louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02492178: Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Kinshasa School of Public Health
First posted: 2015-07-08
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims at describing the pharmacokinetic properties of rectal artesunate in well characterized severely ill patients using intravenous artesunate as a comparator.

Detailed description: Individually randomized, open label, 2-arm, cross-over, clinical trial. Patients are allocated to receive rectal artesunate at admission and intravenous artesunate after 12 hours or intravenous artesunate at admission and rectal artesunate after 12 hours. All patients are treated for severe malaria with intravenous quinine. Frequent blood samples are taken at fixed intervals after the administration of the first and the second dose of study drug. The time frame is 24 hours and thereafter patients continue the standard antimalarial therapy.

Eligibility criteria: Inclusion Criteria:

* Weight ≥6 kilograms and ≤ 34 kilograms
* Severe malaria (WHO Guidelines 2013; Appendix 1)
* P. falciparum infection confirmed by Rapid Diagnostic Test (P. falciparum monoinfection or mixed infection with P. ovale or P. malariae)
* Parents or guardian signed Informed Consent

Exclusion Criteria:

* Acute diarrhoea defined as \> 3 liquid stools in the previous 24 hours
* Visible anorectal malformations or a disease of the rectum
* Known hypersensitivity to quinine or artesunate
* A documented history of an effective dose of parenteral antimalarial in the preceding 24 hours or a single dose of rectal artesunate in the previous 12 hours or a dose of an artemisinin based combination therapy in the previous 6 hours
* Co-morbidity which in the judgement of the investigator would interfere with the patient treatment or results of the study or place the subject at undue risk
* Participation in another clinical trial or earlier in the same clinical trial

Primary outcomes:
measure: Pharmacokinetics profile of rectal artesunate
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
Study officials:
References:
citation: Fanello C, Hoglund RM, Lee SJ, Kayembe D, Ndjowo P, Kabedi C, Badjanga BB, Niamyim P, Tarning J, Woodrow C, Gomes M, Day NP, White NJ, Onyamboko MA. Pharmacokinetic Study of Rectal Artesunate in Children with Severe Malaria in Africa. Antimicrob Agents Chemother. 2021 Mar 18;65(4):e02223-20. doi: 10.1128/AAC.02223-20. Print 2021 Mar 18.
Clinical trial NCT01777178: Comparison of Standard Versus Low Bicarbonate Hemodialysis
Official title: Intradialytic Acid-base Changes and Organic Anion Production With Standard Versus Low Bicarbonate Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
Metabolic Acidosis
Keywords: bicarbonate
dialysis
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate.


Eligibility criteria: Inclusion Criteria:

* Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months
* Age \> 18 years

Exclusion Criteria:

* Use of oral alkali within the previous month
* Hospitalization within the previous month
* Inability to provide written informed consent
* Pregnancy

Primary outcomes:
measure: Change in beta-hydroxybutyrate clearance
timeFrame: 1-2 weeks
measure: Change in lactate clearance
timeFrame: 1-2 weeks
measure: Post-dialysis pH
timeFrame: 1-2 weeks
measure: Post-dialysis bicarbonate
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center/Jack D. Weiler Hospital
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Matthew K Abramowitz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00851578: ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
Official title: ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: AF
atrial fibrillation
LAA occlusion
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-02-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* paroxysma, persistent, or permanent non-vlavular atrial fibrillation
* contraindicated to warfarin
* eligible for clopidogrel, ticlopdine, heparin, or aspirin
* CHADS score 1 or greater

Exclusion Criteria:

* NYHA Class IV
* LAA obliteration
* Heart transplant
* LVEF less than 30%
* greater than 50% carotid stenosis

Primary outcomes:
measure: Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: NA Homolce Hospital
city: Frankfurt
country: Germany
facility: Sankt Katharinen Hospital / Cardiovasculares Centrum
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Regensburg
country: Germany
facility: Chefarzt der Medizinischen Klinik III/Kardiologie
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reddy VY, Mobius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.
Clinical trial NCT00822978: Phase 1 Study for Safety of ACHN-490
Official title: A Double-Blind, Randomized, Placebo-controlled, Parallel-Group, Single and Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-490 Injection Administered Intravenously in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy
volunteers
subjects
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.


Eligibility criteria: Inclusion Criteria:

* Men or women
* Within normal weight limits
* In good health with normal routine laboratory results
* Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noise

Exclusion Criteria:

* No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
* No problems with hearing or balance
* No previous injury or surgery the the ears
* No family history of hearing loss before the age of 65
* Not taking any medication other than birth control medication
* Smokers or use of tobacco products
* Recent blood donor
* Allergy ot iodine, shellfish or aminoglycosides (a type of antibiotic)

Primary outcomes:
measure: Incident and severity of adverse events
timeFrame: 2 weeks after the last dose for each dose group
Secondary outcomes:
measure: Changes from baseline in kidney function, laboratory values, abd vital signs
timeFrame: single and multi-dose
measure: Pharmacokinetic parameters
timeFrame: After single and multiple-dose administration
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic
state: Michigan
Study officials:
affiliation: Jasper Clinic, Michigan
name: Carter Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03734978: Association Between Different Blood Groups and Sepsis in Preterm Infants
Official title: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Clinical Professor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Group Antigen Abnormality
Prematurity
Sepsis
Keywords: Blood group
sepsis
preterms
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Zekai Tahir Burak Women's Health Research and Education Hospital
First posted: 2018-11-08
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates born at gestational age \<32 weeks with birth weight \<1500

Brief summary: To investigate whether there is a relationship between sepsis and blood groups in preterm infants.This retrospective cohort study included preterm neonates born at \<32 weeks of gestation with a birth weight \<1500 g. Neonates were grouped by blood type (O, A, B, AB) and sepsis were compared among these groups.

Detailed description: This retrospective study was conducted on data collected between 1 January 2011 and 31 August 2018 in the neonatal intensive care unit (NICU) of the Health Sciences University Zekai Tahir Burak Women's Health Education and Research Hospital.

Neonates born at GA \<32 weeks with birth weight (BW) \<1500 g were included in the study.

Data pertaining to the neonates were recorded from medical records for each patient, and their ABO blood type was recorded.

The neonates were grouped by blood type (O, A, B, AB) and also separated into non-O (A, B, AB) and O groups and non-A (O, B, AB) and A groups for comparison of early and late onset sepsis.

Eligibility criteria: Inclusion Criteria:

* Preterm neonates born at \<32 weeks of gestation with a birth weight \<1500 g.

Exclusion Criteria:

* Neonates born with severe congenital defects, birth weight ≥1500 g and gestational age ≥32 weeks were excluded.

Primary outcomes:
measure: Association Between Different Blood Groups and Sepsis in Preterm Infants
timeFrame: Through study completion, an average of 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: ufuk cakir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03448978: Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
Official title: Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Descartes-08
CAR T Cell
CART
CAR-T
CAR T-Cell
Multiple Myeloma
BCMA
B-cell maturation antigen
B cell maturation antigen
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.


Eligibility criteria: Inclusion Criteria (condensed):

* Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
* Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, \>5% bone marrow plasma cells.
* Adequate vital organ function as indicated by ANC (\>1000/uL), platelet count (\>50,000/uL), hemoglobin (\>8 g/dL), serum ALT and AST (each \<3.0 x upper limit of normal), total bilirubin (\<2 mg/dL), creatinine clearance (\>30 mL/min), and cardiac ejection fraction (\>45%)

Exclusion Criteria (condensed):

NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary

* Active plasma cell leukemia
* Pregnant or lactating
* Active, uncontrolled infection
* Active and severe auto-immune disease
* Active arrhythmia, or obstructive or restrictive pulmonary disease
* Central nervous system disease

Primary outcomes:
measure: Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 2 weeks
Secondary outcomes:
measure: Treatment response
timeFrame: 1, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: The Center for Cancer and Blood Disorders
state: Maryland
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Fairfax
country: United States
facility: Virgina Cancer Specialists
state: Virginia
Study officials:
affiliation: Cartesian Therapeutics
name: Metin Kurtoglu, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00850278: Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
Official title: Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Brain Tumors
Keywords: Brain tumor
[18F]FLT
[11C]MET
TEP-imaging
tumor cell proliferation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2009-02-24
Enrollment: 50
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 primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a tracor of cell proliferation, using Positron Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.\[F-18\]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using \[11C\]MET tracer, immunohistochemical analysis and clinical parameters.


Eligibility criteria: Inclusion Criteria:

* adults aged between 18 and 70 years
* must have operable grade II, III or IV glioma, recurrent high grade glioma or brain metastases
* KPS \>= 70%
* must have the understanding and ability to sign an informed consent document
* must have adequate liver and kidney function
* be male or non-pregnant, non-lactating females
* patients who are fertile must agree to use an effective method of contraception during participation in the study
* the following laboratory results : absolute neutrophil count \>= 1500 cells/µl, platelet count \>= 100000 cells/µl, SGOT \<= 2.5 x ULN, serum creatinine \<= 1.5 x ULN.

Exclusion Criteria:

* contraindication to surgery
* concomitant radio-, chemo-, or immunotherapy
* history of significant dementia
* known diagnosis of Human Immunodeficiency Virus (HIV) infection
* patient with hepatitis B or C

Primary outcomes:
measure: To evaluated the aggressive potential of brain tumors related to cell proliferation index measured by [18F]FLT
timeFrame: Day 10
Secondary outcomes:
measure: To compare the efficiency of [18F]FLT with [11C]MET
timeFrame: Day 15
measure: To define relations between [18F]FLT uptake and clinical, histological and radiological parameters
timeFrame: Day 90
measure: To define relations between [18F]FLT uptake and patient survival
timeFrame: J90
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Jean-Sébastien Guillamo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Caen
name: Jean-Michel Derlon, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00548678: Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers
Official title: Open-Label, Randomized, Single-Dose, Four-Treatment Crossover Study to Evaluate Platelet Function in Healthy Adult Males After Administration of IV Diclofenac Sodium, Oral Diclofenac Potasssium, IV Ketorolac Tromethamine, and Acetylsalicylic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: diclofenac, platelet aggregation, ketorolac, aspirin
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-10-24
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Detailed description: The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects.
* Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.

Exclusion Criteria:

* Bleeding abnormalities or cardiovascular events.
* Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.

Primary outcomes:
measure: Area under the platelet closure time curve from 0-6 hours (AUC 0-6 hours) as measured by the PFA-100.
timeFrame: 6 hours
Secondary outcomes:
measure: The secondary endpoint is the maximum change from baseline in closure time as measured by the PFA-100.
timeFrame: 6 hours
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Comprehensive Phase One
state: Florida
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06050278: Prospective Evaluation of Single Cell Mutations in a Panel of Known Oncogenes in NSCLC Surgical Specimens
Official title: Prospective Evaluation of Single Cell Mutations in a Panel of Known Oncogenes in NSCLC Surgical Specimens (TAP-NSCLC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects older than 18 years old, male and female, with histological diagnosis of NSCLC technically operable following multisciplinary discussion.

Brief summary: The goal of this observational study is to evaluate the feasibility of a single cell mutation research method in a panel of known oncogenes, using the Tapestri method. Tissue samples will be obtained after surgical treatment in patients with I-II-III stage NSCLC.

Detailed description: NSCLC is a particularly heterogeneous disease with different genetic alterations in oncogenes 'drivers', responsible for the development and progression of the disease. In most cases all these anomalies represent clonal mutations in all neoplastic cells. However, several sub-clonal genetic alterations were identified in some multi-regional sequencing studies, demonstrating an intra-tumor heterogeneity. Tracing the clonal architecture of the disease and also the temporal order of the various mutations appearance, would bring two benefits:

1. prioritize the molecular targets
2. identify evolutionary trajectories associated with the outcome of therapies and survival, useful to stratify patients considering the likelihood and the duration of response For the bioinformatic data analyses will be used the Tapestri MissionBio pipeline.

Given the limited number of patients that can be included in the study (10 patients), no statistical analyzes will be performed. Results will be presented thorugh narrative reports for each patients.

Eligibility criteria: Inclusion Criteria:

* age over 18 years old.
* histological diagnosis of NSCLC technically operable following multidisciplinary discussion
* informed consent freely granted and obtained before the start of the study

Exclusion Criteria:

* age under 18 years old
* unconfirmed NSCLC histological diagnosis
* medical treatment with neoadjuvant purposes
* absence of informed consent

Primary outcomes:
measure: Tapestri success rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: MB
Study officials:
References: