cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of Balanced Salt Solution During Cataract Surgery

This study aims to identify if the use of BSS PLUS® Sterile Intraocular Irrigating Solution as an irrigation solution leads to improved corneal outcomes vs BSS® Sterile Irrigating Solution in more compromised corneas.


Eligibility Criteria:
Inclusion Criteria

1. Adults, 22 years of age or older, with bilateral visually significant cataracts.
2. Subjects with Fuch's Dystrophy that present with:

   1. nonconfluent and confluent guttata; and/or
   2. CCT \> 580 microns.
3. Unremarkable systemic health but inclusive of controlled type II diabetes and hypertension
4. Ability to comprehend and sign a statement of informed consent.
5. Ability to complete all required postoperative visits.
6. Willingness to use at least one medically acceptable form of birth control throughout the duration of study participation. (for female subjects of childbearing potential only).

Exclusion Criteria

1. Planned implantation of multifocal intraocular lenses.
2. Planned secondary procedure(s) to occur in conjunction with cataract surgery (i.e., goniotomy)
3. History of severe dry eye.
4. Retinal and retinal vascular pathologies, age-related macular degeneration
5. Uncontrolled systematic diseases, including: hypertension, diabetes, systemic cardiovascular diseases and hematological diseases.
6. Autoimmune disease such as rheumatoid arthritis.
7. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
* Male or female subjects aged ≥ 65
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

Exclusion Criteria:

* Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
* Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
* Suspected or proven acute promyelocytic leukemia
* Prior bone marrow or stem cell transplantation
* Candidate for allogeneic bone marrow or stem cell transplantation
* AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
* Presence of malignant disease within the previous 12 months with exceptions
STOP PAIN: Septal Closure of PFO - Does it Prevent Migraine?

The primary objective of this Study is to compare the effect of transcatheter device closure of atrial shunting to a non-closure control group over a period from cessation of procedure related medication at 3 months until 9 months post randomization by determining the proportion of patients that experience a 50% or more reduction in the baseline monthly migraine attack frequency in each group.


Eligibility Criteria:
Inclusion Criteria:

* Migraine history of at least 1 year.
* Migraine patients experiencing at least 2 migraine attacks per month.
* Migraine patients experiencing at least 1 migraine attack with aura per month.
* Failure of or intolerance to at least 2 classes of prophylactic migraine medication evaluated in adequate, approved medication trials. At least one of the classes shall come from beta-blockers, anticonvulsants, calcium channel blockers and tricyclic antidepressants.
* Aged 18 - 50 years and of legal age in the host country.
* The patient or legal guardian has signed a study specific informed consent form agreeing to data collection and follow-up requirements.
* The patient agrees to abstain from starting prophylactic migraine medication or agrees to maintain existing prophylactic migraine medication without changing dose or drug from entering the baseline period throughout the duration of the study until final assessments.
* Documented right to left shunt that is suitable for device closure.

Exclusion Criteria:

* Taking migraine preventative medication for conditions other than migraine.
* History of 15 or more headache days per month.
* 8 or more non-migraine headache days per month.
* Overuse of acute headache medication (use on 10 or more days per month).
* Patient has severe central nervous system disease such as seizure disorder, inflammatory disease of the central nervous system, or a previous stroke.
* Previous surgical or device closure of a PFO or ASD.
* Artificial heart valve.
* Pacemaker or ICD implanted within past 3 months.
* Anatomic variant that could affect successful deployment such as coronary sinus, pulmonary veins, Chiari network.
* Uncontrolled bacteremias or dental or surgical procedure within past 30 days or planned within study period.
* Allergy to contrast media, and/or to any component of the device to be used.
* Contraindicated for any medication used during or after the procedure.
* History of atrial fibrillation or atrial flutter (chronic or paroxysmal).
* Patient is enrolled or intends to participate in another clinical study (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrollment in the study.
* Patient is undergoing dialysis for renal failure.
* Patient has NYHA class 3 or 4 cardiac failure.
* Patient is pregnant, or intends to become pregnant during the trial period.
* Patient requires anticoagulation therapy for a concomitant condition.
Non-Encapsulated Heme Levels in Adult Cardiac Surgery

Non-encapsulated (free) heme, a breakdown component of hemoglobin, is associated with oxidative stress and inflammation with consequent cellular and tissue injury (Ryter \& Tyrrell, 2000) (D T G Wagener, et al., 2001). Cardiopulmonary bypass is known to cause trauma to cellular components of the blood, to trigger an inflammatory response, and alter the rheology of the circulation. Prior research has demonstrated an increase in levels of free heme with cardiopulmonary bypass (Wetz, Richardt, Schotola, Bauer, \& Bräuer, 2017) (Kubota, Egi, \& Mizobuchi, 2017). The stress response to cardiac surgery and utilization of blood salvage techniques independent of cardiopulmonary bypass may affect plasma free heme levels as well as regulation of heme metabolism pathways. It is unclear whether and to what degree plasma levels of free heme may vary at discreet time points in the perioperative period during cardiac surgery involving both cardiopulmonary bypass and "off-pump" techniques.

This is an observational, prospective cohort study in which we will assess for red blood cell trauma, free heme levels, and biomarkers for acute kidney injury at various time points throughout cardiac surgery. Urine and arterial blood samples will be collected at our routine, standard of care time points pre-, intra-, and post-operatively and in addition to the standard clinical tests that will be performed (arterial blood gas analysis and activated clotting time) several additional serum biomarkers will be analyzed. Clinical correlation will be performed with levels. Sub-analysis will be performed on the basis of off vs. on pump CABG cases and also in patient that do/not develop AKI post-operatively.

Previous investigations have demonstrated increased levels of free heme in patients undergoing coronary artery bypass grafting utilizing cardiopulmonary bypass. There is evidence of an association between elevations in free heme levels and risk of developing acute kidney injury. The degree of alterations in free heme levels and the heme metabolism pathway in patients undergoing valvular repair or replacement, durable mechanical ventricular assist device placement, or aortic aneurysm repair has not been well characterized. Furthermore, free heme levels after coronary artery bypass grafting without utilization of cardiopulmonary bypass have not been described previously. Cell salvage techniques independent of cardiopulmonary bypass are known to be potentially traumatic to the cellular components of blood and this relationship has not been thoroughly explored in the cardiac surgery population. Lastly, there is scarce prior work attempting to assess the interplay between free heme levels and novel biomarkers of acute kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years, Scheduled adult cardiac surgery

Exclusion Criteria:

* Age \< 18 years, heart transplantation, presence of preoperative ventricular assist device
Cytokine Levels in Conversion Disorder

The aim of this study is whether the proinflammatory cytokine levels in patients with conversion disorder is increased or not changed in the acute phase and subacute - chronic periode, compared with controls.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease

Exclusion Criteria:

* Autoimmune disease
* Neurological disease
* Any organic disorder that could possibly affect proinflammatory cytokines
* Pregnancy
* Any drug usage within 2 weeks
* Any active or passive immunization within 6 months
* Any other DSM-IV axis I psychiatric disorder
* Mental retardation
* Developmental disorder of childhood
Is a Front-of-package Label Contaning Information on Both Nutrient Profile and Ultra-processing Well Understood?

A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.

Two arms will be enrolled. The control arm will not have access to any FOP Label (the current situation in Europe), and the experimental arm will have access to Nutri-Score 2.0. Participants of both arms wil be asked to rank food products of 3 categories (breakfast cereals, cookies, ready-to-eat meals) according to their nutrient profile, and to identify ultra-processed foods.

Eligibility Criteria:
Inclusion Criteria:

Enrolled in the NutriNet-Santé cohort

Exclusion Criteria:

None
Study of Low Dose CT in Sarcoma Patients

The primary outcome of this study is the detection of lung metastases comparing Low dose CT (LDCT) and Minimum dose CT (MnDCT) with CXR.

Hypothesis

1. LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases).
2. MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.

A 3-year prospective phase II non-randomized study commenced May 2003 enrolling 60 high-risk patients with Intermediate and High Grade STS. Each patient is kept under radiological surveillance for 3 years unless lung metastases are detected. Conventional thoracic imaging for staging and surveillance of STS patients is shown in Figure 1. In the trial, LDCT and MnDCT are added to each imaging visit (Figure 1). A 2-view CXR (CR) is performed (Direct View, Kodak, Rochester) followed by thoracic CT scans performed on a Siemens 16 row MDCT (Sensation 16, Siemens, Erlangen), CT acquisition; 120kVp, 5/2.5/2.5mm. Images are reconstructed with high and low spatial frequency filters and soft copy viewing is performed on a standalone PACS workstation using standard mediastinal (w 350, l 40) and lung (w 1500, l -600) settings. Examinations are performed with varying mAs; SDCT 120 mAs, LDCT 40 mAs and MnDCT 20 mAs. The examinations are evaluated, blinded to the results of the alternative and previous studies, for the presence of nodules (defined as a non-calcified focal opacity ≥3 mm \< 3 cm). Surveillance imaging is commenced 3 months post surgery.

Eligibility Criteria:
Inclusion Criteria:

* High Grade Soft tissue sarcoma

Exclusion Criteria:

* None
De-resuscitation Informed by Ultrasound for Patients With Sepsis

Randomized, unblinded clinical trial of 152 critically ill patients with sepsis admitted to the intensive care unit. The primary determine if using the Venous Excess Ultrasound Score (VExUS) to guide fluid deresuscitation in critically ill patients with sepsis reduces net fluid balance at 5 days as compared to usual care.

Physicians can assess venous congestions with point of care ultrasound of intraabdominal veins using the venous excess in ultrasound score (VExUS), which has been shown to predict the harmful effects of volume overload. We seek to determine if VExUS-guided deresuscitation reduces the fluid balance in critically ill patients with sepsis as compared to usual care. This score compiles findings from the inferior vena cava, hepatic vein Doppler waveform, portal vein Doppler waveform, and intrarenal vein Doppler waveform:

Grade 0: IVC \< 2cm, normal pattern in flow patterns of hepatic, portal, and intrarenal veins Grade 1: IVC ≥ 2cm, normal patterns or mild abnormalities in flow patterns of hepatic, portal, and intrarenal veins.

Grade 2: IVC ≥ 2cm, severe venous flow pattern in one among hepatic, portal, and intrarenal veins.

Grade 3: IVC ≥ 2cm, severe venous flow pattern in multiple among hepatic, portal, and intrarenal veins.

After informed consent, subjects will be randomized in a 1:1 ratio to the VExUS-guided intervention arm vs control arm. Subjects in both arms will undergo daily ultrasound, and the investigator will calculate the VExUS immediately after ultrasounds are obtained.

Eligibility Criteria:
Inclusion Criteria:

* 1. Must be suspected by the treating physician to have sepsis as the primary cause of their acute illness as exhibited by 2 or more of the following Systemic Inflammatory Response Syndrome (SIRS) criteria:

  1. Temperature of \> 38 C or \< 36 C
  2. Heart rate of \> 90/min
  3. Respiratory rate of \> 20/min or PaCO2 \< 32 mm Hg
  4. White blood cell count \> 12000/mm3 or \< 4000/mm3 or \>10% immature bands. 2. Known or suspected infection at the time of screening 3. Admission to the ICU for \<24 hours

Since approximately 12% of patients ultimately diagnosed with sepsis do not meet SIRS criteria, SIRS negative patients will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis or septic shock.

Exclusion Criteria:

1. Patients with conditions that may interfere with portal Doppler assessments such as cirrhosis or portal thrombosis
2. Patients with severe chronic kidney disease (estimated glomerular filtration rate\<15 mL/min per 1.73 m2 calculated using the Modified Diet in Renal Disease formula).
3. Age \< 18 years
4. Active atrial fibrillation or atrial flutter
5. Hemodynamic instability due to active hemorrhage
6. Acute cerebral vascular event
7. Acute coronary syndrome (excluding elevated troponin thought to be from demand ischemia)
8. Acute pulmonary edema
9. Status asthmaticus
10. Drug overdose
11. Injury from burn or trauma
12. Status epilepticus
13. Indication for immediate surgery
14. Received CPR within 24 hours of enrollment
15. Pregnancy
16. Incarceration.
A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives are to assess effects on the signs and symptoms of this disorder. Individuals greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 50 years of age or older and may be of either gender.
2. Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee.
3. Patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study).
4. Patients must be able and willing to give informed consent.

Exclusion Criteria:

1. Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study.
2. Patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. Ambulatory aids such as canes and walkers are acceptable.
3. Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded.
4. Patients requiring any dose of glucocorticoids within the past 30 days are excluded.
Intracorporeal Vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

Intracorporeal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporeal urinary diversion (ECD). The investigators' hypothesis that ICD may provide clinical benefit is based on principles of less bowel and ureteral handling, superior operating room workflow, less exposure to the external environment, and optimal visualization with ICD while utilizing a smaller incision compared to ECD. ICD should have less bowel-related complications, lower pain scores allowing patients to be discharged from the hospital sooner and regain functional independence more quickly.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven urothelial cancer being considered for RARC.
* Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ.
* Subject must be already scheduled to have a RARC at the discretion of the surgeon and with the patient's agreement.

Exclusion Criteria:

* Inability to give informed consent
* Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
* At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
* Age \<18 or \>99 years.
Resolution of Allergic Inflammation

After an allergen challenge, the allergic inflammatory response disappears spontaneously. The initiation of the resolution of the inflammatory response is now recognized as a dynamic process, involving active biochemical programs that enable inflamed tissues to return to homeostasis. Recent data established key roles of different specific lipid mediators in the endogenous counter-regulation of inflammation and activation of resolution. Only little is known about kinetics of these specialized pro-resolving lipid mediators during acute allergic inflammation. Therefore, the primary propose of our study is to characterize the temporal evolution of cellular inflammation and specific lipid mediators after allergen challenge.


Eligibility Criteria:
Eligibility criteria:

Inclusion Criteria

* Allergic rhinitis during the grass pollen season with or without asthma, with at least one of the following symptoms: nasal congestion, itching, rhinorrhea, sneezing
* Grass pollen sensitization determined by a positive skin prick test and / or presence of specific IgEs to a grass pollen allergen extract

Exclusion Criteria:

* Smoker
* Specific immunotherapy with grass allergens or other respiratory allergen for inclusion.
* Current exhibition to another clinically relevant respiratory allergen
Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome

The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis of any etiology
* CT scan available

Exclusion Criteria:

* HCC or any malignant disease
L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols

Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or not Arg and ADMA are affected by dietary factors or lifestyle modification in overweight/ obese and T2DM subjects.

The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43)

Eligibility Criteria:
Inclusion Criteria:

* obese and/ or T2DM subjects

Exclusion Criteria:

* type 1 diabetes
* insulin-treated T2DM
* active coronary disease (recent \[≤ 6months\] myocardial infarction, unstable angina, recent coronary catheterization, or coronary bypass grafting
* individuals with significant impairment in liver enzymes (≥ 2.5 the upper limit of the normal range)
* serum creatinine higher than 1.5mg%
* known malabsorption, alcoholism or illicit use of drugs
* abnormal thyroid function tests
* concomitant or recent use of glucocorticoids
* uncertain mental state (to avoid invalid informed consent or lack of compliance).
An Observational Study of Herceptin SC Safety in Breast Cancer

This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.


Eligibility Criteria:
Inclusion Criteria:

- All patients administered Herceptin SC for the locally approved indications

Exclusion Criteria:

N/A