cyrilzakka/clinical-trials huggingface dataset:
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

Eligibility Criteria:
Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

* 18 years of age or older
* Signs and symptoms of DED
* Consent to treat with topical immunomodulator
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

* Patients under the age of 18.
* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Altered nasolacrimal flow of either acquired, induced, or congenital origin
* Hypersensitivity to dexamethasone
* Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
* Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

Multiple Myeloma (MM) is the more common hematological neoplastic disease second only to Hodgkin lymphoma. In MM patients, mutated genes are mainly KRAS (23%), NRAS (20%), FAM46C (11%), DIS3 (11%) e TP53 (8%). Epigenetics studies suggested that Changes in histone modifications and DNA methylation pattern, as well as non-coding RNAs (miRNAs) expression are involved in MM development. In particular, it has been shown that the aberrant expression of different miRNAs could discriminate healthy from ill patients. Unfortunately, the main critical issue for an effective treatment of MM is the intrinsic or acquired resistance to pharmacological treatments, due also to a plasmacellular clonal heterogeneity.

The prospective study will involve a patient cohort with MGUS, MM smouldering and MM, with the aim to characterize different transcriptional and epigenetic features, also including miRNAs, among MM cells susceptible or resistant to conventional therapies. The final goal is to identify new prognostic and predictive biomarkers that could be used as therapeutic tools to improve clinical targeted therapies.


Eligibility Criteria:
Inclusion Criteria:

- Compare Transcriptomics and epigenetic profile

Exclusion Criteria:

* No exclusion criteria
Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion;
* Best corrected visual acuity equal or worse than 20/40 and better than 20/800;
* Central subfield macular thickness greater than 300 µm

Exclusion Criteria:

* Aphakia
* High-risk proliferative diabetic retinopathy
* Previous treatment for DME in the past three months
Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women whose last menstruation was at least two years previously
This is a Retrospective Study on the Use of CENOBAMATE as Adjunctive Treatment in Patients Suffering From Epilepsy in Early Access Program in Germany, France and UK

Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients.

The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.

Cenobamate is a new approved drug used to treat -focal-onset seizures in adult patients. This novel tetrazole-derived carbamate seems to act primarily by two mechanisms that are commonly associated with epilepsy: cenobamate acts as a positive allosteric modulator of the GABAA ion channels and is effective in reducing repetitive neuronal firing by inhibition of voltage-gated sodium channels, although the complete mechanism of action is currently unknown.

In clinical trials, cenobamate showed also low toxicity and adverse drug reaction profile.

In European Union (EU), cenobamate received the marketing authorisation, valid throughout the EU, in March 2021. Starting from September 2020 an EAP was initiated with cenobamate as adjunctive ASM in several EU Countries such as Germany, France, and UK.

Real-world data are of importance to understand and confirm the efficacy and safety profile of drugs outside of the clinical trial setting. The aim of the current study is to analyse the overall effectiveness and tolerability of cenobamate from real-world data in a large series of patients treated with cenobamate as adjunctive ASM.

As a consequence, a retrospective collection and analysis of the data of the patients who participated in the EAP, according to the authorization received from the local regulatory or ethic authorities, was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Data from adult patients diagnosed with epilepsy with FOS participating in the EAP with cenobamate as adjunctive treatment, according to the authorization received from the local regulatory or ethic authorities will be collected and analyzed.
* Available data will be collected after obtaining consent from patient/legal representative to the processing of personal data according to the General Data Protection Regulation (GDPR) and applicable local regulation

Exclusion Criteria:

* Patient enrolled in other clinical trial during the EAP.
* Patient aged less than 18 years old.
* Patient with specific syndrome (e.g. LGS and Dravet)
Biological Effect of Warfarin on Pancreatic Cancer

This study aims to asses the effect of warfarin on markers of AXL pathway in patients with pancreatic adenocarcinoma.

There is emerging evidence from pre-clinical models that Axl activation is critical for the tumorigenesis and metastasis of pancreatic cancer. Warfarin is a readily available drug in the clinical setting and could be easily, safely, and quickly used in patients in combination with known cytotoxic chemotherapies to improve overall survival.

Oral warfarin has been well tolerated in both prophylaxis for catheter-associated thrombosis and in advanced pancreatic cancer patients.

The aim of this trial is to confirm the preclinical evidence that warfarin affects AXL pathway in patients with pancreatic cancer. This will validate the effect of escalating doses of warfarin on circulating biomarkers of AXL.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically-confirmed, localized or metastatic adenocarcinoma of the pancreas. Diagnostic biopsy must be obtained at the study institution prior to enrollment. Pathology material must be available for review.
* Patient must have measurable disease per RECIST criteria
* Started most recent systemic therapy regimen within 15 days of enrollment (any line of therapy is allowed).
* Ability to tolerate, swallow and absorb oral medications.
* Ability to understand and the willingness to sign a written informed consent.
* Age \> 18 years
* Negative blood pregnancy test within seven days of study entry for WOCBP
* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  * Has not undergone a hysterectomy or bilateral oophorectomy; or
  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

* Active radiation therapy, or planned radiation therapy during study period
* Subjects may not be receiving any other investigational agents.
* Pregnant, nursing or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be potentially teratogenic.
* Underlying condition which may increase the risk of complications from warfarin therapy. These can include:

Known major bleeding diathesis:

* Coagulopathy
* Significant GI bleed within 6 months,
* Clinically significant hematuria or hemoptysis,
* Thrombolytic therapy within one month of study entry,
* Active peptic ulcer disease with bleeding. - Significant infection or other coexistent medical condition that would preclude protocol therapy including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Cognitive Behavioral Therapy With Our Without Exposure Therapy for Irritable Bowel Syndrome

Patients with a diagnosis of irritable bowel syndrome (IBS) are recruited by self-referral. They are randomized to two 10 weeks of internet-delivered cognitive behavioral programs. Both programs include mindfulness training, education about how excessive avoidant and control behaviors maintain IBS symptoms, and changing of these behaviors to live a richer life. One of the programs also includes instructions on how to perform systematic exposure. The hypothesis of the study is while both groups will show improvement in terms of IBS symptom severity and quality of life, the addition of systematic exposure will lead to more improvement in symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Fluency in Swedish
* IBS-diagnosis established by physician
* Fulfillment of Rome III criteria for IBS

Exclusion Criteria:

* Diarrhea predominance with no colonoscopy performed
* Blood in stool without benign medical explanation
* Rapid weight loss without benign medical explanation
* Ongoing alcohol or drug abuse
* Suicidal ideation
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18 to 40 years, inclusive
* 55 - 95 kg, inclusive

Exclusion Criteria:

* Evidence of any clinically significant disease
* History of cancer
* History of syncope or severe vasovagal events
* Antibiotic treatment within 60 days of Day 1
* Surgical procedure within 60 days of Day 1
* Hepatitis C, Hepatitis B
* Tuberculosis
* HIV
* Requirement for medications (prescription/OTC) during the study
* Donated \> 250 mL blood within 30 days of Day 1
* Donated \> 750 mL blood within 60 days of Day 1
* In a clinical trial of an immunosuppressive drug within 6 months of Day 1
* Received any vaccination within 6 months of Day 1
* Any clinically important allergy
* Known allergy/sensitivity to lactose and/or polyethylene glycol
Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer

The purpose of this study is to show if the adoptive cellular therapy with autologous dendritic cells and cytokine-induced killer cells (CIK) combined with concurrent chemoradiation could improve the quality of life of the patients with locally advanced esophageal cancer, compared with concurrent chemoradiation only.


Eligibility Criteria:
Inclusion Criteria:

* cytologically or histologically confirmed locally advanced esophageal carcinoma
* Age: \> 18
* Karnofsky performance status ≥ 70
* At least one measurable tumor lesions according to the RECIST criteria.
* Normal functions of heart, lung, liver, kidney and bone marrow
* Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
* Informed consent signed

Exclusion Criteria:

* Patients with metastatic disease in the central nervous system (CNS).
* Patients who are pregnant or nursing.
* Patients with poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
* Patients with contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
* coexisted morbidities that investigators believed not suitable for chemoradiation
Analgesia Following Lumbar Discectomy

Lumbar discectomy surgeries are often the last option for patients with disc herniation who do not improve with conservative treatments. However, these procedures can lead to significant perioperative pain that may become chronic without effective management. While intravenous opioids are commonly used for pain control, they can complicate recovery and pose risks like dependence. In contrast, regional anesthetic techniques offer advantages such as quicker recovery, better postoperative pain relief, and reduced opioid use, which can lead to shorter hospital stays. Our study aims to compare the effectiveness of the retrolaminar block with local wound infiltration for pain management following posterior lumbar discectomy surgeries, potentially improving patient outcomes.

Lumbar discectomy surgeries are the last resort for disc herniation patients not responding to conservative treatment. However, these surgeries are associated with annoying perioperative pain that could be severe and progress to chronic pain if not managed properly. There is no consensus regarding the best approach for postoperative pain management following spine surgeries. Intravenous opioids are still the primary agents used for perioperative pain control, which can complicate the postoperative recovery with the associated side effects and the risk of opioid dependence. Regional anesthetic techniques for spine surgeries allow rapid recovery, prolonged postoperative analgesia, and less opioid consumption, which decreases hospital stays. The current study will compare the analgesic efficacy of the retrolaminar block to the local wound infiltration following posterior lumbar discectomy surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgical decompression of single-level herniated lumbar disc.

Exclusion Criteria:

* Opioid-dependent patients.
* Known hypersensitivity to bupivacaine.
* Diabetic patients.
* Uncooperative patient or with altered mental status.
* Previous spine surgery.
Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.

Primary Objective To assess efficacy of EXPAREL TAP blocks in improving pain scores for 48 hours postoperatively, and in reducing total oral morphine equivalents (OME) use, compared to standard Intrathecal opioid administration (IT).

Secondary Objective Assess the length of stay (LOS), postoperative ileus (POI) incidence, and the use of intravenous patient controlled analgesia (PCA) in patients that had EXPAREL TAP blocs compared to IT.

Eligibility Criteria:
Inclusion Criteria:

* • All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT

  * Age \>18 years
  * BMI \<40
  * Ability to understand and read English

Exclusion Criteria:

* • Not able or unwilling to sign consent.

  * Currently pregnant or lactating.
  * Patients with chronic pain, requiring daily opiate use at time of surgery.
  * Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
  * Patients requiring emergent surgery.
  * Abdominoperineal resections
  * Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology)
  * Patients with a diagnosis of inflammatory bowel disease
Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem cell transplant in treating patients with hematologic cancer.

OBJECTIVES:

* Determine the efficacy and safety of allogeneic peripheral blood stem cell transplantation in achieving engraftment in patients with hematologic malignancy.
* Determine the hematopoietic recovery, incidence of chemoradiotherapeutic toxicity, relapse, graft-versus-host disease, and survival of patients treated with this regimen.

OUTLINE: Patients receive a preparative chemoradiotherapeutic regimen and graft-versus-host disease prophylaxis prior to transplantation. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

Patients are followed every 1-2 weeks for 6 months and at 9, 12, 24, and 36 months.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of one of the following:

  * Chronic myelogenous leukemia

    * Philadelphia chromosome-positive OR
    * Molecular evidence of bcr/abl gene rearrangement
  * Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia

    * Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
  * Multiple myeloma
  * Hereditary immunodeficiency disorders

    * Confirmed by immunologic determination
  * Sickle cell anemia or beta-thalassemia

    * Confirmed by hemoglobin electrophoresis
  * Storage disorders (e.g., Gaucher's disease, Hurler's disease, or metachromatic leukodystrophy)

    * Confirmed by metabolic testing
  * Other non-malignant conditions
* Eligible for allogeneic peripheral blood stem cell or bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

* 65 and under

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
The Impact of SPC on Advanced Breast Cancer Patients

The aim of this prospective, observational study is the evaluation of the effectiveness of a 14-day Specialist Palliative Care therapy in participants with advanced breast cancer carried out in a stationary palliative care unit in Poland. The length of the entire study will be 36 months.


Eligibility Criteria:
Inclusion Criteria:

the patient's conscious consent for examination and the ability to fill in the form by the patient herself.

-

Exclusion Criteria:

* patients with cognitive disturbances disabling credible answers in the questionnaire, deceased patients or those discharged from the ward before 14 days of hospitalisation.
TAVR Without Predilatation

The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.


Eligibility Criteria:
Inclusion criteria:

- patients undergoing TAVR via transfemoral or rascoarotid access

Exclusion criteria:

- others access (subclavian, apical, transaortic)
Patient Registry of the Neurosurgery Department

The investigators record all indications, treatments and outcomes from patients treated at the Neurosurgery Department.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria:

All patients treated at the Neurosurgery Department

Exclusion criteria:

None