louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00255593: Safety and Efficacy Study of Rituximab in Renal Transplantation
Official title: A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Transplantation
Keywords: Kidney
Transplantation
Immunosuppression
Rituximab
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-lymphocyte mediated processes. However there is an increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell mediated rejection of transplants by there ability to act as antigen presenting cells and T-cell activators. Thus there is a significant medical need for effective therapies targeting B cells of transplant patients.One such potential therapy would be to use rituximab, a monoclonal antibody against B-cells in all renal transplant patients. In the present study the efficacy and safety of prophylactic rituximab is studied.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or above
* Recipients of first or second renal transplants
* Recipients of kidneys from living or cadaveric donors
* Single organ recipients (kidney only)
* Patients providing written informed consent
* Patients cooperative and able to complete all the assessment procedures

Exclusion Criteria:

* Patients receiving other immunosuppressive therapy within the preceding 28 days
* Recipients of HLA-identical sibling kidneys
* Patients with flow-PRA \>50% within 6 months prior to enrolment
* Recent history of malignancy
* Active infection
* Pregnant or lactating females
* Women of childbearing potential not willing to use reliable form of contraception

Primary outcomes:
measure: Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation
Secondary outcomes:
measure: Renal function at 6 months
measure: Incidence of infections
measure: Incidence of rituximab-related adverse events
measure: Incidence of malignancies
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Transplantation Surgery, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Gunnar E Tydén, Professor
role: STUDY_DIRECTOR
References:
citation: Genberg H, Hansson A, Wernerson A, Wennberg L, Tyden G. Pharmacodynamics of rituximab in kidney allotransplantation. Am J Transplant. 2006 Oct;6(10):2418-28. doi: 10.1111/j.1600-6143.2006.01497.x. Epub 2006 Aug 21.
Clinical trial NCT02456493: The Effect of Carotid IMT (Intima Media Thickness) on Postoperative Cognitive Dysfunction in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Occlusive Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 224
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are schedued to undergo OPCAB

Brief summary: The patients who have undergone cardiac surgery have higher likelihood of postoperative cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by preoperative B-mode ultrasonography. The cognitive function measured by K-MMSE, MOCA-K before the operation, and on the 7 day, 3 months after operation. The patients in the non-surgical group are measured three times: baseline, after 7days, after 3 months.


Eligibility criteria: Inclusion Criteria:

- patients who are scheduled to undergo OPCAB

Exclusion Criteria:

* severe cognitive dysfunction
* disabling mental change disorder
* unable to communicate or speak Korean
* do not have carotid IMT measurement.

Primary outcomes:
measure: postoperative cognitive dysfunction
timeFrame: 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01458093: Large Overuse of Post-polypectomy Surveillance Colonoscopy
Official title: Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyps
Surveillance
Colonoscopy
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 7081
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to one out of 29 endoscopy units in Italy to undergo colonoscopy

Brief summary: In colorectal cancer screening era a huge burden of medical resources has been applied to surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of surveillance are lacking.

The aim of present study was to evaluate the percentage of subjects in which timing of surveillance colonoscopy in practice agrees with that recommended by guidelines and to identify factors associated to the appropriateness of surveillance.


Eligibility criteria: Inclusion Criteria:

* consecutive colonoscopy outpatients
* adults (18-80 yrs)

Exclusion Criteria:

* Subjects with missing data on polyp findings at previous colonoscopy (number, endoscopic or histological features)
* Subjects with unsatisfactory quality standards of previous examination (no cecal intubation, inadequate bowel preparation, incomplete polyp resection)
* patients with a medical history of inflammatory bowel disease, inherited or other polyposis syndrome and colorectal cancer.

Primary outcomes:
measure: Adherence to post-polypectomy surveillance guidelines
timeFrame: up to one year
Secondary outcomes:
measure: Factors associated to surveillance appropriateness
timeFrame: up to one year
Other outcomes:
Locations:
city: Como
country: Italy
facility: Valduce Hospital
Study officials:
References:
citation: Radaelli F, Paggi S, Bortoli A, De Pretis G; Italian Association of Hospital Gastroenterologists (AIGO). Overutilization of post-polypectomy surveillance colonoscopy in clinical practice: a prospective, multicentre study. Dig Liver Dis. 2012 Sep;44(9):748-53. doi: 10.1016/j.dld.2012.04.015. Epub 2012 May 22.
Clinical trial NCT00000193: Neurobiology of Opioid Dependence: 2 - 2
Official title: Neurobiology of Opioid Dependence: 2
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: Opioid disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Behavioral, subjective, measures of naloxone-preci
measure: Phsyiological, neuroendocrine measures of naloxone
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Marc I Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neuropsychopharmacology, 1996; 14(3) pp 187-193. Neruopsychopharmacology 1996; 14(3), 187-193
Clinical trial NCT05744193: Feeding Study in VLBW Premature Infants
Official title: Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: VLBW - Very Low Birth Weight Infant
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 22
Sex: ALL
Minimum age (years): 168
Maximum age (years): 224
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk


Eligibility criteria: Inclusion Criteria:

* Clinically and metabolically stable
* Birth weight 700 g to less than or equal to 1,250 g
* Appropriate birth weight for gestational age
* 24 0/7 to 32 0/7 weeks' gestational age at birth
* Exclusively fed human milk
* Signed informed consent and authorization to use and/or disclose PHI

Exclusion Criteria:

* Metabolic or chronic disease
* 5-minute Apgar score \<4
* Major surgery
* Ventilator dependent
* Fluid restriction
* Grade III or IV intraventricular hemorrhage (IVH)

Primary outcomes:
measure: Weight gain
timeFrame: Daily for 28 days
Secondary outcomes:
measure: Feeding Tolerance
timeFrame: Daily for 28 days
measure: Rate of Length and head circumference gain
timeFrame: weekly up to day 28
measure: Total energy intake
timeFrame: 28 days
measure: Total protein intake
timeFrame: 28 days
measure: Respiratory status
timeFrame: 28 days
measure: Incidence of NEC
timeFrame: Study Day 0 through 28
measure: Incidence of sepsis - clinical symptoms
timeFrame: Study Day 0 through 28
measure: Incidence of sepsis - culture for pathogens
timeFrame: Study day 0 through 28
measure: Incidence of sepsis - Antibiotic use
timeFrame: Study Day 0 through 28
measure: Total serum CO2
timeFrame: Study days 0, 14, 28
measure: Metabolic Acidosis
timeFrame: Study days 0, 14, 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
city: Mineola
country: United States
facility: NYU Langone Hospital, Long Island
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of NY
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
References:
Clinical trial NCT02898493: Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe
Official title: Translation, Cultural Adaptation and Validation of the Creole Versions of the EQ-5D and the SF-36 Questionnaires in Patients With Type II Diabetes in Reunion Island, Martinique and Guadeloupe
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Keywords: Validation of questionnaire
Quality of life
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type II diabetic patients seen in the department of diabetology at the University Hospital

Brief summary: The evaluation of quality of life in health is particularly important for measuring the impact of the chronic diseases. The scales of measure constitute the main measurement tool in clinical trials because of their psychometrics properties and of their ease of use.

Among these scales, the 36-Item Short Form Survey (SF-36) and the EuroQol five dimensions questionnaire ( EQ-5D) were widely validated in various populations, of which the population of the diabetics patients. Both scales have validated versions in French.

In the Antilles and in Reunion Island, diabetes is a frequent pathology and is the subject of many clinical and epidemiological trials. One of the difficulties encountered during the implementation of these studies is the absence of measurement tools validated for these populations.

Investigators thus suggest, within a common workgroup uniting Guadeloupe, Martinique and Reunion Island, adapting and validating these scales according to an identical procedure in Creole from Guadeloupe, from Martinique and from Reunion Island and validating the French versions of these scales in their populations of type II diabetics patients.


Eligibility criteria: Inclusion Criteria:

* male or female ≥ 18 years of age
* type II diabetes diagnosed more than 1 year ago
* creole speaking
* living on the island for more than 5 years
* agreed and signed the informed consent form

Exclusion Criteria:

* not able to understand and follow the instructions
* patients with proven cognitive issues which do not make possible to complete questionnaire
* patients with current acute and serious complications associated with diabetes
* medical history of stroke with physical or neurological damage
* patients already involved in the study

Primary outcomes:
measure: Internal Consistency (IC) assessed as Cronbach's Alpha Value
timeFrame: 1 day (inclusion day)
Secondary outcomes:
measure: Test-retest Reliability
timeFrame: 3-4 weeks
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: University Hospital of Reunion Island
state: Reunion Island
Study officials:
References:
Clinical trial NCT01607593: A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
Official title: A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posttraumatic Stress Disorder
Keywords: Retrospective
Sertraline
Posttraumatic stress disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-30
Enrollment: 123
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: Patients with PTSD

Brief summary: This is a multicenter retrospective study to investigate the dosage regimens of sertraline in the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and the efficacy and safety of this drug in patients with PTSD. Data will be collected from the medical records of patients with PTSD.

Detailed description: Patients with PTSD who have been dosed with sertraline from July 2006 (i.e., the start of marketing of this drug in Japan) or later to before contracting with each investigational site.

Eligibility criteria: Inclusion Criteria:

* Patients with PTSD who have been dosed with sertraline since July 2006 or later.
* Patients must be Japanese.
* Patients should be started before the conclusion of a contract with each investigational site.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation
timeFrame: Up to 6 years
measure: Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation
timeFrame: Start of administration
measure: Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kurume-city
country: Japan
facility: KURUME University School of Medicine
state: Fukuoka
city: Chuo-ku,Kobe-city
country: Japan
facility: Hyogo Institute for Traumatic Stress
state: Hyogo
city: Tokorozawa-city
country: Japan
facility: National Defense Medical College/Department of Psychiatry
state: Saitama
city: Shinjyuku-ku
country: Japan
facility: Institute of Women?s Health Tokyo Women?s Medical University
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kamo T, Maeda M, Oe M, Kato H, Shigemura J, Kuribayashi K, Hoshino Y. Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study. BMC Psychiatry. 2016 Dec 7;16(1):434. doi: 10.1186/s12888-016-1138-5.
Clinical trial NCT01209793: Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2010-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
* Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive
* Normal vital signs after resting in a sitting position for 5 minutes:
* Normal standard 12-lead ECG
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
* Able to understand and complete study-related questionnaires

Exclusion Criteria:

* Current or prior history of smoking
* Any illness or condition that would adversely affect the subject's participation in this study
* Hospitalization within 60 days of the screening visit
* Any clinically significant abnormalities observed during the screening visit
* History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
* History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit
* History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit
* Known sensitivity to any of the components of the Investigational Product formulation
* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
* Any condition that would place the subject at risk, interfere with participation in the study
* History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area
* Live/attenuated vaccinations within 12 weeks of screening or during the study
* Any subjects with planned elective surgery
* Sexually active men who are unwilling to utilize adequate contraception

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: Baseline through end of study
Secondary outcomes:
measure: PK profile
timeFrame: Baseline through end of study
measure: Immunogenicity
timeFrame: Visits 2, 8, 10 and 12
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT00949793: In Vivo Confocal Endomicroscopy of the Brain
Official title: In Vivo Confocal Endomicroscopy of the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Neoplasms
Keywords: Pathology
Microscopy, Confocal
Microscopy, Fluorescence
Intraoperative Procedures
Lead sponsor: Carl Zeiss Surgical GmbH
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology.

Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.

Detailed description: Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery.

The procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.

Eligibility criteria: Inclusion Criteria:

* All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy.

Exclusion Criteria:

* Pregnant women
* Inability to give informed consent
* History of allergy to fluorescein
* Patients on beta-blockers or ACE inhibitors

Primary outcomes:
measure: To test of the ability of the surgeon to obtain interpretable images during surgery.
timeFrame: During surgery
Secondary outcomes:
measure: To correlate the in vivo endomicroscopy images with traditional histopathology.
timeFrame: one week
measure: To evaluate the usability of the device in the OR environment.
timeFrame: During surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
state: Arizona
Study officials:
affiliation: Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
name: Peter Nakaji, MD
role: PRINCIPAL_INVESTIGATOR
References: