louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01929785: BIIR Gene to Manage Heart Allograft Patients
Official title: Application of In-House Developed Nanomedicine Technology for Diagnosis and Management of Post-Transplant Heart Allograft Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Transplant Failure
Keywords: post tranplant heart allograft
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: heart transplant patients from Baylor University Medical Center,Dallas

Brief summary: This is a single center observational study. Duration of the study is 1 year. Participants will be followed in 2 groups. Group 1 will include all patients who have undergone a heart transplant, through the first year post transplant. Group 2 will include heart transplant recipients from 1 year to 2 years post transplant. Groups will be enrolled simultaneously. It is anticipated each group will have 25 participants.

Detailed description: Application of the BIIR gene expression profile approach to heart transplantation clinical diagnostic issues is likely to create new means to detect rejection at the earliest stages, to help prevent progression through earlier treatment, to discover new avenues targets for treatment of heart graft rejection, and to reduce the cost of post-transplant health care

Eligibility criteria: Inclusion Criteria:

* Patients who will have or have already received a heart transplant.
* Patients who have no other transplant history.
* Men and Women ages 18 to 73

Exclusion Criteria:

* Patients who are pregnant or lactating will not be eligible for this protocol.
* Patients who are cognitively impaired

Primary outcomes:
measure: To systematically collect blood samples from heart allograft recipients who are 0-2 years post-transplant to create a repository for genomic research.
timeFrame: 2 years
Secondary outcomes:
measure: Recent work using our gene expression profiling (GEP) has shown that peripheral blood cells display a unique GEP that is 90% accurate for detection of acute rejection in liver transplant patients & hopefully hearts as well.
timeFrame: 2 years
Other outcomes:
measure: To correlate the BUMC GEP results with AlloMap results.
timeFrame: 2 years
measure: To determine whether immune response status, as reflected by donor specific antibody response adn Cylex ImmuKnow assay, alters the GEP in heart transplant patients.
timeFrame: 2 years
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Shelley Hall, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03355885: Early-onset Pneumonia After Out-of-hospital Cardiac Arrest
Official title: Impact of Early Diagnosis Algorithm for Early-onset Pneumonia Diagnosis on Prognosis of Patients With Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Out-of-Hospital Cardiac Arrest
Keywords: early onset pneumonia
out-of-hospital cardiac arrest
prognosis
antibiotic
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted for out-of-hospital cardiac arrest in intensive care who and treated with hypothermia

Brief summary: Early-onset pneumonia after out-of-hospital cardiac arrest is frequent. An association between early-onset pneumonia and an increase in morbidity has been reported in this population. The diagnosis of early-onset pneumonia inpatients with out-of-hospital cardiac arrest may be challenging as diagnosis criteria are unspecific in this setting. On the other hand some studies have reported an association between early antibiotics and better prognosis in patients with out-of-hospital cardiac arrest suggesting that early diagnosis and treatment of pneumonia would benefit to patients. Nonetheless, adminitration of antibiotics to any patients with out-of-hospital cardiac arrest would expose to antibiotic patients without infection and woould participate to increase in antibiotic resistance.

Therefore, the PP-ACR study aims to evaluate the impact of a diagnosis algorithm including blinded sampling protected brushes on early-onset pneumonia treatment and patient prognosis after out-of-hospital cardiac arrest.

Detailed description: This study is a single centre observational study with a before - after design.

Eligibility criteria: Inclusion Criteria:

* patients admitted for out-of-hospital cardiac arrest and treated with hypothermia

Exclusion Criteria:

* age less than 18
* consent withdrawal

Primary outcomes:
measure: delay between intensive care admission and antibiotic initiation
timeFrame: first 5 days
measure: delta respiratory SOFA score between Day 1 and day 3
timeFrame: first 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT00394485: Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients
Official title: A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
Procaterol
Tiotropium
Lead sponsor: Otsuka Pharmaceutical, Inc., Philippines
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2006-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease

Detailed description: This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD.

After a 1-week wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.

Eligibility criteria: Inclusion Criteria:

1. GOLD criteria for moderate COPD (post-bronchodilator)

   * FEV1/FVC \< 70%
   * 50% ≤ FEV1 \< 80% predicted
   * With or without symptoms
2. Willing to undergo the treatment protocol with signed informed consent

Exclusion Criteria:

1. Exacerbation within 1 month prior to run-in period
2. Significant hypoxemia and/or desaturation at rest and during exercise.
3. Significant cardiac, renal, or other systemic disease
4. History of adverse reaction to any of the two test drugs (tiotropium and procaterol)

Primary outcomes:
measure: [Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks
Secondary outcomes:
measure: [Safety] HR (Heart Rate) and BP (Blood Pressure)
measure: Incidence of adverse reactions and changes
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital
state: National Capital Region
Study officials:
affiliation: University of the Philippines College of Medicine
name: Abundio A Balgos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01856985: Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation
Official title: The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Medical Abortion
Keywords: Medical abortion
Misoprostol
Mifepristone
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.

Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.


Eligibility criteria: Inclusion Criteria:

* Seeking abortion services
* Have an intrauterine pregnancy 78 days through 84 days' LMP
* Be willing and able to sign consent forms
* Agree to comply with study procedures and visit schedule
* Be living with 30 minutes from the hospital

Exclusion Criteria:

* Does not meet the inclusion criteria outlined above

Primary outcomes:
measure: Percentage of women who have undergone a successful abortion
timeFrame: 2 weeks
Secondary outcomes:
measure: Women's acceptability of the assigned method.
timeFrame: 2 weeks
measure: Side effects
timeFrame: 48 hours
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jennifer Blum, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Research and Consultancy in Reproductive Health
name: Nguyen Thu Nhu Ngoc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Dina F Abbas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01024985: Evaluation of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Oct
Official title: Evaluation of Macular and Retinal Nerve Fiber Layer Thickness Measurements for Detection of Neural Loss in Multiple Sclerosis and Neuromyelitis Optica Using High Resolution Optical Coherence Tomography.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Neuromyelitis Optica
Keywords: optic neuritis
longitudinally extensive transverse myelitis
retinal nerve fiber layer
macular thickness
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of ophthalmology and/or neurology departments of hopital das clinicas of medical school of university of sao paulo

Brief summary: The purpose of this study is to determine the ability of STRATUS OCT and high resolution OCT to detect and to quantify the neural loss in multiple sclerosis and neuromyelitis optica and its subtypes.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of multiple sclerosis or neuromyelitis optica
* age between 15 and 60 years
* BCVA better than 20/400
* no optic neuritis crisis in the last 6 months

Exclusion Criteria:

* diagnosis of glaucoma, opacities or disc anomalies
* diagnosis of macular disease
* disc swelling at fundoscopy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Medical School of University of Sao Paulo
Study officials:
References:
citation: Hokazono K, Raza AS, Oyamada MK, Hood DC, Monteiro ML. Pattern electroretinogram in neuromyelitis optica and multiple sclerosis with or without optic neuritis and its correlation with FD-OCT and perimetry. Doc Ophthalmol. 2013 Dec;127(3):201-15. doi: 10.1007/s10633-013-9401-2. Epub 2013 Jul 30.
citation: Monteiro ML, Fernandes DB, Apostolos-Pereira SL, Callegaro D. Quantification of retinal neural loss in patients with neuromyelitis optica and multiple sclerosis with or without optic neuritis using Fourier-domain optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):3959-66. doi: 10.1167/iovs.11-9324.
Clinical trial NCT05538585: A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor
Official title: A Food-Effect Study for the Safety and Assessment of Pharmacokinetics of Navocaftor and Galicaftor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Galicaftor
Navicaftor
ABBV-3067
ABBV-2222
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is =\> 18.0 to \<= 32.0 kg/ m2 after rounding to the tenth's decimal.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to Day 4
measure: Time to Cmax (peak time, Tmax)
timeFrame: Up to Day 4
measure: Terminal Elimination Half-life (t1/2)
timeFrame: Up to Day 4
measure: Area under the plasma curve (AUC)
timeFrame: Up to Day 4
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 38
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami /ID# 249531
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 249532
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02825485: Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
Official title: Minimizing the Utilization of Voiding Cystourethrography for Patients With Antenatal Hydronephrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Antenatal Hydronephrosis
Post-natal Hydronephrosis
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: It has previously been found that there is no correlation between degree of hydronephrosis and presence of reflux; however this is oftentimes the criteria physicians use to obtain a VCUG.

Detailed description: Investigators conducted a previous retrospective study to evaluate other possible findings on ultrasound that may better predict reflux. Investigators found that if a postnatal ultrasound showed any of the three findings of hydroureter, duplication or dysmorphic kidney, then the odds ratio of detecting reflux was 8.07 (95%CI 3.86, 16.87). The purpose of this study is to perform a randomized prospective study to validate this retrospective study. Investigators hypothesis is that patients with hydronephrosis alone will be more likely to have negative VCUG studies; hence obtaining a VCUG for this indication may not be warranted.

Eligibility criteria: Inclusion Criteria:

* Patients with a history of antenatal hydronephrosis who have a post-natal ultrasound demonstrating hydronephrosis alone and no other abnormalities

Exclusion Criteria:

* Patients with a post-natal ultrasound demonstrating bilateral hydronephrosis
* Patients with a history of posterior urethral valve or when a valve is suspected
* Patients who have hydronephrosis on ultrasound as well as other findings including duplication, hydroureter, dysmorphic kidneys, or bladder abnormalities

Primary outcomes:
measure: Development of UTIs
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: The rate of reflux detected on VCUGs
timeFrame: Through study completion, an average of 4 years
measure: Rate of resolution of hydronephrosis
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System, Pediatric Urology, Battle Bldg
state: Virginia
Study officials:
References:
Clinical trial NCT05513885: Bacterial Ecology of Pilonidal Cysts
Official title: Bacterial Ecology of Pilonidal Cysts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pilonidal Cysts
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients operated on for pilonidal cysts and who received the same protocol:

* Antibiotic prophylaxis (injection of 2g of Augmentin)
* Treatment of the cyst by laser, under general anaesthesia, after dilatation of the pilonidal sinus, evisceration and bacteriological swabbing.
* Post-operative monitoring and local care

Brief summary: Bacterial ecology of pilonidal cysts Single centre retrospective exploratory study of medical data contained in the medical records of patients operated on in the centre between 01/08/2020 and 30/11/2020.

Detailed description: From the medical records of a series of patients treated for pilonidal cysts:

1. Describe the bacteriological analyses performed on a series of non-abscessed pilonidal cysts before laser treatment
2. Compare the bacterial flora of cysts operated on in the first instance and those reoperated on

This is a retrospective monocentric study of medical data contained in the medical records of patients operated on for pilonidal cysts and who received the same protocol:

* Antibiotic prophylaxis (injection of 2g of Augmentin)
* Treatment of the cyst by laser, under general anaesthesia, after dilatation of the pilonidal sinus, evisceration and bacteriological swabbing.
* Post-operative monitoring and local care

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older,
* Patient who has been informed about the research;
* Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure.

Exclusion Criteria:

* Patient under legal protection, guardianship or curatorship;
* Patient who has indicated his opposition to the use of his data;
* Patient undergoing emergency surgery for an abscess.

Primary outcomes:
measure: Main germs incidence rate
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT00071656: Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I
Official title: Psychosocial Treatment for ADHD Inattentive Type I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop and implement a treatment that focuses on behaviors to reduce symptom severity and functional impairment in patients with Attention Deficit Hyperactivity Disorder, Predominantly Inattentive Type (ADHD-I). The long-term goal of this study is to apply the treatment to larger-scale trials to determine its effectiveness and generalizability.

Detailed description: ADHD-I is a highly prevalent and serious childhood disorder that affects academic and social development. The symptoms of ADHD-I differ from those of the well-studied ADHD Combined Type. Unfortunately, studies of psychosocial interventions for ADHD-I are currently unavailable. Effective treatments for ADHD-I are still needed.

Participants are randomly assigned to receive either a behavioral intervention or treatment as usual for 10 to 12 weeks. The behavioral intervention includes parent and child skill development groups, family meetings, and consultation with the child's teacher to address attention problems and areas of impairment at home and school. Parent and child interviews, teacher and child ratings, and psychoeducational testing are used to assess participants. Participants are assessed post-treatment and at a 2-month follow-up visit.

Eligibility criteria: Inclusion Criteria:

* ADHD, Predominantly Inattentive Type
* Public or private school attendance
* English speaking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: HALP Clinic, Children's Center at Langley Porter, UCSF
state: California
Study officials:
References: