louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03470571: CMR Features in Patients With Suspected Myocarditis
Official title: Predictive Value of CMR Features in Patients With Suspected Myocarditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outcome, Fatal
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 670
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: The study includes consecutive patients referred by their treating physician to undergo CMR for "suspected myocarditis" as the primary clinical question between December 2002 and December 2015 at our center.

Brief summary: Presentation of myocarditis is heterogeneous, often ranges from being asymptomatic, to chest pain, dyspnoea, palpitations, and even sudden cardiac death. Diagnosing myocarditis is challenging with no current uniform clinical gold-standard. CMR is a key investigative tool, however the predictive value of CMR features is unknown. In this study we assess 670 consecutive patients with suspected myocarditis who were referred for CMR between 2002 and 2015 at the BWH. CMR features such as late gadolinium sizing, T1 mapping, extracellular volume fraction assessment, strain analysis (feature tracking), clinical data, labortory tetsings and electrocardiogramm are linked to the outcome in order to assess its predictive value.


Eligibility criteria: Inclusion Criteria:

* patients referred by their treating physician to undergo CMR for "suspected myocarditis" as the primary clinical question

Exclusion criteria

* evidence of coronary artery disease
* hypertrophic cardiomyopathy
* arrhythmogenic right ventricular cardiomyopathy
* cardiac sarcoidosis
* cardiac amyloidosis
* takotsubo cardiomyopathy
* constrictive pericarditis
* Loeffler endocarditis
* ventricular non-compaction
* cardiac tumor
* pulmonary embolism
* severe valve disease

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital, Shapiro Cardiovascular Center
state: Massachusetts
Study officials:
References:
citation: Fischer K, Obrist SJ, Erne SA, Stark AW, Marggraf M, Kaneko K, Guensch DP, Huber AT, Greulich S, Aghayev A, Steigner M, Blankstein R, Kwong RY, Grani C. Feature Tracking Myocardial Strain Incrementally Improves Prognostication in Myocarditis Beyond Traditional CMR Imaging Features. JACC Cardiovasc Imaging. 2020 Sep;13(9):1891-1901. doi: 10.1016/j.jcmg.2020.04.025. Epub 2020 Jul 15.
citation: Grani C, Eichhorn C, Biere L, Kaneko K, Murthy VL, Agarwal V, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Comparison of myocardial fibrosis quantification methods by cardiovascular magnetic resonance imaging for risk stratification of patients with suspected myocarditis. J Cardiovasc Magn Reson. 2019 Feb 28;21(1):14. doi: 10.1186/s12968-019-0520-0.
Clinical trial NCT00687271: A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy, and Tolerability of MK-6213 Co-Administered With Atorvastatin in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.


Eligibility criteria: Inclusion Criteria:

* 18 to 75 years of age at the time of the study with high cholesterol
* Can have diabetes mellitus but is not currently on lipid lowering therapy
* Have a stable weight for \>6 weeks

Exclusion Criteria:

* Has significant cardiovascular (heart), renal (kidney), neurologic (nervous system), respiratory (lung), hepatic (liver) or metabolic disease
* history of mental instability or drug/alcohol abuse within the past 5 years
* Pregnant or nursing; human immunodeficiency virus (HIV) positive; history of cancer within the past 5 years or participation in an investigational trial within the last 30 days

Primary outcomes:
measure: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline (predose) and Week 4
Secondary outcomes:
measure: Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
timeFrame: Up to 14 days post last dose of study drug (up to 6 weeks)
measure: Percentage of Participants That Had Study Drug Discontinued Due to an AE
timeFrame: up to 4 weeks
measure: Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
timeFrame: Baseline (predose) and Week 4
measure: Percentage Change From Baseline in Apolipoprotein B (ApoB)
timeFrame: Baseline (predose) and Week 4
measure: Percentage Change From Baseline in Total Cholesterol (TC)
timeFrame: Baseline (predose) and Week 4
measure: Percentage Change From Baseline in HDL-C
timeFrame: Baseline (predose) and Week 4
measure: Percentage Change From Baseline in TG
timeFrame: Baseline (predose) and Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00936871: The Effect Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
Official title: A Phase 1, Randomized, Single Dose, Placebo And Active Controlled, 3-Way Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Lersivirine (UK-453,061) On Qt Intervals In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: lersivirine QT QTc ECG HIV NNRTI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study has been designed to investigate the effect of lersivirine on the QT/QTc interval in order to help establish the safety profile of lersivirine.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive, (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, normal 12-lead ECG and clinical laboratory tests)

Exclusion Criteria:

* History of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction).
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
* Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication.

Primary outcomes:
measure: (Part A) To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
timeFrame: 1 day
measure: (Part B) To demonstrate a lack of effect of lersivirine on QTc relative to time-matched placebo.
timeFrame: 3 days
Secondary outcomes:
measure: To determine study sensitivity by comparing the effect of moxifloxacin on QTc relative to time-matched placebo, at the historical moxifloxacin Tmax of 3 hours.
timeFrame: 1 day
measure: To evaluate the safety and toleration of a single dose of lersivirine in healthy male and female subjects.
timeFrame: 1 day
measure: To characterize the exposure-response relationship between lersivirine and changes in QTc using plasma concentrations of lersivirine.
timeFrame: 1 day
measure: To assess the single dose pharmacokinetics of lersivirine.
timeFrame: 1 - 2 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04424771: Post-traumatic Stress Disease in Health Workers During COVID-19 Pandemia
Official title: PTSD in Health Workers During COVID-19 Pandemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Post Traumatic Stress Disorder
Keywords: COVID-19
Lead sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consisted of workers in health services.

Brief summary: The purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.


Eligibility criteria: Inclusion Criteria:

* workers in health services, including phisicians, nurses, inhospital technicians and biologists

Primary outcomes:
measure: Number of patients with diagnosis of PTSD.
timeFrame: Through study completion, an average of 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brindisi
country: Italy
facility: Ospedale Perrino Asl Brindisi
city: Genoa
country: Italy
facility: Piazza della Vittoria 14 Studio medico - Ginecologia e Ostetricia
Study officials:
References:
Clinical trial NCT05454371: Investigation of Urinary Biomarkers for the Detection of Prostate Cancer
Official title: Investigation of Urinary Biomarkers for the Detection of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Urine
Liquid Biopsy
Keywords: First-void urine
Liquid biopsy
Oncology
Biomarker
Colli-Pee
Lead sponsor: Novosanis NV
Sponsor class: INDUSTRY
Collaborators: name: Universiteit Antwerpen
First posted: 2022-07-12
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to investigate and possibly validate urinary biomarkers for prostate cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, CTC or blood derived cfDNA. Proteins will be explored in urine as well.

This is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with prostate cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.


Eligibility criteria: Inclusion Criteria:

* Being at least 18 years old
* Being able to understand and read Dutch
* For cancer patients: being diagnosed with prostate cancer
* For healthy volunteers: being male

Exclusion Criteria:

* For cancer patients: suffering from a blood cancer
* For healthy volunteers: diagnosed with cancer

Primary outcomes:
measure: Detection (absence/presence) of specific urinary biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Detection (absence/presence) of specific biomarker targets (AR-V7, TMPRSS2-ERG) for prostate cancer patients measured using ddPCR.
timeFrame: Through study completion, an average of 1 year
measure: Usability characteristics of the Colli-Pee UAS devices.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair ziekenhuis Antwerpen
state: Antwerpen
Study officials:
References:
Clinical trial NCT01891071: Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis
Official title: Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Lung volume recruitment
Pulmonary function impairment
Cough impairment
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
First posted: 2013-07-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. This pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough.


Eligibility criteria: Inclusion Criteria:

* History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria

Exclusion Criteria:

* Concomitant parenchymal pulmonary disease or pleural disease
* Symptomatic cardiomyopathy
* Unable to perform pulmonary function testing or lung volume recruitment, due to comprehension or cooperation issues, physical inability such as bulbar or cerebellar dysfunction
* Contra-indication to pulmonary function testing or lung volume recruitment such as myocardial infarction, bleeding aortic aneurysm, intracranial hemorrhage within the previous month
* Known susceptibility to pneumothorax or pneumomediastinum
* Not competent to provide informed consent

Primary outcomes:
measure: Rate of decline of FVC (forced vital capacity)
timeFrame: up to 9 months
Secondary outcomes:
measure: Rate of decline of peak cough flow
timeFrame: baseline, 2, 4, 6 and 9 months
measure: Change from baseline in FVC at 2, 4, 6 and 9 months
timeFrame: baseline vs 2, 4, 6 and 9 months
measure: Change from baseline in peak cough flow at 2, 4, 6 and 9 months
timeFrame: baseline vs 2, 4, 6 and 9 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Hôpital Charles-LeMoyne
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Nadim Srour, MD, MSc
role: STUDY_CHAIR
affiliation: The Ottawa Hospital
name: Douglas A McKim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Srour N, LeBlanc C, King J, McKim DA. Lung volume recruitment in multiple sclerosis. PLoS One. 2013;8(1):e56676. doi: 10.1371/journal.pone.0056676. Epub 2013 Jan 31.
Clinical trial NCT06282471: EW and Self-Guided PST in Cancer Survivors and Caregivers
Official title: Expressive Writing (EW) and Self-Guided Problem-Solving Therapy (PST) in Cancer Survivors and Caregivers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cancer Survivors
Informal Caregivers
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 50
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: To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers

Detailed description: This is a single-arm proof-of-concept behavioral clinical trial of a self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof

Eligibility criteria: Inclusion Criteria:

* Cancer diagnosis of any type OR informal caregiver (family member, friend, and/or spouse who provides the majority of caregiving) of someone with cancer
* Patient of Virginia Commonwealth University (VCU) Massey Cancer Center OR informal caregiver (family member, friend, and/or spouse) of a VCU Massey Cancer Center patient

Exclusion Criteria:

* Physical inability to write
* Non-English speaker/writer
* Inability to consent to study participation

Primary outcomes:
measure: Consent Rate
timeFrame: Day 1
measure: Study Retention
timeFrame: Week 6
measure: Completed Journal Entries
timeFrame: Week 6
measure: Patient Satisfaction Questionnaire
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks
timeFrame: Baseline, Week 6
measure: Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks
timeFrame: Baseline, Week 6
measure: Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
measure: Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
measure: Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
measure: Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
measure: Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
measure: Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
measure: Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Susan Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02726971: Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion
Official title: A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Asherman Syndrome
Keywords: Intrauterine Adhesion
Oestrogen Artificial Periodic Therapy
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 141
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.


Eligibility criteria: Inclusion Criteria:

1. Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);
2. Scheduled for hysteroscopic adhesiolysis;
3. Agreed to have two follow-up hysteroscopy; and
4. Written, informed consent obtained.

Exclusion Criteria:

1. Received estrogen therapy within 3 months of enrollment;
2. Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);
3. History of genital tuberculosis; and
4. Contraindication for estrogen therapy.

Primary outcomes:
measure: the AFS Score at Second-look Hysteroscopy
timeFrame: 1 months after the surgery
Secondary outcomes:
measure: the AFS Score at Third-look Hysteroscopy
timeFrame: 2 months after surgery
measure: Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Xing Hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT00563771: Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
Official title: Phase IV, Compassionate Use Program of Rasburicase for Treatment of Hyperuricemia in Children and Adolescence Patients With Tumor Lysis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperuricemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-26
Enrollment: 38
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To provide treatment opportunity to children and adolescent patients with hematologic malignancies by supplying the delayed marketed product and also to observe the efficacy and safety of rasburicase used in the treatment of hyperuricemia


Eligibility criteria: Inclusion Criteria:

* Acute hyperuricemia patients before / during chemotherapy for hematologic malignancies ( uric acid greater than 7.5 mg/dL )

  * With a minimum life expectancy of 3 months
  * Having previously signed a written informed consent.

Exclusion Criteria:

* Hypersensitivity to uricase or any of the excipients.
* Known history of G6PD deficiency.
* Previous treatment with Rasburicase or Uricozyme.
* Treatment with any investigational drug within 30 days before planned first Rasburicase administration.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Response will be defined as achievement of normal uric acid levels (less than or = to 7.0mg/dL)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Choe Seong Choon
role: STUDY_DIRECTOR
References: