cyrilzakka/clinical-trials huggingface dataset:
Peripheral Blood Lymphocyte Therapy to Prevent Lymphoproliferative Disorders Caused by Epstein-Barr Virus in Patients Who Have Undergone Transplantation

RATIONALE: Peripheral blood lymphocyte therapy may be effective in the treatment and prevention of Epstein-Barr virus infection following transplantation.

PURPOSE: Phase II trial to study the effectiveness of peripheral blood lymphocyte therapy in treating and preventing lymphoproliferative disorders in patients who have Epstein-Barr virus infection following transplantation.

OBJECTIVES:

* Compare the efficacy of Epstein Barr virus (EBV) reactive autologous and allogeneic lymphocyte clones ex vivo in targeting EBV immortalized lymphoblasts in patients undergoing a solid organ transplant or T cell depleted bone marrow transplant.
* Determine the efficacy of these regimens as treatment and prophylaxis in those patients who develop EBV viremia or EBV induced lymphoproliferative disease.

OUTLINE: Autologous and allogeneic Epstein Barr virus (EBV) reactive lymphocytes are isolated from patients and siblings and tested in vitro for cytotoxic activity.

Patients who develop EBV viremia or EBV related lymphoproliferative disease after transplant receive autologous Epstein Barr virus (EBV) reactive lymphocytes IV over 20 minutes. Patients receive allogeneic EBV reactive lymphocytes if autologous lymphocytes fail to control EBV proliferation or when sufficient autologous reactive lymphocytes cannot be isolated. Treatment repeats every 4 weeks in the presence of EBV viremia or lymphoproliferative disease. After 5 patients have received therapy without unacceptable toxicity, patients may receive lymphocytes as prophylactic therapy.

Patients are followed at 4 weeks, 8 weeks, 6 months, and 12 months.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients who have received or will receive a solid organ transplant or T cell depleted bone marrow transplant

  * Epstein Barr virus (EBV) DNA detectable and seronegative OR
  * EBV seropositive
* Fully matched or one HLA antigen mismatched sibling donor

  * HIV negative
  * Hepatitis B surface antigen negative
  * Hepatitis C antibody negative
  * No older than 65 years
  * No prior primary malignancy within the past 5 years in donor except previously resected skin cancer

PATIENT CHARACTERISTICS:

Age:

* Not specified

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
Brief Motivational Therapy Versus Usual Care for Alcohol Use Disorders in Primary Care.

Harmful alcohol use is a leading cause of global disability and death. However increased detection and brief intervention capacity of more severe alcohol use disorders (AUD) has not been accompanied by increased availability of treatment services. Incorporating treatment for such disorders into primary care (PC) is of paramount importance for improving access and health outcomes. This study aims to estimate the effectiveness of a Brief Motivational Treatment (BMT) applied in primary care for treatment of these disorders.

This trial aims to test the superiority of BMT over enhanced usual care with a reasonable margin, over which the BMT could be further considered for incorporation into PC in Chile. Its pragmatic approach ultimately aims to inform policymakers about the benefit of including a brief psychosocial treatment into PC.

This exploratory trial aims to estimate the effectiveness of a BMT for AUD provided in PC. The underlying question is whether Chilean PC should incorporate this treatment among its regular programs based on its effectiveness.

To answer this question, a randomised comparison between the manualized BMT and EUC will be undertaken. The main hypothesis is a superiority one:

• Participants under BMT will perform better than EUC in the reduction of alcohol consumption.

Also, there are ancillary questions that deserve special attention. The following hypotheses will help with the explanation of the results:

* Active BMT components (i.e., the working alliance and fidelity to the MI strategies) mediate the effect.
* Participant´s AUD severity mediates the effect.
* Participants under BMT will receive a higher amount of additional care (physician consultations, social worker consultations, participation in alcoholic anonymous, and others).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of alcohol use disorder according to the DSM-V (American Psychiatric Association, 2013
* Must fulfill criteria for alcohol use disorder and criteria for harmful alcohol use during the last month, i.e., five or more heavy drinking occasions in the last month (5 or more drinks in men, 4 or more in women), or an average use of 14 or more drinks a week in men, and 7 or more in women
* Also, alcohol use should be the main problem motivating participants to seek treatment.

Exclusion Criteria:

* Clients under 20 years old
* Clients in whom alcohol use is not the main problem
* Clients who leave the area or are unable for follow-up contact
* Clients with severe mental comorbidity
* Clients with severe cognitive impairment, illiteracy, or unable to follow treatment in Spanish.
* Clients who are concurrently receiving or planning to receive other psychosocial treatment for alcohol use disorder other than usual care, i.e., formal professional treatment outside of primary care. Participation in community services and Alcoholics Anonymous is permissible.
* Clients who have previously participated in the study, or whose family members are or have been participants.
PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures

Pain management is a crucial aspect of the care of hip fracture patients. Patients with poorly controlled pain have an increased risk of delirium, long-term functional impairment, and remain hospitalized longer. Today, to relieve hip fracture pain, fascia iliaca block is routinely performed in the emergency department in addition to other pain medications administered by vein or by mouth. Several studies have questioned the analgesic efficacy of this block, suggesting the superiority of the newer PENG block. The purpose of this multicenter, randomized study is to compare the analgesic efficacy of PENG block versus fascia iliaca block, hypothesizing the superiority of the new approach over the gold standard. Participants will be blindly assigned in a 1:1 ratio to the study or control group, recruited from the Emergency Departments of IRCCS Policlinico San Matteo and Colchester Hospital (UK).

The main outcome is represented by the reduction of pain after the two blocks, measured as %SPID (percentage of "pain intensity difference"), a value derived from VAS scale measurements in the first hour post-procedure. Secondly, we will evaluate the proportion of patients with satisfactory pain control, the amount of opioids used and the safety profile of the two approaches.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Capacity to understand the aim of the study, the potential benefits and side-effects of the procedures
* Capacity to provide consent
* Capacity to provide a self-assessment of pain using the written VAS Scale
* Confirmed radiological diagnosis of hip fractures (including subcapitate, transcervical, intertrochanteric and perthrocanteric fractures)
* Moderate or severe worst pain (visual analogue scale, VAS \>40 mm) (at rest or dynamic)

Exclusion Criteria:

* Known hypersensitivity to local anaesthetics
* Confirmed radiological diagnosis of subtrochanteric or diaphyseal femur fractures
* Hemodynamic instability
* Known diagnosis of severe cognitive impairment
* Dementia and/or delirium (defined by a 4AT score ≥ 2)
* Lack of capacity to provide consent and to understand the aim of the study
* BMI\>35
* Body weight \< 40 Kg
* Prior hip surgery on the same fracture side
* Mild worst pain (visual analogue scale, VAS \< 40 mm) (at rest or dynamic)
Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER

Intro/rationale: Radiotherapy employs uniform, equally spaced weekday fractions that do not account for changes in tumor radiosensitivity. However, radiobiological characteristics evolve during the radiotherapy schedule as reoxygenation increases radiosensitivity. In tumor-response simulations and preclinical experiments, it was superior to prime the tumor with one radiotherapy fraction, followed by a treatment break permitting mitotic cell death and reoxygenation of tumor cells.

Objective: To determine the safety and feasibility of primer shot fractionation for NSCLC.

Study design: A prospective non-randomized feasibility trial to test the safety of primer shot fractionation in a 3+3 phase with increasing treatment breaks, followed by an expansion cohort.

Study population: Patients with NSCLC stage 2-4, referred for palliative radiotherapy of the primary tumor and possibly (lymph node) metastases. Patients are allowed to receive systemic treatments, except for VEGFR-inhibitors. The 3+3 phase is followed by an expansion phase of 22 patients.

Intervention: All treatments are 5x6 Gy to all targets. Patients receive an increasing primer shot treatment break. In the 3+3 phase, the break between the first and the second radiotherapy fraction is: 1, 2 and 3 weeks. The maximum tolerated break length will be used for the expansion cohort.

Main study parameters/endpoints: The main study endpoint is the ability of patients to finish the radiotherapy schedule as planned. Secondary endpoints are tumor response at the end of treatment and 3 months thereafter, and acute toxicity.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Based on simulations and preclinical data, primer shot treatment breaks increase tumor control. However, the increased overall treatment time could potentially increase the chance a patient drops out before the radiotherapy schedule is finished. Because of the gradually prolonged break, this risk is relatively small and acceptable for this population. Additionally, patients are asked to fill in PRO-CTCAE lung subset questionnaires at the start of treatment and during follow-up. They will also receive 1 additional CT with contrast at fraction 5.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* NSCLC (either pathology proven or sufficient clinical suspicion to be treated as NSCLC), referred for palliative radiotherapy of at least the primary tumor site.
* Stage 2-4
* WHO performance score 0-2.
* Provision of signed, written and dated IC prior to any study specific procedures.

Exclusion Criteria:

* Interstitial lung disease
* Treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors
* Prior thoracic radiotherapy (\>20 Gy EQD2 a/b 3) overlapping with the current planning target volume
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance

This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.

This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.

It is hypothesized that the dietary supplement marketed as The Daily will improve subjective wellbeing in trial participants. It is further hypothesized that the dietary supplement will improve plasma biomarkers that have been previously correlated with insulin resistance.

A total of 45 participants will be recruited for the trial following screening, with the expectation that at least 35 will complete the trial. The trial will be fully remote, and all participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Female, aged 18-55 (roughly 75% 18-38 and 25% 45-55)
* Ability to take oral medication and be willing to adhere to the dietary supplement regimen (2 capsules per day)
* Willing to fast overnight (12+ hours) prior to the blood collection, and to perform an at-home fingerprick blood test
* Moderate self-reported discomfort related to perceived hormone imbalance. Participants must answer B or C on at least 3 of the following questions:

Exclusion Criteria:

* Current use of medication for high blood pressure or for blood thinning
* Diabetic, or on medication such as Metformin or Acarbose
* Pregnancy, breastfeeding, or attempting to become pregnant during study
* Known allergic reactions to components of the dietary supplement (sunflower oil, passionflower, berberine, or grape seed extract )
* Has exercised 3+ times per week of 30 minutes or more per session on average over the past 6 month
* On a ketogenic or vegan diet for more than the past 30 days
* If hormonal birth control, cannot stop during the duration of the study.
Laryngeal Mask Airway in Lower Abdominal Surgery

We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. The hypothesis is that the use of laryngeal masks is associated with less impairment of lung function in the immediate postoperative phase.


Eligibility Criteria:
Inclusion Criteria - patients scheduled for elective retropubic radical prostatectomy

Exclusion Criteria:

- increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations
A Prospective Comparison of Alcon LADARVision Wavefront-guided LASIK Enhancement and Conventional LASIK Enhancement for the Correction of Residual Refractive Errors Following LASIK Procedures

The purpose of this study is to conduct a prospective clinical trial to compare conventional and WFG LASIK for enhancements on post-LASIK patients. Differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race, and at least 21 years old at the time of the preoperative exam, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
* At least 6 months from original LASIK surgery.
* Stable refraction with more than 0.75D of spherical equivalent from the desired correction and have less than 1.50D of cylinder in the manifest refraction.
* Both eyes must be within 1.00D spherical equivalent of each other on the manifest refraction test.
* The eye to be treated with wavefront-guided enhancement must have at least a 9.5mm flap.
* Manifest refraction and LADARWave™ refractions must be within 1.00D.
* At least 3 lines potential improvement in UCVA.
* BSCVA of 20/20 or better.
* Good corneal flap and interface.
* Adequate corneal thickness for surgery (residual stromal bed \> 280 microns).
* Able and willing to give informed consent.
* Located in the greater Washington DC area for a 12-month period.
* Access to transportation to meet follow-up requirements.

Exclusion Criteria:

* Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Pregnancy will be ruled out with a urine pregnancy test.
* Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin, as determined by history.
* Medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex (As determined by history).
* Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
* Evidence of glaucoma or an intraocular pressure greater than 22mm Hg at baseline.
* Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
* Flap irregularity(striae, interface debris, scarring, or epithelium).
* Calculated residual stroma bed less than 280.
* Stable refraction with less than 0.75D of spherical equivalent from the desired correction and more than 1.5D of cylinder in the manifest refraction.
Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.

The objectives of this study are:

1. Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
2. to evaluate adverse events.
3. Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.

There is an increasing perception in the Neurovascular community - supported by extensive peer-to-peer and congress communications - that "stent-assisted coiling" of intracranial wide neck aneurysms improves the long term angiographic outcome of treated patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 year's old patient or above.
* every patient suffering from an un-ruptured or ruptured aneurysm, for whom the endovascular treatment approach using the Neuroform3TM stent is considered by the therapeutic team in charge.
* patient who has given his consent to participate to the study and to get his anonymized data collected

Exclusion Criteria:

* patient with dissecting or fusiform aneurysm
* treatment of several aneurysms in the same procedure, except adjacent aneurysm treated by the same stent
* severe vasospasm
* aneurysm associated with an arterio-venous malformation
* use of another Neuroform3TM stent
* woman pregnant or nursing
* patients not likely to be followed upon (living abroad)
* people protected by justice (safeguard of law, supervision or trusteeship)
* patient unsuitable to the anti-thrombotic and/or to anticoagulants therapies
Identification and Characterisation of Sleep Disorders in a Population of Patients With Non-small Cell Lung Cancer

This exploratory study will identify and characterise disorders frequently reported by patients as contributing to or altering their quality of life. This will enable a decision tree to be drawn up for diagnosis, referral and treatment of the sleep disorders collected, tailored to patients in this population.

This decision tree should help to improve the management of patients with a cancer diagnosis presenting with sleep disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over.
* Being monitored and treated for non-small cell lung cancer.
* With or without ongoing cancer-specific treatment. With no neurocognitive impairment (MoCA test score ≥26/30).
* With a clinically assessed life expectancy of more than 3 months (Royal Marsden Hospital 0-1) and general health (ECOG \<2).
* Able to understand the study documents written in French
* Able to complete the study questionnaires written in French.
* Contactable by telephone throughout the study
* Affiliated to a social security scheme or entitled beneficiary
* Not opposed to taking part in the study

Exclusion Criteria:

* Patient refusing to take part in the study
* With a mental illness of the psychosis type monitored and treated prior to the study
* Patient under guardianship or curatorship
* Patient under court protection
Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.

The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant chemotherapy in patients with node-positive breast cancer converted to node negative after treatment by ultrasound. A randomized controlled trial.

Identification of Sentinel node:

* Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and vital blue dye before surgery.
* Arm 2 (Tc+SPIO): Identification of SLN using standard isotope technique of sub-areolar injection of technetium-99m (Tc-99m) before surgery and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)
* Arm 3 (SPIO alone): Identification of SLN using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)

Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown), detection guided by hand probe gamma radiation, colorimetric and / or and SentiMag® paramagnetic probe.

Lymph nodes that are radioactive, blue, magnetic or palpable are considered SLNs and are resected and submitted for pathological analysis. The protocol required that at least 2 SLNs to be resected.

In all cases a completion axillary lymphadenectomy nodes dissection (ALND) will be performed after SLN biopsy. All SLNs will be excised and submitted before performing the ALND.

Characterization of the nodal status of patients with the detection rate and the false negative rate of SLN for each arm.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary invasive breast cancer with clinical stage T1 through T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition
* Completed or were planning to undergo neoadjuvant chemotherapy
* Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy
* The axilla is clinically and radiologically (by ultrasound) negative (ycN0) postchemotherapy and before surgery
* Removal of at least two SLNs
* Signed informed consent from each patient before study entry

Exclusion Criteria:

* T4 tumors, cN3 or cM1
* The axilla is clinically and radiologically (by ultrasound) positive (ycN1) postchemotherapy
* Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.
* Chronic iron overload
* Pacemaker or other metallic implantable device in the chest wall
* Failure to submit to medical study for geographical, social or psychological
* Patient deprived of liberty or under guardianship
* Pregnant or lactating