cyrilzakka/clinical-trials huggingface dataset:
Digital Intervention Postoperative Protocol

Postoperative recovery after head and neck surgery is complex, and often requires utilization of narcotic medications. The aim of this study is to evaluate reduction in pain and use of opioid medications through Virtual Reality (VR) and Fitbit wearable activity devices.

Enhanced Recovery After Surgery (ERAS) protocols were introduced as a method to optimize perioperative patient care. Narcotic medications are frequently utilized in postoperative care, but these have risks including sedation or dependence. Non-pharmacologic measures for postoperative pain control may help limit the need for opioids in postoperative pain control.

Early mobilization is also important after surgery, however postoperative mobility is rarely monitored and relies on subjective reports.

The investigators will seek to examine the implementation of an ERAS protocol using VR and Fitbit wearable activity devices on postoperative recovery after head and neck surgery. This is a prospective, 4-arm, randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* 18 to 89 years of age.
* Planned to undergo major head and neck surgery OHSU with an expected length of stay of two days or more.
* Ability to understand goals of the study and willingness to sign a written informed consent document.

Exclusion Criteria:

* Planned postoperative admission to the intensive care unit (ICU).
* Social or psychiatric conditions that may interfere with compliance.
* Isolation precautions.
* Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset or wear a Fitbit device around the wrist.
* History of seizure or epilepsy.
* History of vertigo or persistent dizziness.
* Limitations that impair mobility.
* Use of a walker or wheelchair at baseline.
Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study

Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network.

Pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (MR) Conditional Tachyarrhythmia Therapy Systems in the MR environment when used according to labeling requirements. Following approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network. MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Eligibility Criteria:
Inclusion Criteria:

* MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.
Predicting Post Extubation Stridor After Maxillomandibular Fixation

Endotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES)

Ultrasound (US) is a useful and non-invasive tool for the evaluation of vocal cords and laryngeal morphology in intubated patients. The laryngeal air-column width (LACW), Laryngeal air column width difference (LACWD), and laryngeal air-column width ratio (LACWR) measured by ultrasound can potentially identify patients at risk of post-extubation stridor, in whom caution should be taken after extubation.

The cuff-leak test can predict successful extubation through using the difference between the expired tidal volume with the cuff inflated and with the cuff deflated; the higher the leak, the lower the likelihood that post-extubation stridor will occur.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years)
* American Society of Anesthesiologists status I and II
* undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation

Exclusion Criteria:

* patients' refusal
* pregnant females
* patients with body mass index \<18.5 or ≥ 35 kg/m2
* risk of aspiration
* cardiorespiratory disorder
* neuromuscular disease
* uncontrolled diabetes mellitus
* gastrointestinal bleeding
* on chronic steroid therapy
* intubated patients or were intubated or had upper airway infection within 1 week prior to surgery
* history of any pathology, radiotherapy or surgery in the neck
* had difficult laryngeal US plane (as neck wound)
A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty

The proposed study aims to objectively assess 2-year clinical and radiographic results for the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This retrospective radiographic review will provide evidence for equivalence or superiority in curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is utilized in conjunction with cement at the glenoid.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed at least 2 years follow-up following their total shoulder replacement
* Patients must have had radiographic imaging obtained at that 2 years

Exclusion Criteria:

* Patients less than 21 years of age
* Patients who have been imprisoned since the time of surgery
* Patients who are mentally impaired
Sleep Modulation to Treat Depression

Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.

The planned study is a single-centre, doubled-blind, randomized, sham controlled, repeated measures within-subject (stimulation and sham) study including patients with major depression and healthy controls, across four sleep laboratory nights (adaptation, baseline, stimulation and sham in counterbalanced order). The investigators will test the primary hypothesis that auditory-closed loop suppression of slow wave sleep will improve depressive clinical symptomatology compared to sham stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* MDD according to ICD-10 criteria (F32.1/2, F33.1/2; i.e. unipolar depression) for patient group

Exclusion Criteria:

* Relevant psychiatric disorders (other than MDD for the patient group), such as organic psychiatric disorders, lifetime history of substance dependency or current substance abuse (smoking will be allowed for recruitment reasons), schizophrenia or other psychotic disorders, affective disorders including bipolar disorder, borderline personality disorder, autism or other severe psychiatric disorders
* Known pregnancy
* Unstable medical conditions, such as unstable cardiovascular or metabolic disorders, etc.
* Relevant neurological disorders, including epilepsy, stroke, etc.
* Organic sleep disorders including relevant sleep apnea (AHI\>15/h), periodic limb movement disorder (PLMS index\>5/h), Restless-Legs-Syndrome (RLS), narcolepsy, circadian rhythm disorder or shift work/ jet lag
* Intake of medication affecting the central nervous system (other than antidepressants and lithium in patients); patients receiving benzodiazepines or (es)ketamine will not be included
* Current brain stimulation treatment, such as electroconvulsive therapy (ECT), TMS or deep brain stimulation
* Contraindications for tDCS or TMS studies, including but not limited to metal in the head/ brain or epilepsy
* Hearing impairment or tinnitus (auditory stimulation study)
* Inability to follow the procedures of the study (for example due to language problems)
* Left-handedness
Naxitamab for High-Risk Neuroblastoma Patients with Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone And/or Bone Marrow

Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose.

Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

Each patient will receive treatment for up to 101 weeks following the first Naxitamab administration. After the end of trial visit, each patient will enter a long-term follow-up where they will be monitored for up to 5 years after first treatment cycle.

Each investigational cycle is started with 5 days, days -4 to 0, of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) administered at 250 µg/m2/day in advance of the start of Naxitamab administration. GM-CSF is thereafter administered at 500 µg/m2/day on days 1 to 5. As standard treatment, Naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5, totalling 9 mg/kg per cycle.

Treatment cycles are repeated every 4 weeks (±1 week) until complete response or partial response followed by 5 additional cycles every 4 weeks (±1 week). Subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. End of treatment will take place around 8 weeks after the last cycle and thereafter long-term follow-up will continue.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria
* High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow.
* Life expectancy ≥ 6 months

Exclusion Criteria:

* Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
* Evaluable neuroblastoma outside bone and bone marrow
* Existing major organ dysfunction \> Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
* Active life-threatening infection
Medication Reconciliation at Discharge: Impact on Patient's Care

Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP). The investigators aim to assess in this study the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of medication reconciliation at discharge we expect a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge.

Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients and may lead to further hospitalization. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP) and from discrepancies between patient's current medications and drugs prescribed at discharge.

Preventing adverse drug events (ADEs) remains a patient safety priority not only in hospitals but also across the continuum of care for patients. Implementing medication reconciliation at all transitions in care is an effective strategy for preventing discrepancies and ADEs. Medication reconciliation prevents and corrects medication errors by promoting transmissions of complete and accurate information about medicines.

Furthermore, ADEs may be the result of a failure to understand and manage post-discharge care needs and can lead to hospital readmission.

We assume that medication reconciliation at discharge, secondarily transmitted to the PCP with a discharge counseling session between the patient and a clinical pharmacist could have a positive impact on the maintenance of therapeutic optimization decided by in-hospital practitioners.

In order to evaluate this assumption, we will conduct a randomized controlled study on 120 patients (as a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge is expected).

The follow-up will last 1 month after discharge from hospital. The first prescription from the PCP will be collected and analyzed. In addition, patients and PCPs will be contacted by the pharmacist to answer specific questionnaires.

The primary objective of the study is to assess the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* hospitalized in infectious disease department
* with a chronic disease and a current medical prescription including at least three drugs
* discharged home or nursing home
* not opposed to the study

Exclusion Criteria:

* foreigners, patients under legal guardianship
* advanced dementia (MMS\<20) or phone tracking impossible
* primary care physician opposed to answer questionnaire
Diastolic Dysfunction PPCM in Patients With Documented Left Ventricular Systolic Function Recovery

The purpose of this project is to evaluate parameters of diastolic dysfunction assessed by clinical echocardiogram in patients who have had recovery of systolic function.


Eligibility Criteria:
Inclusion Criteria:

1. Female.
2. Greater than age 18 years at the time of peripartum cardiomyopathy diagnosis.
3. Adults with a current or prior diagnosis of peripartum cardiomyopathy and documented recovered of left ventricular systolic function.
4. Documented recovered of LV systolic performance defined as LVEF \> 50%.

Exclusion Criteria:

1. No pregnancy history.
2. No diagnosis of peripartum cardiomyopathy.
3. Non-recovery of LV systolic function.
Prognostic Significance of Preoperative Nutritional Status on Postoperative Acute Kidney Injury

The incidence of postoperative acute kidney injury (AKI) is high in patients undergoing lung resection surgery, especially in the elderly. Early identification of high-risk postoperative AKI patients can help develop prevention and treatment management strategies.

The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients under lung resection surgery.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 65 years
2. lung resection surgery including：pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy.

Exclusion Criteria:

1. patients with an American Society of Anesthesiologists (ASA) physical status V.
2. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis).
3. those did not have sufficient data required for nutritional evaluation or AKI evaluation.
Perioperative Pregabalin for Reducing Opioid Consumption After Cardiac Surgery

OPIATE is a double-blinded randomized controlled trial (RCT) comparing pregabalin in addition to usual care to usual care alone for reducing post-operative opioid consumption in patients undergoing on-pump cardiac surgery. Patients will be randomized in a 1:1 ratio to receive either pregabalin (300 mg pre-operatively + 75 mg post-operatively twice daily until discharge or 5 days) in addition to usual care or matching placebos in addition to usual care. The aim of the trial is to show that pregabalin is superior to usual care (i.e. a superiority trial).

By administering oral pregabalin to patients before and after cardiac surgery for pain relief, we aim to reduce the amount of opioids they will require for pain relief and reduce opioid-related side effects that they may experience after surgery. Participants will be randomly assigned to receive either pregabalin in addition to usual care or usual care alone. Participants in the pregabalin group will receive two 150 mg pregabalin capsules (300 mg total dose) within 2 hours before surgery and a 75 mg pregabalin capsule twice daily after surgery until discharge from hospital to a maximum of 5 days after surgery. Participants in the usual care group will receive two placebo study capsules within 2 hours before surgery and a placebo capsule twice daily after surgery until discharged from hospital to a maximum of 5 days after surgery. OPIATE will be the largest clinical trial of pregabalin in cardiac surgery with results that are expected to set new post-operative pain management guidelines to encourage the widespread use of pregabalin in cardiac patients.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Undergoing cardiac surgery with median sternotomy
3. Provide written informed consent

Exclusion Criteria:

1. Use of opioids or cannabis products in the past 30 days
2. Daily use of pregabalin or gabapentin within 7 days of randomization
3. Intravenous drug user
4. Have a hypersensitivity or allergy to pregabalin
5. History of previous cardiac surgery
6. Undergoing minimally invasive surgery
7. Emergency surgery
8. Severe renal impairment (creatinine \> 250 μmol/L)
9. Unable to swallow study medications
10. Pregnant or breast feeding
Obesity Paradox in Non Valvular Atrial Fibrillation Regarding Outcomes: Fact or Fiction

Obesity paradox In patient with non valvular atrial fibrillation

Study role of obesity in outcomes of anticoagulation in patients with non valvular atrial fibrillation

Eligibility Criteria:
Inclusion Criteria:

* patients presented with non valvular AF
* patients on oral anticoagulant

Exclusion Criteria:

* valvular AF
* Mental illness
* History of cerebrovascular stroke
* history of bleeding tendency
* history of Chronic renal failure
A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
2. Male or female subjects aged 18 to 75 years (including 18 and 75 years).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.
5. Adequate tumor tissues submitted for test.
6. Life expectancy of ≥ 12 weeks.
7. Subjects must have measurable disease according to RECIST (version 1.1).
8. Adequate organ functions.
9. Sexually active fertile subjects, and their partners, must agree to use contraception during the study and at least 6 months after termination of study therapy.
10. Subjects are willing to follow study procedures.

Exclusion Criteria:

1. History of another malignancy within 3 years before the first dose of study drug.
2. Ongoing clinically significant toxicities related to prior treatment.
3. Grade ≥ 2 peripheral neuropathy.
4. Severe or uncontrolled gastrointestinal diseases.
5. Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.
6. Experienced clinically significant bleeding or had a clear bleeding tendency.
7. Central nervous system (CNS) metastasis and/or malignant meningitis.
8. Clinically significant pleural, abdominal, or pericardial effusion.
9. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug;
10. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
11. Pregnant and lactating women.
12. Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.

The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.

Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.

There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.


Eligibility Criteria:
Inclusion Criteria:

* Participants' body weight must be ≥ 40 kg at Baseline.
* Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
* CDAI ≥ 220 at Baseline.
* Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
* Participants must demonstrate intolerance or inadequate response to TaTs including biologics

Exclusion Criteria:

* Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
* Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
* Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.