cyrilzakka/clinical-trials huggingface dataset:
Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on Robot-assisted Colorectal Surgery

Being relatively new, the NOL monitor may offer interesting observations in perioperative nociception levels and appropriate analgesic consumption in diverse surgeries, including robot-assisted surgery. These observations may supplement the current efforts towards further advantages in rapid restitution. Therefore, the investigators planned a trial where intra-operative analgesics were guided using an NOL monitor to study if intra-operative NOL guidance influences peri-operative analgesic consumption, postoperative length of stay and quality of recovery of patients subjected for robot-assisted surgery.

During anesthesia for surgical procedures, anesthetic and muscle relaxant drugs can be meticulously administered using Bispectral Index (BIS) and neuromuscular monitors. However, analgesic drugs are still dispensed using poor surrogate parameters such as heart rate and blood pressure. This subjective dosing of analgesic drugs may invariably lead to inappropriate intra-operative consumption. This may result in tachycardia, hypertension, and postoperative pain due to e.g. insufficient analgesia, or hypotension, bradycardia, respiratory depression and Post-Operative Nausea and Vomiting (PONV) secondary to excessive analgesia. These effects may be detrimental to the patients especially those with multiple comorbidities with limited vital organ reserves such as patients classified to III or IV by the American Society of Anaesthesia classification (ASA) Similarly, immediate postoperative recovery may also get delayed due to pain, unstable hemodynamics, nausea and vomiting. In that context, there has long been search for a monitor which can guide meticulous administration of analgesics. Recently, a Nociception Level monitor (NOL) based on advanced software algorithms using multiple physiological parameters has been developed. It offers an objective score (NOL Index) which relates to the level of intra-operative pain. NOL technology has been validated and found superior to existing pain indicators in peer-reviewed publications. The NOL monitor may offer interesting observations in perioperative nociception levels and appropriate analgesic consumption in diverse surgeries, including robot-assisted surgery. These observations may supplement the current efforts towards further advantages in rapid restitution. Therefore, the investigators are planning a trial where intra-operative analgesics are guided using an NOL monitor.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists score III-IV
* Scheduled for elective major robot-assisted colorectal surgeries

Exclusion Criteria:

* Inability to give informed consent
* planned spinal or epidural anaesthesia
* all forms of regional anaesthesia, including wound infiltration
* nonelective procedures
* pregnancy or lactation
* atrial fibrillation
Accelerating Lung Cancer Diagnosis Through Liquid Biopsy

This study will assess the utility of liquid biopsy to accelerate the time to treatment for patients with newly diagnosed advanced non-small cell lung cancer, compared to the conventional diagnostic pathway of molecular testing of tumour tissue after imaging and biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. Lung RAMP Multidisciplinary Cancer Conference or study team confirms radiologic (clinical) evidence of advanced, unresectable lung cancer;
2. Measurable disease (presumed malignant) by RECIST 1.1;
3. Age ≥18 years;
4. Ability to provide written informed consent;
5. Diagnostic biopsy and molecular profiling ordered or planned. Patients remain eligible even if biopsy or tumour testing later fails or is deemed not feasible.

Exclusion Criteria:

1. Pregnancy;
2. Concurrent active malignancy except for localized non-melanomatous skin cancer or non-invasive cervical cancer. Any previous cancer (excluding NSCLC) must have been treated more than 2 years prior to study entry with no current evidence of active disease.
Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve for Solifenacin 10 mg. Hyperactive Bladder Syndrome

* To determine if the T-PTNS is not inferior in the short term (3 months) to one of the usual pharmacological treatments (Solifenacin) in the treatment of hyperactive bladder syndrome and with respect to the percentage of patients that improve 50% any of the 3 signs (Urinary frequency, diurnal / nocturnal frequency, urgency and urinary incontinence).
* To determine prognostic factors associated with insufficient improvement (less than 50% in the 3 main signs of hyperactive bladder syndrome (urinary frequency, urgency and urinary incontinence frequency) after treatment with T-PTNS and Solifenacin.

Patients will be randomized to receive the usual standard treatment with Solifenacin or treatment based on peripheral unilateral transcutaneous neuromodulation of the posterior tibial nerve .

Eligibility Criteria:
Inclusion Criteria:

* Women\> 18 years, diagnosed with hyperactive bladder syndrome for at least 6 months of evolution and who have taken Beta 3 agonists

Exclusion Criteria:

* Patients who can contribute biased information: have previously consumed and abandoned anticholinergic drugs due to lack of efficacy or side effects; Suffering from hyperactive bladder of neurogenic origin (multiple sclerosis, Parkinson's, spinal cord injury); Present cystocele or any pelvic organ prolapse\> 2 according to Pelvic Organ Prolapse-Q classification
* Patients who may become worse with the interventions envisaged in the study: being a implantable automatic defibrillators; With cutaneous alterations in lower extremities that prevent the placement of electrodes on the surface; Women who are pregnant or who may be pregnant during the duration of the clinical trial (prior and at each evaluation visit urine Bhcg will be requested to rule out pregnancy) or patients who are not able to manage transcutaneous electrical neurostimulation on an outpatient basis ) Or patients in whom Solifenacin is contraindicated: urinary retention, severe gastrointestinal disorders (including toxic megacolon), myasthenia gravis, or narrow-angle glaucoma, and in patients at risk of these conditions as hypersensitive at first Active or to any of the excipients, undergoing hemodialysis, with moderate hepatic insufficiency or severe renal insufficiency or in simultaneous treatment with a potent inhibitor of CYP3A4, eg ketoconazole.
ImCardia for DHF to Treat Diastolic Heart Failure (DHF) Patient a Pilot Study

This study is designed to evaluate the ImCardia safety and to demonstrate system functionality in patients undergoing AV replacement with respect to 36 months follow up.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female able to understand and sign a informed consent
2. Be 50 years of age or older
3. NYHA class III, IV
4. EF \>55%
5. Candidates for aortic valve replacement due to aortic stenosis.
6. Agrees to attend all follow- up evaluations

Exclusion Criteria:

1. Free wall thickness less than11.5mm
2. Adhesions are expected from a previous surgery or medical condition (e.g. s/p chest radiation therapy etc.)
3. Presence of significant myocardial scars (e.g. postinfarction) at proposed site for implant of ImCardia™device Attachment screw.
4. Likely to be need CABG following the implantation of the ImCardia™
5. Intra-cardiac thrombus/mass
6. Myocarditis
7. Acute/chronic pericarditis
8. Not a candidate for sternotomy
9. Active infection
10. Stroke, surgery or ICD within 3 months
11. Acute coronary syndrome during the past 6 months
12. Left ventricular regional wall motion abnormalities
13. Significant valvular disease other that aortic stenosis
14. Significant pulmonary disease
15. A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator
16. Participating in another trial (other than non-therapeutic or interventional observation) within the last 60 days.
17. History of noncompliance to medical therapy
Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease

The purpose of this study is to test the routine faisibility of a questionnaire to estimate walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.

The WELCH and WIQ questionnaires are self completed by the patients and scored by the physician after self-completion.

Eligibility Criteria:
Inclusion Criteria:

* Sigjned consent for the data treatment as a database

Exclusion Criteria:

* Non french native language age \< 18 years old
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of systemic juvenile idiopathic arthritis as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with onset of disease \< 16 years of age.

  -Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
* Active disease at the time of enrollment defined as follows:

  * At least 2 joints with active arthritis (using American College of rheumatology) ACR definition of active joint)
  * Documented spiking, intermittent fever (body temperature \> 38oC) for at least 1 day during the screening period within 1 week before first study drug dose
  * C-reactive protein \> 30 mg/L (normal range \< 10 mg/L)
* No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:

  * Stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
  * Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
  * Stable dose of steroid treatment \< or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent

Exclusion criteria:

* Diagnosis of active macrophage-activation syndrome (MAS) within the last 6 months
* Risk factors for tuberculosis
* Patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection

Other protocol inclusion/exclusion criteria may apply
Postpartum Anxiety, Breastfeeding and Infant Health Among Taiwanese Women

This is a prospective, longitudinal and observational study designed to investigate the trajectories of postpartum anxiety and its determinants in the first year after childbirth. This study also examine the associations between postpartum anxiety and infant health outcome, including breastfeeding patterns, excessive crying and body weight growth. Primipara aged 20-49 with term baby will be invited. Demographics, maternal-newborn characteristics, and anxiety symptoms will be collected during the first week postpartum (T1). Questionnaires will be follow-up by mail and telephone reminder in 1 (T2), 3 (T3), 6 (T4) and 12 months (T5) postpartum. The primary outcome is postpartum anxiety using the Spielberger's State-Trait Anxiety Inventory (STAI); the secondary outcomes are infant health outcomes including breastfeeding patterns, excessive crying and body weight growth. A linear mixed model (LMM) is used to determine the trajectories of postpartum anxiety over time and to examine whether specific demographic and maternal characteristics predict the trajectories of postpartum anxiety. The key findings may contribute to promote early identification and secondary preventive interventions for women with postpartum anxiety.

Ditto

Eligibility Criteria:
Inclusion Criteria:

* 20-49 years old
* Primipara

Exclusion Criteria:

* Preterm birth
* Infants with severe congenital malformations/medical conditions or Fetal/neonatal death
* Current use of antidepressant or antipsychotics
* Thoughts of self-harm or suicide
Efficacy and Safety of Synthetic Phosphoethanolamine in Solid Tumor Patients

Synthetic phosphoethanolamine is a primary amine which has a critical role in the biosynthesis of cell membranes. Pre-clinical models have shown potential anticancer activity.

Phase II multi-cohort study based on two-stage Simon design. The primary goal of the study is response rate at 8 weeks in participants with advanced solid tumors treated with synthetic phosphoethanolamine, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) or specific criteria for prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven advanced solid tumor patients (recurrent or metastatic), not amenable to curative therapy. Patients must have progressed to standard treatment proven to prolong survival or no standard treatment exists. Tumor types include head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, breast cancer, cervix cancer, prostate cancer, melanoma, pancreas adenocarcinoma, gastric adenocarcinoma, hepatocellular carcinoma
* No concurrent active systemic treatment
* Measurable disease by RECIST v1.1
* Clinical or radiological progression in the last three months
* Eastern Cooperative Oncology Group Performance Status 0-1
* Ability to consent
* Adequate organ function
* Life expectancy greater than 12 weeks
* Ability to swallow
* No previous malignancy in the last 5 years

Exclusion Criteria:

* Pregnancy
* Corticosteroid therapy for prostate cancer
* Uncontrolled comorbidity
* Known hepatitis B, C and HIV
* Central nervous system involvement, except if controlled symptoms and without corticosteroids
* Previous use of phosphoethalonamine
Amyloid Beta and Cognition in Parkinson Disease

The investigators propose to study persons with Parkinson Disease (PD) with detailed clinical, cognitive and imaging at the time of study entry and repeat these assessments 2 years later. The study looks at how changes in activity of the neurotransmitter acetylcholine relates to changes in cognitive function and to see if there is presence or build up of amyloid protein.

Participants with PD will be studied at initial visit assessing clinical, cognitive, and brain imaging. A one year and, if applicable, three year cognitive assessment will be done, and the entire/complete assessment (same as initial visit) will be repeated again at two years. There will be a maximum of three follow up visits. The imaging test battery will consist of amyloid and acetylcholine brain PET and MRI scans. The use of acetylcholine PET imaging will demonstrate how changes in activity of this neurotransmitter relate to changes in cognitive functions, such as memory and mental concentration. A key question will be whether persons with PD who not only are losing acetylcholine brain cells but also have the buildup of the Alzheimer amyloid protein have a more rapid progression with more severe cognitive decline and behavioral changes compared to persons who do not have the amyloid protein.

Eligibility Criteria:
Inclusion Criteria:

PD diagnosis according to the UK PD Society of Brain Bank research Center criteria PD subjects at risk for dementia Age 50 and above, male or female Absence of dementia confirmed by clinical and detailed neurological assessment -

Exclusion Criteria:

Subjects with contra-indications to MR imaging Evidence of large vessel stroke or mass on on MRI Use of cholinergic or neuroleptic drugs at baseline Evidence of atypical parkinsonism on neurological exam Subjects limited by participation in research procedures involving ionizing radiation Pregnancy(test within 48 hours of each PET session) or breastfeeding

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Effect of Silane Coupling on the Clinical Performance of Repaired Composite

Research Problem : Advances in adhesive technologies have introduced several surface treatment concepts that enable the clinician to adhere resin-based composite restorations onto new composite materials. The service life of faulty direct composite restorations can be prolonged by composite repair wherein durable adhesion between old and new resin-based composite materials is established.

Objectives : A randomized controlled clinical trial was designed to apply the latest results of evidence-based in vitro studies regarding resin-based repair protocol. The study aimed to assess the effect of adding silane coupling agent as a separate step on the clinical performance of repaired composite restorations and compare the results with those of using the usual etch and bond protocol.

Materials and Methods : 45 patients were recruited for this study from patients attending the restorative dentistry clinics for postgraduate students, Jordan University of Science and Technology. Each patient had at least two defected posterior composite restorations that are indicated for repair. With this selection, 116 restorations with localized anatomical deficiencies and/or secondary caries were randomly assigned into three groups according to the type of surface treatment each tooth will receive before the application of the new composite material (Filtek Z250,3M,USA). The teeth in the control group (n = 45): were treated with 37% phosphoric acid etching and conventional one step adhesive (Single Bond,3M,USA). In the Silane-Adhesive group (n = 26): teeth were treated with acid etching and silane coupling agent application (Bis-silane) prior to adhesive bond (Adper single bond). In the Sandblast-Silane-Adhesive group (n = 45): teeth were treated with intra-oral sandblasting and silane coupling agent application (Bis-silane) prior to (Adper Single Bond). The reason of repair, age of old restorations and the location of the restoration-repair interfaces were recorded for every failed restorations. Two examiners followed-up and evaluated the restoration quality after an average of 6 months using modified USPHS criteria. The results of clinical performance were assessed using Chi-square test.

Eligibility Criteria:
Inclusion Criteria:

* Deciduous tooth
* Sustained dentin hypersensitivity
* Irreversible pulpitis , necrotic, or inadequately-treated endodontic teeth
* Grossly defective composite restorations that were indicated for replacement.
* Teeth with compromised periodontal status.
* Patients with poor oral hygiene

Exclusion Criteria:

* Patients older than 18 years.
* Asymptomatic restored premolars or molars.
* Vital or endodontically treated teeth
* Patients with localized, marginal, anatomical deficiencies and/or carious lesions adjacent to composite restorations or esthetically unpleasant restorations.
* Teeth with marginal gingivitis but healthy periodontium.
* Tooth in normal occlusion with antagonist and at least one adjacent tooth.
Photodynamic Therapy in Anal Fistula

Objective: Validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula.

Methods: Prospective observational study including patients treated for complex anal fistula who underwent intralesional photodynamic therapy (i-PDT). Patients were included with a minimum follow up of 1-year, in order to evaluate recurrence, continence and postoperative morbidity. Intralesional 5-aminolevulinic acid gel 2% was directly injected into the fistula. The internal and external orifices were closed. After an incubation period of 2 h, the fistula was irradiated using an optical fibre connected to a red laser (MULTIDIODE 630 PDT, INTERmedic, Spain) operating at 1 W/ cm for 3 min (180 Joules).


Eligibility Criteria:
Inclusion Criteria:

* complex anal fistula according to Parks classification

Exclusion Criteria:

* Non cryptoglandular fistulas
* acute sepsis
* inflammatory bowel diseases
* simple fistulas (defined as subcutaneous, intersphincteric and low transsphincteric fistula)
* pregnant patients
* ASA IV
* patients \<18
* immunocompromised
* patients who refused consent.
Effect of Self-regulated Learning on Academic Performance Among Physical Education Students

Difficulty in employment for college students is a serious social problem in China. All qualification examinations, further education and jobs require written theory tests. Many students are affected by their examinations, additional studies, and employment due to poor academic performance and insufficient learning ability. College students majoring in physical education generally perform better in motor technical skills but often encounter difficulties in theoretical learning.

According to the existing literature and many studies, self-regulated learning is an advanced form of metacognitive learning (Pintrich, 2004). It helps cultivate students\&#39; independent learning ability and can improve their theoretical academic performance. This study attempts to use self-regulated learning in physical education theory classes to examine whether this method can enhance physical education students' theoretical academic performance.

In this study, the experimental group received a 12-week (John, 2017) self-regulated learning strategy based on a learning model teaching intervention designed for this study. In contrast, the control group discussed and studied traditional learning content for 12 weeks with the teacher, and the students in the experimental group learned the self-regulated learning strategy. A cluster-randomised controlled trial (CRCT) design was used, and the experimental and control groups were randomly assigned to two schools. After 12 weeks of learning, both groups were required to conduct a learning performance assessment.

Eligibility Criteria:
Inclusion Criteria:

1. University students;
2. Major in Physical Education;
3. Health;
4. Able to attend all evaluation;
5. Understand the study purposes and procedures;
6. No previous experience performing self-regulated learning strategy.

Exclusion Criteria:

1. University students not majoring in Physical Education;
2. Exclude participants who have not finished all evaluation;
3. Not understanding the study purposes and procedures;
4. Participants with an experience in self-regulated learning strategy.
Effects of Cocoa Flavanol on Skin Aging

Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the intrinsic aging process, and accounts for the majority of age-associated changes in skin appearance. Reactive oxygen species (ROS) likely contribute to this process. Strategies utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have been examined.

Cocoa beans fresh from the tree are exceptionally rich in polyphenols, such as flavanol, and have a higher antioxidant capacity. The present study is designed to investigate the effects of long-term intake of a product rich in cocoa flavanols on facial wrinkles, hydration, elasticity and photosensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy females aged ≥ 40 years
* Facial wrinkle grade ≥ 2

Exclusion Criteria:

* received medical or cosmetic treatment that interferes with the general aging process at least 3 months before the study
* reported taking functional foods 1 month before the study
* history of acute or chronic disease such as severe liver or kidney disease or uncontrolled diabetes
* history of allergies against any component of trial foods
* any visible skin disease that might be confused with a skin reaction to the test procedure