louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00927381: Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation
Official title: Retrospective Evaluation of Treatments and Outcomes Associated With Antivenom Therapy For Crotaline Snakebite - A Comparison Of Severe To Mild/Moderate Envenomations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Snake Envenomation
Lead sponsor: BTG International Inc.
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 247
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients bitten by a pit viper and treated with CroFab between January 1, 2002 and December 31 2004.

Brief summary: Retrospective observational review of severe envenomation treatment with CroFab

Detailed description: The objective of this study is to use previously collected retrospective observational data to compare treatment and outcome in patients treated with CroFab who have a severe envenomation to those with a mild/moderate envenomation.

Eligibility criteria: Inclusion Criteria:

* Must involve treatment of a human patient with CroFab between January 1, 2002 and December 31, 2004
* The record must contain all of the following:

  1. Clinical signs/symptoms prior to the first dose of antivenom,
  2. Documentation of all doses of antivenom used to treat the patient,
  3. Indication of whether or not initial control was achieved with antivenom.

To be included in the Efficacy Evaluable Population (EEP) in the current analysis, each record must meet the following criteria:

* Must contain enough information to calculate a severity score based on the 7-point severity scale.
* All records were included in the Safety Population in the current analysis.

Exclusion Criteria:

* Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.

Primary outcomes:
measure: Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points.
timeFrame: at baseline and following treatment with CroFab
Secondary outcomes:
measure: The presence of venom effects, comparison of venom effects over time, initial control of venom effects, recurrence of venom effects, and delayed onset of venom effects.
timeFrame: following treatment
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Poison and Drug Center
state: Colorado
Study officials:
affiliation: Rocky Mountain Poison and Drug Center
name: Richard C Dart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00867581: Magnetic Resonance Imaging (MRI) Study of the Hippocampus After Infarction in the Territory of the Middle Cerebral Artery
Official title: To Observe Delayed Neuronal Death of Hippocampus After Middle Cerebral Artery Infarction Through Magnetic Resonance Imaging(MRI) Volume Measurement and Magnetic Resonance Spectroscopy(MRS) Study of Hippocampus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: middle cerebral artery
infarction
chronic stage
hippocampal volume
MRI
MRS
neuropsychologic assessment
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic-stage patients of unilateral middle cerebral artery infarction

Brief summary: The purpose of this study is to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

Detailed description: 40 patients with middle cerebral artery infarction and 40 healthy volunteers will be observed. All of them will receive MRI scan and the assessment of the neuropsychological function (MMSE, AVLT, HAMD) intending to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of middle cerebral artery infarction
* At least six months from the stroke
* Must be able to measure his(her) neuropsychologic function (by MMSE, AVLT)

Exclusion Criteria:

* Unable to undergo examinations due to disturbances of consciousness or medical conditions
* Severe dementia, apraxia, disturbances of sensation or perception
* Serious complications including severe heart failure, hepatic dysfunction, renal insufficiency,or shock
* Parkinson's disease, malignant tumor, autoimmune diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00793481: Vascular Reactivity in Metabolic Syndrome and Diabetic Patients Using Diffuse Optical Spectroscopy
Official title: Diffuse Optical Spectroscopy Measure Microvascular Changes in Metabolic Syndrome and Diabetes Mellitus in Order to Assess Cardiovascular Disease Risk.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Metabolic Syndrome
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, community sample

Brief summary: Metabolic Syndrome is a highly prevalent condition that is comprised of several major clustering factors that increase the risk for developing cardiovascular disease. Diffuse Optical Spectroscopy is a non-invasively measure can show changes in the microvasculature of human. Diffuse Optical Spectroscopy measures the optical absorption and scattering properties of near-infrared light in tissues such as muscle in order to quantify the absolute concentration of oxygenated and deoxygenated hemoglobin, water, and lipids. It provides quantitative and functional information on the microvasculature related to tissue perfusion, metabolic changes, and indicators of tissue damage.

Detailed description: The researchers can use Diffuse Optical Spectroscopy to monitor changes in the microvasculature of patients with Metabolic Syndrome and diabetic mellitus, and patients with Diabetic Peripheral and Autonomic Neuropathy, versus non-diseased and predisposed subjects by evaluating the changes in oxygen metabolism. The Diffuse Optical Spectroscopy measure the changes in the concentration and oxygen saturation of hemoglobin in the microvasculature under stress, for example, during exercise and in response to changes in breathing habits. The sensitivity of Diffuse Optical Spectroscopy to tissue hemodynamics provides an impressive arena of useful clinical applications..

Eligibility criteria: Inclusion Criteria:

* Adult ages of 45 to 75
* Have been clinically diagnosed with Type II Diabetes Mellitus
* Have a diagnosis of Metabolic Syndrome

Exclusion Criteria:

* taking light-sensitive drugs for use in photodynamic therapy
* pregnant

Primary outcomes:
measure: Changes in Microvascular
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Joslin Diabetes Center,UCI
name: Ping H Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman Laser Institute
name: Bruce Tromberg, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00266981: Treatment of Whiplash Associated Disorders by APOS Kit
Official title: A Randomized Controlled Trial Which Compare the Effectiveness of an APOS Kit With Short Waves Therapy for Treating Whiplash Associated Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Whiplash Associated Disorders
Cervical Pain
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2005-12-20
Enrollment: 132
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two techniques for treating patients with Whiplash Associated Disorders, in relation to: disability, balance, cervical pain and cervical range of motion.

The hypothesis: The APOS kit treatment is more effective than the short wave therapy.


Eligibility criteria: Inclusion Criteria:Cervical pain, Motor vehicle accident a week prior to cervical pain, age above 16, ability to walk independently, signed inform consent, insured in "Clalit health services" Exclusion Criteria: Inability to walk independently, age 16 or less, not signed an inform consent, WAD grade 4, past treatment for WAD, pregnancy, pacemaker, cancer.

-

Primary outcomes:
measure: neck disability score
measure: neck pain score
measure: balance score
measure: cervical range of motion
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: School of Public Health, Hadassah Medical Organization
name: Milka Donchin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598281: Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics (PK) of Digoxin in Healthy Participants
Official title: An Open-label, Drug-drug Interaction Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics of Digoxin, a P-glycoprotein Substrate, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: AMG 510
Healthy Participants
Digoxin
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone
timeFrame: Day 1
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone
timeFrame: Day 1
measure: AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone
timeFrame: Day 1
measure: Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510
timeFrame: Day 7
measure: AUClast of Digoxin Administered in Combination with AMG 510
timeFrame: Day 7
measure: AUCinf of Digoxin Administered in Combination with AMG 510
timeFrame: Day 7
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 13
measure: Cmax of AMG 510 Administered in Combination with Digoxin
timeFrame: Day 7
measure: AUClast of AMG 510 Administered in Combination with Digoxin
timeFrame: Day 7
measure: AUCinf of AMG 510 Administered in Combination with Digoxin
timeFrame: Day 7
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit, Inc
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00846781: Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cystic Fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 308
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.


Eligibility criteria: Inclusion Criteria:

* Completed Study 08-110

Exclusion Criteria:

* A female patient will not be eligible for the study if she is of childbearing potential and is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device).
* Have a condition that might affect compliance with study procedures

Primary outcomes:
measure: Rate of change in lung function, as measured by change in FEV1
timeFrame: 160 Weeks
Secondary outcomes:
measure: Change in absolute FEV1 from baseline
timeFrame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
measure: Change in FEV1 percent predicted value from baseline
timeFrame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
measure: Change in FEF25%-75% and forced vital capacity (FVC) from baseline
timeFrame: Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
measure: Incidence of pulmonary exacerbations
timeFrame: 160 Weeks
measure: Changes in Pseudomonas aeruginosa status
timeFrame: 160 Weeks
measure: Number of days of intravenous (IV) antibiotic use for a respiratory complaint
timeFrame: 160 Weeks
measure: Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint
timeFrame: 160 Weeks
measure: Number of days hospitalized for a respiratory complaint
timeFrame: 160 Weeks
measure: Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs
timeFrame: 160 Weeks
measure: Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline
timeFrame: 160 Weeks
measure: Changes in physical exam findings including height, weight, and body mass index from baseline
timeFrame: Weeks 48, 96, and 160
measure: Changes in hematology, serum chemistry, and urinalysis parameters from baseline
timeFrame: Weeks 24, 48, 72, 96, 120, 144, and 160
measure: Incidence of hospitalizations/ER visits
timeFrame: 160 Weeks
measure: Incidence of early discontinuations from the study
timeFrame: 160 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medical Monitor
name: Lynn Smiley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02915081: Blue Light Therapy for Liver Surgery
Official title: Blue Light Therapy for Liver Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
Liver Injury
Inflammation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Pittsburgh Medical Center
First posted: 2016-09-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesize that subjects undergoing liver resection and who are exposed preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury, specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent light.


Eligibility criteria: Inclusion Criteria:

* age greater than 17 years
* undergoing right or left hepatic lobectomy

Exclusion Criteria:

* presence of acute traumatic brain injury
* blindness
* immunosuppression or immunocompromised condition

Primary outcomes:
measure: Change from baseline creatinine concentration at 24 hours after surgery
timeFrame: preoperatively and 24 hours after surgery
measure: Change from baseline alanine aminotransferase (ALT) concentration at 24 hours after surgery
timeFrame: preoperatively and 24 hours after surgery
Secondary outcomes:
measure: Change in serum cytokine concentrations at 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Ventilator-free days
timeFrame: for the duration of postoperative inpatient hospital stay up to 28 days
measure: ICU length of stay
timeFrame: for the duration of postoperative inpatient hospital stay up to 28 days
measure: renal replacement therapy
timeFrame: for the duration of postoperative inpatient hospital stay up to 28 days
measure: Change in serum cytokine concentrations at 1 hour after surgery
timeFrame: 1 hours after surgery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00331981: Amisulpride in Schizophrenic Patients
Official title: Study of the Efficacy and Safety After Long-Term Treatment With Amisulpride in Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary purpose:

* To find out how effective is long term treatment with amisulpride on the positive and negative symptoms in schizophrenic patients
* To find out how safe is long term treatment with amisulpride in schizophrenic patients

Secondary purpose:

* To find out how effective is long term treatment with amisulpride on the quality of life in schizophrenic patients
* To find out how effective is long term treatment with amisulpride on the cognitive function in schizophrenic patients


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as schizophrenia or schizophrenic disorder according to DSM-IV
* Patients who need new anti-psychotic drugs or need to change the medication due to aggravations of symptoms or recurrence

Exclusion Criteria:

* Patients with positive symptoms in whom the disorder does not correspond to schizophrenic criteria. (e.g, schizoaffective disorder)
* Patients hypersensitive to the active ingredient or to other ingredients of the study drug
* Prolactin-dependant tumors, pituitary gland prolactinomas and breast cancer
* Pheochromocytoma or Parkinson's disease
* Pregnancy or breast feeding
* Current or recently withdrawn from drug abuse or alcoholism
* Chronic renal failure and other internal or surgical disease which physician decides will be worsened by trial medication or that will affect the metabolism or effects of the trial medication
* Patients with previous histories and clinical improvement was not seen in spite of treatment with 2 anti-psychotics for over 8 weeks
* Slow heart rate of \<55bpm, low blood potassium level, congenital prolongation of the QT interval
* Current treatment with a drug likely to cause markedly slow heart rate(\<55bpm), low blood potassium level, slowing of intercardiac condition or prolongation of the QT interval

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: PANSS scores
timeFrame: at every visit
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Won Sik Lee, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01440881: Does Nesiritide Provide Renal Protection
Official title: Does Nesiritide Provide Renal Protection By Attenuating the Inflammatory Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Failure
Keywords: renal failure
cardiopulmonary bypass
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.

Detailed description: This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with baseline GFR 30-90ml/min. Patients were randomized to either placebo or nesiritide (administered prophylactically starting in the operating room prior to incision at 0.01 mcg/kg /minute with no bolus and continued for 48 hours).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic valve or mitral valve surgery
* Baseline MDRD (modification of diet in renal disease) calculated GFR (Glomerular Filtration Rate) 30-90 ml/min.
* Signed Informed Consent

Exclusion Criteria:

* Age \<18 or \>80
* Ejection Fraction \<30%.
* Presence of endocarditis or other infection.
* Presence or anticipated use of an intra-aortic balloon pump.
* History of an organ transplant.
* History of an adverse reaction to nesiritide.
* Surgery performed without cardiopulmonary bypass.
* Receiving Aprotinin
* Dopamine administered in doses \<5 mcg /kg min.
* Women of child bearing potential or pregnant or breastfeeding.
* Participation in any other investigational trial
* Jehovah Witness
* Bleeding Disorder
* Active Endocarditis

Primary outcomes:
measure: Measure Neutrophils to Measure Kidney Injury
timeFrame: 30 days from the start of infusion
measure: The Examine and Measure Cytokines to Measure Kidney Injury
timeFrame: 30 days from the start of infusion
measure: The Examine and Measure Endothelin-1 to Measure Kidney Injury
timeFrame: 30 days from the start of infusion
measure: The Examine and Measure Urinary NGAL to Measure Kidney Injury
timeFrame: A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Thomas Beaver, MD
role: PRINCIPAL_INVESTIGATOR
References: