cyrilzakka/clinical-trials huggingface dataset:
Early Warning for Desaturation by Oxygen Reserve Index

During the induction of general anesthesia, the anesthesiologist needs to provide the oxygen supply to meet the patient's needs continuously. In the clinical scenario, the pulse oximeter is used as a standard to monitor hemoglobin oxygen saturation (SpO2) but is limited to assess the oxygenation status beyond the measurement of 100%. The Oxygen Reserve Index (ORi) is a dimensionless parameter between 0 and 1 that is related to real-time oxygenation reserve status. This study was designed to evaluate the duration of warning time for desaturation provided by different ORi alarm triggers during prolonged apnea in surgical patients. The primary endpoint was the duration of additional warning time provided by the ORi trigger. The secondary endpoint was the correlation of ORi and PaO2.

This is an observational study of the routine clinical practice with no specific additional interventions required.

The investigators enrolled the American Society of Anesthesiologists (ASA) physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. Patients were positioned supine on the operating room table. Standard monitors and the ORi sensor were placed. The patients were preoxygenated with a facemask (flow rate of 8 to 10 liters/minute) for 3 minutes with spontaneous ventilation. Propofol (2-2.5 mg/kg), fentanyl (2-3 mcg/kg) and rocuronium (0.6-0.9 mg/kg) were administrated to achieve anesthesia induction during following 3 minutes. The patient was keeping ventilated manually by the anesthesiologist during the induction phase and intubated under direct visualization with a video-assisted laryngoscope at 6 minutes. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. The patients remained apneic. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds. Arterial blood is sampled every minute, from preoxygenation to resumed ventilation, to observe blood oxygen concentration changes.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18 to 80 years with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia.

Exclusion Criteria:

* Age \<18 years
* Inability to give primary consent
* Pregnancy
* History of chronic obstructive pulmonary disease (COPD)
* History of asthma
* Suspected difficult intubation
* Preoperative hemoglobin less than 10 mg/dl.
Development of an AF Specific Quality of Life Questionnaire: AF-PROMS

This study is aiming to develop a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF).

This study is aiming to develop and validate a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF). As this questionnaire is currently under development, it is anticipated this measure will be a short questionnaire which will measure various aspects of quality of life. Once the questionnaire has been validated further details of the final metric used and aspects of quality of life covered in the questionnaire can be provided.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation (AF)

Exclusion Criteria:

* Exclude any participants who it is felt participation will cause distress.
* Exclude participants who do not give consent to take part in the study
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens

The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).

This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.

Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option
* Gender: Males and Females.
* Age: 50 or older
* Willing and able to provide written informed consent for participation in the study
* Willing and able to comply with scheduled visits and other study procedures.
* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
* Potential postoperative visual acuity of (20/25 Snellen) or better in both eyes

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Irregular astigmatism (e.g. keratoconus)
* Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
* Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
* Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
* Diabetic retinopathy
* Macular pathology (e.g. ARMD, ERM)
* History of retinal detachment
* Any patient based on Barrett toric calculator that will have ≥ 0.75D residual astigmatism if Clareon® non-toric IOL is implanted
* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity
* Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating)

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
PK Study With Pantoprazole in Obese Children and Adolescents

Multicenter, comparative single-dose pharmacokinetic (PK) study

Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is between 6 and 17 (inclusive) years of age at the time of consent
2. BMI ≥95th percentile
3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:

   1. clinical symptoms consistent with GERD as determined by the investigator
   2. a diagnosis of erosive esophagitis by endoscopy
   3. esophageal biopsy with histopathology consistent with reflux esophagitis
   4. abnormal pH-metry consistent with reflux esophagitis
   5. other test result consistent with GERD
4. Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements

Exclusion Criteria:

1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
2. Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug
3. Consumption of food after midnight on the day of the baseline visit
4. Symptomatic asthma
5. Type I diabetes
6. History of adverse reaction to PPI
7. Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150 IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L
8. Serum creatinine ≥2.0 mg/dL
9. For females of childbearing potential, a positive pregnancy test result
10. Known infection with hepatitis B, C, or HIV
11. Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.
EXercise InTervention in Heart Failure

This is a pragmatic, non-inferiority clinical trial, enrolling heart failure patients who will be randomized to a 12-week exercise training program either centre-based or home-based with telemonitoring. The impact of this intervention will be assessed on established surrogate markers in HF such as maximal exercise capacity, plasma biomarkers and quality of life. The cost-effectiveness and overall satisfaction with the treatment will also be studied. In addition to measure the clinical and economic impact of this innovative way of delivering exercise, it is intended to unravel new molecular pathways and assess a pool of biomarkers that provide a wide mechanistic picture underlying the clinical effects of exercise.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of HFrEF and HFpEF according to criteria of the European Society of Cardiology (2016)
2. Clinical stability for ≥ 6 weeks
3. Optimal medical treatment for ≥ 6 weeks
4. Patients that are able to understand and follow the exercise prescription
5. Written informed consent

Exclusion Criteria:

1. Patients who have undertaken cardiac rehabilitation within the past 12 months
2. Patients who have received an intracardiac defibrillator (ICD), Cardiac 3. Resynchronisation therapy (CRT) or combined CRT/ICD device implanted in the last 6 weeks
3. Inability to exercise or conditions that may interfere with exercise intervention
4. Signs of ischemia during cardiopulmonary exercise test
5. Comorbidity that may influence one-year prognosis
6. Symptomatic and/or exercise induced cardiac arrhythmia or conduction disturbances
7. Currently pregnant or intend to become pregnant in the next year
8. Expectation of receiving a cardiac transplant in the next 6 months
9. Participation in another clinical trial
10. Patients who are unable to understand the study information or unable to complete the outcome questionnaires
Protocol for Prehabilitation Service Implementation in Catalonia

Trimodal prehabilitation consists of a short-term (\~ four to six weeks) preventive intervention to: i) enhance aerobic capacity and daily physical activity; ii) nutritional optimization; and, iii) psychological support before a major surgical procedure. The final aim of prehabilitation is to decrease surgical complications and speed-up postoperative functional recovery.

This is a preventive intervention addressed to high risk candidates for major surgical procedures carried out for a period of approximately four weeks before surgery aiming at reducing complications and enhancing post-surgical recovery. It combines: i) high-intensity endurance exercise training and promotion of daily physical activity; ii) nutritional balance; and, iii) psychological support.

The intervention is currently deployed as mainstream service at Hospital Clinic in several types of major surgeries. During fall 2017, three multidisciplinary workshops using a design-thinking approach were carried out to refine the service workflow and to explore the potential for service scalability. The outcomes of the co-design process provided a robust background for the design of a future personalized perioperative care service at regional level covering three phases: prehabilitation, in-patient care, and, post-discharge care.

The current study protocol aims to assess cost-effectiveness of prehabilitation as mainstream service in the ongoing deployment at Hospital Clinic, as well as to generate a roadmap for regional scalability of the service. It is planned as a quasi-experimental case-control study including 500 patients undertaking prehabilitation, as intervention group, and 250 patients following standard conventional care before surgery. The patients will be included from the following type of surgeries (2:1 intervention to control ratio): major digestive surgery (n, 525), lung volume reduction (n, 30), radical cystectomy (n, 30), major cardiovascular surgery (n, 165). Study groups will be made comparable using propensity score matching with the following matching variables: type of surgery, age, sex and adjusted morbidity groups (GMA) scoring.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old) candidates to colorectal surgery, esophagectomy, gastrectomy, gastric bypass, major liver resection, pancreas resection, lung volume resection, radical cystectomy, cardiac valve surgery or cardiac revascularization.
* Patients at high-risk for surgical complications defined by age \> 70 years old and/or American Society of Anesthesiologists 3-4.

Exclusion Criteria:

* Non-elective surgery
* Metastatic disease known preoperatively
* Unstable cardiac or respiratory disease
* Locomotor limitations precluding exercise performance
* Cognitive deterioration impeding adherence to the program
Biomarker Panel in Ovarian Torsion

The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.

The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.

The specifc aims of the current study are:

1. Screen for changes in blood protein biomarkers concentrations specifc for patients with ovarian torsion. The biomarkers are: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml).
2. Compare the amount of oxidative stress defense proteins SOD1, Catalase, and Thioredoxin amount in the peritoneal fluid wash between patients with or without confirmed ovarian torsion. To our knowledge, this is the first study that specifically evaluates the expression of oxidation stress defense proteins in ovarian torsion. The results will enable us to decide whether to include oxidation stress biomarkers within the panel.
3. Study population methodology and techniques

A prospective, 12-24 months study.

20 Patients with confirmed ovarian torsion will be enrolled.

The patients will complete a questionnaire prior to and following the procedure

3.5ml blood samples will be obtained immediately before laparoscopy, postoperative day, and four weeks after laparoscopy during the follow-up.

The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure.

20 Patients suspected of ovarian torsion with no ovarian torsion, as confirmed by laparoscopy, will be enrolled.

The patients will complete a questionnaire prior to and following the procedure

5ml blood samples will be obtained immediately before laparoscopy and four weeks after laparoscopy during the follow-up.

The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure.

20 Healthy controls will be enrolled and provide a 5ml blood sample.

Eligibility Criteria:
Inclusion Criteria:

* Female patients between 12 and 50 years who were admitted to the gynecological emergency room at Assuta medical center with signs and symptoms suggestive of ovarian torsion
* Patients that will undergo laparoscopy for the diagnosis of ovarian torsion
* Able to provide informed consent for themselves or have a legal guardian that can provide informed consent (in cases of patients under 18 years old)

Exclusion criteria:

\* Patients that are unable to provide informed consent
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19

The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS-CoV-2 infection within 5 days prior to randomization
* Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
* Fertile participants must agree to use a highly effective method of contraception
* Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Exclusion Criteria:

* History of or need for hospitalization for the medical treatment of COVID-19
* Prior to current disease episode, any confirmed SARS-CoV-2 infection
* Known medical history of active liver disease
* Receiving dialysis or have known moderate to severe renal impairment
* Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
* Suspected or confirmed concurrent active systemic infection other than COVID-19
* History of hypersensitivity or other contraindication to any of the components of the study intervention
* Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
* Has received or is expected to receive convalescent COVID-19 plasma
* Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
* Known prior participation in this trial or other trial involving PF-07321332
* Oxygen saturation of \<92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
* Females who are pregnant or breastfeeding
Living With Spinal Cord Injury.

A Spinal Cord Injury (SCI) often drastically disrupts the lives of affected patients and their relatives and caregivers. This observational study will provide new knowledge on how patients and their family caregivers cope in the first years after injury in terms of work inclusion, participation, care giver burden and quality of life. This project will utilize Norwegian spinal cord injury quality register data and link clinical individual data from the quality register to national administrative data on employment and social insurance benefits.

All individuals in the Norwegian Spinal Cord Injury Registry (NorSCIR) in the period 2011-2017, meaning that they have already given their consent, will be asked to participate. They will be sent a letter with information about the study including a questionnaire.

In the letter they will also be asked, if they agree, to forward an invitation letter to their closest caregiver addressed to "the main family caregiver".

Main family caregiver will be defined as persons who are providing unpaid assistance and support to the person with a SCI. The letter for the caregiver with information about the study, includes a questionnaire. All patients in the NorSCIR and their main caregivers (after consent) will be linked to national administrative register to provide data on social insurance benefits, education and work.

Control groups from the general population will be selected and identified in the national registries (for both the patient cohort and caregiver cohort). These control groups will be used to compare the level of work/benefit over time for patients and caregivers with that of the general population. Also, within-person approaches will be used to assess the impact of the injury, comparing each participant's status in the period after injury with their own status at a time period before injury.

20.04.2022 A relatively low proportion of family caregivers responded to the questionnaire (N = 73). Only 61 gave their consent to link their data to data from Statistics Norway and the Norwegian Labour and Welfare Administration. We had, therefore, to reconsider this part of the project. We have now concluded that the caregiver population is too small to link their information to the national administrative registers and to make a comparison with a control group from the general population. A control group for caregivers was therefore not needed anymore.

Eligibility Criteria:
Cohort 1:

Inclusion criteria:

* registered in the Norwegian spinal cord injury quality registry
* giving informed consent, i.e. accept that the information in the registry (included linked information in national registers)

Exclusion criteria:

* younger than 16 years

Cohort 2:

Inclusion criteria:

* providing unpaid assistance and support to the person with a spinal cord injury
* chosen by the patient.

Exclusion criteria:

* younger than 16 years

Cohort 3 :

Inclusion:

* Control groups from the general population, for patients
* identified in the national registries

Exclusion criteria:

* younger than 16 years
High Dose Insulin Therapy to Improve Liver Function

Insulin resistance is one of the key factors in defining a progressive course of chronic Hepatitis C virus (HCV) infection and hepatic fibrosis. Multiple trials have targeted insulin resistance as an adjuvant way to manage hepatitis C liver disease with promising results.

Long term therapy using high dose insulin was shown to significantly reduce insulin resistance in obese patients. In cardiac and critically ill patients, long term insulin was shown to produce better outcomes mainly by reducing the overt inflammatory response. Furthermore, initial results of ongoing trials are revealing more benefits of insulin therapy. Using the (hyperinsulinimic normoglycemic clamp) for eight hours on patients undergoing major liver resection was able to maximize their liver function post-operatively. This trial also demonstrated inhibition of the inflammatory response, improvement in liver glycogen, inhibition of apoptosis and stimulation of liver regeneration.

Putting in mind the potential ability of the liver to regenerate and regain better function. The anti-inflammatory properties of insulin therapy along with its ability to reduce insulin resistance over time has led us to see the potential benefits of using insulin therapy on patients with chronic hepatitis C virus liver cirrhosis. Insulin will target the pathophysiology of the disease at a cellular and a molecular level.

The investigators theorize that long-term high insulin therapy would be able to promote better liver function and slow down fibrosis and injury in this population of patients.


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C positive adult patients (serum HCV antibody positive)
* MELD score 6-15 at the time of inclusion
* Viral genotype "non-3"
* Not on antiviral therapy

Exclusion Criteria:

* HBV or HIV co-infection
* Evidence of hepatocellular carcinoma at the start of the trial either by imaging and or AFP levels above 400
* Undetectable HCV viral load (using HCV PCR test)
* Recent infection or bleeding (in the last 3 months)