cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Hypotension and Perioperative Myocardial Injury

Acute myocardial infarction (MI) is a significant complication following non-cardiac surgery. We sought to evaluate incidence of perioperative MI, its preoperative - and intraoperative - risk factors and outcomes after this complication.

Background:

In Sweden, over 800 000 patents undergo surgery each year. Worldwide, the number of surgical procedures yearly is over 310 million. Surgical care is en essential part of the advancement in treating disease, associated with increased lift expectancy a d improved quality of life. However as surgical volume continues to grow, the number of patients who suffer postoperative complications will also increase.

Hemodynamic instability in the perioperative period is frequent and there has been a cumulative interest in this area and the relation to organ failure over the recent years. There are several studies showing results of associations between intraoperative hypotensive events and perioperative cardiac, kidney and cerebral injury, as well as increased mortality in high-risk surgical patients.

More specifically the project aims to answer how intraoperative events, with a special focus on hypotension, are related to perioperative myocardial and kidney injury.

We hypothesize that patients, with preoperative risk factors, undergoing major non-cardiac surgery are at increased risk of developing perioperative organ damage in the presence of intraoperative hypotension or other events such as tachycardia, hypoxia and extensive blood loss.

Eligibility Criteria:
Cases

Inclusion Criteria:

* Adults (≥18 years), male and female.
* Undergoing elective or non-elective in-patients non-cardiac surgery at 3 University Hospitals in Sweden: Karolinska University hospital, Skåne University hospital and Norrland University hospital.
* Surgeries performed between 2007 and 2014.
* Acute myocardial infarction criteria fulfilled within 30 days after surgery.

Exclusion Criteria:

* Cardiac surgery
* Obstetric surgery

Controls:

Matched (on age, preoperative risk factors, surgical year- site and procedure) surgical patients without myocardial infarction within 30 days after surgery.
Exercise Adherence in a Behavioral Weight Loss Program

To develop intervention strategies that improve long-term exercise adherence in obese adults in in order to improve long-term weight loss.

BACKGROUND:

Even though exercise improves long-term weight loss maintenance and reduces the risks of cardiovascular disease and Type II diabetes mellitus, obese adults are prone to drop out of exercise programs. Dr. Jakicic's prior findings suggest that exercise adherence can be enhanced and short-term weight loss can be improved by making exercise more convenient via prescribing exercise in multiple short bouts, rather than one bout per day. Effects on long-term exercise adherence and weight loss have not been examined, however. His findings also suggest that providing more exercise options by placing exercise equipment in the home may also increase adherence, as evidenced by a significant correlation between the presence of home exercise equipment and physical activity. However, no experimental studies have tested whether placing exercise equipment in the home actually increases exercise adherence and weight loss.

DESIGN NARRATIVE:

The study tested the hypothesis that prescribing exercise in multiple short bouts would improve long-term exercise adherence and long-term weight loss, and that the addition of home exercise equipment would further improve these outcomes. A total of 148 overweight women were recruited and randomized to one of three treatments: 1) long-bout exercise; 2) short-bout exercise; 3) short- bout exercise + home exercise equipment. All subjects participated in an 18-month behavioral weight loss program, in which body weight was assessed at 0, 6, 12, and 18 months and exercise adherence was assessed throughout the 18 months. Cardiorespiratory fitness and cardiovascular disease risk factors were measured at 0, 6, and 18 months.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Effectiveness of Continuous Ketamine Infusion (KONTINUE)

There are different treatment for chronic pain. One possible treatment is intravenous infusions of ketamine.

Ketamine continuous intravenous infusion for 4 days in Hospital with 0.5 mg/kg/day associated with Magnesium Sulfate 1000mg/day.

Evaluation schedules will be performed at day 15,30 and 60.

Eligibility Criteria:
Inclusion Criteria:

- Pain lasting for more than six months without contraindication to treatment

Exclusion Criteria:

* Inability to give consent
* Severe psychiatric disorder
Global Prospective Case Series Using a Single-Use Duodenoscope

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

This study is a prospective, multi-center case series of per standard of care ERCP procedures using a nonsignificant risk single-use duodenoscope. Up to 1000 cases will be included at up to 40 clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated ERCP procedure performed using the study device. Enrolled subjects will be followed for 30 days after their procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Scheduled for a clinically indicated ERCP

Exclusion Criteria:

* Potentially vulnerable subjects, including, but not limited to pregnant women
* Subjects for whom endoscopic techniques are contraindicated
* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
* Investigator discretion
Pre-operative Respiratory Rehabilitation in Coronary Artery Bypass Graft Patients

To compare the effects of conventional preoperative respiratory rehabilitation and specific preoperative respiratory rehabilitation program on pulmonary functions in coronary artery bypass graft patients.

After cardiac surgeries many postoperative changes occur that lead to pulmonary complication such as respiratory changes, functional capacity of lungs and gaseous changes that leads to hypoxemia and ischemic injury of lungs. CABG, although a successful procedure, post operative pulmonary complications still pursue a big challenge to the health and fitness of the patients. Although post operative complications have been managed in in-patient setup post CABG, there are pre-operative measures on the rise to prevent the complications to occur after CABG.

This study will contribute in describing the rate of improvement in pulmonary functions with rehabilitation program including preoperative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume-based incentive spirometry as compared to the conventional treatment of flow-based incentive spirometry and chest percussion in prevention of post operative pulmonary complications occurring after CABG leading to delayed recovery of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective Coronary Artery Bypass Grafting (CABG) surgery for Triple vessel coronary artery disease (TVCAD), double vessel coronary artery disease (DVCAD), single vessel coronary artery disease (SVCAD) and left main stem (LMS) disease.
* Patients who cover at least 400 steps on 6-minute walk test.
* Patients with ejection fraction 45% or more

Exclusion Criteria:

* Acute ailments i.e., patient's cardiac condition deteriorating.
* Cardiac emergency (shock, acute MI)
* Presence of neurological disorders e.g., altered state of consciousness, paralysis.
* Redo surgeries
* Any musculoskeletal disorder e.g., amputation of limb, problems of balance and risks of fall, muscles weakness grade 3 or less, osteoporosis; leading to limitation in exercise.
Comparative Study of Arthrodeses by "Single Posterior Approach" and by "Double Anterior and Posterior Approach"

Extended arthrodesis of the spine is indicated in the treatment of deformities. The principle of the intervention is to correct the spinal imbalance and to obtain a fusion of the vertebral segment operated in order to guarantee the durability of this correction, in order to guarantee a functional result the best possible one.

There is a great disparity in the techniques available to obtain this result: as regards the correction of the deformation itself, it is possible to resort to various types of gestures aimed at "freeing" the spine to allow the getting the correction. It may be staged or transpedicular osteotomies or previous releases (staged discectomies). Regarding the arthrodesis itself, this can be obtained by an isolated posterior graft or by a circumferential graft itself performed in a time using interbody cages PLIF type (posterior lumbar interbody fusion) or TLIF (transforaminal interbody fusion) or in two stages by a complementary anterior graft. These are heavy interventions with a high complication rate.

The choice of this or that technique is based on data from the literature and remains at the discretion of the surgeon who makes the surgical indication. However, it has never been possible to compare these different techniques in a prospective study. The few articles comparing the different techniques tend to show that there is no significant difference between the techniques with a higher complication rate for the two-step techniques. However, these are retrospective studies, with all the biases that this implies and despite these results the disparity in surgical indications remains substantial.

The objective of this work is therefore to evaluate, according to an identical protocol, the different surgical techniques for the treatment of spinal deformities associated with a fusion in order to determine the morbidity associated with each of the techniques and if this morbidity is justified by a better functional result at a minimum follow-up of two years.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years
* Patient operated on an arthrodesis including the sacrum and extending to T11 or greater
* Francophone patient
* Patient not opposing his participation in the research protocol

Exclusion Criteria:

* Patient under tutorship or curatorship
* Patient deprived of liberty
Impact of Computer-Aided Detection (CAD) as Second Reader in CT Colonography

RATIONALE: CT colonography accurately detects large polyps and masses. However, the test is less accurate in identifying lesions between 6 and 9 mm.Use of computer-aided detection (CAD) has shown promising results in providing uniform accuracy and improving CT colonography sensitivity.

PURPOSE:This clinical trial compared the performance of CT colonography with unassisted and CAD-assisted reading in detecting patients with colorectal lesions.

Design: multicenter, cross-sectional study. Each participant underwent CT colonography and colonoscopy on the same day. Expert readers interpreted CT colonography unassisted and then reviewed all colorectal lesion-like structures pinpointed by the CAD algorithm.

Eligibility Criteria:
Inclusion Criteria:

- clinical indication to undergo colonoscopy either for symptoms, or participating a surveillance program or a CRC screening

Exclusion Criteria:

* clinical diagnosis of familial adenomatous polyposis or hereditary nonpolyposis CRC syndrome
* inflammatory bowel disease
* celiac disease
* evidence of increased risk of harm from colonoscopy
* psychological or physical conditions that contraindicated colonoscopy or CT Colonography
Effect of Dried Fruit Intake on Acid-base Balance

Most adults consume acid-producing diets because their high intake of protein and/or cereal grains in relation to their intake of fruits and vegetables. This study is being done to determine whether acid-base balance can be restored by the addition of dried fruits to the diet. In this study adults with low usual fruit intake will be provided with either 100 g per day of a mix of dried fruits or no dried fruit. Participants will be followed for 1 year. Acid-base status will be assessed by measuring the acid content in 24-hour urine collections.

Most adults consume acid-producing diets because their intake of protein and/or cereal grains is high in relation to their intake of fruits and vegetables. Supplementation with alkaline salts such as potassium bicarbonate and potassium citrate have been shown to reduce 24-hr urinary net acid excretion (NAE) in healthy adults. This approach requires taking many capsules daily, in split doses after each meal with a full glass of water. An alternative and perhaps more acceptable approach to achieving acid-base balance for most adults may be to modify their diet by increasing intake of alkali-producing foods, such as fruit. Maintaining acid base balance may be important for preserving bone and muscle and renal function and other outcomes but this has not been established. The investigators propose to determine whether adults who are provided with 100 g per day of a selection of dried fruits will actually consume enough of it to correct their acid-producing diets, as evidenced by a lowering of their urinary NAE. The investigators will also determine whether and how participants will alter their overall diets or their body weight when provided with the dried fruit. The comparator group will receive no dried fruit (or other intervention).

Eligibility Criteria:
Inclusion Criteria:

* usual self-reported fruit intake not greater than 2.5 servings per day
* adequate dentition to chew dried fruit
* willing to avoid potassium supplements during the study
* willing to avoid antacids other than Pepto Bismol during the study

Exclusion Criteria:

Conditions

* diabetes or fasting plasma glucose on screening \>125 mg/dl
* untreated thyroid disease
* untreated parathyroid disease
* cirrhosis
* unstable heart disease
* osteoporosis of the spine or hip
* alcohol use \> 2 drinks per day
* chronic diarrheal syndrome
* estimated glomerular filtration rate \< 50 ml/min
* serum potassium \>5.3 meq/L
* abnormal serum calcium
* dysphasia
* malabsorption
* inflammatory bowel disease
* celiac disease
* chronic constipation
* gastric bypass surgery
* non-English speaking Medications
* potassium sparing diuretics
* oral glucocorticoids
* immunosuppressant drugs
* anabolic steroids in last 6 months
* estrogen in last 6 months
* osteoporosis treatment in the last 12 months with teriparatide abaloparatide calcitonin raloxifene denosumab
* osteoporosis treatment with a bisphosphonate in the last 2 years
* regular use of antacids \> 3 times per week
* regular use of laxatives \> 3 times per week
* any medication taken to alter appetite
Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery

The purpose of this study is to evaluate the impact of a check list on the rate of late cancellation, i.e. the day before or the day of the ambulatory surgery.

The checklist is administered to the patients by phone between 7 and 3 days before the surgery. Each item of the checklist is associated with a decisional algorithm that allows take care for patients in case of any problem.

Eligibility Criteria:
Inclusion Criteria:

* Patient (adult or minor) for which ambulatory surgery is programmed in a multipurpose ASU
* Surgery under general anesthesia or loco
* Regional or neuroleptanalgesia3. Patient contacted by phone
* Patient does not oppose his participation in the study

Exclusion Criteria:

* Patient programmed for endoscopy in ASU non surgical
* Ambulatory surgery scheduled for orthogenic
* Ambulatory surgery scheduled for urgency
* Ambulatory surgery performed under local anesthesia
Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)

This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after administrations of single (SAD) ascending doses in healthy subjects and multiple (MAD) ascending doses in subjects with NCFB.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years at the time of providing written informed consent

For Part A (SAD) Only:

* Healthy and free of medical conditions that could in the opinion of the investigator affect's the subject's participation in the study or the interpretation of results.

For Part B (MAD) Only:

* Diagnosis of NCFB made by a respiratory physician, confirmed per CT showing bronchial wall dilatation with or without bronchial wall thickening, with a FEV1 ≥ 40% of the predicted value regarding age, height, gender, ethnicity, and FEV1 ≥ 1 L (pre-bronchodilator values) at the Screening Visit.
* No antibiotic use within 1 month before the Screening Visit.
* Presence of one or more of the following bacteria (H. influenzae, P. aeruginosa, M. catarrhalis, S. pneumoniae, members of Enterobacterales family or S. aureus) in the sputum culture at the Screening Visit.
* Has been fully vaccinated against COVID-19 (as per country recommendations) at least 7 days prior to Day 1

Exclusion Criteria:

* Evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic; psychiatric; immunodeficiency; cancer.
* History of chronic respiratory disease (eg, COPD or bronchiectasis) or current asthma with regular treatment including occasional use of an inhaler for exercise induced asthma.
* Current moderate-severe allergic disease (eg, allergic rhinitis) with regular treatment.
* Diagnosis of cystic fibrosis, mycobacterial disease, connective tissue disease, or alpha-1 antitrypsin deficiency as underlying disease for bronchiectasis.
* Oral/parenteral corticosteroid 28 days before the Screening Visit until EOS Visit. Use of long acting bronchodilators (long acting muscarinic antagonists (LAMA) and / or long acting beta2 agonists (LABA) and/or inhaled corticosteroids that have been at a stable dose for at least 3 months before the Screening Visit is permitted; inhalation with hypertonic saline solution is permitted up to and including Day -1.
* Any systemic or inhaled antibiotic for acute pulmonary exacerbation within 1 month before the Screening Visit until EOS Visit.
Modulation of Muscle Protein Metabolism by Essential Amino Acids

The investigators plan to explore the ability of amino acids, the building blocks of proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The investigators will investigate how rapidly after one meal the human body is ready to make use of a second meal and look at the molecular mechanisms underlying this. The investigators will look at these phenomena in older men as this group is known to be subject to a gradual loss of muscle mass and strength.

Muscles can stay very constant in size for much of adult life yet dramatic wasting is seen in advanced age and ill health. A better understanding of how muscles regulate their size will help design treatments to slow wasting in disease and to promote active aging. We plan to study a group of older men, \~70yrs, the age at which muscle bulk starts to decrease, to observe how the muscles respond to feeding. We will provide a drink that contains the digested products of proteins from which muscles are built. Taking blood samples and some tiny biopsies of muscle (done under local anaesthesia) will allow us to measure muscle turnover and we will be able to measure for how long after a meal muscles actively take in nutrients before becoming "full". We will also measure how long the muscle remains "full" before it returns to a state where it can again be stimulated to take in nutrients. We will also explore if leucine, one of the component parts of protein (especially in meat and dairy products) and a food widely used supplement, can promote the early re-stimulation of muscle by eating.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 65-75yrs
* BMI 18-28

Exclusion Criteria:

* Type 2 Diabetes mellitus
* Neurological Disease
* Significant cardiac, hepatic or renal disease
* Active malignancy
* Medication inc. Corticosteroids, NSAID use, Beta adrenoblockers.
Effect of a Combined Exercise Program on Neuropathic Pain and Perceived Quality of Life in Type 2 Diabetes

Therapeutic exercise is one of the therapies used as a treatment for diabetic neuropathy, which is a complication of diabetes. In order to reduce pain and improve the perception of quality of life, a combined therapeutic exercise program will be implemented as an adjuvant and non-pharmacological treatment for diabetic neuropathy.

This is a prospective, longitudinal, quasi-experimental study of repeated measures (pretest-posttest), has been approved by the research and ethics committee of the Faculty of Medicine of the Autonomous University of Yucatan, issuing a report on October 26, 2022. An identification form will be filled out that will include socio-demographic and clinical data: presence of type II diabetes, presence of neuropathy, sex, age, marital status, schooling, occupation, BMI, time of diagnosis, HbA1C, insulin use, medical treatment and a neurological examination of the extremities. The DN4 questionnaire will be used to evaluate neuropathic pain and its characteristics, the VAS will be used to evaluate the degree of intensity or severity of pain, and the SF-36 questionnaire will be used to evaluate perception before and after the combined exercise program. During the intervention stage, a therapeutic exercise program will be applied that will include two modalities: aerobic and resistance exercise in the facilities of the Unidad Universitaria de Inserción social de San José Tecoh. The duration will be 8 weeks with a frequency of 3 sessions per week, with a duration per session of 60 minutes each, to achieve the minimum total time suggested by the guidelines of 150 minutes per week. These exercises will be prescribed in three phases to increase times, series, repetitions and resistances in a progressive manner according to the Borg scale. For the analysis of the variables, the parametric Student's t-test for related samples or the nonparametric Wilcoxon test with significance at 95% reliability will be used. The implementation of the study can demonstrate significant improvements in the symptomatology of diabetic neuropathy, directly impacting on the perception of the quality of life of patients with type II diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes type 2
* Patients with neuropathy
* Patients with medical treatment

Exclusion Criteria:

* Patients with several limit function
* Patients with foot ulcer or amputation
* Patients who are involved in a exercise program already