louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06589310: Falcon Real World Evidence Registry
Official title: Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 25000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort will consist of particpants who have scheduled appointments with their primary health care provider at the participating clinics.

Brief summary: This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.

Detailed description: This study was designed to simulate a real-world application of Exact Science's Multicancer Early Detection (MCED) test. Participants will be offered the Exact Science's MCED test annually for 3 years. If at any point during those 3 years a participant is diagnosed with cancer, they will become ineligible for further testing. Data will be collected for 5 years following the baseline test.

There will be two data collection approaches as part of this study. The first will be collection of self-report data related to the testing experience. The second will be periodic and largely automated extraction of pre-specified data elements from existing electronic data sources. A comparison data set will be constructed from records of individuals who did not receive the MCED test.

Eligibility criteria: Inclusion Criteria:

* Participant age at time of consent is between 50 and 80 years
* Agree to receive the Exact Sciences MCED test and follow-up imaging
* Willing and able to provide informed consent
* Access to a suitable technology and willing to complete surveys electronically

Exclusion Criteria:

* Any invasive tumor (excluding non-melanoma skin cancers) or hematological malignancy in the previous three years or current suspicion of cancer and/or in active treatment (e.g., chemotherapy, radiation therapy, immunotherapy, and/or surgery

Primary outcomes:
measure: Vital status
timeFrame: Up to 5 years
measure: Cancer status
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Endeavor Health
state: Illinois
city: Dallas
country: United States
facility: Baylor Scott & White Health
state: Texas
Study officials:
affiliation: Exact Sciences
name: Tomasz M Beer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316510: Probiotics in Infants With Gastroschisis
Official title: Probiotics in Infants With Gastroschisis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroschisis
Keywords: Probiotic
bifidobacteria
intestinal motility
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 24
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Infants born with gastroschisis usually require surgery shortly after birth. After surgery the intestine is often unable to digest human milk or formula for weeks or months. During this time the baby has to remain in the hospital to receive special nutrition through an IV. How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that appear to have beneficial effects on digestion. This study will test whether giving probiotic bacteria to babies after surgery for gastroschisis will change the bacteria in the intestine to be more like those of a healthy breast-fed baby.

Detailed description: Infants with gastroschisis have decreased intestinal motility. This decrease in intestinal motility delays the introduction and advancement of feeds which prolongs hospitalization. The use of probiotic bacteria may improve intestinal motility. It is unknown whether the intestinal microbiota of infants with gastroschisis differs from that of healthy infants without gastroschisis and whether probiotics will change the microbiota. The primary outcome in this study is the composition of the fecal microbiota in infants with gastroschisis following surgical correction treated with Bifidobacterium infantis or placebo. We will also look at differences in hospital length of stay.

Eligibility criteria: Inclusion Criteria:

* Gastroschisis
* Born at or transferred to UC Davis Children's hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Composition of the Fecal Microbiota
timeFrame: Final stool sample at 6 weeks
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Initial discharge from the hospital
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Children's Hospital
state: California
Study officials:
affiliation: UC Davis
name: Mark A Underwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Powell WT, Borghese RA, Kalanetra KM, Mirmiran M, Mills DA, Underwood MA. Probiotic Administration in Infants With Gastroschisis: A Pilot Randomized Placebo-Controlled Trial. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):852-857. doi: 10.1097/MPG.0000000000001031.
Clinical trial NCT01079910: To Investigate the Clinical Efficacy of an Experimental Toothpaste
Official title: Clinical Efficacy of an Experimental Toothpaste
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Gingivitis
Keywords: Plaque
Toothpaste
Gingivitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged 18 years and older
* A minimum of 20 permanent gradable teeth
* For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.

Primary outcomes:
measure: Change from baseline Modified Gingival Index at 24 weeks
timeFrame: baseline to 24 weeks
measure: Change from baseline Bleeding Index at 24 weeks
timeFrame: baseline to 24 weeks
Secondary outcomes:
measure: Change from baseline Modified Gingival Index at weeks 6 & 12
timeFrame: baseline to week 12
measure: Change from baseline Bleeding Index at weeks 6 & 12
timeFrame: baseline to week 12
measure: Change from baseline Plaque Index at weeks 6, 12 & 24
timeFrame: baseline to week 24
measure: Change from baseline plaque bacteria at weeks 12 & 24
timeFrame: baseline to week 24
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02090010: Subclavian Vein catheterization_Seldinger Vs Modified Seldinger
Official title: Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Neoplasm
Intracranial Aneurysm
Cerebrovascular Moyamoya Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 418
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath.

Both technique is widely used in central venous catheterization, however, few researches have been investigated to compare success rate or complications of both methods.

Detailed description: The major complications of central venous catheterization through subclavian vein, are unintended arterial puncture, pneumothorax, hemothorax, malposition of catheter etc,. We assume that using modified Seldinger technique (MST), guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively.

We aimed to compare the Seldinger technique and modified Seldinger technique(MST) on success rate and complications during subclavian central venous catheterization in this prospective, randomized , controlled trials.

Eligibility criteria: Inclusion Criteria:

* patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization

Exclusion Criteria:

* Patient who does not agree to the study
* Inflammation or infection on catheterization site
* Contralateral diaphragmatic dysfunction
* Anatomic anomalies of subclavian artery or vein/clavicle
* Previous lung surgical history
* Patient who has ventriculoperitoneal shunt or chemoport on same side
* Patient who has pneumo/hemothorax or lung parenchymal disease

Primary outcomes:
measure: Major complication rate of subclavian catheterization
timeFrame: intraoperative
Secondary outcomes:
measure: primary success rate of subclavian catheterization
timeFrame: intraoperative
measure: Total insertion time
timeFrame: From skin puctuation until confim the successful catheterization anticipated within 3min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University of Hospital
Study officials:
affiliation: Professor
name: Hee Pyung Park, MD PhD
role: STUDY_DIRECTOR
affiliation: Clinical Instuctor
name: Eugene Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04017910: Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
Official title: Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arteriovenous Fistula
Arteriovenous Graft
Lead sponsor: Sonavex, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-07-12
Enrollment: 17
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: Adult patients undergoing arteriovenous fistula creation for hemodialysis access

Brief summary: This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.

Detailed description: This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
* Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
* Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

* Age \<18 years old
* Patient unable to sign informed consent
* Patient participating in another investigational device or pharmacological study
* Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

Primary outcomes:
measure: Performance: Data Collection
timeFrame: 24 weeks
measure: Performance Endpoint
timeFrame: 24 Weeks
measure: Safety Endpoint
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Roanoke
country: United States
facility: Roanoke Vascular Access Center
state: Virginia
Study officials:
References:
Clinical trial NCT05089110: Expression of Toll-like Receptors 3 , 7 and 9 in Peripheral Blood Mononuclear Cells of COVID-19 Patients
Official title: Expression of Toll-like Receptors 3 , 7 and 9 in Peripheral Blood Mononuclear Cells of COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Respiratory Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital

Brief summary: The aim of the study is to assess the expression of TLR 3, 7, and 9 in the population of peripheral blood mononuclear cells (PBMC) and in B lymphocytes (CD19+), T lymphocytes (CD4+ and CD8+) using flow cytometry in relation to the clinical parameters and outcome of COVID 19 patients .

Detailed description: Abnormal stimulation of innate immunity may have a great influence on the immunopathogenesis of COVID 19 disease .The involvement of innate immunity receptors-toll-like receptors (TLR)-in the pathogenesis of COVID 19 is not adequately studied. The activation of these receptors by specific ligands is thought to initiate autoimmune processes\[1\]. TLR stimulation leads to increased expression of proinflammatory cytokines (IL-6, IFN

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old of both genders.
* Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital.

Exclusion Criteria:

* Children less than 18 years.
* Patients refusal to participate in the study

Primary outcomes:
measure: Cytokines storm occurrence in COVID-19 patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Gamal Agamy, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Mohammad Adam, professor
role: STUDY_CHAIR
References:
citation: Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.
citation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
Clinical trial NCT02572310: Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
Official title: A Prospective Radiostereometric Analysis (RSA) Study of Implant Stability and Clinical Evaluation of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the investigators propose to monitor subjects who have received Triathlon total knee components inserted with HV cement. The primary outcome will be fixation of the tibial implant component as assessed with RSA and to determine the functionality of patients after surgery using self-reported questionnaires. This is a historical control study, comparing the study cohort to a previous group with Triathlon implants and the long-standing Simplex T cement. The secondary outcomes are inducible displacements of the implants as well as a qualitative evaluation of the cement handling characteristics performed by the operating room staff.


Eligibility criteria: Inclusion Criteria:

* Symptomatic arthritis of the knee indicating primary total knee arthroplasty
* Between the ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery
* Severe osteoporosis or osteopenia
* Neuromuscular impairment
* Significant co-morbidity affecting ability to ambulate

Primary outcomes:
measure: Implant Migration measured with Radiostereometric Analysis (RSA)
timeFrame: 2 years
Secondary outcomes:
measure: Qualitative handling characteristics captured through semi-structured interviews
timeFrame: intra-operative
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Michael Dunbar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02318810: Influence of the Neuromuscular Blockade on Mask Ventilation
Official title: The Influence of the Neuromuscular Blockade on Mask Ventilation; a Placebo Controlled, Randomized Trial With Three Different Dosages of Rocuronium (0.3 mg/kg, 0.6 mg/kg and 0.9 mg/kg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Ventilation Therapy
Observation of Neuromuscular Block
Keywords: Muscle relaxants
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation. We will study different dosages of rocuronium; we assume that higher dosages of rocuronium will improve mask ventilation compared with lower dosages.

Detailed description: Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation.We will administer rocuronium 0.3 mg/kg, 0.6 mg/kg, 0.9 mg/kg and saline (placebo group) before starting with mask ventilation. We will grade mask ventilation based on various scores before and after rocuronium application. Afterwards patient's tracheas will be intubated. We assess risk factors for difficult mask ventilation.

We hypothesize that rocuronium 0.9 mg/kg will be superior to rocuronium 0.3 mg/kg and saline.

Eligibility criteria: Inclusion Criteria:

* patients with ASA I-III
* required tracheal intubation
* informed consent

Exclusion Criteria:

* known allergy against anesthetics
* known difficult airway

Primary outcomes:
measure: Incidence of improved mask ventilation after rocuronium administration
timeFrame: Two minutes after rocuronium administration
Secondary outcomes:
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Department of Anesthesia and Intensive Care Medicine, University of Rostock
state: Mecklenburg/Vorpommern
Study officials:
affiliation: University of Rostock
name: Thomas Mencke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177110: A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma
Official title: A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Melanoma
Metastatic Melanoma
Keywords: advanced melanoma
metastatic melanoma
fresh frozen tissue
FFPE tissue
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2014-06-27
Enrollment: 16
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 must have a diagnosis of advanced or metastatic melanoma of the skin

Brief summary: This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average.

Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.

The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.


Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 18 years of age.
2. Patient must be able to give own signed informed consent.
3. Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin.
4. Patients that are planned to receive either:

   * Adjuvant treatment
   * 1st line treatment for metastatic disease
   * 2nd line treatment for metastatic disease
5. Patients with prior adjuvant treatment are allowed.
6. Patients receiving planned standard treatment of one or more of the following:

   * Chemotherapy regimens containing DTIC, TMZ and/or cisplatin
   * Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies)
   * BRAF and/or MEK inhibitors
7. Patients were FFPE and fresh frozen tissue is available (both mandatory).

Exclusion Criteria:

-

Primary outcomes:
measure: Validation of SYS-ACT
timeFrame: 2 years
measure: Progression free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hosptial
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital and Mater Private Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
References: