cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Dobutamine Stress Test With Speckle Tracking to Decrease Postoperative Mortality (ISTMO)

Perioperative adverse cardiovascular events are the leading cause of morbidity and mortality after noncardiac surgery. The implications of perioperative cardiac complications on morbidity and mortality, in-hospital and long-term care, and resource utilization are enormous. The continuously increasing proportion of elderly patients presenting for noncardiac surgery raises serious concerns regarding adverse cardiac events in the perioperative period. The responsibility for early diagnosis and prompt treatment of cardiac complications during surgery rests squarely with the anesthesiologist. Reliable intraoperative identification of patients at high risk for postoperative AMI and/or death is currently inadequate, but may confer substantial benefits to patients as preventive measures could be instituted. A reliable and reproducible quantitative measure of regional and global myocardial function could improve preoperative risk stratification and guide anesthetic management when acute changes in myocardial function occur.

In the present study is hypothesized that intraoperative dobutamine stress echocardiography by 2-dimensional speckle tracking echocardiography can identify patients at higher risk of perioperative adverse cardiac events.


Eligibility Criteria:
Inclusion Criteria:

* Any laparotomy
* Any thoracotomy
* Any hip surgery
* Any complex oncologic surgery o Any thoracoscopy

Exclusion Criteria:

* Females older than 80 year old
* Patients on chronic systemic corticosteroid therapy
* Diagnosed pharyngeal or gastro-esophageal pathologies (such as esophageal varices, stricture, diverticula, tumor, esophagitis, Mallory- Weiss tear, or previous surgery for any of these)
* Signs and symptoms of severe pharyngeal or gastro-esophageal pathologies (including odynophagia, dysphagia)
* Emergency surgery
* Age less than 50 year old
A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain

the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters


Eligibility Criteria:
Inclusion Criteria:

* Elective C section via Pfannenstiel incision
* Living singleton pregnancy
* Gestation week at least 37 weeks
* American Society of Anesthesiologists (ASA) status 1, 2 and 3
* Primary and secondary C sections

Exclusion Criteria:

* Chronic pain
* Opioid tolerant patients
* Allergy to drugs used in the study.
* Cognitive dysfunction
* BMI \> 40
* Coagulation disorder
* Local infection
* Inability to tolerate oral medication
* Previous intra-abdominal surgery
* Patients who will receive a combined spinal epidural for their C section
* Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
* Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)
Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis

This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.

Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis (RA) patient's cells. To date, no studies have been performed to evaluate the effect of Orencia on apoptosis in RA patients.

Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.

Secondary: To evaluate the association between the changes in apoptosis to changes in disease activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of abatacept.

Eligibility Criteria:
Inclusion Criteria:

1. Over age 18
2. Meeting ACR Criteria 1987 for RA diagnosis
3. Naïve to treatment with abatacept
4. Must be able to understand information in the Informed Consent

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Previous exposure to abatacept.
3. History of a concomitant autoimmune disease (eg. SLE, PsA etc.)
4. Patients with history of cancer
Electrocardiogram (ECG) Guided Peripherally Inserted Central Catheter (PICC) Placement

This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines.

There is no formal study hypothesis.

PICC line placement is a common procedure, made more difficult by the need to ensure that catheter tip placement is in an acceptable location, typically the superior vena cava (SVC), and ideally at the junction of the SVC and right atrium. Tip location is determined at present by chest X-ray, which is performed after the procedure. If the tip location is incorrect, additional procedures and/or X-rays are needed until proper placement is ensured.

Use of an electrode placed inside the catheter during insertion has been reported to provide identifiable changes in the p-wave sufficient to guide placement. This study is designed to collect ECG and catheter depth information during routine PICC placement procedures, and to correlate these ECG changes to tip location as determined by contrast enhanced fluoroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Require Power PICC placement as standard care
* Signed informed consent

Exclusion Criteria:

* Has an intracardiac device
* Does not have normal sinus rhythm
* Has known abnormality of central venous system
* Plasma creatinine \>=1.5 mg/dL
* Pregnancy
* Allergy or prior reaction to contrast material
Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. A Vaccine given as a nasal spray may improve compliance and local immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.This study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.


Eligibility Criteria:
Inclusion Criteria:Healthy young(20-45years old) and elderly(65-95 years old) volunteers -

Exclusion Criteria:Known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons

-
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either:

* unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR
* at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy


Eligibility Criteria:
Please call 800-398-9157 for information on this study

Inclusion Criteria:

* Men and women of age 18 years or older inclusive
* Recipient of a renal allograft for at least ≥ 2 months
* EBV positive
* Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to:
* Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures)
* Contraindication to CNIs and/or m-TOR inhibitors

OR

* At imminent risk of losing allograft kidney due to nephrotoxicity
* Renal failure: ≥ Stage 4 on KDOQI Scale (GFR 15 - 29 cc/min)
* And no other renal replacement therapy
* Subjects must be receiving the maintenance immunosuppressants MMF, MPA, or AZA

Exclusion Criteria:

* Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks
* EBV negative
Adult Congenital Heart Disease Surgery

It is now estimated that the number of adults with congenital heart disease in the U.S is over 800,000. Unfortunately, these patients, in some way, have become a lost population. They have congenital abnormalities familiar to a children's hospital, yet have surpassed the age cutoff for admission.

Recently, we have developed a specialized program to care for this unique patient population. Dedicated programs such as ours hope to optimize patient care, consolidate specialized resources, provide sufficient patient numbers for training and maintain expertise and facilitate research in this unique population.

In the United States, approximately 30,000 children are born with congenital heart disease every year. As technology, operative technique, and critical care medicine have improved significantly over the years, more of these children are surviving into adulthood.

Care of the congenital cardiac surgical patient requires a concerted effort on the part of the surgeons, perfusionists, anesthesiologists, intensivists, nurses, respiratory therapists, rehabilitation services and social workers. It is hoped that the same excellent care received in a children's congenital heart surgery program can be continued as these patients graduate into an adult program.

This is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease. The primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. All charts reviewed will be of patients who had their surgery at Children's Healthcare of Atlanta or Emory University between January 1, 2000 and December 31, 2006. We will review approximately 225 charts for this study.

The first aim of the study would be to examine the demographics of the adult congenital heart surgery program itself. The following information will be collected:

* Location of the surgery - children's hospital vs adult hospital
* Surgeon - adult cardiac surgeon vs congenital cardiac surgeon

The second aim of the study would be to analyze the types of surgeries being performed. The following information will be collected:

* Pathologic diagnosis
* Number of re-operative sternotomies
* Number of open-heart surgeries

The third aim of the study would be to analyze our outcomes. The following information will be collected:

- Number of surgical mortalities

Eligibility Criteria:
Inclusion Criteria:

* surgery at Children's Healthcare of Atlanta or Emory University between 1.1.2000 and 12.31.2007
* surgery on patients after 18 years to approximately 65 years of age

Exclusion Criteria:

* Those who do not meet inclusion criteria
Effects of Long-Term Treatment With Nasally Inhaled Triamcinolone Acetonide in Children With Allergic Rhinitis

Seasonal/perennial allergic rhinitis (SAR/PAR) is a common childhood illness. One of the leading therapies for the treatment of SAR/PAR is intranasally inhaled corticosteroids (ICS). One of the major long-term safety concerns is whether ICS interferes with normal growth in allergic rhinitis children. Recent evidence suggests that nasal ICS may cause decreased growth. However, the effect of nasal ICS on long-term growth and the attainment of final adult height is unknown. Another potential systemic adverse effect of ICS use is suppression of the hypothalamic-pituitary-adrenal axis function. The primary hypothesis of this study is that triamcinolone acetonide aqueous nasal spray (TAA) will have no effect on measured adult height in relation to target adult height in children with allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female aged 6-13 years of age
* Diagnosis of SAR/PAR, with symptoms within the past 3 months
* Positive skin test to inhalant allergen with negative saline control
* No previous use of intranasal inhaled, oral, IV or topical steroid use within past 6 months.
* If the subject has asthma, only mild intermittent (per NAPP) guidelines treated with PRN bronchodilator

Exclusion Criteria:

* screening height outside the 5th and 95th percentiles
* History of abnormal growth
* Any other chronic condition beside allergic rhinitis or mild intermittent asthma
* Subject who has insufficient allergic rhinitis symptoms to require daily therapy during the trial.
* Subject with a known hypersensitivity to any active ingredients or excipents in the study medications
* Subject with nasal candidiasis, acute or chronic sinusitis, significant nasal polyposis (impairs nasal breathing), or other gross anatomical deformity of the nose sufficient to impair nasal breathing (e.g., deviated septum)
* Subjects with a history of substance abuse, mental illness or retardation
* Subjects with a history or presence of glaucoma or posterior subcapsular cataract
* Subjects with nocturnal enuresis.
* Use of Theophylline, Intal/Tilade or leukotriene modifiers.
Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

Emergent abdominal surgeries have very high rate of wound contamination due to exposure to bacteria from GI tract. There are several different approaches to wound management in these patients including wet-to-dry dressing or application vacuum assisted device on the wound. The investigators propose using the vacuum assisted device with Dakin's solution on patients undergoing emergency surgery for hollow viscus perforation installed immediately at the end of operation and remained there for the first 3 postoperative days, followed by delayed primary closure on postoperative day 4. The investigators believe this technique can achieve earlier wound closure, decrease patient discomfort, improve cost savings, and potentially standardize and revolutionize the investigators management of heavily contaminated wounds.


Eligibility Criteria:
Inclusion Criteria:

* Emergent surgery involving hollow viscus perforation or necrotic bowel
* Admitted to the University of Arizona Medical Center, Tucson, AZ

Exclusion Criteria:

* Prisoners
* Pregnancy
* Patients with allergy to Dakin's (sodium hypochlorite) solution.
Long Term Outcome Study in Patients With Pituitary Disorders

To determine the outcomes of patients with different pituitary disorders whether they are managed medically, surgically or expectantly.

A chart audit of around 1500 patients seen in two specific clinics, the Medical Pituitary Clinic and the combined Endocrine/Neurosurgical Pituitary Clinic at the University of Alberta Hospital, will be performed to determine the effectiveness of various treatment strategies on the long term outcome of specific pituitary disorders. The investigator's will collect retrospective demographic (age, sex, ethnicity), clinical (mode of presentation, hormonal parameters) and therapeutic outcome (surgical, medical, expectant and / or radiation treatment; co-morbidities and complications) of patients seen in these two clinics between January 2000 and December 2020.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed pituitary disease

Exclusion Criteria:

* patients who do not have confirmed pituitary disease
FS VH S/D 500 S-apr in Vascular Surgery

The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.


Eligibility Criteria:
Inclusion Criteria:

Preoperative inclusion criteria:

* Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:

  * axillo-femoral
  * axillo-bifemoral
  * aorto-bifemoral
  * ilio-femoral
  * femoro-femoral
  * ilio-popliteal
  * femoro-popliteal (including below knee)
  * femoro-tibial vessel bypass
  * arterio-venous shunting for dialysis access in the upper or lower extremity
* Signed informed consent
* Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.
* Subject is willing and able to comply with the requirements of the protocol.

Intraoperative inclusion criterion:

* Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)

Exclusion Criteria:

Preoperative exclusion criteria:

* Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
* Congenital coagulation disorders
* Prior kidney transplantation
* Heparin-induced thrombocytopenia
* Known hypersensitivity to heparin
* Known hypersensitivity to aprotinin or other components of the product
* Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients)
* Prior radiation therapy to the operating field
* Severe local inflammation at the operating field
* Subject is pregnant or lactating at the time of enrollment
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
* Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once.

Intraoperative Exclusion Criteria:

* Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
* Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (eg, abandonment of ePTFE graft placement)
The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life: a Canadian Real-World Study

The purpose of this observational study is to estimate the burden of multiple myeloma on patients and caregivers in terms of QoL. Additionally, this study will assess the correlation between QoL, obtained from commonly used and validated questionnaires, and the perceptions of both patients and caregivers respectively., obtain from a 10-point scale and a comment box.

Potential participants will be identified by Myeloma Canada using their database. Myeloma Canada is a registered non-profit organization created by, and for, Canadians impacted by multiple myeloma. As part of Myeloma Canada website, patients and caregivers can subscribe to a mailing list to receive their monthly newsletter and to participate in surveys. This database comprises about 5,000 individuals, including patients and caregivers.

An e-mail will be sent to 600 patients and 200 caregivers randomly selected to invited them to participate in the survey. Interested participants will be invited to visit the Participant Portal on the PROxy website (https://periproxy.com/en), to sign the informed consent form and complete online questionnaires. Upon request, paper-based documents (i.e., informed consent form and questionnaires) can also be sent by mail. The following questionnaires will be used:

Patients

* Patient Information Questionnaire (i.e., baseline characteristics)
* EORTC QLQ-C30
* EORTC QLQ-MY20
* EQ-5D-5L
* ESAS-R
* Patients Perspective

Caregivers

* Caregiver Information Questionnaire (i.e., baseline characteristics)
* CarGOQoL
* Caregivers Perspective

If the sample size (i.e., 300 patients and 100 caregivers) is not reached one month after the first e-mail, an invitation e-mail will be sent to an additional 600 eligible patients and/or 200 caregivers randomly selected. This scheme of participant identification will be performed until the sample size is reached.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. Part of the Myeloma Canada database;

   1. Identified as a patient with MM or
   2. Identified as a current caregiver of a patient with MM at the time of participation.
3. Ability to read and understand English or French;
4. Signature of informed consent form (ICF).

Exclusion Criteria:

No exclusion criteria
Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic Pain

The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.

The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 40 years or older.
* Clinical diagnosis of osteoarthritis (OA) of the hip or knee.

Exclusion Criteria:

* Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).
Evaluation of the Efficacy and Safety of Zinc in Viral Infections

The main objective of the clinical study is to evaluate the efficacy of Zinc supplementation in non-critically ill Covid-19 patients..

The VIZIR study is a national, longitudinal, multi-centre study conducted over a 3-month follow-up period.

The priori hypothesis was that supplementation with zinc would reduce 30-day mortality and need to intensive care unit (ICU) admission among non critically ill patients with Covid-19.

The VIZIR study will be carried out in Tunisia at the level of consultations of general practitioners of both sectors : public and liberal, as well as in the emergency services of Monastir and Sousse.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and over .
* Sars-Cov2 infection Diagnosed with RT PCR , Rapid Test or Chest CT-Scan performed within the less than 5 days of symptoms.

Exclusion Criteria:

* Patients who received zinc before the start of the protocol.
* heart, liver, malignancies, or renal failure (estimated glomerular filtration rate ≤30 mL/min/1.73 m2);
* Mental disorders .
* Chronic Dialysis.
* Hospitalisation in ICU (use of respiratory or cardiovascular organ support (oxygen delivered by high-flow nasal cannula, noninvasive or invasive mechanical ventilation, or the use of vasopressors or inotropes). .
* Known hypersensitivity to zinc.
* unsuitability for oral administration