cyrilzakka/clinical-trials huggingface dataset:
Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort

The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Age from 20 - 50 years
* ASA (The American Society of Anesthesiologists) I or II,
* undergo percutaneous nephrolithotomy (PCNL)

Exclusion Criteria:

* Patients with history of psychotic illnesses
* Opioid users
* Bladder obstruction,
* Benign prostatic hyperplasia
* Overactive bladder (OAB) defined as frequency _3 times at night or _8 times within 24 hours.
Genicular RFT vs Phenol Management in Patients With Knee Osteoarthritis

The aim of this study was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. The invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC) before, 1 and 3 months after the procedure. The procedures will be performed by applying radiofrequency waves and phenol to the genicular nerves under ultrasound guidance.

Ultrasound-guided genicular nerve ablation is a minimally invasive procedure that reduces or eliminates pain in patients with knee pain by destroying the nerves that transmit pain with heat or chemical drugs such as phenol. Genicular nerve ablation is an effective treatment option for patients with chronic knee pain who cannot undergo prosthesis surgery. In this method, radiofrequency waves or phenol are applied to the nerves going to the knee joint, preventing the transmission of pain signals to the brain.

The procedure is applied as follows:

Haemodynamic monitoring is provided. Superomedial genicular nerve (SMGS), superolateral genicular nerve (SLGS), inferomedial genicular nerve (IMGS) are the nerves to be blocked. The 8-12 Hz linear ultrasound probe is first placed superomedial to the knee and the SMGS and genicular artery are visualised at the junction of the shaft and condyle of the femur. The skin is locally anaesthetised with 2% lidocaine (2 cc) and the needle is inserted in plane with the ultrasound probe. For radiofrequency ablation The cannula placed close to the nerve is connected to the radiofrequency generator with the help of cables. At the tip of the needle, 2% lidocaine (1 cc) is administered and the nerve is heated by applying radiofrequency current. Ablation is performed at 80 °C for 1 minute. This procedure is repeated for other genicular nerves. For phenol ablation, 1 mL of 7% phenol solution is applied to cause neurolysis with the help of a needle placed close to the nerve. Phenol provides ablation by denaturing the proteins in the structure of the nerve.

Patients will be evaluated on NRS and WOMAC scales before, 1 and 3 months after the procedure. The evaluation will be done face to face and by telephone call.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
* Permanent pain for more than 6 months
* Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
* Pain with conservative methods such as analgesics and physiotherapy treatment failure

Exclusion Criteria:

* History of intra-articular knee intervention in the last 6 months
* Cognitive impairment
* Hepatic or renal insufficiency
* Severe psychiatric illness
* Local or systemic infection
* Coagulopathy
Face Mask vs Laryngeal Mask in Neonatal Resuscitation

The goal of this single-centre interventional study without medication neither device (for procedure) is to improve training of health care personnel (physicians, nurses, and midwives) on neonatal resuscitation through manikin simulation.

The main questions it aims to answer are:

* Is it possible to compare the ease of use and speed of application of the laryngeal mask versus the face mask in ventilating the newborn during simulated manikin training?
* What are the differences in the time required to achieve optimal skills in using the two masks?
* What is health care personnel's level of confidence in using laryngeal mask versus face mask?

Maintaining airways and ensuring effective ventilation are the primary goals in the neonatal resuscitation algorithm.To achieve it, there are several devices, more or less invasive, such as a face mask, laryngeal Mask or tracheal tube.Among these, Laryngeal Mask can have significant advantages, including ease of use and speed of application even if used by inexperienced health personnel after a short training program.

The protocol involves the use of a neonatal manikin, which is already in the use at our simulation center. Ventilation of the manikin will be conducted using two possible masks: a face mask and a laryngeal mask. Before the simulations begin, each participant will receive a brief introduction on the technical characteristics of the manikin and how to use the two masks. A stopwatch will be used to record the time required to achieve effective ventilation, defined by the expansion of one-third of the newborn manikin's rib cage. Consideration will also be given to whether corrective maneuvers will need to be performed during the use of each mask and the timing with which these maneuvers will be applied.

Finally, a pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare Workers (physicians, nurses, and midwives) of the Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS Rome
* Signature of an informed consent

Exclusion Criteria:

* Healthcare Workers (physicians, nurses, and midwives) NOT of the Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS Rome
* Failure to sign up for informed consent
Effect of Nitrate-rich Beetroot Juice on Exercise Performance in Heart Failure Patients

Nitrate-rich beetroot juice supplementation has demonstrated reduced oxygen consumption and submaximal exercise performance in healthy adults. Investigation for similar effects in patients with heart failure has not previously been conducted.

This was a randomized, double-blind, placebo controlled trial. Following ingestion of the active agent or placebo, subjects with systolic heart failure underwent submaximal steady state exercise with gas exchange analysis followed thirty minutes later by a six minute walk test. Second testing sessions were performed ten days.

There were no significant differences in the treatment and placebo arms in average oxygen consumption or six minute walk distance.

In conclusion, in patients with heart failure who have ingested a single dose of nitrate-rich beetroot juice concentrate, there is no significant difference with regard to oxygen consumption during submaximal steady state exercise or six minute walk testing distance.

Further study is warranted to determine the true efficacy of nitrate consumption in this population with adjustments in acute or chronic dosing, exercise duration, or intensity.


Eligibility Criteria:
Inclusion Criteria:

* Local institutional beneficiaries between the ages of 18 and 80
* Documentation of left ventricular systolic dysfunction with ejection fraction \< 40% by any modality within the past six months
* Documentation of New York Heart Association class II or III status.

Exclusion Criteria:

* \> 80 years of age
* Unable to adequately or safely perform treadmill exercise
* Pulmonary disease deemed significant enough to be a limitation to exercise
* Greater than moderate stenotic or regurgitant valvular heart disease
* Presence of atrial fibrillation or other uncontrolled arrhythmias
* Uncompensated heart failure
* Continuously paced rhythms
* Pregnant females
* Chronic nitroglycerine use (oral isosorbide di or mono-nitrate, or topical nitroglycerine)
* Phosphodiesterase inhibitor (sildenafil or tadalafil) use within a week
Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease

Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD).

This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.

In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery.

Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease requiring ileocecal resection

Exclusion Criteria:

* age \> 75 years
* age \< 18 years
* inability to give the consent to the participation in the trial
* refusal to participate in the trial after receiving accurate information
Functional and Neurochemical Correlates of Treatment Response in Major Depressive Disorder

This is an ancillary study to a clinical trial that is being conducted at Massachusetts General Hospital. Investigators at MGH are conducting a clinical trial to test the efficacy of ziprasidone together with escitalopram for treatment-resistant depression (NCT00633399). This observational study will involve magnetic resonance scans to examine brain chemistry (neurotransmitter levels), brain activity, and functional connections between brain regions before and after participating in the trial. The neurotransmitters of interest are glutamate, glutamine, and GABA. Comparisons will be made between individuals who receive ziprasidone and individuals who receive an inactive placebo. Differences between participants who respond to standard antidepressants and those who require additional medication will also be examined. All participants will have a baseline magnetic resonance scan before starting medication. The second scan will be after 8 weeks of escitalopram treatment for those who respond or following 8 weeks of escitalopram plus ziaprasidone or placebo (16 weeks after starting) for those who do not respond to escitalopram alone. Participants will complete standard rating scales for depression at each visit.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* Meets DSM-IV criteria for major depressive disorder
* Meets eligibility criteria for clinical trial of ziprasidone augmentation of escitalopram
* Capable of providing informed consent

Exclusion Criteria:

* Meets exclusion criteria for augmentation clinical trial protocol
* Pregnancy or unwillingness to avoid pregnancy during trial
* Current or past psychosis or bipolar disorder
* Substance abuse or dependence in the past six months
* Clinically significant suicidality
* Unstable cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizures
* Use of a concomitant medication that acts on glutamate or GABA neurotransmission
* Contraindication to magnetic resonance imaging (metal implant or device, occupational metal exposure, significant claustrophobia)
Calcinosis in a Single-Center Scleroderma Population

This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis

2) to identify common complications associated with scleroderma-related calcinosis.

.

This is a prospective study of scleroderma- spectrum patients focused on soft tissue calcinosis in order 1) to better understand the risk factors (including clinical/laboratory characteristics, and serology) of calcinosis in the scleroderma-spectrum disorders (limited or diffuse systemic sclerosis with or without overlap of inflammatory arthritis and/or myositis).

2) view common complications associated with calcinosis.

Better understanding of scleroderma calcinosis would lead to other studies that eventually will define better treatment options for this incurable and often disabling complication.

Eligibility Criteria:
Inclusion Criteria:

* Adult scleroderma subjects with and without calcinosis

Exclusion Criteria:

* Subjects unwilling to participate
ERAS Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery

Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. The purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. The investigators plan to compare the feasibility, clinical effectiveness, and cost savings of an ERAS program with traditional treatment program at a major teaching hospital in China.The investigators will apply ERAS plan or traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively. And data Compare the two programs about the incidence of postoperative complications, postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.

Major colorectal surgery usually requires a hospital stay of more than 12 days. Inadequate pain management, intestinal dysfunction and immobilisation are the main factors associated with delay in recovery. This study aims to assess the short and medium term results achieved by an enhanced recovery program based on previously published protocols. This prospective study will be performed at a major hospital in China, involved 200 patients. All patients underwent elective colorectal resection for cancer are divided into enhanced recovery program group or conventional treatment group. The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. Perioperative morbidity and mortality data will be collected and the length of hospital stay and protocol compliance recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Elective laparotomy or laparoscopic intestinal surgery.
2. Age ≥ 18 years old.
3. ASA grade II - IV.
4. General anesthesia.

Exclusion Criteria:

1. Patients with cognitive dysfunction and uncooperative subjects.
2. Failure to obtain informed consent
Clinical Trial of Remote Preconditioning in Patients Undergoing Cervical Decompression Surgery

The purpose of this study is to assess whether a large clinical trial testing the effect of RIPC on neurologic outcome in patients undergoing elective cervical decompression surge is warranted.

Spinal cord ischemia-reperfusion injury commonly contribute to perioperative morbidity and mortality after elective cervical decompression surgery.Remote ischemic preconditioning(RIPC)is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide system protection from prolonged ischemia.The hypothesis of this protocol is that limb ischemic preconditioning could reduces spinal cord ischemia-reperfusion injury induced by elective cervical decompression surgery.Serum s-100B and NSE concentration will be measured before and after induction ,and at 6 hours,1,3,5 and 7days after surgery.JOA scores in all the cases will be evaluated before operation and at 7days ,1,3,6 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical and radiological signs of cervical compression myelopathy(ccm)
* Age 30-75
* Stage 1-2

Exclusion Criteria:

* Age\>75
* History of heart,hepatic,renal or pulmonary disease.
* History of peripheral vascular disease affecting the upper limbs.
Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed

The knowledge of encephalitis associated with antibodies targeting intracellular antigens, and neuronal surface antibody syndromes has expanded considerably in recent times.

The primary purpose of the investigators protocole is to determine the incidence of anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal epilepsy of unknown cause to guide the management of these patients.

The investigators hypothesis is that dysimmune encephalitis is more common than is suggested by the current literature, and that sometimes forms of encephalitis dysimmune "at minimum" can be observed only in the form of focal epilepsy without further manifestation associated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-65 years
* Presenting focal epilepsy on the following arguments

  * Crisis with clinical symptoms indicating focal seizure
  * \& / Or crisis or critical focal inter-recorded on EEG interpreted by a neurologist with expertise in the field of epilepsy.
* Having not yet received a CSF analysis
* From unknown cause:

  * No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts.
  * No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG.
  * No argument for metabolic or neurodegenerative genetic epilepsy.
  * Normal neurological examination.
* Epilepsy that started within a period of two years preceding the study entry (including vegetative symptoms of temporal focal seizures).
* Without treatment or as benzodiazepines or taking anti-epileptic first-line monotherapy (excluding benzodiazepines).
* Informed consent signed
* affiliated with a social security scheme

Exclusion Criteria:

* structural abnormality found in brain MRI (except temporal hyperintensity and / or sclerosis of the hippocampus).
* Background Neurological: hyperthermic seizures in childhood, neonatal distress, history of seizures related to a circumstance, inflammation or infection of the CNS.
* Taking toxic: chronic alcoholism, narcotic consumption
* The case for a genetic / metabolic neurodeg ear /: generalized EEG / photosensitivity / family history of epilepsy / autism / disorder syndrome psychomotor development / dysmorphic syndrome / extrapyramidal syndrome associated discharge
* History of thyroiditis or m. system (LEAD, SGS, PR, Sarcoidosis)
* Immunosuppression innate or acquired
* IC lumbar puncture or have already received a lumbar puncture before inclusion in the protocol.
* Person under supervision or guardianship.
Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas

To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.


Eligibility Criteria:
Inclusion Criteria:

1. The study will include three primary cohorts, with any of the following EBV+ diseases:

   Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.

   Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.

   Cohort C - PTLD, rituximab treatment failure.
2. Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
3. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
4. Absolute lymphocyte count (ALC) \>500/µL
5. Male or female ≥ 12 years of age
6. Weight ≥ 35 kg
7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
8. Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.

Exclusion Criteria:

1. Known central nervous system (CNS) lymphoma
2. Primary refractory HL or DLBCL
3. Bulky disease
4. Relapse or progression following previous autologous EBV specific T cell treatment.
5. Use of systemic corticosteroids \> 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
6. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
7. Patient is pregnant or lactating
8. Systemic fungal, bacterial, viral or other infection that is not controlled
9. Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
10. Known history of primary immunodeficiency
Are Post-operative Antibiotics Indicated in Simple Appendicitis?

Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime in preventing post-operative complications in paediatric patients with simple appendicitis.

This project will compare patients 16 years and under with simple appendicitis (appendicitis that is not perforated or gangrenous). Patients will be randomly divided into two groups;

* Group one will receive a single pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two 'doses' of normal saline (placebo) eight and sixteen hours after the initial dose, respectively.
* Group two will receive one pre-operative dose of antibiotics (metronidazole 12.5mg/kg up to 500mg and cefazolin 25mg/kg up to 1g) and two post-operative doses, eight and sixteen hours after the first dose, respectively.

Group allocation will be concealed from the patient and their guardian, the treating surgical team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if required will be in place.

The aim of the study is to determine if a single dose of antibiotics is as effective as three doses in preventing post-operative infection. This will be assessed by comparing:

* Duration of hospital stay from operation until discharge, based on a standardised discharge criteria.
* Development of wound infection or requirement of antibiotics in the six weeks post-operation
* Need for re-admission.

Information will be collected prospectively from each patient's hospital notes and from a follow-up phone call six weeks after the operation.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have their appendix removed and are found on operation to have 'simple appendicitis' as defined in the Cochrane review\[7\]. That is an appendix that is non-inflamed, acutely inflamed, phlegmonous, suppurative or mildly inflamed.

Exclusion Criteria:

* Patients who on operation are found to have 'complicated appendicitis' defined as an appendix that is gangrenous or perforated.
* Patients who pre-operatively appear to be acutely septic or for another reason require extended antibiotic therapy.
* Patients who, at operation, are found to have other pathology e.g. Meckel's Diverticulum, Intussusception; requiring surgical or medical intervention.
* Any patient whose guardian does not wish for them to participate in the study.
* Patients who have additional co-morbidities, including diabetes, immuno-suppression, cardiac, renal or liver failure.
* If the child continues to show sign of sepsis, in terms of fever, tachycardia, he/she will be discontinued from the study and be given additional doses of antibiotics, as clinically indicated.