louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02491606: Evaluation of Weekly Tafenoquine
Official title: Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: SmithKline Beecham
First posted: 2015-07-08
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.


Eligibility criteria: Inclusion Criteria:

1. Healthy subjects (male or female)
2. Age of 18-55 years
3. Residing in one of the study villages of the Nyanza Province for the entire study

Exclusion Criteria:

1. Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
2. Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
3. Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
4. Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
5. Known hypersensitivity to any study drug.
6. Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
7. Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.

Primary outcomes:
measure: Prophylactic outcome.
timeFrame: 13 Weeks
Secondary outcomes:
measure: Prophylactic outcome after 7 weeks
timeFrame: 7 Weeks
measure: Prophylactic outcome after 10 weeks
timeFrame: 10 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Kenya Medical Research Institute
name: A.J Oloo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Novitt-Moreno A, Ransom J, Dow G, Smith B, Read LT, Toovey S. Tafenoquine for malaria prophylaxis in adults: An integrated safety analysis. Travel Med Infect Dis. 2017 May-Jun;17:19-27. doi: 10.1016/j.tmaid.2017.05.008. Epub 2017 May 8.
Clinical trial NCT02023606: Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M
Official title: An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion (AME) of [14C] Labeled SPN-810M in Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Impulsive Aggression Comorbid With ADHD
Keywords: Impulsive Aggression
ADHD
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 7
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers


Eligibility criteria: Key Entry:

1. Healthy males.
2. Aged 30 to 55 years.
3. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram.
4. Able to voluntarily provide written informed consent to participate in the study.

Primary outcomes:
measure: Urinary and fecal recoveries (mass balance) of total radioactivity.
timeFrame: 10 days post dose.
Secondary outcomes:
measure: Whole blood and plasma partitioning of total radioactivity.
timeFrame: 10 days post dose.
measure: Pharmacokinetics (PK) of total radioactivity in plasma.
timeFrame: 10 days post dose.
measure: PK of SPN-810 in plasma.
timeFrame: 10 days post dose.
measure: PK of the major metabolites of SPN-810 in plasma.
timeFrame: 10 days post dose.
measure: Metabolites of SPN-810 in plasma, urine and feces
timeFrame: 10 days post dose.
measure: Safety and tolerability of SPN-810.
timeFrame: 10 days post dose.
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Clinical
state: Nottingham
Study officials:
affiliation: Quotient Clinical
name: Jo Collier, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02959606: SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study
Official title: SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After endovascular treatment (EVT) for peripheral artery disease (PAD), dual antiplatelet therapy (DAAT) of aspirin (ASA) and clopidogrel are currently drug of choice to prevent occlusion. Anplone SR®, controlled-released Sarpogrelate hydrochloride, has been introduced as an anti-platelet agent for the drug of PAD. The aim of this study was to compare the efficacy and safety of Anplone + aspirin and clopidogrel + aspirin in patients who underwent EVT for femoro-popliteal occlusive disease.


Eligibility criteria: Inclusion Criteria:

1. Adult, \>18 years old
2. Angiographically-confirmed significant femoro-popliteal (FP) stenosis or occlusion by atherosclerosis
3. Successful FP intervention; residual stenosis \<30%
4. Without significant residual inflow disease; Intact iliac artery inflow (with or without intervention of iliac or below knee arteries)
5. patent outflow status; at least 1 arterial runoff in below knee arteries
6. All kind of fem-pop intervention including POBA, stent, DCB, DES for TASC A\~ D

Exclusion Criteria:

1. At risk of hemorrhage, bleeding tendency or thrombophilia
2. Acute limb ischemia / inflammatory arterial disease
3. Contraindication or allergic to ASA, clopidogrel, Anplone
4. Medication of warfarin
5. Pregnancy, hepatic dysfunction, thrombocytopenia
6. Previous FP bypass or intervention
7. Impossible to stop clopidogrel before EVT

Primary outcomes:
measure: Restenosis rate (50%>) in 6 months by CT angiography
timeFrame: 6 months
Secondary outcomes:
measure: Target lesion restenosis(TLR) in 6 months
timeFrame: 6 months
measure: Major bleeding complication
timeFrame: 6 months
measure: Ipsilateral major amputation
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 6 months
measure: All adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seung-Kee Min,
Study officials:
References:
citation: Ahn S, Lee J, Min SK, Ha J, Min SI, Kim SY, Cho MJ, Cho S; SAFE study investigators. SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial. Trials. 2017 Sep 22;18(1):439. doi: 10.1186/s13063-017-2155-5.
Clinical trial NCT00337506: Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Official title: A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: the efficacy and safety of Velcade plus dexamethasone
Multiple Myeloma
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2006-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.


Eligibility criteria: Inclusion Criteria:

* diagnosis of MM according to the SWOG criteria (annex 1)
* previously untreated (localized radiotherapy is allowed)
* symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
* with measurable levels of paraprotein in the serum (\> 1g/dl) or in the urine (\> 0.2g/24h)
* age \< 75 years
* able to understand and to given an informed consent
* male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures.
* no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone.

Exclusion Criteria:

* life expectancy \< 2 months
* ECOG performance status \> 2 (annex 3)
* proven amyloidosis
* positive HIV serology
* antecedents of severe psychiatric disease
* severe diabetes contraindicating the use of high-dose corticoïds
* \> NCI grade 2 peripheral neuropathy (Annex IV)
* serum biochemical values as follow

  * creatinin level \> 200mmol/l
  * bilirubin, transaminases or gGT \> 3 the upper normal limit
* use of any experimental drugs within 30 days of baseline

Primary outcomes:
measure: Complete remission after 4 cycles:
measure: disappearance of serum and/or urine M-component (confirmed by immunofixation)
measure: < 5% plasma cells in the bone marrow resolution of all extra-osseous plasmacytomas
measure: no evidence of bone progression
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Jean-Luc HAROUSSEAU
Study officials:
affiliation: NANTES UH
name: Jean-Luc HAROUSSEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00263406: Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Official title: Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomisation between postoperative administration of an ACE-inhibitor or not.

Detailed description: Children that are undergoing elective surgery for the creation of a Fontan circulation will be randomised to postoperative administration of an ACE-inhibitor or not.

Determination of aldosteron, renine and ADH in serum preoperatively and 1h, 12h and 5 days postoperatively.

Eligibility criteria: Inclusion Criteria:

* All consecutive children with a univentricular heart disease undergoing elective surgery for creation of a Fontan circulation
* Parents have agreed with the study after informed consent

Exclusion Criteria:

* Urgent / Emergent surgery
* Preoperative use of an ACE-inhibitor

Primary outcomes:
measure: Duration of the pleural drainage in the first two postoperative weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Guy Van Nooten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03245099: Management of Non Convulsive Status Epilepticus
Official title: Management of Non Convulsive Status Epilepticus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Status Epilepticus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients 1-18 years
* Generalized tonic clonic convulsions and prolonged post ictal period more than 30 minutes
* Un explained coma ,stupor,confusion and psychic or speech disorder

Brief summary: Non convulsive status epilepticus is a persistent change in behavioural and or mental process from baseline associated with continuous epileptiform activity in electroencephalograph,it occur in about 50 percent in patients with coma and convulsions and in 8-13 percent in intensive care unit patients

Detailed description: Early recognition and treatment of non convulsive status epilepticus are essential to optimize response to treatment and to prevent neurological sequelae, over diagnosis and aggressive use of anticonvulsants can contribute to morbidity and mortality.It displays great diversity in response to anticonvulsants,therefore treatment in intensive care units is required for selected cases .The aetiology and clinical forms are strong predictors for the overall prognosis.Treatment is poorly understood and follows the standard regimen for convulsive status epilepticus

Eligibility criteria: Inclusion Criteria:

* patients who have generalized tonic colonic convulsions and prolonged post ictal state more than 30 minutes
* patients presented with un explained psychic or speech disorder
* patients presented with stupor or confusion
* Patients presented with un explained coma

Exclusion Criteria:

* patients with progressive neurological disease
* Patients with severe cerebral anoxia
* Patients with liver or hepatic impairment

Primary outcomes:
measure: Number of cured patients
timeFrame: An average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
affiliation: Assiut University
name: Rewaa Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01916499: MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries
Official title: MRI Study After Arterial Switch Operation in Patients With Transposition of the Great Arteries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transposition of Great Vessels
Surgery
Keywords: Child, adolescent
Coronary artery disease
Magnetic resonance imaging
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 10-15 years old surgically corrected in the neonatal period with arterial switch procedure for transposition of the great arteries at Rikshospitalet, OUS, Norway.

Brief summary: This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The purpose is to evaluate the coronary arteries and direct and indirect findings of coronary artery disease/complications with 3 tesla magnetic resonance imaging.

Detailed description: This study involves adolescents operated with arterial switch procedure for transposition of the great arteries during the neonatal period. The patients were operated with two different methods of re-implantation of the coronary arteries ("trap-door"/non-"trap-door", see description below).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of transposition of the great arteries with or without ventricular septum defect
* Surgically corrected during neonatal period with arterial switch procedure

Partial or total Exclusion Criteria:

* Heart arrhythmias
* Known allergic reaction to gadolinium based contrast media
* Reduced renal function (below 60 ml/min/1,73m2)

Primary outcomes:
measure: Direct visualization and status of the coronary arteries, global volume measurements, global and regional strain (myocardial contractility), extravascular, extracellular tissue volume fraction and late enhancement (myocardial fibrosis).
timeFrame: 10-15 years after surgery
Secondary outcomes:
measure: Comparison of image quality of direct visualization of the coronary arteries with and without contrast enhanced techniques.
timeFrame: 10-15 years after surgery
measure: Comparison of coronary artery findings corresponding to indirect functional and morphological findings in MRI and echocardiography in the left and right ventricle.
timeFrame: 10-15 years after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Charlotte De Lange, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123199: Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD
Official title: Prospective Observational Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-04-25
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited only after indacaterol has been prescribed and is being used for the patients first maintenance therapy for COPD symptoms.

Brief summary: A prospective observational multi centre research study in GP practices clustered within up to 10 UK Primary care trusts.


Eligibility criteria: Inclusion Criteria:

* Patients with active diagnosis of COPD, confirmed by spirometry documented in medical notes

Exclusion Criteria:

* Patients who are currently receiving other maintenance therapy (except LAMA) for COPD.
* Patients previously prescribed Indacaterol.

Primary outcomes:
measure: Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Change in COPD Assessment test (CAT) score at 6 months after the initiation of indacaterol
timeFrame: 6 months
measure: Impact of indacaterol on patients' lies at 6 - 8 weeks after the initiation of indacaterol.
timeFrame: 6-8 weeks
measure: Physician Global Evaluation of Treatment effectiveness (GETE) at 6-8 weeks and 6 months.
timeFrame: 6-8 weeks and 6 months
measure: Patient Global Evaluation of Treatment effectiveness (GETE) at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06891599: ROTEM in Sepsis Trauma Outcome in Intensive Care
Official title: Advanced Coagulation Diagnostics Using ROTEM and Standard Coagulation Tests in Hospitalized Patients With Sepsis or Trauma - A Prospective Observational Study (ROSTIC - ROTEM for Sepsis and Trauma Induced Coagulopathy)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis - to Reduce Mortality in the Intensive Care Unit
Trauma Coagulopathy
Keywords: Sepsis
ROTEM
Trauma
Coagulopathy
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2025-03-24
Enrollment: 600
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: All patients in Stockhiolm Region

Brief summary: This prospective observational study aims to investigate the ability of advanced ROTEM analysis using Principal Component Analysis (PCA) to detect early signs of disseminated intravascular coagulation (DIC) and trauma-induced coagulopathy (TIC) in hospitalized patients with sepsis or trauma. Standard coagulation tests and ROTEM measurements will be collected and analyzed in relation to clinical outcomes.


Eligibility criteria: Inclusion Criteria:

Trauma patients:

Trauma alarm activated at hospital admission New Injury Severity Score (NISS) \> 15 Transfer to hospital within 7 days of trauma with NISS \> 15

Sepsis patients:

Meeting Sepsis-3 criteria Receipt of intravenous beta-lactam or aminoglycoside antibiotics within 48 hours of admission

Control group:

Patients undergoing elective surgery without expected coagulopathy

Exclusion Criteria:

Trauma patients:

Isolated chronic subdural hematoma No underlying traumatic event despite trauma alarm Age \<18 years

Sepsis patients:

Age \<18 years

Control patients:

Ongoing anticoagulant treatment Life-threatening illness (ASA IV-V) Age \<18 years

Primary outcomes:
measure: Detection of abnormal coagulation clusters via PCA of ROTEM in trauma and sepsis patients
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm
Study officials:
References: