cyrilzakka/clinical-trials huggingface dataset:
Magnesium Administration in Liver Transplantation and Reperfusion Injury

The purpose of this study is to evaluate the effect of intravenous magnesium infusion before reperfusion with employing some clinical parameters including blood lactate levels, because the intraoperative changes in the blood lactate levels after hepatic allograft reperfusion served as an accurate predictor of the initial graft function in living donor liver transplantation.

Clinically significant hemodynamic deterioration occurs immediately after reperfusion of the grafted liver by unclamping of the portal vein. Profound hypotension, bradycardia, systemic vasodilation, and a decrease in cardiac output have been reported, and this is described as postreperfusion syndrome (PRS). This hemodynamic instability usually requires adequate and aggressive cardiovascular pharmacologic management and fluid support, and recovers slowly over a period of 30 to 60 minutes.Because the severity of PRS correlates with patient and allograft outcome, prevention of its occurrence or attenuation of the hemodynamic changes may improve outcome. However, not much is known about how to protect against this reperfusion injury.

Reperfusion injury also occurs in myocardial infarction, ischemic spinal cord injury and stroke. Recent experiments have shown protective effects of magnesium to reduce the reperfusion injury of these conditions. Magnesium administration may provide cellular protection during ischemia and reperfusion with stabilizing the cellular transmembrane potential, suppressing excessive cellular calcium influx and energy demand.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for elective living donor liver transplantation

Exclusion Criteria:

* pediatric patients
* re-transplantation
* renal dysfunction
* cardiovascular disease
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）

This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.

This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.

Eligibility Criteria:
Inclusion Criteria:

* Must meet 1, 2, 3, 4 or 1, 5 to be selected:

  1. Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions\*;
  2. Be able to get in touch with the patient or his legal guardian/relative;
  3. Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;
  4. Sign the informed consent form;
  5. Patients who are known to have died.

     * 4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.

Exclusion Criteria:

1. Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;
2. The investigator judges that the patient's compliance is poor and the study cannot be completed as required.
Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to Right Heart Cath (RHC). The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by CorVista Health (formerly Analytics 4 Life).

Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals. Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and right heart catheterization. In this study, resting phase signals will be acquired in subjects prior to Right Heart Catheterization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old;
2. Scheduled to undergo right heart catheterization;
3. Ability to understand the requirements of the study and to provide written informed consent.
4. Normal Sinus Rhythm (SSR) at time of phase signal collection.

Exclusion Criteria:

1. Prior heart valve replacement
2. Prior lung or heart transplant
3. Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia);
4. Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors;
5. Implantable Neuro-stimulators;
6. Congenital Heart Disease;
7. Pregnant or breast feeding;
8. Currently taking any Type IA, IC or III antiarrhythmics;
9. Any history of amiodarone use;
10. Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum);
11. Breast implants;
12. Neuromuscular Disease if the condition results in tremor or muscle fasciculations.
Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles

Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases.

Shingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.


Eligibility Criteria:
Due to the design of an Observational Cohort Study, no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".

Observational Criteria:

* adult patients
* acute viral infection (especially herpes zoster)
* Primary Care patient
* eligible for add-on therapy with vitamin C
* willingness to provide pseudonymized data to the Sponsor
The Effect of Medication Review in High-risk Emergency Department Patients

Adverse drug events are unintended and harmful events related to medication use and a leading cause of emergency department visits, unplanned hospital admissions and deaths. In the emergency department, physicians frequently misdiagnose adverse drug events leading to treatment delays. Our objective is to evaluate the effect of pharmacist-led medication review in high-risk emergency department patients on prolonged hospital stay.

This prospective multi-centre, quasi-randomized study is nested within an existing quality improvement program. Triage nurses flag incoming emergency department patients at high-risk for adverse drug events by applying a clinical decision rule consisting of four variables (co-morbid conditions, antibiotic use within 7 days, medication changes within 28 days, and age). Consecutive eligible high-risk patients are enrolled into the medication review study, and systematically allocated to pharmacist-led medication review or usual care. In the intervention group, medication review pharmacists collect best-possible medication histories, review the patient's medications for appropriateness and adverse drug events, and communicate the results of medication review to patients, caregivers and physicians. In the usual care group, physicians refer patients to onsite pharmacists for medication management questions on an as needed basis. Health outcomes are assessed using anonymized data linkage to administrative health databases. The primary outcome is the percent of days spent in hospital during the first 30 days after the index emergency department visit


Eligibility Criteria:
Inclusion Criteria:

Consecutive high-risk patients, aged 19 years or older, presenting to a participating emergency department when a medication review pharmacist is on duty are eligible for enrolment.

Exclusion Criteria:

We will exclude patients categorized as Canadian Triage Acuity Score (CTAS) 1 as they require immediate resuscitation, those presenting for multisystem trauma (e.g., penetrating trauma), scheduled visits (e.g., for intravenous antibiotics), sexual assaults, pregnancy-related complications, social problems, and those for whom we cannot link data to administrative records (e.g., out-of-province patients).
Streamlining Care for Patients With Compression Neuropathies: The Carpal Tunnel Plus Pathway

The goal of this clinical trial is to assess the impact of a new care pathway (the Carpal Tunnel Plus Pathway) in patients with carpal tunnel syndrome. The main questions it aims to answer are:

1. What was the effect of the Carpal Tunnel Plus Pathway on wait times between each step of the care pathway (e.g. from referral to initial consult, from initial consult to surgical consult, etc.)?
2. How satisfied are patients with the care they received through the Carpal Tunnel Plus Pathway?

Researchers will compare wait times pre- and post- Pathway implementation to see if there was any change.

Participants will be asked to complete a short patient satisfaction survey.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Referred to the Vancouver General Hospital Neuromuscular Disease Unit or St. Paul's Hospital with a confirmed diagnosis of carpal tunnel syndrome
* Ability to understand English

Exclusion Criteria:

* Inability to provide informed consent
Multicentric Analysis of Predictors of N1 Upstaging After Resection of cStage-I NSCLC

Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery in patients with cStage-I NSCLC . This finding questions the oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar and intrapulmonary lymh node dissection. However, these retrospective studies did not include analysis of central tumor location, although central tumors have a reported higher chance of N1 upstaging . Possibly, this creates a selection bias as surgeons might select central lesions deliberately for open surgery in line with initial VATS feasibility reports

After optimal preoperative staging, 10 to 25% of patients with clinical stage I (cStage-I) non-small cell lung cancer (NSCLC) are found to have unforeseen positive lymph nodes during resection.

Central tumors, even if they are smaller than 3cm (cT1), have a higher incidence of both intrapulmonary or hilar (N1) or ipsilateral mediastinal (N2) lymph node involvement in comparison to peripheral lesions.

In a cohort of patients that underwent identical preoperative mediastinal evaluation and postoperative pathologic tissue examination of equal quality, nodal upstaging can be used as a quality indicator of oncologic thoracic surgery. Or, it can be used as an instrument to compare different techniques, such as thoracoscopic (VATS) versus open lung resections for lung cancer.

Five papers showed a lower N1 nodal upstaging with video-assisted thoracic surgery (VATS) compared to open surgery. These retrospective studies did not include tumor location.

The investigators hypothesize that this creates a bias as surgeons might have chosen an open approach when the tumor was centrally located. This is in line with initial feasibility reports and guidelines that excluded patients with central lesions. This results in a higher prevalence of positive N1 nodes in patients operated with the open approach.

Our single centre analysis showed a one in three chance of nodal upstaging in central located cStage-I tumors , multivariate analysis showed central location to be the only significant predictor for upstaging, and not the surgical technique.

The aim of this multicentric study is to investigate risk factors for nodal upstaging, including tumor location, in patients with cStage-I NSCLC and validate previous findings.

Eligibility Criteria:
Inclusion Criteria:

* Patients operated in 2014
* NSCLC on final pathology
* cStage-I (cT1-2a cN0 cM0 ) before start of incision for anatomical resection.
* This includes: open/VATS/ Robotic Assisted Thoracoscopic Surgery (RATS)
* This includes: lobectomy, bilobectomy, sleeve or pneumonectomy (not wedge)

Exclusion Criteria:

* Higher clinical stage than cStage-I
* Former therapy for lung cancer (chemotherapy, radiotherapy, surgery)
* Metastatic disease
* Induction chemo- or radiotherapy
* Non-anatomical resections (wedge)
* Previous lymph node disease
* No positron emission tomography (PET) or Missing PET report
A Clinical Trial of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management Among Women Facing Partner Violence

1. Aim to investigate the effectiveness of Cognitive Behavior Therapy for Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence
2. To explore the effectiveness of CBT in managing depressive symptoms, stigma, worries, and emotional disturbance among women facing partner violence.

In this Randomized control trial, N=180 participants would be enrolled for eligibility assessment from different shelter homes in the cities of Punjab after the eligibility assessment and screening 108 participants would be allocated to experimental and waitlist treatment conditions. Participants will be allocated through matchable group characteristics. Participant's age range would be between 18 to 45 years. Each of the group will be comprised of the same number of participants. Both groups will be pre-tested and results will be recorded. A cognitive behavior therapy-based treatment plan will be formulated to address Depression, Stigmatization, Excessive Worries, and Emotional Management among Women Facing Partner Violence. 8-10 CBT-based therapeutic sessions with 60 minutes will be conducted with the participant in a one-on-one setting.

Eligibility Criteria:
Inclusion Criteria:

* Women living in the institutions for at least 2 weeks because of partner violence
* Second eligibility criteria would be women with a minimum of 1 year of marital relationship will be included.
* The age range would be 18 -48 years.
* Women whose scores are above average on the partner violence scale would be included in the study

Exclusion Criteria:

* Women greater than 48 years and less than 18 years will be excluded.
* Women with medical and psychiatric comorbidities will be excluded.
Micronutrients to Prevent Noise-induced Hearing Loss

Noise-induced hearing loss (NIHL) is a significant clinical, social, and economic issue. Studies in animals have allowed us to identify mechanisms contributing to NIHL, including direct mechanical trauma, free radicals formed in association with metabolic stress, and reduced blood flow. A combination of antioxidant vitamins (beta-carotene, and vitamins C and E) and the mineral magnesium (which acts in part as a vasodilator but also as an antioxidant) is highly effective in preventing NIHL in animals. These studies evaluate efficacy of this intervention in humans.

Hypothesis: Treatment with these micronutrients provides safe, effective attenuation of acute hearing changes induced by exposure to real-world sounds producing temporary (non-permanent) or permanent hearing changes induced by exposure to real-world sounds.

Experiment 1: "Digital Audio Player" studies (University of Florida, Gainesville). Prevention of \*temporary\* elevations in hearing thresholds, induced by exposure to moderately loud music, will be measured. Subjects will be 70 young adults with equal numbers of male and female participants.

This study assessed the potential for prevention of the temporary changes in hearing that can occur after use of a music player device for 4 hours. All participants listened to one of two playlists (pop or rock) set at the same volumes to provide equivalent and consistent exposures across participants. Participants received either a dietary supplement or a placebo once/daily for three days prior to the day of music exposure, and also on the day of music exposure. The fourth and final dose was consumed immediately prior to music listening and consumption was observed by a member of the study team. Changes in hearing were assessed 15-min post-music, and then 1, 2, and 3 hours later, as well as the following day and 1 week later.

Eligibility Criteria:
Inclusion Criteria:

Hearing inclusion criteria are as follows for all studies:

* subjects must have a normal audiologic assessment at baseline consisting of:

  1. symmetric hearing with air conduction thresholds no worse than 25 dB HL at tested frequencies between .25 - 8 kHz;
  2. no significant threshold asymmetry (i.e., greater than 15 dB) between the ears at any test frequency;
  3. no significant air-bone gaps (i.e., greater than 10 dB); and
  4. Type A tympanograms bilaterally, defined as a range of -140 to +40 daPa based on the 90% range for adults (Margolis \& Hunter 2000).

Additional criteria are as follows:

* No history of ear disease, able to provide informed consent, agree to follow study procedures, normal health screening at study entry

Exclusion Criteria:

* Pregnant or trying to become pregnant within study period (females)
* subjects belonging to vulnerable populations
* subjects with any history of chronic disease
* hearing loss that exceeds limits specified above
* inability or failure to provide informed consent
* medical conditions that require treatment with drugs including anticoagulants
* diuretics
* digoxin
* aspirin/salicylate
* barbiturates
* minocycline
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA) and Canada. This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treated with oral anti-diabetic (OAD) drugs for at least 3 months
* Treated with one or more OAD and in moderate to poor glycemic control
* Body Mass Index (BMI) less than or equal to 45.0 kg/m2

Exclusion Criteria:

* Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator
* Any serious medical condition
* Treatment with any drug that could interfere with glucose level
Study of SyB P-1501 (Fentanyl HCI) for Treatment of Postoperative Pain

This is a Phase 3 clinical trial to compare the safety and efficacy of SyB P-1501 with the SyB P-1501 placebo for the management of the first 24 hours of post-operative pain.


Eligibility Criteria:
Patients who meet all of the inclusion criteria from the day of informed consent to one day before surgery and to whom none of the exclusion criteria is applicable will be eligible to participate in the study.

Inclusion Criteria:

1. Expected to require opioid analgesia for management of post-operative pain for at least 24 hours after surgery and require postoperative pain control
2. Underwent one of the following surgeries under general anesthesia:

   * Abdominal surgery (e.g., gastrointestinal, gynecological)
   * Orthopedic surgery (e.g., spinal surgery)
   * Thoracic surgery (e.g., respiratory surgery not requiring chest tubes after surgery)
3. ASA physical status I, II or III
4. Age: At least 20 years
5. Sex: Men or women (negative pregnancy test for women of childbearing potential).
6. Inpatient/outpatient status: Inpatient
7. Received adequate information about the study and gave a written consent to participate in the study by himself/herself

Exclusion Criteria:

1. Expected to use continuous intra-operative and post-operative analgesia with local pain control techniques (e.g., spinal/epidural analgesia, nerve block)
2. Scheduled for body surface surgery (e.g., burn, breast reconstruction, skin grafting)
3. Hypersensitive/allergic to fentanyl, skin adhesive and/or cetylpyridinium chloride
4. Expected/scheduled to undergo additional surgical procedure within 36 hours post-operation
5. Known or suspected opioid tolerance
6. Skin disorder that precludes application of investigational product
7. Increased intracranial pressure
8. Concomitant asthma, severe respiratory disorder
9. Having had convulsive seizure attacks within 5 years
10. Patient with medical devices implanted in the body, such as cardiac pacemakers or implantable defibrillators
11. History of opioid, drug and/or alcohol abuse
12. Women who are pregnant, might be pregnant, or are breastfeeding
13. Using any investigational drug, used any investigational drug within the last 6 months
14. Otherwise determined ineligible to participate in the study at the discretion of the principal investigator or sub-investigator
Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services

Objective: We aimed at analyzing the relationship between periodontal disease and atherosclerosis in medical treatment and periodontal treatment under medical and dental care across borders in a local cooperation system of Japanese medical services.

Materials and methods:

* A prospective multi-center case cohort study was conducted on 37 ambulatory medical patients (with lifestyle-related diseases under consultation in either of the medical clinics registered as collaborative investigation facilities) and 79 periodontal patients (who were seen by the dental clinics registered as collaborative investigation facilities).
* Medical treatment and clinical periodontal treatment were provided on the subjects under medical and dental care across borders by each internal medicine and dental clinics.
* Systemic examination of lifestyle-related disease and periodontal examination were performed before and after periodontal treatment, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed before and after periodontal treatment.


Eligibility Criteria:
Inclusion Criteria:

* Periodontal disease: inflamed gingiva with positive for bleeding on probing or teeth with probing pocket depth more than 4 mm Lifestyle-related disease: Plaques are included when maximum IMT is measured. Furthermore, hypertension was defined as systolic blood pressure of more than 140 mm Hg or diastolic pressure of more than 90 mm Hg, or both, or patients already being treated by anti-hypertensive agents. Hypercholesterolemia was defined by serum concentration of LDL-C of more than 140 mg/dL, or patients already being treated by lipid-lowering agents. Diabetes mellitus was defined by HbA1c of more than 6.9 % (NGSP value) or fasting blood sugar of more than 126 mg/dl or both, or patients already being treated by agents for diabetes.

Exclusion Criteria:

* At initial consultation and examination (Baseline), patients with less than 6 months after the onset of acute myocardial infarction (AMI), and with a past history or complication of serious heart disease were excluded. Similarly, those with less than 6 months after cardiovascular revascularization surgery, less than 6 months after the onset of cerebrovascular disorder, or serious liver disease or renal disease were also excluded.