louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05591859: Restoration Anatomic Acetabular Shell Revision Study
Official title: Restoration Anatomic Acetabular Shell Revision Study - A Post-market, Multi-center Evaluation of the Clinical Outcomes of the Restoration Anatomic Acetabular Shell in a Revision Indication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthropathy
Hip Arthropathy
Hip Osteoarthritis
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2022-10-24
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* Subject is a candidate for a revision of a failed acetabular component with the Restoration Anatomic Acetabular Shell.
* Subject has signed an IRB-approved, study specific Informed Consent Form (ICF).
* Subject is skeletally mature.
* Subject is a male or non-pregnant female.
* Subject is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

* Subject has a non-Stryker retained stem at the time of study device implantation.
* Subject has a Body Mass Index (BMI) \> 45.
* Subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
* Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
* Subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \> 30 days).
* Subject has a known sensitivity to device materials.
* Subject is a prisoner.

Primary outcomes:
measure: Success rate
timeFrame: 10 years
Secondary outcomes:
measure: Adverse Events
timeFrame: 10 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Regents of the University of Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT06764459: Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments
Official title: Molecular Characterization of Patients With Acute Myeloid Leukemia and the Impact of Clonal Evolution in the Response to Therapeutic Treatments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloid Leukemia, Acute
Keywords: AML
FLT3
single cell sequencing
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 20
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: Flt3 mutated patients treated with specific inhibitors

Brief summary: This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment.

Detailed description: This study aims to analyze patients with mutated FLT3 AML treated with specific therapy by means of single-cell molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment. In this way, it is possible to study how the mutational profile varies under therapeutic pressure and identify any alterations responsible for resistance. It will thus be possible to define a panel of new molecular markers to be included in the diagnostic routine to identify early patients refractory/resistant to treatment with FLT3 inhibitors and thus improve the therapeutic approach of these patients.

Eligibility criteria: Inclusion Criteria:

* FLT3 mutated

Exclusion Criteria:

* Respoder to therapy

Primary outcomes:
measure: Refractoriness to therapy
timeFrame: At the end of the enrollment 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Emanuela Ottaviani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06296459: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation
Official title: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Keywords: Cone beam computed tomography
Sinus anatomy
Dental implant placement
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2 arm study using two methods of imaging in a participant
Primary purpose: TREATMENT

Brief summary: A closed sinus augmentation is performed for dental implant placement.

Detailed description: Patients who are diagnosed as needing sinus augmentation by a closed approach for dental implant placement will be recruited. A cone beam computed tomography (CBCT) study is the standard of care prior to dental implant placement. However, following closed sinus augmentation nothing is known as to the extent of augmentation in the medial to lateral (cross-sectional) dimension. Patients will have a low volume CBCT taken immediately postsurgically, and again at the six-month postoperative visit to determine the dimensional changes in the augmentation. These images will be compared to standard periapical radiographs at the same time points.

Eligibility criteria: Inclusion Criteria:

1. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement.
2. At least 5mm of native bone below the maxillary sinus.
3. Nonsmokers.
4. If diabetic, current HbA1C \<7.0 (less than or equal to 7.0)

Exclusion Criteria:

1. Maxillary sinus disease.
2. Pregnancy or attempting to become pregnant.
3. Diseases that affect bone metabolism.
4. Use of medications known to affect bone metabolism.
5. Tobacco use.
6. Alcoholism or recreational drug use.
7. Diabetic with HbA1C \>7.0 (above 7.0)

Primary outcomes:
measure: Dimensional Change in augmentation at 8mm
timeFrame: Baseline immediately postoperatively and at 6 months
measure: Dimensional Change in augmentation at 10mm
timeFrame: Baseline immediately postoperatively and at 6 months
measure: Dimensional Change in augmentation at 12mm
timeFrame: Baseline immediately postoperatively and at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Charles Powell, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02561559: SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma
Official title: Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastasis From Malignant Tumor of Soft Tissues
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by soft-tissue sarcomas with lung metastases unsuitable for surgery

Brief summary: In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.

Detailed description: The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.

The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.

Eligibility criteria: Inclusion Criteria:

* Age 18 anni -85 years
* PS according to ECOG 0-2
* Histopathologically confirmation of soft tissue sarcoma
* Metastatic lung lesion less than 4
* Controlled primary tumor and other metastatic lesions
* Metastatic lesion less than 5 such as the definition of oligometastatic patients
* Written informed consent
* Contraindication to surgical resection
* Estimated survival ≥ 3 months
* Absence of progressive disease longer than 6 months
* No chemotherapy was given for at least 3 months after SBRT
* Maximum diameter ≤ 5 cm

Exclusion Criteria:

* Prior thorax radiation therapy
* Age \> 85 years
* PS according to ECOG \>2
* Pregnant women
* Maximum diameter ≥ 5.1 cm
* Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima

Primary outcomes:
measure: Local control of treated lesions
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival of treated patients
timeFrame: 4 years
measure: Disease free survival of treated patients
timeFrame: 4 years
Other outcomes:
Locations:
city: Rozzano, MI
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Marta Scorsetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navarria P, Ascolese AM, Cozzi L, Tomatis S, D'Agostino GR, De Rose F, De Sanctis R, Marrari A, Santoro A, Fogliata A, Cariboni U, Alloisio M, Quagliuolo V, Scorsetti M. Stereotactic body radiation therapy for lung metastases from soft tissue sarcoma. Eur J Cancer. 2015 Mar;51(5):668-74. doi: 10.1016/j.ejca.2015.01.061. Epub 2015 Feb 13.
Clinical trial NCT00338559: Does LMA Instead of ET Tube Affect Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction?
Official title: Does Using Laryngeal Mask Airway (LMA) Instead of an Endotracheal Tube (ET Tube) Affect the Incidence of Postoperative Vomiting in Children Undergoing Strabismus Correction? - An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus
Keywords: Strabismus
LMA
ET Tube
POV
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2006-06-20
Enrollment: 71
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred six children between the ages of 1 and 12 years are expected to take part in this study.

Brief summary: The effect of airway management on vomiting after strabismus surgery is unknown. The purpose of this study is to find out whether the use of different airway devices, such as LMA, which is a special mask placed in the throat or Endotracheal tube (ET tube), which is a soft tube placed in the wind pipe, affects the incidence of vomiting after surgery. Two hundred six children between the ages of 2 and 12 years are expected to take part in this study.

Detailed description: The child will be checked by the study doctor to determine if he/she qualifies to be part of the study. The study doctor may not want the child to take part in this study if he/she is currently in another research study; or if the child has been in any other research study within the last 30 days, or if the child is extremely obese, or has reflux or another GI problem.

If the child qualifies for the study, he/she will receive routine general anesthesia. For airway management, the child will have either a LMA or ET tube. The child has an equal chance of receiving either one of these airways devices, much like the coin flip.

After surgery, the child will be transferred to the recovery room (PACU). If the child vomits in PACU, he/she will receive rescue medication, which can be repeated if the need arises.

A research coordinator will call the parents the following day to find out whether the child vomited after leaving the hospital, in the car or at home, for any complications and receiving any medications.

Eligibility criteria: Inclusion Criteria:

* Patients with Elective Uni- or Bilateral Strabismus repair

Exclusion Criteria:

* ASA \>2
* History of Prematurity
* History of Reflux
* History of Neurological Disease
* Difficult Airway
* Obesity

Primary outcomes:
measure: Numbers of the patients that will develop postoperative vomiting in children undergoing strabismus correction
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: University of Texas HSC at Houston
name: Samia N Khalil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01157559: Efficacy and Safety With Ziprasidone in First-episode Psychosis
Official title: Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: First Episode Psychosis
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-07-07
Enrollment: 27
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.


Eligibility criteria: Inclusion Criteria:

* Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder

Exclusion Criteria:

* Patients with previously prescribed antipsychotic medication in 2 weeks or more
* patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.

Primary outcomes:
measure: Symptoms assessment by objective rating scales
timeFrame: week 1
measure: Symptoms assessment by objective rating scales
timeFrame: week 2
measure: Symptoms assessment by objective rating scales
timeFrame: week 4
measure: Symptoms assessment by objective rating scales
timeFrame: week 6
measure: Symptoms assessment by objective rating scales
timeFrame: week 8
Secondary outcomes:
measure: Assessment of adverse events by objective rating scales and self report scales
timeFrame: one-month
measure: Assessment of adverse events by objective rating scales and self report scales
timeFrame: two-month.
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Department of Psychiatry, Chonbuk national University Hospital
city: Jeonju
country: Korea, Republic of
facility: Heo psychiatric Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonju Jesus Hospital
Study officials:
References:
Clinical trial NCT04661059: Study of Late-foetal Human Organ Development
Official title: Study of Late-foetal Human Organ Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Disorders
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As above

Brief summary: Knowledge about abnormal organ development is important to understand pathology and to develop novel treatment approaches for individuals with congenital and acquired disease. Most of our current understanding is based on examination of tissues from the embryo and early fetus, collected from women undergoing termination of pregnancy in the first trimester (third) of pregnancy. There is very little known about normal and abnormal organ development from a developmental perspective during the crucial last two-thirds of pregnancy when much remodelling of fetal tissues occurs. We aim to collect tissue from a variety of developing fetal organs in the last two-thirds of pregnancy from women who decide to undergo a termination of pregnancy and who wish to undergo a clinical fetal postmortem (PM) examination.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old pregnant women who attend the Fetal Medicine Unit for concerns about a fetal abnormality where they decide to proceed to termination of pregnancy

Exclusion Criteria:

* Screening labs positive for maternal HIV, Hepatitis B and Hepatitis C, Chlamydia and Herpes.
* Subject unable to make an informed decision about termination of pregnancy.

Primary outcomes:
measure: Cellular maturity
timeFrame: Immediately after tissue collection
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College Hospitals NHS Foundation Trust
Study officials:
References:
Clinical trial NCT01318759: (MIGA) Mini Geriatric Assessment To Replace the Comprehensive Geriatric Assessment
Official title: (MIGA) Mini Geriatric Assessment as Compared to the Current CGA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Geriatric Disorder
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-03-18
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: people aged over 65

Brief summary: This is a comprehensive Geriatric Assessment (CGA) currently used to evaluate elderly people in order to be able to assess their multiple organ pathology, cognitive, functional and social problems. This CGA is a very time consuming tool although a powerful one.

The investigators want to present a new assessment test witch is short and comprehensive tool witch will be checked in ambulatory and in-hospital geriatric patients.

Detailed description: MIGA test (Mini Geriatric Assessment) includes the following parameters Walking outdoors, Transfer, ADL-Dressing, Washing, Continence, Vision, Hearing, Pain, Sleeping, Weight loss, Get-Up-And-Go test, Short term memory, Clock drawing test, Falls, functional reach of hands, Depression, Behavioral problems, social support, Admissions, Polypharmacy,

All patients will be assessed by the traditional CGA and by the new MIGA test. Time consuming of the two tests will be measured and compared.

Eligibility criteria: Inclusion Criteria:

* Elderly people age 65 and above,
* In patients hospitalized in the geriatric department
* Out patients -from the geriatric out patient clinic
* Elderly patients visiting in the emergency room

Exclusion criteria:

* People under 65 years old
* Critically ill patients ( acute infection, acute myocardial infarction, hypoxia, hemodynamic instability)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Geriatric department , Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Yaffa Lerman, MD
role: STUDY_DIRECTOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Oksana Borodin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371159: A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Official title: A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Healthy.io Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-01
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance,including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the Velieve U.S. device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device.

The use of the Velieve U.S. device will be evaluated for identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Males and Females 18-80 years of age;
* Subjects who are healthy or:
* Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following):

  * Urinary tract infection (UTI)
  * Patients with suspected or known occult blood in urine
  * Pregnant women
  * Other relevant conditions
* Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion)
* Subject is capable and willing to provide informed consent;
* Subject has facility with both hands;
* Subject is capable and willing to adhere to the study procedures.
* Subject is familiar with the use of a smartphone
* Subject is capable of comprehending and following instructions in English

Exclusion Criteria:

* Subject has dementia.
* Subject has mental disorders.
* Subject cannot collect urine in a receptacle.
* Subject is visually impaired (cannot read the user manual).
* Any additional reason the study physician believes disqualifies the subject from participating in the study.

Primary outcomes:
measure: Evaluation of the % agreement of the Velieve U.S., tested by the lay user, as compared to a comparator device, tested by a professional user.
timeFrame: 11 months
Secondary outcomes:
measure: Evaluation of the Velieve U.S. usability success rate, by potential lay users under actual use conditions.
timeFrame: 11 months
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
Study officials:
References: