louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06884878: Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
Official title: Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncologic patients eligible for targeted therapy and/or immunotherapy.

Brief summary: The INNOVA project aims to create an advanced multidisciplinary diagnostic platform to support the Italian healthcare system and translational research. In this context, WP7, coordinated by the Pascale Institute and the focus of this study protocol, is responsible for developing a national platform for the multi-omic profiling of cancer patients eligible for precision medicine treatments, with the goal of supporting clinical decision-making.

Detailed description: The study is multicentric, observational, non-interventional, and both prospective and retrospective.

Eligibility criteria: Inclusion Criteria:

* Consent to participate in the study
* Age \>18 years
* Performance status (PS) 0-1
* Availability of biological samples for multi-omic profiling
* Availability of radiological images for radiomic assessments
* Patients with metastatic disease, i.e., stage IV (except for melanoma, where stage II/III patients eligible for adjuvant therapy may also be considered)
* Patients eligible for targeted therapy and/or immunotherapy
* Patients with aggressive neoplasms, including melanoma, non-small cell lung carcinoma (NSCLC), colon carcinoma (BRAF-mutated, MSI), triple-negative breast cancer, ovarian cancer, and cholangiocarcinoma.

Exclusion Criteria:

* Previous line of immunotherapy or targeted therapy
* Previous radiotherapy at the sites of the most recent diagnostic biopsy
* Most recent diagnostic biopsy performed \>24 months before enrollment
* Absence of measurable lesions
* Presence of active or untreated brain metastases or leptomeningeal carcinomatosis

Primary outcomes:
measure: Disease progression
timeFrame: approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Study officials:
affiliation: IRCCS I.N.T. "G. Pascale"
name: Antonella De Luca
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02814578: Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
Official title: Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: OCT
IVUS
BVS
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2016-06-27
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.


Eligibility criteria: Inclusion Criteria:

* Age 20 years or older
* Patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia
* Willing and able to provide informed written consent
* Eligible for PCI

Exclusion Criteria:

* Patients presenting with STEMI within 2 weeks
* Bypass graft lesion
* Lesion with left main disease
* Expected length of scaffold \> 40 mm
* Bifurcation lesion requiring side branch stenting
* Small vessels \< 2.75 mm
* Stented lesion
* Suspected coronary spasm even after sufficient nitrate injected
* Cases in which the IVUS or OCT imaging catheter failed to cross the lesion
* Poor quality IVUS or OCT images
* Contraindication to dual anti-platelet therapy
* Chronic total occlusion
* Angiographically large-sized vessel (\>3.5mm of reference lumen diameter)
* Life expectancy shorter than 2 years
* Pregnancy

Primary outcomes:
measure: OCT-measured in-scaffold minimal lumen area
timeFrame: 1 year
Secondary outcomes:
measure: OCT-measured minimal scaffold area (MSA)
timeFrame: 1 year
measure: OCT-measured mean scaffold expansion
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
Clinical trial NCT03464578: Evidence Based Algorithm for Proximal Humerus Fractures
Official title: Evidence Based Algorithm to Treat Patients With Proximal Humerus Fractures - A Prospective Study With Early Clinical and Overall Performance Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 143
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with an acute proximal humeral fracture admitted to our institution.

Brief summary: Proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. The goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures.

Objective(s):

1. Test the algorithm in terms of clinical applicability and clinical outcome
2. Compare general outcome and general complication/revision rate to the literature.

Inclusion / Exclusion criteria: Inclusion: All patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. Exclusion: Multilevel and pathological fractures are excluded.

Terminally ill patients and those not being able, or willing to sing the informed consent.

Project Centre(s): Single-centre.

Statistical Considerations: Standard descriptive statistics will be performed using R-statistics program. Considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05.

Other methodological Considerations: Terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.


Eligibility criteria: Inclusion Criteria:

* Acute traumatic proximal humeral fracture
* Signed informed consent

Exclusion Criteria:

* Fracture older than 48 hours at admission
* Multilevel fractures of the humerus
* Pathological fractures
* Terminally ill patients.

Primary outcomes:
measure: Constant Score
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Department of Orthopaedic Surgery and Traumatology
Study officials:
affiliation: Head of the departement
name: Bernhard Jost, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03673878: Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)
Official title: Study on the Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pruritus
Brain Tumor
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 200
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: Patient who are seen in radiotherapy consultation and / or hospitalization of neurosurgery Fulfilling the inclusion criteria, not falling within the exclusion criteria Presence of itching for more than 1 week in a patient with one or more brain tumor(s), primary or secondary, benign(s) or malignant(s).

Brief summary: The association between the presence of pruritus, especially centrofacial, and the presence of a brain tumor is a widespread notion in the medical community but based on a single publication by Andreev et al. in the British Journal of Dermatology published in 1975. No other study has studied this association with a rigorous methodology. The aim of this study is to evaluate the prevalence of pruritus in patients with one or more primary or secondary brain tumor(s), benign(s) or malignant(s).

Detailed description: * Monocentric prospective observational study
* On the inclusion period
* Patients who are seen in radiotherapy consultation and / or department of neurosurgery
* Complying with the inclusion criteria, not falling within the exclusion criteria
* Re-reading of cerebral MRI (cMRI) with precision on the location(s) of the brain tumor(s) according to a predefined anatomic descriptive diagram
* Complete the questionnaire by a dermatologist (characteristics of pruritus, brain lesion(s), characteristics of the population)

Eligibility criteria: Inclusion criteria:

* Age \> 18 years
* Diagnosis of benign or malignant brain tumor, primary or secondary.
* Accepted non-opposition
* Realization of a cerebral MRI (cMRI)

Exclusion criteria:

* Age \< 18 years
* Absence of cerebral imaging of the cMRI type
* Absence of non opposition
* Realization of a treatment modifying the brain structure (radiotherapy / surgery)

Primary outcomes:
measure: Presence of itching for more than 1 week in a patient with one or more brain tumor(s), primary or secondary, benign(s) or malignant(s).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Service de dermatologie, CHRU BREST
Study officials:
References:
Clinical trial NCT04438278: Profile Fecal Analysis of Neutropenic Enterocolitis
Official title: Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neutropenic Enterocolitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML)

Brief summary: A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis


Eligibility criteria: Inclusion Criteria:

* patient\>= 18 years old;
* cytological diagnosis of de novo Acute Myeloid Leukemia (AML) (\>20% myeloid blasts);
* eligible for intensive chemotherapy (no severe co-morbidity);
* not having received any prior chemotherapy;
* affiliation to the national social security system.

Exclusion Criteria:

* acute promyelocytic leukemia (AML 3);
* inability to understand the nature of investigations or to give informed non-opposition;
* person subject to a legal protection measure.

Primary outcomes:
measure: Shannon index of α-diversity
timeFrame: At day 1, before chemotherapy initiation
Secondary outcomes:
measure: Fecal microbiota's profile
timeFrame: At day 14
measure: Intensive Care Unit (ICU) - mortality
timeFrame: 60 days
measure: Hospital - mortality
timeFrame: 60 days
measure: 1-year mortality
timeFrame: 1 year
measure: Occurrence of any local neutropenic enterocolitis complications
timeFrame: 60 days
measure: Occurrence of microbiologically documented infections in patients with severe neutropenic enterocolitis
timeFrame: 60 days
measure: Occurrence of malnutrition in patients with severe neutropenic enterocolitis
timeFrame: 60 days
measure: Biodiversity in microbiota
timeFrame: Day 1, day 14, day 28, day 42
measure: Whole-blood metatranscriptomic profile evolution
timeFrame: Day 1, day 14, day 28, day 42
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Hôpital Saint Louis
Study officials:
References:
Clinical trial NCT04648878: A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton
Official title: A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton in the Treatment of Individuals With Sub-acute and Chronic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Exoskeleton
Gait
Physical Therapy
Motor-learning
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this investigator-initiated study is to establish if powered exoskeleton therapy as a part of a rehabilitation program can be used as a standard of care in stroke rehabilitation.

Detailed description: This prospective randomized control trial with three treatment arms will begin by:

* Determining if the subject is a candidate for exoskeleton treatment.
* Randomly assigning subjects to three groups (physical therapy only, exoskeleton only, or a hybrid of physical therapy and exoskeleton).
* Body measurements to individualize the fit of the exoskeleton to each subject at each session.
* Activities-based balance confidence (ABC) questionnaire will be administered before and after the study begins.
* Timed up and go test (TUGT).
* Ten-meter walk test (10MWT).
* Six-minute walk test (6MWT)
* Berg Balance Test (BBT).
* Five times sit to stand (5XSTS).
* Heart rate through a portable heartrate monitor.

Eligibility criteria: Inclusion Criteria:

* Males and Females 18 years of age or older post-stroke

  * 3 Ashworth score are involved in a standing program less than 220 lbs 5'0" through 6'4" have the ability to follow one-step commands near normal range-of-motion for the knees, hips, and ankles

Exclusion Criteria:

* Exclusion criteria will include those who have already experienced powered exoskeleton therapy.

Primary outcomes:
measure: Timed up and go test
timeFrame: Pre and post tests up to six weeks apart
measure: Ten meter walk test
timeFrame: Pre and post tests up to six weeks apart
measure: 6 minute walk test
timeFrame: Pre and post tests up to six weeks apart
measure: Berg Balance Test
timeFrame: Pre and post tests up to six weeks apart
measure: The Activities-specific Balance Confidence (ABC) Scale
timeFrame: Pre and post tests up to six weeks apart
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University O&P
name: Michael Davidson, MSE MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03430778: Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring
Official title: Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effect of pneumoperitoneum on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy


Eligibility criteria: Inclusion Criteria:

* Laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

* atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Primary outcomes:
measure: difference between SpHb value and SaHb value (SpHb - SaHb)
timeFrame: from the start of anesthesia to the end of anesthesia, an average 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoum
Study officials:
References:
Clinical trial NCT00004478: Droxidopa in Treating Patients With Neurogenic Hypotension
Official title: Study of Droxidopa in Patients With Neurologic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shy-Drager Syndrome
Orthostatic Hypotension
Keywords: Shy-Drager Syndrome
cardiovascular and respiratory diseases
neurologic and psychiatric disorders
orthostatic hypotension
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Please note that the continuation study can be found at http://clinicaltrials.gov/show/NCT00633880.

RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal. It causes one to feel dizzy, light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a drug that may increase blood pressure, may be an effective treatment for neurogenic hypotension.

PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have neurogenic hypotension.

Detailed description: PROTOCOL OUTLINE:

Patients receive escalating doses of droxidopa or placebo for 7-14 days. Patients undergo blood pressure measurements hourly in both supine and standing positions.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Orthostatic hypotension due to autonomic nervous system failure Fall in systolic blood pressure (supine to standing) of at least 20 mm Hg and diastolic blood pressure of at least 15 mm Hg AND Symptoms of hypotension such as dizziness, light-headedness, unsteadiness, dimming or blurred vision
* History of syncope or near-syncope

--Prior/Concurrent Therapy--

* Endocrine therapy: No concurrent adrenergics Concurrent fludrocortisone allowed
* Other: Concurrent indomethacin, support garments, and high salt diets allowed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Horacio Kaufmann, MD
role: STUDY_CHAIR
References:
citation: Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, Nardin R, Freeman R. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation. 2003 Aug 12;108(6):724-8. doi: 10.1161/01.CIR.0000083721.49847.D7. Epub 2003 Jul 28.
citation: Goldstein DS, Holmes C, Kaufmann H, Freeman R. Clinical pharmacokinetics of the norepinephrine precursor L-threo-DOPS in primary chronic autonomic failure. Clin Auton Res. 2004 Dec;14(6):363-8. doi: 10.1007/s10286-004-0221-z.
Clinical trial NCT02744378: Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus
Official title: Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus- A Double-blinded Randomized Clinical Trial in Sri Lanka
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Lichen Planus
Lead sponsor: University of Peradeniya
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in symptomatic Oral Lichen Planus.


Eligibility criteria: Inclusion Criteria:

* Clinically and Histologically proven Oral Lichen Planus
* Symptomatic

Exclusion Criteria:

* topical/ systemic medication for OLP in the previous three months
* contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus
* immunosuppression, or pregnant / lactating females
* lichenoid reactions either drug induced or due to dental amalgam
* diabetes mellitus and on oral hypoglycemic drugs
* systemic involvement such as concurrent skin/genital lesions

Primary outcomes:
measure: The intensity of Pain
timeFrame: Three weeks after the application of drugs
measure: The clinical response
timeFrame: Three weeks after the application of drugs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: