cyrilzakka/clinical-trials huggingface dataset:
Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain

Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of dexmedetomidine (DEX) in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation.

Objective: To investigate the per-operative effects of DEX preemptive analgesia.

Method:The patients scheduled noncardiac surgery undergoing general anesthesia were selected and divided into DEX group and Placebo group randmized. The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and 15min after induction. The Placebo group was infused with equal amounts of normal saline.The Coprimary efficacy outcome was a composite of analgesia effect, one is the Compliance Rate of IOC2 target in intra-operation, another is the the rate of none-to-slight post-operative pain assessed with the p-NRS≦3 at 12 hours after surgery \[Pain numeric rating scale was assessed with the (Numeric Rating Scale, p-NRS)\].

Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of DEX in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation.

Objective: To investigate the per-operative effects of DEX preemptive analgesia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years to 85 years old,
* body mass index (BMI,calculated as weight in kilograms divided by height in meters squared): 18.5\~35.
* ASA (American Society of Anesthesiologists) Grade I- III;
* Scheduled for non-cardiac surgery undergoing general anesthesia
* expected duration of operation 0.5\~3 h.

Exclusion Criteria:

* disagreed to participate;
* body mass index (BMI) of greater 35
* American Society of Anesthesiologists (ASA) classification 4 or above;
* previous severe central nervous systemheart, liver, kidney or and lung dysfunction ;
* diagnosed neuropsychological disorders, that is, schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis，Alzheimer's disease and other autonomic disorders of patients affecting EEG outcomes;
* comatose, dementia, or language barrier which impeded communication and assessment;
* history of neurosurgical procedures;
* Systolic blood pressure continuously lower than 85mmHg or higher than 180mmHg; heart rate continuously lower than 45 times / min; sever arrhythmia need intervation and implantable pacemaker.
Effectiveness of the Addition of the Kinesio Taping Method to Conventional Physical Therapy Treatment in Patients With Chronic Nonspecific Low Back Pain

The purpose of this study is to determine the effectiveness of the addition of the use of Kinesio Taping in patients with chronic nonspecific low back pain who receive conventional physical therapy.

One hundred and forty-eight patients will be randomized to receive either conventional physical therapy, which consist of a combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization (Conventional Physical Therapy Group) or to receive conventional physical therapy plus the addition of the Kinesio Taping in the lumbar spine (Conventional Physical Therapy plus Kinesio Taping), over a period of 5 weeks (10 sessions of treatment).

Clinical outcomes (pain intensity, disability and global perceived effect ) will be collected at baseline and at 5 weeks, 3 and 6 months after randomization. Data will be collected by a blinded examiner who will be unaware about the group allocation. All statistical analysis will be conducted following the principles of intention to treat analysis and the between-group differences will be performed using Mixed Linear Models.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific low back pain longer than 12 weeks
* Seeking care for low back pain

Exclusion Criteria:

* Contra indications to physical exercise
* Serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases)
* Nerve root compromise
* Contra indications to the Kinesio Taping (e.g. intolerance to tapes, band aids etc)
* Pregnancy
* Severe cardiorespiratory conditions
Span-C-SBRT for Pancreatic Cancer

To assess the freedom from local failure at 12 months after Stereotactic Body Radiotherapy (SBRT). Also to assess the safety, efficacy and feasibility of SBRT in the treatment of high risk localised pancreatic cancer.

Patients must have histologically or cytologically confirmed high risk localised adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced pancreatic cancer as defined by Australasian Gastro-Intestinal Trials Group (AGITG) guidelines. ECOG performance status 0-1, suitable for chemotherapy and radiotherapy.

After a minimum of 2 months of neoadjuvant chemotherapy using either an oxaliplatin- based regimen (FOLFOX, FOLFIRINOX, mFOLFIRINOX)+/- immunotherapy/molecular agent or gemcitabine based chemotherapy (eg gemcitabine / gemcitabine/abraxane). Participants will receive SBRT (30-45Gray in 5 fractions over 2 weeks. Prior to SBRT, fiducial markers will be placed to aid with image guidance during radiation delivery. Four weeks after completion of SBRT participants will have re-staging using positron emission tomography (PET) and computed tomography (CT) scan. Participants will be discussed in the multidisciplinary team meeting for consideration of surgery. Those considered to be resectable will proceed to have surgery 6-10 weeks post SBRT.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and able to give informed consent
* Patients with histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced as defined by AGITG guidelines
* ECOG performance status 0-1
* Measurable disease as defined by RECIST 1.1
* Have received or plan to receive chemotherapy
* Successful insertion of fiducial markers

Exclusion Criteria:

* Patients with metastatic pancreas cancer
* Prior abdominal radiotherapy
* Active malignancy excluding non melanomatous skin cancer
* Neuroendocrine pancreatic carcinoma
* Pregnant or lactating women
* Tumour size greater then 70mm
* Age \>85
Effect of 24 h Severe Energy Restriction on Appetite Regulation and Ad-libitum Energy Intake

Long term maintenance of weight loss is generally poor, which is at least partly due to increased feelings of hunger associated with restricting what can be eaten. Intermittent severe energy restriction is a novel dietary strategy that requires individuals to consume a very-low energy diet for 1-4 days per week, allowing normal feeding patterns to be adopted on the other days in the week. However, the effect of a consuming a very-low energy diet on appetite regulation, which might represent a key marker of long-term adherence to dieting, has not been determined. This study aimed to assess the effects of severely restricting energy intake for 24 h on markers of appetite regulation, energy balance and metabolism compared to an adequate energy trial.


Eligibility Criteria:
Inclusion Criteria:

* non-smoker, not currently dieting, weight stable for \>6 months (self-reported), no known history of cardiovascular or renal disease.

Exclusion Criteria:

* food allergies, dislike or intolerance of study foods and drinks, irregular eating patterns, use of medication that could influence hormone concentrations, excessive alcohol consumption (\>4 units/day), intensive training schedule (\>10 h/week)
Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated With PCI

Randomized Controlled Trials of Electro-acupuncture Effects on Perioperative Anxiety in Patients Treated with PCI


Eligibility Criteria:
Inclusion Criteria:

* The main inclusion criteria were patients who underwent coronary angiography. Patients suffer from Generalized anxiety disorder(GOD).

Exclusion Criteria:

* The exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.
Laryngeal Disorders and GERD in Assiut University

Study laryngeal disorders by laryngoscopic examination by two physicians on GERD patients diagnosed by gastroenterology department by endoscopy and effect of GERD treatment for 3 months on these laryngeal disorders without any treatment to laryngeal disorders


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed GERD by gastroenterology department before start of treatment and have laryngeal symptoms

Exclusion Criteria:

* voice abusers as singers ,teachers and readers.
Myocardial Protection in Minimally Invasive Mitral Valve Surgery

Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest.

Aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair.

A single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Surgical indication for mitral valve repair.
* Right mini-thoracotomy approach.
* Retrograde arterial perfusion.

Exclusion Criteria:

* Age more than 75 years.
* Cardiac ejection fraction lower than 40%.
* Previous cardiac surgery procedures for coronary artery bypass graft.
* Any degree of coronary artery disease.
* Severe peripheral vascular disease.
* Concomitant procedures for atrial fibrillation ablation.
Effectiveness of Sitagliptin in Glycemic Control in Real World

This study will evaluate whether the addition of sitagliptin treatment provides additional decrease in HbA1C levels and increase in goal attainment in patients with inadequate glycemic control on their current oral anti-glycemic therapy in real world practice.

To explore the change of glycemic control (HbA1c or FPG) before and after 24 weeks of Sitagliptin treatment in Type 2 Diabetic patients who have started Sitagliptin as add on therapy during the index period and received Sitagliptin continuously\* for at least 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects diagnosed of type 2 diabetes (ICD-9 code= 250.0; 250.1; 250.2; 250.3; 250.4; 250.5; 250.6) and have been followed up regularly in the study center who have started to receive Sitagliptin as an add-on treatment to their prior regimen during the index period
2. Subjects must be on a stable dose of all antidiabetic regimens, with stable dose defined as "at least 3 months with no therapy/dose change" prior to adding sitagliptin
3. Subjects in whose medical records a minimum core data set can be found.
4. Outpatient

Exclusion Criteria:

1. Subjects with type 1 DM
2. Subjects have been treated with insulin regularly
3. Subject with DM which results from other general diseases, e.g. surgery, pharmaceutical products, malnutrition, infections and other conditions
4. Subjects who participated in a clinical trial or other clinical study during the index period
Deformity of the Forefoot in Children With Unilateral Cerebral Palsy

Midfoot and backfoot deformities are well described in children with Cerebral palsy. However, data regarding forefoot deformities in Cerebral palsy remain scarce in a population were foot deformities are the most frequent musculo-skeletal deformities.

Foot deformities are the most frequent musculo-skeletal deformities in children with Cerebral palsy. Pain starts in the foot, especially during gait in Cerebral Palsy Children (GMFCS I and II) and induce gait limitations, balance disorders, wounds, aesthetic disorders and difficulties to support shoes.

Metatarsus Adductus is the most common foot deformity in children with or without disorder, occuring on 1-2/1000 births. In 4 to 14% of the children, evolution is not favorable at 5 years. In that case, the diagnostic of Cerebral palsy have to be considered.

Eligibility Criteria:
Inclusion Criteria:

* Child who benefit a standardised clinical evaluation before a 3D Gait Analysis with forefoot deformity measure
* Child age less than 18 years old
* Child with left or right unilateral cerebral palsy
* Walking child ( GMFCS score I, II or III)
* In case of several 3D Gait Analysis for the child: the 3D gait analysis was chosen first before any local spasticity treatment with botulinic toxin injection or the 3D gait evaluation the more far from local spastica treatment with botulinic toxin injection was chosen in second .

Exclusion Criteria:

* Hemiplegia due to another etiology
* History of lower limb or foot surgery before the clinical evaluation
* Local spasticy treatment with botulinic toxin injection less than 3 months before the clinical evaluation
* Participation refusal
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."


Eligibility Criteria:
Inclusion Criteria:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.
Effectiveness Evaluation of 'The Endeavour Programme'

This study aims to evaluate the effectiveness of Dialectical Behaviour Therapy for adults with Borderline Personality Disorder attending Community Mental Health Services in Cork, Ireland.

The main objective of the current study is to determine if completion of a 12 month DBT programme is associated with improved outcomes in terms of borderline symptoms, anxiety, hopelessness, suicidal behaviour, depression and quality of life.

A secondary objective includes assessing client progress across multiple time-points throughout the treatment.

Dialectical Behaviour Therapy (DBT) is noted to be an intervention with a growing evidence base which demonstrates its effectiveness in treating individuals with Borderline Personality Disorder (BPD). Nine randomised controlled trials have been completed at six independent sites. These trials have found a reduction in suicidal behaviours, intentional self-injury, depression, hopelessness and other difficulties associated with this mental health diagnosis.

While the efficacy of DBT has been demonstrated through multiple RCTs, few studies have examined the effectiveness of DBT in community mental health settings. In particular, no study to our knowledge has evaluated the standard 12-month DBT programme for adults with BPD in an Irish community setting. "Standard" DBT is delivered by a team of multidisciplinary mental health professionals, and comprises of individual therapy sessions for each patient, group skills training sessions, phone coaching and consultation meetings for the clinicians on the DBT team.

The current study thus aims to evaluate the effectiveness of the standard 12-month DBT programme (The Endeavour Programme) in an Irish community setting.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria for diagnosis of either Borderline Personality Disorder (DSM IV/V) or Emotionally Unstable Personality Disorder (ICD-10)
* Current emotion and behavioural dysregulation
* A history of self-harm behaviour
* The client will have discussed the diagnosis with a member of the DBT team and will have expressed an interest in, and commitment to the 12 month programme.

Exclusion Criteria:

* An active psychosis
* If the client has severe developmental delays, cognitive impairment or learning disabilities (exceeding mild range)
* If a clients' substance/drug dependence, eating disorder or any other mental health issue/behaviour is at such a level that it would impede their engaging with any of the modalities of DBT
Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty

The goal of this observational study is to asses the natural course of blood homocysteine levels in patients who underwent primary total joint arthroplasty surgery. The main question\[s\] it aims to answer are:

* İs homocysteine a good marker for determining periprosthetic joint infection ?
* İs homocysteine more sensitive marker for periprosthetic joint infections ?


Eligibility Criteria:
Inclusion Criteria:

* People who have undergone Total Knee Arthroplasty operation
* People who have undergone Total Hip Arthroplasty operation

Exclusion Criteria:

* People who have undergone total knee arthroplasty operation and developed a periprosthetic joint infection
* People who have undergone total hip arthroplasty operation and developed a periprosthetic joint infection
Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL)

An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent from patient and/or legally acceptable representative has been obtained
* Outpatients of any sex or ethnic origin
* Patients \>= 2 years of age (depending on study step)
* Patients must be suffering from primary bullous/non-bullous impetigo or SITL

Exclusion Criteria:

* Presence of skin diseases at or near the investigational area
* Immunosuppressed state or other serious systemic disease
* Signs and/or symptoms of systemic infection
* Presence of skin infection/disorder not amenable to topical antibacterial treatment only
* Presence of secondarily-infected animal/human bite
* Presence of secondarily infected burnwound
* Topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs
* Known or suspected hypersensitivity to TD1414 or any of the excipients in the TD1414 2% cream
* Known or suspected hypersensitivity to mupirocin or any of the excipients in the Bactroban® (mupirocin) 2% cream
* Participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation
* Patients previously enrolled/randomised in this study
* Abnormal ECG at baseline though the PR interval may be up to 220 ms, the QRS interval up to 110 ms and the QTc interval up to 450 ms
Cyclic Versus Continuous Sacral Neuromodulation for LUTS

This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) for OAB.

Overactive bladder (OAB) is characterized by urinary frequency, urgency, incontinence, and nocturia in the absence of other pathology. AUA guidelines recommend trial of sacral neuromodulation (SNM) for patients with refractory OAB who have failed treatment with behavioral modification and medication. SNM settings are typically selected based on discussion between the patient and device representative. There is a paucity of rigorous data assessing optimal SNM stimulation programming for symptomatic improvement.

This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) in patients undergoing SNM for OAB.

Patients \> age 18 with a diagnosis of refractory OAB being scheduled for a trial of SNM (either stage I lead/temporary battery placement or office peripheral nerve evaluation) will be approached by study personnel during their clinic visit or by a phone call to determine if they are interested in participating in the programming study.

Patients interested in participating will provide written informed consent. After informed consent is obtained, a baseline evaluation will be performed. This includes history, 3-day voiding diary (# voiding episodes, # nocturia episodes, # urge incontinence episodes/24h), urinalysis, urine culture (if indicated), post void residuals, and symptom assessments using questionnaires.

Only those with successful trial and eligible/ interested in permanent SNM placement will participate in this trial. Randomization will occur after stage 2/ full permanent implantation when the neuromodulator is being programmed in the recovery room. Patients will be randomly assigned to either continuous stimulation or cyclic stimulation.

Patients will then be followed with clinical evaluation and questionnaires repeated at 1 month, 6 months, 12 months, 3 years, and 5 years post-op.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Female
* English Speaking
* Diagnosis of urinary urge incontinence or overactive bladder
* Meet criteria for and are planning permanent SNM (ie. successful stage I or office PNE trial of SNM with 50% or more reduction in UUI episodes)
* Willing and able to complete all study related items

Exclusion Criteria:

* Patients less than 18 years of age
* Unable to provide consent
* Non-English speaking
* Relevant neurologic diseases (multiple sclerosis, Parkinson Disease, myasthenia gravis, - - - Charcot-Marie-Tooth disease, complete spinal cord injury)
* Current or prior bladder malignancy
Comparison of Two Therapeutic Strategies of Dermoval in Treatment of Bullous Pemphigus

to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18
* immunoflurescence, histological exam, predictive value according to bullous pemphigus diagnostic
* consentment patient

Exclusion Criteria:

* age \< 18
* no consentment
* localized bullous pemphigus (\<400cm2)
* linear IgA pemphigus
* corticothérapy, immunotherapy
* pregnant woman pemphigus