louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04960111: Radiostereometry in Knee Arthroplasty
Official title: Radiostereometry (Model Based RSA) in the Assessment of Knee Prosthesis Outcome:a Prospective,Pilot,Single-center Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Knee Arthropathy
Aseptic Loosening
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The innovative aspect of this research is the possibility of combining the data collected with radiostereometric model based Radiostereometry with the data collected through the Galeazzi Institute Registry.This opens the prospect of an earlier identification of patients undergoing prosthetic knee replacement with initial aseptic loosening.


Eligibility criteria: Inclusion Criteria:

* age more than 18
* patients underwent total knee arthroplasty without controindications for this procedure
* patients enrolled in PatientsReportedOutcomesMeasureS (PROMS) study

Exclusion Criteria:

* age less than 18
* comorbility that make difficult come back for follow-up
* patients with allergy at materials used in Radiostereometry tecnique
* infection
* anemia, obesity, osteoporosis
* pregnancy

Primary outcomes:
measure: micro-movement detection with radiostereometry and the patient's perception, measured with Short Form health survey12 at 12 month after surgery.
timeFrame: 12 months
Secondary outcomes:
measure: correlation of micromovements and Patient reported outcomes at follow up
timeFrame: baseline to 24 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT06898411: Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth Restorations
Official title: Retrospective Clinical Study to Investigate the Longevity of Long-term Single Tooth Restorations From IPS e.Max CAD and Press
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Single Tooth Restoration
Longevity
Keywords: crown
inlay
onlay
glass ceramic
veneer
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults recieving indirect single tooth restorations (inlay, onlay, veneer or crown) within the internal clinic of Ivoclar Vivadent AG between 2006 and 2010.

Brief summary: This retrospective study investigates the longevity of lithium disilicate based glass-ceramic single tooth restorations placed with IPS e.max CAD and IPS e.max Press after a wearing period of more than 15 years. The primary objective is to assess the survival rate of single tooth restorations with IPS e.max CAD and IPS e.max Press after a wearing period of at least 15 years. The secondary objectives are to assess the quality of the single tooth restorations in regard of aesthetic, functional and biological properties.


Eligibility criteria: Inclusion Criteria:

* Age: \> 18 years
* Informed consent signed and understood by the subject
* Received indirect single tooth restoration (inlay, onlay, veneer or crown) within the internal clinic of Ivoclar Vivadent AG between 2006 and 2010
* Single tooth restoration was done with IPS e.max CAD or IPS e.max Press
* Able to visit the internal clinic of Ivoclar Vivadent AG in Schaan, FL.

Exclusion Criteria:

* Health status (physical and mental) does not allow participation

Primary outcomes:
measure: Survival Rate of single tooth restorations
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent AG
Study officials:
References:
Clinical trial NCT00505011: Genetic Polymorphisms Associated With Cigarette Smoking and Risk of Graves' Disease
Official title: Study of the Influence of the GST, CYP and TP53 Gene Polymorphisms in the Risk of Graves' Disease and Its Outcome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves' Disease
Keywords: susceptibility
genes
environment
ophthalmopathy
outcome
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2007-07-20
Enrollment: 1998
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Cigarette smoking is a well-recognized risk factor of Graves' disease and, particularly, Graves' ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes belonging to the major DNA repair/apoptosis pathways might have an important role in disease susceptibility. In addition, as some of these genes are regulated by thyroid hormones, they could affect the outcome of these patients. Our objective was to assess the influence of the GST, CYP and TP53 gene polymorphisms in the risk of Graves' disease and its outcome.

Detailed description: Although the role of many polymorphisms of genes related to toxins' metabolism has been extensively investigated regarding the susceptibility to thyroid cancer, their influence in thyroid autoimmune diseases risk is still largely unknown. Hence, this study was designed to assess the influence of GSTT1, GSTM1, GSTP1, CYP1A1 and 72TP53 polymorphic inheritance on the susceptibility to Graves' disease and to its response to the treatment.

Eligibility criteria: Inclusion Criteria:

* Graves' disease patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: State University of Campinas- UNICAMP
name: Laura S Ward, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05367011: Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU
Official title: Etude de Cohorte de Suivi thérapeutique de l'antibiothérapie Chez Les Patients de réanimation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intensive Care Unit
Antibiotic Therapy
Pharmacokinetic
Keywords: Antibiotic
Intensive care
Therapeutic drug monitoring
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 2500
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: Intensive care patients with to serious infections

Brief summary: Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Pharmacokinetic therapeutic monitoring and dosage adjustments are recommended for large families of antibiotics such as glycopeptides and aminoglycosides for a long time, but to this day still insufficiently practiced. Concerning Beta-Lactamines this practice is recommended by french society of pharmacology and therapeutic (SFPT) and french society of anesthesiology and intensive care (SFAR) since 2018.

The main goal of the POP-TDM-ICU study is to find the predictive factors of clinical therapeutic efficacy of antibiotic therapy in sepsis or septic shock in intensive care, among which the use of the dosage pharmacokinetics of antibiotic therapy (TDM = Therapeutic Drug Monitoring).

This study is a non-interventional study. Patients bacterial samples already collected in standard care and additional plasma samples will be collected as part of a biological collection with the consent of the patient or family member.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 year-old.
* Patient hospitalized in intensive care,
* Patient receiving an antibiotic for sepsis or septic shock
* Patient or family member who does not object to participating in the study

Exclusion Criteria:

Patient at risk of death, for a cause other than infectious, within 48 hours following the introduction of antibiotic therapy.

* Patient receiving antibiotic treatment for antibiotic prophylaxis.
* Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
* Pregnant and / or lactating women.

Primary outcomes:
measure: Clinical therapeutic efficacy at the end treatment or at day 14 in the event of prolonged treatment, defined by the combination of the following 3 points.
timeFrame: up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00347711: Bevacizumab and Retinal Vascular Occlusions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Edema Macular
Vascular Occlusion
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the effects of Intravitreal Bevacizumab in macular edema in retinal vascular occlusion.


Eligibility criteria: Inclusion Criteria:

* Vascular occlusion and edema macular diagnosticated by fluorescein angiography and coherent optic tomography

Exclusion Criteria:

* Previous surgery
* Uveitis
* Glaucoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
state: D.F. Mexico
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Griselda Alvarez, Fellow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05025111: Entia Liberty: Capillary Validation
Official title: Entia Liberty: Clinical Performance Validation - Capillary Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
Collaborators: name: The Christie NHS Foundation Trust
First posted: 2021-08-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the outpatients clinic at the Christie, while they are waiting for their blood tests.

Brief summary: This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old at the time of study entry
* Currently receiving standard of care systemic anti- cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle.
* Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
* Can provide written informed consent
* Blood samples collected and stored in K2-EDTA vacutainers only

Exclusion Criteria:

* Known inherited or acquired bleeding disorder
* History of haematological malignancy
* Known poorly controlled anti-coagulation
* Inadequate use and understanding of the English language, requiring a translator

Primary outcomes:
measure: To obtain/validate the value of the total error of the Entia Liberty device.
timeFrame: 3 months
measure: To obtain/validate the value of the linearity of the Entia Liberty device.
timeFrame: 3 months
measure: To obtain/validate the value of the bias of the Entia Liberty device.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
Study officials:
References:
Clinical trial NCT05885711: Self-management Pessary Project
Official title: Dutch Title: Zelfmanagement Pessarium Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
pessary
self-management
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 288
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New patients that get fitted a pessary in second line (hospital)

Brief summary: The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse.

The primary question it aims to answer is:

• how many patients succeed learning self-management if offered a standardized training?

Secondary outcomes are:

* how many patients are willing to learn self-management?
* what patient factors contribute to successfully learning self-management and willingness to self-manage?
* how satisfied are patients with pessary therapy and self-management?
* the occurrence of side-effects
* continuation and quitting of pessary therapy and self-management
* cross-over to surgery
* number of visits to doctor because of pessary therapy
* healthcare costs

Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary).

Researchers will compare the self-managing patient to the non-self-managing patients.


Eligibility criteria: Inclusion Criteria:

* fitted a ring, sieve of knob pessary
* above 18 years old
* able to understand patient information

Exclusion Criteria:

* fitted a new pessary to replace an old one (continuing former pessary therapy)
* fitted a new pessary after they experienced adverse effects of a former pessary

Primary outcomes:
measure: Number of patients that succeed in learning self-management of the pessary
timeFrame: immediately after self-management training, it is determined whether patients can remove and insert their pessary
Secondary outcomes:
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
Study officials:
affiliation: Zuyderland Medisch Centrum
name: M Weemhoff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02243111: Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound
Official title: Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Systemic Sclerosis
Pulmonary Hypertension
Keywords: Systemic sclerosis, pulmonary hypertension
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS signals that are related to pulmonary hypertension.

The TPD performance in detecting PAH in SSc patients will be assessed in the study.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to give signed informed consent prior to enrollment
2. Male or female, ≥ 18 years of age
3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
5. No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria:

1. People unable or unwilling to give informed consent.
2. PCWP or LVEDP \> 15 mmHg
3. Any PH etiology outside Group 1 (Dana Point, 2008)
4. Pregnant women
5. Patients having severe chest wall deformity

Primary outcomes:
measure: Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Reumatology department, Rabin medical center
Study officials:
affiliation: Reumatology department, Rabin medical center
name: Yair Molad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00590811: Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults
Official title: Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysmenorrhea
Pelvic Pain
Keywords: adolescents
young adults
dysmenorrhea
pelvic pain
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3rd year high school girls and 1st year university young females having a routine visit to the school doctor or student doctor.

Brief summary: The aim of this study is to determine the prevalence of menstrual cycle related pain complains in adolescents and young adults.

Detailed description: An internet questionnaire with 12 items was used:

Adolescents

* start of menstruation
* characteristics of menstrual cycle
* pain related to menstrual cycle (questions based on well-known pain-complaints related to the presence of endometriosis)
* analgetics
* influence on school carrier
* influence on social life

Young adults

* idem as for adolescents
* influence of pain on an eventual sexual relationship

Eligibility criteria: Inclusion Criteria:

* 3rd year high school girls
* 1st year university young females

Exclusion Criteria:

* pre-menarcheal girls

Primary outcomes:
measure: Prevalence of menstrual cycle related pain complains
timeFrame: 3rd year high school & first year university
Secondary outcomes:
measure: Relationship between level of pain complains and characteristics of menstrual cycle
timeFrame: 3rd year high school & first year university
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: MPTC
city: Leuven
country: Belgium
facility: VCLB
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Christel LC Meuleman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06401811: Reliability, Validity, and Responsiveness of the Turkish Version of Eating Assessment Tool-10 for Patients With Primer Sjögren's Syndrome
Official title: Reliability, Validity, and Responsiveness of the Turkish Version of Eating Assessment Tool-10 for Patients With Primer Sjögren's Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sjogren's Syndrome
Keywords: Primer Sjogren's Syndrome
swallowing disorder
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primer Sjogren's Syndrome diagnosed by a rheumatologist.

Brief summary: Evaluations will be made by researchers following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management.

In addition, for the reliability of the Turkish Eating Assessment Tool-10, the Turkish Eating Assessment Tool-10 will be repeated on patients at least one-fifth of the number of individuals included, after one week.

For the sensitivity of the scale, an exercise that is routinely applied in the Rheumatological Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation will be invited and after 3 months, the same evaluations as applied in the first measurement will be made again on individuals at least one-fifth of the number of individuals included.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Primary Sjögren's Syndrome
* 18 years or older

Exclusion Criteria:

* Patients with Secondary Sjögren's Syndrome,
* Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
* Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Primary outcomes:
measure: Turkish Eating Assessment Tool
timeFrame: Baseline-first week-third month
Secondary outcomes:
measure: Yale Swallow Protocol
timeFrame: Baseline-third month
Other outcomes:
measure: Test of Mastication and Swallowing Solids
timeFrame: Baseline-third month
measure: Dysphagia limit
timeFrame: Baseline-third month
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: