cyrilzakka/clinical-trials huggingface dataset:
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer

Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.

Investigators designed a prospective phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) scheduled for oligometastatic breast cancer patients unsuitable for surgery with age major than 18 years old and with adequate performance status (ECOG), using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years with ECOG 0-2
* Diagnosis of Breast Cancer
* DFI (Disease-free interval) \> 1 year
* No extrapulmonary and/or extrahepatic disease or other metastatic sites stable or responding after chemotherapy
* No life threatening conditions
* Lung and liver lesions \< 5 (with maximum diameter \< 5 cm)
* Chemotherapy completed at least 3 weeks before treatment
* Chemotherapy started at least 2 weeks after treatment allowed
* Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
* Written informed consent

Exclusion Criteria:

* ECOG \> 2
* Pregnant women
* Patients with inability to consent
Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis

Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline.

This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any race and ≥ 18 years of age.
2. Willing and able to provide voluntary written informed consent.
3. Moderate to severe conjunctivochalasis defined by:

   * LIPCOF score ≥ 2; and
   * Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
4. Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:

   * Subject has been diagnosed or treated for another malignancy within 3 years of screening, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
   * A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
2. Subjects with pterygium.
3. Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
4. Subjects with blepharitis requiring treatment.
5. Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
6. Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
7. Subjects who have used any of the following medications or treatments:

   * LASIK or PRK surgery within 12 months of Visit 1.
   * Use of contact lenses within 7 days of Visit 1.
   * Punctal plug insertion within 30 days of Visit 1.
   * Use of topical or systemic cyclosporine within 30 days of Visit 1.
   * Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit 1.
8. Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).
9. Active abuse of alcohol or drugs.
10. Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
11. Participation in a clinical trial of an investigational (unapproved) drug or device within 1 month prior to screening or scheduled to receive another investigational drug or device during this study
The Effects of Active Surveillance Protocol on Long Term Quality of Life in Patients With Mild Pericoronitis

The complications that could occur during or after the extraction of the mandibular third molar teeth with pericoronitis affect patient's life quality considerably. Various scales are used to reveal how much the life quality of patients is affected this treatment. The aim of this study is to identify the long term life quality of patients through the OHIP-14 TR scale without removing the mandibular third molar teeth with mild pericoronitis.

Increasing the lenght stay in the mouth at a maximum rate and following the patient up after the necessary treatment and information procedures are completed. As a result of clinical and radiographical examinations fifty-five voluntary patients whose average age was 24 and who have semi or fully errupted vertical mandibular third molar teeth with the diagnosis of mild pericoronitis were included in the study.After the patients in the study filled out the form including their contact and demographic data and dental symptomsand completed OHIP-14 TR scale which last about 5 minutes, their curretage and operculectomy treatments were done under local anesthesia. The patients were invited for reexamination on seventh day after the treatment. Also, an active patient follow up about life quality was performed by phone at 1,3,6 month after the treatment using the self -assessment question form and the OHIP-14 TR scale.

Eligibility Criteria:
Inclusion Criteria:

* having the first episode of mild pericoronitis, having a good periodontal health, having an age between 18 and 25 years
* having a diagnosis of pericoronitis of a vertically erupted or semi erupted lower third molar, having no systemic discomfort and being in the ASA I and ASAII

Exclusion Criteria:

* having no lower third molar with a vertical position
* having a systemic discomfort
* having moderate to severe pericoronitis
* having a history antibiotics or NSAIID
Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients

The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit (ICU) who received continuous glucose monitoring (CGM) vs point of care (POC) glucose monitoring. The study will examine relevant outcomes for patients in the ICU with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).

Study Purpose:

The purpose of this study is to compare the use of continuous glucose monitoring (CGM) versus point of care (POC) glucose monitoring in the intensive care unit (ICU) setting for differences in glycemic control and other important outcomes.

Research Plan:

This will be a prospective, single-center, randomized comparative trial of adult patients at North Florida/South Georgia Veterans Health System anticipated to be admitted to an ICU for a minimum of 48 hours after enrollment. Study participants will be randomly assigned to one of the study groups (CGM or POC) after being found eligible for inclusion and giving consent to participate. The CGM group will receive glycemic management based on CGM readings. The POC group will receive glycemic management based on POC glucose readings.

Study Outcomes:

Groups will be compared for differences in clinical and safety outcomes. The primary outcome will be the proportion of time in target range (BG 70-180mg/dL). Secondary outcomes will include mean glucose, hypoglycemia, hyperglycemia, ICU length of stay, mortality, glucose variability, cost, and patient satisfaction. Safety outcomes will include new infection, acute kidney injury, delirium, agitation, and pain.

Analysis Methods:

Descriptive statistics and inferential statistical methods will be used as appropriate to report findings of this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-89
* Past medical history of any diabetes mellitus OR patients with at least 1 measured BG of 180 being treated with insulin (subcutaneous or infusion)
* Enrollment will occur within 72 hours after being admitted to an ICU if history of diabetes
* Enrollment will occur within 72 hours after developing hyperglycemia in ICU if no diabetes

Exclusion Criteria:

* Pregnant patients
* Patients using CGMs in the outpatient setting
* Diagnosis of diabetic ketoacidosis (DKA)
* Diagnosis of hyperosmolar hyperglycemic state (HHS)
* Anticipated to require prone positioning while on insulin therapy
* Any contraindications to CGMs based on manufacturer labeling
* BG above maximum reading for CGM (e.g. greater than 400 mg/dL)
* Receiving medication that could interfere with CGM readings (based on manufacturer specifications)
* Receiving any dose of hydroxyurea as this could falsely elevate the sensor readings (if applicable for specific CGM)
* Receiving greater than 1,000mg acetaminophen every 6 hours in any form as this could falsely elevate the sensor readings (if applicable for specific CGM)
Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

Vasoplegic syndrome (VS) is a common and serious complication of cardiopulmonary bypass (CPB) procedures associated with a significant increase in morbidity and mortality. VS is defined as significant hypotension, high or normal cardiac outputs, low systemic vascular resistance, low cardiac filling pressures, and vasopressor requirement despite adequate fluid resuscitation following CPB. Extensive research has been performed regarding the pathophysiologic response to CPB and risk factors associated with VS. No safe and effective preventive strategy has gained widespread use. Supportive care with intravenous (IV) vasopressors has thus been adopted as standard of care. The use of these medications, while effective in the majority of patients, generally necessitates close monitoring in an intensive care unit (ICU) setting. These patients are subject to prolonged ICU and hospital stays, as well as the potential complications of prolonged use of central venous lines (CVL) required to give these medications. Recent studies suggest midodrine, a generic oral vasopressor, may accelerate the decline in IV vasopressor requirements in select ICU patients. At our institution, the addition of midodrine to IV vasopressors for the treatment of VS has been observed to be effective in reducing IV vasopressor duration. No literature exists describing the use of midodrine in this patient population. The goal of this study is to investigate the novel use of midodrine in CPB surgery complicated by VS. Ultimately, we hope to produce literature supporting its use that may be applied on a global scale to improve patient care


Eligibility Criteria:
Inclusion Criteria:

* post-cardiopulmonary bypass surgery
* vasoplegic syndrome criteria

  1. MAP \< 65mmHg
  2. Cardiac index\>/=2.4 L/min/m\^2, as determined by Swan-
  3. systemic vascular resistance index \</=1400 dynes s/cm\^5/m\^2
  4. adequate fluid resuscitation as determined by treating critical care team
* vasopressor requirement

  1. norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT
  2. vasopressin any dose

Exclusion Criteria:

* allergy to midodrine
* pregnancy
* midodrine or cardiac glycoside as preadmission medication
* history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma
* severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease)
* liver failure/cirrhosis
* chronic kidney disease (GFR \<30mL/hr)
* ventricular assist device implantation procedure, intra-aortic balloon pump placement, or heart transplantion
* unresolved post-operative acute kidney injury (rise in serum creatinine by \>/= 0.5mg/dl from baseline
* inadequate tissue oxygenation (lactate \> 2 mmol/L)
* inability to take oral medications
Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation

This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.


Eligibility Criteria:
Inclusion Criteria:

Severe functional tricuspid regurgitation

Exclusion Criteria:

prior surgery or congenital heart diseases with involvement of the tricuspid valve
Intra-articular Lopain (MTX-071) Phase I/IIa Study in Chronic Osteoarthritic Knee Joint Pain

Phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.

Open label, single-dose, dose-escalating phase I/IIa study to determine the safety and clinical effects of intra-articular injections of MTX-071 (Lopain) in patients with chronic osteoarthritic knee-joint pain.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Written informed consent
* Men or women aged between 40 and 70 years
* At least 40 mm on motion and at least 10 mm at rest on the 100 mm-VAS (Visual Analog Scale) for average arthritic joint pain in the knee to be studied during the last 2 days, with or without pain medication.
* Previously documented radiography showing a Kellgren Lawrence Grade 2 - 4 severity.
* Female patients of childbearing potential or female partners of childbearing potential of male patients must agree to use a reliable contraceptive method for at least one month after the injection of MTX-071.
* Subject is highly likely to comply with the protocol and complete the study.

Exclusion Criteria:

* Knee surgery within 6 months before study start or planned for any time during the next 6 months.
* Any injection into the knee to be studied within the preceding 7 days or trauma to the knee not yet healed.
* History of any clinically significant cardiac, renal, and/or other relevant disease or malignancy.
* History of severe allergic or anaphylactic reactions.
* Pregnancy.
* Major bleeding disorder.
* Clinically significant deviation from the normal laboratory values.
* Clinically significant abnormal ECG
* History of clinically relevant drug/chemical/ substance/alcohol abuse within the past 2 years prior to screening.
* Symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration.
* Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg), tuberculosis.
* Patients who had a corticosteroid injection in the knee to be studied within 3 months prior to baseline or are planned to get a corticosteroid injection within 4 weeks following the injection of MTX-071.
* Vaccination within 60 days prior to study medication administration.
* Systemic immunosuppressant agent within 6 months prior to study medication administration
* Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
* Any other condition, which in the opinion of the investigator, precludes the subject's participation in the trial.
* Patients who are dependent on the sponsor or investigator.
An Expanded Access Program for Risdiplam in Participants With Spinal Muscular Atrophy (SMA)

This expanded access program (EAP) will provide access to risdiplam for eligible participants with Type 1 or Type 2 spinal muscular atrophy (SMA) before it is commercially available in the United States for the indication of SMA.


Eligibility Criteria:
Inclusion Criteria:

All Participants:

* Not eligible for treatment with currently approved treatments for SMA, or cannot continue treatment with currently approved medications as documented by the treating physician, or in the treating physician's judgment, the participant is at risk of lack/loss of treatment efficacy of the current therapy.
* The participant does not qualify for and has no access to SMA treatment in the context of an ongoing clinical trial.
* Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate, in the opinion of the treating physician.
* Participants with retinopathy of prematurity should have evidence of stable disease.

Type 1 SMA Participants:

- Confirmed diagnosis of 5q-autosomal recessive SMA.

Type 2 SMA Participants:

* Confirmed diagnosis of 5q-autosomal recessive SMA.
* Negative blood pregnancy test at screening (all women of childbearing potential, including those who have had a tubal ligation), and agreement to comply with measures to prevent pregnancy and restrictions on egg and sperm donation.
* Males with female partners of reproductive potential must agree to use highly effective contraception during therapy, and for at least 4 months after treatment discontinuation.

Exclusion Criteria:

* Inability to meet program requirements.
* Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening or 5 half-lives, whichever is longer.
* Administration of other SMN-2 targeting therapy within 120 days of starting risdiplam therapy.
* Administration of SMA gene therapy within the last 3 months (12 weeks) of receiving risdiplam therapy.
* Any serious medical condition, treatment, or abnormality in clinical laboratory tests that, in the treating physician's judgment, precludes the participant's safe participation in the program.
* Ascertained or presumptive hypersensitivity (e.g., anaphylactic reaction) to risdiplam or to the constituents of its formulation.
* Suspicion of illicit drug or alcohol abuse, in the treating physician's judgment.
* Any prior use of an inhibitor or inducer of flavin-containing monooxygenases 1 (FMO1) or flavin-containing monooxygenases 3 (FMO3) taken within 2 weeks (or within 5 times the elimination half-life, whichever is longer) prior to dosing.
The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study

Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA).

The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18 years old to perimenopause who present with or without abnormal uterine bleeding and who have an endometrial biopsy result which shows endometrial hyperplasia without atypia
* women willing to have the etonogestrel implant (Implant NXT) for the duration of treatment (6-12 months)
* women who wish to retain their uterus

Exclusion Criteria:

-
Contrast-associated Acute Kidney Injury in Patients With Different Types of Coronary Artery Disease

The goal of the study is to assess the prevalence of contrast-associated acute kidney injury in patients with stable coronary artery disease, ST-elevation myocardial infarction and unstable angina/NSTEMI, assess the risk factors of contrast-induced acute kidney injury development and the influence of contrast-induced kidney injury on 1-year prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-80
* Stable CAD receiving optimal medical treatment requiring PCI or STEMI or NSTEMI
* Intra-arterial injection of iodinated contrast media
* Informed consent

Exclusion Criteria:

* Age less than 18
* Pregnancy, lactation
* Refuse to sign the informed consent
* Contraindications for PCI
* Other conditions affecting prognosis (oncology, liver failure etc)
* CKD stage 4-5
* Patients receiving nephrotoxic drugs
Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis

Randomized controlled trial on high-risk patients with ACC. Consecutive patients with a diagnosis of ACC, if they meet the inclusion and exclusion criteria, will be randomized to receive Laparoscopic cholecystectomy (LC) or transmural ultrasound-guided gallbladder drainage (TUGD) with lumen-apposing self-expandable metal stents (LAMSs) within 10 days from onset of symptoms. Blood cultures will be performed at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. Bile samples will be taken during the procedure for microbiological exam and culture. Blood samples will collected from all patients at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure.

The follow-up will be performed after 30 days and after 6 months from intervention with an outpatient medical examination.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
* be ≥ 18 years old
* have a POSSUM PS ≥ 25
* onset of symptoms \<= 7 days before Emergency Department (ED) admission
* provide signed and dated informed consent form
* willing to comply with all study procedures and be available for the duration of the study
* have an Israelian Score (IS) (Table 3) for the risk of main bile duct stones \<2 or an IS =2 and an EUS or a MRCP negative for main bile duct stones

Exclusion Criteria:

* Pregnancy
* Patients unwilling to undergo follow-up assessments
* Patients diagnosed with concomitant pancreatitis
* Acute cholecystitis not related to a gallstone etiology
* Onset of symptoms \>7 days before ED admission
* Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
* Previous drainage of the gallbladder
* Biliary peritonitis