louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05215132: Investigational MRI Clinical Software and Hardware
Official title: Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Image, Body
Keywords: MRI hardware testing
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: If a research MRI is combined with a clinically ordered MRI, the research scan will add about 15 minutes to the clinical MRI procedure. If a research MRI is conducted during a separate visit, it is expected that the research-only MRI visit will last about 1-2 hours. An individual may voluntarily participate in the study on multiple occasions.
Primary purpose: DIAGNOSTIC

Brief summary: Patients and healthy volunteers will be scanned in order to test new sequences.

Detailed description: The aims of this study are to:

1. Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.
2. Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.

Eligibility criteria: Inclusion Criteria:

* • At least 18 years of age

  * Able to complete the MR safety questionnaire.
  * Able to comprehend and provide informed consent in English.
  * When contrast is being administered: healthy volunteers with a GFR≥60 ml/min
  * When contrast is being administered: patients with a GFR ≥30 ml/min

Exclusion Criteria:

* • When contrast is being administered: subjects with a GFR \< 30 ml/min

  * When contrast is being administered: subjects with acute kidney injury
  * When contrast is administered, allergy to gadolinium-containing contrast media
  * Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
  * Adults unable to consent
  * Individuals who are not yet adults
  * Pregnant or breastfeeding women
  * Prisoners

Primary outcomes:
measure: Conduct clinical protocol development and validation
timeFrame: 5 years
Secondary outcomes:
measure: Demonstrate and train
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University- Feinberg School of Medicine
state: Illinois
Study officials:
References:
Clinical trial NCT01585532: Alere Mycobacterium Tuberculosis Urine Study
Official title: Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Tuberculosis
Urine
Nucleic acid
Alere
Borstel
Lead sponsor: Research Center Borstel
Sponsor class: OTHER
Collaborators: name: Alere Technologies GmbH
First posted: 2012-04-26
Enrollment: 60
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 with suspected or confirmed tuberculosis

Brief summary: Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.


Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed tuberculosis
* Age \>18 years
* informed consent obtained

Exclusion Criteria:

* Previous participation in the study
* Simultaneous participation in a clinical trial investigating a new drug
* Inability to give consent
* Member of a vulnerable study population

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: On admission to hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Borstel
country: Germany
facility: Research Center Borstel
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT05694832: Expressive Writing in GVHD
Official title: Assessing the Impact of Expressive Writing as a Nonpharmacologic Therapeutic Intervention Within a New Support Group for Patients With Cutaneous Graft-versus-Host Disease (EXPRESS-C-GVHD): A Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Graft Versus Host Disease
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 3
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: Graft-versus-host-disease (GVHD) is a disease phenomenon that occurs when immune cells of the donor recognize and attack healthy tissue within the transplant recipient, or host. It is ultimately the result of the same immunological mechanisms that provide benefit to patients receiving hematopoietic stem cell transplantation (HSCT). In patients with hematologic malignancies, HSCT can be therapeutic, as donor T cells recognize and mount a response against cancerous cells. HSCT is also used in the setting of certain immunodeficiencies and inborn errors of metabolism for which therapeutic benefit is found in immunologic repletion.

To our knowledge, support groups have yet to be investigated in academic literature as a nonpharmacologic, therapeutic intervention for cutaneous GVHD patients to improve their distress, systemic disease, and quality of life. Given the dearth of research on nonpharmacologic therapies for cutaneous GVHD that address quality of life impairments, we seek to characterize the effect of an expressive writing and peer helping intervention contextualized within the framework of a support group. The primary goal of this study is to provide preliminary efficacy data of expressive writing as an intervention in patients with cutaneous GVHD to trial.


Eligibility criteria: Inclusion Criteria:

* Patients must have an active or previously diagnosed chronic cutaneous graft-versus-host disease (cGVHD).
* Patients must be age ≥18 years.
* Patients must be able to write using a utensil and paper or be able to type.
* Patients must have access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences (Zoom).
* Patients should be able to and planning to attend all four live videoconferencing sessions for the support group via Zoom.
* Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients with limited level of oral and written English.

Primary outcomes:
measure: Change in Dermatology Life Quality Index scores
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Short Form-36 scores
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Department of Dermatology, Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jennifer Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784732: A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
Official title: A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis
Environmental Exposure Chamber
nasal lavage
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 44
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: This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.


Eligibility criteria: Inclusion Criteria:

* Positive skin prick test to ragweed allergen
* FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2.
* Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2.
* Non-smokers and ex-smokers (≤10 pack years and \>6 months of smoking abstinence).
* Understand and sign the written informed consent

Exclusion Criteria:

* Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing.
* Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Significant illness within two (2) weeks prior to initial dosing.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC
timeFrame: TNSS: 6-8h during EEC exposure on Day 10
Secondary outcomes:
measure: Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)
timeFrame: After 8h exposure in EEC
measure: Absolute eosinophil count from nasal lavage collected
timeFrame: During exposure in EEC
measure: Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC
timeFrame: During exposure in EEC
measure: Total Ocular Symptom Score measured during exposure in the EEC
timeFrame: During exposure in EEC
measure: Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis
timeFrame: Through out study
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274932: Exercise With Blood Flow Restriction in Knee Osteoarthritis
Official title: Neuromuscular Responses, Pain Intensity and Perceived Exertion of Resistance Exercise With Blood Flow Restriction in Patients With Severe Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Electromyography
Muscle Activity
Resistance Training
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure.


Eligibility criteria: Inclusion Criteria:

* men and women above 55 years old.
* diagnosed with severe knee osteoarthritis.
* scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.

Exclusion Criteria:

* pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
* another hip or knee joint replacement in the previous year.
* any medical condition in which exercise was contraindicated.
* participated in exercise programs (\>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
* history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.

Primary outcomes:
measure: Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
timeFrame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
measure: Pressure pain thresholds
timeFrame: Pre exercise, immediate post session, and 10 minutes after session.
measure: HDsEMG
timeFrame: During each experimental session and during each exercise condition.
Secondary outcomes:
measure: Tampa Scale of Kinesiophobia (TSK 11)
timeFrame: Pre session.
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Pre session.
measure: Chronic Pain Self-Efficacy Scale (CPSS)
timeFrame: Pre session.
measure: WOMAC questionaire for patients with hip or knee osteoarthritis.
timeFrame: Pre session.
measure: Heart Rate
timeFrame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
measure: Rating of perceived exertion (RPE) based on Borg's CR10 scale
timeFrame: Immediate post exercise.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Clinic Universitary Hospital of Valencia
Study officials:
affiliation: University of Valencia
name: José Casaña
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Joaquín Calatayud
role: STUDY_CHAIR
References:
Clinical trial NCT04205032: Evaluation in Healthy Volunteers of CARDIOSPACE II
Official title: Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Centre National des Etudes Spatiales - French Space Agency (CNES)
name: Astronautic Center of China (ACC)
First posted: 2019-12-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.

* Electrocardiogram
* Vascular doppler
* Laser doppler with iontophoresis
* Continuous blood pressure recording at the finger level
* Brachial blood pressure
* Ultrasound
* Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder


Eligibility criteria: Inclusion Criteria:

* Height between 160 et 180 cm
* Body mass index between 18 et 24
* Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest
* Normal electrocardiogram
* Possibility to perform transcranial doppler
* Able to understand aims and constraints of this study
* National health insurance
* Signature of the informed consent form

Exclusion Criteria:

* Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding
* Participating at the time to another clinical trial investigating
* Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)
* Taking any chronic treatment
* Any sign of cardiovascular or respiration disease
* Any sign of syncopal events by questioning (\>2 events per year)
* Contraindication to perform physical activity

Primary outcomes:
measure: Quality of the ECG signal given by CARDIOSPACE II: scale
timeFrame: Through study completion, an average of 6 months
measure: Quality of the vascular Doppler signal: scale
timeFrame: Through study completion, an average of 6 months
measure: Quality of the laser doppler signal: scale
timeFrame: Through study completion, an average of 6 months
measure: Quality of the ultrasound images: scale
timeFrame: Through study completion, an average of 6 months
measure: Quality of the blood pressure wave: scale
timeFrame: Through study completion, an average of 6 months
measure: Quality of the ambulatory measurements (ECG / SAO2)
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers, Clinical Research Center
state: Maine Et Loire
Study officials:
References:
Clinical trial NCT06131632: Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy
Official title: Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Breast Cancer
Keywords: inflammatory breast cancer
breast conserving surgery
radical mastectomy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 300
Sex: FEMALE
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: Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.

Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.

In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.

There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory breast cancer
* Clinical complete response after neoadjuvant chemiotherapy
* Targeted tumor
* Written informed consent

Exclusion Criteria:

* Metastasis
* Progression disease
* Recurrent disease
* Contraindications to adjuvant radiation therapy

Primary outcomes:
measure: local recurrence rate
timeFrame: 24 months
Secondary outcomes:
measure: local recurrence-free survival
timeFrame: 24 months
measure: overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS,
Study officials:
References:
Clinical trial NCT05592132: Use of Virtual Reality in Pain Management in Pediatric Oncology
Official title: Use of Virtual Reality in Pain Management During Invasive Gestures in Pediatric Oncology: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Tumor
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention plus standard care versus standard care
Primary purpose: OTHER

Brief summary: DOREVI is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. Two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). The pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.


Eligibility criteria: Inclusion Criteria:

* patient who tolerates the virtual reality headset
* patient followed in pediatric oncology
* patient with a diagnosis of benign tumor or cancer
* patient who needs to have painful medical procedure during their treatment
* patient whose parents have signed the informed consent
* patient affiliated with social security or equivalent

Exclusion Criteria:

* patient with visual or hearing impairement
* patient with epilepsy or other neurological disease
* patient with psychiatric disease

Primary outcomes:
measure: Self pain evaluation
timeFrame: before blood sampling on catheter with implantable chamber
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de La Réunion
Study officials:
affiliation: CHU de La Réunion
name: Yves REGUERRE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04819932: Pharmacokinetics and Safety of DWJ1451 in Healthy Adults
Official title: An Open-label, Randomized, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1451 and Co-administration of DWC202008 and DWC202009 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax


Eligibility criteria: Inclusion Criteria:

* Age 19 to 55 years
* Healthy Adult

Exclusion Criteria:

* Non-Healthy

Primary outcomes:
measure: Pharmacokinetic parameter of DWJ1451:AUC0-t
timeFrame: 0 - 72 hours after dosing
measure: Pharmacokinetic parameter of DWJ1451:Cmax
timeFrame: 0 - 72 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: