louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00803764: Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions
Official title: Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalency
Keywords: bioequivalency
naproxen
Lead sponsor: Perrigo Company
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy men or women, non-smoker, 18 years of age or older
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* clinically significant illnesses or surgery within 4 weeks prior to study dosing
* body mass index greater than or equal to 30.0
* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
* history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs
* history or known presence of gastrointestinal ulceration, bleeding and perforation
* use of tobacco products within 6 months prior to study dosing
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 30 days prior to study dosing

Primary outcomes:
measure: Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01440764: Aerosol Inhalation Treatment for Dyspnea
Official title: Aerosol Inhalation Treatment for Dyspnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Dyspnea
Keywords: dyspnea
Laboratory model of dyspnea in healthy subjects
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-09-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this protocol is to develop and test optimal delivery of aerosol furosemide, a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

Detailed description: This is study of aerosol treatment in a laboratory model of dyspnea in healthy subjects. This study is the first in a series of studies that will include investigation of a second dose in the laboratory and investigation of the treatment effect in hospitalized patients with refractory dyspnea. The outcome of this first study will determine the details of protocol for the succeeding studies.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Unstable heart or circulation disease
* Stroke
* Seizure disorder
* Severe migraine headaches
* Liver or kidney disease
* Adrenal gland problem (Pheochromocytoma)
* Nerve problems that may affect your breathing sensation
* Brain cancer
* Drug or alcohol problem
* Systemic lupus erythematosis (SLE)
* High levels of depression, panic disorder, or other significant mental health problems
* Serious ongoing pain
* Pregnant
* Under 18 years old
* Not Fluent in English

Primary outcomes:
measure: Subject Rating of Breathing Discomfort (Dyspnea)
timeFrame: The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.
Secondary outcomes:
measure: Multidimensional Dyspnea Profile
timeFrame: Measured before intervention
measure: Urine Output
timeFrame: Cumulative urine output 1 hour after intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Hospital
name: Robert B Banzett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banzett RB, Adams L, O'Donnell CR, Gilman SA, Lansing RW, Schwartzstein RM. Using laboratory models to test treatment: morphine reduces dyspnea and hypercapnic ventilatory response. Am J Respir Crit Care Med. 2011 Oct 15;184(8):920-7. doi: 10.1164/rccm.201101-0005OC. Epub 2011 Jul 21.
Clinical trial NCT00781664: Cumulative Irritation Test
Official title: 21-Day Cumulative Irritation Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tinea Pedis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Detailed description: Healthy, adult volunteers of either sex will be patched daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria for inclusion in the study.

1. Healthy volunteers of either sex, at least 18 years of age or older.
2. Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile \[bilateral oophorectomy and/or total hysterectomy\]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
3. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
4. Willingness to follow the study procedures and complete the study.
5. Written informed consent obtained.

Exclusion Criteria:

1. Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
2. Chronic asthma will be excluded.
3. Pregnant or nursing mothers.
4. A history of sensitivity to any component of any of the formulations.
5. Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.

Primary outcomes:
measure: Irritation Score (5-point scale)
timeFrame: Daily for 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc.
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02926664: Delta qSOFA for Risk Stratification in Emergency Infected Patients
Official title: Prognostic Value of Quick Sequential Organ Failure Assessment Kinetics After Fluids Challenge in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Societe Française de Medecine d'urgence
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 512
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: Adult patients in the ED who presents with suspicion of infection AND a qSOFA of at least 2.

Brief summary: The study will investigate the prognostic value of qSOFA (quick Sequential Organ Failure Assessment) kinetics between H0 and H1, and between H0 and H3 in patients with suspicion of Sepsis, i.e. an initial qSOFA of at least of 2.

Detailed description: qSOFA has been reported as a good tool for risk stratification in the ED for patients with infection.

However, it is not clear whether qSOFA remains stable during the ED stay, nor whether its kinetics can have prognostic added value.

Patients with a qSOFA of at least 2 in the ED, and suspicion of infection will be included.

After treatment is initiated and fluids challenge performed, we will collect qSOFA value at 1 hour and 3 hours.

Our hypothesis is that a decrease in qSOFA between H0 and H3 is associated with better outcome. We assume that 50% of patients will have a deltaqSOFA \>0, with an overall mortality of 23% (according to previous cohort). Under the hypothesis of difference of at least 15% in mortality between the two groups (DeltaqSOFA \> 0 and Delta qSOFA\<=0), with a power of 90% and an alpha of 0.05, we need to recruit 322 patients.

Eligibility criteria: Inclusion Criteria:

* suspicion of infection by the emergency physicians
* at least two of the following criteria : respiratory rate \<= 22, systolic blood pressure \<= 100 mmHg and altered mental status

Exclusion Criteria:

* Infection ruled out by the expert after chart review
* patient who refuse to participate

Primary outcomes:
measure: In-hospital mortality
timeFrame: 60 days
Secondary outcomes:
measure: ICU admission more than 72 hours
timeFrame: 60 days
measure: ICU admission
timeFrame: 60 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques St Luc
city: Nimes
country: France
facility: CHU Nimes
city: Paris
country: France
facility: Cochin
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Pitié-Salpêtrière
city: Paris
country: France
facility: Hopital Tenon
city: Paris
country: France
facility: Lariboisière
city: Paris
country: France
facility: Saint Antoine
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Emergency Department - hopital pitie salpetriere, Paris, France
name: Yonathan Freund
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054664: The Incidence of Occult Hepatitis C Virus Infection in Hemodialysed Patients With Liver Enzymes Disturbances
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysed Patients With Impaired Liver Enzymes
Keywords: liver enzymes
peripheral mononuclear blood cells
hemodialysis
hepatitis C
RNA
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hemodialysis patients with impaired liver enzymes

Brief summary: To assess the incidence of occult hepatitis C virus in hemodialysed patients with mild impairment of liver enzymes

Detailed description: occult hepatitis C virus will be checked in monocytes of hemodialyzed patients with permanent mild impairment of liver enzymes This population has no evidence of hepatitis B or C according to standard laboratory tests (HVC antibodies,HCV PCR, hepatitis B antibodies) Hepatitis C virus RNA will be performed in peripheral blood mononuclear cells of hemodialysed patients

Eligibility criteria: Inclusion Criteria:

* Hemodialysed patients with impaired liver enzymes

Exclusion Criteria:

* hepatitis B and C positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Plotkin Eleonora
Study officials:
References:
Clinical trial NCT02222064: Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain
Official title: Exploratory Study of Mindfulness for Inpatients With Chronic Gastrointestinal Pain: Does it Reduce Pain Related Distress and Increase Confidence in Pain Self-management?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-intestinal Pain
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Research questions/hypotheses

1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients reduce pain-related distress, improve quality of life, and increase confidence in pain self-management?
2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness methods?


Eligibility criteria: Inclusion Criteria:

* \>18 years, pain experienced
* \>3 months, proficiency in English

Exclusion Criteria:

* previous mindfulness experience
* severe cognitive impairment
* profound hearing difficulties

Primary outcomes:
measure: Change in pain distress rating on 11 point numerical rating scale
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: At baseline, week 8
measure: Pain Self Efficacy Questionnaire
timeFrame: At baseline, week 8
measure: Chronic Pain Acceptance Questionnaire
timeFrame: At baseline, week 8
measure: Five Facet Mindfulness Questionnaire
timeFrame: At baseline, week 8
measure: Self-report record of using mindfulness exercises (frequency and duration)
timeFrame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
measure: Brief account of experience of pain and doing the mindfulness exercises
timeFrame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
measure: Change in pain intensity rating on 11 point numerical rating scale
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College Hospital
Study officials:
References:
Clinical trial NCT06900764: A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus
Official title: A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: SLE
Systemic Lupus Erythematosus
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.


Eligibility criteria: Inclusion Criteria:

* Male or female, between 18 and 65 years old;
* Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
* Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
* SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
* Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
* Good organ functions;
* Voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria:

* Had or has active malignancy;
* Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
* Combined with other autoimmune disease that needs treatment;
* Pregnant or lactating women;
* Has other factors that deemed not suitable by investigator.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 0~28 day after treatment
measure: Frequency of AEs, SAEs
timeFrame: 0 day to 24 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT00153764: Effectiveness of a Vitamin Mineral Supplement
Official title: Effectiveness of a One-a-Day Cooper Complete Vitamin / Mineral Supplement With or Without Omega-3 Fatty Acid Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: supplement
omega-3 fatty acid
Homocysteine
LDL cholesterol
Lead sponsor: The Cooper Institute
Sponsor class: OTHER
Collaborators: name: Cooper Clinic
First posted: 2005-09-12
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete vitamin supplement with or without a combined omega-3 fatty acid supplement on selected clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Detailed description: Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3, or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week washout period before beginning the study. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Eligibility criteria: Inclusion Criteria:

* 30-70 years of age, maintain current diet and exercise regimen, not currently taking vitamins or agree to stop for 6 weeks

Exclusion Criteria:

* BMI \<18.5 or \>34.9, recent blood donation, elevated blood pressure, cholesterol, or fasting blood glucose that requires medication, plans to move soon, or pregnant or plans to become pregnant

Primary outcomes:
measure: homocycsteine
measure: LDL cholesterol oxidation rate
Secondary outcomes:
measure: fasting plasma glucose
measure: C-reactive protein
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Cooper Institute
state: Texas
Study officials:
affiliation: The Cooper Institute
name: Conrad Earnest, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04698564: Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging
Official title: Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population


Eligibility criteria: Inclusion Criteria:

1. Age greater than 40 and less than 80 years
2. Clinical suspicion or history of prostate cancer reflected by one of the following:

   * PSA \> 4ng/ml
   * Abnormal DRE exam
   * Known tissue diagnosis of prostate cancer from prior workup
3. Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment

Exclusion Criteria:

1. Inability to undergo MRI scan
2. Inability to receive IV contrast as per institutional protocol.

Primary outcomes:
measure: CTCAE v4.0 higher than grade 2
timeFrame: Within three years post treatment
Secondary outcomes:
measure: Accuracy of metabolic MRI to diagnose prostate cancer
timeFrame: Within three years post treatment
measure: Utility of metabolic MRI over standard MRI imaging in the diagnosis of prostate cancer
timeFrame: Within three years post treatment
measure: Correlative metabolic analysis of tissue metabolite concentrations versus cancer diagnosis
timeFrame: Within three years post treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT00385164: The Utility of FDG-PET for Radiation Treatment in NSCLC
Official title: The Utility of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for Radiation Treatment Planning in Non-Small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Positron Emission Tomography
Keywords: lung neoplasms
positron emissions tomography
radiotherapy planning
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Calgary Health Region
First posted: 2006-10-06
Enrollment: 50
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: Non-small cell lung cancer

Brief summary: Patients planned for radical radiation for NSCLC will undergo conventional CT stimulation and also PET/CT scans for definition of radiation target volumes


Eligibility criteria: Inclusion Criteria:

* Non-small cell lung cancer to receive radical radiation

Exclusion Criteria:

* unable to tolerate PET/CT scan

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Harold P Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: