louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00733135: Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Official title: Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripheral Arterial Disease
Keywords: peripheral vascular disease
atherectomy
atherosclerosis
calcified lesions
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 133
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: This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.


Eligibility criteria: Inclusion Criteria:

* Provides written informed consent
* Willing to comply with follow-up evaluations at specified times
* Has leg pain due to peripheral arterial disease
* Disease located within the femoropopliteal artery
* Moderate to severe calcification

Exclusion Criteria:

* Previously implanted stent(s) or stent graft(s) in target leg
* Life expectancy less than 12 months
* Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure

Primary outcomes:
measure: Successful Revascularization
timeFrame: at the end of the procedure
measure: Major Adverse Event Free Rate 30 Days
timeFrame: 30 Days
Secondary outcomes:
measure: Technical Procedural Success
timeFrame: at the end of the procedure
measure: Residual Diameter Stenosis
timeFrame: at the end of the procedure
measure: Presence of Debris in Deployed SpiderFx™ Embolic Protection Device
timeFrame: at the end of the procedure
measure: Preservation of Run-off Distal to the Filter
timeFrame: at the end of the procedure
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Daniel Clair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Medical Center
name: David Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D; DEFINITIVE Ca(+)(+) Investigators. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca(+)(+) trial. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. doi: 10.1002/ccd.25384. Epub 2014 Feb 5.
Clinical trial NCT01606735: Efficacy and Safety of IBI-10090 in Ocular Surgery Patients
Official title: A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammation Associated With Cataract Surgery
Keywords: cataract surgery
ocular inflammation
Lead sponsor: ICON Bioscience Inc
Sponsor class: INDUSTRY
First posted: 2012-05-28
Enrollment: 172
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for unilateral cataract surgery

Exclusion Criteria:

* Ocular, topical, or oral corticosteroids within 7 days of Day 0

Primary outcomes:
measure: Anterior Chamber Cell Count at Day 8 Post-Treatment
timeFrame: 8 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Temecula
country: United States
facility: California Eye Professionals
state: California
Study officials:
affiliation: Sponsor GmbH
name: Wendy Murahashi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04413435: Clinical Characteristics of Critically Ill Patients With COVID-19
Official title: Clinical Characteristics of Critically Ill Patients With 2019 Novel Coronavirus (COVID-19): Do We Need a New Triage System?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Critical Illness
Characteristics Disease
Lead sponsor: Nevsehir Public Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-04
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with confirmed COVID-19 and suspected COVID-19 patients who hospitalized in ICUs allocated for patients with novel coronavirus disease.

Brief summary: Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Hence, it may be need a new scoring system for contagious critically ill patients.

Detailed description: Critically ill patients with COVID-19 have hospitalized in an ICU due to the closer monitoring and therapy. In fact, ICU admissions are dependent on the severity of illness and the ICU capacity of the health-care system. Therefore, many patients with confirmed COVID-19 with RT-PCR and/or suspected COVID-19 were hospitalized in ICUs with a limited number of beds. This ambiguity can result in both contamination risk to uninfected patients and occupancy rate of the limited ICU beds. Hence, it may be need a new scoring system for contagious critically ill patients. The aim of this study was to describe the epidemiological and clinical features of 75 critically ill patients due to COVID-19 and to compare confirmed COVID-19 cases with suspected COVID-19 cases in our critical care units.

Eligibility criteria: Inclusion Criteria:

* All patients with confirmed COVID-19 and suspected COVID-19

Exclusion Criteria:

* All patients \<18 years old

Primary outcomes:
measure: Polymerase Chain Reaction (PCR) test
timeFrame: 5 days
Secondary outcomes:
measure: A scoring system for patients to be admitted to the intensive care unit
timeFrame: 5 days
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Trainig and Research Hospital
Study officials:
References:
Clinical trial NCT05093335: In-Human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET
Official title: In-human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Non-Hodgkin Lymphoma
Multiple Myeloma
Histiocytic Neoplasms
Erdheim-Chester Disease
Rosai-Dorfman Disease
Keywords: [68Ga]-Pentixafor
PET/CT scan
In-human CXCR4 Imaging
21-356
Symptomatic multiple myeloma
pre-cursor myeloma
MGUS
SMM
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Pentixapharm AG
First posted: 2021-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This protocol is a pilot protocol.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the uptake of the imaging agent \[68Ga\]-pentixafor with PET/CT scans in people with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and non-Hodgkin lymphoma (NHL), or you have histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD).


Eligibility criteria: Inclusion Criteria:

Twenty patients with histologically proven treatment-naïve, therapy-refractory or relapsed blood cancers meeting the below criteria will be included:

* Indolent B- or T-cell Non-Hodgkin lymphoma (including cutaneous lymphomas) or Non-Hodgkin lymphoma with variable FDG uptake and clinical course, such as mantle cell lymphoma; and measurable disease according to Lugano criteria

or

* Histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD)
* MGUS/SMM or MM according to IMWG definitions
* Solid tumors, such as lung cancers, meningioma, adrenocortical neoplasms including cortisol-producing adenomas or high suspicion for tumor, such as in patients with Cushing's disease.
* Age ≥18
* Negative serum pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \& Guidelines) from assays obtained \<2 weeks prior to study enrollment/intervention; or negative urine pregnancy test performed on the day of intervention
* MSKCC patients

Exclusion Criteria:

* Breast-feeding
* History of renal functional disorders (chronic kidney disease with eGFR\<30)
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)

Primary outcomes:
measure: Tumor standard uptake value (SUV)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anton Nosov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05761535: Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia
Official title: Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodegenerative Diseases
Lead sponsor: IRCCS SYNLAB SDN
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD)

Brief summary: The correlation between data obtained by "imaging" in patients with neurodegenerative diseases characterized by inflammation and the presence in the peripheral blood of the same patients "biopsies liquid biopsies" of specific circulating nucleic acids, could enable the development of methods and algorithms capable of identifying novel biomarkers that serve as targets for the development of probes diagnostics and therapeutics. This is the context for the project idea, which is aimed at developing development of a performant multi parameter system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease


Eligibility criteria: Inclusion Criteria:

All subjects of either sex aged 18 to 85 years who are able to provide voluntary consent, suffering from neurodegenerative diseases (AD and PD)

Exclusion Criteria:

All patients for whom there are contraindications to performing MRI. Also excluded from the study will be subjects who are pregnant, or presumed to be pregnant or undergoing of lactation and subjects with claustrophobia

Primary outcomes:
measure: Development of a performant multiparametric system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease
timeFrame: 1-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: IRCCS Synlab SDN
Study officials:
References:
Clinical trial NCT05352035: Multiomics Tumor Evolution Model of NSCLC
Official title: A Multiomics Study of Tumor Evolution Characteristics and Prognostic Model in Early-stage Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Multiomics analysis
Tumor evolution
Tumor immune microenvironment
Circulating tumor DNA
Radiomics
Prognostic model
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Research Unit of Intelligence Diagnosis and treatment of early-stage non-small cell lung cancer, Chinese Academy of Medical Sciences
First posted: 2022-04-28
Enrollment: 300
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: Patients who meet the eligibility criteria will be included consecutively.

Brief summary: The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Detailed description: Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. Early-stage NSCLC patients underwent radical surgical resection;
3. Sufficient tumor tissue and blood sample for study use;
4. Available clinical-pathologic data, imaging data and follow-up date;
5. Written informed consent.

Exclusion Criteria:

1. History of other malignant tumors;
2. Evidence of distant metastasis before surgery;
3. Insufficient tumor tissue or blood sample for study use;
4. Clinical-pathologic data, imaging data or follow-up date is not available;
5. Other judgments by the Investigator that the patient should not participate in the study.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Through study completion, an average of 2 years
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Relationship between translational biomarkers and clinical outcome
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang
role: STUDY_CHAIR
References:
Clinical trial NCT05691335: Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
Official title: Analysis of the Outcomes of Three Different Cross-linking Protocols for Treatment of Pediatric Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Ectasia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 97
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking

Detailed description: comparison between standard cross-linking protocol and accelerated and transepithelial cross-linking for treatment of documented pediatric keratoconus progression. The study patients are divided into 3 groups. Group A patient treated with standard cross-linking. Group B patients treated with accelerated cross-linking. Group C patients treated with transepithelial cross-linking.

Eligibility criteria: Inclusion Criteria:

* pediatric patient less than 18 years old
* keratoconus stage I-III ABCD keratoconus grading system

Exclusion Criteria:

* age more than 18 years
* previous eye surgery
* current eye infection or pathology

Primary outcomes:
measure: Uncorrected distance visual acuity
timeFrame: 36 months
measure: Corrected distance visual acuity
timeFrame: 36 months
measure: Sphere
timeFrame: 36 months
measure: Cylinder
timeFrame: 36 months
measure: Keratometry (Kmax)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Sohag University
name: Mohammed Iqbal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04592835: To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003
Official title: A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19 Patients
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2020-10-19
Enrollment: 24
Sex: ALL
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: This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
2. Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).
3. Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken

Exclusion Criteria:

1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
3. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: follow-up 35 days after dosing
Secondary outcomes:
measure: To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax
timeFrame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
measure: To assess PK parameters of niclosamide injectable (DWRX2003) through tmax
timeFrame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
measure: To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last
timeFrame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
measure: To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞
timeFrame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
measure: To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2
timeFrame: at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03173235: Plasma Concentrations of Calcium, Phosphate, FGF23, Klotho, 25 (OH) D3 and 1,25 (OH) 2D3 from Patients Who Wants to Have Children
Official title: Plasma Concentrations of Calcium, Phosphate, FGF23, Klotho, 25 (OH) D3 and 1,25 (OH) 2D3 from Patients Who Wants to Have Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in the age of 18 to 45 years

Brief summary: 1,25-dihydroxy-vitamin D3 (1,25 (OH) 2D3) or calcitriol regulates plasma calcium and phosphate concentrations in the blood by stimulating intestinal absorption and renal reabsorption of calcium and phosphate. 1.25 (OH) 2D3 is formed by the renal 1α25OH vitamin D-hydroxylase (Cyp27b1) and inactivated by the renal 25-hydroxy vitamin D-24-hydroxylase (Cyp24). Unpublished studies in mice revealed an inhibitory effect of 1.25 (OH) 2D3 on embryo implanation. An excess of 1.25 (OH) 2D3 could therefore lead to female infertility. The excess of 1.25 (OH) 2D3 could result from uncritical vitamin D intake with insufficient negative feedback by FGF23 / Klotho. The aim of the study is to identify patients with an excess of 1.25 (OH) 2D3.

Detailed description: The physiological institute of the University Tübinge has succeeded in preventing vascular calcification in Klotho-deficient mice by inhibiting osteogenic signal transduction. The animals reach an almost normal life span despite increased 1.25 (OH) 2D3, Ca2 + and phosphate plasma concentrations. The male animals are again fertilized, but not the female animals. However, if the plasma concentrations of 1.25 (OH) 2D3 are normalized by administration of a vitamin-poor diet, the female animals are fertilized within two weeks. Further investigations revealed an inhibitory effect of 1.25 (OH) 2D3 on the implantation of the embryo. In the meantime the 1,25 (OH) 2D3-dependent signal transduction could be revealed, which prevents the implantation of the embryo. The vitamin D receptor and the elements of signal transduction are also expressed in the human endometrium. It is therefore possible that increased 1.25 (OH) 2D3 plasma concentrations also prevent embryo implantation in humans.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Known systemic diseases, e.g. Autoimmune disease, scleroderma, malignant disease

Primary outcomes:
measure: Plasma level of 25(OH)D3 and 1,25(OH)2D3
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Women's Hospital
Study officials:
References: