louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00734500: Anidulafungin PK in Infants and Toddlers
Official title: Anidulafungin PK in Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Invasive Fungal Infections
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 48
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.


Eligibility criteria: Inclusion Criteria:

* Age \< 24 months at the time of enrollment
* Patient must have sufficient venous access to permit administration of study medication
* Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
* Availability and willingness of the parent/legally authorized representative to provide written informed consent.

Exclusion Criteria:

* Patients with a history of anaphylaxis attributed to an echinocandin
* Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
* Previous participation in this study
* Previous exposure to an echinocandin in the month prior to study.

Primary outcomes:
measure: The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
timeFrame: 5 days
Secondary outcomes:
measure: Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
timeFrame: During and up to 10 days after last dose of study drug.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT02992600: Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes
Official title: Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Keywords: non-cardiac surgery
Postoperative Cognitive Dysfunction
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included 300 male and female patients undergoing non-cardiac surgery at the Affiliated Hospital of Xuzhou Medical University and 30 healthy volunteers.

Brief summary: To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a predictor of POCD and to provide reference for POCD prevention, early detection and timely diagnosis and treatment.


Eligibility criteria: Inclusion criteria:

* Between 60 to 85 years old;
* Undergoing non-cardiac and non-neurological surgery under general anesthesia;
* Expected hospital stay ≥5 days;
* American Society of Anesthesiologists class I or II.

Exclusion criteria:

* Mental or neurodegenerative diseases;
* History of severe trauma or surgery within one year;
* History of nasal or sinus illness or surgery;
* Cold or influenza within 3 weeks;
* Significant history of organ dysfunction;
* Previous neuropsychological testing;
* Difficulty to perform tests (including severe visual or auditory disorders);
* Mini-Mental State Examination (MMSE) \<24 points, \<20 points if the participant only attended elementary school, or \<17 points if the participant did not go to school.

Primary outcomes:
measure: the neuropsychological test battery to measure cognitive function
timeFrame: 1 day before surgery(baseline)
measure: olfaction test to measure the sense of smell
timeFrame: 1 day before surgery(baseline)
measure: the neuropsychological tests to measure cognitive function
timeFrame: within 5 to 10 days (average of 7 days) after surgery
measure: olfaction test to measure the sense of smell
timeFrame: within 5 to 10 days (average of 7 days) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00269100: Prevention of Bacteremia Induced by Debridement of Pressure Ulcer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pressure Ulcers
Bacteremia
Keywords: Debridement
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2005-12-23
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers in patients in the complex nursing department.


Eligibility criteria: Inclusion Criteria:

* Patient in the complex nursing department
* With contaminated pressure ulcers
* Going to have a debridement procedure

Exclusion Criteria:

* Penicillin sensitivity
* Bacteremia that does not react to the antibiotic treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital
Study officials:
affiliation: Herzog Hospital
name: Efraim Jaul
role: STUDY_DIRECTOR
References:
Clinical trial NCT01244100: Food-Effect Pharmacokinetic Study of PL2200
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Food-effects PK study in healthy subjects.
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.


Eligibility criteria: Inclusion Criteria:

* Healthy normal male and female volunteers between 21 and 65 years of age.

Exclusion Criteria:

* Abnormal findings on physical examination or clinical laboratories, or significant medical history.
* Subject with hypersensitivity or contraindications to aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drug (NSAID).

Primary outcomes:
measure: Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state.
timeFrame: 24 hours
measure: Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-inf of the primary metabolite, salicylic acid, in the fed state versus the fasted state.
timeFrame: 24 hours
measure: Effect of food by ratio of least-squares means (LSM) of the PK parameter of Cmax of the primary metabolite, salicylic acid, in the fed state versus the fasted state.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
Study officials:
affiliation: PLx Pharma Inc.
name: Upendra K Marathi, PhD
role: STUDY_DIRECTOR
References:
citation: Angiolillo DJ, Bhatt DL, Lanza F, Deliargyris EN, Prats J, Fan W, Marathi U. Bioavailability of aspirin in fasted and fed states of a novel pharmaceutical lipid aspirin complex formulation. J Thromb Thrombolysis. 2020 Apr;49(3):337-343. doi: 10.1007/s11239-020-02051-5.
Clinical trial NCT03352700: Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
Official title: Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation Scale
the Amount of Air Bubble
Adenoma Detection Rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.


Eligibility criteria: Inclusion Criteria:

1. Patients are between 18-75 years old
2. undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up

Exclusion Criteria:

1. suspected gastrointestinal obstruction or perforation
2. severe acute inflammatory bowel disease
3. toxic megacolon
4. ileus or gastric retention, ileostomy,
5. hypersensitivity to any of the ingredients
6. pregnancy and lactation and/or at a risk of becoming pregnant

Primary outcomes:
measure: the amount of air bubbles
timeFrame: 2 days
Secondary outcomes:
measure: adenoma detection rate
timeFrame: 2 days
measure: mean total adenomas detected beyond first
timeFrame: 2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Peng Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03255200: ReActiv8 Post Market Surveillance Registry
Official title: ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Lead sponsor: Mainstay Medical
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.

Brief summary: To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.


Eligibility criteria: Inclusion Criteria:

1. Meet the Indications for ReActiv8
2. Willing to sign the Informed Consent for the Registry
3. Age ≥ 18 years

Exclusion Criteria:

1. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.

Primary outcomes:
measure: Low Back Pain - Numeric Pain Rating (NRS) Scale
timeFrame: 90 days, 180 days, 1 year, 2 years post Activation
Secondary outcomes:
measure: Serious Adverse Device Effects
timeFrame: Through 2 years post Activation
Other outcomes:
Locations:
city: Werneck
country: Germany
facility: Orthopadisches Krankenhaus Schloss Werneck
state: Balthasar-Neumann
city: Halle
country: Germany
facility: BG Klinikum Bergmannstrost
city: Itzehoe
country: Germany
facility: Medizinisches Versorgungszentrum Steinburg gGmbH
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
Study officials:
affiliation: SANA Klinikum Duisburg
name: Stefan Schu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04414800: Intranasal Ketamine Versus Intranasal Fentanyl
Official title: Intranasal Ketamine Versus Intranasal Fentanyl on Pain Management in Isolated Traumatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Trauma
Pain, Acute
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 125
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abstract Background: Given the inadequate control of pain in patients with injury that refer to the emergency departments, the rapid onset of action of intranasal administration in pain management, and the avoidance of administering opioid medications, the present study aimed at evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in isolated traumatic patients Materials and Methods: The current study was performed on 125 patients that were divided into the following three groups: control group (n = 41), 1 mg/kg intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after the intervention.


Eligibility criteria: Inclusion Criteria:

* patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg
* lack of pregnancy
* no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen,
* no history of liver diseases,
* no acute or chronic structural or functional nasal obstruction diseases,
* no history of drug or psychiatric addiction,
* no pain medication within the past four hours,
* no history of heart disease,
* and the presentation of the written consent to participate in the study.

Exclusion Criteria:

* a decrease in GCS score to less than or equal to 14,
* an elevated systolic blood pressure to higher than 180 mmHg,
* a decreased diastolic blood pressure to less than 80 mmHg,
* inability to understand the VAS pain rating system,
* symptoms of acute heart disease and respiratory depression (respiratory rate \<8 / min),
* and the patient's dissatisfaction to continue the cooperation in study

Primary outcomes:
measure: Visual analogue score
timeFrame: Change from baseline at 40 minutes
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: Change from baseline at 40 minutes
measure: Blood pressure (BP)
timeFrame: Change from baseline at 40 minutes
measure: Respiratory rate (RR)
timeFrame: Change from baseline at 40 minutes
measure: SPO2
timeFrame: Change from baseline at 40 minutes
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-Zahra University Hospital
Study officials:
References:
Clinical trial NCT05873400: Effect of Renin Angiotensin Aldosterone System Genetic Polymorphism on the Pharmacological Effect of Mineralocorticoid Receptor Antagonists in Patients With Myocardial Infarction
Official title: Effect of Renin Angiotensin Aldosterone System Genetic Polymorphism on the Pharmacological Effect of Mineralocorticoid Receptor Antagonists in Patients With Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Keywords: Aldosterone Antagonist
Myocardial Infarction
Cardiac remodeling
Gene polymorphism
Remodeling Marker
Stress Marker
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Myocardial Infarction patients taking Aldosterone antagonist

Brief summary: Early treatment of Myocardial Infarction patients with mineralocorticoid receptor antagonist with help reduces the incidence of cardiac remodeling and development into heart failure. Also studying aldosterone synthase (CYP11B2) and mineralocorticoid receptor (NR3C2) gene polymorphisms in Egyptian Myocardial Infarction patients will help tailor medication therapy and optimize therapeutic effects with the least adverse effects.


Eligibility criteria: Inclusion Criteria:

* ST- segment elevation patients.
* Patients who are candidate for add-on treatment with Mineralocorticoid receptor antagonists (MRAs) to improve cardiac remodeling.
* Age of 18 years to 80 years.
* Written informed consent of the subject to participate in the study.

Exclusion Criteria:

* Contraindications to Mineralocorticoid receptor antagonists (MRA) including: serum potassium \>5.5 mEq/L at initiation; CrCl ≤30 mL/minute; concomitant use of strong CYP3A4 inhibitors; concomitant use with potassium supplements or potassium-sparing diuretics.
* Mild-to-severe valvular stenosis or severe (grade III/IV) valvular regurgitation
* Pregnant or nursing women.
* Non cardiac disorders associated with increased growth factor (e.g., HIV, Alzheimer, Crohn's disease, Cancer, glomerulonephritis, glomerulosclerosis, diabetic nephropathy, muscle atrophy, fibrotic conditions and burns).
* Patients with chronic heart failure with reduced ejection fraction (LVEF \<40%).

Primary outcomes:
measure: Genetic polymorphism
timeFrame: 3 months
Secondary outcomes:
measure: Gene Interaction
timeFrame: 3 months
measure: Gene incidence
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT05772000: Clinical Significance of Occult Central Nervous System Localization
Official title: Clinical Significance of Occult Central Nervous System Localization in Adult Patients With Acute Lymphoblastic Leukemia. Prospective, Multicenter Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 70
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: Adult patients affected by acute lymphoblastic leukemia

Brief summary: In acute lymphoblastic leukemia (ALL), the occult central nervous system (CNS) involvement appears to be associated with poor prognosis. Flow cytometry (FCM) allows detection of occult CNS localization. The current international guidelines do not recommend the use of FCM in the assessment of CNS at onset in adult ALL patients. Large-scale prospective studies will help to clarify whether or not patients with occult CNS localization should undergo CNS-directed therapy. Understanding this seems particularly important nowadays considering that with the introduction of new drugs (monoclonal antibodies, next-generation tyrosine kinase inhibitors, CAR-T) the therapeutic approach of patients with ALS is increasingly "chemo-free"

Detailed description: The investigators propose a multicenter prospective study to evaluate the incidence of occult CNS localization and the impact of such localization on clinical outcome.Adult ALL patients routinely undergo diagnostic lumbar puncture (PL); cerebrospinal fluids (CSF )samples will be studied by investigation of conventional cytology (CC) and FCM at the time of the first and subsequent diagnostic PLs.

Eligibility criteria: Inclusion criteria.

* Patients aged more than18 years with diagnosis of ALL at onset undergoing diagnostic-therapeutic PL.
* Signed written informed consent in accordance with ICH/EU/GCP guidelines and national and local laws.

Exclusion criteria.

* Patients \<18 years of age
* Diagnosis other than ALL
* Inability to perform PL

Primary outcomes:
measure: To assess the incidence of occult CNS localization in adult patients with ALL
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Tor Vergata University
state: RM
Study officials:
affiliation: University of Rome Tor Vergata
name: Maria Ilaria Del Principe, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00048100: Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
Official title: Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Leukemia, Myelocytic, Acute
Keywords: Dendritic cells
Lymphocytes
AML
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2002-10-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives:

1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.
3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.


Eligibility criteria: Inclusion Criteria:

* AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.
* Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.
* Stem cell or marrow donor willing to have apheresis for T-Cell collection.
* Written voluntary informed consent must be obtained from patient and donor.

Exclusion Criteria:

* Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
* AML French-American-British (FAB) subtype M3.

Primary outcomes:
measure: Participant Toxicity Levels
timeFrame: From stem cell transplant baseline to 30 plus days post transplant.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Elizabeth J. Shpall, MD
role: PRINCIPAL_INVESTIGATOR
References: