cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C

The fibrosis of liver is a complication of chronic hepatitis C. There is actually no established treatment for fibrosis of the liver. Pentoxyphilline and tocopherol may have an activity on fibrosis. The aim of the study is to analyse the efficacy and the safety of the combination with pentoxyphilline and tocopherol (12 months) on liver fibrosis, in patients with chronic hepatitis C, who are non-long-term responders, or with intolerance or contra-indication to interferon-alfa and ribavirin.

The aim of this study is to analyse the efficacy and the safety of the combination of pentoxyphilline (400 mg, twice a day) and tocopherol (500 mg, twice a day), given during 12 months on the fibrosis related to HCV chronic hepatitis in 100 patients who are non-long-term responders, or with contra-indication or intolerance to the current treatment of reference (combination with interferon-alfa and ribavirin). It is a therapeutic, national, multicentric, double-blind, placebo-controlled phase III trial. The patients included had histological liver injuries with a Metavir score of A 0 to 2, F 2 or 3 and no other etiology of liver disease. The primary objective is to analyse the variation of the liver fibrosis evaluated by morphometric analysis between the 2 liver biopsies performed at the end of the trial and within 3 years before the treatment. The secondary objectives are the variation of the Metavir fibrosis and activity scores, of serum markers of fibrosis (hyaluronate, PIIIP, TNF-alfa, fibrotest) and ALT between the end and the beginning of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Chronic hepatitis C defined by positive HCV Ab and HCV RNA and histological proven injuries
* Liver biopsy with a size over or equal to 15mm, performed within 3 years of enrolment, with a Metavir score of activity from 0 to 2 and fibrosis score of 2 or 3.
* Non long term responders or patients with contra-indication or intolerance to interferon alfa or ribavirin
* No anti-viral treatment during the trial
* Signed written informed consent

Exclusion Criteria:

* Alcohol consumption over or equal to 40 g/d
* Allergy to tocopherol or pentoxyphilline
* Treatment with platelet anti-aggregates, anti-vitamin K, theophylline, armophylline
* Treatment with tocopherol or pentoxyphilline since the last liver biopsy
* Pregnancy, breast feeding, lack of contraception
* Decompensated cirrhosis, organ graft, chronic renal insufficiency
* BMI over 27
* Diabetes type I or II
* Other etiology of liver disease (HBV, HIV, hemochromatosis, alfa-1 antitrypsin deficiency, Wilson's disease, auto-immune hepatitis, drug-related hepatitis)
Using Telemedicine to Improve Veteran Sleep Apnea Care

Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider.

Background:

Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider

Objectives:

The objective of this proposal is to explore the feasibility and initially evaluate the potential efficacy of a video teleconferencing system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient- centered, collaborative management for patients who are prescribed the gold-standard treatment, continuous positive airway pressure (CPAP).

Methods:

The evaluative aspect of this proposal was designed as a pilot randomized, controlled clinical trial of Video Teleconferencing (VTC) compared to Usual Care (UC). The key feature of the Video Teleconferencing intervention was the use of a telemedicine system that allows for audio/visual conferencing with the patient in their home environment from the start of treatment initialization. The provider is able provide more direct feedback to the patient based on the telemedicine interaction, and the patient benefits from increased contact with the provider. Specific inclusion and exclusion criteria included: age \> 18 years; confirmed diagnosis of moderate-severe OSA; being newly prescribed CPAP therapy; having chronic symptoms as noted on screening symptom checklist; and fluency in English. Patients were recruited from the VA San Diego Healthcare System Pulmonary Sleep Clinic. Patients were enrolled for a 2-month time period. Groups were compared on quantitative and qualitative measures.

Status:

Study Complete

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Moderate to Severe Sleep Apnea
* Live in San Diego County
* Veteran

Exclusion Criteria:

* Previous use of positive pressure airway therapy
* Residence outside of San Diego county
LUCAS Chest Compressor Versus Manual Chest Compression in Out-of-hospital Sudden Cardiac Arrest. LUCAT Trial

The goal of this study is to show the superiority in survival at hospital admittance and in neurological outcome on hospital discharge of continuous mechanical chest compression using LUCAS device versus manual chest compressions in patients who suffered an out-of-hospital cardiac arrest.

The primary goals of the trial are:

* To show a survival increase at hospital admittance after out-of-hospital cardiac arrest of patients treated by continuous chest compressions LUCAS device compared with patients treated by manual chest compressions.
* To evaluate neurological outcome on hospital discharge, in two centres (Vall d'Hebron Hospital and Josep Trueta Hospital).

Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 80 years ,
* Suffering from NON traumatic or an unexpected SCA,
* SCA witnessed (seen, heard or monitored),
* Attended by an advanced support ambulance (served by doctor or nurse) in Barcelona city, or in the Girona or Lleida area
* Time between alarm-call to SEM 061 and reaching patient is less than 12 minutes.

Exclusion Criteria:

* Biological signs of death
* Age under 18 or over 80 years
* Trauma caused cardio respiratory arrest (CRA), including hanging
* Secondary CRA or intoxication
* Return of spontaneous circulation previous to arrival of SEM's medical team
* Known pregnancy
* Inadequate size for LUCAS device
* Anything in the study that can delay treatment
Dosage of Epidural Morphine in Elderly Patients

This a clinical trial that evaluates the efficacy and safety of three different doses of morphine, namely 1.5 mg, 3 mg and 4.5 mg, via the epidural route regarding reducing pain in elderly patients after a cancer surgery in the lower abdomen

Acute postoperative pain is a common complaint for several days after surgery. However, acute postoperative pain remains even more under controlled in elderly patients, especially those with cognitive impairment and malignancy. Geriatric population is reported to be at higher risk for unwanted side effects from analgesic treatments compared to younger patients due to different major risk factors such as: decline in organ function, polypharmacy, pharmacokinetics, drug sensitivity, and frailty. Despite of the higher risk of opioids, especially morphine, causing toxicity and adverse effect; they are still the cornerstone treatment of severe acute postoperative pain. Morphine in those patients is very likely to cause toxicity because of accumulation of its active metabolites compared to other opioids with fewer or no active metabolites. Epidural morphine is an effective route for an effective drug. Furthermore, unwanted side effects with neuraxial opioids are minor and managed easily. Regarding clinical outcomes, clinical studies showed a lot of improvements associated with postoperative opioid analgesia. Now, there is a clinical necessity to achieve the best management of acute postoperative pain in elderly patients with the least possibility of adverse side effects. We aim in this randomized, assessor blinded, clinical trial at Assuit University to determine the optimum dose of epidural morphine for the highest control of acute postoperative pain in geriatrics who are planned to have lower abdominal cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged ≥ 60 years, who are planned to undergo lower abdominal cancer surgery.

2- ASA I and II classifications. 2. Surgeries via infra-umbilical abdominal incision is considered eligible.

Exclusion Criteria:

1. Patient refusal.
2. Patients who are morbidly obese (body mass index ≥ 40 kg/m2).
3. Those with contraindications to neuraxial analgesia. 4- psychiatric illness that would interfere with the perception and the assessment of pain.
Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies

Unexplained fatigue is a frequent (60-70%) chronic complaint in Sjögren's syndrome (SjS) with a clear unmet therapeutic need, despite the recommendation of adapted physical activity (APA) programs, which are effective and feasible, but only to some extent. Hence, other therapeutic approaches, such as Acupuncture (ACU) or transcutaneous vagal nerve stimulation (tVNS), have been evaluated during the past years, with varying degrees of success in alleviating fatigue.

FESSONA has been designed as a randomized controlled monocentric trial, aiming at comparing the effects of 3 different programs on fatigue in SjS: APA alone, APA+ACU and APA+tVNS. Relevant controls will be included as well (sham ACU and simulated tVNS).

Multiple fatigue and SjS-related features will be measured before (at inclusion) and after (week 12) the intervention, as well as at week 24 and 48, to evaluate the short- and long-term impact of each program. Tolerance and feasibility will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme.
* Age \> 18 years.
* Patient informed and having signed the information form and consent to participate in the study.
* Patient with Sjögren's syndrome according to ACR/EULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently
* Fatigue present for ≥ 6 months, without obvious explanation and/or specific treatment to conduct (e.g., disease's flare, chronic infection), with a current FACIT-F score \< 34

Exclusion Criteria:

* Pre-existing atrial fibrillation or severe cardiac conduction disorders,
* Recent stroke or myocardial infarction (\<6 months),
* Left ventricular ejection fraction \<40% or severe heart failure (New York Heart Association functional class III or IV)
* Recurrent episodes of vasovagal syncope, or history of vagotomy
* People with dermatological problems in the area where the stimulation electrodes are to be placed
* Current episode of venous or arterial thrombosis
* Pregnancy or breastfeeding
* Patient under protective measures (legal protection, curatorship, guardianship)
* Inability or refusal to understand and/or sign informed consent to participate in the study, or to perform follow-up examinations required under the study
Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators

This study aims to investigate the effect of a 15-minute meditation practice on sleep architecture and high-frequency Heart Rate Variability (HF-HRV), as well as cognitive performance after both a well-rested and sleep-deprived night.

Sleep is physiologically important for memory consolidation, mood and hormonal regulation, and maintaining low levels of systemic inflammation. However, a substantial proportion of people are reported to regularly sleep less than the recommended 7-9 hours a night. Meditation may be a means to mitigate the negative effects of sleep deprivation, as many types of meditations are associated with increasing high-frequency heart rate variability (HF-HRV), which is an index of parasympathetic control of the heart. Greater parasympathetic drive may be associated with physiological buffering of the detrimental effects of sleep deprivation.

The investigators want to conduct a prospective cohort study where subjects are asked to learn and practice a 15-minute meditation (shoonya meditation) or continue their usual routine. Subjects will be asked to complete some cognitive tests before and after a night of sleep and a night of sleep deprivation. During the night of sleep, participants will undergo polysomnography recording for sleep architecture and quality.

The intervention group will be asked to undergo these same study procedures after 2 months of meditation practice. The control group, which continues their usual routine, will only undergo one visit.

Eligibility Criteria:
Inclusion Criteria:

1. Shoonya meditation program participants/individuals eligible to participate who are healthy adults of age 18 or older, and reside in the United States. Participants must be able and willing to travel to Boston.
2. Nap Group: Healthy adults of age 18 or older that reside in the United States, nap regularly (at least 3 times a week), and do not meditate regularly.

Exclusion Criteria:

1. History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis)
2. History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder)
3. Current use of cognition enhancing medications
4. Active history (within the last 5 years) of alcohol or drug abuse (\> 10 drinks per week)
5. History (within the last 5 years) of stroke/aneurysm
6. Recent history (\< 3 months) of seizures
7. 60 years of age or older
8. History of Heart Attack and Ejection Fraction less than or equal to 30%
9. Pregnancy
10. Non-English speaking
11. History/Diagnosis of any sleep disorder
12. Consumption of 3 or more cups of coffee a day
13. Previously learned shoonya meditation (for the meditator groups)
Prophylaxis Of Wound Infections- Antibiotics in Renal Donation

The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.

Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
* Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
* Women of child-bearing age taking adequate contraception will be included.

Exclusion Criteria:

* Patients with a known allergy to penicillin or other antibiotics.
* Patients with MRSA colonisation.
* Participation in another investigational study within the previous 90 days.
* Pregnant or breast-feeding women.
Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness

Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness based on Electroencephalography and Auditory Event-related Potentials


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years old, native Chinese speaker, dextromanuality;
* Chronic disorder of consciousness;
* Spinal cord electrical stimulator implantation under general anesthesia;
* Signed informed consent.

Exclusion Criteria:

* Continuous sedation was administered within 72 hours prior to the study;
* Open head injury, parenchymatectomy and other damage of brain structural integrity;
* The intracranial compliance decreased due to hydrocephalus and swelling;
* Known hearing impairment;
* Airway stenosis and various causes of severe ventilation or ventilation dysfunction;
* Known or suspected cardiac dysfunction;
* Allergic to intravenous general anesthetics;
* Associated with other mental or neurological diseases;
* Other reasons are not suitable to participate in this study.
Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital

In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. The investigators will test this hypothesis in a randomized, crossover trial.


Eligibility Criteria:
Inclusion Criteria:

* All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine

Exclusion Criteria:

* Patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness
A Prospective, Noninterventional, Observational Study of Late-Onset Pompe Disease

Study 701-901, a multicenter, multinational, longitudinal, non-interventional observational study in subjects, at least 18 years old, diagnosed with late-onset Pompe disease prospectively collects data to understand clinical progression in terms of respiratory function, symptomology, genotype, biochemistry, endurance and selected subject-reported measures for 24 weeks followed by a 240 week additional observation period for up to 100 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent after the nature of the study has been explained and prior to any study-related procedure
* Diagnosed with late-onset Pompe disease based on current or previous genomic testing and/or endogenous GAA activity
* At least 18 years of age at study entry
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Requires non-invasive ventilatory support while awake and in the upright position
* Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise study completion or data collection
* Unable to perform baseline efficacy assessments
Psychometric / Validation Study

Data for the study will be collected from therapist across the world. The therapists will share data they have already compiled from their caseload. Data will be stripped of all personal identifiers and personal health information. The TWU SCOPE research team has no contact with clients whose assessment data is being shared for secondary analysis or clinical data repository. For educational and training purposes clients can be videotaped by the therapist who will obtain consent and/or assent from the client. Not every client will be videotaped. The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity. The total amount of data collected from all participating therapists will be 500 pieces.

Therapists will be recruited by a TWU SCOPE research team member via email. Therapists who wish to participate will send a data sharing letter to the PI of the study. Once the TWU SCOPE research team has received the data sharing letter, a clinical data packet will then be distributed to the therapist through the U.S. mail or an email will be sent containing a web address link to http://www.myweb.twu.edu/\~ttioseco for access to the clinical data packet via the internet. Those therapists who collect ten pieces or more of de-identified data and send them to the TWU SCOPE research team will receive an incentive in the form of a gift card.

Flow Chart of Research Study Process Collaborators (share new de-identified data) → databank (new de-identified data input) → data analysis (analysis of new and old de-identified data) → publication/presentation

No risks are involved because data collected is without any personal identifiers.

Eligibility Criteria:
Inclusion Criteria:

Subjects receiving therapy from participating therapists.

Exclusion Criteria:

Age over 21.
Cardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention

Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary intervention (PCI) and is associated with subsequent cardiovascular events. This study assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg around the upper arm, separated by 5-minute intervals of reperfusion) \< 2 hours before the PCI procedure, and the control group (n = 100).


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 85 years of age,
* scheduled to undergo an elective PCI and
* able to give an informed consent were eligible for enrollment in the study.
* Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

Exclusion Criteria:

* (1) emergency PCI, (2) baseline troponin value ≥ 0.04 ng/mL, (3) nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively), (4) those who could not give informed consent, and (5) patients with severe renal impairment or on regular dialysis.
Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiovascular surgery intervention(s).

The secondary objective is to determine the incidence of IAH and ACS in the cardiovascular surgery population and the correlation of these diagnoses to the diagnosis of AKI.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (age ≥ 18).
2. Monitored on the Accuryn® Monitoring System during hospital stay.
3. Patient is undergoing cardiovascular surgical intervention(s).

Exclusion Criteria:

1. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as prisoners or those detained in a penal institution.