cyrilzakka/clinical-trials huggingface dataset:
Impact of Standing Orders Optimization

This trial will look at the impact of optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders.

The researchers will conduct a cluster randomized clinical trial. The trial will look at the impact of optimizing HPV vaccine standing orders. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive a communication training. Other clinics will receive a communication training and tools for optimizing the use of their standing orders. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The researchers will also use survey data to compare HPV vaccine communication and implementation of standing orders among clinical staff. The study will engage clinical staff. Researchers will not have direct contact with children or their families.

Eligibility Criteria:
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children and survey data from clinical staff to evaluate intervention effectiveness. We will not enroll children or interact with them directly.

Inclusion Criteria

Clinics are eligible if they:

* provide HPV vaccine to children ages 9-12
* have standing orders for HPV vaccination approved but not routinely used or be willing to adopt them prior to the start of the trial
* have rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined

Children's medical records will be eligible to be included in the dataset if children:

* are between the ages of 9-12 years at baseline
* are attributed to a participating clinic at 12- or 24-month follow-up

Clinical staff's survey data will be eligible to be included in the dataset if clinical staff complete the follow-up survey.

Exclusion Criteria

Clinics are excluded if they:

* do not provide HPV vaccine to children ages 9-12
* do not have standing orders for HPV vaccination or are not willing to adopt them prior to the start of the trial
* have rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined
* have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings
* have quality improvement efforts to change HPV vaccine standing orders during the trial

Children's medical records will not be eligible to be included in the dataset if children:

* are not between the ages of 9-12 years at baseline
* are not attributed to a participating clinic at 12- or 24-month follow-up
* are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications

Clinical staff's survey data will be not eligible to be included in the dataset if clinical staff do not complete the follow-up survey.
Early Enteral Tube Feedings in Children Receiving Chemo for AML/MDS & High Risk Solid Tumors

RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer.

PURPOSE: This clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or high-risk solid tumors.

OBJECTIVES:

Primary

* To determine the feasibility and acceptance of undertaking early enteral tube feedings in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia or myelodysplastic syndromes, primary cancers of the central nervous system, or high-risk solid tumors.

Secondary

* To determine the safety of proactive enteral nutrition in these patients.
* To evaluate the effect of enteral nutrition on nutritional status in these patients.

OUTLINE: Patients have a small (6 or 8 French) nasogastral feeding tube or enterostomy tube inserted after diagnosis. Peptamen® AF tube feeding is administered via the enteral tube. Tube feedings are started as a continuous drip using an enteral feeding pump with a subsequent steady daily rate increase. Patients receive enteral feeding during courses 1-4 of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Newly confirmed diagnosis of 1 of the following:

  * Acute myeloid leukemia
  * Myelodysplastic syndromes
  * Sarcoma
  * Any other stage IV solid tumor including:

    * Wilms
    * Neuroblastoma
    * Hepatoblastoma
  * Any primary cancer of the central nervous system including:

    * Cerebellar astrocytoma
    * Medulloblastoma
    * Ependymoma
    * Spine tumors

Exclusion Criteria:

* No contraindication to enteral tube feeding including, but not limited to, any of the following:

  * Gastrointestinal tract dysfunction (i.e., ileus, peritonitis, obstruction)
  * Active sinusitis (can be waived for patients with gastrostomy tubes)
  * Obstructive tumor in the nasopharynx

PRIOR CONCURRENT THERAPY:

* No prior hematopoietic stem cell transplant
* All clinically indicated medications are permitted during the course of the study
* No other concurrent nutritional supplements
A Multicenter Prospective Cohort Study Study of CLAG Regimen in Acute Myeloid Leukemia Patients With First-induction Failure

Most of patients with acute myeloid leukemia achieved complete remission (CR) after primary induction chemotherapy, there were 20-30% patients without CR after first-induction. It was uncertain how to treat these patients. It was investigated in our study that these patients were re-induced with CLAG Regimen. The CR ratio, overall survival (OS) and relapsed-free survival (RFS) was statistically analysed in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia patients with first-induction failure

Exclusion Criteria:

* Acute myeloid leukemia patients with serious infection and organ dysfunction.
A Conversational AI System to Enhance Knowledge About Vaccines and Promote Vaccination

This study is designed to contribute to the growing body of evidence on the efficacy of digital health interventions. By rigorously evaluating the impact of the AI system on vaccine knowledge and acceptance, the study aims to inform future health communication strategies and policies. It stands as a potential model for integrating AI into public health initiatives, showcasing how technology can be harnessed to improve health outcomes on a large scale.


Eligibility Criteria:
Inclusion Criteria

* Individuals aged 18 or above
* Owning a smartphone/tablet capable of using the study app
* Willing to provide informed consent.

Exclusion Criteria

* Individuals with ocular or hearing disorders that preclude the use of mobile phones or reading.
* Individuals with mental disorders that preclude the use of mobile phones or reading.
Fospropofol for Sedation During Elective Awake Intubation

Patients scheduled for awake fiberoptic intubation (AFI) because of potential difficult airway will be consented prior to intubation ASA Physical Status classification and history of difficult intubation will be recorded at screening. The investigators will also record the results of airway examination including Mallampati classification, thyromental distance, mouth opening, neck circumference, neck range of motion, presence or absence of beard and overbite, history of neck radiation, and mandibular protrusion test Informed consent will be obtained prior to the procedure from those patients who meet the inclusion and exclusion criteria.

Standard hemodynamic monitoring will be used in all patients including EKG, blood pressure, heart rate, respiratory rate and oxygen saturation. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale will be used to assess the level of alertness/sedation. Two consecutive MOAA/S scores of 4 will be considered as the desired effect of moderate sedation.

For AFI procedure, IV will be started and oxygen will be administered. 4 L of oxygen will be delivered through nasal canula until the completion of the AFI procedure. Patient head will be positioned in the sniffing position, Topical anesthesia would be achieved using the topical administration of 4 percent lidocaine using atomized and MaDgic nebulizer, and 2% xylocaine Jel applied to the surface of Williams airway in a total dose of lidocaine not exceeding 10 mg/kg. Patients will be randomized to one of the four fospropofol treatment arms: 2, 3.5, 5, or 6.5 mg/kg


Eligibility Criteria:
Inclusion Criteria:

* Age: between 18-64 years of age
* ASA physical status 1-3 ( Except patients with severe cardiac and/or pulmonary disease
* Weight 60-90 Kg
* Elective surgery requiring awake FOI
* Male or female, female patients should not be pregnant (documented by morning of surgery urine pregnancy test result as per routine hospital policy) or lactating

Exclusion Criteria:

* Previous exposure to any experimental drug within 30 days prior to study drug administration
* Raised intracranial pressure
* Patients for whom propofol is contraindicated
* Allergy to midazolam and/or fentanyl
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 'Ursa Complex Soft Cap. (UDCA-004)' in Patients With Physical Fatigue.

A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'Ursa Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.


Eligibility Criteria:
Inclusion Criteria:

* CIS greater than or equal to 76, HADS less than or equal to 10

Exclusion Criteria:

* Subjects who have diseases that can cause fatigue
* Subjects who are taking medication that can cause fatigue
Central Venous Access Device Removal in Cancer Patients

Background:

Central venous catheters are frequently used during cancer treatment with the aim of venepreservation. It can facilitate venous access for the safe administration of irritating or vesicant intravenous cancer medications and / or other fluids, to collect blood samples or to ensure accurate venous access for contrast during medical imaging. In addition, this means more comfort for the patient who needs to be punctured less peripherally. However, central venous catheters can also be a source of bloodstream infections and other complications, leading to increased morbidity and hospital costs (1). In our hospital, there is a general practice that if an infection of the device is suspected, the central venous catheter should be removed if antibiotics do not seem or prove to be effective.

The objective of this trial is to assess the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device in a particular oncology center over a time period of seven years. Furthermore, evidence for real device infections (per/post-surgery) and the potential contribution of different (institution-specific) risk factors on device infection will be explored. There will be focused on implanted port catheters only, as this is the main used central venous access device within the oncological population.

Trial objectives:

The primary aim of this retrospective descriptive trial is to evaluate the frequency of implanted port catheter-removal in cancer patients due to suspected infection of the device, over a time period of seven years.

The secondary aim is to examine whether the device infection could be confirmed during or after removal of the device.

At last, the tertiary aim is to verify whether certain variables can be denoted as potential risk factors for central venous access infection. Selection of those variables of interest will be based on a thorough review of the literature and discussion with the responsible healthcare professionals.


Eligibility Criteria:
Inclusion Criteria:

* Central venous access device removal in our general hospital
* Cancer patient

Exclusion Criteria:

-
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome

The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women.


Eligibility Criteria:
Key Inclusion Criteria:

* PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or oligomenorrhea and exclusion of other causes of hyperandrogenism.
* Overweight/obese female subjects with BMI of 28 - 45 kg/m\^2, inclusive, and stable weight +/- 3 kg over previous 3 months
* Subjects must use non-hormonal methods of contraception during the study.

Key Exclusion Criteria:

* Subjects with exogenous causes of hirsutism
* Menstruation in the 30 days prior to screening or treatment
* Pregnant or nursing (lactating) women
* Use of prohibited medications
* Preexisting medical condition which may significantly alter the absorption, metabolism, or excretion of the study drug, or which may jeopardize the subject in case of participation in the study
Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma

Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures. Urine DNA methylation testing is a promising non-invasive method for early UC detection. To evaluate the sensitivity and specificity of urine DNA methylation testing for detecting UC, using standard clinical and pathological diagnoses as the gold standard.

Urothelial carcinoma (UC) is the most common malignancy of the urinary system, and early detection and diagnosis are crucial for patient prognosis. Hematuria is a significant clinical manifestation of UC, but its diagnosis often relies on invasive procedures and imaging, posing a substantial burden on patients. With the advancement of molecular biology techniques, urine DNA methylation testing has emerged as a non-invasive and highly sensitive method for early UC detection. This study aims to evaluate the performance of urine DNA methylation testing in detecting UC in patients with hematuria.

All patients with hematuria will receive standard clinical diagnosis, including examinations, tests, surgeries, and pathological assessments to determine the presence of UC. These clinical diagnoses will serve as the gold standard to evaluate the sensitivity and specificity of urine DNA methylation testing in detecting UC in patients with hematuria.

To ensure accuracy and reliability of the results, select a subset of samples with known test results for external methylation sequencing. Authorized researchers will unblind the samples, and the statistical team will analyze the results, calculating sensitivity, specificity, positive predictive value, and negative predictive value of the urine DNA methylation test.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 90 years, with gross or microscopic hematuria.
* Able to provide enough urine for testing before surgery.
* Consent to participate in the study and sign the informed consent form.

Exclusion Criteria:

* With history of any malignancies (including Urothelial carcinoma).
* Severe urinary tract infection leading to sepsis.
* Patients with indwelling catheters, nephrostomy, or cystostomy.
* Severe liver or kidney failure or other conditions deemed unsuitable for the study.
* Samples with insufficient DNA content or other quality control failures.
* Incomplete clinical or pathological data.
* Patients currently undergoing intravesical or systemic chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Surgery in the Prone Position

Long standing prone position could affect vision or optic nerve. To measure the optic nerve sheath diameter using ultrasound is quick and useful assessments of patients.

This study will look at the change of optic nerve sheath diameters of patients undergoing surgery in prone position


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery in prone position

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients has ophthalmic diseases
* Patients has previous history of ophthalmic surgery.
* Patients has neurological disorders.
* Patients has history of head surgery.
* Severe anaphylactic allergy to ultrasound gel or Tegaderm
Procedural Advantages of a Novel Drug-Eluting Coronary Stent

This study sought to compare procedural performance of a new coronary stent generation, that is already available in Germany, with hitherto established current drug-eluting stents.


Eligibility Criteria:
Inclusion Criteria:

* CAD for PCI, consecutive patients

Exclusion Criteria:

* Age under 18
* Bare Metal Stents or Scaffolds
Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain

The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.


Eligibility Criteria:
Inclusion Criteria:

* Patient is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
* Patient had successful Algovita SCS system stimulation trial with an Algovita SCS system and will be implanted with a permanent Algovita SCS system; prior approval must be obtained from the Sponsor if another SCS system was used for the stimulation trial
* Patient is willing and able to sign an IRB/EC approved informed consent, and in the United States, a Privacy Protection Authorization, as required

Exclusion Criteria:

* Patient is contraindicated for an Algovita SCS system
* Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
* Patient has a life expectancy of less than 2 years
* Patient is participating in another clinical study that would confound data analysis
* Patient has a coexisting pain condition that might confound pain ratings
Optimization of Desflurane in Elderly Patients

Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing.

Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia.

The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).

The objectives of this study is to compare the time to emergence and quality of recovery in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).

Inclusion Criteria:

- Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients

Exclusion Criteria:

- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI\>35)

Eligibility Criteria:
Inclusion Criteria:

- Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients

Exclusion Criteria:

- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI\>35)
T and B Cell Response to Avian Flu Vaccine

The purpose of this substudy study is to evaluate the types of cells involved in fighting infection to the A/H5N1 (avian flu virus) vaccine. A maximum of 30 healthy adults ages 18-64 years, enrolled at Stanford University Hospital and participating in another clinical trial (DMID Protocol 04-062) will be enrolled into this substudy to collect additional samples of blood for testing before and approximately one week after each vaccination.

A human vaccination trial involving influenza A/H5N1 vaccine with different adjuvants is being conducted in a healthy adult population aged 18-64 years (DMID 04-062) to test the safety, reactogenicity, and immunogenicity of monovalent inactivated influenza A/H5N1 vaccine when given with either alone (no adjuvant), or given along with either alum or MF59. Two doses of the vaccine/adjuvent will be administered day 0 and day 28. This study is linked to DMID protocol 04-062. This protocol is a substudy to collect additional blood samples to specifically evaluate the cell-mediated immune responses generated from the vaccine. Primary goals of this study are 1) to establish reproducible, functional cell-mediate immune response assays to evaluate the magnitude and functional capacity of B cells, NK cells and T cells responding to monovalent subvirion H5 influenza vaccine 2) to evaluate the percent of subjects demonstrating B cell, NK cell, CD8+ and/or CD4+ response. The secondary goal of this study is to examine and compare the adjuvant effect of Alum or MF59 compared to no adjuvant on cell mediated immune responses.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects who are eligible and enrolled in 04-062 and have agreed to the extra blood draws for this substudy will be considered for enrollment if they will be receiving 15 micorgrams of the H5N1 vaccine without an adjuvant or with 15 micrograms of the H5N1 vaccine with alum or MF59 adjuvant. Subjects will not be recruited outside the main vaccine trial.
2. Subjects who understand and sign the consent form for this study.
3. Subjects who meet pre-screening qualifications will be eligible for the initial pre-vaccination blood draw.

Exclusion Criteria:

1. All subjects who are ineligible for the main monovalent subvirion H5 vaccine trials will not be eligible for the CMI sub-study.
Pain Neurophysiology Education and Exercise for Adolescents With Chronic Idiopathic Neck Pain

This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).

Forty three adolescents with chronic idiopathic neck pain were randomly allocated to receive pain neurophysiology education and shoulder/neck exercises (n=21) or no intervention (n=22). Data on pain intensity (Visual Analogue Scale), pain disability, neck flexor and extensor muscles endurance, scapulae stabilizers endurance, pain catastrophizing (Pain catastrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and knowledge of pain neurophysiology (Neurophysiology of Pain Questionnaire) were collected. Measurements were taken before and after the intervention.

Statistical analysis were performed using a mixed-methods ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* To be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months.

Exclusion Criteria:

* No exclusion criteria