cyrilzakka/clinical-trials huggingface dataset:
Arginase Inhibition and Microvascular Endothelial Function in Type 2 Diabetes

The present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications.

Background

The development of microvascular complications in diabetes is a complex process, in which endothelial dysfunction is of importance. Emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus (T2DM) by reciprocally regulating nitric oxide bioavailability. The aim of this study was to test the hypothesis that arginase activity is increased and that arginase contributes to microvascular endothelial function in patients with T2DM and microvascular dysfunction.

Method

Microvascular endothelium-dependent and -independent vasodilatation are investigated in patients with T2DM (n =12) and healthy age-matched control subjects (n =12) with laser-Doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after intra-arterial administration of the arginase inhibitor N-hydroxy-nor-L-arginine (0.1 mg/min) for 120 min.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus and microvascular dysfunction defined as microalbuminuria \> 3.0 mg/mmol or presence of retinopathy.

Exclusion Criteria:

* Myocardial infarction or unstable angina within the last three months,
* Changed dose of any vasodilator drug during the preceding six weeks,
* Ongoing treatment with warfarin
* Concomitant disease that may have interfered with the possibility for the patients to comply with or complete the study protocol
Therapeutic Adherence of Multiple Sclerosis Patients

The goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients. This study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment, and identify the risk factors and vulnerability of each patient.

Multiple sclerosis is a chronic and progressive disease that affects young adults (between 20 and 40 years old), impacting significantly the patients quality of life.

The adherence to therapy affects the long-term functional clinical course (lower risk of relapses, reduction in disability progression and quality of life). The non-adherence rate to therapy in multiple sclerosis is estimated at 40%. The main identified causes of non-adherence are: forgetting to take treatment and adverse effects of drugs.

Sociocognitive models as the Theory of Planned Behaviour (TPB) have been developed to help to understand and predict health-related behaviours. This model postulates that the intention to adopt a behaviour is one of the major determinants in the context of health. This intention comes from three independent elements :

* Personal positive or negative attitudes towards the behaviour,
* Social expectations or entourage perception (subjective norms),
* Difficulty in accomplishing this behaviour (perceived control)

Multiple sclerosis adherence to therapy studies have mainly focused on somatic variables (physical disability, illness duration, type of treatment) and some clinical variables (cognitive impairment, fatigue, depression). The few studies that have examined the multiple sclerosis therapeutic adherence determinants have mainly taken a one-dimensional perspective, such as perceived control.

In the FELSA-SEP study, the role of sociocognitive factors (norms and beliefs, perceived threat to disease and health behaviours) and interpersonal factors (social support, patient-doctor relationship) will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis defined according to McDonald criteria;
* Already undergone or beginning substantive treatment (self-managed, excluding treatment administered in hospital)
* Aged ≥ 18 years;
* Given the informed consent form.

Exclusion Criteria:

* Severe cognitive impairment (score below the 5th percentile);
* Any associated neurological pathology or serious or chronic somatic disease (cancer);
* Being under a legal protection measure.
Evaluation of a Remote Monitoring Smartphone Application and Care Model of COVID-19 Patients in the Community (ReCOVER)

This is a multi-site, prospective, non-randomised trial assessing the implementation of a smartphone application-based model of care for patients with COVID-19 infection managed in community isolation. We will recruit 2000 COVID +ve patients aged 18 years and over who are managed at home. The objective will be to describe the rates of avoidable presentations to ED and 30 day all case mortality per diagnosed COVID-19 case and to compare these to a propensity matched and synthetic control group.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater or equal to 18 years
2. Able to provide informed consent
3. Proven diagnosis of COVID-19 based on positive virology testing
4. Patients who are being managed at home OR those who are being discharged from hospital for ongoing home-based care in isolation.
5. Access to a smartphone or device that is compatible with the TCC-COVID app

   * Any iPhone or iPad running iOS 9 or above (essentially any iPhone 5 or above)
   * Any Android phone that is operating Android 7.0 or above
6. Speaks adequate English

Exclusion Criteria:

1. Patient meets clinical criteria for hospital-based care.
2. Inability to use the TCC-COVID app and pulse oximeter due to reasons including but not limited to:

   * Cognitive impairment
   * Impaired dexterity
   * Visual impairment
   * Language barrier
3. Patient residing outside the SESLHD catchment area during their period of isolation
Shared Decision Making With Breast Cancer Patients

The aim of this project is to elucidate whether the use of shared decision making will influence patient engagement in the decision making process about adjuvant radiotherapy after breast conserving surgery for local breast cancer or early stages of local breast cancer.

The risk of recurrence of breast cancer is lowered by adjuvant medical treatment as well as by radiotherapy (RT). On the other hand, all adjuvant treatments involve a risk of side effects; some are acute and transient while others are long-term. Considering the well-known side effects of irradiation, it seems appropriate to involve patients in the decision on whether to receive irradiation.

In the shared decision making (SDM) process clinicians and patients work together to make appropriate health decisions based on clinical evidence and the patient's informed preferences. A patient decision aid (PtDA) is instrumental in the SDM process.

This study is a multicenter, national trial randomizing doctors to either use or not use SDM and a PtDA when informing the patients about benefits and risks of receiving adjuvant radiotherapy.

It is not expected that significantly less patients will receive radiotherapy as a consequence of SDM. The primary aim of the study is to evaluate whether patient engagement in decision making is affected by SDM and the use of an in-consultation PtDA.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified breast cancer or ductal carcinoma in situ breast cancer
* Candidate for adjuvant radiotherapy Danish Breast Cancer Group type F after breast-conserving surgery for T1-2, N0-Nmi, M0 disease according to national guidelines.
* Signed confirmation of participation.

Exclusion Criteria:

* Bilateral breast cancer or suspicion of disseminated cancer
* Unable to understand the information, the planned treatment or follow-up for any reason.
* Earlier radiotherapy towards the thoracic region.
Predictors of OSA in Patients With COPD

Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea(OSA) are common disorders ,the co-existence of both conditions is called overlap syndrome Smoking , obesity , airway resistance and inflammation are considered risk factors for both conditions ,interestingly either COPD and OSA are associated with increased cardiovascular complications with further increased risk in overlap syndrome Multiple theories could explain that one disorder can predispose or exaggerate the other. For example, in COPD cigarette smoking and inhaled steroids are linked to myopathy of upper airway dilator muscles. Moreover in core-pulmonale redistribution of edema fluid in supine position during sleep can also contribute to or exacerbate OSA .

On the other hand , OSA patients might smoke frequently and more heavily to compensate for excessive daytime sleepiness and to help them to lose weight , which results in exaggerated airway inflammation and exacerbate COPD. Rationale of the study was to assess the prevalence and predictors of OSA among patients with stable COPD.


Eligibility Criteria:
Inclusion Criteria:

* All stable COPD patients

Exclusion Criteria:

* Patients with end organ failure
Bereaving, But Not Alone : the Development and Actualization of a Mutual Aid Group for Children Who Have Lost a Parent.

The methodology of this clinical trial is based on the realisation of a group intervention with children who lost a parent. Interviews preintervention and postintervention with participants will be done as well. The purpose of this study is to answer the following question: "What are the benefits for children who are in the process of bereaving a parent to participate in a group work intervention based on the mutual aid model ?". The aim of the research is to explore the benefits for grieving children to participate in an group work intervention based on the mutual aid model. To do so, the research has three distinct objectives : 1) to develop and apply a program of group work interventions for grieving children based on the mutual aid model ; 2) to explore the extent to which participation in the group facilitates changes in the children's discourse about death and the loss of their parents, and 3) to examine, from the children's own perceptive, the possible impact that their participation in the group have on their experience of bereavement.


Eligibility Criteria:
Inclusion Criteria:

* Children between 8 and 12 years old.
* Children who had lost a parent within 3 months and two years before the beginning of the group intervention.

Exclusion Criteria:

* Children who experimented death of his parent by suicide.
A Study of Nemonoxacin Malate Sodium Chloride Injection Administered by Intravenous Infusion

The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

Single dose safety and tolerability study: evaluate safety and tolerability of intravenous infusion nemonoxacin 25mg, 50mg, 125mg, 250mg, 500mg, 750mg, 1000mg and 1250mg.

Single dose pharmacokinetic (PK) study:evaluate PK profile of doses of 250mg, 500mg or 750mg intravenous infusion nemonoxacin .

Multiple dose study: evaluate PK profile of doses of 500mg, 650mg or 750mg intravenous infusion nemonoxacin after consecutive 10 days.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female, aged 18 \~45
2. A male volunteer should be willing to use a double-barrier contraception until the study is completed, and should not make his partner pregnant during the study and within 3 months after completing the study
3. Volunteers who have never used any tobacco or nicotine-containing product within three months before use of the investigational product
4. Volunteers who are willing to abstain from caffeine- or xanthine- containing drinks or food within 24h before being enrolled in the study and throughout the study,such as coffee and tea,chocolate,alcohol, grapefruit juice,orange juice,etc.
5. The body mass index (BMI) of the volunteer must be 19\~24, and the weight of a male should be at least 50kg,and that of a female should be at least 45kg.
6. Volunteers who are able to sign the informed consent form (ICF) of their own accord.

Exclusion Criteria:

1. History of diabetes,or cardiovascular,hepatic or renal disease.
2. Had surgery or trauma within 6 months prior to this study
3. Alcohol or drug abuse
4. HIV, HBV or HCV positive
5. subject used any known hepatic enzyme inducer/hepatic enzyme inhibitor product within 30 days prior to the study
6. Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study
7. Donated 400ml of blood or plasma within 3 months prior to this study
8. Have an abnormal laboratory examination value that exceeds the normal range by 10%
9. Drug allergies
10. Have cardiac disorders or have a family history of cardiac disorders
11. Have abnormal 12-lead ECG during screening
12. Pregnant or lactating
13. Participated in any study within 3 months prior to this study
14. according to the investigator's judgment, affect the safety or efficacy evaluation.
Arginine Plaque Metabolism Pilot Clinical Study

Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the nine-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Good general health

Exclusion Criteria:

* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate care.
* Concurrent participation in any other oral care clinical study or test panel.
* Self-reported pregnant or lactating women.
* Dental prophylaxis received in the past four weeks prior to baseline examinations
* History of tobacco use-smoking, vaping and chewing tobacco
* Presence of orthodontic bands, presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Use of antibiotics or stain inducing medications any time during the two month prior to entry into the study
* Use of oral care products containing antimicrobials (Zn, Sn, CPC, triclosan, alcohol containing mouthwash, etc
Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial

The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are:

1. To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery
2. To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection.

Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS.

Participants will:

1. Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal.
2. Keep a diary of their symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Based on the NCCN guidelines for the pathological diagnosis of rectal cancer, patients are identified as having Primary Rectal Adenocarcinoma.
* ≥18 years.
* For the first time, anterior rectal dissection combined with prophylactic ileostomy was performed using laparoscopic, robotic, and open techniques.
* The patient exhibits normal cognitive and expressive abilities.
* Informed consent was obtained for voluntary participation in the study.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) Class III or higher.
* A combination of other intestinal conditions, including inflammatory bowel disease and Crohn's disease.
* Mental disorders and prolonged use of psychotropic medications.
* The presence of contraindications to enema administration.
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)

This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.

This is a prospective, randomized, double-masked, two-arm, multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at Week 48 in participants with DR.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* Type 1 or 2 diabetes mellitus and HbA1c of ≤12%.
* DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
* CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR
* CST \>320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.

Exclusion Criteria:

* Prior PRP in the Study Eye.
* Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
* Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
* Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
* Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye.
* History of vitreoretinal surgery in the Study Eye.
* History of uveitis in either eye.
* Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
* Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT, or FP.
* Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or alter visual acuity during the study.
* Active or suspected ocular or periocular infection or inflammation.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
* Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
* Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest.
* Other protocol-specified exclusion criteria may apply.
Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol

The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode of action is responsible for its opioid-sparing effect, which contributes to a reduction in some of the typical opioid-related adverse effects

Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of Anesthesiologists (ASA) physical status: 1 \& 2, posted for elective lower limb orthopedic surgeries Exclusion criteria

1. Sepsis at the site of injection
2. Coagulopathy
3. Patients with history of renal, hepatic, cardiovascular disease
4. Patient on chronic opioid use Outcome Comparing postoperative analgesia between the groups every 12 hours after the intervention till about 72 hours post intervention. The secondary outcome is to compare the need for the rescue analgesia between the groups

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 \& 2
2. Posted for elective lower limb orthopaedic surgeries

Exclusion Criteria:

1. Sepsis at the site of injection
2. Coagulopathy
3. Patients with history of renal, hepatic, cardiovascular disease
4. Patient on chronic opioid use
Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver Transplantation

The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.

Liver transplantation requires a long operation time and is often associated with a significant amount of surgical bleeding. It is common for the anesthesiologist to infuse large amounts of fluid or blood products due to bleeding, hemodynamic instability, or ascites drainage. Therefore, in the anesthesia for liver transplantation, optimal management of fluid administration is necessary and the choice of the type of crystalloid may affect the prognosis or the incidence of postoperative complications of patients.

The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2004 and 2018

Exclusion Criteria:

* patients with baseline renal dysfunction of hepatorenal syndrome or chronic kidney disease
* missing preoperative serum creatinine value
* missing other baseline or outcome variables
* patients who received retransplantation