of surgery during study period

Primary outcomes:
measure: Fat mass
timeFrame: 6-weeks after surgery
Secondary outcomes:
measure: Lean mass
timeFrame: 6-weeks after surgery
measure: Weight
timeFrame: 6-weeks after surgery
measure: Body mass index
timeFrame: 6-weeks after surgery
Other outcomes:
Locations:
city: Amherst
country: United States
facility: UBMD Orthopaedics & Sports Medicine
state: New York
Study officials:
affiliation: University at Buffalo
name: Leslie Bisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669551: A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy
Official title: A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Structural and Valvular Heart Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with structural or valvular heart disease

Brief summary: This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Specifically those patients would be those scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.


Eligibility criteria: Inclusion Criteria:

* patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease

Exclusion Criteria:

* Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac thrombus or DVT

Primary outcomes:
measure: Comparison of volume intracardiac echo imaging to 2 dimensional echo
timeFrame: Comparison study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Howard Herrmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silvestry FE, Kadakia MB, Willhide J, Herrmann HC. Initial experience with a novel real-time three-dimensional intracardiac ultrasound system to guide percutaneous cardiac structural interventions: a phase 1 feasibility study of volume intracardiac echocardiography in the assessment of patients with structural heart disease undergoing percutaneous transcatheter therapy. J Am Soc Echocardiogr. 2014 Sep;27(9):978-83. doi: 10.1016/j.echo.2014.04.022. Epub 2014 Jun 11.
citation: Kadakia MB, Silvestry FE, Herrmann HC. Intracardiac echocardiography-guided transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):497-501. doi: 10.1002/ccd.25409. Epub 2014 Feb 10.
Clinical trial NCT01192451: Prospective Cohort of Respiratory Insufficiency Outcome
Official title: Prospective Cohort of Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Domiciliary Noninvasive Positive Pressure Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Non Invasive Ventilation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients undergoing domiciliary noninvasive ventilation

Brief summary: The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing domiciliary noninvasive positive pressure ventilation.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of COPD
* domiciliary noninvasive ventilation

Exclusion Criteria:

* noninvasive ventilation set up for a neuromuscular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
city: Lyon
country: France
facility: Hopital de La Croix Rousse
city: Paris
country: France
facility: Hopital de La Pitie Salpetriere
city: Saint Etienne
country: France
facility: Hopital Nord
Study officials:
References:
citation: Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.
Clinical trial NCT00002051: Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Official title: Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Thymopentin
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Examine the ability of thymopentin (Timunox) to:

Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.


Eligibility criteria: Inclusion Criteria

Concurrent Treatment:

Allowed:

* Aerosolized pentamidine.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia (\< 75000 platelets/mm3).
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to entry.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Known hypersensitivity to thymopentin.

Prior Medication:

Excluded within 30 days of study entry:

* Immunomodulatory or experimental therapy.
* Excluded within 90 days of study entry:
* Zidovudine (AZT).

Patients must not have:

* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia (\< 75000 platelets/mm3).

Patients with the following conditions are included:

* Seropositive for HIV-1 (ELISA assay) confirmed by Western blot.
* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions.
* HIV "wasting syndrome".
* Must voluntarily sign consent.

History of intravenous drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Annandale
country: United States
facility: Immunobiology Research Institute
state: New Jersey
Study officials:
References:
Clinical trial NCT02491151: Variability of Fluconazole Concentration in Critically Ill Patients
Official title: Fluconazole Exposure in Critically Ill Patients and the Value of Therapeutic Drug Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Candidiasis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 50
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: All patients admitted to the University Medical Center Groningen who receive fluconazole

Brief summary: Fluconazole is the first-line agent in the treatment of invasive candidiasis. Studies showed inappropriate drug exposure causes high mortality in critically ill patients. Under-dosing and ineffective fluconazole trough serum concentrations were found in a recent retrospective study. Variability in fluconazole exposure can be easily measured with therapeutic drug monitoring. For patient groups who are at risk for drug underexposure, therapeutic drug monitoring can be valuable regards decreasing mortality.


Eligibility criteria: Inclusion Criteria:

* Patient is 18 years or older.
* Treatment with fluconazole.
* Written informed consent obtained from patient.
* Written informed consent obtained from representative of patient.

Exclusion Criteria:

* Blood sampling not possible

Primary outcomes:
measure: Plasma concentrations of fluconazole in critically ill patients
timeFrame: Up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Jan-WIllem Alffenaar, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boonstra JM, Martson AG, Sandaradura I, Kosterink JGW, van der Werf TS, Marriott DJE, Zijlstra JG, Touw DJ, Alffenaar JWC. Optimization of Fluconazole Dosing for the Prevention and Treatment of Invasive Candidiasis Based on the Pharmacokinetics of Fluconazole in Critically Ill Patients. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e01554-20. doi: 10.1128/AAC.01554-20. Print 2021 Feb 17.