louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02578576: The Diagnostic Methods of Early Postoperative Flare-up of Crohn's Disease
Official title: The Diagnostic Methods of Crohn's Disease Flare-up Within One Month After Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn's Disease
Keywords: Diagnostic Techniques
Digestive System
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with Crohn's disease

Brief summary: Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high rate of postoperative anastomotic complications and recurrences. Surgery itself can influence immunologic function and trigger inflammatory response, which may result in the flare of Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to the the complexity of perioperative period and dangerous of invasive examine, it is difficult to distinguish disease flare from postoperative complications.

In this study, the investigators aim to development a diagnostic method of flare-up within one month after surgery, which can help us to detect and then treat disease flare in time.

Detailed description: HBI score, serum CRP, ESR, WBC, Hb, PLT, IL-6，PCT and fecal Calprotectin will be monitored within one month after resection.

Eligibility criteria: Inclusion Criteria:

* patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis,

Exclusion Criteria:

* patients have an anastomosis which is endoscopically inaccessible by standard colonoscopy;
* patients withs persisting macroscopic abnormality after surgical resection;
* patients with an end stoma (ileostomy or colostomy);
* patients are not suitable to undergo endoscopy because of co-morbidities or an unwell clinical state;
* patients who are unable to give informed consent;
* patients who are pregnant

Primary outcomes:
measure: flare-up confirmed by coloscopy
timeFrame: one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
state: Jiangsu
Study officials:
References:
Clinical trial NCT02946476: Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients
Official title: Prevalence and Prognostic Impact of Noncardiac Comorbidities in Heart Failure Outpatients With Preserved and Reduced Ejection Fraction: A Community-Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Diastolic
Heart Failure, Systolic
Lead sponsor: Ospedale Maggiore Di Trieste
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 2314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We studied all consecutive heart failure patients with diagnostic codes presenting clinical findings compatible with heart failure

Brief summary: To better understand the public health prognostic impact of noncardiac chronic illnesses, we explored the attributable risk of noncardiac comorbidities on outcomes between heart failure patients with reduced ejection fraction (HFREF) and heart failure patients with preserved ejection fraction (HFpEF) in a large contemporary heart failure (HF) population The adjusted hazard ratio (HR) and the population attributable risk were used to compare the contributions of 15 noncardiac comorbidities to adverse outcome. The comorbidities that contributed to high attributable risk were: anemia, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and peripheral artery disease. These findings were similar for HFrEF and HFpEF groups. Interaction analysis confirmed similar results.


Eligibility criteria: Inclusion Criteria:

* All consecutive heart failure patients with left ventricular ejction fraction available before or within 3 months from the index visit

Exclusion Criteria:

* We excluded all patients who had severe primary left-sided valvular disease

Primary outcomes:
measure: overall mortality
timeFrame: 2 years
Secondary outcomes:
measure: First all-cause hospitalization
timeFrame: 2 years
measure: Heart Failure hospitalization
timeFrame: 2 years
measure: noncardiovascular hospitalization
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02768376: Spinal for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 60
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: In this study, the investigators will study spinal anesthesia for laparoscopic cholecystectomy in comparison to general anesthesia (GA) regarding patient satisfaction as a primary variable, intraoperative complications, postoperative analgesic requirements, postoperative nausea and vomiting, patient hospital stay (secondary variables).


Eligibility criteria: Inclusion Criteria:

* patients scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* coagulopathy
* Patient refusal
* previous spine surgery
* Obesity BMI more than 30

Primary outcomes:
measure: Patient satisfaction (over a scale from 1 to 4)
timeFrame: 24 hours
measure: Postoperative analgesic consumption (mg morphine)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT06954376: Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability
Official title: Hyperbaric Oxygen Therapy as a Neuroprotective Intervention in Pediatric Acquired Brain Injury With Cognitive Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperbaric Oxygen Therapy
Neuroprotective
Pediatric
Acquired Brain Injury
Cognitive Disability
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aimed to investigate the effectiveness of hyperbaric oxygen therapy as a neuroprotective strategy for improving neurological outcomes in pediatric patients who have sustained acquired brain injury.

Detailed description: Hyperbaric oxygen therapy (HBOT) is a medical treatment that delivers high-concentration oxygen in a pressurized chamber. It was developed initially from diving physiology research and popularized by Dutch surgeon Boerema for its life-sustaining plasma oxygen diffusion under hyperbaric conditions.

The fundamental mechanism of HBOT operates through Henry's Law, enabling unprecedented increases in tissue oxygen partial pressures that surpass levels achievable in normal atmospheric conditions.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 4-12 years with acquired brain injury.
* Confirmed neurological sequelae (e.g., cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, hypoxia) via MRI/neurological exam.

Exclusion Criteria:

* Positive family history of degenerative brain insults.
* Behavioral problems.
* Hyperbaric oxygen therapy contraindications:

  * Active epilepsy.
  * Respiratory insufficiency.
  * Uncontrolled heart failure.
  * Eustachian tube dysfunction.
  * Tympanic membrane rupture.
  * Mechanical ventilation dependency.

Primary outcomes:
measure: Communication Function Classification System
timeFrame: Eight months post-intervention
Secondary outcomes:
measure: Nutritional intake functionality
timeFrame: Eight months post-intervention
measure: Visual function assessment
timeFrame: Eight months post-intervention
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT00966576: Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy
Official title: The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
IOP
AZARGA
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.


Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent.
* 21 years of age or older.
* Able to follow instructions and willing to attend required study visits.
* Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
* Intra-ocular pressure (IOP) considered to be safe in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
* Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Presence of other primary or secondary glaucomas not listed in inclusion criterion.
* Presence of corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
* Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* Participation in any other investigational study within 30 days prior to Visit 1.
* Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
* Severe allergic rhinitis
* History of ocular herpes simplex.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success
timeFrame: Week 4 and Week 12
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
References:
citation: Lorenz K, Rosbach K, Matt A, Pfeiffer N. Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension. Clin Ophthalmol. 2011;5:1745-50. doi: 10.2147/OPTH.S25987. Epub 2011 Dec 9.
Clinical trial NCT00707876: Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
Official title: A Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA Versus Ferumoxytol Vascular Enhanced MRI (VE-MRI) for the Detection of Clinically Significant Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in Subjects With Peripheral Arterial Disease Scheduled for Digital Subtraction Angiography (DSA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Arterial Disease (PAD)
Keywords: Peripheral arterial disease (PAD); Magnetic Resonance Angiography (MRA); Magnetic Resonance Imaging (MRI), imaging agent or biomarker
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI. Both methods will be compared with Digital Subtraction Angiography (DSA).


Eligibility criteria: Inclusion Criteria:

* Subjects with symptoms of PAD
* Scheduled for DSA

Exclusion Criteria:

* Critical leg ischemia manifested by ulcers, gangrene or leg amputation
* Laboratory evidence of iron overload, liver disease, pregnancy
* History of allergy to or recent exposure to radiocontrast, gadolinium chelates, or intravenous iron therapy
* Clinical concerns about co-morbidities, subject suitability

Primary outcomes:
measure: To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels
timeFrame: 3 weeks
Secondary outcomes:
measure: To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
state: Massachusetts
Study officials:
affiliation: AMAG Pharmaceuticals, Inc.
name: William Strauss, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02126176: Protopic Adherence and Efficacy in Korean Eczema Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with atopic dermatitis

Brief summary: The purpose of this study is to determine whether the dosage of 0.1% tacrolimus ointment applied on unit area of eczema influence the efficacy of treatment.


Eligibility criteria: Inclusion Criteria:

* at least 19 years of age with a diagnosis of atopic dermatitis
* treated with protopic 0.1% ointment

Exclusion Criteria:

* treated with other medication or topical agent
* skin lesion on the scalp or hand and foot
* pregnant women/lactating women

Primary outcomes:
measure: clinical assessments of erythema, scaling, and pruritus
timeFrame: 2 weeks
measure: clinical assessments of erythema, scaling, and pruritus
timeFrame: 2 weeks
measure: clinical assessments of erythema, scaling, and pruritus
timeFrame: 2 weeks
measure: clinical assessments of erythema, scaling, and pruritus
timeFrame: 2 weeks
measure: clinical assessments of erythema, scaling, and pruritus
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of dermatology, Pusan National University Hospital
Study officials:
References:
Clinical trial NCT00666276: Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
Official title: Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 1004
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A5951142 prescribes the Linezolid.

Brief summary: Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection disease.

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Linezolid should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered Linezolid in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Linezolid.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reaction Not Expected From the Japanese Package Insert.
timeFrame: Baseline to 8 weeks
measure: Number of Participants With Adverse Drug Reactions(ADRs).
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Gender.
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Age
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Hepatic Dysfunctions.
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Renal Dysfunctions.
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Duration of Drug Administration.
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Route of Administration.
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Weight.
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Concomitant Drugs.
timeFrame: 8 weeks
measure: Factors Considered to Affect the Safety of Linezolid - Non-drug Therapies.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03108976: Build-up of Action Representation in Autism Spectrum Disorders
Official title: Build-up of Action Representation During Neurodevelopment: Dysfunctions in Autism Spectrum Disorders?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Autism Spectrum Disorder
Keywords: Autism
Sensori-motor learning
Development
Neuroimaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 54
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core feature is social and communications disorders. Motor skill impairments are frequently described in autism, but few studies have addressed the question of their origin and their specificity. Furthermore, it is not clear whether motor problems encountered in autism are related to dyspraxia, or if they present with specific features. This project aims at deciphering the origin of motor problems encountered by children who grow-up with autism in order to propose early interventions that could influence the other developmental trajectories, such as the social one.

Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely: proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory executive control will be correlated to brain oscillation modulation, both topographically and temporally. Two groups of children (aged between 7 and 12) are compared: a group of children with ASD and a control group of typically developing children.


Eligibility criteria: Inclusion Criteria:

* Control group: children aged between 7 and 12
* Case group: children aged between 7 and 12 with a diagnostic of Autism Spectrum Disorders

Exclusion Criteria:

* Control group: presence of a neurological pathology, mental retardation or language and motor developmental delay
* Case group: presence of a neurological pathology, mental retardation

Primary outcomes:
measure: Changes of cerebral oscillations in three frequency bands (alpha, beta, gamma) during sensori-motor learning.
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between oscillatory measures and learning performance.
timeFrame: Day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: CH le Vinatier
Study officials:
affiliation: CH le Vinatier
name: Sandrine SONIE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03315676: Efficacy of Proton Pump Inhibitors in Gastrointestinal Erosions and/or Ulcers
Official title: RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Erosions and/or Ulcers
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to collect the data of clinical efficacy and safety after the usage of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole

Exclusion Criteria:

* Patients allergic to Bonoprazan or Esomeprazole

Primary outcomes:
measure: Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps
timeFrame: Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References: