louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01115595: Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais
Official title: Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Perennial
Keywords: Allergic rhinitis
Allergen injection immunotherapy
Efficacy
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2010-05-04
Enrollment: 84
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the efficacy of allergen injection immunotherapy for allergic rhinitis by

* symptoms score
* medication score
* quality of life
* immunologic test from blood

Detailed description: Compare the efficacy of allergen injection immunotherapy between the treatment group and the placebo group after injection for

* 2 months
* 6 months
* 12 months

Eligibility criteria: Inclusion Criteria:

* patients with the symptoms of allergic rhinitis who sensitized to mite (Dermatophagoides pteronyssinus)
* positive skin prick test to D.p. at 4+ degree

Exclusion Criteria:

* steroid dependent asthma
* force expiratory volume (FEV1) less than 70% of predicted value
* previous injection immunotherapy within 2 years
* pregnancy
* medical conditions such as ischemic heart disease, autoimmune disease, cancer, previous history of anaphylaxis

Primary outcomes:
measure: Total nasal symptoms score
timeFrame: average within 1 week
Secondary outcomes:
measure: Combined total symptoms score and medication score
timeFrame: average within 1 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University
Study officials:
affiliation: Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University
name: Pongsakorn Tantilipikorn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01202695: Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anthrax
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary:

• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo

Secondary:

* To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
* To evaluate the immunogenicity of AVP-21D9

Detailed description: This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.

Eligibility criteria: Key Inclusion Criteria:

* Healthy volunteers, between 18 and 45 years of age
* Normal laboratory (blood test) results

Key Exclusion Criteria:

* Prior immunization with anthrax vaccine

Primary outcomes:
measure: Safety assessments
timeFrame: 90 days following infusion
Secondary outcomes:
measure: Pharmacokinetics (PK) analysis
timeFrame: 90 days following infusion
measure: Immunogenicity analysis
timeFrame: From day 1 up to day 90 following infusion
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Development Solutions
state: Texas
Study officials:
affiliation: Emergent BioSolutions
name: Robert Hopkins, MD
role: STUDY_DIRECTOR
References:
citation: Malkevich NV, Hopkins RJ, Bernton E, Meister GT, Vela EM, Atiee G, Johnson V, Nabors GS, Aimes RT, Ionin B, Skiadopoulos MH. Efficacy and safety of AVP-21D9, an anthrax monoclonal antibody, in animal models and humans. Antimicrob Agents Chemother. 2014 Jul;58(7):3618-25. doi: 10.1128/AAC.02295-13. Epub 2014 Apr 14.
Clinical trial NCT00894595: Preventing Knee Injuries in Adolescent Female Football Players
Official title: Preventing Knee Injuries in Adolescent Female Football Players - Protocol of a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injury
Keywords: Incidence of ACL injury
Risk factors for ACL injury
Prevention of ACL injury or any acute knee injury
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Swedish Football Association
name: Folksam
name: Swedish National Centre for Research in Sports
First posted: 2009-05-07
Enrollment: 4564
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Football-related knee injuries are common and especially the anterior cruciate ligament (ACL) injury constitute a serious problem in football regardless of the playing level. The purpose of this study is to conduct a randomized controlled trial evaluating the effect of a training program designed to prevent acute knee injury in female adolescent football players.

The investigators' hypotheses are:

1. a preventive training program reduces the incidence of ACL injury, and
2. a high match frequency and match play at senior level increase the risk of ACL injury.


Eligibility criteria: Inclusion Criteria:

* Teams with female football players aged 13-17 years

Exclusion Criteria:

* Teams that did not reply to the invitation or declined participation
* Teams having less than two scheduled training sessions per week
* Teams already using the preventive program

Primary outcomes:
measure: The incidence of ACL injury
timeFrame: One competitive football season
Secondary outcomes:
measure: The incidence of any acute knee injury except contusion
timeFrame: One competitive football season
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Medical and Health Sciences, Linköping University
Study officials:
affiliation: Linkoeping University
name: Markus Waldén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walden M, Atroshi I, Magnusson H, Wagner P, Hagglund M. Prevention of acute knee injuries in adolescent female football players: cluster randomised controlled trial. BMJ. 2012 May 3;344:e3042. doi: 10.1136/bmj.e3042.
citation: Hagglund M, Walden M, Atroshi I. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595]. BMC Musculoskelet Disord. 2009 Jun 23;10:75. doi: 10.1186/1471-2474-10-75.
Clinical trial NCT02818595: Development of Maternal Voice Recognition in Preterm Neonates
Official title: Development of Maternal Voice Recognition in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: voice recognition
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 22
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Many cognitive functions in humans are based on asymmetrical brain networks. For example, in most adults, the language is essentially processed by the left hemisphere, while other auditory functions, such as voice recognition, tend to be processed by the right hemisphere. Many studies, especially those conducted by Ghislaine Dehaene's team, have demonstrated the presence of anatomical and functional asymmetries by the first months of life. What are the causes of these asymmetries? How do they develop? Are they necessary for functioning or effective learning?

This study, conducted in collaboration with the Compiègne applied mathematics team (Abdelatif El Badia) and the INSERM team (Ghislaine Dehaene), is designed to determine the stage of development at which hemispheric dominance for voice recognition is first observed and to identify the brain structure involved in preterm neonates whose sound environment is usually very different from that of the foetus. The impact of this environment on the infant's brain development and early learning will be evaluated.


Eligibility criteria: Inclusion Criteria:

* The distribution of children in the different groups of infants included in the study will be validated at the time of the acquisitions.
* Normal group of children: A child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF, Scanner, MRI).
* Group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (ETF, Scanner, MRI).

Exclusion Criteria:

About history:

* All children with severe congenital malformation

Regarding the study period;

* Any refusal of a parent
* Children with severe impairment of the general condition and vital functions
* Children with dermatitis of the face or scalp
* Children treated with ventilation High Frequency (HFO)
* Presence of intravenous access on the scalp (preventing the realization of the ETF, EEG and NIRS

Primary outcomes:
measure: The difference in amplitude
timeFrame: 10 weeks
measure: The difference in latency
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Fabrice WALLOIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05708495: Ilium Mobilization in Patellofemoral Pain Syndrome Treatment
Official title: Efficacy of Adding Posterior Ilium Mobilization With Movement to Treatment of Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: patellofemoral pain syndrome
strength
stretch
mobilization
ilium
innominate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to investigate the effect of adding posterior ilium mobilization on knee pain, knee function, anterior pelvic tilt, dynamic knee valgus, muscle strength of extensors, abductors and external rotators of hip and knee extensors in patients with patellofemoral pain syndrome.


Eligibility criteria: Inclusion Criteria:

1. Age of the subjects between 18-35 years.
2. BMI will be ≤ 29.5
3. Anterior or retro patellar knee pain for at least 6 weeks duration.
4. Foot posture index score from +6 to +12.
5. Anterior pelvic tilt angle more than 8 degree.
6. Pain elicited at least by two of the following four tests; (i) Isometric muscle contraction with slight bent knee,(ii) palpation of the patellofemoral joint line, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
7. Pain intensity more than 3 at ANPS and provoked by at least two of the following activities: running, walking, hopping, squatting, stair negotiation, kneeling, or prolonged sitting.

Exclusion Criteria:

1. Meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement.
2. A history of traumatic patellar subluxation or dislocation.
3. Previous surgery in the knee, ankle and hip joints.
4. Knee, ankle and hip joints osteoarthritis.
5. Taking non-steroidal anti-inflammatory drugs or corticosteroids within 24 h before the test.
6. History of brain injury or vestibular disorder within the last 6 months.
7. Pregnant female.

Primary outcomes:
measure: Changes in pain
timeFrame: It will be assessed at baseline and after 4 weeks
measure: Changes in knee functional disability
timeFrame: It will be assessed at baseline and after 4 weeks
Secondary outcomes:
measure: Changes in hip abductors strength
timeFrame: It will be assessed at baseline and after 4 weeks
measure: Changes in hip extensors strength
timeFrame: It will be assessed at baseline and after 4 weeks
measure: Changes in hip external rotators strength
timeFrame: It will be assessed at baseline and after 4 weeks
measure: Changes in knee extensors strength
timeFrame: It will be assessed at baseline and after 4 weeks
measure: Changes in dynamic knee valgus
timeFrame: It will be assessed at baseline and after 4 weeks
measure: Changes in pelvic tilt angle
timeFrame: It will be assessed at baseline and after 4 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
References:
Clinical trial NCT04388995: SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Official title: Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Volume Variation
Pulse Pressure Variation
Fluid Responsiveness
Fluid Therapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.


Eligibility criteria: Inclusion Criteria:

* 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I \~II. 4.BMI 18 \~ 24 kg/m2

Exclusion Criteria:

* 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.

Primary outcomes:
measure: Fluid responsiveness
timeFrame: immediately after the fluid therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Haidian
Study officials:
References:
Clinical trial NCT04071795: Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
Official title: Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm cluster randomized study design
Primary purpose: TREATMENT

Brief summary: This study will use a scientifically robust, mixed-methods, two-arm cluster-randomized study design. Investigators will implement a tobacco use clinical reminder for outpatient psychiatrists practicing at the VA New York Harbor Healthcare System (N = 20). Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting (Opt-In Reminder). The other half will receive a clinical reminder that includes a standing nicotine replacement therapy (NRT) order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out (Opt-Out Reminder). Prior to implementation of the reminders, psychiatrists in both arms will receive a one-hour training on tobacco treatment and individual education outreach to demonstrate the clinical reminder and answer questions (academic detailing).


Eligibility criteria: Inclusion Criteria:

* Psychiatrists
* Works in outpatient psychiatry at Manhattan or Brooklyn VA campus and has no plans to leave in the next 6 months
* Patient Post-Visit Survey Population
* Had a visit with a psychiatrist included in the study Current smoker

Exclusion Criteria:

* Outpatient Psychiatrists:
* None
* Patient Post-Visit Survey Population:
* Non-English speaking

Primary outcomes:
measure: Number of Patients Screened for Smoking
timeFrame: Up to Month 6
measure: Number of Smokers Prescribed a Cessation Medication
timeFrame: Up to Month 6
measure: Number of Smokers Referred to Counseling
timeFrame: Up to Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Erin Rogers, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers ES, Wysota C, Prochaska JJ, Tenner C, Dognin J, Wang B, Sherman SE. A behavioral economic intervention to increase psychiatrist adherence to tobacco treatment guidelines: a provider-randomized study protocol. Implement Sci Commun. 2020;1:32. doi: 10.1186/s43058-020-00011-x. Epub 2020 Feb 25.
Clinical trial NCT00327795: Surgical Outcomes in Pediatric Patients With Coarctation and VSD
Official title: Staged Approach to Coarctation and VSD Can Offer Optimal Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diagnosis of Coarctation of the Aorta and VSD
Surgical Repair at CHOA
Between January 1, 2002 and December 31, 2005
Keywords: congenital heart disease
pediatric
surgical outcomes
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosis of coarctation and VSD

Brief summary: Recently, a paper was published that compared outcomes of patients requiring repair of aortic coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one surgery while other surgeons do the repair in two separate operations. Recently at Children's Healthcare of Atlanta, we have adopted the practice of correcting both defects during the same operation but through two separate incisions (one on the chest and the other through the ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass machine during surgery. This study is a review of patient charts to compare outcomes of patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.

Detailed description: This study is a retrospective chart review of patients who carry the diagnosis of aortic coarctation and VSD and have had their surgical repair at Children's Healthcare of Atlanta between the dates of January 1, 2002 and December 31, 2005. The data collected will be surgical data such as type of repair, and the time the patient required cross clamp, circulatory arrest and cardiopulmonary bypass while in the operating room for the repair(s). We would also like to gather post-operative information such as time the patient required ventilation, whether they required a re-operation during the same admission, along with intensive care hours and hospital length of stay.

Eligibility criteria: Inclusion Criteria:

* diagnosis of coarctation and VSD
* surgical repair at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.

Exclusion Criteria:

* does not have coarctation and VSD
* did not have surgery at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Kirk R Kanter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059695: Analysis of the Results of Treatment for Cervical Carcinoma in Limburg
Official title: Retrospective Analysis of Treatment and Quality of Life of Women Treated for Cervical Carcinoma FIGO Stage IB-1 to IVb From 2000-2008 in Limburg, a Province in the South of the Netherlands.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: cervical cancer
retrospective
quality of life
treatment
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Atrium Medical Center
First posted: 2010-02-01
Enrollment: 220
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women diagnosed with cervical cancer FIGO stage IB-1 to IV between 2000 and 2008 in Limburg, a province in the south of the Netherlands.

Brief summary: Analysis of all women treated for cervical cancer between 2000 and 2008 in Limburg, a province in the south of the Netherlands. Patient characteristics, diagnosis, treatment modalities, complications and survival will be analyzed by record review. Quality of life of the living study population will be assessed using the EORTC QLQ-C30 and QOQ-CX24 questionnaire. Patients will be identified via registration data from the Integraal Kankercentrum Limburg.


Eligibility criteria: Inclusion Criteria:

* cervical cancer FIGO stage IB-1 to IVB
* Treated in Limburg between 2000 and 2008

Exclusion Criteria:

* none

Primary outcomes:
measure: Quality of life
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: