louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00748397: Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery
Official title: An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Jaw, Edentulous
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.

Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.


Eligibility criteria: Inclusion Criteria:

* 18-75 years of age
* Sufficient amount of bone to give good support for implants of at least 9 mm length.
* Willing to give signed informed consent

Exclusion Criteria:

* Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Unable or unwilling to return for follow-up visits

Primary outcomes:
measure: Implant survival
timeFrame: Continuously during 5,5 years after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University Medical Center, School of Dentistry
state: Louisiana
city: Heidelberg
country: Germany
facility: Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität
city: Madrid
country: Spain
facility: Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia
city: Malmö
country: Sweden
facility: Käkkirurgiska kliniken, Universitetssjukhuset MAS
Study officials:
affiliation: Käkkirurgiska kliniken, Universitetssjukhuset MAS
name: Bo Sunzel, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06998797: Efficacy of Subcutaneous Infliximab in Acute Severe Ulcerative Colitis: a Multicenter Retrospective Study
Official title: Efficacy of Subcutaneous Infliximab in Acute Severe Ulcerative Colitis: a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 50
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: Patients in acute severe ulcerative colitis treated with subcutaneous Infliximab

Brief summary: Around 25% of patients with ulcerative colitis will develop acute severe colitis during the course of their disease. The first-line treatment for acute severe colitis is intravenous corticosteroid therapy. In case of a cortico-resistant form, treatment with intravenous (ciclosporin or Infliximab is indicated), according to European guidelines.

The emergence of biosimilar in the last years is a turning point in a context of optimizing healthcare costs and improving patient quality of life, with the arrival of the subcutaneous form of Infliximab in 2020, with similar results in terms of clinical remission, but also blood levels of Infliximab compared with the intravenous form. To our knowledge, there are very few data on the use of subcutaneous Infliximab after intravenous induction in patients with acute severe colitis.

The aim of this study is to evaluate the efficacy of subcutaneous Infliximab in ulcerative colitis patients with acute severe colitis, and the factors associated with treatment failure.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old
* Diagnosis of acute severe ulcerative colitis according to Truelove Witts criteria
* Patients treated with at least one injection of subcutaneous Infliximab after induction with two or three intravenous perfusions of Infliximab
* Patients with a follow-up of at least 12 months after the first subcutaneous injection
* 12-month data available in medical records
* Patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data.

Exclusion Criteria:

* Patients with intravenous Infliximab as a maintenance treatment
* Patients switched from intravenous to subcutaneous form during follow-up, and who received more than three intravenous perfusions
* Protected persons.

Primary outcomes:
measure: Treatment failure at 12 months to describe treatment effectiveness
timeFrame: After study completion, average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06448897: Development of an Imaging Prediction Model for Pelvic Lymph Node Metastasis of Cervical Cancer Using Artificial Intelligence Techniques.
Official title: Development of an Imaging Prediction Model for Pelvic Lymph Node Metastasis of Cervical Cancer Using Artificial Intelligence Techniques.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Lymph Node Metastasis
Artificial Intelligence
Keywords: Cervical Cancer
Lymph Node Metastasis
Artificial Interlligence
Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient information and imaging data were collected from the Obstetrics and Gynecology Hospital of Fudan University. This hospital is a specialized tertiary care facility and is recognized as the leading Obstetrics and Gynecology hospital in China.

Brief summary: This study is a retrospective exploratory trial conducted at a single center, aiming to develop and validate a preoperative lymphatic metastasis model for cervical cancer using artificial intelligence deep learning. The model is trained using preoperative imaging and postoperative pathological findings of cervical cancer patients, with the goal of enhancing the accuracy of lymphatic metastasis prediction through preoperative imaging and offering insights for treatment decisions.


Eligibility criteria: Inclusion criteria:

1. patients with preoperative diagnosis of invasive cervical cancer stage I-III, with any type of pathology, and patients who underwent radical/modified radical cervical cancer surgery + pelvic lymph node dissection in our hospital.
2. Age ≥18 years old and ≤80 years old
3. patients with complete preoperative pelvic MRI images and postoperative pathology and clinical data in our hospital

Exclusion criteria:

1. Patients during pregnancy or breastfeeding, patients within 42 days of abortion
2. Patients who have received neoadjuvant chemotherapy or radiotherapy before surgery for this previous cervical cancer
3. Patients with other malignant tumors within 5 years
4. Combination of other underlying diseases that may lead to enlarged pelvic lymph nodes
5. Imaging report more than 1 month prior to surgery
6. Poor image quality and unrecognizable

Primary outcomes:
measure: A model for identifying pelvic lymph node metastases on preoperative imaging
timeFrame: From enrollment to the end of development of model at 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04951297: Development and Validation of a Bowel-routine-based Self Report Questionnaire for Sacral Sparing After Spinal Cord Injury
Official title: Development and Validation of a Bowel-routine-based Self Report Questionnaire for Sacral Sparing After Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 102

Brief summary: To develop a self-administered tool for assessment of sacral sparing after spinal cord injury (SCI) and to test its validity in individuals with SCI.


Eligibility criteria: Inclusion Criteria:

* patients with SCI

Exclusion Criteria:

* had neurologic impairments unrelated to SCI, such as peripheral nerve injury, brain injury and cognitive deficits, or if they were unable to complete the questionnaire.

Primary outcomes:
measure: sacral sparing self-report questionnaire
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00676897: Statin Therapy in the Treatment of Sepsis
Official title: Study of Statin Therapy in the Treatment of Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Septic Shock
Keywords: statin, sepsis, septic shock, simvastatin
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years old
* Hypotensive requiring vasopressors
* Suspected Infection

Exclusion Criteria:

* Pregnant
* Liver Failure (ALT or AST \> 120)
* Rhabomyolysis (CPK \> 3x normal)
* Comfort care measures status
* Chronic Liver Disease (Cirrhosis)
* Use of Cyclosporin, Digoxin, Statins
* Patients who are unable to take medications by mouth or NGT

Primary outcomes:
measure: Time to Shock Reversal
timeFrame: up to 7 days
Secondary outcomes:
measure: Inflammatory Marker Levels
timeFrame: over 24 hours (time zero and time 24 hours)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael W Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghosh CC, Thamm K, Berghelli AV, Schrimpf C, Maski MR, Abid T, Milam KE, Rajakumar A, Santel A, Kielstein JT, Ahmed A, Thickett D, Wang K, Chase M, Donnino MW, Aird WC, Haller H, David S, Parikh SM. Drug Repurposing Screen Identifies Foxo1-Dependent Angiopoietin-2 Regulation in Sepsis. Crit Care Med. 2015 Jul;43(7):e230-40. doi: 10.1097/CCM.0000000000000993.
citation: Dobesh PP, Olsen KM. Statins role in the prevention and treatment of sepsis. Pharmacol Res. 2014 Oct;88:31-40. doi: 10.1016/j.phrs.2014.04.010. Epub 2014 May 2.
citation: Donnino MW, Cocchi MN, Salciccioli JD, Kim D, Naini AB, Buettner C, Akuthota P. Coenzyme Q10 levels are low and may be associated with the inflammatory cascade in septic shock. Crit Care. 2011 Aug 9;15(4):R189. doi: 10.1186/cc10343.
Clinical trial NCT00005405: Parity and Serum Lipids in White and Hispanic Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To analyze the relationships between parity (childbirth) or gravidity (pregnancy) and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study.

Detailed description: BACKGROUND:

The relationships between parity or gravidity and measures of lipids in groups of women from the Hispanic Health and Nutrition Examination Survey (Hispanic HANES) and the Framingham Heart Study offered insights into the health of an important minority group in the United States and provided clues regarding hormonal mechanisms in lipoprotein metabolism.

DESIGN NARRATIVE:

In the Framingham cohort, the relationships among gravidity, LDL-cholesterol, HDL-cholesterol and total cholesterol were prospectively studied. Each of these serum lipids was tested as a potential mediator of associations between gravidity and various cardiovascular endpoints. In the Hispanic HANES, the associations among parity, gravidity, and lipid levels were examined in cross-sectional data on women of a different ethnic background in whom birth rates tended to be high. Secondary analysis of these two datasets was conducted, carefully considering aspects of the study designs. Bivariate analyses generated mean lipid levels within parity or gravidity groups. HDL, LDL, and total cholesterol were then stratified both by parity and other variables (such as age and smoking status) so that interactions could be considered. Multivariate analyses were used to analyze the effect of parity on lipids and cardiovascular disease events while controlling for a variety of potentially confounding factors (such as body mass index, subscapular/triceps, skinfold ratio, education, income, cigarette smoking, alcohol consumption, oral contraceptive use, estrogen replacement therapy, menopausal status and type of menopause). Interactions were also considered in multivariate models.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05293405: Neuroinflammatory PET Imaging in Autoimmune Encephalomyelitis
Official title: Neuroinflammatory Imaging Using TSPO PET Tracer in Paients With Autoimmune Encephalomyelitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoimmune Encephalomyelitis
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Autoimmune encephalomyelitis is a heterogeneous group of central nervous system (CNS) autoimmune diseases characterized by the production of anti-neuron-associated autoantibodies which target neuronal surface proteins, synaptic receptors and intracellular antigens. MRI, as a current first-line imaging tool of CNS inflammation, is difficult to diagnose them because the majority of patients have normal MRI images, and only a few may show local signal or structural abnormalities (including inflammation, edema, or atrophy). The 18 kDa translocator protein (TSPO) expression in the CNS is upregulated in response to microglia activation. DPA-714 is high affinity for binding to TSPO, making 18F-labeled DPA-714 (18F-DPA-714) PET a very promising diagnostic imaging tool for neuroinflammation in patients with autoimmune encephalomyelitis.This study aims to explore the value of 18F-DPA-714 PET in the early diagnosis, therapeutic assessment and prognosis in patients with autoimmune encephalomyelitis.


Eligibility criteria: Experimental group:

Inclusion criteria:

1. Patients with onset for less than 2 years
2. Serum autoantibody positive
3. cognitive impairment or movement disorder diagnosed by two or more certified specialists.

Exclusion criteria:

1. Patients who do not meet the clinical、laboratory and imaging criteria of immune-related cognitive and movement disorders
2. Medical history of surgery, trauma, stroke, tumor in brain or spine cord
3. Alcoholism or drug dependence (addiction)
4. Patients with pregnancy

Healthy Volunteers group:

Inclusion criteria:

1. able to understand the purpose of clinical research and test plan
2. In the brain and spine cord MR assessment, it is judged as "normal"

Exclusion criteria:

1. Any major mental illness; history of schizophrenia or schizoaffective disorder
2. Any important neurological disease, such as cerebrovascular disease, inflammation or infectious disease, demyelinating disease, neurodegenerative disease, trauma in brain or spine cord
3. History of alcohol or drug abuse/dependence
4. Medical history of cardiac and lung disease, tumors, blood disease, poorly controlled chronic diseases
5. Patients with pregnancy

Primary outcomes:
measure: TSPO expression level
timeFrame: Baseline
measure: TSPO expression level
timeFrame: 3 months after baseline
measure: TSPO expression level
timeFrame: 12 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References:
Clinical trial NCT00982605: EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)
Official title: EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with operable non-small cell lung cancer

Brief summary: The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA).

Detailed description: NSCLC is a common cancer. Accurate and early staging has a significant impact on outcome. EBUS-TBNA of involved mediastinal lymph nodes is critical. Molecular markers could improve mediastinal staging.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Samples are collected before surgery or before any therapy
* ECOG 0 or 1
* Clinical stage I-II, T1-2, N0-1, M0)
* Surgically respectable
* Patient with enlarged med. lymphnodes (control group)

Exclusion Criteria:

* Previous RT/CHT
* Previous or current cancer of other entity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care
Study officials:
affiliation: Thoraxklinik Heidelberg, Germany
name: Michael Kreuter, MD
role: STUDY_DIRECTOR
References:
citation: Herth FJ, Annema JT, Eberhardt R, Yasufuku K, Ernst A, Krasnik M, Rintoul RC. Endobronchial ultrasound with transbronchial needle aspiration for restaging the mediastinum in lung cancer. J Clin Oncol. 2008 Jul 10;26(20):3346-50. doi: 10.1200/JCO.2007.14.9229. Epub 2008 Jun 2.
citation: Herth FJ, Eberhardt R. Actual role of endobronchial ultrasound (EBUS). Eur Radiol. 2007 Jul;17(7):1806-12. doi: 10.1007/s00330-006-0497-6. Epub 2007 Jan 6.
citation: Herth FJ, Ernst A, Eberhardt R, Vilmann P, Dienemann H, Krasnik M. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum. Eur Respir J. 2006 Nov;28(5):910-4. doi: 10.1183/09031936.06.00124905. Epub 2006 Jun 28.
citation: Herth FJ, Eberhardt R, Vilmann P, Krasnik M, Ernst A. Real-time endobronchial ultrasound guided transbronchial needle aspiration for sampling mediastinal lymph nodes. Thorax. 2006 Sep;61(9):795-8. doi: 10.1136/thx.2005.047829. Epub 2006 May 31.
citation: Al-Haddad M, Wallace MB. Molecular diagnostics of non-small cell lung cancer using mediastinal lymph nodes sampled by endoscopic ultrasound-guided needle aspiration. Cytopathology. 2006 Feb;17(1):3-9. doi: 10.1111/j.1365-2303.2006.00318.x.
Clinical trial NCT04609605: Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography
Official title: Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 1. To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography
2. To evaluate its relationship to long term mortality.

Detailed description: Pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction and stroke . The incidence of PE has been increasing ,with significant associated mortality; a recent registry of PE patients reported a mortality rate \> 10% at 30 days. There are a number of emerging contemporary PE therapies, including thrombolysis, catheter intervention and surgery. Early and accurate identification of PE in patients is therefore critical. A transthoracic echocardiogram (TTE) may help when there is a clinical suspicion for PE, and its use in confirmed PE is widely recommended . A number of right atrial (RA) and right ventricular (RV) parameters have been shown to be abnormal in patients with PE . In addition, RA and RV enlargement portends a worse prognosis in these patients .

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of acute pulmonary embolism
2. Age: 20 - 70 years.

Exclusion Criteria:

1. coronary artery disease
2. patient of Atrial fibrillation.
3. Patient of impaired RV function due to chest disease (Cor-pulmonale)
4. patient with impaired Ejection fraction (EF) \<50%
5. Moderate to severe valvular heart disease.
6. Atrio-ventricular conduction disturbance.
7. Poor echogenicity

Primary outcomes:
measure: improve management of acute pulmonary embolism
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.
citation: McConnell MV, Solomon SD, Rayan ME, Come PC, Goldhaber SZ, Lee RT. Regional right ventricular dysfunction detected by echocardiography in acute pulmonary embolism. Am J Cardiol. 1996 Aug 15;78(4):469-73. doi: 10.1016/s0002-9149(96)00339-6.
citation: Fields JM, Davis J, Girson L, Au A, Potts J, Morgan CJ, Vetter I, Riesenberg LA. Transthoracic Echocardiography for Diagnosing Pulmonary Embolism: A Systematic Review and Meta-Analysis. J Am Soc Echocardiogr. 2017 Jul;30(7):714-723.e4. doi: 10.1016/j.echo.2017.03.004. Epub 2017 May 9.
citation: Trivedi SJ, Altman M, Stanton T, Thomas L. Echocardiographic Strain in Clinical Practice. Heart Lung Circ. 2019 Sep;28(9):1320-1330. doi: 10.1016/j.hlc.2019.03.012. Epub 2019 Apr 12.