cyrilzakka/clinical-trials huggingface dataset:
Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection

Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to decrease this rate with little improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease postoperative UTIs. The investigators have designed a prospective randomized controlled study to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Adult women at least 18 years of age
* Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ prolapse repair that require cystoscopy.

Exclusion Criteria:

* Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair
* Pregnancy
* History of nephrolithiasis
* Allergy to study medications
* Congenital urogenital anomaly
* Neurogenic bladder
Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tamsulosin HCl Tablet" and Astellas Phama Korea Inc. "Harnal-D" in healthy volunteers

To healthy subjects of thirty (30), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: Harnal-D Tab. / Test drug: Chong Kun Dang Tamsulosin HCl Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subject older than 19 years men at the screening
2. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
3. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG etc.)
4. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

   \* BMI = Weight(kg)/ Height(m)2
5. Individuals who had agreed to participate in the study
6. Individuals without mental illness history within five year prior to the screening
7. Individuals without a medical history of gastrointestinal operations that may affect drug absorption
8. Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days after investigational product(s) administration

Exclusion Criteria:

1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs within the 1 month
2. Individuals who had excessive drinking within the 1 month

   \*Men: 21 glasses/week exceeded(1 glass: distilled spirits 45 mL, wine 150 mL, beer 360 mL)
3. Individuals who had taken any medication within 10 days prior to the first day of dosing
4. Individuals who were deemed to be inappropriate to participate in the study by the investigator
5. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
6. Individuals who donated whole blood within the 2 months, or blood components within 1 weeks prior to the first dose of the investigational product(s)
7. Individuals with hypersensitivity (include Vascular edema) to ingredients used in the investigational product(s)
8. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
9. Individuals with orthostatic hypotension
10. Individuals with severe hepatopathy
11. Individuals who had taken alpha-1 blocker
12. Individuals who had history of micturition syncope
13. Individuals with nephropathy
14. Elderly person
15. Individuals who had taken PDE5(phosphodiesterase-5) inhibitor
16. Individuals who had taken CYP3A4 inhibitor
17. Individuals who had taken antihypertensive drug(s)
Discontinuation of Automated Engagement Support

The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving care from Empire Physicians Medical Group (EPMG), an Independent Practice Association located in Palm Desert, California. The system monitors routine clinical laboratory test results and send messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. This study will assess what happens to laboratory results, utilization of laboratory tests, and costs of care when ther system is discontinued.

The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving care from Empire Physicians Medical Group (EPMG), an Independent Practice Association located in Palm Desert, California. The system monitors routine clinical laboratory test results and send messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. Patients receive first class letters directing them to call their provider. Providers receive fax or electronic messages directing them to reach out to the patient to arrange follow-up care. It has been used for over three years and appears to have improved adherence to Chronic Kidney Disease (CKD) treatment guidelines by influencing both patient and provider actions. EPMG wishes to restrict the service to those patients with advanced CKD and discontinue it for CKD stages 1-3. The investigators propose implementing this new policy in a randomized fashion with one half of the current early stage patients continuing to receive the service while the other half will no longer receive messages. The investigators will monitor laboratory results and health care utilization for both groups to determine what effect, if any, discontinuation has on quality of care.

Human subjects will either continue to receive letters from the service when their tests are overdue or require additional clinical attention, or will no longer receive the service. All subjects will continue to receive care from their providers. The main outcomes include the frequency of recommended tests for CKD, the level of those tests, and utilization of health care services as indicated by claims data provided by EPMG. No additional data collection will occur beyond that which has been routinely done for clinical care. The study will continue for 36 months.

Eligibility Criteria:
Inclusion Criteria:

Receiving services from Patient Engagement Services at randomization. CKD Stages 1, 2 or 3. Under the care of Empire Physicians Medical Group of Palm Desert, California.

Exclusion Criteria:

Patient refusal.
Self-management of Anticoagulation Treatment

The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.

Patients (n=23) on anticoagulant treatment with warfarin participated in a 27 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek® XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for 28 weeks. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. Ten INR values and complications before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after 28 weeks of self-management.

Eligibility Criteria:
Inclusion Criteria:

* on life-long oral anticoagulation therapy
* Live in Bergen municipality
* Judged to be qualified for patient self-management anticoagulation treatment by their GP
* Motivated to follow the training program

Exclusion Criteria:

* Drug abuse
* Liver disease
Developing a Brief Intervention to Communicate Cardiovascular Risk to Patients Presenting to the Emergency Department with Chest Pain: a Co-Production Approach. Phase 2.

Some patients who come to the emergency department with chest pain and have not had a heart attack, are at an increased risk of having a heart attack in the future. We know this by taking a blood test (troponin) which looks at damage to their heart.

These patients are often sent home from hospital with no information about their risk of heart disease. A patient survey revealed that patients in the emergency department would like to receive more information about heart disease.

In this study we will provide patients who are at increased risk of cardiovascular disease with their troponin value. We will deliver this information within a cardiovascular brief intervention, which is a short conversation with a patient about their health. In a previous study we carried out some interviews with patients to find out how we should deliver their results and what information they would like to receive in a cardiovascular brief intervention. We also asked them the best way to provide patients with this information. The aim of this part of the study it to determine if the new cardiovascular brief intervention helps patients understand their risk and if it results in them making changes to their health.


Eligibility Criteria:
Inclusion Criteria:

* i) Patients who present to the Emergency Department with symptoms suggestive of acute coronary syndrome ii) A maximum high-sensitivity cardiac troponin I between 5 ng/L and the sex-specific 99th centile.

iii) Resides in Scotland and has a CHI number iv) Adults aged 18 and over v) No history of cardiovascular disease vi) At least 1 modifiable cardiovascular risk factor: current smoker, hypertension (140/90 mmHg), hypercholesterolaemia (\>6.0 mmol/L), overweight and obesity (BMI \>25), hyperglycaemia or diabetes mellitus.

vii) Patients who are able to provide informed consent

Exclusion Criteria:

* i) Patients with a diagnosis of acute coronary syndrome during index presentation ii) Patients who are not able to give informed consent iii) Patients who do not speak English iv) Patients who are unable to attend hospital as outpatient to receive the cardiovascular brief intervention v) Patients with ongoing or planned cardiovascular investigations or interventions vi) Patients with chronic kidney disease and a eGFR below 30 ml/min
Ischemia In Hemodialysed Patients: Ivabradine Versus Carvedilol

In hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. Most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. Among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. Ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. Aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

* documented CAD evidenced by either coronary angiography (\>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction
* transient ischemia evidenced by abnormalities during an exercise ECG (standard Bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry

Exclusion Criteria:

* unstable angina pectoris
* myocardial infarction or coronary revascularization within 3 months of study entry
* an ECG abnormality interfering with exercise ST-segment interpretation (eg, ST-segment depression \>0.5 mm, QRS duration \>0.1 second, R-wave amplitude \<8 mm,preexcitation,or atrial fibrillation)
* inability to undergo exercise testing
* uncontrolled hypertension
* other serious condition (medical, psychiatric, cognitive, or social)
* symptoms of sufficient severity (Canadian class II or higher) to require antianginal medications other than nitrates
* heart failure
* greater than first-degree atrio-ventricular block, asthma, or other contraindications to betablocker therapy
Five-year Outcome of Laparoscopic Gastric Sleeve

The aim of this study is to evaluate the long-term (5-year follow-up) results of laparoscopic gastric sleeve (LGS) in terms of weight loss and obesity related comorbidities, as well as the risk factors associated with postoperative nutritional deficiencies.

The consecutive patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital are followed prospectively in cohort study. The outpatient hospital follow-up visits are conducted at 3 months, 1 year and 5 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* The criteria for bariatric surgery: BMI of \>40, or \>35 with certain obesity related comorbidities

Exclusion Criteria:

* Patients who did not fill the inclusion criteria
Trial of Epinephrine and Albuterol in Bronchiolitis

The purpose of this study is to see which of the two most common drugs used to treat bronchiolitis works better. A child's participation in this study is expected to last less than 4 hours. Approximately 600 patients will be recruited to participate in this study at Kern Medical Center (KMC).

Bronchiolitis is a very common lung infection in babies. There are many drugs used to treat this disease but nobody knows which one, if any, works the best. Two of the most commonly used drugs are albuterol and epinephrine. These are both drugs given during breathing treatments with oxygen and a mask. We are doing this study to see which of these drugs works better or if they are both equally good. The study works as follows: after the consent process the baby gets three treatments.

* Nebulizer 1 (Treatment)
* Treatment + 30 minutes (approximately) Nebulizer 2
* Treatment + 60 minutes (approximately) Nebulizer 3
* Treatment + 120 minutes (approximately)

The baby will be reevaluated and either discharged home or revert to standard therapy. If the baby is discharged directly from the emergency department (E.D.), we will call you in three days time to see how he/she is doing.

Double blind RCT. Primary outcome measure is admission defined as actual admission or discharge with unscheduled return leading to admission within 72 hours. Secondary endpoints include change in severity of illness and response of respiratory parameters to treatment.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of bronchiolitis

Exclusion Criteria:

* Age greater than 18 months
* Disease too mild to warrant any treatment
* Emergent intubation on arrival at the ED
* Participation within another study within 30 days
* Refusal of informed parental consent
Metabolic, Physical Responses To Exercise In Patients With Type 2 Diabetes Mellitus

The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on metabolic parameters, physical measures, fitness level, body composition and miRNA-143 level in patients with type 2 diabetes mellitus.

Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, fitness level measured by exercise testing, body composition measured by bioimpedance, metabolic parameters such as blood glucose level, HbA1C and measured by blood tests.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have type 2 Diabetes mellitus less than 10 years and more than 1 year.
2. Participants must have appropriate medical therapy and diet.
3. Participants must not be treated with insulin.
4. Participants must be exercising less than 210 minutes/ week.

Exclusion Criteria:

1. Participants with prominent cardiovascular disease
2. Participants with coronary artery disease
3. Participants with moderate to severe valvular disease
4. Participants with atrial fibrillation
5. Participants with untreated hypertension
6. Participants with congenital heart disease
7. Participants with retinopathy
8. Participants with neuropathy
9. Participants with macro albuminuria
10. Participants with cerebrovascular disease
11. Participants with ejection fraction less than 40
12. Participants with body mass index greater than 35.
13. Participants with prominent ischemic changes in EKG at rest or during exercise.
14. Participants with cigarette or alcohol addiction
15. Participants on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones)
Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone

Buccal bone is prone to resorb after tooth extraction specially with immediate tooth implantation which could compromise the esthetics of the patient. socket shield technique retains the buccal aspect of the extracted root fragment which may help in preventing the buccal bone from resorbing and prevent esthetics deterioration

The alveolar ridge resorbs and collapses following tooth removal which continues to be a major concern for practitioners. Many researchers concluded that buccal aspect of the ridge is more prone to resorption, as it is primarily supplied by the periodontal tissues and ligments of the tooth. Therefore, extraction of the hopeless tooth, may be a reason for buccal cortical plate resorbing at a faster rate than the palatal plate leading to its total degradation. This may lead to dimensional changes in the human ridge and the aesthetic area is highly affected by this process. Several techniques in the litreture were proposed to solve the problem of thin buccal bone resorption with or without immediate implantation in the aesthetic area. Some of these techniques are the guided bone and soft tissue regenraton and bone augmentation but proved to be slight aggressive with high morbidity rate. Recently, several papers were published concerning the socket shield technique explaining how to maintain the ridge width and height. Socket shield technique that was first introduced in 2010 aids at retaining the buccal fragment of root in place and intact thus placing the implant behind the lingual aspect of that fragment so that the periodontal ligments and tissues preserve its vitality and aids in preventing the collapsing of the buccal bone. This would help in improving aesthetics especially during immediate implant placment in the anterior maxillary region.

Eligibility Criteria:
Inclusion Criteria:

* • Humans

  * Esthetic area (anterior and first premolars)
  * Intact labial plate
  * Hopeless tooth indicated for extraction and immediate implant placement

Exclusion Criteria:

* • Implantation after trauma

  * Peri-implantits defects
  * Use of barrier membranes(GBR)
  * Socket preservation
Nasya in Allergic Rhinitis

The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.


Eligibility Criteria:
Inclusion Criteria:

* History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years
* Written informed consent

Exclusion Criteria:

* Clinically significant disease that could interfere with the evaluation of study medication
* Participation in other studies within the last 4 weeks / during the study
Effects of Race Pace Based Approach in Recreational Runners

The aim of the study was to compare the performance effects of the intensity demarcation model based on the race pace based approach with the triphasic physiological model and heart rate variability guidelines (HR+HRV)

After being informed and signing informed consent about the present study, participants were randomly assigned to one of three groups before the intervention phase using a Web-based computer program (www.randomizer.org). Groups were matched on a 1:1:1 basis by gender, age, and performance in an official 10-km race in the previous month. Once selected, participants in the heart rate variability (HRV) group began daily measurements to obtain their personalized parameters.

The groups changed according to the intensity zone demarcation pattern: heart rate (HR), race pace (RP) and HR+HRV. The HR group was considered the active control group, as considered the current best practice according to the current literature in endurance running. A 4-week pre-intervention plus 6-week intervention program was set up.

Participants were assessed in four different sessions, two for laboratory evaluations and two for time trial performance. The first session consisted of a running economy test, and, after at least half an hour of rest, a maximal incremental treadmill run. They familiarised themselves with the training sessions according to their group (i.e., running based on HR, RP or HR+HRV guidelines, respectively).

The HRV4training mobile application (https://www.hrv4training.com) was used to assess HRV for one minute in the morning. The difference in RR intervals between heartbeats is used to calculate HRV. The program then uses this information to calculate the rMSSD and moving average (LnrMSSD7-d), converting the results to a number between 5 and 10. Then, the participant must answer a series of questions including his or her current physical state, sleep quality, muscle soreness, etc. After interpolating these variables, the application shows the subjective value derived from the body's reaction to stresses. As a result, daily indications are given in numerical form, with a range of normality (for HR and HRV) that varies each day depending on how the person reacts to stress. Participants were instructed to take the measurement as soon as they woke up, with an empty bladder, lying down, trying to limit movement, and breathing naturally

Training variables (total time, distance, total time spent in each zone) and Training Impulse (TRIMP) were the same for all groups

Eligibility Criteria:
Inclusion Criteria:

* Being adults
* VO2max between 45 and 60 mL·min-1·kg\^-1 for men
* VO2max between 40 and 55 mL·min\^-1 for women
* More than 4 days per week of training frequency
* Running experience ≥ 2 years
* Record HR data of all training sessions during the study

Exclusion Criteria:

* Previous injuries for at least three months
* Smokers
* Any cardiovascular condition that compromises health status and participation in the study