louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05303324: Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
Official title: A Phase 1, Randomized, Open-Label, 2-Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric-Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN1840
Enteric-coated tablet
Pharmacokinetics
Pharmacodynamics
Healthy
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).


Eligibility criteria: Inclusion Criteria:

* Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
* Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
* Willing to adhere to contraception requirements.
* Satisfactory medical assessment with no clinically significant or relevant abnormalities.

Exclusion Criteria:

* Current or recurrent/chronic disease
* Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
* Acute or chronic hepatitis C virus infection.
* History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
* Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
* Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
* Serum ceruloplasmin value outside of the normal range at Screening
* Female participants who were breastfeeding.
* Prior exposure to ALXN1840.
* Major surgery or hospitalization within 90 days prior to dosing on Day 1.

Primary outcomes:
measure: Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum
timeFrame: Up to 240 hours postdose
measure: Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) of Total Molybdenum
timeFrame: Up to 240 hours postdose
Secondary outcomes:
measure: Number of Participants With a Treatment-Emergent Adverse Event (TEAEs)
timeFrame: Baseline up to Day 43
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Clinical Trial Site
Study officials:
References:
Clinical trial NCT05052424: Immun Response in Children With MIS-C
Official title: Cellular and Molecular Characterization of the Immune Response in Children and Adolescents With Inflammatory Syndrome in Children (MIS-C)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MIS-C Multisystem Inflammatory Syndrome in Children
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with MIS-C

Brief summary: Multi-system inflammatory syndrome in children (MIS-C) is a post-viral inflammatory vasculopathy of children and adolescents following Covid-19 infection. It affects one of 1000-5000 children. Latency between mild or asymptomatic Covid-19 infection and MIS-C is 4-6 weeks. The immune response in MIS-C seems to be dysregulated and different from that during acute SARS-CoV-2 infection.

The investigators are planning to investigate the immune response in children with MIS-C.

RNA and protein expression of cytokines and immune cell-related markers will be determined via multiplex ELISA, FACS, quantitative PCR, RNAseq, and Western blot.

The use of highly sensitive multiplex methods will allow for the analysis of a large number of parameters in the smallest possible amount of sample. Sample preparation and analysis will be performed in close collaboration with the Centre for Molecular Medicine Cologne (CMMC) and the Institute of Virology.

With this project the investigators hope to identify risk factors for developing MIS-C and extend the knowledge on therapeutic options for the treatment of this condition.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with MIS-C (WHO criteria)
* \<18 years
* Hospitalized in the Children´s University Hospital of Cologne

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Immune response in MIS-C
timeFrame: December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Medical Faculty
Study officials:
References:
Clinical trial NCT00515424: Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
Official title: A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
RKI983
Primary Open Angle Glaucoma and Ocular Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
* Females must be post-menopausal or surgically sterile

Exclusion Criteria:

* Other types of glaucoma
* Eye pressure lowering surgeries
* A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.
Secondary outcomes:
measure: Change in ocular hypertension from Baseline to Day 7.
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Independent Central IRB
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05337124: A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
Official title: A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Nephritis
Lead sponsor: Aurinia Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: United BioSource, LLC
First posted: 2022-04-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All lupus nephritis patients that meet the eligibility criteria

Brief summary: This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).

Detailed description: This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in patients with lupus nephritis (LN) in the United States (US). This registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on LUPKYNIS.

Eligibility criteria: Inclusion Criteria:

* Lupus nephritis (LN) confirmed by biopsy
* Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI)
* Written informed consent

Exclusion Criteria:

- Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)

Primary outcomes:
measure: LUPKYNIS utilization patterns
timeFrame: 12 months (1 year) to 60 months (5 years)
measure: Effectiveness of LUPKYNIS
timeFrame: 12 months (1 year) to 60 months (5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: S. Gate
country: United States
facility: Site 00-05
state: California
Study officials:
affiliation: Aurinia Pharmaceuticals Inc.
name: Aurinia Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00641524: Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease
Official title: Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Non-alcoholic fatty liver disease
liver fibrosis
metabolic syndrome
iron overload
phlebotomy
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2008-03-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment for patients with non-alcoholic fatty liver disease.

Detailed description: In this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease (NAFLD), a common and important cause of liver disease. Phlebotomy has been used for many years in the treatment of disorders of iron overload such as hemochromatosis, where it is well tolerated and improves symptoms and survival. There is some evidence that it is also effective in treating NAFLD. However, previous studies have not evaluated whether phlebotomy improves liver biopsy findings. We will measure the severity disease in NAFLD patients prior to phlebotomy therapy and again at the end of treatment. This will allow us to accurately determine the benefit of this therapy in these patients.

Eligibility criteria: Inclusion Criteria:

* Patients 18y or older
* Diagnosis of Non-alcoholic Fatty Liver Disease

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Alcohol consumption of \>10g/day for women and \>20g/day for men

Primary outcomes:
measure: Severity of liver disease
timeFrame: 6 months after final treatment
Secondary outcomes:
measure: Severity of metabolic disease
timeFrame: 6 months after final treatment
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Melanie D Beaton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaton MD, Chakrabarti S, Levstik M, Speechley M, Marotta P, Adams P. Phase II clinical trial of phlebotomy for non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013 Apr;37(7):720-9. doi: 10.1111/apt.12255. Epub 2013 Feb 26.
Clinical trial NCT02778724: France PCI Registry : National Observatory of Interventional Cardiology
Official title: France PCI Registry : National Observatory of Interventional Cardiology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interventional
Cardiology
Angioplasty
Coronary
STEMI
Database
Lead sponsor: Club Régional des Angioplasticiens de la région Centre
Sponsor class: OTHER
Collaborators: name: Agence Régional de Santé du Centre
name: Direction Générale de l'Offre de Soins
name: France PCI Association
First posted: 2016-05-20
Enrollment: 40000
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: patients aged over 18 undergoing coronary angiogram or angioplasty

Brief summary: Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014.

CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.


Eligibility criteria: Inclusion Criteria:

* Age =\>18 years at enrollment
* Patient who have had a coronary angiogram or angioplasty

Exclusion Criteria:

* Patient who didn't want to participated

Primary outcomes:
measure: Census of interventional cardiology activity
timeFrame: 1 year
Secondary outcomes:
measure: Optimization of STEMI patient care time
timeFrame: Less than 24 hours
Other outcomes:
Locations:
city: Le Coudray
country: France
facility: Research Cardiology Unit / Les hopitaux de Chartres
state: Eure Et Loire
city: Aurillac
country: France
facility: Centre Hospitalier Henri Mondor d'Aurillac
city: Bourges
country: France
facility: Centre Hospitalier Jacques Coeur de Bourges
city: Caen
country: France
facility: CHU Caen - Hôpital Côte de Nacre
city: Caen
country: France
facility: Hôpital Privé Saint-Martin Caen
city: Chambray-lès-Tours
country: France
facility: CHRU Hôpitaux de Tours - Trousseau
city: Clermont-Ferrand
country: France
facility: CHU Gabriel-Montpied de Clermont-Ferrand
city: Le Havre
country: France
facility: Hôpital Privé de l'Estuaire
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod
city: Orléans
country: France
facility: CHR Orléans - Hôpital de la Source
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles-Nicolle
city: Rouen
country: France
facility: Clinique Saint-Hilaire - Rouen
city: Saran
country: France
facility: Pôle Santé Oréliance - Clinique de la Reine Blanche
city: Tours
country: France
facility: Clinique Saint-Gatien
city: Évreux
country: France
facility: Clinique Bergouignan
Study officials:
References:
Clinical trial NCT04213924: Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL
Official title: The Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plan Block in Patients Undergoing ESWL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary System Stones
Pain
Keywords: Extracorporeal Shockwave Lithotripsy
Erector Spinae Plane Block
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extracorporeal shock wave lithotripsy (ESWL) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. To achieve fragmentation in ESWL, shock waves must be applied with sufficient power and time. Providing effective analgesia during this procedure is crucial to the success of the procedure. Erector Spinae Plan Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. This study aimed to investigate the efficacy of ESPB in patients undergoing ESWL.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing Extracorporeal Shockwave Lithotripsy

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases

Primary outcomes:
measure: Opioid Consumption
timeFrame: Intraoperative 30 minutes
Secondary outcomes:
measure: Visual Analog Pain Score
timeFrame: Intraoperative 30 minutes
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: a prospective randomized controlled study. Scand J Urol. 2019 Dec;53(6):411-416. doi: 10.1080/21681805.2019.1658636. Epub 2019 Sep 9.
citation: Yayik AM, Celik EC, Ahiskalioglu A. An unusual usage for ultrasound guided Quadratus Lumborum Block: Pediatric extracorporeal shock wave lithotripsy. J Clin Anesth. 2018 May;46:47-48. doi: 10.1016/j.jclinane.2018.01.016. Epub 2018 Mar 26. No abstract available.
Clinical trial NCT00190424: Randomized Phase 2 With CpG-ODN in Malignant Glioblastoma
Official title: Multicentric Randomized Phase 2. Immunotherapy With CpG-ODN in Malignant Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Glioblastoma
Immunotherapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the immunostimulating agent CpG-ODN is effective in the treatment of glioblastoma


Eligibility criteria: Inclusion Criteria:

* Glioblastoma
* Karnofsky Performance Status ≥ 60%

Exclusion Criteria:

* Severe or uncontrolled systemic disease
* Active auto-immune disease
* Uncontrolled epilepsia
* Platelets \< 100 000/mm3 ; or Neutrophils \<500 /mm3 ; or lymphocytes \<300/ mm3

Primary outcomes:
measure: Survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Tolerance
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Salpetriere
city: Paris
country: France
facility: Hopital Lariboisiere
Study officials:
affiliation: Hopital Lariboisiere, Päris
name: Alexandre CARPENTIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00432224: Treatment of Actinic Keratoses With Photodynamic Therapy Using Sunlight Versus Red Light
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratoses
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2007-02-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the use of sunlight instead of red light during photodynamic therapy of actinic keratoses using methyl aminolevulinate


Eligibility criteria: Inclusion Criteria:

* symmetric actinic keratoses in scalp or face

Exclusion Criteria:

* porphyria, pregnancy, breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Hans Christian Wulf, Professor, MD
role: STUDY_DIRECTOR
affiliation: Bispebjerg Hospital
name: Merete Hædersdal, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05916924: A Study for Collecting Data on the Motion Analysis of Stroke Patients
Official title: A Study for Collecting Data on the Motion Analysis of Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients

Brief summary: An observational study to collect (functional evaluation and daily motion) for composing 3D kinematic data that will be the basis for setting rehabilitation goal points for each stroke patient and developing virtual reality rehabilitation contents via video shooting.


Eligibility criteria: 1. Inclusion criteria

1. Over 20 years of age
2. More than 1 month after onset of stroke
3. After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions

2. Exclusion criteria

1. Patients who correspond to one or more of the following cannot participate in the study.
2. Patients with systemic infectious symptoms at the time of participation in the study
3. In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person without a guardian
4. Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
5. Other cases where the researcher judges that participation in this study is not suitable (Patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)

Primary outcomes:
measure: Changes in motion analysis in gait spatiotemporal parameters
timeFrame: Change from baseline to 1 day and 14 days
measure: Changes in motion analysis in gait spatiotemporal parameters
timeFrame: Change from baseline to 1 day and 14 days
measure: Changes in motion analysis in kinematic parameters
timeFrame: Change from baseline to 1 day and 14 days
Secondary outcomes:
measure: Changes in manual muscle test (MMT)
timeFrame: Change from baseline to 1 day and 14 days
measure: Changes in motricity index (MI)
timeFrame: Change from baseline to 1 day and 14 days
measure: Changes in berg balance scale (BBS)
timeFrame: Change from baseline to 1 day and 14 days
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center
Study officials:
References: