cyrilzakka/clinical-trials huggingface dataset:
Co-induction Ketamine-propofol: Effects on Laryngeal Mask Airway Insertion Conditions in Children

Background: Large doses of propofol needed for induction and laryngeal mask (LM) insertion in children may be associated with hemodynamic sides effects. Co-induction with low doses of ketamine 0.5 mg/ kg has the advantage of reducing dose and therefore maintaining hemodynamic stability.

Aim: To examine the effect of co-induction on LM insertion, hemodynamics and recovery in children

A prospective, randomized, double-blind, controlled study was conducted including120 ASA physical status I ⁄ II unpremedicated children, aged 1-8 years. Inhalatory induction with sevoflurane at 7% to insert an intravenous canula was first used then decreased to 2%. Normal saline or ketamine (0.5 mg/kg) were administered in groups P (propofol), PK (propofol-ketamine) respectively, 1 min prior to the administration of the induction dose of propofol. Propofol 3mg/kg was used for induction in the 2 groups, LM inserted 60 s later and insertion conditions assessed. Heart rate and blood pressure were recorded immediately after propofol bolus, then after LM insertion, at the 3rd ,5th and 10th minutes later. Recovery was assessed using Steward's Score

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status I and II
* unpremedicated
* ambulatory surgery

Exclusion Criteria:

* surgery complication
* upper air way complications
The Role of Rotator Interval Closure in Bankart Lesion Repair

The null hypothesis is that there is no statistical difference between the two treatment groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion repair with rotator interval closure will have lower quality of life and less external rotation compared to patients who undergo a Bankart lesion repair alone. No difference will be observed for recurrence rate between the two treatment groups

Research assessing the role and effectiveness of rotator interval closure is important to attempt to determine the most beneficial and efficient treatment for Bankart lesions and anterior shoulder instability. To date there is only weak evidence supporting the superiority of Bankart lesion repair in addition to rotator interval closure compared to Bankart lesion repair alone.

Does Bankart lesion repair with rotator interval closure result in differences in quality of life, range of motion and recurrence at 3 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years in similar patients with Bankart lesions who are treated with Bankart lesion repair alone?

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 15 to 50 years
* At least one episode of demonstrated dislocation
* Bankart lesion of the anterior glenoid labrum
* Absence of other capsular and tendon injuries
* Absence of glenoid fractures or divots

Exclusion Criteria:

* Posterior instability or the need for posterior surgical reconstruction
* Significant bone lesions greater than 3mm of the humeral head anterior-to- posterior (Hill-Sachs lesions)
* Presence of other pathologic conditions of the shoulder (excluding SLAP lesions)
RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

The mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy may fail in 15-25% of patients. The self-expandable metal stent has been described in case series as having a very high efficacy at control of haemorrhage from oesophageal varices when used as rescue therapy. This randomised controlled trial aims to assess for any potential superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy for bleeding oesophageal varices.

Despite improvements in recent years, mortality from variceal bleeding remains significant. The routine use of banding ligation, vasoactive drugs, and antibiotics has had an impact on survival rates such that survival rates of patients with Childs-Pugh A and B class cirrhosis may be as high as 90% at 30 days. However, the successful outcome of variceal bleeding is compromised in some patients because of initial failure to control bleeding or early re-bleeding, both of which have a significant impact on mortality.

The SX-Ella Danis stent (Ella-CS, Hradec Kralove, Czech Republic) is a removable, covered, self-expanding mesh-metal stent (SEMS) that can be deployed in the lower oesophagus over an endoscopically placed guidewire without radiological screening. The stent controls bleeding by tamponade of varices in the lower oesophagus.

The series reported to date suggest that the self-expandable covered stents can provide 100% haemostasis rates when applied for refractory oesophageal variceal bleeding. Given the potentially lower risks of re-bleeding and safe, easy insertion techniques the self-expandable covered stents may offer a superior alternative to standard endoscopic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Arm 1: Participants with Child-Pugh grade B or C cirrhosis with variceal haemorrhage, where the bleeding is from a site which would ordinarily be treated with band ligation . The diagnosis of cirrhosis may be proven by previous histology or suspected using clinical, radiological and biochemical data.
* Arm 2: Participants with Child-Pugh grade A, B or C cirrhosis who present with failure to control bleeding within 5 days of an initial attempt at standard endoscopic therapy of acute haemorrhage from a site which would ordinarily be treated with band ligation.

Exclusion Criteria:

* \< 18 Years of age
* Child-Pugh grade A cirrhosis (for Arm 1 only)
* Varices which would not be treated with band ligation as standard therapy
* Non-cirrhotic portal hypertension
* Malignancy of the oesophagus, stomach or upper respiratory tract
* Oesophageal stenosis which prohibits endoscopy
* Recent oesophageal surgery
* A large hiatus hernia which prevents stent placement
* Known hepatocellular carcinoma considered to be incurable (according to Milan Criteria)
* Patients in the terminal phases of hepatological or other disease
* Pregnancy
Cardiotoxicity of Carbon Monoxide in Patients Treated With Hyperbaric Oxygen Therapy

Carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. Its toxicity is based on the CO binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and ischemia-reperfusion injury.

This study aims to investigate the early and late cardiologic effects of CO in patients treated with hyperbaric oxygen (HBOT) for CO poisoning

This is a single-center retrospective study on health data. The methodology includes a collection of data on health and history data of patients treated by HBOT fo CO poisoning between 01/01/2015 and 31/12/2021 and carrying out a telephone interview of patients who have had early cardiovascular manifestations of CO poisoning.

One month between the start of theses interviews, an information letter on the study is sent by post, giving the possibility of opposing it.

Eligibility Criteria:
Inclusion Criteria:

Patients treated for CO poisoning with HBOT in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2021/12/31

Exclusion Criteria:

* refusal
A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase

This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).


Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status of ≤ 2 and life expectancy of ≥ 12 weeks.
* Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists. Only patients with tumors characterized by genetic abnormalities in ALK were enrolled.
* For NSCLC, an ALK translocation must be detected by FISH in ≥ 15% of tumor cells.
* In patients with diseases other than NSCLC, ALK translocation is not required and overexpression of ALK protein may be considered indicative of a genetic abnormality in ALK.
* Patients with measurable or non-measurable disease as determined by modified RECIST version 1.0 in dose-escalation phase, and patients with at least one measurable lesion as determined by RECIST 1.0 in expansion phase.

Exclusion Criteria:

* Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or required increasing doses of steroids to control their CNS disease were excluded.
* Patients with a prior or current history of a second malignancy, impaired GI function, history of pancreatitis or increased amylase or lipase, known diagnosis of HIV, and clinically significant cardiac disease were excluded.
* Patients treated with chemotherapy or biologic therapy or other investigational agent \< 2 weeks prior to starting study drug for compounds with a half-life ≤ 3 days, and \< 4 weeks prior to starting study drug for compounds with a prolonged half-life were excluded.
* Further, patients treated with medications that were known to be strong inhibitors or inducers of CYP3A4/5 that could not be discontinued at least a week prior to start of treatment with LDK378 and for the duration of the study were also excluded.

Other protocol-defined inclusion/exclusion criteria may apply
JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine.

The guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs.

To address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more personalized approach to cardiac surveillance. Participants will be classified based on their risk of heart problems: low or intermediate. Instead of testing every patient every three months, those in the intermediate group will be tested every 4 months, and those in the low-risk group will be tested every 6 months. The researchers will compare this new approach to the current system to see if fewer tests are just as safe and effective.

The researchers will measure heart health, how well cancer treatments are completed, and how patients feel about having fewer tests. If this new approach works, it could save money and reduce the burden on female patients without risking their health.


Eligibility Criteria:
Inclusion Criteria:

1. Stage 1-3 breast cancer (BC).
2. Age 18-79 years.
3. HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.

Exclusion Criteria:

1. Distant metastases detected clinically, radiographically, or histologically
2. Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)
3. Pre-existing cardiovascular disease, defined as:

   1. Prior myocardial infarction (even if LVEF has normalized)
   2. Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)
   3. Baseline LVEF \<55%
   4. Atrial fibrillation
   5. Greater than moderate valvular disease (i.e., severe, or moderate-severe)
4. Cumulative anthracycline exposure ≥250mg/m2 before starting HER2TT
5. New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score \>2\*
6. Symptoms potentially due to serious cardiac disease as per investigator's judgement\* \*Exclusion criterion adopted as they make clinical assessment less reliable to detect emergent HF.
This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery

The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial will be chest tube output at 24 hours. In addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 - 85 years of age, inclusive
* Willing and able to provide informed consent
* Elective primary coronary artery bypass graft (CABG) requiring cardiopulmonary bypass, isolated valve repair, or isolated valve replacement surgery, or combined single valve plus CABG.

Exclusion Criteria:

* Emergency surgery (\< 12 hours from determination of need for surgery)
* Significant other concomitant surgery (including, but not limited to, multiple valve replacement, CEA, planned circulatory arrest, etc.)
* LVEF \< 25 %
* Preoperative use of inotropes
* Preoperative intraoartic balloon pump (IABP)
* Renal dysfunction: Serum Creatinine \>140 μmol/L
* Hepatic dysfunction: AST or ALT \> 2.5 x upper limit normal; or otherwise known hepatic disease
* Preoperative Hb \< 100 g/L
* Platelet count \<100,000/mm3,
* INR \> 1.3; PTT \> 38 sec (with the exception of patients receiving preoperative heparin)
* History or family history of bleeding disorder
* Patients currently receiving: Eptifibatide (Integrilin) within 12 hours Danaparoid, Enoxaparin sodium (Lovenox) or other low molecular weight heparin within 24 hours ,Clopidogrel (Plavix) within 7 days ,Warfarin (Coumadin) within 5 days, Ticlopidine (Ticlid) within 7 day
* Dermatological syndromes with pruritus
* Planned neuraxial anesthetic technique
* Receipt of an investigational drug or device, within 30 days prior to study treatment
* Pregnant or breast feeding females
Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment

Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.

The study was submitted to Health Canada and received the letter of no objection. A randomized, double-blind, placebo-controlled study. The randomization scheme will be prepared and will be done by the pharmacy department at McMaster University. Ninety patients undergoing primary knee arthroplasty will be recruited from the preoperative clinic. Forty-five patients in each population will be allocated to a gabapentin group and the other forty-five to a placebo group.

Eligibility Criteria:
Inclusion Criteria:

* participants aged 19-90
* elective single joint, primary total knee arthroplasty
* use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist

Exclusion Criteria:

* bilateral total knee arthroplasty
* revision knee arthroplasty
* underlying disease of epilepsy, seizure, or chronic pain syndrome
* active gastrointestinal bleeding within the last 6 months
* history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
* known or suspected history of drug or alcohol abuse
* participant currently takes gabapentin or pregabalin for any reason
* participant currently takes pain medication that is more potency than codeine or oxycodone (morphine, hydromorphone, meperidine, methadone, fentanyl, including any long acting narcotics)
* known allergy to study medications: gabapentin, morphine, NSAID, acetaminophen
* unable to tolerate morphine
* liver impairments
* kidney impairment or calculated creatinine clearance by Cockcroft-Gault formula is \<=60ml/min
* pregnancy or breast-feeding
* participant currently receives associated worker's compensation benefits (WSIB)
* participant unable or unwilling to give written or informed consent
* unable to use PCA
Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain

This is a clinical research trial to evaluate the efficacy of delivering exercise therapy for knee pain via the Internet utilizing an algorithm designed to adjust a home exercise program based on user input. The investigators hypothesize that exercise therapy can be delivered safely and effectively with increased participant satisfaction compared to the current standard.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64 with anterior knee pain
* Have computer access
* Cleared for exercise by a medical professional, if not possible or a medical professional on the study team over the phone and the PAR-Q (Physical Activity Readiness Questionnaire)
* Have consented to participate in the trial

Exclusion Criteria:

* Age \< 18 or \> 64
* Screened as unsafe for exercise by a medical professional or the, study team and/ or Screened out by the PAR-Q
* Does not consent to the trial
The Effect of Therapeutic Treatment on Stress and Coping Stress

Nursing students are exposed to intensive theoretical and clinical applications throughout their academic education. During this educational process, students' stress increases and their coping behaviors are affected.

This study was conducted to determine the effects of therapeutic touch applied to nursing students on stress levels and coping behaviors. The nurses in the intervention group were given therapeutic touch for 15 minutes once a week for two weeks, and the patients in the control group did not receive any treatment other than their routine care.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18, Maximum age 24 Volunteer to work, Nursing students who had not received touch therapy before were included in the study.

Exclusion Criteria:

* • Previous or current tactile therapy,

  * A therapeutic touch therapist,
  * Nursing students who did not volunteer for the study were not included in the study.
A One-year Trajectory of Depression Status Changes in Older Adults With MCI and SD: a Longitudinal Cohort Study

The purpose of this study is to investigate the one-year trajectory of changes in depression status in older adults with mild cognitive impairment and subthreshold depression, and to explore relevant risk factors for predicting changes in depression status. This one-year prospective longitudinal follow-up study involved 400 (expected) subjects who met the diagnostic criteria for mild cognitive impairment combined with subthreshold depression in older adults, and their depressive status was assessed using the Geriatric Depression Scale (GDS). Follow up monitoring of depression status at 6 and 12 months. Obtain factors related to changes in depressive status (such as age, gender, education level, cognitive function, anxiety level, sleep status, social support, psychological resilience, social network, etc.). By studying the longitudinal trajectory of depression status in elderly patients with mild cognitive impairment and subthreshold depression, a multi state Markov model with time and state discreteness is constructed, namely: State 1 (normal); State 2 (subthreshold depression); State 3 (mild depression); State 4 (moderate depression); State 5 (severe depression). Deeply explore and analyze the impact of certain factors and indicators on the transition between states, and estimate the probability of transition between states.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 60 years old
2. Meets the diagnostic criteria for mild cognitive impairment and subthreshold depression
3. Having basic comprehension and verbal expression skills
4. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Diagnosed as depression patients, including patients with organic mental disorders and patients with a history of depression related mental disorders
2. Cognitive impairment caused by other diseases (such as neurological and psychiatric disorders, metabolic disorders, poisoning, infections, etc.)
3. Severe heart, liver, and kidney diseases
4. Serious chronic diseases and complications, such as congestive heart failure, hypertension, diabetes and other diseases with serious complications
Periodontal Phenotype and Scaling and Root Planing

Periodontal phenotype has been recognized as one of the key factors that may potentially impact the outcome of a variety of periodontal surgical and non-surgical procedures. Taking into consideration the inconsistent findings of the studies done in this regard,outcomes of scaling and root planing with respect to periodontal phenotype.

With this aim, the present study would be conducted to assess the influence of periodontal phenotype on outcome of scaling and root planing in periodontitis patients.

AIM: To evaluate the influence of periodontal phenotype on the outcomes of scaling and root planing in periodontitis patients.

OBJECTIVES:

To assess the improvement in pocket probing depth (PPD), clinical attachment level (CAL), bleeding in pocket probing (BOPP), bleeding on marginal probing (BOMP), gingival marginal position (GMP), gingival recession (GR), plaque index (PI), and gingival index (GI) after scaling and root planing (SRP) in periodontitis patients with thin or thick periodontal phenotype.

SETTING: Department of periodontics and oral implantology, PGIDS, Rohtak, Haryana.

STUDY DESIGN: Comparative Interventional study.

TIME FRAME: 12 months (september 2021- August 2022)

POPULATION:

Systemically healthy patients with periodontitis (periodontitis stage II and stage III) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients with periodontitis (periodontitis stage 2 and stage 3) and thin/thick periodontal phenotype in maxillary and mandibular incisors will be included.

Exclusion Criteria:

* Systemic condition known to affect the course of periodontal disease like diabetes mellitus or immunogenic disorders.
* Patient on anti-inflammatory drugs or antibiotics or history of treatment with medication known to influence periodontal status or healing within last 2 years.
* Current or former smoker or use of tobacco in any form
* History of periodontal treatment in last 2 years
* Crowding in anterior teeth.
* Pregnant or lactating females.
* Individuals with restorations on anterior teeth.