louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06666023: Paper-based Electrochemical Point-of-care Device in Diagnostic of Orthopedic Infections
Official title: The Diagnostic Pillar for Diagnosis of Infections in the Orthopedic Field: Smart and Sustainable Paper-based Electrochemical Point-of-care Device Assisted by Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PJI
Spondylodiscitis
Keywords: infections;
orthopedic surgery;
sensor;
PJI,
spondylodiscitis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Ministero della Salute, Italy
First posted: 2024-10-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a suspected history of PJI or spondylodiscitis according to international guidelines and subsequent diagnostic confirmation of infection.

Brief summary: Periprosthetic Joint infections (PJI) and spondylodiscitis are considered some of the most costly infectious diseases because require at least one surgery, prolonged hospitalisation, rehabilitation care, prolonged antibiotherapy, and extended absence from work in working-age patients. Ortho-PoC will face this issue with a smart and highly innovative diagnostic tool, starting from the point-of-care device for infection diagnosis in the orthopedic field developed and published by the coordinator Fondazione Policlinico Universitario Agostino Gemelli IRCCS and one partner Università degli Studi di Roma Tor Vergata. Ortho-PoC will further go beyond the state of the art by delivering a point-of-care device based on multiparametric analysis, in easily collected synovial fluids or pus. Several samples will be analysed using Ortho-PoC at three different Hospitals (Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Ospedali Riuniti di Foggia, Azienza Ospedaliera Universitaria Policlinico Vanvitelli Napoli) and the data will be treated with artificial intelligence (AI) to deliver an AI-assisted robust, effective, and smart diagnostic device for PJI.


Eligibility criteria: Inclusion Criteria:

* patients that received a joint implant or spine surgery, clear signs of infection (according to international guidelines)
* patients off antibiotic therapy at least for two weeks
* Sample biopsy of minimum 1 ml.

Exclusion Criteria:

* pregnant women,
* patient affected by cancer
* patient under antibiotic therapy

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: at enrollement
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giulio Maccauro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402323: Gingival Clefts and Orthodontic Movement
Official title: A Prospective Split-mouth Designed Study on the Incidence of Gingival Clefts During Orthodontic Space Closure Into Recent or Healed Extraction Sockets.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Clefts
Extraction Socket
Orthodontic Movement
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Clefts or invaginations of the gingival tissue are a frequent finding during orthodontic space closure after extraction of a tooth. They occur in about 35% of the cases. Increased risk of developing a gingival cleft is given in the mandibular arch. A gingival invagination impairs aesthetics, orthodontic treatment and periodontal health. The aim of this prospective split-mouth designed observer blinded study is to evaluate possible differences between tooth movement in recent or in healed extraction sockets on incidence of gingival clefts. We hypothesize, that similar to the results originated from an animal study immediate movement in extraction sockets reduces incidence of gingival clefts during orthodontic space closure.


Eligibility criteria: Inclusion Criteria:

* extraction of both molars or premolars in the upper or lower jaw and orthodontic space closure

Exclusion Criteria:

* periodontal status not allowing orthodontic treatment

Primary outcomes:
measure: incidence of gingival clefts
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Bernhard Gottlieb School of Dentistry, Medical University of Vienna
Study officials:
References:
Clinical trial NCT05431023: Effect of Lactoferrin in Pneumonia Treatment
Official title: Efficacy of Lactoferrin as Adjunct Therapy for Pneumonia in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pneumonia is defind as the inflammation of lung tissue caused by an infectious agent that results in acute respiratory signs and symptoms. Community acquired pneumonia (CAP) is a major cause of morbidity and increased health care costs. In developing nations, pneumonia remains a significant cause of mortality in children.

Pneumonia occurs in 30 to 45 of every 1,000 children under 5 years of age; it is less common in 5- to 9-year olds (16 to 22/1,000) and in older children (7 to 16/1,000).

Streptococcus pneumoniae is the primary bacterial cause of pneumonia in infants and children. Viral etiologies become less prevalent and mycoplasmal and chlamydial infections become more prevalent with increasing age

Detailed description: Lactoferrin (LF) is iron-binding glycoprotein of the transferrin family that is expressed and secreted by glandular cells and is found in most body fluids . It appears at especially high concentrations in mammalian milk and was first identified in bovine milk , and was subsequently isolated from human milk.

LFs bacteriostatic function is due to its ability to take up the Fe3+ ion, limiting use of this nutrient by bacteria at the infection site and inhibiting the growth of these microorganisms as well as the expression of their virulence factors .

Eligibility criteria: Inclusion Criteria:

* Pneumonia patients
* from the age of one month to the age of 18 years .

Exclusion Criteria:

Neonates and any children with :

* immune deficiency
* congenital heart disease
* neuromascular disorder
* genetic syndromes

Primary outcomes:
measure: Survival rate.
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Mean change in the disease severity (clinical assessment)
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04276623: Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment
Official title: Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: Dupilumab
Dupixent
Conjunctivitis
Bioday
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2020-02-19
Enrollment: 150
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: Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment .

Brief summary: Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.


Eligibility criteria: Inclusion Criteria:

* Adult patients with atopic dermatitis indicated for dupilumab, without current use of oral immunosuppressive treatment .

Exclusion Criteria:

* Treatment with oral or ocular immunosuppressive drugs 2 weeks prior to start of dupilumab treatment

Primary outcomes:
measure: Relationship between goblet cell density and the incidence of conjunctivitis over time
timeFrame: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
measure: Relationship between goblet cell density and the risk of conjunctivitis
timeFrame: change of goblet cell density between baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
Secondary outcomes:
measure: Conjunctival changes during dupilumab treatment using Impression Cytology
timeFrame: baseline, 4 weeks and 28 weeks after start dupilumab, at the moment of the development of eye symptoms, 4 weeks after ocular treatment
measure: Optimal treatment of conjunctivitis
timeFrame: at the moment of the development of eye symptoms, 4 weeks after ocular treatment
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
Clinical trial NCT00017823: Acupressure to Treat Nausea and Vomiting in HIV/AIDS Patients
Official title: The Acupressure Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: complementary therapies
Acupressure
HIV Infections
Nausea
Vomiting
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2001-06-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether acupressure (acupuncture using pressure applied by the hands instead of needles) can help nausea and vomiting in persons with HIV/AIDS.

Detailed description: This is a Phase I trial (a study to evaluate effectiveness in a small number of patients). Patients will get 4 acupressure treatments and will wear acupressure wristbands for 1 week. Patients will write down all drugs they take and will make a note of when they get nausea and vomiting. They also will give written answers to different questions. No drugs will be given as part of this study. Patients will be paid for participating.

Eligibility criteria: Inclusion Criteria:

* Are HIV-positive.
* Have nausea and/or vomiting an average of 2 times per day for at least 1 week.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Univ School of Nursing / Center for AIDS Research
state: New York
Study officials:
References:
Clinical trial NCT01572623: Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting
Official title: Efficacy of Two Different Pre-Intervention Therapeutic Strategies With Clopidogrel and Atorvastatin for the Prevention of Cerebral Damage During Carotid Artery Stenting. Armyda-Caro Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carotid Stenosis
Keywords: Therapeutic strategies for carotid artery stenting
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty.


Eligibility criteria: Inclusion Criteria:

* symptomatic and asymptomatic patients with finding of significant carotid stenosis

Exclusion Criteria:

* patients with acute injuries to the baseline MRI of the brain,
* patients with active bleeding,
* contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).

Primary outcomes:
measure: Cerebral damage
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Campus Bio Medico University of Rome
state: RM
Study officials:
affiliation: Campus Bio-Medico University
name: Patti Giuseppe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patti G, Tomai F, Melfi R, Ricottini E, Macri M, Sedati P, Giardina A, Aurigemma C, Leporace M, D'Ambrosio A, Di Sciascio G. Strategies of clopidogrel load and atorvastatin reload to prevent ischemic cerebral events in patients undergoing protected carotid stenting. Results of the randomized ARMYDA-9 CAROTID (Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting) study. J Am Coll Cardiol. 2013 Apr 2;61(13):1379-87. doi: 10.1016/j.jacc.2013.01.015. Epub 2013 Mar 9.
Clinical trial NCT02495623: A Study of the Effect of SYN-010 on Subjects With IBS-C
Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the Effect of Two Dosage Strengths of SYN-010 Compared With Placebo on Breath Methane Production in Breath Methane-Positive Subjects With IBS-C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Lead sponsor: Theriva Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)

Detailed description: This is a Phase 2, randomized, multi-center, multi-dose study. Sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. The entire duration of the study may be up to 43 days (from Screening to the post end-of-study \[EOS\] visit telephone call).

Eligibility criteria: Inclusion Criteria:

* Subjects must have IBS-C and have a positive breath CH4 test result (\> 10 ppm) at Screening.
* Subject must meet the modified Rome III criteria for IBS-C.
* Subject must have an average abdominal pain intensity score of ≥ 3 (scale 0-10) reported at Screening and Baseline.
* Subject must have an average of fewer than 3 complete spontaneous bowel movement (CSBMs) per week.
* Subject must agree to refrain from making any lifestyle changes that may affect IBS-C symptoms from the time of Screening to the end of the study.

Exclusion Criteria:

* Subject has taken IBS treatments (prescription or over-the-counter), proton pump inhibitors, laxatives, antibiotics.
* Subject currently has any structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility, or any unexplained and clinically significant symptoms such as lower GI bleeding, rectal bleeding, heme-positive stool, iron-deficiency anemia, weight loss, or systemic signs of infection.
* Subject has been diagnosed with or has a family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer.
* Subject reports loose (mushy) or watery stools (Bristol Stool Form Scale \[BSFS\] score of 6 or 7).

Primary outcomes:
measure: Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Synthetic Biologics
name: Michael Kaleko, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05030623: The Phosphodiesterase Inhibitor Tadalafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Official title: The Phosphodiesterase Inhibitor Tadalafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients: Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antidepressant-like effects of tadalafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with tadalafil was shown to be PKG-dependent and lead to increased expression of cGMP, pCREB, BDNF and VGF in the hippocampus and prefrontal cortex (PFC), brain areas relevant to mood disorders pathophysiology. Low-dose tadalafil improved both depressive symptoms in patients with erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).

Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

Patients with bipolar I or bipolar II disorder Patients with personality disorders Patients with eating disorders Patients with substance dependence or abuse Patients with concurrent active medical condition Patients with history of seizures Patients with history of receiving Electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Cardiovascular disorders Severe renal impairment: creatinine clearance of ≤ 25 ml/min Moderate or severe hepatic impairment

Primary outcomes:
measure: Effect on Hamilton Depression rating scale score (HAM-D score)
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect on biological markers
timeFrame: At baseline and after 12 weeks of intervention
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Pharmacy
state: Menoufia
Study officials:
References:
Clinical trial NCT06298123: Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling
Official title: Risk Factor Analysis and Prognostic Modelling of Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Adjuvant Immunotherapy
Checkpoint Inhibitor
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatocellular carcinoma (HCC) who underwent radical hepatectomy with adjuvant immunotherapy at the Liver Surgery Centre of Tongji Hospital between February 2019 and February 2023.

Brief summary: The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors.

Detailed description: By retrospectively collecting patient data from a single centre of liver surgery at Tongji Hospital between February 2019 and February 2023, the study aimed to comprehensively evaluate patients' demographic characteristics, oncological parameters, surgical details and response to immunotherapy to identify the key factors affecting postoperative recurrence and survival.

Eligibility criteria: Inclusion Criteria:

* HCC confirmed by pathologists
* Undergone a curative resection (R0)
* Aged 18-75 years
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma or recurrent HCC
* Any preoperative treatment for HCC including local and systemic therapy
* Unable to receive adjuvant therapy due to surgery-related complications, acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* incomplete clinical data

Primary outcomes:
measure: Recurrence-Free Survival (RFS)
timeFrame: 2019-2023
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2019-2023
Other outcomes:
measure: Imaging data (enhanced CT and MRI） and histopathology data, if available.
timeFrame: 2019-2023
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT01642823: Cancer Biology of Retinoblastoma
Official title: Cancer Biology of Retinoblastoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Retinoblastoma
Keywords: retinoblastoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 8
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retinoblastoma patients undergoing surgical removal of part or all of their tumor, with or without the remainder of the eye

Brief summary: Many children with the childhood cancer, Retinoblastoma, have surgery to remove the tumor and sometimes the entire eye. The purpose of this study is to collect the extra tissue from patients who undergo tumor removal for laboratory experiments that will help us understand not only what occurs in retinoblastoma cells but also how cells normally function. Some of these studies will include an evaluation of how cells control the way that genes are expressed, how cells "know" to become retinal cells, how cells remain retinal cells, how cells lose their identity as retinal cells, what changes make retinoblastoma cells different from normal retinal cells, and what changes make some retinoblastomas worse than others.


Eligibility criteria: Inclusion Criteria:

* Patient must have retinoblastoma
* Patient must be receiving biopsy, partial surgical excision of the tumor, complete excision of the tumor, or enucleation of the eye as part of their standard care.
* Parental consent

Exclusion Criteria:

* Diagnosis other than Retinoblastoma
* No surgical sampling of tumor is planned as part of standard care
* Parental preference to not participate.

Primary outcomes:
measure: Change in efficiency of reprogramming in cells with "naturally occurring" retinoblastoma mutations
timeFrame: After appropriate time, e.g., 7, 10, 14 days after reprogramming
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Institute
state: California
city: Guatemala
country: Guatemala
facility: Unidad Nacional de Oncologia Pediatrica
Study officials:
affiliation: Stanford University
name: Julien Sage
role: PRINCIPAL_INVESTIGATOR
References: