louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06957353: Oblique K-wire Control in Calcaneal Osteotomy for Flatfoot Correction
Official title: Oblique Sliding K-wire Technique For Controlling Calcaneal Displacement Osteotomy In Flat Foot Correction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Flat Foot
Keywords: flat foot
calcaneal osteotomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: using an oblique K-wire technique in controlling Calcaneal displacement during osteotomy in flatfoot correction
Primary purpose: TREATMENT

Brief summary: Adult-acquired flatfoot deformity (AAFD) often requires surgical correction when conservative methods fail. Calcaneal displacement osteotomy is a key procedure in restoring alignment. This study introduces a novel K-wire technique to enhance control during surgery and minimize complications related to manual manipulation. It builds on prior research highlighting the limitations of traditional approaches in achieving precise fragment positioning.

Detailed description: Flat foot deformity, particularly adult - acquired flatfoot (AAFD), often necessitates surgical intervention when conservative treatment fail. Calcaneal displacement osteotomy is a common surgical procedure for correcting calcaneal displacement and achieving stable fixation. The proposed K-wire technique offers a novel approach to improve control and reduce complications associated with manual manipulation during surgery. Previous studies have indicated challenges with traditional methods in achieving precise fragment control. This study aims to address these gaps.

Eligibility criteria: Inclusion Criteria:

* symptomatic flatfoot that will undergo flatfoot correction with calcaneal displacement osteotomy.

Exclusion Criteria:

* prior foot surgery
* Severe comorbidities or contradictions of the surgery

Primary outcomes:
measure: assessment of degree of desired displacement
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Mohammed Mostafa Kotb, professir
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cai Y, Zhao Z, Huang J, Yu Z, Jiang M, Kang S, Yuan X, Liu Y, Wu X, Ouyang J, Li W, Qian L. Morphological changes in flatfoot: a 3D analysis using weight-bearing CT scans. BMC Med Imaging. 2024 Aug 19;24(1):219. doi: 10.1186/s12880-024-01396-0.
citation: Brilhault J. Calcaneal osteotomy for hindfoot deformity. Orthop Traumatol Surg Res. 2022 Feb;108(1S):103121. doi: 10.1016/j.otsr.2021.103121. Epub 2021 Oct 20.
citation: Mueller G, Frosch KH, Barg A, Schlickewei C, Weel H, Krahenbuhl N, Priemel M, Mueller E. Impact of the medial displacement calcaneal osteotomy on foot biomechanics: a systematic literature review. Arch Orthop Trauma Surg. 2024 May;144(5):1955-1967. doi: 10.1007/s00402-024-05267-9. Epub 2024 Mar 30.
Clinical trial NCT05095753: Data Collection of Heart Rate and Blood Pressure
Official title: Data Collection of Heart Rate and Blood Pressure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy People
Lead sponsor: MindMics Inc
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy cohort

Brief summary: The purpose of the study is data collection for building and validating the algorithms for analytics of vital signs using wearable earphones (MindMics device).

Detailed description: MindMics is developing technology to enhance an individual's quality of life by continuously monitoring the heart rate, stress thereby allowing people to make better decisions regarding their health. MindMics has a working prototype of the ear buds which will perform all the conventional tasks earbuds do (listen to music, etc.), but, in addition, will measure your vital signs. The earbuds capture the sounds made by the various cardiac structures pulsing and moving blood.

Eligibility criteria: Inclusion Criteria:

* Ages 18-90
* No gender restrictions
* Cognitive ability to consent

Exclusion Criteria:

* Patients with pacemakers
* Patients with irregular heart rhythms

Primary outcomes:
measure: RR Interval from ECG signal
timeFrame: 20 minutes
measure: Inter-beat Interval from earbud signal
timeFrame: 20 minutes
measure: Systolic and diastolic blood pressure from blood pressure cuff
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: MindMics, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT03338153: Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control
Official title: Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control Referring to Tehran Heart Center Since June 2007 to June 2009
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Coronary Artery Disease
Lead sponsor: Tehran Heart Center
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 1353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing per-cutaneous coronary intervention between October 2007 and December 2009

Brief summary: the purpose of this study is to determine whether appropriate control of diabetes around the PCI time is related with MACE and outcome of diabetic patients.

Detailed description: Despite recent advances in coronary revascularization, cardiovascular disease accounts for about 75% of all hospital admissions in diabetic patients.although the introduction of drug-eluting stents has reduced the rates of restenosis after PCI, diabetic patients undergoing PCI will have poorer clinical outcomes.In this study, we sought to investigate whether a pre and post procedural glycemic control in diabetic patients,as reflected by HgbA1C prior,1 and 6 months after elective PCI,was related to major advance cardiac events (MACE) during 3 year follow up.

Eligibility criteria: Inclusion Criteria:

* age between 18-75
* coronary stenosis \> 70%

Exclusion Criteria:

* Myocardial infarction in 72 hours prior to PCI
* LVEF \< 30%
* Residual Stenosis\>30%
* Cr level \> 2.0
* hemodynamic compromise during intervention
* Left main lesions
* PCI for vein grafts

Primary outcomes:
measure: Major adverse cardiac event
timeFrame: during 3 years after per-cutaneous coronary intervention
Secondary outcomes:
measure: target vessel revascularization
timeFrame: during 3 years after PCI
measure: target lesion revascularization
timeFrame: during 3 years after PCI
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran heart center, Tehran university of medical sciences
Study officials:
affiliation: Tehran Heart Center
name: Ebrahim kassaian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375453: Dose Escalation Study of SH U04722 in Solid Tumors
Official title: Phase I, Open-label, Dose Escalation Study for Evaluation of Safety, Tolerability, Pharmacokinetics, and Tumor-suppressive Efficacy of SH U04722 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tumors
Keywords: Paclitaxel
Advanced Solid Tumors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of SH U04722 in patients with solid tumor cancers. In addition, this study will identify the recommended dose and administration schedule of SH U04722 for phase II development in Japanese cancer patients, evaluate the pharmacokinetic profile of SH U04722 and gather preliminary data on the effectiveness of SH U04722 in patients with solid tumors.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:-Refractory to conventional antineoplastic treatment or no standard therapy option available-ECOG Performance Status score of \< 2-Agreement not to take vitamin E products such as Juvela (except for over-the-counter \[OTC\] and diet supplements). Exclusion Criteria:- Patients treated with other unapproved drugs/investigational drugs, chemotherapy, biological response modifiers, immunotherapy or endocrinotherapy within 4 weeks prior to entry in this study or nitrosoureas within 6 weeks before initial dosing of SH U04722 -Patients on concurrent therapy with warfarin or coumarin derivatives.-Patients who had radiation therapy within 2 weeks prior to entry into this study. -Patients with a history of serious hypersensitivity to taxanes.-Patients with current peripheral neuropathy (? Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 2)

Primary outcomes:
measure: The number of patients with dose limiting toxicity (DLT) observed between Days 1 and 21 after start of treatment (after first 3 weekly administrations of SH U04722 plus 7 days)
Secondary outcomes:
measure: The number of patients with DLT observed by the end of Week 8
measure: dose intensity (whether or not 75% of the planned dose can be done) for 8 weeks after the first dosing
Other outcomes:
Locations:
city: Hidaka-shi
country: Japan
state: Saitama
city: Iruma-gun
country: Japan
state: Saitama
city: Koutou-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02344953: Prospective and Retrospective Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and During Treatment or Thereafter in Acute Leukemia (Acute Leukemia HSCT Cohort)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Leukemia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sampling is performed in patients diagnosed with acute leukemia who underwent allo-HSCT in Severance Hospital.

Every eligible patients in peroid of study are enrolled. Patients must have the ability and willingness to sign a written informed consent document. Planned number of patients is 1000 considering annual incidence rate.

Brief summary: The objective of this study is to evaluate the prognostic factors of acute leukemia patients received stem cell transplantation and to invent the molecular genetic test for sensitive detection of minimal residual disease, and thereby this study would contribute to plan the risk adapted treatment. Patients will have samples of blood and/or bone marrow collected during treatment or thereafter


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with acute leukemia who underwent allo-HSCT in Severance Hospital.
* Both genders of 16 Years and older
* sign a written informed consent document
* exemption of consent in patient who died in study period.

Exclusion Criteria:

* No comprehension or willingness to sign a written informed consent document.

Primary outcomes:
measure: Overall survival
timeFrame: 10years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 10years
measure: Treatment-related mortality
timeFrame: 10years
measure: Complete remission rate
timeFrame: 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00992953: Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)
Official title: The Efficacy of Virtual Reality (VR) as an Adjunct Therapy for Acute Combat-related Post-Traumatic Stress Disorder (PTSD) in Non-Combatants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post-Traumatic Stress Disorder
Keywords: Virtual Reality
Post Traumatic Stress Disorder
Combat
Military
Major Depressive Disorder
Anxiety
Virtual Reality Exposure with Stimulus Control
Treatment as Usual
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Naval Hospital Camp Pendleton
name: Virtual Reality Medical Center
name: United States Naval Medical Center, San Diego
First posted: 2009-10-09
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is proposed that using Virtual Reality as part of therapy will result in improvements in Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq and/or Afghanistan.

Detailed description: In the treatment development phase, participants will be enrolled in Virtual Reality therapy. The therapy will be based on principals of exposure therapy, but will also incorporate aspects of physiological monitoring, and cognitive restructuring. The therapy will be modified as indicated by clinical feedback, with a fixed protocol to be developed (with length of treatment and exact methods to be used to be determined). After a fixed protocol is agreed upon, the project will enter the randomized phase. In this portion, subjects will be randomly assigned to receive either the Virtual Reality Treatment, or sent back to a waiting list during which time they will receive usual treatment. Participants will be assessed to determine which treatment (VR or treatment as usual) results in the greatest improvements in PTSD, as measured by independent assessors using the Clinician Administered PTSD scale.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Post Traumatic Stress Disorder related to military service in Iraq or Afghanistan by a Military Medical Provider.

Willing and able to give informed consent to participate Willing to give up intoxicating substances on the days of therapy

Exclusion Criteria:

* Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Camp Pendlton
country: United States
facility: Naval Hosptial Camp Pendleton
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego (NMCSD)
state: California
Study officials:
affiliation: Virtual Reality Medical Center
name: Brenda Wiederhold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964353: Clinical and Economic Implications of Genetic Testing for Warfarin Management
Official title: The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Coagulation Disorders
Keywords: coumadine
genotype
genes
Warfarin
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2009-08-24
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.

Detailed description: The overall goal of this project is to develop and assess the effectiveness and cost-effectiveness of strategies that use genetic testing in the management of anticoagulation among racially diverse hospitalized patients. The project has four specific aims.

Aim 1: To contribute patients initiating therapy at the University of Chicago Medical Center (UCMC) and affiliated hospitals to a genetic registry of a racially diverse set of patients undergoing warfarin therapy.

Aim 2: To perform a randomized trial to determine the efficacy, costs and cost-effectiveness of existing pharmacogenetic algorithms for the management of warfarin therapy among hospitalized patients of all races.

Aim 3: To develop clinical pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Aim 4: To perform a randomized trial to determine and compare the efficacy, costs and cost-effectiveness of existing clinical and non-racially tailored pharmacogenetic algorithms to racially tailored pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Eligibility criteria: Inclusion Criteria:

* warfarin-naive patients
* ages 18 and older
* are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation

Exclusion Criteria:

* patients who are not warfarin-naive
* 17 years of age or younger

Primary outcomes:
measure: Inpatient Length of Stay
timeFrame: during hospital stay, up to 60 days
Secondary outcomes:
measure: Supratherapeutic Dosing
timeFrame: during hospital stay, up to 60 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: David O Meltzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02116153: Mi-RNAs and Specificity of Hs-TnT in Symptomatic ED Patients
Official title: Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Myocardial Infarction
Keywords: Cardiac Troponin T
Micro-RNA
Sensitivity
Specificity
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für Herzforschung
First posted: 2014-04-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department with symptoms suggestive of acute coronary syndrome.

Brief summary: Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of non-STEMI and the detection of troponin in individuals that would have been classified as unstable angina with former assays. As many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased. Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. The aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the emergency department ("chest pain unit"), Dept. of Cardiology, University Hospital Heidelberg
* Symptoms suggestive of ACS incl. chest pain, dyspnea, atypical pain
* Age \>= 18 years
* Written informed consent

Exclusion Criteria:

* Mental disorders, dementia
* Pregnancy, breast feeding
* Age \< 18 years

Primary outcomes:
measure: Death
timeFrame: 90 days
Secondary outcomes:
measure: Myocardial Infraction
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Heidelberg
name: Evangelos Giannitsis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Hugo A Katus, MD
role: STUDY_DIRECTOR
References:
citation: Biener M, Giannitsis E, Thum T, Bar C, Costa A, Andrzejewski T, Stoyanov KM, Vafaie M, Meder B, Katus HA, de Gonzalo-Calvo D, Mueller-Hennessen M. Diagnostic value of circulating microRNAs compared to high-sensitivity troponin T for the detection of non-ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):653-660. doi: 10.1093/ehjacc/zuaa034.
Clinical trial NCT05143853: HORizontal Instability AC Joint Study: A Prospective Randomised Clinical Trial
Official title: Does Additional Horizontal Fixation After Arthroscopically Assisted Coracoclavicular Stabilisation Matter in Final Outcome Measures: a Prospective Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acromioclavicular Separation
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing different treatement strategies in augmenting clavicle stabilisation


Eligibility criteria: Inclusion Criteria:

* consensus indication for surgical treatment of AC syndesmolysis
* OP in 3 weeks after injury
* patient age between 16 and 65 years
* normal shoulder function before injury

Exclusion Criteria:

* open injury
* ipsilateral arm/shoulder girdle/hand injuries
* very low patient's physical demands
* previous injuries of the affected area
* Rockwood classification 1, 2, or 6

Primary outcomes:
measure: Constant-Murley score, minimum score 1, maximum score 100 (higher = better)
timeFrame: 1 year
Secondary outcomes:
measure: SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)
timeFrame: 1 year
measure: Horizontal RTG measurements, measured in mm
timeFrame: 1 year
measure: Horizontal RTG measurements, measured in mm2
timeFrame: 1 year
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References: