cyrilzakka/clinical-trials huggingface dataset:
Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)

The Researchers are studying whether a vascular boot warming program plus standard of care anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT) ±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS). Additionally, to learn whether a more detailed imaging of the affected lower extremities will provide a more accurate and reliable method to guide treatment for this condition.

Participants with diagnosis of acute lower extremity DVT (proximal and distal) and/or pulmonary embolism will be identified and approached for participation, when they are seen in the Thrombophilia Clinic or Mayo Hospital for management of the acute VTE. If they match the preset inclusion and exclusion criteria, they would then be consented during this visit and scheduled for baseline studies at a later date. Baseline tests include Venous plethysmorgraphy, Lower Extremity Ultrasound, and Medical history, will be conducted and if eligible, participant will then be randomized to vascular boot plus standard anti coagulation program or standard anti coagulation using a randomization program. Participants will be randomized into two groups and followed for 3 months. Standard of Care (SOC) Group (no vascular boot utilized): Patients will receive standard anticoagulation (determined at discretion of the treating provider), baseline studies, and follow up at the end of treatment (3months). Vascular Boot (VB) Group (includes vascular boot in addition to SOC): Patients will receive standard anticoagulation (determined at discretion of the treating provider), baseline studies and standardized vascular boot warming. All patients randomized to this group will wear the vascular boot for a minimum of 30 minutes per day for the first 10 days of participation. Patients in this group may initially be enrolled at either the thrombophilia clinic or the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Able to tolerate wearing a vascular boot, if randomized to this group.
* Diagnosis of acute DVT±PE (within 24 - 48 hours) and received approximately 24 hours of anticoagulation prior to starting the study.

Exclusion Criteria:

* Unable to tolerate wearing a vascular boot
* Unable to comply with keeping log of activity/ of wearing a vascular boot.
* Weight \> 300 pounds. (weight limit for the venous plethysmography chair)
* Previous history of DVT or PE.
* On anticoagulation for another purpose (example stroke prevention with atrial fibrillation).
* Patients who do not accept to participate in research studies.
* Pregnant women will not be allowed to participate
* Patients less than 18 yrs
Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy

This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.

To achieve this:

* The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2\*. The other data will be extracted from usual sequences.
* Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
* Usual blood samples will be completed by samples for the serum library


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been informed about the research
* Patients with national health insurance cover
* Patients who are overweight (BMI \> 25) or have type 2 diabetes suggesting a disturbance of hepatic enzymes (ASAT \< 8 times normal values and ALAT \> twice normal values) after a complete hepatopathy assessment
* Obese patients with a hepatic anomaly (steatosis) revealed by imaging or biological assessment (ASAT \< 8 times normal values and ALAT \> twice normal values) who are eligible for bariatric surgery and a preoperative liver MRI examination.

Exclusion Criteria:

* Non-corrected coagulation disorder.
* Patients aged over 80 years
* Patients aged less than 18 years
* Patients without legal protection
* Patients with a contra-indication for MRI (Pacemaker, intraocular metallic foreign body, weight\>150kg)
* Patients without national health insurance cover
Trifecta™ GT Post Market Clinical Follow-up

The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide.

Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
2. Subject is of legal age in the country where the subject is enrolled.
3. Subject must be willing and able to provide written informed consent to participate in this study.
4. Subject must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
2. Subject has contraindication for cardiac surgery.
3. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
4. Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
5. Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
6. Subject is undergoing renal dialysis.
7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
8. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
9. Subject has a left ventricular ejection fraction \< 30%.
10. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
12. Subject has a life expectancy less than 2 years.
Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device

The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions

During the study, the investigators are planning to make a secondary use of vaginal discharge samples that are primarily taken for routine wet mount microscopic diagnostics in a vulvovaginal clinic at the Women's health center, Ramat-Eshkol, Jerusalem.

In order to create an anonymous archive of digital microscopy images, before each swab is disposed of, the investigator will dilute the collected discharge on the swab with 0.5ml Saline into an Eppendorf tube. The diluted discharge will then be applied onto the GynTools LTD VagX tray that is then scanned by a tabletop scanner. At this point the VagX tray will be washed with water, soap and both the swab and tube will be disposed of.

No of participating patients: 1000 Patients age: 18 years and above. Only from patients capable of signing an informed consent.

Eligibility Criteria:
Inclusion Criteria:

Vulvovaginal complaints

Exclusion Criteria:

Younger than 18y or cannot sign an informed consent form
Honduras Liger Thermocoagulator Study

This was a prospective study to evaluate the short-term safety and acceptability of the Liger Medical thermal coagulation device for treatment of cervical precancerous lesions. Study results will inform the Honduras Ministry of Health regarding potential use of the Liger device for precancer treatment in Honduras and results may be of interest to other Latin American settings as well.

The research was conducted in the Tegucigalpa Region in Honduras in 4 health facilities in urban and peri-urban settings. Participants were women ages 30-49 who met the study eligibility criteria. Human papilloma virus (HPV) and visual inspection with acetic acid (VIA)-positive women who were eligible for ablative treatment were offered thermal coagulation with the Liger instrument to treat their lesions and asked about acceptability of the treatment. At this visit, biopsies were also be taken. Women were followed-up at 1 month to evaluate short-term safety outcomes with a physical exam and receive their biopsy results. Depending on their biopsy results, they will be asked to return for repeat screening, referred for further treatment or asked to come back for a 12-month study visit. At the 12-month visit after treatment, women were followed up to evaluate cure rates.

A second investigational device, Pocket Colposcope, was used to take cervix photos at the enrollment and 12-month study visit with participant consent. The photos were used to explore factors influencing treatment failure. De-identified photos and women's diagnosis information were also shared with the device developers, Duke University, for the purposes of improving their device. Women had the option to opt out of having cervix photos taken and still participate in the treatment portion of the study.


Eligibility Criteria:
Inclusion Criteria:

Women

* Aged 30 to 49 years.
* HPV and VIA positive.
* Eligible for ablative treatment using World Health Organization Guidelines \[29\].

  * The lesion covers \<75% of the cervix, the lesion does not enter the endocervical canal, the entire lesion can be visualized and covered by the Liger Medical Thermocoagulator probe, and there is no suspicion for invasive cancer.

Exclusion Criteria:

* Are pregnant or less than 3 months post-partum
* Are not HPV and VIA positive
* Do not have a cervical lesion that qualifies for ablative treatment
* Have a bleeding disorder or taking anti-coagulant medication.
* Do not give informed consent; or unable to provide the consent.
Revised Capsular Polishing and Its Impact on the Positioning of the Intraocular Lens and Visual Quality Following Femtosecond Laser-assisted Cataract Surgery

This study aims to investigate the impact of improved capsular polishing on the long-term stability of effective lens position (ELP) and visual quality in patients following femtosecond laser-assisted cataract surgery combined with intraocular lens implantation. Throughout the follow-up period, changes in ELP were observed using OCT to measure the central corneal posterior surface to the IOL anterior surface. The contraction of the anterior capsule orifice was assessed through anterior segment photography, and its diameter and area were measured and analyzed using drawing software at each follow-up visit. Additionally, the investigators analyzed the correlation between the degree of anterior capsule orifice contraction and ELP, as well as examined whether ACO formed and its degree, PCO formation and its degree. Objective examination using OQAS II was conducted to measure PSF, MTF, OSI, and SR of patients; high-order aberrations including astigmatism, trifolium, and spherical aberration were measured by OPD-Scan III. Furthermore, the investigators investigated the correlation between ACO/PCO degrees and visual quality.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with age-related cataract
2. Patients seeking to reduce their reliance on corrective eyewear postoperative and exhibiting high expectations for optimal visual acuity at all distances - near, intermediate, and distant
3. Anticipated postoperative astigmatism of ≤1.00D
4. Pupil diameter in a darkened environment ranging from 3.0-5.5 mm
5. Kappa angle ≤0.5 mm or less than half the diameter of the central refractive optical zone of the MIOL.

Exclusion Criteria:

1. Progressive and aggravated retinal diseases, such as diabetic retinopathy, macular degeneration, preretinal membrane, vitreous macular traction syndrome, Stargardt disease, retinitis pigmentosa, etc., and serious optic nerve diseases
2. Small eyeballs, ultra-high myopia, obvious pupil abnormalities, severe corneal lesions, severe irregular astigmatism, chronic uveitis, glaucoma, obvious abnormalities of lens capsule membrane and suspension ligament, major degree alternating strabismus and other ocular organic diseases and amblyopia
3. Severe mental and psychological diseases
4. History of internal eye surgery
5. Posterior capsule rupture or uneventful in-the-bag IOL implantation
Treatment of Patients With Nocturia

The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 50 years or older
* Nocturia of 6 or more months duration averaging 2 episodes or more per night

Exclusion Criteria:

* CHF
* Diabetes
* Diabetes Insipidus
* Renal Insufficiency
* Hepatic Insufficiency
* Incontinence
* Illness requiring steroids
* Current or past urologic malignancy
* Nephrotic Syndrome
* Unexplained pelvic masses
* Urinary bladder neurological dysfunction
* Urinary bladder surgery or radiotherapy
* Sleep Apnea
* Pregnant or breast feeding
Complaints and Presumptive Diagnosis in a Danish Emergency Department

Acute patients in Denmark are often admitted to Emergency Departments by their General Practitioner with a presumptive diagnosis.

The aim of this study is to evaluate the diagnostic value of the pre-admission presumptive diagnosis and to assess if the presumptive diagnosis could be replaced by a number of symptom-based groups.


Eligibility Criteria:
Inclusion Criteria:

* all acute patients admitted to emergency department

Exclusion Criteria:

-
Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry

Myocardial bridge (MB) is a congenital anomaly of epicardial circulation characterized by an intramural course of a coronary segment. This anatomical arrangement causes the artery to be squeezed during systole potentially causing flow impairment and ischemia. For this study, MB is defined as the presence of systolic compression in an epicardial vessel causing at least 50% of caliber reduction from diastole. MB can be disabling as it worsens the quality of life. Early detection of this congenital condition is crucial, and an invasive functional assessment of the ischemic burden should be considered to evaluate the need for medical or surgical therapy.

This is an observational study, involving four Italian centres. Study Objectives are: To assess the risk of future cardiovascular complications in patients with MB referred for coronary angiography and the role of beta-blocker therapy; To describe the clinical and anatomical characteristics of patients presenting with MB; To determine the impact of cardiovascular medications on symptoms in patients with MB; To describe the anatomical and clinical features associated with the invasive evidence of ischemia in patients with MB; To assess the relation between invasively documented ischemia and clinical manifestations in patients with the MB. Inclusion Criteria: patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have an MB with or without other epicardial lesions amenable to revascularization; Age above 18 y.o.; Ability to provide Informed Consent. Exclusion Criteria are Patients with life expectancy below 12 months and Patients with severe valvular heart disease. The primary endpoint is the incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization, and target vessel revascularization. The secondary endpoint is evaluating the Rate of patients with SAQ \< 70 and the Rate of patients with "high-risk features" on CT scan.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization
* Age above 18 y.o.
* Ability to provide Informed Consent

Exclusion Criteria:

* Patients with life expectancy below 12 months
* Patients with severe valvular heart disease
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer

The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy.

Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.

The primary objective is to evaluate the efficacy of AMG 386 in combination with sorafenib as measured by the progression free survival (PFS) rate at 4 months in subjects with advanced or inoperable hepatocellular carcinoma (HCC).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or inoperable HCC
* Child-Pugh A liver function score
* Measurable disease with at least one unidimensionally measurable lesion per RECIST 1.0 guidelines with modifications
* Adequate organ and hematological function
* Men or women greater than or equal to 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less

Exclusion Criteria:

* Subject is eligible for a liver transplant per investigators discretion
* Any previous systemic chemotherapy for HCC
* History of arterial or venous thromboembolism within 12 months prior to enrollment
* History of clinically significant bleeding within 6 months prior to enrollment
* History of central nervous system metastases
* Clinically significant cardiovascular disease within 12 months
* Uncontrolled hypertension
* Subjects with a history of prior malignancy
Evaluate the Relationship of Bone Remodeling Markers for Skeletal Complications in Metastatic Breast Cancer Patients

to evaluate whether bone marker can provide the valuable predictor of skeletal complications and whether regular assessing of NTX(N-telopeptide of type I collagen) and osteocalcin can be useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.

to evaluate the efficacy and safety of zoledronic acid by measuring changes in bone turnover markers

* the incidence of skeletal-related events
* time to skeletal-related events
* time to bone metastases progression
* overall survival
* the incidence of each adverse event including osteonecrosis

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or CT/MR imaging)
2. Men or women aged ≥ 18 years
3. WHO (ECOG) performance status 0-2
4. Women of child-bearing potential must be using a reliable and appropriate method of contraception
5. Urine sample taken and sent to the central laboratory for baseline Ntx analysis
6. Written informed consent.

Exclusion Criteria:

1. Bisphosphonate treatment within the 4 weeks prior to planned first study treatment
2. Abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute
3. Poor venous access
4. Metabolic bone disease
5. Unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements
6. Estimated life expectancy of \< 6 months
7. Treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry
8. Wide field (hemi-body) radiotherapy within the 3 months prior to study entry
9. Concomitant medication with drugs known to affect bone metabolism
10. Pregnancy or breast-feeding
11. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (ONJ)
12. Recent (within 4 weeks of study entry\*) or planned dental or jaw surgery
Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients

Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase III trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multidrug-resistant TB, but sensitive to levofloxacin and moxifloxacin

Exclusion Criteria:

* Achieved negative conversion of M. TB culture before the enrollment
* Positive anti-HIV antibody
* Pregnant women or sexually active women without using proper birth control method
* Serum creatine grater than 2mg/dL, or urine protein greater than 2+
* Serum total bilirubin greater than 2 mg/dL or AST and ALT greater than 1.5 times of normal upper limit
* History or current arrhythmia
* Hypersensitivity to levofloxacin, moxifloxacin,or rifabutin
* Should use drug containing metal-ion, warfarin, phenytoin, theophylline, probenecid regularly