louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06573736: Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation
Official title: Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 500
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men meeting local standard of care to undergo prostate MRI for suspicion of prostate cancer

Brief summary: Men meeting local clinical standard of care to undergo a prostate MRI for suspicion of prostate cancer will be included. Blood sample will be drawn on the day of MRI or immediately prior to MRI for measurement of the prostate cancer biomarker Stockholm3. Specifically, the Stockholm3 test will be performed in a retrospective manner and no clinical decisions will be made based on the results. The patients will not receive the results of the Stockholm3 assay. A Stockholm3 score will be reported for each patient.

The primary aim is to show superior specificity of Stockholm3 (at different thresholds) for MRI selection compared to PSA (at different thresholds) (I.e., the proportion of men with a negative Stockholm3 test or a negative PSA test among those with a normal MRI).

Additional aims:

1. To show non-inferior relative sensitivity in detection of csPC of Stockholm3 compared to PSA (The proportion of men with a positive Stockholm3 test (at different thresholds) or a positive PSA test (at different thresholds) among those diagnosed with csPC will be calculated).
2. To evaluate Stockholm3 risk thresholds to determine if it can be used to further reduce MRI, biopsy and Gleason grade group 1 cancers without reducing sensitivity of csPC detection.


Eligibility criteria: Inclusion Criteria:

* Men with age range (40.0 - 80.0 years)
* Already scheduled to undergo MRI for prostate cancer screening (both negative and positive MRI included).

Exclusion Criteria:

* PSA \< 1.5 ng/mL
* Any known diagnosis of prostate cancer (patient on active surveillance)
* Men that have undergone digital rectal exam (DRE) immediately before blood draw (DRE within 5 days of study blood draw are excluded).
* Men who in the three (3) months prior to study participation received any invasive urologic procedure such as thermotherapy, microwave therapy, laser therapy, transurethral resection of the prostate (TURP), urethral catheterization, and lower genitourinary tract endoscopy (cystoscopy)
* No history of new treatment for BPH in three (3) months prior to study participation.

Primary outcomes:
measure: Abnormal MRI
timeFrame: From enrollment up to 24 weeks
Secondary outcomes:
measure: Clinically significant prostate cancer
timeFrame: From enrollment up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05520736: Mhealth Supported Bundle to Improve Vaccination Completion
Official title: Implementing a Mobile Health Supported Bundle to Improve Routine Vaccination Completion Rate in a Low-resource Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaccination
Keywords: Vaccination
Childhood
Low- and middle-income country
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-08-30
Enrollment: 2855
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Supported be a digital vaccine registry the investigators will test the impact of automated appointment reminders, real time appointment reminders, motivational interviewing and targeted vaccine on routine childhood vaccine completion rates.

Detailed description: Bundling three high-impact mHealth interventions (a digital vaccine registry (supply side), a reminder system (demand side), and targeted vaccine drive (demand and supply-side) will be feasible, acceptable, carried out with fidelity, and result in a 10% improvement in vaccine completion rates compared to the year prior to implementation.

Eligibility criteria: Inclusion Criteria:

* All parents or caregivers of patients who bring their child to the vaccine clinic to receive immunization for their first vaccine visit.

Exclusion Criteria:

* Parents or caregivers not willing to participate.

Primary outcomes:
measure: Vaccine completion rates
timeFrame: 15 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Akure
country: Nigeria
facility: Mother and Child Hospital Akure
state: Ondo
Study officials:
affiliation: Indiana University
name: Osayame A Ekhaguere
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06967636: The Impact of Successful Quitting Smoking After Intensive Smoking Cessation Interventions on Morbidity and Mortality Among Smokers With Severe Mental Disorders - A Nationwide Cohort Study From the Danish Smoking Cessation Database
Official title: The Impact of Successful Quitting Smoking After the Intensive Gold Standard Programme (GSP) on Morbidity and Mortality Among Smokers With Severe Mental Disorders - A Nationwide Cohort Study From the Danish STOPbase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation, Mental Health Disorders, Inequality in Health Prevention
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 15863
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: All participants \>18 years with a severe mental disorder (SMD) undergoing the GSP in Denmark at local clinics with consent to follow up.

Brief summary: We evaluate intensive smoking cessation interventions (GSP) on morbidity and mortality in terms of assessing the impact among quitters and non-quitters with severe mental disorders (SMD)


Eligibility criteria: Inclusion Criteria:

* F20-F29, F30-F39, F60-F69, F10-F16, F18, F19
* Participation in the GSP in Denmark

Exclusion Criteria:

* Dual diagnosis (F00-F99 and a co-occurring substance-use disorder (F10-F16, F18, F19)
* \< 18 years
* No consent to follow-up
* No baseline smoking status

Primary outcomes:
measure: All-cause morbidity
timeFrame: January 2006 to January 2020
measure: All-cause mortality
timeFrame: January 2006 to January 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03204136: Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease
Official title: Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China
Sponsor class: OTHER_GOV
First posted: 2017-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inflammatory bowel disease patients who are refractory or intolerance to conventional therapy (including mesalazine, steroid, azathioprine and biological agents). Tarcolimus or methotrexate was used in these patients.

Brief summary: Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. Yet some patients develop severe side effects or initial invalid to conventional therapies. Some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. Here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.


Eligibility criteria: Inclusion Criteria:

* Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents

Exclusion Criteria:

* Pregnant woman

Primary outcomes:
measure: disease activity assessment after one year treatment
timeFrame: one year
Secondary outcomes:
measure: The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events.
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health；Shanghai Inflammatory Bowel Disease Research Center；Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health；Shanghai Inflammatory Bowel Disease Research Center；Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Shanghai Institute of
name: Zhihua Ran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02730936: Antimicrobial Hernia Repair Device
Official title: Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ventral Hernias
Incisional Hernias
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2016-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.


Eligibility criteria: Inclusion Criteria:

* Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.

Exclusion Criteria:

* Less than 21 years old
* Unwilling or unable to sign and date the informed consent
* Pregnant, breastfeeding, or planning to become pregnant prior to completing the study
* Unable or unwilling to comply with follow-up schedule
* Simultaneously participating in another investigational drug or device study.
* Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.

Primary outcomes:
measure: Number of patients that develop a surgical site infection
timeFrame: 6 months
Secondary outcomes:
measure: Number of hernia recurrences
timeFrame: 24 months
measure: Frequency of procedural and post-operative adverse events
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05782036: Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)
Official title: Development, Validation and Clinical Application of a Recovery Scale After Cardiac Surgery: the Fuwai-CRS (Fuwai- Cardiac Recovery Scale)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Recovery
Cardiac Surgery
PROM
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-03-23
Enrollment: 3043
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 18 years or older, undergoing elective cardiac surgery.

Brief summary: Improving patient recovery after cardiac surgery is a critical priority. While improved surgical techniques have substantially reduced procedural mortality over the past decades, the inherent physiological insult of median sternotomy, cardiopulmonary bypass, and myocardial manipulation continues to impose significant challenges in patient's recovery experience, such as pain, sleep disorders. Paradoxically, this critical recovery phase remains underexplored, as traditional outcome metrics predominantly focus on mortality and major morbidity endpoints. However, no cardiac surgery-specific tools currently exist to adequately capture postoperative recovery experience, creating barriers to optimal care. Accordingly, the investigators aim to develop and validate a recovery scale after cardiac surgery and evaluate its clinical performance compared to the generic scale (QoR-15)


Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Age ≤ 18 years
* Refuse to participate in this study
* prolonged postoperative mechanical ventilation exceeding 24 hours reoperation or perioperative death

Primary outcomes:
measure: Death or unplanned readmission
timeFrame: 3-month post operative
Secondary outcomes:
measure: In-hospital mortality
timeFrame: From surgery to discharge, up to 7 days
measure: In-hospital stroke
timeFrame: From surgery to discharge, up to 7 days
measure: In-hospital myocardial infarction
timeFrame: From surgery to discharge, up to 7 days
measure: In-hospital acute renal failure
timeFrame: From surgery to discharge, up to 7 days
measure: In-hospital sternal wound infection
timeFrame: From surgery to discharge, up to 7 days
measure: In-hospital reoperation
timeFrame: From surgery to discharge, up to 7 days
measure: Length of hospital stay
timeFrame: Approximately 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04548336: Mental Practice on Balance
Official title: Effects of Motor Imagery and Action Observation on Static and Dynamic Balance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Movement, Involuntary
Keywords: Motor imagery
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2020-09-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of this research is to see the effect of two mental practice techniques on static and dynamic balance.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no pain subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.

Primary outcomes:
measure: Posturography
timeFrame: Change in immediately at the end of the intervention.
Secondary outcomes:
measure: Visual and Kinesthetic Motor Imagery Ability
timeFrame: Immediately before the intervention
measure: The degree of physical activity
timeFrame: Immediately before the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT03096236: Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD
Official title: Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Feasibility, Complications
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastric SET

Brief summary: Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Gastric SET up to 15 mm (measurement: endoscopic ultrasound)

Exclusion Criteria:

* Age \< 18 years
* Gastric SET \> 15 mm and/or large extramural part
* Criteria of Lipoma (endoscopic ultrasound)
* Positive lymph nodes (endoscopic ultrasound)
* Stenosis (Esophagus)
* Diverticulum (Esophagus)
* Pregnancy or Nursing period

Primary outcomes:
measure: Technical success
timeFrame: 1 minute (immediate)
Secondary outcomes:
measure: R0-Resection
timeFrame: three days
measure: Histologically confirmed full thickness resection
timeFrame: three days
measure: Procedure-associated complications
timeFrame: three months
measure: Necessity of surgical treatment
timeFrame: three months
measure: Residual or recurrent adenoma/carcinoma at endoscopic follow up
timeFrame: three months
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
Study officials:
References:
citation: Meier B, Schmidt A, Glaser N, Meining A, Walter B, Wannhoff A, Riecken B, Caca K. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc. 2020 Feb;34(2):853-860. doi: 10.1007/s00464-019-06839-2. Epub 2019 Jun 11.
Clinical trial NCT03286036: Clinical and Molecular Staging of Lung Cancer Stages I and IIp
Official title: Clinical and Molecular Staging of Lung Cancer Stages I and IIp: Generation and Initial Analysis of a Clinical and Molecular Knowledge Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Biomarkers, early detection
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
First posted: 2017-09-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lung cancer patients who undergo surgical resection of their tumors in a Spanish hospital with thoracic surgery and pathological anatomy departments

Brief summary: The classification of lung cancer (LC) according to the degree of anatomical extension (TNM) allows the estimation of the prognosis of the patient, although its accuracy is limited. In fact, one third of surgically-treated patients with initial disease have recurrences during follow-up, despite the negativity of node dissection at surgery. The incorporation of genetic, epigenetic and proteomic information to TNM staging will characterize more accurately the lung cancer, and thereby improve the prognostic and the prediction of the therapeutic response in these patients.In this project a prospective cohort of 320 patients with lung cancer staged I-IIp will be studied, combining the clinical and pathologic information available with genetic, epigenetic and proteomic markers in tumour samples, pulmonary tissue, regional nodes and peripheral blood, preserved in suitable systems for the application of complex analytical methodologies. Thus, a knowledge database will be created with the aim of improving the prognostic and prediction capabilities of TNM staging.This project is coordinated with related sub-projects that cover the required laboratory tests on biological samples and with Spanish collaborative group in lung cancer.


Eligibility criteria: Inclusion Criteria:

* over 18 years old
* Able to understand and sign the informed consent

Exclusion Criteria:

* Absence of mediastinal disease

Primary outcomes:
measure: Cohort creation
timeFrame: 6 years
Secondary outcomes:
measure: Biological markers
timeFrame: 3 years
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
Study officials:
References:
citation: Monso E, Montuenga LM, Sanchez de Cos J, Villena C; Lung Cancer CIBERES-RTICC-SEPAR-Plataforma Biobanco Pulmonar. Biological Marker Analysis as Part of the CIBERES-RTIC Cancer-SEPAR Strategic Project on Lung Cancer. Arch Bronconeumol. 2015 Sep;51(9):462-7. doi: 10.1016/j.arbres.2014.11.010. Epub 2015 Jan 19. English, Spanish.
Clinical trial NCT00583336: Physician Preference Study of ShuntCheck - Madsen
Official title: Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CSF Flow Through the Shunt of a Hydrocephalus Patient
Lead sponsor: NeuroDx Development
Sponsor class: INDUSTRY
Collaborators: name: Boston Children's Hospital
First posted: 2007-12-31
Enrollment: 200
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.

Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)


Eligibility criteria: Inclusion Criteria:

1. Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
2. Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
3. Subjects must be physically stable as determined by the physician.

Exclusion Criteria:

1. Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
2. Subjects unable to lie supine with head elevated 30 degrees or less
3. Subjects who have had shunt surgery within two weeks.
4. Inability or unwillingness of subject to endure the test.
5. Other judgments of the investigator.

Primary outcomes:
measure: ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
timeFrame: Tested in single visit
Secondary outcomes:
measure: ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction
timeFrame: Single visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Joseph R Madsen, MD
role: PRINCIPAL_INVESTIGATOR
References: