cyrilzakka/clinical-trials huggingface dataset:
Billroth II or Roux-en-Y Reconstruction for GJ After PD: Randomized Controlled Trial (PAUDA TRIAL)

The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.

The pancreaticoduodenectomy (DPC) is the procedure of choice of the tumors of the head of the pancreas, periampullary tumors and intractable inflammatory pathology.

The high postoperative morbidity (50%) involve a mean hospital stay of 15 days after surgery. The most common complication is delayed gastric emptying (DGE), defined as the intolerance to solid oral intake by 7th day postoperative. In some severe cases, oral intolerance can occur after the 21th postoperative day. Therefore, the patient requires parenteral nutrition and prolonged hospital stay.

The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC.

The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.

A pilot randomized clinical trial has been designed to compare two surgical techniques for reconstruction of digestive tract after DPC in patients treated in our center. The patients are randomized after tumor resection and before the reconstruction througt computer-generated random numbers using a sealed envelope technique. The primary endpoint is the incidence of DGE. Secondary endpoints are postoperative morbidity and specific complications as pancreatic fistula, the hospital stay, and postoperative endocrine and exocrine function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic head cancer considered resectable after the extension study
* Patients suffering from periampullary tumors considered resectable after the extension study
* Patients suffering from pancreatic inflammatory disease with medically intractable pain
* Patients who have read the information sheet of the study and signed the informed consent form

Exclusion Criteria:

* Patients with history of previous gastrectomy
* Patients with associated resections of other organs, except for the superior portal vein or mesenteric vein
* Patients with enlargement to total pancreatectomy
* Patients who has recieved neoadjuvant treatment
* Patients with plastic peritonitis
* Patients with liver cirrhosis.
Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study

Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.

We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.

This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.

The purpose of this study is to evaluate the stiffness during open heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Patients older than 18 years
* Every patient scheduled for cardiac surgery
* Cardiac catheterization within 6 months before surgery,
* Women of childbearing age in effective contraception (a urine pregnancy test will be performed)
* Patient affiliated or covered by a plan of health insurance.
* Francophone

Exclusion Criteria:

* Pregnant or lactating woman,
* Functional walking disability,
* Patient placed under judicial protection: guardianship,
* Patient participating in another trial and / or participated in another trial within two months,
* Patient under guardianship or trusteeship,
* Women who are not effective contraception,
* Patient with no liberty by administrative or judicial decision
BCMA-directed CAR-T Cell Therapy in Adult Patients With Multiple Myeloma

This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as a single agent in multiple myeloma

This is a phase I, open label study to characterize the safety and tolerability of a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) manufactured with a new process. In the dose escalation part (Part A) of the study, the anti-BCMA CAR-T cell therapy will be studied in adult multiple myeloma (MM) subjects who are relapsed and/or refractory. In the dose evaluation part (Part B) of the study, the anti-BCMA CAR-T cell therapy will be studied in newly diagnosed adult subject with MM.

Eligibility Criteria:
Inclusion Criteria:

* Part A: Subjects with MM who are relapsed and/or refractory to at least 2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (IMWG criteria)
* Part A: ECOG performance status that is either 0 or 1 at screening
* Part B: Subjects with newly diagnosed multiple myeloma (NDMM) who have received a minimum of 4 and up to 6 cycles of standard induction therapy with VRd, D-VRd, or D-Rd, and have achieved a response of PR or better. One cycle of CyBorDex is allowed prior to induction.
* Part B: ECOG performance status that is either 0,1 or 2 at screening
* Measurable disease as defined by the protocol
* Adequate hematological values
* Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Exclusion Criteria:

* Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Patients who have received prior BCMA-directed bi-specific antibodies or antibody-drug conjugates (ADC) are not excluded.
* Autologous HSCT within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (HSCT)
* Chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (LD) chemotherapy) within 2 weeks prior to apheresis
* Treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter
* Have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. Daratumumab within 3 weeks prior to apheresis collection.
Impact of Rapid Flu Testing in BMC ED

The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 21 years of age or older
* Presenting to the BMC main ED or Urgent Care area with influenza-like illness
* Physician ordered an influenza A/B diagnostic test

Exclusion Criteria:

* Previously enrolled in the study
* Any Influenza test result already available at the time approached by the ED RA
* Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
* Unable to give informed consent
Effect of Ondansetron for Withdrawal Symptoms

We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.


Eligibility Criteria:
Inclusion Criteria:-Over 18 years of age

* No medical contraindications to medication
* Able to fulfill research procedures Exclusion Criteria:-Subjects who are unable to respond to our questionnaires or to stimuli as required by the experimental protocol will be excluded.
* Subjects will be excluded if they have a history of significant psychiatric disorders that would prevent them from engaging in a treatment program.
* Participating in other studies that would interfere with the procedures in this study
* Known or apparent pregnancy
Early Lung Rehabilitation Care for Patients After Double Lung Transplantation

Develop appropriate individual programs for patients to implement lung rehabilitation safely and effectively.

Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.

Eligibility Criteria:
Inclusion Criteria:

* Patients after double lung transplantation; informed consent

Exclusion Criteria:

* unstable condition
KRN7000 in Treating Patients With Solid Tumors

RATIONALE: Biological therapies such as KRN7000 use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase I trial to study the effectiveness of KRN7000 in treating patients who have solid tumors that have not responded to previous treatment.

OBJECTIVES: I. Determine the safety profile and maximum tolerated dose of KRN7000 in patients with solid tumors. II. Assess the biological and immunological parameters that would suggest the optimal biologically active dose of KRN7000 in these patients. III. Determine the pharmacokinetics of KRN7000 at the different dose levels in these patients. IV. Measure any antitumor activity in these patients treated with this regimen.

OUTLINE: This is a dose escalation study. Patients receive KRN7000 by slow intravenous injection on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each receive escalating doses of KRN7000 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor that is refractory to conventional treatment or for which no curative or standard palliative treatment exists No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG/WHO 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Lymphocyte count at least 600/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal No liver cirrhosis Hepatitis B surface antigen negative Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Immunologic: No immunodeficiency No autoimmune disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No nonmalignant disease incompatible with study No prior alcoholism, drug addiction, or psychotic disorders unless suitable for adequate follow up No cerebroside metabolite abnormalities (e.g., Gaucher's disease) HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent cytokines Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose chemotherapy) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational or antitumor drugs
Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis

The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily.

Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)

Eligibility Criteria:
Inclusion Criteria:

* Patients 20 years to 75 years of age
* Eosinophilic chronic rhinosinusitis with a total score of ≥ 11 according to the diagnosis of eosinophilic chronic rhinosinusitis at enrollment
* A minimum bilateral nasal polyp score of 3 out of the maximum score of 8 (with a score of at least 1 out of the maximum score of 4 for each nostril) at screening and at enrollment
* Weight of ≥ 40 kg at screening

Exclusion Criteria:

* A Sino-Nasal Outcome Test-22 (SNOT-22) score of \< 7 at enrollment
* Any nasal surgery (including polypectomy) within 1 year prior to the date of consent
* Hospitalization for ≥ 24 hours for treatment of asthma exacerbation, within 12 weeks prior to the date of consent
* Exposure to any commercially available (e.g., omalizumab) or investigational biologic agent within 16 weeks or 5 half-lives prior to enrollment, whichever is longer
* Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (except spraying) within 4 weeks prior to enrollment or planned use of such medications during the double-blind period
* Prior treatment with benralizumab
Efficacy of Sitagliptin and Glibenclamide on the Glucose Variability in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431-355)

This is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (CGM) in Japanese participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (MAGE) through continuous glucose monitoring (CGM) after 13 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Japanese participants with a diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

* History of Type 1 diabetes mellitus or ketoacidosis
* History of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation
Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

The survival of the refractory CRC is dismal and therapy options are limited ，the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metastatic colorectal cancer in a real-world setting.

The invesgators conducted a retrospective single arm, single-center study in which patients with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; with patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).The primary endpoint was overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

1. patients with MSS/pMMR mCRC who have been received Fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022;
2. Eligible patients were aged 18 years or older
3. had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
4. patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).
5. an Eastern Cooperative Oncology Group performance status of 0-2;

Exclusion Criteria:

1. Pregnancy, lactating female or possibility of becoming pregnant during the study.
2. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
3. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
4. Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
EUS-FNA With and Without Suction

To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to UAB Endoscopy Unit for assessment of pancreatic mass lesions that requires FNA.

Exclusion Criteria:

* Age \< 19 years

  * Unable to safely undergo EUS for any reason
  * Coagulopathy (INR\>1.6, Prothrombin Time\>18 secs, Thrombocytopenia \< 80,000 cells/ml)
  * Unable to consent
  * Non-English speaking patients
Engage for Late-Life Depression and Comorbid Executive Dysfunction

Although there are an increasing number of mental health treatment adaptations for older adults, there are still a number of factors to consider when making these adaptations. Cognitive decline is one such factor that places significant burden on older adults and can interfere with traditional mental health therapies. Engage is a behavioral treatment approach that has shown to be effective in treating late life depression. The investigators are testing the feasibility of Engage as a treatment method for late life depression in older adults with cognitive decline. The objective is to corroborate Engage as an alternative late life depression treatment method for a sub-population of older adults with cognitive decline. Cognitive decline poses a unique mental health treatment barrier that is often over looked in younger populations. With a relatively higher prevalence of cognitive decline in older adulthood, it is imperative that a feasible mental health treatment program that can be effective in the presence of cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 or older
* Ability to read, write, and speak English
* Located in Las Vegas or surrounding area
* Ability to travel to UNLV campus by self or possible caregiver for regular study visits
* Clinically significant symptoms of depression as evidenced by: 1) Scores \> 5 on the Geriatric Depression Scale-Short Form (GDS-SF)
* Mild cognitive impairment as evidenced by: 1) Scores \> 18 and \< 25 on the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

* Active suicidal ideation
* History of suicide attempt(s)
* Current symptoms of: 1) Psychosis; 2) Active substance use disorder
* Reported history of: 1) Bipolar disorder ("manic depression"); 2) Intellectual disability
* Currently in or scheduled to initiate individual psychotherapy to avoid treatment interference
* Psychotropic medication permitted if dose was stable over the past 2 weeks
* Currently living in an institutional setting (e.g., assisted living, inpatient, skilled nursing)
* Presence of notable memory-specific cognitive deficits as evidenced by: scores \< 9 on the MoCA memory subscale (rendering it difficult to participate in and track/recall events for weekly psychotherapy)
FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke

The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite for a pathologic gait. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals.

At D0 and D7, the patient is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Hemiparetic patients have two measurements 7 days apart. The patient repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the patient.


Eligibility Criteria:
Inclusion Criteria:

* Have more than 18 years old
* Don't be pregnant or breast feeding
* Have a stroke for more than 6 months

Exclusion Criteria:

* Be part of another study
* Not be able to give consent
* Not have access to social security
Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study

Ten years after our team's publication, practices have changed considerably in the management of severe cirrhotic patients. This study will analyse these practices in primary care hospitals and in a tertiary centre, and assess the impact of these changes on the prognosis of these patients.

The following hypotheses will be tested:

* Improvement in intensive care and overall prognosis compared with data from the literature prior to 2014
* Improved access to liver transplantation compared with the literature prior to 2014
* Improvement in intensive care unit practices (for example: application of recommendations published by learned societies concerning the intensive care unit management of patients with cirrhosis, access to comfort care, degree of clinical severity on admission to the intensive care unit, etc.).
* Centre' effect: variability in the phenotype of patients admitted to intensive care depending on the technical facilities available and whether or not the hospital centre has access to TH.


Eligibility Criteria:
Inclusion Criteria:

Patients with cirrhosis over 18 years of age (cirrhosis either histologically proven or diagnosed by hepatologists according to clinical, biological and ultrasound criteria) admitted to intensive care between January 2014 and December 2024.

Exclusion Criteria:

None
Evaluation of the Functional Results of Bilateral Amygdalotomy for Refractory Aggressive Patients

Aggressiveness has a high prevalence in the psychiatry population and is of major concern. Though pharmacological treatments are effective for most patients, there is a portion that doesn't respond properly and is considered medically refractory. For them, surgical procedures (i.e. stereotactic lesions) have been performed as an attempt to reintegrate patient into society. The amygdala is a main structure in the control of aggressive behavior and amygdala lesion could improve behavior without neurological or other behavioral impairment. In this study, it will evaluate the functional results of the bilateral amygdala lesion of aggressive refractory patients through neuroimaging, clinical assessment and blood hormonal levels. To better understand the neurobiology of aggression, aggressive patients that are not refractory will also be studied through neuroimaging and hormonal levels.


Eligibility Criteria:
Inclusion Criteria:

* Refractory aggression (Adler et al., 2015) defined by extreme levels of aggression after the use of Risperidone or Aripiprazole ou combination of others psychoactive drugs.

Exclusion Criteria:

* Patients with anatomical alterations that may disrupt the surgery, infections or non-controlled diseases, treatment with other experimental drugs, pregnant women or during lactation, psychological or sociological conditions that will not permit the patient to be accompanied by the medical staff.