cyrilzakka/clinical-trials huggingface dataset:
Pringle Manoeuvre Versus Portal Vein Clamping for Liver Resection

Liver resection is an operation to remove the diseased part of the liver. The liver is supplied by two vessels, the hepatic artery and the portal vein supplying 25% and 75% respectively of the total blood flow with 50% oxygen from each vessel. During liver resection it is standard practice to clamp both vessels(Pringle's manoeuvre), so as to avoid bleeding. Clamping both the vessels deprives the unaffected liver from nutrients required for survival. Reinstating the blood supply causes further damage by pouring harmful substances into the liver, which accumulate during the clamping. We hypothesize that not clamping the oxygen rich hepatic artery will cause less damage to the liver.

Our aim is to compare the Pringle manoeuvre with portal vein clamping, to identify if the latter will result in less tissue injury and thereby fewer complications. Initially we aim to conduct a pilot study. The main objective is to ensure that patients can be successfully recruited and that data capture is complete. The secondary outcomes will be development of infective complications by 30 days following surgery, bleeding and blood transfusion requirements, heart/chest complications, recovery of liver functions, growth of remnant liver, death within 30 days following surgery, length of high dependency unit/hospital stay and quality of life at 3 months after surgery.

There is published literature on the safety of this method and in the event of any intraoperative problems, the procedure will be converted to the standard Pringle manoeuvre. The Liver Unit at St James's University Hospital has four surgeons performing around 270 liver cancer resections per year, of which nearly 160 are for bowel cancer spread. Considering the team's experience in research and liver surgery, we believe it is well placed to conduct the trial in a safe and efficient manner.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Undergoing liver resection for CRLM
* Portal venous clamping as considered appropriate
* Participating patients should be able to understand the study objectives and be able to give written consent
* Able to complete study questionnaire

Exclusion Criteria:

* Patients having simultaneous bowel and hepatic surgery
* Patients participating in other trials that could impact the outcomes measures being recorded
* Patients who are pregnant
* Patients taking immunosuppressive medication
Green Tea Consumption and Coronary Heart Disease

To examine the prospective association of green tea consumption to the incidence and mortality of coronary heart disease (CHD) using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.

BACKGROUND:

Both in vivo and in vitro experiments have show that flavonoids, antioxidants which are rich in green tea, are potentially as beneficial as vitamin E, beta-carotene and vitamin C in reducing the risk of cardiovascular disease. Thus, the possible preventive effects of green tea on CHD have begun to raise research interests in green tea sufficiently to inquire about its beneficial effects formally in humans. However, few epidemiologic studies have been carried out to directly examine the effects of green tea on CHD. The Honolulu Heart Program (HHP) is a 30 year longitudinal study of CHD and stroke among 8,006 Japanese American men living on Oahu Hawaii. Until the end of 1992, 1,888 men from this cohort were defined as having incident CHD; this includes 396 deaths due to CHD. The baseline examination for the HHP was conducted during 1965-68. A comprehensive physical examination and 24 hour dietary recall interview were administered. Within the original cohort more than 75 percent men reported to have drunk green tea daily. The amount consumed per day varied considerably from low to high doses. The high prevalence of green tea consumption coupled with dose information (i.e low, moderate and high consumption) provides good opportunities to examine the relationships of green tea consumption and CHD.

DESIGN NARRATIVE:

The study uses the Honolulu Heart Program data to examine the prospective association of green tea consumption to the incidence and mortality of CHD using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.

This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 years or older
* Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
* At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
* Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Women of childbearing potential are willing to use contraception during study.

Exclusion Criteria:

* Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score \<3 in pain scores.
* Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
* Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Recurrent Persistent Atrial Fibrillation:In-situ Ablation Vs Extensive Ablation

This is an open label, randomized parallel control clinical trial, to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.

This is an open label, randomized parallel control clinical trial. Patients with recurrent persistent atrial fibrillation are 1:1 randomized into EXT group(Extra-PV extensive ablation) and IN-SITU group(Repeat same PVI and linear ablation as the first procedure). Postoperative recurrence rate and other indicators are analyzed to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older; 2) Diagnosed as recurrent PerAF according to the latest clinical guidelines; 3) Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment; 4) the first ablation procedure was PVI and linear ablation; 5) consented to receive radiofrequency catheter ablation.

Exclusion Criteria:

* 1) Recurrent atrial flutter/atrial tachycardia; 2) The first ablation procedure included extra-PV substrate ablation; 3) The first low voltage area\>30%; 4) Serious complications during the first procedure; 5) The first ablation was paroxysmal atrial fibrillation. 6) Uncontrolled congestive heart failure; 7) History of severe valve disease and/or prosthetic valve replacement; 8) Left atrial thrombus confirmed by preoperative esophageal ultrasound; 9) Severe congenital heart disease; 10) Severe lung disease; 11) Left atrial diameter ≥60mm; 12) Contraindications for cardiac catheterization; 13) Myocardial infarction or stroke within 6 months; 14) Contrast agent allergy; 15) The use of anticoagulant drugs is contraindicated; 16) Have performed any cardiac surgery within 2 months;17) life expectancy is less than one year, including factors such as physical inability to tolerate ablation or unstable disease conditions.
Diagnostic Value of the Electrocardiogram in Fabry Disease

Cardiac complications occur in 78% of patients with Fabry disease and are mainly characterized by a high frequency of left ventricular hypertrophy resulting from an accumulation of GL3 in cardiomyocytes. Apart from family screening, left ventricular hypertrophy is an important factor in the diagnosis of Fabry disease. This left ventricular hypertrophy is more often concentric and homogeneous, but it can also be asymmetric and mimic the patterns seen in so-called familial hypertrophic cardiomyopathies caused by mutations in the sarcomere protein genes. Electrocardiogram has been suggested as a screening tool for Fabry disease. Analysis of the PQ interval would be of interest. An algorithm has even been proposed to differentiate Fabry disease from amyloidosis with excellent sensitivity and specificity. The only criterion of left ventricular hypertrophy used in all studies is the Sokolov-Lyon index, but this index has many limitations and does not appear to be discriminatory for Fabry disease. Other validated criteria for left ventricular hypertrophy, such as the Cornell, Lewis, Gubner index or the Romhilt-Estes point score, have never been tested in Fabry disease. The primary objective of our study is to evaluate the diagnostic value of different electrocardiographic scores of left ventricular hypertrophy in Fabry disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years, with genetically confirmed Fabry disease complicated by LVH.
* Patients aged \> 18 years, with sarcomeric hypertrophic cardiomyopathy.

Exclusion Criteria:

* Patients aged \< 18 years. Sarcomeric hypertrophic cardiomyopathy for which Fabry disease has not been excluded by alpha-galactosidase A assay (in men) and genetic analysis (GLA gene mutation) in women.
A Prospective, Randomised Long-term Follow-up of Operative Versus Non-operative Treatment of Gr. 3 Acromioclavicular Dislocation

The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.

The optimal treatment of Rockwood type 3 AC joint injuries is still controversial. This controversy results from the low level of evidence of the early literature and the evaluation of all AC joint injuries with a type I through III classification system.

There are no prospective randomized controlled long-term studies on the treatment of Tossy type 3 AC dislocation using primary repair and minimal pin fixation.

In this study, the non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The surgical treatment consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study
* A written informed consent.

Exclusion Criteria:

* Not written informed consent
Study of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours

This is a first-in-human, Phase I/II, open-label, multi-centre, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of LM-108 as a single agent or in combination with an anti-PD-1 mAb in subjects with solid tumours.


Eligibility Criteria:
Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
2. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose

Key Exclusion Criteria:

1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
2. Uncontrolled tumour-related pain
3. Known central nervous system (CNS)
4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
5. Use of inhaled corticosteroids
6. Known history of autoimmune disease
7. Use of any live attenuated vaccines within 28 days
8. Have severe cardiovascular disease
9. Uncontrolled or severe illness
10. History of immunodeficiency disease
11. Active malignancies which are likely to require the treatment.
12. Child-bearing potential female
13. Have psychiatric illness or disorders

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.

This project will investigate the efficacy of a cognitive remediation programme in patients treated for breast cancer. patients will be randomized between "no intervention" and "intervention programme". Efficay will be assessed in term of improved quality of life.

Medical progress in the treatment of cancer has prolonged patients' life expectancy. This improvement has led researchers to become concerned about the long-term negative effects of cancer treatments on quality-of-life. In particular, previous studies have identified complaints that have been submitted concerning the cognitive status of patients treated with chemotherapy (Berglund et coll., 1991). All of these cognitive changes are collectively grouped under the term chemobrain.

The consequences of treatments remain however underestimated, as the priority when diagnosing cancer remains the patient's short- to medium-term survival; yet, quality-of-life contributes to the long-term survival of patients (Kramer, 2000).

In addition to medical treatments, psychosocial care adapted to the specific needs of subjects is thus important for improving their quality-of-life and helping them return to work. Even if initiatives have multiplied over the past few decades in the psychosocial management of these subjects (e.g., supportive care), that related to cognitive disorders in subjects having survived cancer remains a little documented field. Cognitive deficiency in cancer survivors is said to be moderate (Razaq et coll., 2017), which makes survivors ideal candidates for cognitive rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20 to 60 years inclusive.
2. Localised breast cancer having required neoadjuvant or adjuvant chemotherapy, the last cycle of which took place between 2 and 24 months prior to inclusion.
3. Informed consent dated and signed.
4. Patient with French social security cover in accordance with French law on biomedical research (Article 1121-11 of the French code of public health).

Exclusion Criteria:

1. Metastatic breast cancer.
2. Presence of unstable psychiatric or neurological disorders likely to affect cognition (information requested directly from the participant)
3. History of drug abuse.
4. Patient who cannot read or understand French.
5. Patient already included in this study.
6. Patient having participated in onCOGITE workshops.
7. Patient participating in another clinical trial evaluating cognitive remediation.
8. Patient deprived of freedom or subject to legal protection measures (under guardianship, in custody of the court, or family-member guardianship order).
Efficacy and Safety of Mometasone Furoate Plus Azelastine HCl Combination Versus Mometasone Furoate Alone or Azelastine Alone in Patients With Perennial Allergic Rhinitis

The purpose of this study is to evaluate of efficacy and safety of mometasone furoate plus azelastine HCl in patients with perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 12 years of age
* Medical history of perennial allergic rhinitis for at least two years
* Moderate ro severe nasal symptom (during placebo run-in period AM rTNSS or PM rTNSS≥8)
* Positive skin prick test result within the previous 12 months

Exclusion Criteria:

* patients with active asthma that required therapy with inhaled or oral corticosteroids or long-term β-agonist
* patients with severe rhinostenosis, severely deviated nasal septum or local infection on the nasal mucous membrane
* patients with herpes zoster, glaucoma or cataract
* patients with history of operation or damage on nasal cavity or ocular region
* patients with drug-induced rhinitis
* patients with history of respiratory infection which requires antibiotic therapy within the previous 14 days
* Patients with lung disease including COPD
* Patients with history of immunotherapy or ongoing immunotherapy
* patients administered with super potent or potent corticosteroid
* patients administered with intra-muscular or intra-articular steroid within the previous 3 months
* patients administered with subcutaneous omalizumab within the previous 5 months
Effect of Virtual Reality Distraction on Anxiety Control During Impacted Molar Tooth Surgery

The goal of this clinical trial is to investigate the effectiveness of virtual reality distraction therapy using virtual reality glasses in reducing dental anxiety during the surgical extraction of impacted lower third molar teeth.The main questions it aims to answer are:

* Is the use of the virtual reality distraction during the procedure effective on perceived pain and anxiety?
* Evaluation of the effectiveness of the virtual reality distraction based on initial anxiety test scores.
* Does the use of the virtual reality headset cause difficulties for the clinician in performing the procedure?

Patients will undergo anxiety tests before surgery.

Pre-operative vital signs will be recorded.

The procedure will be performed either with or without virtual reality glasses, according to the randomly assigned groups.

Post-operative vital signs will be recorded.

At the end of the procedure, all patients will undergo anxiety tests and verbal rating scales.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Being systemically healthy
* Needing surgical extraction treatment of impacted lower third molar (in mesioangular position according to Tetsch and Wagner Classification)
* Having a score of 11 or higher on the dental anxiety scale

Exclusion Criteria:

* History of seizures or convulsive disorders
* Balance disorders such as nystagmus or vertigo
* Use of psychotropic medications
* Undergoing treatment for anxiety
* Patients with psychiatric disorders
* Presence of dermatological lesions, especially around the face and eyes
* Presence of any lesion in the eye that would prevent the use of virtual reality
* Presence of systemic diseases and medication use contraindicating surgical extraction of impacted teeth
Cannabis Tolerance Break Resource Study: T-Break Guide

The purpose of this pilot study is to conduct research into the value of using the T-Break Guide for assisting people taking a tolerance break from cannabis. The hope is that this initial research will yield some insights and benchmarks into the Guide's efficacy, and provide a foundation for a later randomized control study.

The following are some key research questions:

1. How did participants use the Guide? (Eg: daily; read once; 'a la carte')
2. How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)?
3. Did using the Guide yield any benefits beyond tolerance break fidelity? (Eg: insight into patterns of use)

The pilot study used a pretest-posttest design in which participants completed a baseline survey and were asked to attempt a 21-day period of cannabis abstinence, to consider using the T-Break Guide (intervention) in their attempt, and to complete a follow-up survey after 30 days.

Participants were young adults aged 18-29 recruited through posters and tabling events at the University of Vermont (UVM), a post on a UVM webpage, emails on listservs of seven other universities, and a post on a subreddit focusing on responsible cannabis use. The posters and online announcements directed participants to the online baseline survey, which contained consent information before allowing participants to complete.

After completing the baseline survey, participants received a link to an online version of the T-Break Guide through email. After 30 days, participants received another email prompting them to complete the follow-up survey. The UVM Institutional Review Board reviewed and approved all study procedures (STUDY00001489).

Eligibility Criteria:
Inclusion Criteria:

* Current cannabis partakers, willing to attempt at 21 day tolerance break (ie, period of cannabis abstinence)

Exclusion Criteria:

* No cannabis use in past month
Safety Study of Oral Edaravone Administered in Subjects With ALS

The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed
* Subjects will be diagnosed with Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS.
* Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed
* Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%.
* Subjects whose first symptom of ALS occurred within 3 years of the time of providing written informed consent.

Exclusion Criteria:

* Subjects who have the presence or history of any clinically significant disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
* Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.
* Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
* Subjects who have a significant risk of suicidality. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.
* Subjects who have ALT or AST elevations greater than 2 times the ULN at screening.
* Subjects with a Glomerular Filtration Rate (GFR) \<30 mL/Min Per 1.73 m2.
* Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
* Subjects with hereditary fructose intolerance.
* Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer before providing informed consent for the present study.
* Subjects who are unable to take their medications orally.