cyrilzakka/clinical-trials huggingface dataset:
Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage

The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. These parameters are: Patient general condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive protein), white blood cells, blood gases.The patients are their own controls when the purpose is to see if you can detect early complications with Onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. The patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of Onzurf probe. No interventions will be carried out on the patient.

Eligibility Criteria:
Inclusion Criteria:

* All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department

Exclusion Criteria:

* Surgical recontruction other than Gastric Tube
Ischemic Compression on Post-needling Soreness

Myofascial trigger points (MTrPs) are identified through physical examination as hypersensitive spots within taut bands of skeletal muscle, painful on compression, triggering characteristic referred pain and generating motor dysfunction as well as autonomic phenomena. Different dry needling procedures have been described in the treatment of MTrPs. Needling therapies which consist in partially inserting and withdrawing the needle from the trigger point site in order to elicit local twitch responses are associated with higher effectiveness in releasing MTrPs. Deep dry needling has obtained a grade A recommendation compared to sham, for immediate reduction of pain in patients with upper-quadrant myofascial pain syndrome. Nevertheless, trigger point dry needling are frequently associated to a post-needling soreness. The application of ischemic compression (IC) after trigger point injection in the upper trapezius muscle has shown higher reduction of pain and disability in myofascial pain patients, compared with trigger point injection alone. To the authors' knowledge, no previous studies have evaluated the effectiveness of IC or any manual therapy methods for the treatment of post-needling soreness. The aims of this study were: (a) to evaluate the effectiveness of IC on reducing post-needling soreness after dry needling of one latent MTrP in the upper trapezius muscle, and (b) to investigate the effect dry needling combined with IC, compared to dry needling alone and dry needling combined with placebo IC will have on cervical range of motion (c) to determine whether psychological factors are predictive of postneedling pain and (d) to analyze if the relationships between psychological variables and postneedling pain varied as a function of postneedling soreness treatment


Eligibility Criteria:
Inclusion Criteria:

* Subjects were included if they presented at least one latent MTrP in the upper trapezius muscle

Exclusion Criteria:

* Presence of coagulation disorders
* Neck or facial pain
* Previous application of a dry needling technique
* MTrP therapy in head or neck within the previous 3 months
* Fibromyalgia
* An insurmountable fear of needles as a reason of refusing the treatment
* History of surgery in the head or neck area
Nexium 40mg Once Daily vs Prevacid 30mg Twice a Day for Control of Severe GERD

The purpose of this study is to determine if people taking lansoprazole two times a day to control severe GERD symptoms can be controlled just as well, if not better, by taking Nexium just once a day.

approximately 20% of patients taking first generation proton pump inhibitors (PPIs) are taking more than the standard approved dose. This dosing is required to attain adequate control of the gastric and intraesophageal pH in order to affect the desired clinical improvement. It is recognized that the b.i.d dosing strategy increases the intragastric pH control of \<4 from approximately 12 hours to almost 16 hours. The refinement of the S isomer of omeprazole (Nexium)has led to a way to more effectively control acid exposure. Comparative trials with all the PPIs have shown significantly greater pH control of \<4 and head to head comparisons as well as a recent crossover study. One study suggests that Nexium dosing contains approximately 16.5 hours of a pH control of \<4. Conceivably, this duration of pH control suggests that b.i.d. dosing of other PPIs might be avoided. Furthermore, it suggests that patients currently taking b.i.d. PPIs might be successful candidates for conversion to q.d. Nexium. This would provide a considerable cost implication to health care plans and for patients who are responsible for paying for their PPI therapy. To date, esomeprazole has not been studied in comparison to b.i.d. dosing with other PPIs. There is pharmacologic evidence to suggest, however, that it is comparable. In this proposed study, we believe that by beginning with patients who were well controlled should make for a cleaner definition and a higher likelihood to demonstrate efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of severe GERD.
* Male or female 18-80 years of age
* Ability to read, understand and provide informed consent
* GERD is Adequately controlled on BID lansoprazole as evidenced by GERD-HRQL score of \</= 11
* Females of childbearing potential must use an acceptable method of birth control for the duration of the study.

Exclusion Criteria:

* Known contraindications to Nexium
* Current or historical evidence of \>3 cm histologically confirmed Barrett's metaplasia without current dysplasia, esophageal stricture or extraesophageal GERD symptoms.
* Previous Esophageal gastric surgery
* Pregnant or nursing Females
* Clinically significant abnormal laboratory values
* Medical condition that may be adversely impacted by participation in this study
* History of or current drug or alcohol abuse
* Known malignancy
* Need for concurrent therapy with any acid suppressive therapy other than the study drug, antacids, alginates, NSAIDS, \>165 mg ASA, prostaglandin analogs, prokinetic drug, antineoplastic agents, Ketoconazole, Itraconazole, Voriconazole, Clarithromycin, Telithromycin, HIV protease inhibitors, Rifampin, Phenobarbital, or Digoxin
* Use of investigational drug or experimental device within 30 days prior to screening
Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie

Colorectal cancer is one of the most common tumors and is the second most prevalent cause of cancer death, leading to almost 1 million deaths per year.Elovie is a bevacizumab biosimilar medicine marketed by Libbs Farmacêutica, which had its registration approved by ANVISA in May 2022.At the time of registration a robust evidence package was presented that included, for example, pharmacokinetic bioequivalence studies in patients with metastatic RCC (mRCC) and a phase III study in participants with non-small cell lung cancer .Conducting a real-world study to evaluate the effectiveness and safety of bevacizumab biosimilar Elovie in patients with mCRC is crucial to provide relevant information on how this therapy behaves in real-world clinical conditions in brazilian population.

Observational, multicenter study with real-world data from specialized cancer centers in Brazil. Participants over 18 years of age, of both sexes, with unresectable clinical stage IV metastatic colorectal cancer, who have received Elovie® (bevacizumab biosimilar) at participating centers and who meet the eligibility criteria will be invited to participate. In this study, data on the effectiveness and safety of treatment with Elovie, as well as clinical and demographic characteristics and treatment patterns will be collected.

Participants will undergo standard treatment and clinical follow-up as determined by the treating physician.

Data collection will be performed by the researcher and the data transcribed into the Case Report Form data collection form designed specifically for the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes aged 18 years or older at the start of treatment with bevacizumab.
* Participants diagnosed with metastatic colorectal cancer, clinical stage IV, unresectable, by clinical definition in medical records
* Participants who are undergoing first-line treatment with Elovie and who have completed at least 1 cycle of treatment or participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) but who have currently switched to Elovie and completed at least 1 cycle of treatment with it
* Participants with the capacity to understand and consent to their participation in the study through the Free and Informed Consent Form

Exclusion Criteria:

* Participants who are or have used bevacizumab in a manner other than that described in the package insert
* Participants who have been treated with Elovie for a period longer than 6 treatment cycles
* Participants who have started first-line treatment with another bevacizumab (reference or another biosimilar other than Elovie) and have completed more than 2 treatment cycles with this
Drug Provocation Test (DPT) to Non Steroidal Anti-inflammatory Drugs (NSAID)

Background : Non steroidal anti-inflammatory drugs are responsible for 25% of reported adverse drug events which include immunological and non-immunological hypersensitivity reactions. NSAIDs have been reported to be the second most common cause of drug-induced hypersensitivity reaction (DHR). They are almost mandatory in a human life and therefore, the drug allergy work-up goes up until a DPT in order to confirm or rule out the diagnosis.

Objective: Detect eliciting dose thresholds during NSAIDs DPT in order to suggest optimal step doses and to describe subgroups at higher risk during the DPT

Methods:This retrospective study, using the survival analysis, comprised all patients who attended the allergy service of the UH of Montpellier from 1997 till 2017 with a clinical history related to NSAIDs DHR, who underwent NDAIDs DPT that turned positive and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy \& Hypersensitivity Database (DAHD).

DHRs to NSAIDs may be induced by both specific immunological mechanisms and mechanisms not based on immunological recognition (cross-hypersensitivity reactions \[CRs\]) .They are almost mandatory in a human life and therefore, the drug allergy work-up goes up until a DPT in order to confirm or rule out the diagnosis. Although the overall prevalence of NSAID hypersensitivity has been reported between 0.6 and 7% of the general population .

The NSAIDs-induced hypersensitivity reactions involve different mechanisms and present a wide range of clinical manifestations from anaphylaxis or severe bronchospasm developing within minutes after drug ingestion to non-immediate responses appearing after days and weeks This data-driven approach in designing the DPT protocol is the second step in improving DPT standardization, after BL antibiotics.

Eligibility Criteria:
Inclusion criteria:

- Patients with one or more positives DPT to NSAIDs

Exclusion criteria:

- Patients refusing to take part in the study
Comparison Between HA330 Hemoperfusion Filter Hemodialysis and Conventional High-Flux Hemodialysis Filter

The purpose of this study is to compare the effectiveness between conventional hemodialysis and hemodialysis using hemoperfusion adsorbents in renal dysfunction caused by sepsis

This study is an open randomized clinical trial. Data were taken prospectively until the number of samples was fulfilled for analysis. Due to the intervention provided, this study was not blinded. Subjects were divided into 2 groups (group undergoing conventional hemodialysis and group undergoing HA330 hemoperfusion). Both groups underwent therapy for 4 hours, 3 times a week, with two days apart between dialysis. Inflammatory mediator levels were assessed 4 times, before and after each intervention. All subjects were given standard therapy as indicated such as antibiotics, oxygen supplementation, administration of vasopressors, nutrition, and other therapies as indicated.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 - 65 years old
* Patients diagnosed with sepsis with acute kidney injury whose indicated for hemodialysis. Including fluid overload, life-threatening metabolic acidosis, hypercalcemia, pulmonary edema, and uremic

Exclusion Criteria:

* Patients with hemodynamic instability who need norepinephrine more than 0.5 microgram/kg/minute
* Patients denied to be included in the study
Diabeloop WP6.2 : Crossover Evaluation of Glycemic Control

The study will be conducted in crossover trial, with two 72-hour hospitalization separated by a period Wash-out of at least one week. Each hospitalization is a period of treatment. According to randomization, patients will be provided with either Diabeloop system or the usual system.

In both treatment periods:

* patients in a situation of sedentarity or physical activity, will be equipped with ActiGraph (measuring motricity) and a ActiHeart ( measuring heart rate)
* meals and physical activities will be similar in both periods
* the same blood glucose meter will be used throughout the duration of the study.
* the capillary blood glucose will be performed : before bolus and 2 hours after a meal, before exercise, in case of hypo or hyper-glycemic episodes and when the patient and / or investigator deem it necessary.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patient for at least one year, treated by external insulin pump for at least 6 months
* Patient with 7.5 % \< HbA1c \< 9.5 %
* Patient practicing functional insulin therapy
* In the situation of physical activity , the patient must be able to perform one or more daily physical activities for 3 days in each treatment session
* Patient aged over 18 years
* Patient affiliated to Social Security
* Patient who agreed to participate in the study and who signed an informed consent

Exclusion Criteria:

* Type 2 diabetic patients
* Any serious illness that may impair study participation\*
* Patient with insulin resistance defined in insulin requirements \> 1.5 U / kg / day
* Patient no longer sensing his hypoglycemia
* Patient enjoying a measure of legal protection
* Pregnant woman or likely to be
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids

This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or 300 mg.

Potential subjects were screened within 21 days prior to dosing of study drug (Medisorb naltrexone or placebo) on Day 0. Screening evaluations included a baseline hydromorphone challenge session in which increasing doses of hydromorphone (0 mg \[placebo\], 3 mg, 4.5 mg, and 6 mg) were administered at hourly intervals to produce a cumulative dose-response curve. Throughout the 4-hour challenge period, subject-rated measures (Visual Analog Scale \[VAS\] questions) and physiological measures (ie, pupil size) were recorded.

As a safety measure, at least 7 days after the baseline hydromorphone challenge, a naloxone challenge was performed followed by a 1-day oral naltrexone tolerability assessment. On Day 0, eligible subjects were administered a single dose of study drug. To assess the level of opiate blockade and surmountability attributable to Medisorb naltrexone, experimental hydromorphone challenge sessions were conducted postdose at Days 7, 14, 21, 28, 42, and 56, with a single placebo hydromorphone challenge administered at a randomly selected visit. Pupil size was measured 15 minutes prior to the first hydromorphone dose and at 15, 30, 45, and minutes after each ascending hydromorphone/placebo for hydromorphone dose. Blood samples for measurement of naltrexone and 6B-naltrexol were obtained at screening and before hydromorphone/placebo administration on Days 7, 14, 21, 28, 42, and 56.

Subjects were monitored for safety through Day 56.

Eligibility Criteria:
Primary Inclusion Criteria:

* Adults who had used opioids: non-medically for at least 1 year; at least once per week for at least some period during their use history; and fewer than 3 times per week on average for the 30 days prior to screening.
* Provided written informed consent
* Demonstrated a positive response to hydromorphone challenge during screening
* Willing to use contraception for study duration if of childbearing potential

Primary Exclusion Criteria:

* Any clinically significant medical condition or laboratory abnormality at screening
* Participated in a clinical trial within prior 30 days
* Dependent on opioids
* Seeking treatment for opioid abuse
* Psychosis or any major mood or anxiety disorder
* Pregnancy or lactation
Provider Burnout During COVID-19

Since the novel coronavirus, SARS-CoV-2, was first reported in the Hubei province of China in December 2019, the US has become an epicenter for the pandemic, accounting for more than 220,000 cases and 4,800 deaths (CDC). The rapid spread of the associated disease, COVID-19, has overwhelmed healthcare systems in spite of unprecedented measures to reduce contagion. The resulting uncertainty with regard to the duration and magnitude of the pandemic and limited availability of resources and treatment have been detrimental to the mental health of frontline healthcare providers (NIH). Preserving the psychological wellbeing of these individuals is paramount to mitigating the effect of COVID-19 and delivering optimal patient care.

Of particularly grave concern is how professional and personal distress caused by the COVID-19 pandemic will affect provider burnout (Lai et al. JAMA Network Open 2020). Professional burnout, characterized by emotional exhaustion, career de-prioritization, and loss of self-efficacy, represents a significant threat to the US healthcare system (Shanafelt et al. Ann Surg 2010; Han et al. Annals of Internal Medicine 2019). While burnout has been described as a reaction to chronic work-related stress (Melamed et al. Psychol. Bull. 2006), individual factors such as anxiety increase susceptibility to burnout (Sun et al. J Occup Health 2012). Although data suggests that occupational stress might amplify risk of anxiety (DiGiacomo and Adamson J Allied Health 2001), we have yet to understand how intensified anxiety among frontline providers during global health crises contributes to burnout. Similarly, it is unknown whether factors such as perceived organizational support (POS), a key driver of job satisfaction and performance (Muse and Stamper, J Managerial Issues 2007), modify anxiety and burnout under these circumstances. We hypothesize that diminished POS in response to the COVID-19 pandemic is associated with burnout and that this relationship is mediated by an increase in providers' anxiety. Delineating this relationship is a critical first step in developing interventions that ease the mental health burden of this pandemic and future crises for healthcare providers.


Eligibility Criteria:
Inclusion Criteria:

* All UPMC healthcare providers with patient-care responsibilities (respiratory therapists, physical therapists, nursing staff, residents, attendings, midlevel providers, and clinical faculty) will be contacted via email and asked if they would be willing to participate in this study (participant recruitment email).

Exclusion Criteria:

* All individuals \<18 yo and those providers without direct patient-care responsibilities will be excluded.
Efficacy of CART-19 Cell Therapy in B Cell Acute Lymphoblastic Leukemia

This is a single arm, open-label, multi-center study to determine the efficacy and safety of an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell ALL.

This is a single arm, open-label, multi-center, phase I study to determine the efficacy of CTL019 in patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Primary Follow-up, Secondary Follow-up (if applicable) and Survival Follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with CD 19+ B cell acute lymphoblastic leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled

  1. Age 1 to 60 years.
  2. Expected survival \> 12 weeks
  3. Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
  4. ALT ≤ 5x normal
  5. Bilirubin \<2.0 mg/dl
  6. Any relapse after prior SCT will make patient eligible regardless of other prior therapy
  7. Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and

     ①. Have no active GVHD and require no immunosuppression

     ②. Are more than 4 months from transplant
  8. For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis
  9. Voluntary informed consent is given
  10. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion)

      Exclusion Criteria:

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  1. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  2. Uncontrolled active infection
  3. Active hepatitis B or hepatitis C infection
  4. Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids, or hydrocortisone for physiological replacement in patients with adrenal insufficiency are permitted as well
  5. Presence of grade 2-4 acute or extensive chronic GVHD
  6. Under treatment for GVHD
  7. Previous treatment with any gene therapy products
  8. Any uncontrolled active medical disorder that would preclude participation as outlined.
  9. HIV infection.
  10. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity