cyrilzakka/clinical-trials huggingface dataset:
Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction

The objective of this clinical trial is provide in vivo data thus to model the ligament biomechanical behavior within the physiologically healthy joint and to use the implemented model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament (ACL) reconstruction. Current ACL surgery offers 3 alternatives: autografts, allografts and bioengineered grafts; the choice of the implant and its characteristics still remains a critical point. The knowledge of patient-specific joint and graft biomechanics is fundamental to reduce surgical revision rate and low functional outcome. This clinical trial will provide data coming from patient-specific biomechanics into a prognostic computational model, able to provide information on both the optimal customized reconstruction and graft status during the early rehabilitation phase. This patient-specific approach will lead to quicker return to sports activity, reducing also the possibility of early osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Primary ACL lesion
* Ability to read and sign the informed consent.
* Age between 16 and 50 years old

Exclusion Criteria:

* Prior surgeries at the same knee
* Grade II or higher lesions at the collateral ligaments
* Posterior Cruciate Ligament lesion
* Inflammatory arthritis or other forms systemic inflammatory diseases
* Local or systemic infections
* Any injury or condition that adversely affects the ability to walk or to participate to I/II level activities
* Previous or concomitant lesions at the contralateral knee
* Skeletal immaturity
* Other potential risk factors for the development of osteoarthritis
Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 20 - 75 years old
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is 6.5 - 9.5%
* Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with serious diabetic complications
* Patients who are habitual excessive alcohol consumption.
* Patients with severe hepatic disorder or severe renal disorder.
* Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Using 18F- FDG,18F-DOPA and 68Ga-DOTATATE PET/CT in Detection and Evaluation of Response in Patients With NET Undergoing PRRT

the investigators will follow up after patients with neuroendocrine tumors who undergo PRRT treatment and evaluate the response for treatment using PET/CT with different tracers

patients with suspected or biopsy proven NET will undergo imaging using a Combination of 18F- FDG , 18F-DOPA and 68Ga-DOTATATE PET/CT before the stat of PRRT . after two cycles of treatment another two PET/CT are done using 18F- FDG and 18F-DOPA and about 6-8 weeks from last treatment the patient will undergo PET/CT using 18F-DOPA .

Eligibility Criteria:
Inclusion Criteria:

* patient with neuroendocrine tumor
* eligible for PRRT

Exclusion Criteria:

* younger than 18 years old
* pregnancy
Telemedicine in Cardiac Surgery: A Pilot Study

Telemedicine has been widely used in managing patients with neurologic disorders or mental illness. Telemedicine is defined as the use of medical information exchanged from one site to another via electronic communications for the health and education of the patient or healthcare provider and for the purpose of improving patient care. According to our knowledge, it has not been used to manage cardiac patients who need postoperative care after discharge from hospitals.

The use of telemedicine has the potential to reduce the cost of unnecessary travel by assessing the patient's postoperative status prior to making decisions as to whether or not a face-to-face consultation is necessary.

In this pilot study we will compare the accuracy of surgeons' decisions during follow-up visits via video-teleconference (V-Visit) to surgeons' decisions during traditional face-to-face follow-up visits (FTF-Visits). Both the V-Visit and the FTF-Visit will take place at the Houston Michael E DeBakey VA Medical Center on the same day. We will also ask both patients and providers to complete short questionnaires after each V-Visit regarding their acceptability of using telemedicine for these post-operative follow-up visits.

Information collected as part of this pilot study will be used to design a future full randomized controlled trial (RCT) on the use of telemedicine in evaluating post-operative cardiac surgical patients.

The specific aims are:

1. To compare surgeons' decisions on patient disposition between V-visits and FTF-visits (gold standard).
2. To assess the acceptability to patients and surgeons of using V-visits in the postoperative care of cardiac surgical patients;
3. To assess the technical feasibility of using community-based outpatient clinics (CBOCs) for delivery of postoperative cardiac surgical care;
4. To determine the recruitment rate for eligible subjects.

We plan to conduct this pilot study at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) in Houston, Texas, along with satellite CBOC facilities in Lufkin and Conroe. Once the accuracy, acceptability, and feasibility of the use of video conferencing (VC) in the postoperative care for cardiac surgical patients are established, we will submit a full proposal to conduct a two-arm RCT in future.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years of age
2. Patients who have undergone one of the following cardiac surgical procedures:

Coronary artery bypass grafting (CABG) and/or Cardiac valvular operations

Exclusion Criteria:

1. Patients who have undergone aortic dissection/aneurysm operations
2. Patients who have been diagnosed with atrial fibrillation
The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis

To date, focused and radial types of extracorporeal shock wave therapy have been effectively used in lateral epicondylitis. However, studies directly addressing a comparison between radial and focused types of extracorporeal shock wave therapy in lateral epicondylitis have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused extracorporeal shock wave therapy options on lateral epicondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lateral epicondylitis
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* be have not completed the assessment process.
* elbow deformity
* psychological illness
Anticoagulant Treatments and Percutaneous Coronary Angioplasty

The purpose of this study is to determine whether adjunction of intravenous anticoagulant therapy (enoxaparin, HNF, bivalirudin) to antiaggregation with clopidogrel and aspirin improves in-hospital results of percutaneous transluminal coronary angioplasty (ptca) in selected patients.

* Background : We don't know if using IV anticoagulant therapy is necessary for percutaneous coronary angioplasty in stable patients.
* Purpose : to compare efficacy and security of use or not of different anticoagulant treatments during percutaneous coronary angioplasty in patients with double antiaggregant therapy.
* Abstract : In stable patients pretreated with double antiaggregant therapy use of IV anticoagulants has not been yet evaluated during angioplasty. In this prospective randomized trial we want to compare in such patients the efficacy and security of the administration of IV heparin, IV enoxaparin, IV bivalirudin and no use of anticoagulant during coronary angioplasty. We will evaluate in each group ischaemic events (clinic, ECG and biology) and haemorrhagic events (clinic, biology) with a one month follow up.
* Primary outcome: ischaemic events via troponin Ic measurements during 24 hours post procedure.
* Secondary outcomes: haemorrhagic events : clinical and biological evaluation (Hb, Ht, TIMI score)
* Study design : monocentric randomized clinical trial type therapeutic equivalence phase IV.
* Interventions : In patients prepared with therapeutic association (aspirin clopidogrel) comparison between use or no of anticoagulant (IV heparin, IV enoxaparin or IV bivalirudin).
* Number of subjects : 120 per group (total of 480).
* Statistical analysis : multivariate analysis with logistic regression models : each end point (troponin Ic increase, haemoglobin decrease, ...) will be explicated with treatment group and other covariates (sex, age, creatinine, ...).

Eligibility Criteria:
Inclusion Criteria:

* stable angina pectoris or silent ischaemia

Exclusion Criteria:

* instable angina or ACS (Acute Coronary Syndrome)
Mason Heart Study With MCG

Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The Mason Heart Study-MCG (MHS-MCG) registry is designed to collect magnetocardiography (MCG) scans on a select group of healthy volunteers who work for the city of Mason, OH, with and without cardiac symptoms, illnesses, and/or risk factors. CardioFlux is used as a noninvasive MCG tool that analyzes and records the magnetic fields of the heart to detect various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 250 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of enrollment.

Exclusion Criteria:

1. \< 18 years of age
2. Patients unable to fit into device
3. Non-ambulatory patients
4. Positive response on CardioFlux Pre-Screening Form
5. Patients with claustrophobia or unable to lie supine for 5 minutes
6. Pregnant women
7. Poor candidate for follow-up (e.g. no access to phone)
8. Prisoners
Evidence of Spreading Vasoconstriction in Human Gingiva

The aim of this study is to observe the mechanism of spreading vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". The different placement of the solution causes different effect in the microcirculation.

Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasoconstriction such as spreading vasoconstriction in human gingiva.

The epinephrine is a daily used vasoconstrictor material in dentistry and it will be used to trigger remote effect on gingiva. Epinephrine in 1 mg/ml concentration. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva in group "A". The solution will be dropped on the surface of tooth 12 next to the sulcus into the well in case of group "B". The changes of the blood flow will be monitor at the test side with surrounding gingival area by LSCI. The control side in each case will be - appropriately to the test side - at tooth 21 with phisiologocal saline.

Eligibility Criteria:
Inclusion Criteria:

* at least 5 mm keratinized gingiva at the upper front teeth
* general health

Exclusion Criteria:

* pregnancy, breast-feeding
* any medication
* smoking, gingivitis, caries and coronal restoration with insufficient marginal integrity
Accuracy of Tooth Guided Immediate Implant Placement at Molar Region

Introduction: The concept of immediate implant placement has become popular due to reduced trauma and reduced overall treatment time. Removal of molar teeth provides a challenging and intriguing dilemma due to multiple root morphology. In cases of extraction and immediate placement of implants in the molar region, removal of the inter-radicular septum should be avoided to attain initial implant stability at the time of placement, and prevent slipping of the implant into the extraction socket. Following this technique prevents the slippage of the implant and allows the implant to be guided into the inter-radicular septum.

Objectives: To assess the accuracy of implant placement using the remaining roots of multi-radicular mandibular molars, evaluate bone density around implants and implant stability in fresh extracted site.

Materials and Methods: A prospective study was done on 10 patients with badly destructed mandibular molars. The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum.


Eligibility Criteria:
Inclusion Criteria:

* Badly destructed mandibular molar teeth.
* Integrity of the roots.
* Bone coverage of 2/3 of the root.
* Sufficient bone volume.
* Adequate interocclusal distance \>7mm.
* Adequate amount of keratinized mucosa.
* Age ranging from 20-45 years.
* Medically fit patients.

Exclusion Criteria:

* Unfavorable position of the tooth or remaining roots.
* Molars with Fused roots.
* Root ankylosis.
* Patients with systemic conditions known to affect the periodontal status and healing such as uncontrolled diabetes and osteoporosis.
* Patients receiving chemotherapy or radiotherapy.
* Heavy smokers.
VEHICLE Registry: Venous Stenting for IIH in the MENA Region

The VEHICLE Registry is a multicenter observational study aimed at evaluating the management and outcomes of patients with Idiopathic Intracranial Hypertension (IIH) undergoing venous sinus stenting in the Middle East and North Africa (MENA) region. The study focuses on assessing clinical characteristics, treatment efficacy, safety, and the role of venous sinus stenting as a therapeutic modality in IIH.

Idiopathic Intracranial Hypertension (IIH) is a condition characterized by elevated intracranial pressure without an identifiable cause, leading to symptoms such as headaches, visual disturbances, and potential vision loss due to papilledema. The condition predominantly affects obese women of childbearing age and is associated with risk factors like obesity, recent weight gain, hypothyroidism, and polycystic ovary syndrome (PCOS).

Venous sinus stenosis has been implicated in the pathophysiology of IIH. Venous sinus stenting has emerged as a promising treatment option for patients who are refractory to medical therapy or intolerant to medications like acetazolamide.

The VEHICLE Registry collects real-world data from multiple centers in the MENA region to evaluate the efficacy and safety of venous sinus stenting in patients with IIH. The registry analyzes patient demographics, clinical presentations, imaging findings, treatment details, and outcomes over a six-month follow-up period to improve understanding and management of IIH in this population.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 60 years.

Diagnosed with Idiopathic Intracranial Hypertension (IIH) based on the modified Dandy criteria, including:

Symptoms of increased intracranial pressure (e.g., headache, visual disturbances).

Elevated opening pressure (\>250 mm H₂O) on lumbar puncture with normal cerebrospinal fluid composition.

No evidence of intracranial pathology (e.g., mass lesion, hydrocephalus) on neuroimaging.

Presence of papilledema. Evidence of venous sinus stenosis on Magnetic Resonance Venography (MRV) or Digital Subtraction Angiography (DSA).

Refractory to medical therapy or intolerant to medications (e.g., acetazolamide).

Willingness to undergo venous sinus stenting. Provided informed consent for participation.

Exclusion Criteria:

* Secondary causes of intracranial hypertension (e.g., cerebral venous sinus thrombosis, neoplasm).

Coagulopathies or contraindications to antiplatelet or anticoagulation therapy. Pregnancy or lactation. Incomplete baseline data or inability to complete follow-up assessments. Severe comorbid conditions that preclude endovascular procedures.
Re-treatment From a Phase I Study of MSC-AFP in Patients With Perianal Fistulas

This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and 15-003200 (cryptoglandular perianal fistulas).

This study is an extension to re-treat partial and non-responders from the previously approved Phase 1 MCS-AFP protocols IRB #12-009716 (Crohn's Disease perianal fistulas) and 15-003200 (cryptoglandular perianal fistulas). This study will enroll patients that have persistent symptomatic perianal disease despite being treated with an MSC coated fistula plug, and also treat patients that have had recurrence of their perianal fistula.

As per the previously approval treatment under IND 15356, patients will have a single affected fistula treated, which is the same fistula that was treated in the original protocol. The matrix for delivering the cells is a Gore Bio-A Fistula Plug.

Subjects will be screened at outpatient clinic visits and interested qualified subjects will be offered participation in the trial and consented. At the first study visit (Visit 1; Screening visit), the patient will be evaluated and assessment will be made if an EUA is clinically necessary to assess the fistula. As this is a re-treatment trial, patients with incomplete response to initial plug placement typically have close follow up, recent MRI imaging, and may have a seton in place. If an EUA is clinically indicated, this would be by a colorectal surgeon for drainage of sepsis and placement of a seton as part of the standard clinical care for perianal fistula.

Patients will return on: Day 1, Week 4, Week 12, and Week 24.

Eligibility Criteria:
Inclusion Criteria

1. Males and females 18-65 years of age.
2. Residents of the United States.
3. Single draining perianal fistula for at least three months despite standard therapy
4. Concurrent therapies are permitted (such as antibiotics, corticosteroids, thiopurines).
5. Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
6. Ability to comply with protocol
7. Competent and able to provide written informed consent
8. Patients that were treated with an MSC-coated fistula plug in the study IRB#12-009716 or IRB#15-003200

Exclusion Criteria

1. Inability to give informed consent.
2. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
3. Specific exclusions: Evidence of hepatitis B, C, or HIV
4. History of cancer including melanoma (with the exception of localized skin cancers)
5. Investigational drug within thirty (30) days of baseline
6. A resident outside the United States
7. Previous allergic reaction to a perianal fistula plug.
8. Allergic to local anesthetics
9. Pregnant patients or trying to become pregnant or breast feeding.
10. Non-enterocutaneous tracts (i.e. recto-vaginal, entero-vesicular)
Utilisation of Telemedicine in Optimal Cardiac Rehabilitation Program in Patients After Myocardial Revascularization

Although clinical data demonstrate advantages of combining complete revascularization with optimal cardiac rehabilitation (CR) less than one-third of patients in European countries participate in cardiac rehabilitation programs. Therefore, in cooperation with Polish leaders in cardiovascular medicine, rehabilitation and medical software design we aim to introduce and evaluate the system of optimal cardiac telerehabilitation in addition to optimal treatment of coronary artery disease.

Although clinical data demonstrate advantages of combining complete revascularization with optimal cardiac rehabilitation (OCR) less than one-third of patients in European countries participate in cardiac rehabilitation programs.

In addition, the major limitations of current CR programs are their short duration without long-term follow-up, lack of appropriate clinical and functional monitoring, and structural problems including geographic misdistribution of available programs. Therefore, in cooperation with Polish leaders in cardiovascular medicine, rehabilitation and medical software design we aim to introduce and evaluate the system of optimal cardiac telerehabilitation in addition to optimal treatment of coronary artery disease. Primarily, the telerehabilitation system will be designed and developed. Secondly, coordinating center will be build and technical tests will be performed in order to evaluate its integrity with telerehabilitation system. Thirdly, the whole system will be validated in clinical settings on patients' population with coronary artery disease and completed revascularization. Finally, procedural steps will be executed in order to prepare the whole system of optimal cardiac telerehabilitation for implementation.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 and below 70
* completed revascularization in patients with stable or unstable angina or after myocardial infarction without ST-segment elevation (NSTEMI)
* in patients with suspected myocardial scars, MRI will be recommended to confirm myocardial viability.
* eligibility to participate in a program of early cardiac rehabilitation
* signed informed consent form
* the ability to use telerehabilitation system

Exclusion Criteria:

* acute myocardial infarction with ST segment elevation/new onset of left bundle branch block (LBBB),
* suboptimal (not completed) revascularisation
* ejection fraction \<40%.
* acute heart failure (Killip IV) at the time of admission to the hospital
* dual antiplatelet therapy can not be maintained for 1 year after PCI
* haemorrhagic stroke in the past
* ischemic stroke or transient ischemia in previous 6 weeks
* platelet count \<100,000 / mm3
* chronic renal failure with creatinine clearance \<30ml / min / 1.73m2
* planned surgery
* pregnancy or planned pregnancies
* expected life expectancy less than 3 years after enrollment