louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01540734: Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®
Official title: A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: paracetamol
pharmacokinetic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A single dose pharmacokinetic study investigating two paracetamol formulations


Eligibility criteria: Inclusion Criteria:

* Good general heatlh with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination

Exclusion Criteria:

* Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the remainder of the study.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
* Current (within 14 days of screening) or regular use of any prescription, over the counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.

Primary outcomes:
measure: To compare bioavailability as measured by Area under the Curve in both fed and fasted states
timeFrame: Visit 1 through Visit 3 (Day 13)
measure: To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax
timeFrame: Visit 1 through Visit 3 (Day 13)
Secondary outcomes:
measure: To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)
timeFrame: Visit 1 through Visit 3 (Day 13)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services NEBRASKA
state: Nebraska
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00040534: Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Advanced Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-07-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase

Inhibitor (SCH 66336) when given in combination with Gemcitabine and Cisplatin in patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced cancer for which there is no treatment available which would have a reasonable chance of disease palliation or cure
* Age greater than or equal to 18.
* SWOG performance Status less than or equal to 2.
* Meets protocol requirements for specified laboratory values.
* Written informed consent and cooperation of patient.

Exclusion Criteria:

* Prior treatment with an FPTI
* Knowledge of intracranial metastases or carcinomatous meningitis.
* Poor medical risks because of nonmalignant systemic disease or uncontrolled active infection.
* Medical conditions that would interfere with taking oral medications.
* Significant uncontrolled diarrhea.
* Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior treatment.
* Concomitant use of CYP3A inhibitors/inducers per protocol.
* Known HIV positivity or AIDS-related illness.
* Pregnant or nursing women.
* Men or women of childbearing potential who are not using an effective method of contraception.
* Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy.
* QTc prolongation (\>440 msecs) at baseline.
* Patients with previous high-dose therapy requiring stem cell rescue or bone marrow transplant, or irradiation to \>30% of bone marrow-containing areas.
* Patients that have received Mitomycin-C or nitrosoureas.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chow LQ, Eckhardt SG, O'Bryant CL, Schultz MK, Morrow M, Grolnic S, Basche M, Gore L. A phase I safety, pharmacological, and biological study of the farnesyl protein transferase inhibitor, lonafarnib (SCH 663366), in combination with cisplatin and gemcitabine in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2008 Sep;62(4):631-46. doi: 10.1007/s00280-007-0646-x. Epub 2007 Dec 6.
Clinical trial NCT04425434: Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma
Official title: Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinoblastoma
Lead sponsor: French Africa Pediatric Oncology Group
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 3000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all children presenting at participating units who can be treated

Brief summary: As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.

Detailed description: In this study we will try to improve the outcome for children with stage II disease. It is hoped that we will be able to show that with early intervention correct early diagnosis the survival of these children is greatly improved. The collection of data in this observational study will allow us to show this improvement, by analysis of stage, treatment and outcome.

Eligibility criteria: Inclusion Criteria:

* Unilateral intraocular Retinoblastoma (RB)
* Unilateral extraocular intraorbital (RB)
* Bilateral intraocular (RB)
* bilateral intraocular (RB) on one side and extraocular but intraorbital on the other side.

Exclusion Criteria:

* Externalized tumor mass
* massive extension to optic nerve up to optical channeltumor
* intracranial extension leptomeninges
* cerebral parenchyma
* extension to regional lymph nodes and/or remote metastases.
* cerebrospinal fluid involvement.
* Trilateral RB
* Incapacity to followed the whole treatement.

Primary outcomes:
measure: Number of cases with retinoblastoma in each participating hospital.
timeFrame: 10 years
measure: Number of cases with stage 2 disease
timeFrame: 10 years
measure: Feasibility of these therapeutic recommendations in an African setting
timeFrame: 10 years
measure: Evaluating the treatment given.
timeFrame: 10 years
measure: follow up
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Hopital Yalgado Ouedraogo
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: CUK (Cliniques Universitaires de Kinshasa)
city: Lubumbashi
country: Congo, The Democratic Republic of the
facility: Cliniques Universitaires de Lubumbashi (CUL)
city: Abidjan
country: Côte D'Ivoire
facility: CHU de Treichville à ABIDJAN
city: Antananarivo
country: Madagascar
facility: HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
state: Ampefiloha
city: Bamako
country: Mali
facility: CHU Gabriel Touré (HGT)
city: Dakar
country: Senegal
facility: Hôpital Aristide Le Dantec,
Study officials:
affiliation: AMCC AND GFAOP
name: FOUSSEYNI Mr TRAORE, Dr;
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04329234: Korean Heart Failure Registry III
Official title: Korean Heart Failure Registry Ⅲ of Korean Society of Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Heart Failure
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Heart Failure
First posted: 2020-04-01
Enrollment: 10000
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 with acute heart failure

Brief summary: KorHF III is a multi-center, nationwide, prospective registry of the Korean Society of Heart Failure, which enrolls patients with acute heart failure in Korea.

The aim of this registry is to analyze the etiology, treatment, treatment, and prognosis to develop strategies for managing acute heart failure.


Eligibility criteria: All consecutive hospitalized adult heart failure patients who fulfill one of 1-3 and 4

Inclusion Criteria:

1. Symptoms of heart failure
2. Signs of heart failure
3. Lung congestion in Chest-x-ray
4. Objective finding of structural and/or functional disorder of the heart or elevated natriuretic peptide levels

Exclusion Criteria:

1. Patients younger than 18 years old
2. Patients who do no consent

Primary outcomes:
measure: In-hospital mortality
timeFrame: 5 years
measure: Post-discharge mortality
timeFrame: 5 years
measure: Post-discharge re-hospitalization
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT03840434: COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure
Official title: COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compartment Syndrome
Keywords: compartment syndrome
intramuscular punction Versus non invasive assessment
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO.
Primary purpose: DIAGNOSTIC

Brief summary: Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed.

Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS.

Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.

Detailed description: Patients referred for suspected chronic compartment syndrome causing will be included.

After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.

Eligibility criteria: Inclusion Criteria:

* Affiliation to the French National healthcare system
* French speaking patients
* Referred for investigation of compartment syndrome causing

Exclusion Criteria:

* Pregnancy
* Inability to understand the study goal
* Patients protected by decision of law
* Extended dermatosis
* Coagulation disorder

Primary outcomes:
measure: Diagnostic performance of MyotonPRO
timeFrame: 3 years
Secondary outcomes:
measure: Diagnostic performance of MyotonPRO at 1 minute post-exercise
timeFrame: 3 years
measure: Diagnostic performance of MyotonPRO at 5 minute post-exercise
timeFrame: 3 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: UH Angers
name: Antoine BRUNEAU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06682234: Study of Obeldesivir as Postexposure Prophylaxis for Marburg Virus Disease
Official title: A Phase 2, Single-Arm Study of Obeldesivir for Postexposure Prophylaxis of Marburg Virus Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Postexposure Prophylaxis Marburg Virus Disease
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 400
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: The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV), and how safe and effective it is preventing Marburg virus disease (MVD) in participants with known or suspected exposure to Marburg virus (MARV).

The primary objective is to evaluate the safety and tolerability of ODV for MARV postexposure prophylaxis (PEP).


Eligibility criteria: Key Inclusion Criteria:

* Able to understand and give written informed consent and comply with treatment and follow up.
* Individuals who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
* Known or suspected high-risk exposure to MARV within 21 days of Day 1. High-risk exposure may include the following:

  1. Direct contact with bodily fluids from a confirmed MVD case.
  2. Needle stick injury with a needle potentially contaminated with MARV.
  3. Prolonged exposure to an individual with MARV infection or MVD without (adequate) personal protective equipment.

Key Exclusion Criteria:

* Individuals with plans to breastfeed during the study period and 21 days following the last dose of study intervention. World Health Organization guidance on breastfeeding should be followed.
* Known hypersensitivity to the study intervention, its metabolites, or formulation excipient.
* Known MARV reverse transcriptase-polymerase chain reaction (RT-PCR) positivity or symptomatic MVD as attributed by the investigator.
* Known moderate or severe renal impairment or known estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2.
* Decompensated cirrhosis (Child-Pugh Class C), acute liver injury/failure (eg, new onset \[\< 2 weeks\] of easy bruising, jaundice, ascites, hepatic encephalopathy, asterixis), and/or known alanine aminotransferase ≥5 × upper limit of normal.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: First dose date up to 29 Days
Secondary outcomes:
measure: Proportion of Participants with Symptomatic MVD by Day 29
timeFrame: Up to 29 Days
measure: Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed MARV Infections by Day 29
timeFrame: Up to 29 Days
measure: Proportion of Participants with All-Cause Death by Day 29
timeFrame: Up to 29 Days
Other outcomes:
Locations:
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04502134: Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function
Official title: Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tears
Rotator Cuff Tendinosis
Keywords: ultrasonography
rotator cuff tendinopathy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ultrasound diagnosis of damage to the shoulder rotator tendon, calcification, acromion bursitis or viscous shoulder capsule

Brief summary: The purpose of this project is to extract effusions and damaged tendons during tendon repair therapy in patients with tendon tears. Then, we would analyze tendon-related transcription factors from histology and cytology, and compare changes in tendon with ultrasound images. Helps to understand the mechanism of tendon lesions.

Detailed description: According to past studies, it is often observed that changes in extracellular matrix, growth factors, and cytokines in degenerative tendons, indicating that the tendon is constantly changing. This change will in turn produce a change in the morphology of the tendon tissue in the ultrasound image. However, there have been few studies in the past literature on the correlation between constant changes in tendon-specific transcription factors and characterization on clinical ultrasound images. Therefore, the purpose of this project is to extract the effusion and damaged tendon while performing tendon repair therapy in patients with tendon tears, and to analyze the tendon-related transcription factors from histology and cytology to understand the changes in tendon homeostasis. At the same time, the interpretation of clinical ultrasound images was combined to establish the relationship between the biochemical factors of the cell tissues of chronic tendon lesions and the clinical ultrasound image. This study will help us to understand the mechanism of chronic tendinopathy.

Eligibility criteria: Inclusion Criteria:

* age older than 20 y
* shoulder pain more than 3 months and Visual Analogue Scale (VAS) \>4
* shoulder tendon defect on ultrasound images

Exclusion Criteria:

* diagnosis of cervical radiculopathy or other central or peripheral neuropathy
* rheumatoid arthritis or other autoimmune diseases
* have received any shoulder joint injection within three months
* tumor or systematic inflammation

Primary outcomes:
measure: correlation between ultrasound image and tendon tissue sectioning and staining
timeFrame: Month 2
Secondary outcomes:
measure: tendon-related transcription factors
timeFrame: Month 1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT04892134: Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis
Official title: Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: biomarker
progression
MRI
cognition
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria with suspected or proven multiple sclerosis

Brief summary: By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained

Detailed description: The current study aims to comprehensively investigate the individual clinical, morphological and biochemical aspects of MS in order to elucidate underlying mechanisms leading to disease progression. This shall ultimately serve to identify imaging and biochemical markers, which may support clinical management of persons with MS (pwMS). The following markers will be assessed: demographics (age, sex), clinical (EDSS at baseline, disease duration); neuropsychological (SDMT (Symbol Digit Modalities Test) score); MRI (Magnetic Resonance Imaging) (lesion load, atrophy); Biochemical markers analyzed in cerebrospinal fluid (CSF), blood, DNA, RNA, peripheral blood mononuclear cells (PBMCs)

Eligibility criteria: Inclusion Criteria:

* Patients with suspected or proven multiple sclerosis
* The participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria

Exclusion Criteria:

* Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic

Primary outcomes:
measure: Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease
timeFrame: a maximum of 4 years
Secondary outcomes:
measure: Prediction of clinical relapses
timeFrame: a maximum of 4 years
measure: Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria
timeFrame: a maximum of 4 years
measure: Time of transition to progressive form of MS
timeFrame: a maximum of 4 years
measure: Neuropsychological progression (decrease in SDMT performance)
timeFrame: a maximum of 4 years
measure: Increase in morphological damage (lesion load, atrophy)
timeFrame: a maximum of 4 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Christian Enzinger, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06569134: Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest (MIRA29)
Official title: Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest in the North Finistère Population: Derivation and Validation of a Predictive Score
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Arrest
Neurologic Dysfunction
Cognitive Impairment
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting a cardiac arrest requiring cardiopulmonary resuscitation, taken in charge by the Northern Finistere Prehospital Care System, will be included Datafiles will be individually revised

Brief summary: From the informatized prehospital care registry, data will be collected anonymously for all patients' requiring cardiopulmonary resuscitation for an out-of-hospital cardiac arrest within the Norther Finistere sanitary region.

First step of the model derivation will consist in multivariate analysis to extract the most pertinent variates associated with neurological outcome (evaluated using the CPC Score); Second step will consist in the use of artificial intelligence and machine-learning to derive the most discriminant score.


Eligibility criteria: Inclusion Criteria:

* Cardiac arrest requiring cardiopulmonary resuscitation

Exclusion Criteria:

* Death before cardiopulmonary resuscitation
* Pediatric Patients

Primary outcomes:
measure: Cognitive Outcome
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: Death OoH
timeFrame: Before hospital arrival
measure: Death ICU
timeFrame: During ICU stay
measure: Death at Day 28
timeFrame: 28 days after cardiac arrest
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
city: Morlaix
country: France
facility: CH des pays de Morlaix
Study officials:
References: