louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05314738: Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Official title: A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Progressive Keratoconus
Keywords: Eye rubbing
Collagen cross-linking
Keratoconus
Progressive Keratoconus
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

Detailed description: This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.

Eligibility criteria: Inclusion Criteria:

* Provide written informed consent
* Ability to hold gaze sufficiently stable for study testing
* Willingness and ability to follow all instructions and comply with schedule for follow-up visits
* Have a diagnosis of keratoconus

Exclusion Criteria:

* Known allergy or sensitivity to the test articles or components
* Any disease causing abnormal topography other than keratoconus
* Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications

Primary outcomes:
measure: Topography
timeFrame: 12 Months
Secondary outcomes:
measure: Distance Uncorrected Visual Acuity (UCVA)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Glaukos Investigative Site
state: Alabama
city: Teaneck
country: United States
facility: Glaukos Investigative Site
state: New Jersey
city: Westerville
country: United States
facility: Glaukos Investigative Site
state: Ohio
Study officials:
References:
Clinical trial NCT01192438: Laser Based Focal Ablation of Low Grade Prostate Cancer
Official title: A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Grade Prostate Cancer
Keywords: prostate
cancer
ablation
laser-induced
focal therapy
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Visualase, Inc.
First posted: 2010-09-01
Enrollment: 9
Sex: MALE
Minimum age (years): 45
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 evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Male, 45 years of age or older
* Diagnosis of prostate adenocarcinoma
* Clinical stage T1c or T2a
* Gleason score of 7 or less
* A minimum of 12 biopsy cores sampled during diagnostic biopsy
* Three or fewer biopsy cores with prostate cancer
* No single biopsy core with greater than 50% of tumor involvement
* A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
* A documented Karnofsky performance status of at least 70
* Estimated survival of 20 years or greater, as determined by treating physician
* Ability to give informed consent

Exclusion Criteria:

* Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
* History of previous pelvic radiation
* Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
* History of other primary non-skin malignancy within previous three years

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: Within 6 months of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Scott E Eggener, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02259738: Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Infarction
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Human urinary kallidinogenase can promote the establishment of collateral circulation in the ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then increase the perfusion.

Detailed description: Patients with acute ischemic stroke will be given human urinary kallidinogenase .Then we will estimate the cerebral collateral circulation in ischemic regions and final infarct volume, comparing with traditional therapy such as Shuxuening injection, which will provide new evidence for the treatment of ischemic stroke. Perfusion Weighted Imaging(PWI) could be a method to reflect the infarction center and low perfusion of tissue.

Eligibility criteria: Inclusion Criteria:

* Age:greater than or equal to 18 years old and less than or equal to 70 years old;
* Time of onset is less than 7 days;
* Acute cerebral infarction due to the stenosis or occlusion of middle cerebral artery diagnosed by CT or MRI;
* The National Institute of Health Stroke Scale(NIHSS) score is 4 to 20;
* Excluding intracranial hemorrhage using CT or MRI.

Exclusion Criteria:

* The NIHSS score is less than or equal to 3;
* Patients with cerebral aneurysm, cerebral hemorrhage, brain tumor, brain contusion and laceration of brain and other diseases;
* Intracranial hemorrhage displaying by CT or MRI; Cardiac insufficiency;
* Cardiac insufficiency;
* Chronic liver disease(A/G inversion),elevated alanine aminotransferase(ALT)(more than 1.5 times the normal value);
* Increased serum creatinine(more than 1.5 times the normal value);
* Poorly controlled diabetes;
* Recently suffered from hemorrhagic disease or bleeding tendency;
* Recent use of angiotensin-converting enzyme inhibitor (ACEI) drugs;
* Allergic constitution and had a variety of drug allergy history;
* Women in period of pregnancy or lactation.

Primary outcomes:
measure: Perfusion Weighted Imaging
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Neurolgy,Xuanwu Hospital of Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06744738: Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence
Official title: Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
End Stage Renal Disease Requiring Hemodialysis
Keywords: Adherences
Chronic kidney disease
ESRD
Behavioral intervention
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from BCT. The study includes two groups: usual care and pharmacist-led intervention groups.


Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years of age), chronic kidney disease patients on standard in-center hemodialysis for at least three months, patients receiving 4 hours per session, moderate to poor adherence to their therapeutic regimen according to End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at the time of inclusion

Exclusion Criteria:

* Switching from hemodialysis to peritoneal dialysis, receiving transplantation during the research period, inability to communicate for any reason (cognitive impairment, hearing and visual loss, etc.), hemodialysis patients with viral hepatitis, and patient refusal to participate.

Primary outcomes:
measure: End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores
timeFrame: At the start of the study, and after one month of the start of the study.
Secondary outcomes:
measure: Serum Phosphate
timeFrame: At the start of the study, and after one month of the start of the study.
measure: Interdialytic weight gain (IDWG)
timeFrame: At the start of the study, and after one month of the start of the study.
measure: Total serum Calcium
timeFrame: At the start of the study, and after one month of the start of the study.
measure: Hemoglobin levels
timeFrame: At the start of the study, and after one month of the start of the study.
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad Medical City
Study officials:
References:
Clinical trial NCT03395743: Individual Patient Expanded Access for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic
Official title: Expanded Access Program for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic, for the Treatment of Individual Patients With Serious or Immediately Life-threatening Infections Caused by Pseudomonas Aeruginosa
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Armata Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-10
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-PA01, for patients with serious or immediately life-threatening Pseudomonas aeruginosa infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation.

To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with "Expanded Access Request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition.

Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01259843: French National Observatory of Aortic Syndromes
Official title: French National Observatory of Aortic Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Aortic Syndrome
Keywords: Acute aortic syndrome
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to cardiology, radiology or surgery for a clinical picture suggestive of acute aortic syndrome whose diagnosis was subsequently confirmed in due course of hospitalization by further investigations.

Brief summary: The study examined the clinical characteristics and conditions of care for patients with acute aortic syndrome (AAS) that will identify patients at risk for increased morbidity and mortality and provide a basis for the eventual achievement of specific studies on the optimal therapeutic management according to different risk profiles. The aim of the Observatory is to provide a photograph "size" of practices in France at present, both in the larger centers than in smaller and optimize diagnostic and therapeutic currently available by the activation pathways of rational management.


Eligibility criteria: Inclusion Criteria:

* Male or female age (e) over 18 years old
* Patients with a AAS duly authenticated by further tests
* Patients who consented to participate in the study

Exclusion Criteria:

* Refusal of consent for study participation and ancillary studies
* AAS occurring in the aftermath of a traumatic thoracic
* Diagnosis AAS aside in favor of an alternative diagnosis

Primary outcomes:
measure: Etiology of AAS
timeFrame: 1 day
Secondary outcomes:
measure: Clinical picture
timeFrame: 1 day
measure: Diagnostic tests
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Elbaz Meyer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946243: The Feasibility of Florbetapir Quantitation
Official title: The Feasibility and Reliability of Utilizing Commercially Available Quantitative Analysis Software as an Adjunct to the Clinical Qualitative Interpretation of Amyvid Brain Scans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimers Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-09-19
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.


Eligibility criteria: Inclusion Criteria:

* Readers have undergone Amyvid reader training
* Readers have minimal experience with quantitation of amyloid PET scans

Exclusion Criteria:

* Readers have previously been trained to quantitate amyloid PET scans

Primary outcomes:
measure: Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)
timeFrame: Scan acquired 50-60 min post-injection
measure: Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)
timeFrame: Scan acquired 50-60 min post-injection
Secondary outcomes:
measure: Change in Total Accuracy (MIMNeuro Software, All Readers)
timeFrame: Scan acquired 50-60 min post-injection
measure: Change in Reliability (MIMNeuro Software)
timeFrame: Scan acquired 50-60 min post-injection
measure: Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)
timeFrame: Scan acquired 50-60 min post-injection
measure: Change in Reliability (Siemens Syngo.PET Software)
timeFrame: Scan acquired 50-60 min post-injection
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT00171743: Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients
Official title: Switch From Tacrolimus to Cyclosporine Microemulsion: Immunosuppressive Agents and Diabetes Management in Liver Transplant Recipients in Maintenance (DIALIVER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplant
Keywords: Adults
Post transplant diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.


Eligibility criteria: Inclusion Criteria:

* At least 4 months post-transplant
* Patients in treatment with tacrolimus
* Post-transplant diabetes treated with insulin for at least one month

Exclusion Criteria

* Known hypersensitivity to cyclosporine microemulsion
* Investigational drug within 60 days before baseline or during the study
* Patients who cannot comply with the study requirements

Other protocol-defined exclusion criteria applied

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Rathi M, Rajkumar V, Rao N, Sharma A, Kumar S, Ramachandran R, Kumar V, Kohli HS, Gupta KL, Sakhuja V. Conversion from tacrolimus to cyclosporine in patients with new-onset diabetes after renal transplant: an open-label randomized prospective pilot study. Transplant Proc. 2015 May;47(4):1158-61. doi: 10.1016/j.transproceed.2014.12.050.
Clinical trial NCT04528043: Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Unit
Official title: Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Impact on the Mortality and Morbidity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Enterobacteriaceae Infections
Antibiotic Resistant Infection
Keywords: Third group Enterobacteriaceae
infection
colonization
resistance
AMPc cephalosporinase
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults (≥ 18 years-old) patients admitted in the participating ICUs with LOS ≥ 24 hours during the study period were enrolled if they had presented a colonization and/or an infection caused by an EB3 (Enterobacter cloacae, Enterobacter aerogenes, Morganella morganii, Serratia marcescens, Hafnia alvei et Citrobacter freundii), from 1st January 2016 to 31th December 2016.

Participating ICUs of the university hospital of Nancy:

* two Medical ICU
* 3 surgical ICU

Brief summary: There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. We focused on the sub type Enterobacter regarding its a priori higher risk of resistance.


Eligibility criteria: Inclusion Criteria:

* adults critically ill patients admitted to the the participating ICUs during the study period
* with colonization and/or infection with a third group enterobacteriacea
* and with a lenght of stay \> 24h

Exclusion Criteria:

* minors patients
* lenght of stay \< 24h

Primary outcomes:
measure: all cause mortality
timeFrame: Day 180
Secondary outcomes:
measure: Resistance strains of sub type enterobacter
timeFrame: DAY 90
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Emmanuel NOVY
state: Lorraine
Study officials:
References:
Clinical trial NCT00243243: Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Official title: Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Keywords: Burns
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2005-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower the amount of blood lost during burn surgery.

Detailed description: To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Burn wounds
* 18-65 years of age
* Scheduled excision of burn wound of at least 20 percent TBSA

Exclusion Criteria:

* Age greater than 65 years
* History of blood coagulation disorders
* Taking anti-coagulation medication
* Contraindication for heparin therapy
* Pregnant or nursing females
* Unstable angina
* MI within the last 6 months
* Recent of diagnosis of DVT, stroke within the last 6 months
* Renal failure requiring dialysis or creatinine clearance less than 25 ml/min
* Religious prohibition to blood transfusion
* Have received rFVIIa during current hospitalization
* Previous enrollment in this study

Primary outcomes:
measure: Total Number of Blood Components Transfused During and up to 24 Hours Post Operatively
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ft Sam Houston
country: United States
facility: United States Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: United States Army Institute of Surgical Research
name: Myung S Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deveras RA, Kessler CM. Reversal of warfarin-induced excessive anticoagulation with recombinant human factor VIIa concentrate. Ann Intern Med. 2002 Dec 3;137(11):884-8. doi: 10.7326/0003-4819-137-11-200212030-00009.