louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02750488: 18793 - Human Photoallergy Test
Official title: Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 54
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: OTHER

Brief summary: To evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive
* be lightly pigmented (Fitzpatrick Skin Type I, II, III)
* have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form (Health Insurance Portability and Accountability Act) in conformance with 45CFR Parts 160 and 164
* be in general good health as determined by the subject's medical history and in the discretion of the investigator

Exclusion Criteria:

* have a visible sunburn
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
* subjects who are employees of the CRO (Contract Research Organization) and/or Bayer or is a household member of an employee

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point scale
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01596088: A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Official title: A Multicenter, Open Label, Single-arm Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Extravasations of Anthracycline Anti-cancer Agents
Keywords: Extravasation
Anthracyclines
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents.


Eligibility criteria: Inclusion Criteria:

* Patients suspected to have been exposed to extravasation of anthracycline

Exclusion Criteria:

* Patients reasonably suspected to have been exposed to extravasation by other compounds than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration

Primary outcomes:
measure: Adverse Events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Tatsuro Takei
role: STUDY_DIRECTOR
References:
Clinical trial NCT04517188: Halodine Nasal Antiseptic in Patients With COVID-19
Official title: A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: SARS-CoV-2 Infection
Keywords: Nasopharyngeal SARS-CoV-2 Viral Load
Lead sponsor: Halodine LLC
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Povidone iodine (PVP-I) is a well-known broad spectrum, resistance free antimicrobial agent that has a long history of safe and effective use. Halodine Nasal Antiseptic is formulated for topical application PVP-I to nasal passages, and has demonstrated effectiveness against SARS-COV-2 in vitro - 99.99% inactivation within 15 seconds. This study will evaluate the ability of Halodine Nasal Antiseptic to impact SARS-CoV-2 in vivo.

Detailed description: This is a multicenter, phase 4 prospective, single-cohort study in adult male and female volunteers hospitalized with COVID-19. Baseline nasopharyngeal swabs will be performed on all individuals. Halodine Nasal Antiseptic will then be applied to the anterior nares. Serial nasopharyngeal samples will then be collected at specified time points after the application. All samples will be tested for SARS-CoV-2 by real-time reverse transcription (rRT)-PCR assay.

Eligibility criteria: Inclusion Criteria:

* Hospitalized with COVID-19
* Positive SARS-CoV-2 (rRT)-PCR within 48 hours of enrollment

Exclusion Criteria:

* Allergies to iodine-containing compounds

Primary outcomes:
measure: Nasopharyngeal SARS-CoV-2 Viral Load
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Halodine LLC
name: Samuel Barone, MD
role: STUDY_DIRECTOR
References:
citation: Bidra AS, Pelletier JS, Westover JB, Frank S, Brown SM, Tessema B. Rapid In-Vitro Inactivation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Using Povidone-Iodine Oral Antiseptic Rinse. J Prosthodont. 2020 Jul;29(6):529-533. doi: 10.1111/jopr.13209. Epub 2020 Jun 16.
Clinical trial NCT05862688: A Cohort Study on Anti-microbial Stewardship in PICU
Official title: A Cohort Study on Anti-microbial Stewardship in PICU
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infections
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patient

Brief summary: Appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. Inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. Critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. Initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. Antimicrobial stewardship teams can assist ICU providers in managing and implementing these tactics. ICUs would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy.

Detailed description: Appropriate antimicrobial therapy is essential to ensuring positive patient outcomes. Inappropriate or suboptimal utilization of antibiotics can lead to increased length of stay, multidrug-resistant infections, and mortality. Critically ill intensive care patients are at risk of antibiotic failure and secondary infections associated with incorrect antibiotic use. Initiating effective therapy for infections based upon patients' risk factors, collection of appropriate cultures, daily evaluation of clinical status, and laboratory data, including antibiotic time outs, and shortened duration of therapy are ways to improve patients outcomes. Antimicrobial stewardship teams can assist ICU providers in managing and implementing these tactics. ICUs would benefit from employing empiric guidelines for antibiotic use, collecting appropriate specimens and implementing molecular diagnostics, optimizing the dosing of antibiotics, and reducing the duration of total therapy. This study conducted an antibiotic management cohort study in PICUs to discover the distribution of nosocomial infections in PICUs and to find controllable factors for the occurrence of nosocomial infections.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU for more than 48 hour

Exclusion Criteria:

* Patients admitted to ICU less than 48 hours

Primary outcomes:
measure: survival rate
timeFrame: 21 days after ICU admission
Secondary outcomes:
measure: the length of ICU stay time
timeFrame: 21 days after ICU admission
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01603888: Molecular Forms of Plasma and Urinary B-type Natriuretic Peptide and Its N-terminal Prohormone in Health and Disease in Pediatric Cardiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Health
Keywords: children with heart disease
infants
healthy newborns
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal newborn infants and premature babies. Infants and children with significant heart disease.

Brief summary: B-type natriuretic Peptide (BNP) is a cardiac hormone secreted from the cardiac myocytes in response to volume load. Plasma levels of BNP, as measured by immunoassay methods, are elevated in patients with heart diseases. However, the biological effects of BNP are blunted in heart failure and other cardiac conditions. Moreover, the peptide levels are also elevated in non cardiac conditions such as the neonatal period, sepsis and renal failure. Recent investigations suggest alteration of the peptide molecular structure in heart failure. These alterations may explain, at least partially, the reduced biological activities of BNP in heart failure.

Immunoreactive BNP and NT-proBNP have been identified in human urine. It has been suggested that urinary BNP correlates with plasma BNP, and may serve as a non-invasive measure for this cardiac marker. It is unclear what BNP fractions are cleared in the urine in health and disease.

The aim of the proposed studies is to elucidate precisely the molecular form of BNP in various disease and specific physiological states in plasma and urine of infants and children.


Eligibility criteria: Inclusion Criteria:

1. Healthy newborn infants with normal pregnancy and delivery
2. Premature infants
3. Infants and children with heart disease who have NT-proBNP levels taken as part of cardiac evaluation

Exclusion Criteria:

1. Patients with non cardiac disease (renal, hepatic)
2. Patients with acute urinary disease or other acute non-cardiac diseases.

Primary outcomes:
measure: molecular forms of BNP in healthy newborns, infants and children with heart disease.
timeFrame: one year
Secondary outcomes:
measure: BNP presence and define its molecular forms in urine of healthy newborns,infants and children with heart disease. BNP presence and define its molecular forms in urine of healthy newborns and infant and children with heart disease. BNP presence and
timeFrame: one year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT01971788: The MATRIX OCT Substudy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy
Lead sponsor: S.M. Misericordia Hospital
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. In order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of PCI has been proposed.

This aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5 days follow-up.

A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study will be selected showing the following inclusion criteria:

* patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
* patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
* patients whose anatomy is suitable for OCT evaluation.


Eligibility criteria: Inclusion Criteria:

* Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features:

  1. patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
  2. patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
  3. patients with a coronary anatomy suitable for OCT evaluation.

Exclusion Criteria:

* The same criteria used in MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study.

Primary outcomes:
measure: Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up
timeFrame: At the end of primary PCI and 4-5 day later
Secondary outcomes:
measure: Change in the number of stent cross sections with a thrombotic area > 10% measured at the end of prymary PCI and at 4/5-day follow-up
timeFrame: Athe end of primary PCI and 4/5 days later
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: Misericordia Hospital
Study officials:
References:
Clinical trial NCT00453778: A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients
Official title: A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Mild Asthma
Keywords: mild asthma
FLIXOTIDE
methacholine
bronchial challenge
leukotriene D4
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.


Eligibility criteria: Inclusion:

* Diagnosed history of asthma
* Non smoker last two years
* \< 5 pack years
* FEV1 \>70% of predicted
* Mild and stable asthma
* Only using short acting b2-agonist as rescue for the last 4 weeks
* Have a history of atopy.

Exclusion:

* Any significant respiratory disease, other than asthma
* Subjects with seasonal asthma may not be included if they are in their season
* Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
* Upper or lower RTI within 6 weeks
* Evidence of any disease that in the investigators mind would affect the results of the study
* Participating in another study within 4 weeks
* Females who are pregnant, intend to be or who are lactating
* Methacholine PD20 \> 454mcg
* Negative scin prick test

Primary outcomes:
measure: LTD4 PC20
Secondary outcomes:
measure: Shift in methacholine PD20
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00215878: D-serine for Posttraumatic Stress Disorder Treatment
Official title: D-serine for Posttraumatic Stress Disorder Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to asses the effects of the NMDA receptor full agonist D-serine while used as adjuvant treatment for individuals suffering from chronic posttraumatic stress disorder (PTSD). Dysfunction of neurotransmission mediated at NMDA receptor plays a cardinal role in the pathophysiology of PTSD and PTSD patients typically suffer from cognitive dysfunctions and avoidance\& depressive symptomatology that may be mediated by NMDA receptor function deficits.

Thus, enhancement of NMDA activity by using D-serine may be beneficial in the treatment of PTSD. The study design involves two 6 week periods during which the participants will be randomly assigned to receive treatment with D-serine (\~2g /dy)and placebo. This design allows each participant the opportunity to respond to the experimental treatment.


Eligibility criteria: Inclusion Criteria:

• Chronic PTSD (DSM-IV diagnosis)

Exclusion Criteria:

* Other psychiatric diagnosis
* Substance abuse
* Unstable medical condition

Primary outcomes:
measure: CAPS scores
timeFrame: 6 week treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Ezrat Nashim-Herzog Memorial Hospital
Study officials:
affiliation: Ezrat Nashim-Herzog Memorial Hospital
name: Uriel Heresco-Levy, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heresco-Levy U, Vass A, Bloch B, Wolosker H, Dumin E, Balan L, Deutsch L, Kremer I. Pilot controlled trial of D-serine for the treatment of post-traumatic stress disorder. Int J Neuropsychopharmacol. 2009 Oct;12(9):1275-82. doi: 10.1017/S1461145709000339. Epub 2009 Apr 15.
Clinical trial NCT02147678: A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hysteroscopy
Hemodynamics
Sedation
Lead sponsor: Shaanxi Provincial People's Hospital
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients


Eligibility criteria: Inclusion Criteria:

1. Aged between 60 and 80 years
2. Selective hysteroscopic operation
3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
4. Signed informed consent form
5. Expected operation duration is within 60 minutes

Exclusion Criteria:

1. Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis
2. Long use of hormone or history of adrenal suppression
3. Allergy to trial drug or other contraindication
4. History or expected difficult airway
5. Identified, suspected abuse or long use of narcotic analgesia
6. Neuromuscular diseases
7. Mentally unstable or has a mental illness
8. Dysfunction of communication
9. Trend of malignant hyperthermia
10. Pregnant or breast-feeding women
11. Attended other trial past 30 days;

Primary outcomes:
measure: Heart rate
timeFrame: Immediately after the entrance to the operating room until until 60 minutes after the operation
measure: Mean arterial pressure
timeFrame: Immediately after the entrance to the operating room until until 60 minutes after the operation
measure: Pulse oxygen saturation
timeFrame: Immediately after the entrance to the operating room until until 60 minutes after the operation
measure: Respiratory rate
timeFrame: Immediately after the entrance to the operating room until until 60 minutes after the operation
measure: Narcotrend index
timeFrame: Immediately after the entrance to the operating room until until 60 minutes after the operation
Secondary outcomes:
measure: Cerebral injury parameters
timeFrame: Immediately after the entrance to the operating room until until 60 minutes after the operation
measure: Length of stay
timeFrame: from the date of admission to the day of discharge, expected to 3 days
measure: Score of Minimum Mental State Examination
timeFrame: 1 day before the operation to 45 minutes after the operation
measure: Verbal Fluency test
timeFrame: 1 day before the operation to 60 minutes after the operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00793078: Arterial Blood Pressure-complexity in Septic Patients
Official title: Investigation of Arterial Blood Pressure-complexity and Its Relation to Outcome in Comparison Between Cardiac Surgery Versus Non-cardiac Surgery Septic Patients
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Sepsis
Keywords: sepsis
arterial blood pressure
complexity
variability
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated at the Intensive Care Unit of a University Hospital

Brief summary: Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops resulting in a variable and complex time course. According to the "decomplexification theory of illness", disease is characterised by a loss or impaired function of feedback loops resulting in a decreased complexity of the ABP-time course and an impaired adaptability of the cardiovascular system.

Decomplexification of physiologic parameters has been shown to occur in coronary heart disease, Parkinson's and Hodgkin's disease, and in subarachnoid hemorrhage, but has not been evaluated in sepsis.

This study is intended to test the hypothesis that complexity of ABP

* is lower in cardiac surgery versus non-cardiac surgery septic patients,
* decreases as severity of sepsis increases to severe sepsis and septic shock,
* is associated with outcome three month after sepsis.


Eligibility criteria: Inclusion Criteria:

* patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: short form-36
timeFrame: 3 month after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Study officials:
affiliation: Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
name: Martin Soehle, M.D., D.E.S.A., D. habil.
role: PRINCIPAL_INVESTIGATOR
References: