cyrilzakka/clinical-trials huggingface dataset:
Prospective Robotic-assisted Revisional Bariatric Study

Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older at the time of consent
2. Subject has a history of prior bariatric surgery
3. Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS)
4. Subject undergoes revisional bariatric surgery that is applicable to study

Exclusion Criteria:

1. Subject is undergoing a primary bariatric procedure
2. Subject has undergone more than one previous bariatric procedure
3. Subject's revisional bariatric procedure is an emergent procedure
4. Subject is contraindicated for general anesthesia or surgery
5. Subject is unable to comply with the follow-up visit schedule
6. Subject is pregnant or suspects pregnancy
7. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
8. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Effect of Green Coffee Extract Combined With Alpha-Lipoic Acid on Blood Glucose Homeostasis in Healthy Adults

Green coffee extract (GCE) supplementation has been shown to induce favourable health benefits on glucose metabolism and weight management. Previous literature suggests that the benefits of GCE are due to the high bioavailability of chlorogenic acid (CGA) which is known for its antioxidant and anti-inflammatory properties but is destroyed during the bean roasting process used to make coffee in Western societies. Whilst some studies examining chronic and high dose GCE supplementation (4-12 weeks) report beneficial effects on glucose metabolism and reductions in body mass following supplementation, comparably less is known about the effect of acute (single dose) GCE supplementation. Another natural compound, alpha-lipoic acid (ALA) has antioxidant properties and may also benefit glucose metabolism. The purpose of the current study is to determine the impact of acute supplementation of GCE with ALA on postprandial blood glucose concentration following consumption of a carbohydrate drink in healthy adults. A secondary objective is to evaluate the effect of GCE+ALA on blood insulin concentrations, insulin sensitivity, glucose oxidation, and perceptions of appetite.

The primary purpose of this study is to determine if GCE combined with ALA supplementation influences postprandial glucose metabolism. Participants will complete 3 visits to the investigator's laboratory at the University of Toronto. On each occasion, participants will consume a sugary drink (75g sugar) and investigators will take blood and breath samples for 2 hours. Participants will also be asked to fill out some questionnaires about appetite during this time. Thirty minutes before consuming the sugary drink, participants will consume one of the following pill supplements in a randomized order: 1) 200mg CGE + 200mg ALA; 2) 200mg GCE + 400mg ALA; or 3) Placebo (no CGE or ALA).

The study will advance knowledge regarding the effects of GCE and ALA on postprandial glycemia and insulin sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* BMI 20 - 30 kg/m2
* Weight stable (within ± 2kg for at least 6 months)
* Experiencing monthly menstrual periods (eumenorrheic) if female
* Non-smoker

Exclusion Criteria:

* Previous history of cardiovascular or metabolic disease
* Use of medication for managing blood glucose or lipid metabolism
* Current use of monophasic or biphasic oral contraceptives within the last 3 months (triphasic oral contraceptives are okay)
* Current supplementation of green coffee extract or supplementing in the last 3 months
* Irregular menstrual cycles (\<21 days or \>35 days)
* Pregnant or lactating
* Recreational smoking of any form (tobacco or cannabis)
* Not willing to consume the 24-hour control diet prior to metabolic trials
Effects of the Elastic Bandage on the Postural Balance of Young Women

Elastic Bandaging Therapy (BET) is a technique that consists of the application of elastic adhesive tape directed on a skin, and is used for pain reduction, improvement of flexibility, postural alignment. It is believed that it can help proprioception by increasing or reducing muscle tension by acting on motor coordination and balance. The present study aims to evaluate the effect of the application of different BET strategies on the postural balance of healthy young women through measures obtained through a proper instrument for a balance assessment, a force platform.


Eligibility Criteria:
Inclusion Criteria:

* women aged between 18 and 35 years;
* not present chronic pain defined as daily or almost daily pain during the last three months;
* not participate in rehabilitation programs.

Exclusion Criteria:

* present any type of neurological, cardiorespiratory, metabolic and / or orthopedic disease of high severity;
* vestibulopathies and labyrinthine crises;
* mental problems, attention and speech disorders;
* some other type of impediment or problem that interfered with physical and functional tests;
* Have undergone some kind of locomotor surgery;
* pregnancy;
* no participation in the three days of the research;
* lack of understanding or non-cooperation regarding research procedures and methods;
* do not volunteer.
Extended and Controlled Release Liposomal Formulated Dexamethasone for Chronic Knee OA Pain

Phase 3 randomized, double-blind, placebo- and active comparator-controlled study of TLC599.

This is a Phase 3 randomized, double-blind, placebo- and active comparator-controlled pivotal study. Approximately 500 adult patients with moderate to severe pain due to OA of the knee will be enrolled and randomized. All patients will be followed for a total of 52 weeks. Efficacy and safety of 2 doses of TLC599 will be evaluated in comparison to Placebo and DSP through Week 52.

Eligibility Criteria:
Inclusion Criteria:

Male or female ≥40 years of age. BMI ≤ 40 kg/m2. Radiographically documented OA with Kellgren-Lawrence severity Grade 2 or 3 and associated symptoms Patient-reported pain with NRS score ≥4 (on a 0-10 scale) Able to read, understand, and sign the informed consent form, communicate with the investigator, complete study diaries, and understand and comply with protocol requirements.

Exclusion Criteria:

Recent use of IA or systemic corticosteroids Patient who is not ambulatory Any surgery or arthroscopy in the index knee within 12 months Any condition that could possibly confound the patient's assessment of index knee pain Substance abuse disorder, or positive urine drug test for illegal drug substances History of acquired or congenital immunodeficiency diseases History of treated malignancy which is disease free for ≤5 years Known allergy or hypersensitivity to the study drugs or their components
Visual Outcomes After Vivity Toric IOL Implantation

The purpose of this study is to evaluate patient satisfaction after bilateral implantation of Vivity Toric Extended Vision Intraocular lens and visual outcomes.

To evaluate and report outcomes including postoperative uncorrected visual acuity, postoperative best corrected visual acuity, postoperative refractive error, and IOL rotational stability after Vivity Toric Extended Vision intraocular lens (IOL) implantation.

Eligibility Criteria:
Inclusion Criteria:

* Calculated lens power within study IOL range of 15.0 diopters to 25.0 diopters and toric range of T3 to T6
* Willing and able to comprehend informed consent form and to complete 1 day and 3-4 month postoperative visit
* Potential postoperative best corrected distance visual acuity of 20/20 or better in each eye based on medical opinion of investigator

Exclusion Criteria:

* Ocular pathology or comorbidity that could reduce potential postoperative best corrected distance visual acuity
* Ocular trauma or zonular weakness/instability
* Diagnosis of glaucoma or high-risk glaucoma suspect
* Previous refractive surgery
* Unreliable preoperative biometry measurements
* Severe dry eye or ocular surface disease
Identification of Predictors for Early Cognitive Decline in Men

The research program explores how aging influences brain function in test-persons from a Danish birth cohort of men born in 1953.

The research program explores how ageing influences brain function in healthy test-persons from a Danish birth cohort of men born in 1953 in the Metropolitan area of Copenhagen. These test-persons are divided into two groups based on performance in cognitive tests at late midlife compared to young adulthood; Positive expected performance and negative expected performance and sampled from a birth cohort of 11.532 men.

Additionally, persons diagnosed with either MCI or AD will be included from the Memory Clinic at Herlev Hospital.

Researchers aim to identify factors earlier in life that affects or predict changes in cognitive function, specifically of cognitive decline in order to predict healthy vs unhealthy cognitive ageing, including progression to possible dementia. The objective is to be able to predict cognitive decline in ageing.

During the years of data collection, approximately 550 participants will be included and examined.

The examinations include:

* Cognitive test including Cambridge Neuropsychological test automated Battery (CANTAB);
* Sleep
* Life events
* Depression questionnaire
* Blood sample analysis including functional analyses of mitochondria and gene analyses such as genome scanning, SNP analysis
* ApoE ε-type
* Structural and functional changes in the brain measured with magnetic resonance (fMRI)
* Electroencephalography (EEG) recordings of electrical activity and visual attention
* PET-scan (Amyloid and FDG)

The results from these studies will hopefully point to new avenues for intervention in order to change the course of brain ageing

Eligibility Criteria:
Inclusion Criteria:

* Participants who have participated in the Metropolit study and the Copenhagen Aging and Midlife Biobank project
* Participants who have been informed about the project and who have signed the informed consent form

Exclusion Criteria:

* Persons who have been asked to participate in the past and have rejected
* Reduced ability to understand project information
* Reduced ability to complete the examinations
* Abuse of alcohol, psychedelic drugs or habit-forming drugs
* Certain neurological disorders
* Certain neurological, mental or psychiatric diagnoses
* Certain depressive diseases
* Former traumatic brain injury
* Contraindication for MR scanning
* Pathological MR result
* Persons that do not like to be informed about a possible pathological result
KRN125 for Mobilization of Hematopoietic Stem Cells

Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.

KRN125 is administered as a single SC dose to the Day 1. The stem cell mobilization protocols will be monitored for safety and efficacy during the mobilization period.

Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects aged 20 to 55 years or younger at the submission of the written informed consent form
* Women weighing 40 kg or more and 80 kg or less and men weighing 45 kg or more and 80 kg or less at the time of the preliminary examination

Exclusion Criteria:

* Subjects with a current medical history or who have been judged to be inappropriate for the study (e.g., significant neurological, hepatic, renal, endocrine, cardiovascular, blood, gastrointestinal, respiratory, and metabolic diseases, malignancies, myeloproliferative disorder, or psychiatric disorders)
* Individuals with alcohol or drug dependence, or individuals who have not tested negative for all drugs of abuse in the preliminary test
* Subjects with a history or current history of drug allergy or symptomatic allergy
* .Active infection or history of recurrent infection- However, only patients who are HBsantibody-positive by hepatitis B vaccination and whose HBV-DNA is less than the lower limit of quantitation will be allowed to participate in this study.
* Subjects who used drugs within 2 weeks before administration of the investigational drug.
* Subjects who have had at least 200 mL of blood drawn within 3 months before administration of the investigational drug.
* Pregnant or lactating
Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration

Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.

While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue.

Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included.

With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Hemodialysis more than 3 months because of end-stage renal disease
* Consent to the study protocol

Exclusion Criteria:

* Already receiving online hemodiafiltration before study enrollment
* Dialysis schedule other than three times per week (e.g., once per week)
* Receiving concurrent peritoneal dialysis
* Having a plan to receive kidney transplantation within 1 year
* Having multiple myeloma or monoclonal gammopathy
* Having advanced or active malignancy
* Having a plan to be pregnant or being pregnant / breast-feeding or not having a plan to use contraception
* Participating in other clinical trials
Hypertensive Heart Failure Treatment in SSA

Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.

A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.

We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.

Even though, the African-American Heart Failure Trial (A- HeFT) demonstrated that a combination ISDN and HYD (BiDil) improved survival among African-American patients with HF, when compared to placebo, there is no trial on chronic heart failure patients secondary to hypertensive heart disease which is the commonest etiological factor for heart failure in sub-Saharan Africa.

A previous study (The Bi treatment with hydralazine/nitrate versus placebo in Africans admitted with acute Heart Failure (BAHEF) which was on acute heart failure patients with varying aetiology, was under powered as the study could not achieve the estimated sample size because of logistic issues.

We therefore are trying to determine the feasibility of a randomised, open-label, parallel group, two-arm, superiority trial of ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA. To determine the tolerability of ISDN and hydralazine in sSA.

The secondary objectives on the other hand are:

1. To determine fidelity to the trial protocol and CRF by investigators when completing a trial utilising ISDN and hydralazine in patients with chronic hypertensive heart failure in sSA.
2. To determine the effect of ISDN-HYD on the following:

   * Death and hospitalisation rates
   * Changes in office BP
   * Changes in 6MWT
   * Changes in echocardiographic left ventricular ejection fraction

Eligibility Criteria:
Inclusion Criteria:

* Black male or female aged 18 years
* Evidence of hypertensive heart failure
* LVEF \<40% as assessed by 2D echocardiography (modified Simpson method)
* Ability to provide written informed consent for participation in the study
* Available for regular follow-up as outlined in the schedule of assessments

Exclusion Criteria:

* Evidence of heart failure from a cause other than hypertension
* A cardiovascular/cerebrovascular event/intervention in the last three months (e.g., acute
* coronary syndrome, unstable angina, MI, PCI, CABG, stroke, carotid endarterectomy, etc.,)
* Office SBP \<100 mmHg or DBP \<70 mmHg
* Marked renal impairment (e.g., eGFR \<45 mls/min at screening, dialysis)
* Marked hepatic impairment (e.g., history of chronic liver disease, γGT/bilirubin/ALP/ALT

  * twice the upper limit of normal)
To Validate the Specific Patterns of Magnetocardiography, a Non-invasive Non-contact Examination for Patients With Ischemic Heart Disease or Cardiac Arrhythmia

ECG is one of the most important non-invasive method to diagnose CAD and arrhythmia. However, clinically it still has its limitation. Because the electrical field could induce a magnetic field, the newly developed non-contact technique, magnetocardiography, was established to detect the local magnetic field component of the heart. It is safe and more convenient. In this study, we try to define and validate the magnetocardiographic patterns in the patients with cardiac arrhythmias or ischemia.


Eligibility Criteria:
Patient enrollment:

* patients older than 18 years old,
* having received 1) 12-lead ECG examination for suspected cardiac arrhythmias or 2) stress tests for suspected coronary artery disease, will be invited.
* The patients who have medical devices made of metallic or magnetic material (ex. pacemaker, mechanical valve and arthroplasty) will be excluded to prevent the experimental bias.
Treatment of Fecal Incontinence and Constipation in Patients With Spinal Cord Injury

The study aims to compare a newly developed system for transanal colonic irrigation (Peristeen Anal Irrigation) with a bowel management regime that does not include irrigation in a prospective, randomized trial in spinal cord lesion patients (SCL- patients) with faecal incontinence and/or constipation.

Population; 80 SCL- patients with faecal incontinence and/or constipation from five countries.

Focus on:

Bowel symptom score Neurogenic Bowel Dysfunction score Symptom related quality of life questionnaire Time expenditure for performance of bowel care ans side effects

The magnitude of bowel dysfunction in spinal cord injury patients has been documented in several studies. Spinal cord injury affects colorectal motility, transit times, and bowel emptying often leading to constipation, fecal incontinence or a combination of both. Although these symptoms are not life-threatening, they may have a severe impact on quality of life as well as increase levels of anxiety and depression.

Various bowel management programs have been empirical, and individual solutions have been sought on a trial-and-error basis. Transanal irrigation has been used in selected patients with constipation or fecal incontinence. The majority of spinal cord injured patients in a recent study benefited from the treatment. However, there is limited evidence in the literature supporting any bowel management program in spinal cord injury in favor of another and well-designed controlled trials are still lacking. Therefore, the present study aims to compare transanal irrigation with conservative bowel management, defined as best supportive bowel care without irrigation, in a prospective, randomized, controlled, multicentre study among spinal cord injured patients with neurogenic bowel dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Spinal cord lesion at any level at least 3 months from injury
* At least one or more of the following symptoms:
* Spending ½ hour or more attempting to defecate each day or every second day
* Symptoms of autonomic dysreflexia before or during defecation
* Abdominal discomfort before or during defecation
* Episodes of faecal incontinence once or more per month
* The patient is able to understand the treatment and is willing to comply with the prescribed regimen
* The patient is able to perform transanal colonic irrigation seated on a toilet commode with or without assistance
* Signed informed consent has been obtained

Exclusion Criteria:

* Co-existing major unsolved physical problems due to the injury
* Perform transanal retrograde irrigation on a regular basis
* Evidence of bowel obstruction
* Evidence of inflammatory bowel disease
* History of cerebral palsy or cerebral apoplexy
* Multiple sclerosis
* Diabetic polyneuropathy
* Previous abdominal or perianal surgery (not including minor surgery as appendectomy or haemorrhoidectomy)
* Pregnant or lactating
* Evidence of spinal chock
* Mentally unstable
* Treatment with more than 5 mg prednisolon per day.
* PNS implant (sacral nerve stimulation)