cyrilzakka/clinical-trials huggingface dataset:
Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients

National early warning score (NEWS) enables early detection of patient deterioration in hospital floors. However, there is limited data on the prognostic value of NEWS among actual general ward patients. Further, there is no data on how changes in NEWS-values impact patient outcomes. Very little is known on how post-operative nausea and vomiting (PONV) and pain influences NEWS values and vital signs in general.

The investigators aim to collect detailed data on patients' vital signs, NEWSs, pain scores and PONV scores through electronic data records, where these values are automatically stored with mobile mobile smart devices used by nursing staff. The expected volume of the cohort is 50,000 patients and 300,000 recordings of vital signs.

In addition to the scores and vital signs, the registry will include patients' identification numbers (IDs), dates and times of the recordings, and ward numbers. With the IDs, mortality data up to 90-days for the patients will be obtained from the national population register centre. All data will be handled in a pseudonymized form in a secure computer inside hospital, and approval to use the registry in study purposes will be obtained from the Ethics Committee of Tampere University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Adult in-hospital patients with recordings of vital signs

Exclusion Criteria:

* Patients under 18 years
Rehabilitation Methods of Children With Cochlear Implant

The goal of this observational study is to describe the type of the rehabilitation method for italian children with cochlear implant . The main questions are:

What is the most used rehabilitation methods in implanted children? Which is the prevalence of each method related to the clinical features of the patients?

The cochlear implant represents the gold standard in the treatment of children with bilateral severe-profound deafness. However, the current Italian and international guidelines do not address the issue of rehabilitation and how the different rehabilitation methods should be applied in relation to the different clinical pictures. The aim of this study is therefore to describe which methods are used today in the rehabilitation of deaf children with cochlear implants followed at the Phoniatrics and Speech Therapy service of the A. Gemelli Polyclinic Foundation. The creation of a questionnaire directed to the speech therapist who treats the specific patient is available in order to collect data concerning the characteristics of the setting and the rehabilitation method in relation to the most applied methodologies, i.e. Auditory-verbal therapy, oral-cognitive therapy, bimodal method and the Drežančić method.

Inclusion Criteria:

* Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico universitario a. Gemelli in the last 10 years;
* Age \>12 months and \<10 years

Exclusion Criteria:

* Children diagnosed with mild to moderate hearing loss without a cochlear implant;
* Age \<12 months and \>10 years

Outcomes measures

* Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant
* Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.

Endpoints:

-% distribution of the 4 rehabilitation methods: cognitive oralism, verb-tonal, Auditory-Verbal therapy and bimodal

- % distribution of the 4 rehabilitation methods: cognitive oralism, verbal-tonal, Auditory-Verbal Therapy and bimodal in relation to the clinical characteristics of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with severe to profound hearing loss who underwent cochlear implant placement surgery in the last 10 years;
* Age \>12 months and \<10 years

Exclusion Criteria:

* Patients diagnosed with mild to moderate hearing loss without a cochlear implant
* Age \<12 months and \>10 years
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.

During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.

Eligibility Criteria:
Inclusion Criteria

Your child may be eligible for this study if he/she:

* Is 3 months to 16 years old.
* Is HIV-positive.
* Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry.
* Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry.
* Agrees to use effective barrier methods of birth control, such as condoms, during the study.
* Has consent of parent or guardian.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

* Has ever taken NFV.
* Has a history of opportunistic (AIDS-related) infection.
* Has any disease or illness that would prevent him/her from completing the study, including cancer.
* Has taken certain medications, including protease inhibitors at study entry.
* Is receiving an HIV vaccine at study entry.
* Is pregnant.
A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy

To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy in the outpatient setting.

A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo operative hysteroscopy either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.

Eligibility Criteria:
Inclusion Criteria:

* . Women with suspected infection
* women considered not suitable to undergo an office hysteroscopy
* women who reported the use of analgesia 6 hours prior to the procedure.

Exclusion Criteria:

* patient needed office hysteroscopy
taVNS Cold Pressor

This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS), a new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past medical or psychiatric history will be recruited to participate in a phone screen followed by 1 lab visit. During the lab visit, subjects will participate twice in a validated stress induction technique called the cold pressor test, while concurrently receiving either active or sham taVNS. The cold pressor test consists of subjects placing their feet in an ice bath for a short period of time. Researchers will measure participant's heart rate while they receive taVNS (ear stimulation) and participate in the cold pressor test. Assessments of mood, anxiety, and stress will be collected at the beginning and end of the visit.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65 years
* English speaking
* Non-treatment-seeking community members

Exclusion Criteria:

* Diagnosis of COVID-19 in the past 14 days
* Facial or ear pain or recent ear trauma.
* Metal implant devices in the head, heart or neck.
* History of brain stimulation or other brain surgery.
* History of myocardial infarction or arrhythmia, bradycardia.
* Use of B-blockers, antiarrhythmic medication (sodium/potassium/calcium-channel blockers), or blood pressure medications.
* Active respiratory disorder.
* Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
* Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
* Individuals suffering from frequent/severe headaches.
* Individuals with a reported history of any mental health disorder or taking any psychotropic medications.
* Moderate to severe alcohol or substance use disorder.
* Pregnancy
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial

This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.

This is a phase I/II open-label study to determine the lowest safe, effective dose of budesonide given with calfactant as the vehicle; the investigators will perform an unblinded dose escalation study. The investigators will administer four dosing levels of budesonide suspended in calfactant beginning with 0.025 mg/kg of budesonide administered to 8 extremely low gestational age newborns (ELGANs) who are intubated at 3-10 days of age. Daily doses (at the same dosage) will be administered to infants who remain intubated for a potential of 5 total doses in each patient. Subsequent groups of 8 infants each will receive 0.05 mg/kg, 0.10 mg/kg, and 0.15 mg/kg of budesonide in calfactant (up to 5 total doses in each patient). A total of up to 32 infants will be enrolled in the trial. The investigators will evaluate the clinical, laboratory and safety data from each group of treated infants to 28 days of age before moving to the next dosing level of budesonide.

Eligibility Criteria:
Inclusion Criteria:

1. \> 23 0/7 and \< 27 6/7 weeks of gestational age based on center's best estimate of due date (using earliest obstetrical ultrasound, last menstrual period, examination, and other pertinent available information)
2. Day of life 3-14 from the date and time of delivery, with the date of birth being DOL 0
3. Intubated and mechanically ventilated and do not anticipate extubation in next 24 hours

Exclusion Criteria:

1. Serious congenital malformations or chromosomal abnormality
2. Likely to be extubated in next 24 hours
3. Clinically unstable
4. Infants who have received systemic steroids prior to dosing with study medication.
5. Infants who have received Indocin, Ibuprofen, or acetaminophen ≤ 96 hours prior to enrollment window ending
Outcome of Laparoscopic Appendicectomy Versus Open Appendicectomy in Sudanese Patients

Background: Laparoscopic appendectomy as a minimal invasive procedure had low morbidity and mortality. It affords a direct diagnosis of the problem, allows determination of the appropriate treatment. Open appendectomy is global treatment of acute appendicitis can be done by many incisions, and associated with considerable complications.

Materials and Methods: This is a cross sectional descriptive hospital-based study to study the outcome of laparoscopic appendectomy versus open appendectomy at Elmak Nimer University Hospital over the study period. All patients in the study period who underwent appendectomy was included, data is collected through standard structured data collection sheet and analyzed by using SPSS v24.0.


Eligibility Criteria:
Inclusion Criteria:

* All patients in the study period who underwent appendectomy were included.

Exclusion Criteria:

* Patientspresented with complicated appendicitis
* Acute appendicitis with comorbiditites
* Pregnant ladies
* Patients of stump appendicitis .
* Patient with inadequate data
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

In recent years, circulating tumor DNA (ctDNA)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. The presence of ctDNA after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood.

The results of the PRODIGE-12/ACCORD-18 study showed that, with a median follow-up of 47 months, the adjuvant chemotherapy arm did not lead to a significant improvement in recurrence-free survival (RFS) and overall survival (OS). Notably, the patients with gallbladder cancer experienced adjuvant chemotherapy significantly worse RFS and OS compared to those in the monitoring arm. ctDNA risk stratifies patients to guide adjuvant treatment decisions This study aimed to demonstrate that a escalation strategy of ctDNA guided adjuvant chemotherapy is superior to standard of care treatment as measured by 2 year disease free survival (DFS) in patients with stage II- III biliary tract cancers with minimal residual disease (MRD) (ctDNA positive).

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients with pathologically confirmed BTCs according to the UICC/AJCC TNM staging system (8th edition 2017) for stage II-III tumours. Patients eligible for radical resection of BTCs. No synchronous or metastatic malignant tumour found in other organs other than the primary tumor.

  2) Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 \~ 2.

  3）With expected survival of more than 12 months. 4) Radical operation performed.

Exclusion Criteria:

* 1) Patients with positive surgical margins and residual lesions after biliary tract tumor surgery.

  2) Blood transfusion performed during operation or within 2 weeks before operation.

  3) Have a history of other malignant tumors within 5 years.
Evaluation of a New Open Source Virtual Bronchoscope Navigation System

To evaluate the feasibility of the Fraxinus Virtual Bronchoscope Navigation (VBN) System in the bronchoscopic access to target lesions. The study emphasizes the system´s efficacy in diagnostics of peripheral pulmonary lesions and the ease of use for the operator.

Multi-center study. The study explores Fraxinus which is an open source, software only, simple guiding system for bronchoscopy. The system provides 3D maps with centerline-to-target information extracted from preoperative computed tomography. The ability of the system to guide a user to a peripheral target lesion will be evaluated. During bronchoscopy any established method for diagnostic sampling is allowed. User Evaluation will be essential to decide if the Fraxinus VBN System is beneficial in a clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* referred to thoracic department in any of the participating hospitals with undiagnosed peripheral pulmonary lesion(s) not visible by bronchoscopy
* voluntary signed an informed consent

Exclusion Criteria:

* pregnancy
* Any patient that the Investigator feels is not appropriate for this study for any reason
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
2. The area of total burn injury is 5-50% TBSA inclusive.
3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
4. The subject is at least 5 years of age.
5. The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol.
6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria:

1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
2. The subject is unable to follow the protocol.
3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
5. Life expectancy is less than 1 year.
Evaluation of the Entresto Effect on Sympathic Nervous System in Patient With Heart Failure

The hyperactivation of the sympathetic nervous system is a feature of the heart failure and the determinants of disease progression and risk of sudden cardiac death. This research project aims to study, in the drug use conditions provided in the summary of product characteristics based on European marketing authorization (indications and dosage), the effect of the Entresto® on the activity of sympathic nervous system using the reference method, the microneurographic recording of sympathetic activity in muscle destiny (MSNA). This study will try to determine if the double inhibition of AT1 receptor and neprilysin activity result in lower sympathic nervous system burst rate versus single AT1 receptor inhibition using angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Men or women with heart failure with symptomatic left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 40 %) with :

  * Functional class New York Heart Association II and at least 2 hospitalizations for cardiac decompensation in the year with N terminal pro brain-type natriuretic peptide ≥300 pg/ml (or brain-type natriuretic peptide ≥100 pg/ml) or usage of intravenous diuretics,
  * Functional class New York Heart Association III-IV,
  * Insufficiently controlled by alternative drug-free therapies (surgery, cardiac resynchronization ...) or well managed drug therapies: angiotensin-converting-enzyme inhibitor, AT1 receptor of angiotensin II inhibitor diuretics or beta blockers.
  * Treated by maximum dosage of AT1 receptor of angiotensin II inhibitor or angiotensin-converting-enzyme inhibitor for New York Heart Association II patient or 50% of the recommended dose for New York Heart Association III-IV patients or New York Heart Association II patients with clinical manifestation restricting the use of maximum dosage, like orthostatic hypotension.
* Patient member of his home social security scheme

Exclusion Criteria:

* Patient who are receiving direct renin inhibitor like aliskiren
* Patient who are receiving phosphodiesterase V inhibitors
* Patient who are receiving a potassium-sparing drug
* Patient with medical history of angioedema with previous treatment by angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II inhibitor
* Hypersensitivity to any component of Entresto®
* Adult protected by the law
* Severe renal impairment (DFGe \<30 ml/min/1,73 m2)
* Severe hepatic impairment, cirrhosis or cholestasis (Child-Pugh C class)
* Patient with are receiving anticoagulant therapies or suffering from known hemostatic trouble
* Patient participating in another biomedical research or with an active exclusion period
* Pregnancy
* Breast-feeding
Safety of Pulsing Heating Device Use on the Skin

We hope to assess the safety of a recurrent heating device for pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Individuals in good general health.
* No known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Subjects 18 year of age and older.

Exclusion Criteria:

* Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator.
* Individuals with peripheral neuropathy or a neuropathic condition that would alter their ability to sense pain.
* Individuals with clinically significant unstable medical disorders that would disqualify the participant at the discretion of the investigator.
* Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.
* Women who are pregnant.
A Clinical Trial Assessing Safety of MF101 for Hot Flushes

This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.

MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.

Eligibility Criteria:
Inclusion Criteria (partial list):

* Postmenopausal women aged 40-65 years.
* Provide informed consent.
* Currently receive medical care from a health care provider. Other inclusions apply.

Exclusion Criteria (partial list):

* History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening.
* Unexplained uterine bleeding within 6 months prior to Screening.
* History of deep vein thrombosis or pulmonary embolism.
* Active liver disease or a history of impaired.
* Active gallbladder disease. Other exclusions apply.
Acute Preoperative Stress and Hypotension After Spinal Anesthesia. SAS for "Salivary Amylase and Stress "

Spinal anesthesia is the technique of choice for planned cesarean section. It is associated with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by maternal stress that can be measured with salivary amylase. The goal of this study is to assess the relationship between salivary amylase and severity of maternal hypotension after spinal anesthesia for planned cesarean section.

Salivary amylase, heart rate variability, Spielberger state-trait inventory are assessed on the morning of surgery, on the surgical ward, and repeated in the operating room, before performing spinal anesthesia. Spinal anesthesia use hyperbaric bupivacaine (11 mg), sufentanil (5 µg) and morphine (100 µg). Prophylactic treatment of hypotension uses a continuous infusion of ephedrine (0.6 mg/ml) and phenylephrine (10 µg/ml). Rate of the continuous infusion is adapted to keep maternal systolic blood pressure between 95-105% of preinduction values. Total dose of ephedrine and phenylephrine infused from spinal anesthesia to delivery of the newborn is recorded (about 20 minutes for the estimated time frame). Association between stress markers and total dose of vasoactive drugs will be tested with the Spearman's correlation coefficient.

The study is observational. The subjects do receive a therapeutic intervention but the investigator does not assign patients to this intervention since this intervention is a routine care (spinal anesthesia for planned cesarian section) that would have been performed in the absence of the study.

Eligibility Criteria:
Pregnant women undergoing planned cesarean section under spinal anesthesia