louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04234594: Comparing the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Males.
Official title: A Randomized, Double-blind and Single-dose Study to Compare the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Males
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-21
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind and parallel group study to compare the pharmacokinetic and safety of QL1203 and Vectibix® in healthy males.

Detailed description: This is a phase I,single center, randomized, double-blind，single-dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of of QL1203 or Vectibix® in healthy male volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of QL1203 or Vectibix® in healthy male volunteers".

Eligibility criteria: Inclusion Criteria:

* Subjects sign the informed consent form and fully understand purpose, nature, process and possible adverse reactions of the study, and are able to complete the study according to the study plan requirements.
* Male,18 years to 65 years of age.
* Weight ≧50.0 kg; body mass index (BMI) in the range of 19.0～ 26.0 kg / m\^2.
* Subjects have no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymph, endocrine, immune, psychiatric, nervous, gastrointestinal system diseases and the general health is good.
* Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.

Exclusion Criteria:

* Subjects have used any biological product within 3 months prior to receiving the study drug, or have used any monoclonal antibody drugs within 9 months.
* Subjects have anallergic history to study drug or any drug component; or persons with allergic history to two or more drugs and food.
* Subjects have a history of interstitial lung disease.
* Subjects have a history of keratitis or long-term wearing of contact lens.
* Subjects have used any prescription drugs, over-the-counter medicines, Chinese herbal medicines, and vitamins within 2 weeks before receiving the study drugs.

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC0-t )
timeFrame: 36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Cancer Hospital of Guizhou Province
name: Weiwei Ouyang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235494: Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas
Official title: Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2010-11-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To develop techniques with MRI of Helium-3 gas to give functional images of the lungs. The goal is to test a single breath-hold functional 3-He MRI pulse sequence with sensitivity to multiple functional aspects of the luncg physiology. A group of 20 healthy volunteers willbe recruited from the local research group and the results compared with existing methods that require seperate breath-holds of 3He gas


Eligibility criteria: Inclusion Criteria:

* age 18 -70

Exclusion Criteria:

* contraindication to MRI
* Resting oxygen saturation \<95%
* Volunteers requiring bronchodilators less than 4 hourly
* additional respiratory diagnoses
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Academic Unit of Radiology, Univeristy of Sheffield
state: South Yorkshire
Study officials:
References:
Clinical trial NCT05864794: Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer
Official title: ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer Metastatic
Keywords: brain metastasis
screening
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an MRI of the brain to screen for brain disease.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed stage IV metastatic NSCLC, not amenable to curative treatment.
* Fit for systemic treatment (PS 0-2) according to standard of care.
* No symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist.

Exclusion Criteria:

* Prior/concomitant therapy for stage IV disease.
* Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with approved targeted treatment.
* Contraindications for MRI scan with contrast as per standard of care protocol of the institution.

Primary outcomes:
measure: Clinical value of the MRI
timeFrame: up to 6 months after the MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT01912794: Postural Responses to External Perturbation in Post-Stroke
Official title: Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Cerebrovascular Accident
Rehabilitation
Sensory System
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To maintain stable body balance in daily activities, the ability to respond to external perturbations is an essential factor. Such capacity is limited in pathological conditions, such as in stroke, in which postural control is impaired due to lesions to the central nervous system. Impairment to postural control increases body sway during upright posture and leads to augmented frequency of falls. In this sense, the identification of mechanisms involved in body balance disorders after stroke is particularly important in situations of postural perturbation. The purpose of this project is to evaluate reactive postural responses to unpredictable external perturbations, analyzing postural dysfunctions caused by lesion to different brain areas as a result of stroke, and test principles of dynamic body balance rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are as follows. Healthy participants: absence of detectable neurological or physical malfunction which might affect postural control, no use of drugs affecting body balance and preserved mental capacity. Stroke patients: capacity to sustain independently orthostatic posture for at least 5 min. and preserved mental capacity.

Exclusion Criteria:

* Exclusion Criteria are: no orthopedic malfunction, no clinical instability associated with systemic disease, no use of drugs affecting body balance and presence of "pusher syndrome".

Primary outcomes:
measure: Displacement amplitude of the CP to the anterior-posterior and medial-lateral
timeFrame: 2 months
Secondary outcomes:
measure: Coordination between the hip and ankle joint
timeFrame: 2 months
Other outcomes:
measure: Muscle activation latency
timeFrame: 2 months
Locations:
city: São Paulo
country: Brazil
facility: Escola de Educação física e Esporte, Universidade de São Paulo
Study officials:
name: Luis A Teixeira, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00122291: A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
Official title: A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Neoplasm Metastasis
Keywords: preoperative
chemotherapy
radiation therapy
rectal cancer
transmural rectal wall invasion
nodal metastasis
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-07-22
Enrollment: 66
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Detailed description: The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Eligibility criteria: Inclusion Criteria:

* Biopsy - proven rectal cancer
* Transmural rectal wall invasion
* Karnofsky performance status \>70
* Normal bone marrow, liver and kidney function

Exclusion Criteria:

* Distant metastases
* Prior pelvic radiation
* Inflammatory bowel disease
* Severe ischemic heart disease
* Anticoagulant therapy
* Pregnancy

Primary outcomes:
measure: safety
measure: response
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Gwyn Bebb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05115591: Ultrasound Predictors of Difficult Spinal Anesthesia
Official title: The Use of Ultrasound to Predict a Difficult Spinal Anesthesia: a Prospective Single-blind Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Procedural Complication
Keywords: Spinal Anesthesia
Ultrasound
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 100
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: Patients undergoing spinal anesthesia for elective orthopedic and urologic surgery

Brief summary: This prospective observational study aims to investigate about the efficacy of spine ultrasound in predicting difficult spinal anesthesia


Eligibility criteria: Inclusion Criteria:

* Patients undergoing spinal anesthesia for elective surgery
* ASA physical status score \< 4

Exclusion Criteria:

* Contraindications to regional anesthesia
* ASA physical status score ≥ 4
* Patient's refusal or inability to sing the informed consent
* Previous spine surgery affecting the intervertebral space chosen for spinal anesthesia

Primary outcomes:
measure: Ultrasound View
timeFrame: 10 minutes
measure: Difficulty in performing spinal anesthesia
timeFrame: 20 minutes
Secondary outcomes:
measure: Failure Rate
timeFrame: 20 minutes
measure: Duration
timeFrame: 20 minutes
measure: Spinal needle replacements
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Campus Biomedico
Study officials:
affiliation: Campus Biomedico of Rome
name: Felice E Agrò, Prof.
role: STUDY_CHAIR
References:
citation: Chin KJ, Ramlogan R, Arzola C, Singh M, Chan V. The utility of ultrasound imaging in predicting ease of performance of spinal anesthesia in an orthopedic patient population. Reg Anesth Pain Med. 2013 Jan-Feb;38(1):34-8. doi: 10.1097/AAP.0b013e3182734927.
citation: Weed JT, Taenzer AH, Finkel KJ, Sites BD. Evaluation of pre-procedure ultrasound examination as a screening tool for difficult spinal anaesthesia*. Anaesthesia. 2011 Oct;66(10):925-30. doi: 10.1111/j.1365-2044.2011.06834.x. Epub 2011 Jul 25.
citation: Del Buono R, Pascarella G, Costa F, Terranova G, Leoni ML, Barbara E, Carassiti M, Agro FE. Predicting difficult spinal anesthesia: development of a neuraxial block assessment score. Minerva Anestesiol. 2021 Jun;87(6):648-654. doi: 10.23736/S0375-9393.20.14892-2. Epub 2020 Dec 16.
Clinical trial NCT04001491: Interest of 18F-FDG Positron Emission Tomography in the Management of Fevers and Inflammatory Syndromes
Official title: Evaluation of the Interest of 18F-FDG Positron Emission Tomography in the Management of Unexplained Fevers and Inflammatory Syndromes in Elderly Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammation
Keywords: Inflammation
Inflammatory syndromes
fever
Tomography
Positron emission at 18F-FDG
Elderly patients
Internal medicine
Pet-Scan
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated at the University Hospitals of Strasbourg for a check-up of fever or inflammatory syndrome, regardless of the duration of the evolution and the examinations already carried out

Brief summary: Patients aged 75 and over represent a heterogeneous population with fragile subjects who have a higher risk of poor tolerance to many tests and especially who have a risk of major functional loss in the event of hospitalization. It is therefore necessary to adapt our prescriptions and not to impose on these patients an examination that is unnecessary. Or on the contrary, not to do without, out of ignorance, a minimally invasive examination that could be useful to these patients.

In this study, the investigators wish to evaluate the interest of the Pet-Scan in the therapeutic management of these elderly patients


Eligibility criteria: Inclusion criteria:

* Patient aged 75 years and over,
* Patients cared for at the HUS, in hospital or in consultation, during the defined period (from 01/05/2013 to 31/12/2018)
* Having had an 18FDG-PET/TDM
* For fever or inflammatory syndrome check-ups, regardless of the duration of the evolution and the examinations already carried out
* Patient who has not expressed opposition to the reuse of their data for the purposes of this research.

Exclusion criteria:

* Patient who has expressed opposition to participating in the study
* Known explanation for fever or inflammatory syndrome
* Subjects under legal protection
* Subject under the protection of justice
* Subject under guardianship or curatorship

Translated with www.DeepL.com/Translator

Primary outcomes:
measure: Evaluate the interest of the Pet-Scan in the therapeutic management of subjects aged 75 years and over with unexplained fever or inflammatory syndrome.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Emmanuel ANDRES, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03065491: Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function
Official title: Effect of Red Yeast Rice, Phytosterols and L-tyrosol on Lipid Profile and Endothelial Function: a Double-blind, Placebo-controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Red yeast rice
Phytosterols
L-Tyrosol
Lipids
LDL-cholesterol
Endothelial function
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A large body of evidence confirm the cholesterol lowering effect of red yeast rice, phytosterols and L-tyrosol. Because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) LDL cholesterolemia reduction.

Detailed description: European Food Safety Authority approves some health claim related to the cardiometabolic effects of some nutraceuticals, and in particular of red yeast rice, phytosterols and L-tyrosol.

In a previous study the investigators have already demonstrated the synergistic effect of red yeast rice and phytosterols in term of lipid-lowering activity.

Preliminary data suggest that these nutraceuticals could also exert a positive effect on vascular health beyond the direct effects on serum lipids.

No data are available on the combined effects of these dietary supplement in humans.

Eligibility criteria: Inclusion Criteria:

* Suboptimal LDL level (115-160 mg/dL)
* TG\<400 mg/dL
* Signed informed consent form

Exclusion Criteria:

* Patients already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk\> 10 years
* LDL-C\<115 mg/dL or \>160 mg/dL, TG\>400 mg/dL
* Obesity (BMI\>30 kg/m2) or diabetes mellitus
* Assumption of lipid lowering drugs or dietary supplements, or drugs potentially affecting the lipid metabolism
* Antihypertensive treatment not stabilized since at least 3 months
* Known current thyroid, gastrointestinal or liver diseases
* Any medical or surgical condition that would limit the patient adhesion to the study protocol

Primary outcomes:
measure: LDL-cholesterolemia absolute reduction from baseline and between groups
timeFrame: 8 weeks
measure: LDL-cholesterolemia % reduction from baseline and between groups
timeFrame: 8 weeks
Secondary outcomes:
measure: Flow-mediated dilation improvement from baseline and between groups
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S. Orsola-Malpighi University Hospital
state: BO
Study officials:
affiliation: S. Orsola-Malpighi University Hospital
name: Claudio Borghi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01687491: Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome
Official title: Comparison of Anti-Xa Activity in the Treatment With Enoxaparin in ACS Admitted to the Emergency. Randomized Clinical Trial ENOXA ® Versus LOVENOX ®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Factor X
Keywords: Enoxaparin
Acute Coronary Syndrome
Factor X
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Fattouma Bourguiba
First posted: 2012-09-19
Enrollment: 179
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®, conducted on two parallel groups of patients admitted in emergency for acute coronary syndrome.

Detailed description: The patients included in this study with an acute coronary Syndrome be admitted to the emergency room and receive treatment with enoxaparin. Low molecular weight heparin (LMWH) treatment in this indication is usually spread over a week. The experience of the study intends to focus only on the first injection administered in selected patients.

Two assays are carried out, including an assessment of the anti-Xa activity initially before injection of enoxaparin, and 4 hours after administration of the first syringe.

Clinical monitoring is intrahospital from the date of hospitalization of patients included until emergency exit (transfer to another service, or return home)

Tolerance assessment (clinical and biological) is performed during follow-up.

Eligibility criteria: Inclusion Criteria:

* Male or female over the age of 20 years
* acute coronary syndrome
* Admission to the emergency department

Exclusion Criteria:

* Patient participating in another study
* Pregnant or lactating or of childbearing potential not using medically accepted method of contraception
* Taking an anticoagulant in the last three months
* Patient with known haemostatic disorder
* Contraindication absolute and / or relative to the use of enoxaparin
* Nobody wishing to participate in this study or not having the ability to understand its objectives

Primary outcomes:
measure: anti-Xa activity
timeFrame: 4 hours
Secondary outcomes:
measure: adverse events
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Departement of Emergency
Study officials:
affiliation: Fattouma Bourguiba Hospital, Monastir
name: Semir Nouira, PHD
role: STUDY_CHAIR
affiliation: Fattouma Bourguiba, Monastir
name: Mohsen Hassine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boubaker H MD, Grissa MH MD, Sassi M MD, Chakroun T MD, Beltaief K MD, et al. (2015) Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study. J Bioequiv Availab 7: 225-228. doi:10.4172/jbb.1000244