cyrilzakka/clinical-trials huggingface dataset:
Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

The aim of the study is to analyze the postoperative complication rate of intracorporeal versus extracorporeal anastomotic technique in laparoscopic or video assisted right hemicolectomy for malignant and benign neoplasms . The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study

CoDIG is a cohort, observational, prospective, multi-centric national study about ileo-colic anastomosis performing with EC or IC Technique during right laparoscopic hemicolectomy.

The observational period lasts from march 2018 and September 2018. The promoter of the study is "Istituto di Chirurgia Generale 1" of Ferrara University Hospital.

135 Italian Hospitals, accredited by Health Ministry, have been contacted via e-mail and all data was compiled into a web accessible SICE database, 85 Italian clinical centres, with demonstrated experience in colorectal laparoscopic surgery, have joined the study.

Every centre was asked not to change its surgical habits concerning the technologies used, the surgical approach, the anastomotic method, the post-operative management.

Every patient involved into the study was asked to sign a consent form in order to the Helsinki Declaration.

Eligibility Criteria:
Inclusion Criteria:

* Patients and/or legal guardians exhaustively informed by the investigator, and who have voluntarily provided written informed consent or, when unable to read and/or write, verbal consent put into writing by a third person
* Patients who underwent elective laparoscopic or video assisted right hemicolectomy at U.O. General and Thoracic Surgery for malignant or bening pathology.
* Patients who had prior chemotherapy and radiotherapy

Exclusion Criteria:

* Patients operated in emergency
* Pregnant women
* Right laparotomic hemicolectomy
* BMI\> 35
Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)

This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms.

The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.


Eligibility Criteria:
Inclusion Criteria:

* Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
* IPSS\>=8
* Prostate volume \[40-80\] ml measured via transrectal ultrasound
* Peak flow rate (Qmax) \<= 15 ml / s,
* Verified obstruction by urodynamic studies (cystometry)
* Surgery not contraindicated

Exclusion Criteria:

* Prostate cancer
* Severe atherosclerosis
* Kidney failure
* Urethral stricture
* Active cystitis or prostatitis
* Bladder stone.
* Neurogenic bladder disorder
* Contrast product allergy
VEST III PMS Clinical Protocol

Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.


Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled for on-pump CABG on clinical grounds
2. Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
3. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
4. Ability to give their informed written consent
5. Ability and willingness to comply with study follow up requirements
6. Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years

Exclusion Criteria:

1. Concomitant non-CABG cardiac procedure
2. Prior cardiac surgery
3. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
4. Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)
5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest, before randomization
6. Severe vein varicosity
7. Prior debilitating stroke less than 1 year before surgery
8. Severe renal dysfunction (Cr\>2.0 mg/dL or \>177 μmol/L)
9. Women of child bearing age
10. Concomitant life-threatening disease likely to limit life expectancy to less than 5 years
11. Indication for Warfarin up to time of surgery
12. Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.
13. inability to take aspirin
14. Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
15. Inability to comply with required follow-ups including angiographic and/or CT imaging methods.
16. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer

This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is \< 3 months, and the target sample size is \< 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-80 years of age;
* rectal cancer;
* planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* previous radiotherapy or chemotherapy for colorectal cancer;
* clinically significant cardiovascular disease;
* significant gastric or small intestine disease;
* serious uncontrolled active infection
Comarum Palustre in Knee Osteoarthritis and Diabetes

The study evaluates analgesic, antiinflammatory and metabolic effects of Comarum palustre in patients with knee osteoarthritis (OA) and diabetes mellitus. Patients with osteoarthritis will receive Comarum palustre together with conventional treatment of osteoarthritis and diabetes.

Comarum palustre have been shown to exert analgesic properties in patients with knee osteoarthritis not responding to diclofenac. In animal models comarum palustre showed anti-inflammatory, immunomodulatory, analgesic, antioxidant, antihistamine, and membrane-stabilizing effects. Thus, pleiotropic properties of Comarum Palustre may provide a rationale for this use in patients having both osteoarthritis and diabetes mellitus. In this group of patients Comarum Palustre may not only relieve OA-related pain but reduce systemic inflammation, decrease progression of atherosclerosis and diabetes complications.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
* diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

* use of NSAIDs one month prior to study entry (paracetamol is allowed)
* pregnancy and lactation
* increased sensitivity to the study drug
* clinically significant renal function impairment
* use of antidepressants
* diagnosis of bipolar disorder
* use of symptomatic slow acting drugs of OA (SYSADOA) one month prior to study entry
* any condition which may lead to difficulties to participation in the study from the viewpoint of Investigator
Preventing Early Childhood Caries With Silver Diamine Fluoride

Background: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trial has been performed to study this topic. The aim of this randomised clinical trial is to assess whether 38% SDF is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth.

Methods/Design: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF is more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 2,100 three-year-old kindergarten children who are generally healthy and with parental consent will be recruited. This sample size is sufficient for an appropriate statistical analysis of superiority trial with power at 80%, allowing for a 15% drop-out rate. Stratified randomization will be adopted for the intervention allocation. The intervention is either 38% SDF or 5% NaF (as positive control) therapy on primary upper anterior teeth. Dental examination followed by fluoride therapy will be conducted every six months until 30 months in kindergartens by a single examiner. The examiner, children and children's parents will be blinded to the treatment allocation. Questionnaire survey will be conducted to study the children's oral health-related behaviours and their socioeconomic backgrounds.

Discussion: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, it will help change the standard of care that using 5% NaF for ECC prevention. In addition, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy, with parental consents

Exclusion Criteria:

* uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.
Effect of Shock Waves on Dental Parameters

This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. The hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal stability would reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding tissues.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients which don´t fulfill the exclusion criteria

Exclusion Criteria:

* diseases (syndroms, infections,...) which influence the bone turnover and blood flow
* medication, which influences the bone turnover and blood flow
* pregnancy
Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.

The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written and dated informed consent
* BMI between 19 and 27 kg/m2
* Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

* History of any clinical significant disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy

Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after thyroidectomy.

Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after thyroidectomy. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed

Eligibility Criteria:
Inclusion Criteria:

* the patients undergoing scheduled thyroidectomy
* American Society of Anesthesiologists status 1 or 2

Exclusion Criteria:

* refusal to be enrolled in the study
* emergency surgery
* hepatic or renal disease
* on chronic pain medications
* psychiatric disorders
* pregnancy, lactation
* allergy or contraindication to the study drug
Neurophysiological Correlates of Dissociation Induced by Virtual Reality Hypnosis (VRH) in a Clinical Population

Hypnosis and virtual reality are potential tools for treating acute. Nevertheless, the neurophysiological correlates of such tools used together, i.e. 'virtual reality hypnosis' (VRH) (Patterson et al., 2004) remain mostly understudied. This study aims to improve our knowledge and understanding of the dissociation (i.e., a mental separation of components of behaviours that normally would be processed together) occurring during VRH. This is a clinical trial aiming at understanding if the VRH reduces pain during a port-a-cath intervention in oncological patients and if dissociation may explain the pain alteration.

The study will be focused on oncological patients undergoing a port-a-cath placement procedure. Day-1 and Day-2 with a one-day follow-up Day-3:

I. Day-1: Oncological Population (Feasibility)

1. Recruitment and questionnaires on the day of the port-a-cath preparation consultation (DAY-1): i. A medical screening will be performed to assess eligibility, ii. Elkins Hypnotizability Scale. iii. State Trait Anxiety Inventory-trait (anxiety trait) iv. Dissociative Experience Scale. v. Tellegen Absorption Scale. vi. Questionnaire of Immersion Propensity.

II. Day-2:

1. Intervention day:

   i. Visual Analogy Scale:
   * Anxiety.
   * Pain. ii. 4-Electrodes EEG device from Oncomfort during port-a-cath (Port) placement procedure under Virtual Reality Hypnosis (VRH), combined standard monitoring (spO2, heart rate, etc.) iii. Adverse events will be recorded throughout the experiment iv. Visual Analogy Scale:
   * Dissociation.
   * Pain.
   * Anxiety
   * Absorption.
   * Arousal/wakefulness.
   * Automaticity v. Time Perception (open-ended question) vi. Presence questionnaire. vii. Satisfaction questionnaire.
2. Follow-up (DAY-3):

   i. A follow-up questionnaire using the Brief Pain Inventory (BPI) French version will be sent to the patient one week after the intervention to measure outcomes.

Eligibility Criteria:
Inclusion Criteria: Subject more than 18 years old

Exclusion Criteria:

1. Low auditory and/or visual acuity precludes the use of the device.
2. Head or face wounds precluding the use of the device.
3. Schizophrenia, dissociative disorder or any other psychiatric disorder.
4. Non-proficiency in French (Research language).
5. Patient under 18 years old.
6. Phobia of deep water.
7. Allergy to cutaneous electrodes.
8. Chronic pain and/or chronic analgesics consumption.
9. Medication affecting the autonomic nervous system.
10. Dizziness.
Clinical Evaluation of New Computerized Labor Monitoring System

The study is an open label feasibility study. The purpose of the study is to evaluate the ease of use of the Cervical ITR in terms of duration of attachment and number of detachments.

Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.

To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Eligibility Criteria:
Inclusion Criteria:

* Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
* Gestational age 37-42 weeks. (GA)
* Single fetus
* Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria:

* Women with abnormal placentation (placenta previa)
* Women with coagulation abnormalities.
* Abnormal fetal presentation (breech presentation)
* Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
* Preterm premature rupture of membranes.
* Need for immediate delivery (cord prolapsed or suspected placental abruption
Body Image and Sexuality After Bariatric Surgery

Sexual desire may decrease among obese individuals who feel worthless and therefore there may be behaviors that avoid sexuality. Sexuality, one of the activities of daily life, is an issue that is affected by cultural norms and rules and individuals have difficulties expressing their sexual problems comfortably. In a systematic review which is about the effect of bariatric surgery on sexuality; it was emphasized that bariatric surgery, the most widely used treatment in obesity, has positive effects upon reproductive hormones and sexual functions thanks to weight loss. In light of these information above-mentioned; the study was done to examine the correlation between body perception and sexual life before and after bariatric surgery among obese individuals.

Obese individuals who want to learn healthy life behaviors and wish to acquire and to realize behavioral changes that will help them cope with health problems are in need of training and counseling. In this process, nurses -being in close and continuous contact with individuals- play counselor role as a part of their educator roles. It is stated that nurses need to understand, empathize with and support individuals who suffer from different problems while they play this role. In presence of obesity, which is a psychophysiological condition; nurses should also consider the fact that obese individuals who face bitter criticisms and social exclusion may show low self-esteem and impaired body image due to excessive weight and therefore they should give these individuals opportunities to express their feelings as to how they perceive themselves. The studies in literature that investigated the correlation between body mass index (BMI) and self-esteem and body perception report that obese individuals demonstrate relatively lower self-esteem and body perception as compared to the normal individuals. Psychological and hormonal disorders, impaired body image and chronic diseases that develop with obesity influence sexual life negatively, too. Therefore; sexual desire may decrease among obese individuals who feel worthless and therefore there may be behaviors that avoid sexuality. Sexuality, one of the activities of daily life, is an issue that is affected by cultural norms and rules and individuals have difficulties expressing their sexual problems comfortably.

Eligibility Criteria:
Inclusion Criteria:

* Accepted to join the study,
* Did not have such psychiatric disorders as anxiety, depression and personality disorders
* Were aged between 18 and 65.

Exclusion Criteria:

* Do not accepting to join the study,
* Have such psychiatric disorders as anxiety, depression and personality disorders
* Older from 65, under the age of 18.
Comparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.

This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel techniques (causing least discomfort to the patients) for the detection of impaired vocal-cord movement after thyroid surgery.

In this prospective study 100 patients posted for Thyroid surgery will be included, after explaining the procedure and written informed consent, all included patients in the study will be assessed for vocal cord mobility by C-Mac video laryngoscope (manufactured by KARL STORZ Video Laryngoscopes) followed by airway ultrasonography (USG). Linear transducer (7.5 MHz) will be used for scanning the airway placed at the level of thyroid cartilage with 10-15 degree cephalad tilt so to get proper acoustic window and for optimal visualization of laryngeal structures. C-Mac video laryngoscope will be required for virtual visualization of glottis apertures and vocal cord movement. All patients will be scanned pre-operatively by indirect laryngoscopy to see vocal cord mobility as a reference value. Immediately after extubation the patient will be scanned for vocal cord mobility by videolaryngoscope by first examiner, After oxygenation and stabilization of haemodynamic, ultrasound of airway will be performed to study the vocal cord movement by the other examiner (blinded to the laryngoscopy finding).Visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. According to points the acoustic window scoring for glottis aperture will be graded as fair (score1-2), good(score3-4) and very good(score5-6) Findings of both the examiners will be collected by the primary investigator for data collection and analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patient's undergoing thyroid and parathyroid surgery.

Exclusion Criteria:

* patients not extubated.