cyrilzakka/clinical-trials huggingface dataset:
Analgesia by Single or Dual Acupoints Stimulation After Radical Mastectomy

The purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (TEAS) pretreatment on incidence of Post-Mastectomy Pain Syndrome(PMPS) in patients undergoing operation of breast cancer.

Patients were randomly assigned to three groups, receiving 30min TEAS before anesthesia respectively. The acupoints of dual point group are bilateral Neiguan points(PC6) combined with Danzhong point(RN17), single point group is bilateral Neiguan points(PC6), and the false stimulation group only attach electrodes without electric current. The frequency of TEAS is set to 2/15 Hz. Intraoperative anesthetic dosage of propofol and remifentanil was recorded. Three and six months after surgery, follow-up about chronic pain was made by telephone or face-to-face using the follow-up questionnaire. The adverse events were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for operation of breast cancer；
* ASA（American Society of Anesthesiologists）I-II；
* Aged between 18 and 65；
* Informed consented。

Exclusion Criteria:

* Suffered from the contraindication of TEAS including the local skin breakage, infection or planted with the electrophysiology device；
* Unable to communicate and coordinate with the researcher, such as suffering from language comprehension deficits or mental diseases；
* Certain/suspicious addiction with alcohol, analgesics or other drugs；
* Unstable Angina or myocardial infarction occurred in 3 months; NYHA（New York Heart Association） is 3 or higher;
* Blood pressure ≥ 180/110 mm Hg while preoperative visiting;
* Suffered from diabetic complications including diabetic ketoacidosis, hyperosmolar coma, infection, macroangiopathy, diabetic nephropathy, retinopathy, cardiomyopathy, neuropathy and diabetic foot;
* Severe dysfunction of liver or kidney meaning one of ALT（Alanine Transaminase）, AST（Aspartate Transaminase）, ALP（alkaline phosphatase） or TBIL（total bilirubin） is 2 times higher that normal or creatinine clearance \< 30 ml/min or serum creatinine \> 177umol/L;
* Participate in the other clinical trial 3 month before the enrollment.
Prognostic Indicators of Survival Following Cardiopulmonary Resuscitation in Patients With Cardiac Arrest

Cardiopulmonary resuscitation (CPR) occurs approximately 200,000 times/yr in hospitals in the UnitedStates, with 18% of patients surviving to discharge. Just over half of these survivors are neurologically intact or with mild defiits at the time of discharge. Do-not-resuscitate (DNR) orders are used to withhold CPR from patients who are unlikely to benefi or for whom it is inconsistent with their treatment goals or personal preferences. It would be helpful to identify patients with a very low likelihood of survival to discharge neurologically intact or with mild defiits were they to experience cardiopulmonary arrest (CPA), so their physician can present the option of a DNR order. This information would also be useful anytime a patient raises the question of the likelihood of survival should they undergo CPA.The objective of this study was to determine key indicators for good outcome in patients with sudden cardiac arrest undergoing CPR and develop a prediction model to predict survival to hospital discharge in these patients.

A CPR coordinator prospectively collected data for the CPR registry according to the Utstein-style guidelines. Te registry included the following information:

demographic data, comorbidities, whether the arrest was witnessed, the incidence of suspected or confrmed trauma, presumed arrest time; presence of bystander CPR, frst documented arrest rhythm by the emergency medical service (EMS) provider, any return of spontaneous circulation (ROSC), presence of ECPR, the presence of return of spontaneous heart beating (ROSB) after CPR, presumed cause of arrest; the application of therapeutic hypothermia and the use of coronary angiography(CAG) or percutaneous coronary intervention (PCI),24-hour survival, the presence of ROSC more than 20 min, hospital length of stay (LOS), survival to hospital discharge,Glasgow-Pittsburgh cerebral performance category (CPC) score at discharge, and the fnal diagnosis at discharge. Te comorbidity score was calculated using the Charlson comorbidity index. Te duration of CPR was defned as the time interval from the frst chest compression provided by healthcare providers to the termination of resuscitation eforts due to ROSC (more than 20 min),ROSB after CPR, or a declaration of death. A favorable neurologic outcome was defned as a CPC score of 1 or 2 on the fve-category scale.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years,
* sudden arrest with potentially reversible causes,
* a short no fow time (time interval from presumed arrest to CPR initiation)
* even for unwitnessed arrests

Exclusion Criteria:

* presence of a terminal illness or malignancy, severe irreversible neurologic defcit,
* suspected or confrmed traumatic origin of arrest,
* no informed consent from the family
Virtual Clinical Simulation for Training Amongst Undergraduate Medical Students: A Pilot Randomised Trial

In this trial, undergraduate medical students will be randomised to undergo training using a virtual reality simulator (BodyInteract®) or a standard small-group interactive discussion of a clinical scenario. Adherence to current clinical recommendations will be considered as primary outcomes for this study.

Objective: To assess whether a virtual reality simulator might facilitate learning and improve adherence to current clinical guidelines. Methodology: A double-masked randomised trial will be held among students at the School of Medicine of the Universidad Andres Bello. Participants will be randomised to receive training using a clinical virtual simulator (Body Interact®, Body Interact Inc, Austin, TX) designed to review key concepts in Cardiology. Students allocated to the control group will receive a small-group discussion lasting up to 60 minutes in which key topics regarding the same clinical condition will be reviewed as well. Main outcomes include the overall performance in an objective structured clinical examination (OSCE) that will be reviewed by an expert panel prior to its implementation and adherence to specific recommendations in current national guidelines. This OSCE will be held 15 days after the educational session has taken place. Analyses will be undertaken under the intention to treat principle and missing data will be handled using multiple imputation techniques.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate medical student at the Universidad Andrés Bello
* Currently undergoing the 4th or 5th year of medical training in Chile
* Obtained a passing grade in Cardiology for general physicians.

Exclusion Criteria:

* Refusal to participate.
Efficacy and Safety of Calcipotriol Cream and (Calcipotriol + Betamethasone Dipropionate) Ointment in Psoriasis Vulgaris

Patients with psoriasis vulgaris of the trunk and/or limbs are randomised to treatment with:

1. 4 weeks of ointment containing calcipotriol and betamethasone dipropionate followed by 8 weeks of calcipotriol cream
2. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of calcipotriol cream on weekdays/ (calcipotriol plus betamethasone dipropionate) ointment on weekends
3. 4 weeks of (calcipotriol plus betamethasone dipropionate) ointment followed by 8 weeks of vehicle of calcipotriol cream

The objective is to compare the efficacy and safety of the different treatment regimens

A phase IV study of different treatment regimens of calcipotriol 50 mcg/g cream and combination (calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)) ointment following treatment with combination ointment in psoriasis vulgaris

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis vulgaris of trunk and/or limbs

Exclusion Criteria:

-
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy.
* Failed standard therapy (\>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression

Exclusion Criteria:

* Diabetes
GDT Vs ST for Pancreas Transplant Surgery

A Pancreas Transplant is the accepted treatment in patients with Insulin Dependent Diabetes Mellitus (IDDM) and end-organ failure. Simultaneous Pancreas and Kidney (SPK) Transplant is done in over 90% of cases. At present there is a 5- 8% 30-day mortality with over 80% graft survival at 1 year. At Manchester Royal Infirmary (MRI) approximately 40 cases are done per year.

Goal-Directed Therapy (GDT) involves fluid resuscitation intra-operatively and early in the post-operative period, guided by cardiac output monitoring. The mechanism of therapeutic benefit is thought to be related to improved tissue oxygenation and oxygen delivery. There are a number of studies showing significantly improved biochemical markers of inflammation in animal models and in studies on septic patients (patients with an overwhelming infection) following GDT. Studies have also shown that GDT improves clinical outcome in post-operative patients and in serum inflammatory mediators. These studies have looked at "major abdominal surgery" but none have investigated transplant patients. Given the nature of surgery we feel that our patients would benefit with reduced Intensive Care Unit stay, reduced length of hospital stays and reduced rates of post-operative complications.

The study will be conducted on all adult patients undergoing pancreas transplant at MRI. It will last for 2 years and we hope to recruit 60 patients

Patients will be randomised into Standard Therapy (ST) or GDT groups, with ST being current practice. Each intervention will last for six hours post-operatively before continuing with normal care thereafter. Omental fat biopsies will be taken from patients intra-operatively and blood samples will be taken from patients at regular intervals for 72 hours intra- and post- operatively. Patients will be followed up daily while an in-patient and at three-monthly intervals in out-patients for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* All adult pancreas transplant recipients between November 2011- November 2013

Exclusion Criteria:

* Those unable to consent
* Paediatric recipients
* Patients unable to meet follow-up protocol
* Patients with a contra-indication to central venous catheterisation
* Patients with advanced directives, restricting the implementation of the study protocol
Performance of Glass-ionomer Cements: 2-year Follow-up

The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.

Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
* Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.

Exclusion Criteria:

* Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
* No history of spontaneous pulpal pain.
This is a Study to Get More Information About Non Ambulatory Boys & Men With Duchenne Muscular Dystrophy

Many therapeutic trials in DMD exclude non-ambulatory boys and men. Rate of progression in these non-ambulatory patients has been studied but consensus has not been reached for what measures are most reliable and reproducible. Furthermore, any treatment trial would be expected to demonstrate improved function and improvement in quality of life. Therefore, function, strength, and quality of life must be understood and standardized. While the goal of this proposal is to standardize clinical outcomes for therapeutic trials, careful understanding of the progression of DMD in non ambulatory boys may also lead to better medical treatment.

For Non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year.

Age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years.

Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with biopsy/genetic confirmation in a primary relative.

Eligibility Criteria:
Inclusion Criteria:

1. For Non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year.
2. Age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years.
3. Genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of DMD with biopsy/genetic confirmation in a primary relative.

Exclusion Criteria:

1. For Non-ambulatory study, the inability to understand and cooperate with the testing would exclude a subject. -
Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes

Background: Osteoporotic fractures are a major public health issue. They cause substantial disability, loss of autonomy, morbidity and excess mortality. Diabetes is also associated with increased risk for falls and fractures through a direct impact of elevated blood glucose on the skeleton and on muscles.

Research project overview: The investigators propose a cross-sectional study that will involve 2 research centers in the province of Quebec. The investigators will recruit 20 obese participants, without diabetes, who have not undergone bariatric surgery, for one-time measurements to be compared with baseline measurements (pre-surgery) from participants in the bariatric obese diabetic groups with type II diabetes mellitus from the ongoing study BODI study (NCT03455868). Bone Mineral Density as well as muscle quality, strength and function will be evaluated at a single study visit.

Relevance: This data will permit the evaluation of the bone-muscle unit in patients with obesity with and without diabetes, and assess whether the presence and duration of diabetes impacts further on clinical and functional musculoskeletal outcomes (falls, fractures and mobility and strength) in this population. AGEs, if associated with muscle and bone deterioration, might become an easily accessible biomarker of musculoskeletal health in the clinical setting.


Eligibility Criteria:
Inclusion Criteria:

A) Diabetic group

* BMI \>=35 kg/m2
* Clinical diagnosis of type 2 diabetes
* Use of oral hypoglycemic agents or insulin or 2 of the following tests confirming type 2 diabetes: HbA1c \>=6.5%; fasting glucose \>=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) \>=11.1 mM)

B) Non-diabetic group:

* BMI \>=35 kg/m2
* Normoglycemia (HgbA1c \<5.7% and Fasting glucose \<5.6 nM)

Exclusion Criteria:

* BMI \>60 kg/m2
* Clinical diagnosis of type 1 diabetes
* Disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \<60 ml/min)
* Medication (e.g. gluccocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism
* Pregnancy
* History of oesophageal, gastric, digestive or bariatric surgery
* Prosthesis that could interfere with interpretation of imaging data
* Chronic severe condition or illness precluding from participation in the project.
The Efficacy of Brisement Compared to Physical Therapy for the Treatment of Achilles Tendinosis

The purpose of this study is to compare the effectiveness of ultrasound guided brisement, brisement without ultrasound guidance and standard conservative treatment in patients who have been diagnosed with Achilles tendinosis. We are asking you to take part in this research study because you are a patient of the Brigham Foot and Ankle Clinic who has been diagnosed with Achilles tendinosis. About 100 people will take part in this research study, all at Brigham and Women's Hospital (BWH).

To our knowledge, there has been very little research in the efficacy of the addition of briesment injections to standard, conservative treatment of Achilles tendinosis. We hope our results will show which method is the most effective conservative treatment for Achilles tendinosis. This information will help doctors make decisions in the future.


Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled in the study must have a diagnosis of Achilles tendinosis with at least 2 weeks of pain at the distal Achilles tendon which is typically worsened with activity. Only cases of non-insertional Achilles tendinosis (tendinosis occurring above the point of tendon insertion) will be included.

Exclusion Criteria:

* Patients with a prior Achilles tendon tear, chronic inflammatory disease, or history of posterior calf surgery will be excluded from the study. Additionally, patients with prior injuries or fractures to the ankle and hind foot (talus and calcaneus) requiring surgery will be excluded.
Liposomal Bupivacaine in Total Knee Arthroplasty

Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a primary unilateral total knee arthroplasty by the PI of the trial

Exclusion Criteria:

* Patients with a sensitivity to marcaine
* Pregnant or lactating women
* Non-English speaking individuals
Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling

The currently available data are insufficient to develop a model that achieves optimum morphine dose individualization at the postoperative period of coronary artery bypass grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could justify morphine consumption, drug plasma concentration and pain intensity during the postoperative period after CABG and evaluate the post operative pain.

The protocol was a prospective, open-label study, approved by the institutional ethical committee of the hospital where the study was performed. Patients were randomly assigned to receive general anesthesia plus intrathecal morphine at a dosage of 400 mcg (morphine group) or general anesthesia alone (control group) according to a simple computer-generated list.

Eligibility Criteria:
Inclusion Criteria:

* eligible to cardiopulmonary artery bypass grafting surgery

Exclusion Criteria:

* fraction of ejection below 40%
* contraindications to neuraxial blockage
* coagulopathy
* use of low-weight heparin
* warfarin or a platelet aggregation inhibitor other than aspirin,
* systemic or local infection
* and patients with a specific contraindication on the medication employed in the study
Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

Older patients spend most of their time in situations of muscle disuse during acute hospitalization. Physical inactivity is a key factor for the development of adverse events caused by hospitalization, known as iatrogenic nosocomial disability. Adopting a multicomponent training program during acute hospitalization can be an efficient strategy to reduce adverse effects and promote improvements in older health. This study is a randomized clinical trial with acutely hospitalized older individuals. Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. The control group will receive only the usual care and rehabilitation.

This study is a randomized controlled trial with acutely hospitalized older individuals. The first aim is to evaluate the effects of a multicomponent training intervention on functionality, cognitive ability and inflammatory profile in older patients during acute hospitalization.

The population studied will be older patients (≥ 70 years), admitted to the Internal Medicine sector of the Hospital de Clinicas de Porto Alegre. The number of older people obtained through sample calculation is 30 individuals per group, totaling 60 participants in the study.

Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. Exercises aimed at the lower and upper limbs will be performed, such as sitting and standing up from a chair, leg press, bilateral knee extension and bench press with elastic tape. Balance and gait exercises will also be performed. The training session will be considered complete if patients are able to perform 90% or more of the scheduled exercises, the frequency and possible adverse events will be documented in daily records. The control group will not receive multicomponent physical training, only the usual care provided by the hospital. Both groups will be evaluated before and after 5-7 days of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years and older;
* Able to tolerate exercise;
* Barthel Index ≥60;
* Be able to walk alone or with the aid of a cane, crutch or walkers;
* Be able to communicate and inform consent to participate in the research.

Exclusion Criteria:

* Length of stay \<5 days;
* Inability to participate in the testing procedures and/or the multi-component training program, as determined by the physician;
* Present one or more factors:

  1. Terminal illness;
  2. Myocardial infarction in the last 3 months;
  3. Unstable cardiovascular disease;
  4. Any type of fracture in the last 3 months, which makes it impossible to carry out the movements;
  5. Severe dementia.
Eye Health in Children and Adolescents: Repeated Cross-sectional Survey

The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health and individual-level outcomes

The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health (e.g., social environment, preventive behaviours, risk factors, knowledge and attitudes, health and social care, etc.) and individual-level outcomes (e.g., clinical parameters and symptoms, biomarkers, self-reported measures, risk profiles, etc.).

Eligibility Criteria:
Inclusion:

* Subjects with valid information on eye health-related profiles
* Completion of eye health examination delivered by trained ophthalmic professionals

Exclusion:

* Inability to give informed consent
* Unable to retrieve individual records on eye health examination