cyrilzakka/clinical-trials huggingface dataset:
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use

The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.


Eligibility Criteria:
Inclusion Criteria:

* The patient has alcohol dependence, diagnosed at screening according to DSM-IV-TR™
* The patient has had an average alcohol consumption at, at least, a high drinking risk level (that is \>60 g of alcohol/day for men and \>40 g of alcohol/day for women) in the 4 weeks preceding the Screening Visit and in the period between the Screening and Inclusion Visits (that is, in the Screening Period)
* The patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the Screening Visit (both criteria have to be fulfilled): liver stiffness (LS) as measured by Fibroscan \>6 kPa, elevated transaminases (AST or ALT). Transaminase levels up to 5 times the upper limit of the reference range and γGT levels up to 10 times the upper limit of the reference range are allowed. At the discretion of the investigator, transaminase levels \>5 times the upper limit of the reference range and γGT \>10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the Screening Period
* The patient has a breath alcohol concentration (BrAC) \<0.02% at the Screening Visit.
* The patient provides a stable address and telephone number
* The patient is a man or woman, aged ≥ 18 years
* The patient has BMI≤30 kg/m2

Exclusion Criteria:

* The patient has any psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than alcohol dependence assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview , that in any way will interfere with the ability of the patient to take part in the study
* The patient has reported current use of, or has been tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines \[including ecstasy\], barbiturates)
* The patient has severe liver impairment classified with a Child-Pugh Score C
* The patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, that are of potential risk to the patient's safety, or the patient has: Severe renal impairment (eGFR \<30 mL/min per 1.73 m2), and/or Hypercholesterolemia with serum cholesterol levels \> 300 mg/dL, (\>7,758 mmol/L), and/or bilirubin \> 3 mg/dL (50 μmol/L)
* The patient has had \<6 heavy drinking days (HDDs, defined by the European Medicines Agency as a day with an alcohol consumption \>60 g for men or \>40 g for women) in the 4 weeks preceding the Screening Visit
* The patient has \>5 consecutive abstinence days in the 4 weeks preceding the Screening Visit
* The patient has a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)

Other protocol-defined inclusion and exclusion criteria may apply.
"Critical State" Early Warning Score After CHD Surgery and Rapid Response Team

By establishing a warning scoring tool for the early \&#34;critical state\&#34; after congenital heart disease surgery, the multidisciplinary rapid response team is proactively activated, forming an integrated treatment model of early warning-team decision-making-organ assistance.

All children aged 0-14 years admitted to the PICU from 2021-2022 were enrolled continuously, and their baseline data such as gender, age, RACHS-1 score, cardiopulmonary bypass time, aortic clamping time, whether there was chromosomal lesions, whether there was preoperative endotracheal intubation/heart failure, changes in oxygenation index, lactate, and vasoactive drug scores were obtained. All variables that may lead to composite malignant events including death in the early postoperative period were included, including death, pulmonary hypertension crisis, malignant arrhythmias (supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, high-degree atrioventricular block) requiring antiarrhythmic drugs or pacemaker treatment, cardiopulmonary resuscitation, ECPR, emergency sternal expansion, severe AKI, severe ARDS, neurological complications (cerebral hemorrhage, cerebral infarction), gastrointestinal complications (gastrointestinal bleeding, intestinal obstruction, intestinal necrosis).The variables were included in the machine learning analysis to establish the model.

Eligibility Criteria:
Inclusion Criteria:

* pediatrics admitted to ICU

Exclusion Criteria:

* surgery without cardiopulmonary bypass
* neonatal
* using extra-corporeal circulation during surgery
* Delayed chest closing during surgery
Developing a Chatbot to Promote HIV Testing

In this study, the feasibility of a Chatbot in promoting HIV testing in a pilot RCT with 80 men who have sex with men in Kuala Lumpur, Malaysia will be studied. Participants will be randomized to Chatbot or treatment as usual (TAU) groups. Participants in the intervention group will receive automated personalized messages containing HIV testing-related information, motivation and skills.

After informed consent, participants will be randomly assigned to Chatbot or TAU groups using stratified randomization by age. Participants in TAU will receive attention-matched educational materials manually sent by the research assistant. Participants in the intervention group will receive an automated personalized question message (root-node message) from the Chabot. In each round of the interactive communication, the Chatbot will provide automated personalized messages containing HIV testing-related information, motivation and skills based on participants' answers and will continuously update over time. Participants will be observed over 180 days with responses and interactions stored on a HIPAA-compliant and protected cloud. An independent assessment of recent testing and reasons why will be sent by link to both TAU and intervention groups using a link to a Qualtrics survey housed on REDCap at baseline and after 90 and 180 days. After 180 days, the RA will send an additional REDCap survey to intervention participants to assess the feasibility of the Chabot to measure 4 key elements: acceptability, practicality, demand, and adaptation.

Eligibility Criteria:
Inclusion Criteria:

* cis-gender male
* 18+ years;
* had condomless sex with men in the past 6 months
* has a smartphone
* speaks Bahasa Malay or English.

Exclusion Criteria:

* Not able to read Malay or English
MINS, AKI and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery

Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.

The main issues are:

* To investigate if coronary calcification predisposes the development of myocardial injury and causes an increased mortality rate.
* To evaluate the predictive value of NT-pro-BNP in relation to the development of MINS and the mortality rate.
* To evaluate the predictive value of different biomarkers of AKI in relation to which patients develop AKI.
* To examine the proteins, exosomes and single cell RNA during acute kidney injury in order to describe the molecular processes in the kidney during AKI.
* To examine whether a chest CT scan without contrast enhancement will change treatment decisions in the acute gastrointestinal patient compared with a chest x-ray.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years).
* Patients included in the AHA regimen undergoing CT on suspicion acute high-risk abdominal disorder e.g.g bowel obstruction GI perforation or ischemia, and need of emergency abdominal surgery, either laparoscopic surgery or laparotomy.
* Able to speak Danish. In case Danish was not spoken an interpreter was used to obtain the informed consent.
* Able to give informed consent.

Exclusion Criteria:

* Patients who cannot give informed consent to participate in the study 15 minutes after receiving verbal information regarding the study.
* Known chronic kidney disease requiring dialysis at the time of admission (only exclusion criteria for the part of the study relating to AKI).
* Patients included in the AHA regimen, but conservative treatment is chosen (only exclusion criteria for the part of the study relating to MINS and AKI).
* Patients not resident in Denmark.
* Patients not able to give informed consent.
* Patient not able to speak Danish and not enough time to obtain an interpreter.
MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning

This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block) will be assessed.

Patients with hip fractures are anticipated to endure sever pain caused by positional changes required for spinal anesthesia. Providing analgesia before positioning not only increases patient comfort but also improves positioning and successful spinal block. Peripheral nerve block is an effective strategy for relieving pain during postures change for spinal anesthesia in patients with hip fractures. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block), has been successfully used for analgesia for spinal anesthesia positioning in patients with hip fractures. However, the minimum effective dose of local anesthetics for these three types of peripheral nerve block is not known. This study aims to determine the minimum effective dose of ropovacaine in the three types of peripheral nerve block using a biased coin design up-and-down sequential method. Successful block is defined as NRS score ≤3 by positional changes for spinal anesthesia, achieved at 20min after the block. MED90 of ropivacaine for fascia iliaca block, femoral nerve block and PENG block be assessed respectively. Patients will receive ultrasound guided peripheral nerve block. The initial dose is chosen as 80 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the ropivacaine dose is increased by 8 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 8 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks for each type of nerve block will be accomplished. MED90 of each type of nerve block will be calculated by isotonic regression.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 - 85 years
* American Society of Anesthesiologists physical statusⅠ- Ⅲ
* Patients will receive hip replacement

Exclusion Criteria:

* Patient refusal
* Cognitive impairment(NRS pain score cannot be assessed)
* Peripheral neuropathy
* Mutiple furacture
* skin infection at the site of injection
* allergy to ropivacaine、lidocaine or bupivacaine
* contraindication to spinal anesthesia
Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting

The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.

The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events (MACCE) and procedural success.

Prospective, single-center, randomized trial, intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease:

1. MICS CABG. Minimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy). (MICS CABG group, n=50).
2. OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
3. ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). The endpoints: The primary endpoints will be death, MI, stroke, or new myocardial ischemia and will be target vessel revascularization and non-target vessel revascularization at 30 days, 12 months and 3-year follow-up.

The secondary endpoints: Procedural success, Procedural and post-procedural blood loss and number of transfusions, Wound complications, Recovery time, Heart Failure (New York Heart Association (NYHA)), Life quality assessed by one of the life quality questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Multi-vessel coronary artery disease with ≥ 70% artery stenosis (according to QCA)
* II-IV Canadian Cardiovascular Society functional class of angina
* Patients at 1 month after acute myocardial infarction
* Ability to perform either of revascularization methods (MICS CABG, OPCABG, ONCABG)
* Patients must have signed an informed consent

Exclusion Criteria:

* Pregnancy.
* Acute coronary syndrome.
* Previous CABG.
* Severe comorbidity with high procedural risk for either of the studied strategies.
* Mental diseases which block the revascularization procedure.
* Severe peripheral artery disease.
* Other serious diseases limiting life expectancy (e.g. oncology)
* Inability for long-term follow-up.
* Participation in other clinical trials.
* Single vessel disease.
* Need for emergency revascularization (Acute MI, Acute coronary syndrome etc.)
Efficacy Study of a Facemask Device to Treat Hypotension

The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss, sepsis, or dehydration.

The study is designed to test the hypothesis that use of the ITD will result in a rapid rise in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD will be applied to hypotensive patients when initially presented to the emergency department with a systolic blood pressure of \<95mmHg. The main endpoint of this study will be the rise in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well as clinical studies performed to date, we hypothesize that use of the active ITD will result in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical parameters will also be compared between the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* Conscious patient
* Systolic blood pressure \< 95 mmHg
* Hypotension caused by blood loss, sepsis, or dehydration

Exclusion Criteria:

* Hypotension secondary to heart failure
* Complaints of chest pain
* History of heart failure
* Complaints of shortness of breath
Polyneuropathy in Diabetes Mellitus Type 2

This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).

Perspective: The study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.

Diabetic polyneuropathy is one of the most common long-term complications of diabetes. Neuronal hyperexcitability is thought to be a key factor in the development of neuropathic pain.

The overall purpose of this study is to evaluate the prevalence and underlying mechanisms of diabetic polyneuropathy and painful diabetic polyneuropathy.

Eligibility Criteria:
Inclusion Criteria T2D patients:

* Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

* Pregnancy
* Poor or no Danish language skills
* Insufficient mental capacity to provide informed consent or complete questionnaires

Additional criteria for healthy controls:

* Any neurological or psychiatric disorder
* Chronic pain
* Severe illness
* Pain treatment 3 days before the examination
Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis

Corneal infection or infectious keratitis (IK) is the most common cause of corneal blindness worldwide, particu-larly in the developing countries1. The incidence was estimated at 2.5-799 per 100,000 population/year. It is a painful and potentially blinding ocular emergency that often requires hospital admission for intensive medical and/or surgical treatment. Depending on the geographical and temporal variations and population-based risk factors (e.g. agricultural practice, trauma, use of contact lens and others), bacteria and fungi have been shown to be the main causative microorganisms for IK, followed by viruses, parasites and polymicrobial infection. Amniotic membrane (AM) is the innermost layer of the placenta, which consists of a single layer of meta-bolically active epithelium, a thick basement membrane, and an avascular stromal matrix (15).

It has been shown to exhibit a wide array of biological properties, including wound healing, anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others. To date, a number of studies have evaluated the benefit of AMT for treating active IK, though the majority of them were of small case series or case reports. In clinical practice, AMT is usually reserved as a second-line therapy in IK, mainly to promote cornea healing in non-healing ulcer after the sterilization phase.


Eligibility Criteria:
Inclusion Criteria:

* Size more than 5 mm.
* Deep ulcers i.e. \> 50% stromal thickness.
* Located within 3mm of the visual axis.
* Patients with descemetoceles and corneal perforations will also be included

Exclusion Criteria:

* Corneal ulcers of size \< 5mm depth \< 50%
* Associated glaucoma
* Associated chronic dacryocystitis
* Ulcers with entropion
The PulsePoint Randomized Controlled Trial

"Sudden cardiac arrest" occurs when someone's heart stops beating unexpectedly. Each year, more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve survival: Call 911,start chest compressions and apply a defibrillator. Together, these actions can increase survival by up to 800%. The problem is that bystanders to cardiac arrest only provide CPR in about 3 of every 10 cardiac arrest cases and AED use in about 3 of every 100 cardiac arrest cases. There are many people in the community who are trained and willing to provide help for cardiac arrest victims such as off-duty paramedics, fire fighters, nurses, etc. When a cardiac arrest occurs in the city, it is likely that one of these people is nearby, but unaware of the emergency. The PulsePoint smartphone application enables these people to be notified by the local emergency 911 service when there is a cardiac arrest near to them. It can be freely downloaded to several common types of smartphones. When there is a cardiac arrest emergency, all nearby PulsePoint users are sent an alert from the 911 service. When the phones receive the alert, they ring, vibrate and display a text message saying "CPR NEEDED". The user's current location and the exact location of the cardiac arrest are then displayed on a map. Nearby public access AEDs are also indicated on the map. The smartphone users can then go to provide chest compressions and use an AED while paramedics are on their way. A video at www.pulsepoint.org shows how this works. The objective of the investigators is to measure whether the PulsePoint smartphone application increases bystander CPR or AED use for victims of cardiac arrest outside the hospital. This project will happen in the City of Toronto. The investigators have a plan to get as many people as possible to download the application, focusing on health care professionals who know CPR. The investigators will set up a webpage that helps people download the software to their phone. The investigators will randomize 911 calls to have a PulsePoint alert sent or not. The investigators will use statistical analysis to measure whether sending an alert to a smartphone increases the chances of bystander resuscitation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with 911 calls assigned MPDS code 09-E-01 (Suspected atraumatic cardiac arrest not breathing), and 09-E-02 (Suspected cardiac arrest, not breathing normally),
2. Out-of-hospital cardiac arrest as defined within the ROC Epistry Database

Exclusion Criteria:

1. Trauma (including burns) associated with cardiac arrest
2. Cardiac arrests occurring in prisons, etc
3. Patients not treated by paramedics because of a DNR order or signs of obvious death as per Ontario provincial paramedic medical directives (e.g. decapitation, decomposition, rigour mortis)
Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Varenicline(Champix).
Mindfulness Program for Older-Diabetes

This study aimed to evaluate the effectiveness of the newly developed Mindfulness-Based Stress Reduction-Taiwan program (MBSR-T) for old people with type 2 diabetes living in long-term care facilities.

This study reported the first randomized controlled trial of Mindfulness-based reduction stress for residents with type 2 diabetes newly moved into long-term care facilities on depression, relocation stress and HbA1c levels. The results highlighted the benefits of using strategies in the MBSR-T to promote good quality of diabetes care for residents in long-term care.

The contents of the 9-week MBSR-T program were adapted from an initial MBSR program by the Taiwan Mindfulness Association for older people with diabetes (Chinese version). The program consisted of a 1.5-hour session each week for 9-weeks for a group of 8 to 10 participants. Each session included 30 minutes of mindful deep breathing relaxation and 60 minutes of practicing mindfulness activities.

A total sample of 140 was determined. All eligible individuals in each long-term care facility were randomized by computerized random numbers, sequence generated by an independent statistician with one-to-one ratio for allocating to either control or intervention group. All participants were blinded to group allocation. Participants in the control group received usual care, while participants in the intervention group received the MBSR-T in addition to the usual care. All sessions in the MBSR-T were delivered by a trained mindfulness registered nurse who had received additional trainer qualification of mindfulness. A research assistant was blinded to the study protocol, who was employed to undertake data collection at baseline, at 3, 6, and 9 weeks (T0, T1, T2, T3).

Eligibility Criteria:
Inclusion Criteria:

* Age 65-85 years old
* Diagnosed with type 2 diabetes
* Moving into the facility within a year
* No obvious delirium, confusion or current psychiatric illness
* Being able to communicate in Chinese.

Exclusion Criteria:

* Terminally ill
* Unable to communicate in Chinese.