cyrilzakka/clinical-trials huggingface dataset:
Collagen Paste vs Mucosal Advancement Flap for FIA

The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.

Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle. With this technique, it shows promising results with success rate of approximately 60%. However, complications have been reported, in particular with a change of continence in 30-35% of patients.

Collagen paste is a novel sphincter-preserving method for fistula closure. Permacol (Medtronic, USA) is a sterile acellular cross-linked porcine dermal collagen matrix suspension. The paste-like suspension form a matrix that accelerates neovascularization, cellular infiltration which promotes healing and fistula closure. The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract. This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement. Limited data is available to date. Success rates of collagen paste range from 47.6% to 63%. Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of high cryptoglandular fistula-in-ano.
* Patients must have undergone a prior EUA to characterise the nature of the fistula.
* The fistula tract should be ≥ 2 cm in length.
* Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain.
* Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation.
* Patients must be aged ≥ 18 years and able to provide informed consent.
* Fistulas must be of cryptoglandular aetiology.

Exclusion Criteria:

* Unable/unwilling to provide informed consent.
* Contraindication to general anaesthesia or spinal anaesthesia.
* Low trans-sphincteric fistulas.
* Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.).
* Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.).
* Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug.
* Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail.
* Cultural or religious objection to the use of pig tissue.
* Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker).
* Patients with recurrent anal fistulas previously treated with a fistula plug.
Effects of Xanthohumol on Resting Energy Expenditure and Substrate Oxidation in Healthy Women

The aim of this study is to investigate the effects of Xanthohumol on resting energy expenditure and substrate oxidation in healthy women. It is assumed that resting energy expenditure and fatty acid oxidation is higher after Xanthohumol ingestion.

In a crossover design, 16 healthy young women ingest 172 mg micellar solubilized Xanthohumol or placebo in a randomized fashion. During an observational period of 3 hours, the acute effects of Xanthohumol on the resting energy expenditure and substrate oxidation is determined by respiratory gas analysis. An additional 30-minute determination of the resting energy expenditure and substrate oxidation is executed 24 hours after Xanthohumol ingestion. The wash-out period will be 28 days.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 18,5 - 24,9 kg/m2
* metabolically healthy
* written consent

Exclusion Criteria:

* smoking
* low or high blood pressure
* dyslipidemia
* insulin resistance or diabetes mellitus type 1 or type 2
* gastrointestinal diseases (e.g. food intolerances or allergies)
* liver, kidney and/or thyroid diseases
* hepatitis B or C, HIV Infection
* chronic inflammatory diseases
* disordered eating
* psychological diseases
* alcohol and/or drug abuse
* use of medication
* pregnancy or lactating
* participation in another intervention study
* irregular menstrual cycle
* more than 6 hours of sports per week
Differences In The Severity Of Diabetic Neuropathy Based On Electromyography In Type 2 Diabetes Mellitus Patients With And Without Comorbidities

The goal of this clinical trial is to learn the differences severity level of diabetic neuropathy based on electromyelography in type II diabetic patient with and without comorbidities. The main questions of this study:

1. What is the electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
2. Is there any differences in electromyography result in type II diabetic patient who: has no comorbidities, with hypertension, with hypertension and dyslipidemia?
3. Is there any association between distal latency with nerve conduction velocity in type II diabetic patient with and without comorbidities?
4. Is there any association between distal latency with amplitude in type II diabetic patient with and without comorbidities?
5. Is there any differences on diabetic neuropathy severity based on age, height, and A1C levels in type II diabetic patient with and without comorbidities?

Researchers will collect information based on hospital registry as secondary data of in type II diabetic patient with and without comorbidities. The data consist of demographic data, clinical presentation, laboratory, and electromyography were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic neuropathy patient who classified as distal symmetrical polyneuropathy
* Diabetic neuropathy patient who has no comorbidities
* Diabetic neuropathy patient who has hypertension
* Diabetic neuropathy patient who has hypertension and dyslipidemia

Exclusion Criteria:

* Diabetic neuropathy patient with history of chemotherapy
* Diabetic neuropathy patient with history of hernia nucleus pulposus
* Diabetic neuropathy patient with history of CKD stage V or on routine dyalisis
* Missing data on medical record
Virtual Reality Assisted Conscious Sedation During TAVI

Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.


Eligibility Criteria:
Inclusion Criteria:

* Interventional transfemoral TAVI
* Informed consent
* Normal or corrected vision (through glasses)

Exclusion Criteria:

* Patients whose communication is limited due to a language barrier
* Patients who could not watch the 3D video due to uncorrectable vision
* all patients with transapical TAVI were also excluded.
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake

The investigators hypothesize that different types of starch vary in their effects on appetite, blood sugar and food intake. In this study, subjects consumed five soups containing 50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added starch at one week intervals. The investigators measured food intake at 30 minutes, appetite and blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males with a BMI of 20-24.9 kg/m2

Exclusion Criteria:

* Females
* Smokers
* Breakfast skippers
* Individuals with diabetes or other metabolic diseases
Changes of Parameters of Transcranial Magnetic Stimulation in Patients With Spinal Cord Injury

CNS reorganization is evidenced in patients with CNS lesion, no exception to the patients with spinal cord injury. The paraplegics have to increase their loading of upper extremities to compesate the lost function of lower extremities. We hypothesize that CNS reorganization can happen in the chronic paraplegics. We try to compare the changes of parameters of transcranial magnetic stimulation in these patients with the normal population cross-sectionally.


Eligibility Criteria:
Inclusion Criteria:

* patients with complete thoracic spinal cord injury
* onset \> 6 months
* ASIA scale: A
* normal bilateral upper extremities

Exclusion Criteria:

* Evidence of brain injury
* Evidence of peripheral neuropathy
* Active major medical diseases (eg: fever, maligancies, DM, liver or kidney diseases)
A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.

This was a Phase 2/3, multicenter study offered to participants who received at least one dose of an ABT-493- and/or ABT-530-containing regimen at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV and elected to enroll in this study. The participant must have completed the follow-up period of the prior eligible AbbVie study. Participants were followed for a total of approximately 3 years after their last dose of DAA in the previous HCV clinical study. The 3 years were inclusive of any post-treatment period in the prior study, as well as any gaps between the end of the prior study and enrollment in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is male or female 18 years of age or older
2. Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study
3. The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA) therapy from the previous clinical study and enrollment in Study M13-576 must be no longer than 2 years for subjects who have not been retreated. Participants who have been treated with a commercially available anti-HCV treatment may be enrolled greater than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical study.
4. Participant must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures.
5. Participant completed the post-treatment period of an eligible prior study.

Exclusion Criteria:

1. The investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study).
2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.
3. Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530.
4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.
Evaluating the Safety and Effectiveness of the Flex Robotic System for the Surgical Removal of Colorectal Lesions

This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.

PRIMARY OBJECTIVE:

I. To assess the rates of complete en bloc resection and adverse events of the Flex Robotic System for distal colorectal lesions.

OUTLINE:

Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 22 years (minimum age approved for use)
* Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification
* Colorectal lesions situated between 5 and 15 cm from the dentate line
* Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter
* Colorectal subepithelial lesions \< 2 cm in size
* Absence of uncorrectable bleeding disorder or coagulopathy
* Platelet count \> 50,000
* International normalized ratio (INR) \< 1.5
* Ability to give informed consent

Exclusion Criteria:

* Inability to receive general anesthesia
* Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy)
* Excavated (0-III) colorectal lesions according to Paris classification
* Suboptimal colon preparation
* Clinical discretion of the provider
Radiofrequency Ablation of Ectopic Atrial Tachycardia

A retrospective chart review will be performed on 50 patients who received RFA for the treatment of EAT between August 1992 and August 2003 at Children's Healthcare of Atlanta.

The use of the CARTO/Biosense catheter has improved outcomes with decreased radiation exposure to patients.

Ectopic Atrial Tachycardia (EAT) is a relatively rare arrhythmia in the pediatric population. It is defined by a run of more than 3 premature atrial contractions together. In EAT, the arrhythmia tends to increase in rate over a period of time and then slows down gradually to a normal rhythm. Ectopic Atrial Tachycardia (EAT) is mostly encountered in patients with structurally normal hearts however, occasionally physicians do observe this type of disorder in children following surgery for congenital heart defects. Current reports suggest that EAT occurs in approximately 1 in 10,000 children (Hamilton, 2002).

Children with EAT usually present with a multitude of symptoms. The most common symptoms associated with pediatric EAT are palpitations, chest pain, lightheadedness, presyncope, and dyspnea. Other symptoms can include exercise intolerance and congestive heart failure. These are usually late manifestations. In the patients with tachycardia induced CM, the time of development of CM is dependent on the rate and duration of the tachycardia however, in most cases, dilation is present upon diagnosis. This CM can be reversed with successful treatment of the arrhythmia.

The treatment for chronic EAT includes medications such as adenosine and for difficult to control cases, Radiofrequency Ablation (RFA). RF ablation has been successful in curing EAT, with success rates ranging from 75-100%. It has been shown that the complication rates are similar to other RF ablation procedures, with a higher risk of recurrence (Hamilton, 2002).

At Children's Healthcare of Atlanta, the cardiac catheterization lab performs approximately 10 Radiofrequency ablations for EAT each year. The goal of this retrospective review is to assess the frequency of recurrence of the EAT among a subset of patients receiving treatment between August 1992 - August 2003

Eligibility Criteria:
Inclusion Criteria:

* 50 patients who received RFA for treatment of EAT between August 2992 and August 2003
* Treatment at Children's Healthcare of Atlanta

Exclusion Criteria:

* those who do not meet inclusion criteria
Feasibility Pilot for the ReBOO-trial

This is a pilot testing the feasibility of the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' trial (ReBOO-trial). The full-scale ReBOO will further investigate safety and efficacy of intragastric injections of botulinum toxin A into the antrum area of the stomach. These injections will be repeated every six months.

The study sample will be adolescents with obesity who have not responded to standard conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Written (signed) informed consent
2. Age and gender adjusted body mass index (ISO-BMI) ≥ 35 or ISO-BMI \> 30 with comorbidities including hypertension, non-alcoholic fatty liver disease, hyperlipidemia or impaired glucose tolerance
3. Having partaken in a comprehensive multi-disciplinary lifestyle treatment for obesity of duration 12 months or more, without achieving a clinically significant weight loss (non-responder)

Exclusion Criteria:

1. Known hypersensitivity to excipients in the investigational medicine product (IMP)
2. Neuromuscular disorders
3. History of dysphagia
4. History of aspiration tendency or aspiration pneumonia
5. Known lung disease under continuous treatment
6. Congenital or acquired heart disease
7. Previous experience of side effects to Botulinum toxin type A
8. Present gastric diseases or dysfunction
9. Previous bariatric surgery
10. History of cancer
11. Serious binge eating disorder
12. Untreated hypothyroidism
13. Use of aminoglycoside antibiotics or spectinomycin in the week prior to injection, or any other medicinal product that interfere with neuromuscular transmission (neuromuscular blocking agents)
14. Medication known to affect appetite
15. Syndromic obesity
16. Mentally immature to a degree that there is doubt about the subject's ability to assent
17. Issues relating to language or culture that may complicate trial participation
18. Pregnancy or breastfeeding
Electrostimulation PROTOCOL Incontinence

To verify the effect of an adapted electrostimulation (EE) protocol for stress and mixed urinary incontinence (SUI / M) and its impact on quality of life (QoL)

Controlled and randomized clinical trial performed at the Physiotherapy Outpatient Clinic at the Magalhães Neto Pavilion of ComHUPES / UFBA. Women aged between 30 and 65 years and diagnosis of SUI / IUM. The patients were allocated to two groups (GA) submitted to selective electrostimulation for tonic fiber, phasic fibers IIa / IIb and different times of electrical stimulation; (GB) used 50hz for all fibers by 20mm, both answered the questionnaire King's Health Questionnaire (KHQ).

Eligibility Criteria:
Inclusion Criteria:

* women between the ages of 30 and 65
* With diagnosis of stress urinary incontinence and / or mixed
* Perineal muscle weakness
* Accepted to sign the TCLE

Exclusion Criteria:

* Women with neurological changes
* Pregnant women
* IUD use
* Pacemaker
* Genitourinary tract infection
* Cancer
* Refuse to sign the TCLE
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
* Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
* Subject has a Screening serum urate level ≥ 8 mg/dL.
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Subject is unable to take colchicine for gout flare prophylaxis.
* Subject has a history or suspicion of kidney stones.
* Subject has any gastrointestinal disorder that affects motility and/or absorption.
* Subject had unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
* Subject has Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
* Subject has an estimated creatinine clearance \< 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
* Subject is taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing.
* Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.