cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of Prime-boost Vaccination of SARS-CoV-2 in Patients With Cancer

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has caused a global pandemic since late 2019 that resulted in more than 360 million population infection. Patients with cancers may be at higher risk of infection and severity than those without cancer. Mass vaccination has been carried out, but reinfection and vaccine breakthrough cases still occur. Now, the prime-boost regimen was identified safe and efficient, but the reactogenicity and immunogenicity of prime-boost vaccine strategy in cancer patients were not known.

This study is a prospective, single-arm, open-label clinical trial. A total of 100 patients with different cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included in this heterologous prime-boost vaccination study. All of the patients will further accept 12 months follow-up study after prime-boost vaccination. Safety, reactogenicity and immunogenicity of the prime-boost vaccination in those patients will be carefully recorded and detected.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years.
2. Patients with diagnosed cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer.
3. Patients who have received local or systemic anti-cancer therapies according to the treatment guidelines previously or currently, and have a stable condition with the ECOG score below 2.
4. The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.

Exclusion Criteria:

1. Patients with acute attack of chronic diseases.
2. Patients have history of convulsion, epilepsy, encephalopathy and psychosis. Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
3. Pregnant or lactating women.
4. Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.

   Patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.
5. Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.
Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

The primary purpose of this prospective cohort study is to develop a simplified risk model for post-discharge nausea and vomiting (PDNV) in adult same-day surgery patients in the US that will allow clinicians to identify those patients who would benefit from prophylactic antiemetic strategies.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* scheduled for an elective outpatient surgical procedure
* understands the nature and purpose of this survey and has signed an informed consent form
* willing and able to complete daily components of the Patient Diary from the day of surgery until the end of the 48 hour assessment
* undergoing general anesthesia requiring a tracheal tube or laryngeal mask airway

Exclusion Criteria:

* planned inpatient surgery
* inability to communicate in English
* regional anesthesia alone without general anesthesia, as PONV in this setting is known to be significantly lower \[18, 19\]
* persistent or recurrent nausea and/or vomiting before anesthesia due to other etiologies, unless clearly related only to the anxiety due to impending surgery
* minors (\< 18 years of age)
* current pregnancy by self-report (potentially confounding for etiology of nausea)
Peritonsillar Bupivacaine Infiltration After Tonsillectomy In Children

To evaluate the effect of peritonsillar bupivacaine infiltration on the development of postoperative delirium in pediatric patients undergoing tonsillectomy or adenotonsillectomy.

Postoperative emergence delirium (ED) is an important clinical condition characterized by crying, irritability and severe restlessness in subjects recovering from anesthesia. ED is more common in children than in adults. Among the types of surgery, the ED is common in ENT surgery in which the prevalence was reported between 13%-26%. The adenotonsillectomy, which is a common ENT procedure carry a high risk for development of ED.

The ED can cause the child recovering from anesthesia to harm himself/herself and the surgical site and may cause parents to question the quality of anesthesia. It is associated with postoperative increased morbidity. Several anesthetic strategies exists (intranasal premedication, deep versus awake removal of the laryngeal mask, different intravenous anesthetic combinations) in the literature in order to prevent delirium. Local anesthetic application as xylocaine was shown to reduce the postoperative pain and ED. In addition it is generally accepted that that postoperative ED can be reduced with good analgesia.

Local infiltration of peritonsillar fossa with various local anesthetics, steroids etc. is an established technique for relieving the postoperative pain. Bupivacaine as a long-acting local anesthetic is widely used for local infiltration anesthesia. It is a safe technique and several comparative studies exists in the literature on efficacy. A few number of studies exists that evaluates the relationship between effective pain control and postoperative ED development in children with regional anesthesia applications. However, in English literature we could not find a study on the effect of local infiltration of peritonsillar fossa on development of ED in subjects who underwent tonsillectomy/adenotonsillectomy operations.

The aim of this study is to evaluate the effect of peritonsillar bupivacaine infiltration on the development of postoperative delirium in pediatric patients undergoing tonsillectomy/adenotonsillectomy.

Eligibility Criteria:
Inclusion Criteria:

* patient have adenotonsillectomy
* age 3-7 years
* ASA-1

Exclusion Criteria:

* active infection,
* bleeding-coagulation disorder,
* neuropsychiatric disorder,
* bupivacaine hypersensitivity,
* postoperative delirium history,
* history of surgery for different reasons within 1 year,
* history of long-term hospitalization,
* chronic disease,
* chronic pain condition
* chronic analgesic use
The Effect of E-Health Management on Gestational Diabetes Control

The purpose of this study was to develop an e-heath management platform(eHMP) for women with high risk of gestational diabetes mellitus (GDM) and to evaluate the longitudinal effects between groups of eHMP intervention.

Background: Women with previous gestational diabetes mellitus are at increased risk for developing type2 diabetes mellitus or metabolic syndrome in their later life. Infants of mothers with GDM are more susceptible to stillbirth and more serious health concerns. With limited time for visits and the predicament of education, applying web-based intervention has become a convenient tool for health management.

Objectives: The approved project aimed to develop an e-heath management platform(eHMP) for women with high risk of gestational diabetes mellitus (GDM) and to evaluate the longitudinal effects between groups of eHMP intervention. The eHMP integrate GDM health care knowledge, self-awareness of health, self-monitoring of health status (i.e., recording weight and measurement data of metabolic syndrome risk factors and monitoring changes in data trends); participation in discussions or browsing forums; healthy lifestyle guidance and counseling; reminder systems, a token system of earning points in exchange for prizes.

Methods: Pregnant women aged 18-45 years with high risk of metabolic syndrome who have a singleton pregnancy, are eligible to participate in this study. Women who agree to participate in the study will be given a participant information sheet and consent form. Participants will be recruited from the Pregnancy diabetes Clinic, at Chang Gung memorial hospital and introduced to the eHMP using the mobile phone in the clinic. Participants will also be given the URL to access to the program and they can learn the modules at home by using their home PCs, mobile phones, or tablets. They were followed up for three times: 28 weeks' gestation, 36-40 weeks' gestation and 6-12 weeks postpartum. SPSS version 20.0 software was used to compile and analyze the research data, including questionnaires and blood test for metabolic index.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women (pre-pregnancy body mass index ≧ 24) must meet at least one of the following conditions and agree to be interviewed:

* Age over 34 years old;
* Ever had giant infant delivery (weight ≧ 4.5 kg);
* Previous diagnosed with gestational diabetes ;
* Family history of diabetes.

Exclusion Criteria:

* Pre-existing diabetes (types 1 and 2);
* Unable to write and understand Chinese;
* Subject has cognitive impairment;
* Subject has intellectual disability or mental illness;
* Dependent on medical care (eg, anti-depressants, or any psychiatric medication)
The PaWS (Pedometer and Walking Study)

The literature has shown that supervised exercise programs for patients with PAD and who report intermittent claudication (IC) have improved health outcomes, but this is not locally available. Introducing the use of a pedometer may act as a method to encourage patients to continue on their independent exercise regimen. There is very little literature which has examined the effectiveness using pedometers as a measure of compliance within this population.

It has been established that exercise therapy has a central role in the management of peripheral arterial disease. Such treatment should be comprised of intermittent walking of sufficient distance to induce significant discomfort, and be carried out over a period of at least several months. Supervised exercise training utilizing intermittent treadmill walking is a well-validated treatment for claudication. Most prospective randomized single site studies have reported significant improvement in walking distance following supervised exercise training but not with non-supervised regimens.

Furthermore, this has been acknowledged in both the current AHA/ACC 'Guidelines for the management of patients with peripheral arterial disease', which recommends supervised exercise training as an initial treatment modality with a Class 1A level of evidence (highest), as well as in the TransAtlantic Intersocietal Consensus, which provides an 'A' categorical recommendation. In spite of these peer-reviewed, published recommendations, supervised exercise training remains little used, expensive, not reimbursed by Ontario Health Insurance Plan, and therefore is rarely available to patients with claudication in Ontario.

The purpose of this multicentre study is to examine whether the use of a pedometer enhances patient compliance with walking as compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Males or females with a diagnosis of PAD (ABI \< 0.9) who report symptoms of IC,
* Independent with ambulation (assistive device is permitted) and living independently,
* No previous vascular surgical interventions,
* Fluency in English is preferable but not required,
* Patients need to be willing to return for monthly assessment.

Exclusion Criteria:

* Previous vascular surgical intervention,
* Non-ambulatory,
* Unstable cardiac status (cardiac event \< 6 months),
* Cognitive difficulties,
* Unwilling to engage in regular exercise
Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

This is a randomized, double-blind, placebo controlled, multicenter, phase III study evaluating the efficacy and safety of ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy as first-line treatment for participants with locally advanced or metastatic NSCLC without actionable driver mutations.

Participants will receive study treatment every three weeks and will continue to receive it until RECIST 1.1 disease progression as determined by Investigator and confirmed by BIRC, unacceptable toxicity that precludes further treatment, treatment is discontinued at the discretion of the Investigator or participant, participant withdrawal of consent, pregnancy, lost to follow-up, or death.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation, radiation or surgery) or metastatic (stage IV) NSCLC (according to AJCC: Cancer Staging Manual, 8th edition) participants with no previous systemic treatment for advanced disease.
* Known PD-L1 status determined, prior to study randomization
* At least one measurable lesion as defined by RECIST 1.1 according to local radiology assessment at screening.
* ECOG performance status ≤1.

Key Exclusion Criteria:

* Active autoimmune diseases requiring treatment with steroids or immunosuppressors in the past 2 years prior to randomization.
* History of severe hypersensitivity reaction or any contraindication to ociperlimab, tislelizumab, pembrolizumab (or any other monoclonal antibodies), platinum containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of these drugs.
* Participants with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Participants with documented epidermal growth factor receptor (EGFR) sensitizing mutations, and/or ALK rearrangement assessed as part of the patients's standard of care by a validated test, as per local regulations will be excluded from the study.
* Participants with other known druggable molecular drivers (any histology) such as BRAF V600, KRASG12C, MET exon 14 mutations, NTRK, RET or ROS-1 rearrangement diagnosed per local tests who might be candidates for alternative targeted therapies as applicable per local regulations and treatment guidelines are excluded.

Other inclusion/exclusion criteria may apply
Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections

Hypothesis: A short course (3-5 days) of antibiotic therapy (experimental arm) is as safe and effective as a long course of antibiotic therapy for the treatment of catheter-associated urinary tract infections.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatients ≥ 21 years old.
2. Presence of indwelling urinary catheter at the time of urine culture for ≥2days.
3. Fever \>38°C.
4. A urine specimen sent to the hospital microbiological laboratory for culture.
5. An antibiotic order for presumed symptomatic catheter associated urinary tract infection.

Exclusion Criteria:

1. Persistent fever \>38°C for more than 24 hours, or any fever \>38.9°C.
2. Haemodynamic instability, defined as:

   * Requirement for intravenous vasopressor agents
   * Systolic blood pressure \<90 mmHg
   * Acute hypotensive event with drop in systolic blood pressure of \>30 mmHg or diastolic blood pressure of \>20 mmHg
3. The following laboratory values within the previous 48 hours (if available):

   * White blood cell count\>15 or \<4 x10\^9/L.
   * Procalcitonin\>0.25ug/mL
   * C Reactive Protein \>100mg/mL
   * An increase in the serum creatinine of more than 50% from baseline
4. New requirement for oxygen supplement.
5. Current admission to a high dependency unit or ICU.
6. Radiological evidence of an upper urinary tract infection
7. Flank pain or tenderness, suggesting an upper urinary tract infection
8. Urologic surgical procedure within the previous 72 hours
9. Known structural genitourinary abnormalities including:

   * Nephrostomy tubes
   * Tumours of the urinary tract
   * Ureteric stenting
   * Ureteric strictures
   * Urolithiasis
10. Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.
11. Received antibiotics for more than 48 hours prior to randomization.
12. Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.
13. Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.
14. Pregnancy.
Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1

In the present study we will measure and compare the unbound, i.e. microbiologically active concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis technique, which allows for the continuous measurement of unbound drug concentrations in the interstitial space fluid. The findings of the present study will help to assess whether currently employed therapy regimens with doripenem provide effective antimicrobial concentrations in different compartments in man


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male

Exclusion Criteria:

* Female
* Ill
Diagnostic Accuracy of the Preoperative Clinical Examination in Upper Limb Injuries

The purpose of this study is to determine the accuracy of preoperative clinical examination in penetrating injuries

Penetrating injuries is a common cause of severe neurovascular damage, both in adults and children.we evaluated the accuracy of the preoperative clinical examination in depicting lesions caused by penetrating wounds of hands or forearms.

Eligibility Criteria:
Inclusion Criteria:

Deep penetrating injury to upper limb

Exclusion Criteria:

none
A Clinical Follow-up Study on the Efficacy of Thumbtack Needle for Postoperative Sleep and Recovery Treatment

To understand the impact of thumb-tack needle therapy on postoperative sleep and recovery in patients who have undergone general anesthesia, and to explore the clinical significance of thumb-tack needle therapy in improving postoperative sleep quality, preventing postoperative sleep disorders, and promoting postoperative recovery


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing breast cancer surgery with general anesthesia in the hospital;
2. American Society of Anesthesiologists (ASA) classification I-II;
3. Women aged 18-55 years;
4. No history of chronic insomnia;
5. Individuals who have not taken sedative-hypnotic drugs within the past month.

Exclusion Criteria:

1. Those who do not meet the aforementioned inclusion criteria;
2. A history of severe heart, brain, lung, or kidney diseases (such as acute coronary syndrome (ACS), severe heart failure classified as NYHA Class III or IV, severe arrhythmias, severe valvular disease; acute aortic disease, and severe peripheral vascular disease, etc.), or poor physical condition (including reduced exercise tolerance, multi-organ dysfunction, malnutrition, etc.);
3. A history of sleep disorders and psychiatric history;
4. Inability to receive thumb-tack needle treatment.
Cases With Traumatic and Non Traumatic Brain Damage Treated in the Intensive Care

Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.

After local ethics committee approval, a total of 1004 patients treated in the ICU in a 2-year period were retrospectively reviewed. 135 patients, determined with traumatic or nontraumatic brain damage, with a more than 24-hour stay in the ICU, included the study. Reasons for brain damage were determined as brain damage associated with pure head trauma (Group HT), head trauma accompanying general body trauma (Group HT+GBT) and spontaneous haemorrhage (Group SH). The type of brain damage was defined from the radiological diagnosis as subarachnoid haemorrhage, intracranial haemorrhage (ICH), subdural haematoma(SDH), epidural haematoma(EDH), skull fracture, brain contusion or a combination of these (COM).

Eligibility Criteria:
Inclusion Criteria:

* Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay.

Exclusion Criteria:

* Patients admitted less than 24 hour.
Remote COVID-19 Symptom Tracking for Cancer Patients at Home During the Pandemic

This project will evaluate the benefit of an automated home symptom monitoring system, Symptom Care at Home, to track COVID-19 symptoms, provide instructions to reduce COVID-19 exposure, and reduce cancer symptom severity during the COVID-19 pandemic. The investigators will determine if Symptom Care at Home decreases the need for cancer patients to use emergency departments and hospitalization for cancer symptom care. The project addresses the urgent public health need for cancer patients to reduce their risk for COVID-19 exposure.

In response to the COVID-19 pandemic, there is an opportunity to rapidly flex platforms for remote cancer symptom tracking and management to incorporate COVID-19 symptom monitoring and reinforce risk-reducing precautions. It is critical for cancer patients at home to monitor early indications of COVID-19 symptoms, to adhere to mitigation strategies, as well as to manage their cancer-related symptoms so that patients can decrease the need to utilize the emergency department or unplanned hospitalizations for symptom care, which is a common occurrence during cancer care. Remote monitoring adds a layer of home-based support which can benefit all cancer patients and is not restricted to geographic proximity to oncology providers or distance from a cancer center. The Symptom Care at Home (SCH) system, utilized for the Principal Investigator's currently funded R01CA206522 project to monitor and manage patient-reported (PRO) cancer symptoms, includes these necessary elements: remote PRO symptom monitoring, patient self-management information, and oncology provider (nurse practitioner) notification of symptoms exceeding pre-set thresholds. The overall purpose of this project is to describe the impacts of COVID-19 on cancer patients' well-being at home and evaluate, through a randomized clinical trial, if a systematic patient-reported outcomes (PRO) reporting process improves cancer care during a pandemic as compared to usual care. Specific Aims include: 1) describe patient-reported COVID-19 and cancer symptom trajectories over time, COVID-19 social distancing and hygiene practices, and COVID-19 related cancer treatment and daily living impacts on cancer patients receiving the SCH-COVID intervention and 2) compare the SCH-COVID intervention to enhanced usual care on health care utilization, COVID-19 diagnosis and outcomes, cancer treatment delays or changes, and patient-reported global health, anxiety, mood, and feelings of social isolation.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be patients who are receiving treatment for a cancer diagnosis at Huntsman Cancer Hospital.
* Must be able to speak, read, and understand English language.
* Must have a smartphone and be willing and able to download the SCH application and enter data into the application OR must be willing to make phone calls to report symptoms using the telephone interactive voice response (IVR) system.

Exclusion Criteria:

* Patients enrolled in another study protocol that prohibits participation in other trials.
* Patients under the age of 18.