louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01490177: Single Center Food Allergy Oral Immunotherapy Study
Official title: Single Center, Phase I Food Allergy Oral Immunotherapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System Diseases
Keywords: Multiple food allergies
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Primary Objective of the study is to develop a customized regimen for oral immunotherapy that reflects what the subject is allergic in a clinically significant way (i.e., the offending food allergen is defined as a food allergen with a positive skin test or positive specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single and multiple food allergy subjects are included in the study.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
* Sensitivity to food allergen will be documented by a positive skin prick test result (see Appendix for details) or allergen specific ImmunoCAP IgE level with 7 kU/L as a lower limit of eligibility.

Exclusion Criteria:

* No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
* Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.

Primary outcomes:
measure: Number of adverse events in the treatment population
timeFrame: 2 years
Secondary outcomes:
measure: Number of subjects who reach 2g or more of food flour
timeFrame: 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
citation: Begin P, Winterroth LC, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, Trela A, Hoyte E, O'Riordan G, Seki S, Blakemore A, Woch M, Hamilton RG, Nadeau KC. Safety and feasibility of oral immunotherapy to multiple allergens for food allergy. Allergy Asthma Clin Immunol. 2014 Jan 15;10(1):1. doi: 10.1186/1710-1492-10-1.
Clinical trial NCT04065477: Improving Time-Based Prospective Memory in TBI
Official title: Improving Time-Based Prospective Memory in TBI: A Feasibility and Dosing Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
TBI
Brain Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).

Detailed description: This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI), particularly improving the ability to remember to do things in the future.

Eligibility criteria: Inclusion Criteria:

* Sustained a moderate-to-severe TBI at least one year prior to assessment
* Fluent in English
* Demonstrate impairment in strategic cognitive abilities

Exclusion Criteria:

* Significant neurological history other than TBI
* Significant psychiatric history (e.g., bipolar disorder, schizophrenia)
* Significant substance abuse history
* Steroid and/or benzodiazepine use

Primary outcomes:
measure: Intervention Tolerability Assessment Scale
timeFrame: baseline through final follow-up assessment (16 weeks)
measure: Recruitment rate percentage
timeFrame: phone screen to in-person screen (within 2 weeks)
measure: Retention rate percentage
timeFrame: baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)
Secondary outcomes:
measure: Changes in time monitoring & time-based prospective memory
timeFrame: 16 weeks
measure: Changes in strategic cognitive functions (performance on NIH EXAMINER)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Erica Weber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575977: Stress Analysis of Hip Dysplasia
Official title: Stress Analysis of Hip Dysplasia After Corrective Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Dysplasia
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-40 years old

Brief summary: The main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (PAO).

Detailed description: PAO was designed as a joint preserving surgical procedure to compensate for a shallow acetabulum by re-orienting the acetabulum into a position that provides better coverage of the femoral head. Although the overall theory that increasing load bearing area (improving coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony surface may not behave in this manner. It is possible that joint stress may increase when the acetabulum is reoriented into a position that increases load bearing area if post-operative joint congruency is worse than pre-operative.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-40 years
* Patients who have undergone periacetabular osteotomy by Dr. Peters for treatment of hip dysplasia.
* Patients who have previously participated in IRB #10983 "Comparative Stress Analysis of Hip Dysplasia".

Exclusion Criteria:

* Persons with a history of allergies to lidocaine or seafood.
* Children under the age of 18.
* Persons incarcerated, on trial, or parole.
* Women who are pregnant.
* Subjects who do not have high quality pre-operative images available or have not been surgically treated by periacetabular osteotomy.

Primary outcomes:
measure: To predict cartilage contact pressures in the hip joint during simulated daily activities before and after periacetabular osteotomy (PAO) for correction of traditional dysplasia/retroversion.
timeFrame: 1 year post surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthopedic Surgery Operations
name: Andrew Anderson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04455477: Nesiritide for Ventilated Congestive Heart Failure
Official title: Hemodynamic Effects of Nesiritide on Congestive Heart Failure Patients Receiving Mechanical Ventilation: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Mechanical Ventilation
Using Nesiritide
Venous Return
Cardiac Function
Keywords: Congestive Heart Failure
Nesiritide
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Congestive heart failure patients relying on mechanical ventilation and therefore decide to try the Nesiritide.

Brief summary: The congestive heart failure is a common disease among patients who receive cardiac surgery and may lead to prolonged ventilation support. Nesiritide was a potential therapy for congestive heart failure. This study aimed to compare the Nesiritide induced hemodynamical status changes among congestive heart failure patients with invasive ventilation support.


Eligibility criteria: Inclusion Criteria:

* Age≥18 years；
* Congestive Heart Failure;
* With mechanical ventilation；
* With hemodynamic monitoring devices;
* The physicians made the decision of using Nesiritide.

Exclusion Criteria:

* Unstable hemodynamic status；
* Severe renal dysfunction.

Primary outcomes:
measure: Changes of cardiac output
timeFrame: Before and 30-min after using a standard dose of Nesiritide
measure: Changes of systemic filling pressure
timeFrame: Before and 30-min after using a standard dose of Nesiritide
Secondary outcomes:
measure: Changes of cardiac function curve
timeFrame: Before and 30-min after using a standard dose of Nesiritide
measure: Changes of venous return curve
timeFrame: Before and 30-min after using a standard dose of Nesiritide
Other outcomes:
Locations:
city: Xuhui
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00810277: A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs
Official title: An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* moderate to severe rheumatoid arthritis;
* inadequate response to current non-biologic DMARDs

Exclusion Criteria:

* rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
* previous treatment with other biologics.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Disease Activity Score (DAS28)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: C-Reactive Protein (CRP) Level
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Who Discontinued the Study
timeFrame: Up to Week 24
measure: Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal
timeFrame: Up to Week 24
measure: Percentage of Participants With Lipid Level Elevations
timeFrame: Week 24
measure: Neutrophil Count
timeFrame: Baseline, Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Hyvinkää
country: Finland
facility: Kiljavan Lääketutkimus Oy
city: Hämeenlinna
country: Finland
facility: Kanta-Hämeen Keskussairaala ; Reumatologia
city: Riihimäki
country: Finland
facility: Kanta-Hämeen keskussairaala; Riihimäen aluesairaala Reumapoliklinikka
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00668577: Dermatological Evaluation of Topic Compatibility - Dermacyd Breeze
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region

Exclusion Criteria:

* Use of Antiinflammatory and/or immunosuppression drugs
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Active cutaneous disease
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05953077: The Effect of Prior Learning on Treatment of Morpheme Errors
Official title: The Effect of Prior Learning on Treatment of Morpheme Errors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Language Disorder
Keywords: treatment
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: quasi-experimental design with two active treatment groups
Primary purpose: TREATMENT

Brief summary: This is a small-scale treatment study designed to determine which teaching methods result in the best learning. Treatment focuses on helping children with a developmental language disorder learn parts of grammar. Preschool children will receive assessments to determine whether they have a developmental language disorder and what parts of grammar they have not mastered. Children will receive one-on-one behavioral treatment over a six week period. Half of the children will be first taught a grammatical form they sometimes use and then one they rarely use. The other half will start with a grammatical form they rarely use. The study seeks to determine whether starting with something children sometimes use correctly (an easier part of speech) will speed later learning of something that is harder for them. The children's ability to use the grammatical forms taught to them will be assessed throughout the treatment period and approximately six weeks after treatment ends.


Eligibility criteria: Inclusion Criteria:

* Native English speaking
* Passed a pure-tone hearing screening
* 4-6 years of age
* SPELT-P2 (language) test score of \< 87
* K-ABC-II Nonverbal Scale (cognition) test score of \>75
* Sufficient morpheme errors to serve as treatment and control targets
* Articulations skills sufficient to judge use of language targets
* Able to attend treatment daily

Exclusion Criteria:

* Parent report of other handicapping conditions
* Clinical signs of other disorders
* Enrolled in outside treatment

Primary outcomes:
measure: Change in the use of treated grammatical forms in untreated contexts
timeFrame: 3 days per week over 6 weeks
measure: Change in the use of grammatical forms in untreated contexts
timeFrame: 3 days per week over 6 weeks
measure: Retention of trained grammatical forms
timeFrame: One session, approximately 6 weeks after treatment concludes.
measure: Retention of untrained grammatical forms
timeFrame: One session, approximately 6 weeks after treatment concludes.
Secondary outcomes:
measure: Change in spontaneous use
timeFrame: 5 sessions a week over 6 weeks.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References:
Clinical trial NCT01514253: Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1
Official title: Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Newborn, Diseases
Keywords: glucose
analgesic
newborns
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2012-01-23
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.

Detailed description: During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.

Pain experienced during the neonatal period is known to have long term effects on the baby.

The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.

Eligibility criteria: Inclusion Criteria:

* Full term above 37 weeks gestation.
* Normal birth-weight, healthy infants
* Males and Females
* Whose parents have signed the informed consent form

Exclusion Criteria:

* Premature born below 37 weeks
* Chromosomal abnormalities or congenital malformation.
* Suffering neurological imbalance
* Inability of oral feeding

Primary outcomes:
measure: less discomfort
timeFrame: immediate, during examination (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: NICU Department, The Baruch Padeh medical Center - Poriya
Study officials:
affiliation: The Baruch Pade Medical Center - Poriya
name: Shay Barak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Baruch Padeh Medical Center - Poria
name: Amir Kushnir, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01782053: Communicating Smoking Risks Through Graphic Warning Labels
Official title: Communicating Smoking Risks Through Graphic Warning Labels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Heart Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2013-02-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette packs as well as nine new statements of smoking risks. This trial tests the effectiveness of the warnings proposed by the Food and Drug Administration by providing cigarettes with the proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In addition, the trial tests the effects of different warning label components.


Eligibility criteria: Inclusion Criteria:

* smoke between 5 and 40 cigarettes per day and 100 in lifetime
* Not currently trying to quit
* between 18 and 65 years of age

Exclusion Criteria:

* smokes 120's or roll-your own or noncommercial cigarettes
* pregnant or breastfeeding
* history of substance abuse past 5 years
* more than 25 standard alcohol drinks per week
* use of other nicotine products, such as cigars, nicotine gum
* current treatment for copd, cancer, pulmonary disease, alcohol/drug dependence
* current treatment for a psychiatric condition
* physical/visual/mental impairment that prevents reading from a computer screen
* not US resident
* unable to read English
* English not main language
* other member of household in study
* friend who smokes in study
* unable to attend weekly appointments between 9 am and 6 pm Monday-Friday
* unable to use hand-held computer to enter daily mood ratings

Primary outcomes:
measure: Intention to try to quit smoking in next 30 days
timeFrame: Assessed after 4 weeks of exposure to new labels
Secondary outcomes:
measure: Affective reactions toward cigarettes and smoking cues
timeFrame: After 4 weeks of exposure to the new warning labels
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Lazenby Hall, Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Annenberg Public Policy Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Daniel Romer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Ellen Peters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans AT, Peters E, Strasser AA, Emery LF, Sheerin KM, Romer D. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial. PLoS One. 2015 Dec 16;10(12):e0142879. doi: 10.1371/journal.pone.0142879. eCollection 2015.