louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06178887: Role of Cardiac AngioMR in Diagnosis of Cardiac and Vascular Anomalies in Adult Patients with Turner Syndrome
Official title: Role of Cardiac Magnetic Resonance Angiography (1.5-T) in the Diagnosis of Cardiac and Thoraco-abdominal Vascular Tree Anomalies in Adult Patients with Turner Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anomaly Heart
Turner Syndrome
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 33
Sex: FEMALE
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: cohort of patients with Turner syndrome \> 18 years

Brief summary: Considering the high prevalence of cardiovascular disease in Turner syndrome patients, noninvasive cardiac imaging is crucial for diagnosis and follow-up. From the review of the literature, it was evident that the imaging techniques used involved the evaluation of only the thoracic findings, in particular the heart and the thoracic aorta, while no data are currently available on the distal abdominal aorta or iliac arteries, since ultrasound and MRI are interrupted at the diaphragmatic level.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of Turner Syndrome
* patients underwent angioMR 1.5 T
* age \> 18 years

Primary outcomes:
measure: Vascular and cardiac anomalies
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Unit of Endocrinology of Azienda Ospedaliera-Universitaria di Modena
Study officials:
References:
Clinical trial NCT02566187: A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 99
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.


Eligibility criteria: Inclusion Criteria:

* a Healthy male subject, aged 19- 50 years

Exclusion Criteria:

* History of clinically significant hypersensitivity to study drug, any other drug
* Hypotension or hypertension
* Active liver disease
* History of gastrointestinal disease
* History of excessive alcohol abuse
* Participation in any other study within 3 months

Primary outcomes:
measure: Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin
timeFrame: 0~48 hour after medication
measure: Area under the curve(AUCt) of Fimasartan and Atorvastatin
timeFrame: 0~48 hour after medication
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
References:
Clinical trial NCT02862587: Precision Cell Immunotherapy Combined With TACE in Advanced Liver Cancer
Official title: Clinical Study Using Precision Cell Immunotherapy Combined With Transcatheter Arterial Chemoembolization in Advanced Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Precision Cells
Chemotherapy
Advanced Lung Cancer
Keywords: Precision Cells
Chemotherapy
Advanced Lung Cancer
Lead sponsor: Shanghai International Medical Center
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:

To evaluate the safety and effectiveness of cell therapy using precision cells to treat Advanced Lung Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.

Detailed description: A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria: Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Life expectancy≥6 months;
* ECOG score: 0-3;
* Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
* Enough venous channel, no other contraindications to the separation and collection of white blood cells;
* Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
* Signed informed consent;
* Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

* Expected Overall survival \< 6 months;
* Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months;
* Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
* Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month;
* Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progress-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai International Medical Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00369187: Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose of rHuPH20 will increase the bioavailability of large molecule drug administration.

Detailed description: Sequential enrollment into four rHuPH20 dose cohorts.

Eligibility criteria: Inclusion Criteria:

1. Males or females at least 18 years of age with RA treated with MTX who have been treated with:

   * co-injected large molecule protein for at least two cycles, and
   * have had stable disease with no symptom flares in the previous 30 days.
2. AST (SGOT) and ALT (SGPT) within normal range within 7 days prior to entry in the study.
3. Adequate venous access in at least one extremity.
4. A negative pregnancy test (if female of child-bearing potential) within 7 days prior to entry in the study.
5. Decision-making capacity.
6. Signed, written IRB-approved informed consent.

Exclusion Criteria:

1. Unacceptable toxicity to the large molecule protein, or contraindication to or other reason to not continue the large molecule protein per the package insert (e.g., active or latent tuberculosis, chronic or localized infections, or concurrent treatment with anakinra).
2. History of active tuberculosis, or known positive tuberculin skin test unless the patient has successfully completed a nine-month course of isoniazid therapy.
3. Concurrent use of any disease-modifying anti-rheumatic drug except the large molecule protein and MTX.
4. Any anticipation that the dose of the large molecule protein or MTX would be changed within 4 weeks following entry in the study.
5. Known allergy to hyaluronidase or any hyaluronidase product.
6. Known allergy to bee or vespid venom.
7. Contraindication to IV heparin lock or known hypersensitivity to heparin.
8. Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
9. Presence of any other medical condition that would present an unacceptable safety risk to the patient.
10. Participation in a study of any investigational drug or device within 30 days of enrollment in this study.

Primary outcomes:
measure: AUC
Secondary outcomes:
measure: Tmax, Cmax, half-lives, injection site reactions, safety and tolerability, NAbs
Other outcomes:
Locations:
Study officials:
affiliation: Arthritic Center of Reno
name: Malin Prupas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00077987: Assessment Of Safety And Efficacy Of SU11248 In Patients With Metastatic Colorectal Cancer Who Have Failed Selected Previous Treatments.
Official title: A Phase II Study Of SU011248 In Patients With Metastatic Colorectal Cancer Who Have Previously Failed Treatment With Irinotecan, Oxaliplatin, And A Fluoropyrimidine, With And Without Bevacizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-02-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of safety and efficacy of SU11248 in patients with metastatic colorectal cancer who have failed selected previous treatments.


Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal cancer
* Failed selected cancer therapies in the past.

Exclusion Criteria:

* Prior treatment with tyrosine kinase inhibitors or VEGF inhibitors other than bevacizumab.

Primary outcomes:
measure: Anti-tumor efficacy
Secondary outcomes:
measure: Tumor control survival safety
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06252987: The Effects of tDCS Combined With rTMS on Post-stroke Cognitive Impairment
Official title: The Second Hospital of Dalian Medical University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Second Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\]

The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:

* \[Search for effective treatments of cognitive impairment after stroke\]
* \[Explore brain network features with functional near-infrared spectroscopy\] Participants will receive conventional treatment, tDCS treatment, or rTMS treatment, or tDCS-rTMS treatment.

And then compare cognitive function and brain function.


Eligibility criteria: Inclusion Criteria:

* Meet the clinical diagnostic criteria of the Expert Consensus on the Management of Cognitive Impairment after Stroke in 2021;
* 30-80 years old, right-handed, unilateral hemiplegia;
* Verbal expression can cooperate with the completion of the evaluation, sustained attention time is longer than 5 minutes;
* Simple Mental State Examination Scale (MMSE) score ≤26 points; MoCA scale score \< 26 points; Memory test (RMBT) score less than 21 points;
* patients or their family agree to sign the informed consent;
* The Ethics Committee approved the trial.

Exclusion Criteria:

* Memory dysfunction caused by other diseases, such as Alzheimer's disease, lewy body dementia, pituitary tumor surgery, hypothyroidism, etc.;
* There are contraindications of rTMS and tDCS for untreated intracranial aneurysms, severe epilepsy, intracranial metal, etc.
* Patients with severe visual, cognitive or speech impairment who cannot cooperate with treatment;
* The condition is not stable; Or other serious physical diseases.

Primary outcomes:
measure: Concentration of brain's HbO by functional near-infrared spectroscopy
timeFrame: 2 weeks
Secondary outcomes:
measure: Score of Mini-Mental State Examination
timeFrame: 2 weeks
measure: Score of The Frontal Assessment Battery
timeFrame: 2 weeks
measure: Score of Attention assessment by the digit span task
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dalian
country: China
facility: Lily
state: Liaoning
Study officials:
affiliation: Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University
name: Yongmei Jiang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05168787: Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction
Official title: Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Heart Failure
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AAs with HFrEF on sacubitril/valsartan therapy

Brief summary: There is limited long-term evidence specific to AAs with HFrEF on sacubitril/valsartan therapy. Plasma NT-proBNP levels are lower in AA individuals as compared to Caucasian individuals in general. However, the mechanism of action of sacubitril specifically targets the activity of BNP. Therefore, there is the potential that the mechanism of action of sacubitril/valsartan may be less effective in AAs.

Detailed description: To assess the efficacy and safety of sacubitril/valsartan in AA patients with HFrEF by comparing the outcomes of AA patients on ARNI therapy plus SOC (with or without hydralazine/isosorbide \[H-IDSN\]) to AA patients receiving ACEi/ARB therapy plus SOC (with or without H-ISDN).

Eligibility criteria: Inclusion Criteria:

* Self-identified as AA
* NYHA class II-IV symptoms
* Left ventricle EF \<40%
* Receiving stable doses of standard therapy, including ACE inhibitors or ARBs, ARNI (within a month from discharge), combination H-ISDN, beta blockers, digoxin, spironolactone, and diuretics as tolerated.
* Patient must have minimum of three months follow-up

Exclusion Criteria:

* Patients not meeting inclusion criteria

Primary outcomes:
measure: Composite CV mortality or HF hospitalization
timeFrame: April 2017 to August 2020
Secondary outcomes:
measure: CV mortality
timeFrame: April 2017 to August 2020
measure: HF hospitalization
timeFrame: April 2017 to August 2020
measure: All-cause mortality
timeFrame: April 2017 to August 2020
measure: New atrial fibrillation
timeFrame: April 2017 to August 2020
measure: Renal function decline
timeFrame: April 2017 to August 2020
measure: Change in EF
timeFrame: April 2017 to August 2020
measure: Change in NYHA classification
timeFrame: April 2017 to August 2020
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center Pharmacy
state: Texas
Study officials:
affiliation: Methodist Dallas Medical Center Pharmacy
name: Crystal Brown, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860287: The Effects of Buprenorphine on Responses to Verbal Tasks
Official title: The Effects of Buprenorphine on Responses to Verbal Tasks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Basic Science
Keywords: opioid
subjective
stress
buprenorphine
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators will examine the effects of buprenorphine, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. Recently it has been shown that buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions in humans. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of buprenorphine. The investigators hypothesize that buprenorphine with reduce both physiological and subjective measures of stress.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* ages 18-40 years
* high school education
* fluent in English

Exclusion Criteria:

* history of adverse drug reactions
* taking oral contraceptives or planning to become pregnant
* taking any medications
* smokers
* night shift workers
* drink more than 4 alcoholic or caffeinated drinks per day

Primary outcomes:
measure: Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
timeFrame: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Jerome Jaffe, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00848887: A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
Official title: A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
Flu
Vaccine
Adjuvant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2009-02-20
Enrollment: 410
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.


Eligibility criteria: Inclusion Criteria:

* Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.

Exclusion Criteria:

* History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.

Primary outcomes:
measure: Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
timeFrame: 50 days
Secondary outcomes:
measure: Strain-specific influenza antibody titers will be used to assess Immunogenicity
timeFrame: 50 days
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UCL St. Luc - Pharmacy
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59((R))-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub 2011 Sep 9.
Clinical trial NCT04345887: Spironolactone in Covid-19 Induced ARDS
Official title: The Effect of Spironolactone on Oxygenation in Covid-19 ARDS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 60
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: All adult patients admitted to the ICU due to Covid-19 ARDS requiring diuretic

Brief summary: This study intended to evaluate the effects of commonly used diuretic, spironolactone, on oxygenation in covid-19 ARDS patients.


Eligibility criteria: Inclusion Criteria:

* Hemodynamically stable
* Hypoxemia, i.e. p/f \<150
* Admitted to ICU within 48 hours
* Not moribund has a life expectancy greater than 24 hours

Exclusion Criteria:

* Age criteria
* Pregnancy
* Unwillingness to participate

Primary outcomes:
measure: p/f ratio
timeFrame: 5 days
Secondary outcomes:
measure: SOFA
timeFrame: 5 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
affiliation: Prof
name: Yalim Dikmen
role: STUDY_DIRECTOR
References:
citation: Vaduganathan M, Vardeny O, Michel T, McMurray JJV, Pfeffer MA, Solomon SD. Renin-Angiotensin-Aldosterone System Inhibitors in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):1653-1659. doi: 10.1056/NEJMsr2005760. Epub 2020 Mar 30. No abstract available.