cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Moderna COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)

The goal of this observational study is to analyze binding antibody levels in adults in the United States (US) after receiving coronavirus disease 2019 (COVID-19) bivalent boosters (original and omicron BA.4/5) and updated COVID-19 vaccines (XBB.1.5).


Eligibility Criteria:
Inclusion Criteria:

* Lives in the continental United States (US).
* Speaks, reads, and understands English.
* Is willing and able to submit vaccination card photo(s) or vaccination records.
* Is willing and able to self-collect capillary blood during the study period via an at-home whole-blood collection device.
* Is fully vaccinated against COVID-19 per protocol specified criteria.

Exclusion Criteria:

* Has been diagnosed with significant cognitive impairment or dementia.
* Is pregnant or planning to become pregnant during the study period.
* Primary mailing address is a Post Office box, Army Post Office, Fleet Post Office, or Diplomatic Post Office address.
* Currently lives in a US military base located overseas, or US territories (Puerto Rico, US Virgin Islands, Guam, Northern Mariana Island, or American Samoa).
* Is currently participating in a COVID-19 vaccine clinical trial.
* Is currently receiving chemotherapy or has received chemotherapy in the past 6 months.
* Is currently taking steroids, such as prednisone, for any condition.
* Has been diagnosed with and taking immunosuppressants for rheumatoid arthritis, lupus or multiple sclerosis.
* Has received an organ transplant.
* Is currently undergoing dialysis of any kind (for example, hemodialysis or chronic ambulatory dialysis) for kidney disease.
Infectious Outcomes Following Pancreas Transplantation

The proposed protocol aims to characterize the infectious episodes in pancreas transplant recipients under the current medical care. Knowing these patients infectious risks, the types of infections that commonly affect them and the morbidity and mortality associated with it will provide valuable information in the evaluation of the safety and efficacy of the current practices. The information generated by this study will also serve as the basis for development of strategies targeting prophylaxis of infectious episodes.

The objectives of the study are:

1. To determine what is the frequency of infectious complications following pancreas transplantation
2. Characterize the clinical and microbiological aspects of the infectious complications following pancreas transplantation
3. Identify predictors for infection following pancreas transplantation
4. Determine the frequency of graft loss and associated mortality of infectious complications following pancreas transplantation

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent pancreas with or without kidney transplantation at the University of Pittsburgh Medical Center from January 1st 2002 to December 31st 2005
* Patients must be above 18 years of age
* Patients undergoing retransplantation may be included.

Exclusion Criteria:

* History of pancreas transplantation at another institution
Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.

We are performing a study of 40 patients with current accepted indications for CRT and no MRI contraindications. These patients will have a pre-CRT MRI and another post-CRT MRI 6 months after the CRT procedure. Echocardiography, cardiopulmonary exercise testing, symptom assessment, and laboratory testing are also performed before and after CRT. Modifications to the post-CRT MRI protocol include the use of gradient echo cine imaging rather than steady state free precession imaging, application of wideband imaging to the LGE acquisitions, and strain imaging with cine Displacement Encoding with Stimulated Echoes (DENSE) tailored for device patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic systolic HF
* LVEF 35% or less
* Guideline-based class I or IIa indication for CRT
* 25 and 85 years old
* Predominantly in sinus rhythm
* GFR ≥ 40 ml/min/1.73m2\* \*Contrast will not be given for the 6-month follow-up scan if the GFR falls to \< 40 ml/min/1.73m2.

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
* Preexisting pacemaker or defibrillator prior to enrollment
* Cerebral aneurysm clips; 6) cochlear implants
* Other metallic implants (prior to enrollment) known to be contraindications to MRI
* Severe claustrophobia
* Acute kidney injury
* Acute renal failure or chronic kidney disease with GFR \< 40 cc/min
* Liver transplant
* Gadolinium allergy
Effects of Duloxetine on Pathological Worry in Patients With Generalized Anxiety Disorder: A fMRI Study

(1) to compare the differences of neural activation of pathological worry between pre-treatment GAD patients and normal subjects; (2) to measure the differences of brain activation on worry in GAD patients before and after duloxetine treatment

The study will recruit 20 GAD patients and 20 healthy controls. Both patients and controls receive a medical and psychiatric screening procedure at visit 1 and are asked to complete three self-rating questionnaires and one health questionnaire at visit 1. All qualified participants will receive functional magnetic resonance imaging (fMRI) at baseline.

The patients will begin treatment with duloxetine 30 mg/day at visit 2 and will be titrated to 60 mg/day at visit 3 (2 week since drug dispensed). The dosage will be maintained on 60 mg/day for 6 more weeks. During the period, the patients will receive periodic evaluations at visit 2 (0 week drug dispensed), 3 (2 week since drug dispensed), 4 (4 weeks since drug dispensed), and 5 (8 weeks since drug dispensed). The patients will receive fMRI examination at baseline and at the end of the 8-week treatment.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria of generalized anxiety disorders with moderate degree
* Participants above 18 years old

Exclusion Criteria:

* Major depression
* Panic disorder
* Obsessive-compulsive disorder
* Post-traumatic disorder
* Eating disorders
* Psychotic disorders; and
* Alcohol or other substance use disorders
* Neurological disease
* Cardio-vascular disease
* Respiratory disease
* Head trauma
Hypnosis for Bladder Pain Syndrome

This is a pilot randomized control trial of 30 women with interstitial cystitis/bladder pain syndrome to determine the feasibility of delivering a hypnosis intervention or usual care on bladder pain (primary outcome) and cerebral blood flow (secondary outcome). Women in the hypnosis group will undergo treatment with three hypnotherapy sessions in addition to a mobile web-based hypnosis application. Neuroimagning (fMRI) will occur after the first follow up visit.

Available treatments do not provide adequate relief for bladder pain syndrome/interstitial cystitis (BPS/IC), a chronic painful condition that affects 10 million women in the United States. The investigators plan to conduct a pilot randomized control study to determine the feasibility of conducting a combined CBT-hypnosis intervention vs. usual care in women with BPS/IC for a subgroup of women, we will determine the effect of specific hypnotic words on brain function using functional brain imaging. All women will have a pre-existing diagnosis of BPS/IC and their baseline pain prior to therapy and novel (arterial spin labeling) and more traditional (BOLD fMRI) neuroimaging techniques will be collected. Women in the hypnosis group will undergo treatment with three in-person hypnotherapy sessions in addition to a mobile web-based hypnosis application. Women in the usual care group will continue their usual care for BPS/IC. Subjects in both groups will complete a variety of questionnaires on bladder pain, urinary symptoms, sleep, mood, affect, disability, and sexual function before and after treatment. The first follow up visit will occur at the end of treatment (4 weeks after randomization). A select group of patients who are eligible to undergo neuroimaging will be invited to participate in neuroimaging after the first follow up visit. Data will also be collected at a second follow up visit at 2 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Women greater than or equal to 18 years old who are diagnosed with interstitial cystitis or bladder pain syndrome.
* Meet AUA criteria for BPS/IC: an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks, in the absence of infection or other identifiable causes. - A minimum score greater than or equal to 8 on the Interstitial Cystitis Symptom Index and Problem Index will be required for participation.
* A negative urinalysis or urine culture within 2 months,
* Fluent in English language,
* No changes in IC treatment regimen within 4 weeks of beginning assigned intervention.

Exclusion Criteria:

* Patients who are treatment naive or undergoing 3rd line or higher treatments,
* Pregnant or lactating,
* Unevaluated hematuria, urinary retention,
* A history of cystectomy, urinary diversion or augmentation cystoplasty,
* Other sources of bladder pain (stone, uncontrolled recurrent UTI, radiation cystitis, bladder cancer) or who have a primary diagnosis of another chronic pain condition (such as back pain, fibromyalgia).
Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Chronic Lumbar Radiculopathy

Transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation. The aim of our study is to evaluate the effect of metabolic syndrome on the treatment results of transforaminal epidural steroid injection in patients with chronic radicular low back pain due to lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* lumbar radiculopathy due to lumbar disc herniation, unresponsive to conservative treatments, duration of pain is less than 3 months, Patients aged 18 to 65 years

Exclusion Criteria:

* the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...), to have a history of lumbar spinal surgery, inflammatory diseases (rheumatoid arthritis, spondyloarthropathy), spinal infection or malignancy, systemic infection, Spondylolisthesis or spinal stenoz at the involved or adjacent segments, allergies to local anesthetics, contrast dyes or steroids, Refusal of a patient, History of prior lumbar spine surgery, presence of hip pathology (avascular necrosis, congenital hip dislocation etc...
Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

The purpose of this study is to evaluate the feasibility to stratify liver fibrosis in patients with chronic liver disease through non-invasive, spectral CT.

This is a retrospective study, in which a FDA approved imaging device (spectral CT scanner) currently used for several clinical applications will be evaluated for feasibility of studying chronic liver disease (this application has not yet been validated).

Tomographic imaging has assumed a fundamental role in patients with Chronic Liver Disease (CLD) to screen patients for hepatocellular carcinoma (HCC), and, is increasingly being explored as a noninvasive alternative for characterizing liver fibrosis. The overarching goal of this study is to improve noninvasive characterization of liver fibrosis through spectral CT.

Hypothesis: concentration of iodine-based contrast agent in the liver parenchyma during the delayed phase, as measured with spectral CT imaging, increases monotonically with Ishak fibrosis score obtained from liver biopsy. This hypothesis is supported by the literature and our preliminary data, described in the references section (Lamb et al. 2015).

We will evaluate multiphase spectral CT images consisting of the arterial phase, 2-minute delayed phase, and 5-minute delayed phase. Fibrosis will be assessed on both delayed phase images, where it is assumed that any remaining contrast agent, in the liver, is due to the presence of fibrosis. This type of multiphase protocol can still be used to image CLD patients with spectral CT for HCC detection and, thus, will not interfere with liver lesion workup and evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with chronic liver disease undergoing CT scan for/suspicion of hepatocellular carcinoma.
* Patients should be scheduled for/or should have obtained a multiphasic MRI of the liver.

Exclusion Criteria:

* Patients \< 18 years old.
* History of allergy to intravenous contrast.
* Patients at risk for contrast-induced-nephropathy,
* Pregnant patients.
Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy

This study learns if depression, anxiety, and catastrophizing (thought patterns that prompt people to expect the worst) are associated with chronic pain after surgery among patients who are scheduled to have cytoreductive surgery with intraoperative hyperthermic chemotherapy. Information from this study may improve the understanding of persistent and chronic postsurgical pain integrating multiple layers of biological and behavioral sciences.

PRIMARY OBJECTIVE:

I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of chronic postsurgical pain after cytoreductive surgery with intraoperative hyperthermic chemotherapy (CRS-HIPEC).

SECONDARY OBJECTIVES:

I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of persistent postsurgical pain after CRS-HIPEC.

II. To evaluate the association between preoperative abnormal sensory disturbances and chronic postsurgical pain after CRS-HIPEC.

III. To assess the association of blood micro ribonucleic acids (RNAs) signatures with the development of chronic postsurgical pain after CRS-HIPEC.

IV. To determine the rate of and factors associated with persistent and chronic opioid use after CRS-HIPEC.

V. To determine the rate of persistent and chronic postsurgical anxiety and depression.

VI. To investigate changes in psychological risk factors (depression, anxiety or catastrophizing) and sensory disturbances after CRS-HIPEC overtime.

EXPLORATORY OBJECTIVE:

I. To explore the impact of perioperative (in-patient) opioid use, non-opioid analgesic use and anesthetics on the development of persistent and chronic opioid use after CRS-HIPEC.

OUTLINE:

Patients complete questionnaires over 15 minutes and undergo pain assessments prior to surgery and at 3, 6 and 12 months after surgery. Patients also undergo blood sample collection before surgery and optionally at 3, 6 and 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older; with or without history of preoperative abdominal pain
* American Society of Anesthesiologists physical status (ASA) 1-4
* Scheduled surgery: open CRS-HIPEC surgery for primary peritoneal malignancy or secondary carcinomatosis (i.e., appendiceal, colorectal and gastric cancers)
* Written informed consent

Exclusion Criteria:

* ASA \>= 4 or emergency surgeries
* Patients with extra-abdominal metastatic disease
* Patients cognitive or neurologically unable to complete questionnaires preoperatively
* Non-English-speaking patients
* Pregnant women
Convalescent Plasma as Adjunctive Therapy for Hospitalized Patients With COVID-19

This protocol provides access to investigational convalescent plasma for hospitalized patients with COVID-19. Following provision of informed consent, patients will be administered around 500 mL of convalescent plasma obtained from an individual who has recovered from a documented SARS-CoV-2 infection. The study aims to evaluate the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of ICU admission) among hospitalized patients with COVID-19. Safety outcomes include serious adverse events judged to be related to convalescent plasma. Other information which will be collected includes patient demographics and clinical data which includes quick SOFA scores, ventilator-free days, ICU-free days, dialysis-free days and 28-day mortality.

This is a phase 3, randomized, non-placebo controlled, open-label, single-center clinical trial which will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma given from the 3rd to 14th day of illness after the onset of symptoms in preventing ICU admission among hospitalized COVID-19 patients compared to standard of care. Consecutive patients with COVID-19 admitted to the UP Philippine General Hospital will be offered participation into the study. Patients in the intervention group will receive one dose of type-specific anti-SARS-CoV-2 convalescent plasma (500 mL collected by whole blood donation or standard pheresis at the UP-PGH blood bank from a volunteer who recovered from COVID-19). The primary safety endpoints include serious adverse events judged to be related to convalescent plasma. The study also aims to compare anti-SARS-CoV-2 antibody titers and rates, levels, and duration of SARS-CoV-2 RNA in nasopharyngeal swabs using RT-PCR between the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 19 years of age or older
* Hospitalized with COVID-19 and confirmed via SARS-CoV-2 RT-PCR testing
* Patient is willing and able to provide written consent and comply with all protocol requirements
* Patient agrees to storage of specimens for future testing

Exclusion Criteria:

* Female subjects with positive pregnancy test, are breastfeeding or planning to become pregnant/breastfeed during the study period
* Symptomatic illness exceeding 14 days from onset of illness at time of enrollment
* ICU admission on initial presentation at the hospital (includes patients with clinical indications for ICU admission as follows:

  1. Respiratory distress with requirement of O2 \>6 lpm to maintain O2 sat \>92%
  2. Rapid escalation of O2 requirement/significant work of breathing
  3. Hemodynamic instability: SBP \<90, MAP \<65
* Receipt of any blood products including pooled immunoglobulin or intravenous immunoglobulin (IVIg) in the past 30 days prior to enrolment
* Known IgA deficiency
* Presence of any contraindication to transfusion (or history of prior severe reactions to transfusion of blood products)
Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas

For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.

Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).

However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.

In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).

It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged \> 18 ans and ≤ 75 ans
* Suspicion of adenocarcinoma of the head of the pancreas leading to the placement of a biliary stent
* Either metastatic or "borderline" (at the limit of resectability) or locally advanced
* PS = 0 or 1
* Hematological laboratory parameters (ANC ≥ 1.5 \*\* 10 9 / l (/ mm3), platelets ≥ 100 \*\* 10 9 / l (G / L)) and kidney (calculated creatinin clearance\> 60 ml / min)
* Jaundice (bilirubin\> 20 mmol / L) by compressing the lower part of the bile duct (dilatation of the extrahepatic bile duct)
* Written informed Consent
* Affiliation to social security

Exclusion Criteria:

* Pregnant or lactating woman or without contraception (for child bearing potential women)
* Patient deprived of liberty or under supervision of a guardian
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
* Contra-indication for study procedure
* Predictable technical impossibility to position a stent endoscopically (prior upper GI surgery)
* Life expectancy assumed less than 3 months
Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis

Comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol

A randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. One group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). Both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. Drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. Both group receive also the same standardised systemic analgetics with no further use of tramadol.

Eligibility Criteria:
Inclusion Criteria:

* Patients with foot fracture scheduled for surgical repair in spinal anesthesia
* Informed consent

Exclusion Criteria:

* No consent
* Spinal anesthesia or sciatic nerve block contraindicated
* Known intolerance to tramadol or other contraindications for the drug