louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00488761: Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI
Official title: A Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Tigecycline to Treat Complicated Skin and Skin Structure Infections (cSSSI) in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Diseases, Infectious
Keywords: Tigecycline
cSSSI
complicated skin and skin structure infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.

Detailed description: To evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.

Eligibility criteria: Inclusion Criteria:

* Hospitalized male and female patients, 18 years of age or older.
* Anticipated need for intravenous antibiotic therapy of 5 days or longer.
* Patients known or suspected to have a complicated skin and skin structure infection.

Exclusion Criteria:

* Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
* Patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely.
* Infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing.

Primary outcomes:
measure: The primary efficacy endpoint will be the clinical response for all clinically evaluable patients (primary population) at the test-of-cure visit
Secondary outcomes:
measure: microbiological response at the patient level microbiological response at the pathogen level clinical cure rates by baseline pathogen response rates for patients with polymicrobial and monomicrobial infections
Other outcomes:
Locations:
city: Multiple Cities
country: Taiwan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Taiwan, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04317261: Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
Official title: Role of Novel Urinary Genomic and Metablomic Markers in Diagnosis of Bladder Cancer in Patients With Hematuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematuria
Bladder Cancer
Keywords: Hematuria
Bladder cancer
Biomarkers
mRNA
Cytology
metabolomics
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Our goal is to develop a noninvasive, fast and simple assay to detect BCa on the GeneXpert system and metablomic genes.

Detailed description: The Xpert BCa monitor is a novel mRNA-based urine test that measures five mRNA targets (ABL1, ANXA10, UPK1B, CRH, and IGF2) in urine sample by real time RT-PCR. Previous studies had investigated the feasibility and diagnostic performance characteristics of Xpert monitor for surveillance of NMIBC patients (12, 13). It demonstrated a high SN and NPV in relation to urine cytology.

On the other hand, metabolic dysfunction has been implicated in a wide variety of human diseases including BC (14). Growth and division of tumor cells are associated with an increase in the activity of a variety of metabolic pathways. Significant alterations in the carnitine-acylcarnitine metabolic pathways were detected in urine speci¬mens from BC patients compared to those of healthy controls (15). The expression of six genes involved in the carnitine-acylcarni¬tine metabolic pathway (CPT1A, CPT1B, CPT1C, CPT2, SLC25A20, and CRAT) was assessed by Won and colleagues. CRAT and SLC25A20 were found to be significantly down regulated in BC patients (16).

In this context, we aimed in the current study at prospective assessment of diagnostic performance characteristics of Xpert Bladder Cancer Monitor (Xpert Monitor) test and urinary metabolomics (urinary metabolites of tissue mRNA genes expression CRAT and SLC 25A20) for bladder cancer detection in patients with hematuria.

Eligibility criteria: Inclusion Criteria:

* Patients with gross or persistent microscopic hematuria with irritative bladder symptoms

Exclusion Criteria:

* patients on anticoagulants
* patients with history of radiotherapy

Primary outcomes:
measure: Diagnostic performance of Xpert Bladder Cancer Monitor (Xpert Monitor) test
timeFrame: 1 year
measure: Diagnostic performance of assay of urinary metabolomics (gene expression of CRAT and SLC)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
References:
Clinical trial NCT04388761: Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
Official title: Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Ischemia Reperfusion Injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant.


Eligibility criteria: Inclusion Criteria:

* Male or female kidney transplant candidates age 18 and above.
* Patient is receiving kidney allograft from deceased donor with KDPI\>85%.
* Ability of subject to give appropriate consent.
* Females of childbearing potential with agreement to use birth control for six months post-transplant.
* Approved by the Mayo Clinic Transplant Selection Committee.
* Signed Authorization for Donation of Anatomical Gifts on file.

Exclusion Criteria:

* Positive pregnancy test at the time of the kidney offer is called for the potential recipient.
* Kidney transplant potential recipients with active malignancy (except none melanoma skin malignancies).
* Patients with previous history of solid organ transplant (Heart, Lung, Intestine, Kidney and/or Pancreas).
* Patients with previous history of bone marrow transplant.

Primary outcomes:
measure: Serious Adverse Events (SAEs)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Tambi Jarmi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01695161: Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.
Official title: Corneal-Compensated Intraocular Pressure, Corneal Hysteresis and Corneal Resistance Factor Measurements Performed With the Ocular Response Analyzer and Their Correlation to Conventional Goldmann Applanation Tonometry.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mucopolysaccharidosis
Fabry Disease
Keywords: Mucopolysaccharidosis
Fabry disease
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 eyes of MPS patients 25 eyes of Fabry patients 25 eyes of healthy age matched controls (a difference of ± 5 years in the mean between both groups is accepted)

Brief summary: The aim of the present study is to compare intraocular pressure (IOP) values assessed with Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want to investigate biomechanical characteristics of the cornea and their influence on the IOP-measurements.


Eligibility criteria: Inclusion Criteria:

* MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.)
* Fabry patients with cornea verticillata \> grade 1
* Age ≥ 12 years
* Patient is able to comply with the study procedure
* Patient has consented to be in the trial
* Ability to fixate a target

Exclusion Criteria:

* History of corneal transplantation or refractive surgery
* Corneal pathologies other than MPS-associated corneal opacity
* Corneal, conjunctival or intraocular inflammation

Primary outcomes:
measure: agreement between ccIOP and GAT in MPS, Fabry and healthy controls
timeFrame: Sep 2013 (anticipated)
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
Study officials:
affiliation: Department of Ophthalmology, University Medical Center, Johannes Gutenberg-
name: Susanne Pitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wasielica-Poslednik J, Politino G, Schmidtmann I, Lorenz K, Bell K, Pfeiffer N, Pitz S. Influence of Corneal Opacity on Intraocular Pressure Assessment in Patients with Lysosomal Storage Diseases. PLoS One. 2017 Jan 12;12(1):e0168698. doi: 10.1371/journal.pone.0168698. eCollection 2017.
Clinical trial NCT06386861: Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM).
Official title: Developing Culturally-Tailored Interventions to Overcome Genomic Health Disparities in Communities of Color
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adult ALL
Keywords: genomics
precision medicine
attitudes and beliefs
health literacy
health numeracy
Lead sponsor: Boston College
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 500 English-speaking individuals identifying as Hispanic, Latino, or Latina 500 Spanish-speaking individuals identifying as Hispanic, Latino, or Latina
Primary purpose: OTHER

Brief summary: The investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino, or Latina. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population.

Detailed description: The investigators will recruit 1,000 individuals (500 English-speaking and 500 Spanish-speaking) to complete the AGPM and previously validated instruments assessing health literacy and numeracy. Results will establish the psychometric properties of the Spanish version of the AGPM.

Eligibility criteria: Inclusion Criteria:

* adult (18+ yrs.)
* identifying as Hispanic, Latino, or Latina
* able to provide opt-in electronic informed consent

Exclusion Criteria:

* under age 18 yrs.
* not identifying as Hispanic, Latino, or Latina
* not able to provide opt-in electronic informed consent

Primary outcomes:
measure: Psychometric properties
timeFrame: up to two weeks
Secondary outcomes:
measure: Health literacy/numeracy
timeFrame: up to two weeks
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Boston College
state: Massachusetts
Study officials:
affiliation: Boston College
name: Andrew A Dwyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DuBois JM, Mozersky J, Antes A, English T, Parsons MV, Baldwin K. Attitudes toward genomics and precision medicine. J Clin Transl Sci. 2021 Apr 8;5(1):e120. doi: 10.1017/cts.2021.774. eCollection 2021.
Clinical trial NCT02380261: A Clinical Study of Systane® Lid Wipes in Brazil
Official title: Assessment Of The Skin And Ocular Tolerance Of The Product Systane® Lid Wipes (050343-01) And Assessment Of The Study Subject Acceptance, Under Normal Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Tolerance
Skin Tolerance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: NOVARTIS BIOCIENCIAS S/A
First posted: 2015-03-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.


Eligibility criteria: Inclusion Criteria:

* Must sign informed consent.
* Agree to adhere to the procedures and requirements of the study.
* Wears makeup daily.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Ocular conditions as specified in protocol.
* Medical conditions as specified in protocol.
* Skin conditions as specified in protocol.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With a Contact-dermatitis Adverse Reaction
timeFrame: Day 21
measure: Number of Participants With Ocular Clinical Signs and Discomfort Sensations
timeFrame: Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Novartis Biociencias SA
Study officials:
affiliation: Alcon Brazil
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03784261: Usefulness of Non TNF Usage in RA Patients
Official title: Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:

1. Sarilumab treatment for 12 months
2. Tocilizmab treatment for 12 months
3. Abatacept treatment for 12 months


Eligibility criteria: Inclusion Criteria:

・RA patients

Exclusion Criteria:

* Not RA patients
* RA patients who are allergic to the drugs, refused to do this research, or who are pregnant

Primary outcomes:
measure: Change from Baseline Values of DAS28-CRP
timeFrame: Baseline and 1 year
measure: Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
timeFrame: at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT05047861: Implant Placement in the Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast
Official title: Evaluation of Implant Placement in Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast (Controlled Clinical and Radiographic Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teeth Extraction
Tooth Socket
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket dimensions for new bone formation.

This study aims to compare implants placed in two differently preserved sockets, the first one preserved using Socket Shield technique with Autogenous Dentin Graft while the other socket preserved using socket shield technique with Alloplastic bone graft material


Eligibility criteria: Inclusion Criteria:

* One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
* Intact labial/buccal periodontal tissues.
* Sufficient bone volume to allow placement of an implant.
* Non-Smoker
* Ability to read and sign an informed consent form

Exclusion Criteria:

* A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status,current radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
* Untreated periodontal disease. \[15,18\]
* Vertical root fractures on the buccal aspect. \[26\]
* Tooth /teeth with horizontal fractures below bone level. \[26\]
* Tooth /teeth with external or internal resorptions.

Primary outcomes:
measure: Change in implant stability
timeFrame: immeditely and at 3 months
measure: change in bone density
timeFrame: at baseline and 3 months
measure: change in bone height
timeFrame: at baseline and 3 months
measure: change in Labio/Bucco-Palatal width
timeFrame: at baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT07008261: Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions.
Official title: Prospective Evaluation of Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusion Requirements.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transfusions
Cystectomy
Blood Loss Requiring Transfusion
Anaemia
Anaemia Postoperative
Pain, Postoperative
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2025-06-06
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: Patients with a mostly oncological indication for radical cystectomy

Brief summary: What influence does robot-assisted surgical treatment in the sense of a radical cystectomy and possibly bladder reconstruction have on blood loss, pain and transfusion requirements? We intend to conduct a corresponding prospective observational study at a tertiary centre.


Eligibility criteria: Inclusion Criteria:

* planned radical cystectomy

Exclusion Criteria:

* ASA classification V
* Previously known coagulation disorder

Primary outcomes:
measure: perioperative blood loss
timeFrame: 6 hours
Secondary outcomes:
measure: Preoperative iron deficiency
timeFrame: up to 4 weeks prior surgery
measure: RBC transfusion
timeFrame: perioperative up to hospital discharge or death (up to 4 weeks)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02009761: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).
Official title: Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of Open Label Study With Multiple (and for Non Responders) Escalating Subcutaneous Doses of BI 655064 Once a Week in Patients With Chronic Primary Immune Thrombocytopenic Purpura.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Purpura, Thrombocytopenic, Idiopathic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.


Eligibility criteria: Inclusion criteria:

Male and female chronic immune ITP patients

Exclusion criteria:

Any treatment of ITP excluded except for a stable dose of corticosteroids (up to 20 mg)

Primary outcomes:
measure: Number of Patients With Response in Platelet Count
timeFrame: Up to 12 weeks.
Secondary outcomes:
measure: Number of Subjects With Drug-related Adverse Events
timeFrame: From first drug administration until end of the Residual Effect Period (REP), up to 6 weeks.
measure: Number of Patients Reaching the Cut-off Point for Immune Thrombocytopenic Purpura [ITP]
timeFrame: Up to 12 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: New York
country: United States
facility: New York Hospital, Cornell Medical Center
state: New York
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: