cyrilzakka/clinical-trials huggingface dataset:
Intensive Insulin Treatment and Ischemic Foot Ulcer

We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional insulin treatment (ICT) compared to standard insulin treatment (ST).

The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomiz (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.

In the present study, 96 patients from the SDIS study were asked to participate in current study and to investigate their skin microcirculation, in which 72 patients agreed (ICT; n=35 vs. ST; n=37). Also, nineteen healthy subjects participated as controls for the method of iontophoresis, with no intention to be followed-up. Exclusions criteria were; any history or ongoing ischemic foot ulcer or peripheral artery disease or osteoartropathy. The iontophoresis investigation took place 5.5 years ± 2 months, after the primary randomization ceased (7.5 years). All participants (except the control subjects) were then followed-up until first time hospitalization for ischemic foot ulcer or until 31 december 2011.

Eligibility Criteria:
Inclusion Criteria:

Born 1930 or later, Type 1 diabetes appearing at age 30 or earlier and with insulin dependency within 1 year from diagnosis, no known abuse of alcohol or drugs, non-prolipherative retinopathy of any degree present, no previous photocoagulation, normal serum creatinine, unsatsifactory blood glucose control according to the physician in charge of the patients.

Exclusion Criteria:

Any history or ongoing ischemic foot ulcer,or peripheral artery disease,or osteoartropathy.
Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment.
* No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
* Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout period.
* Demonstrating a Screening Baseline FEV1 that is 50 - 90% of predicted normal value.
* Demonstrating at least a 12% Airway Reversibility.
* Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter.
* Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study.

Exclusion Criteria:

* A smoking history of 10-pack years, or having smoked within 12 months of screening.
* Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma.
* Concurrent clinically significant diseases.
* Known intolerance or hypersensitivity to any component of the study drugs.
* Recent infection of the respiratory tract, before screening.
* Use of prohibited medications.
* Having been on other investigational drug/device studies in the last 30 days prior to screening.
* Known or highly suspected substance abuse.
Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA \< 50 copies/mL, at 12 months after initiating or switching to bictegravir/ emtricitabine/tenofovir alafenamide (B/F/TAF).


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* Signed informed consent
* Initiating treatment with B/F/TAF

Exclusion Criteria:

* Participation in any interventional clinical trial
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels

This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted.

This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted. Cohorts of Subjects will be given a single, ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ages 21 to 75 inclusive. Female subjects must be of non-childbearing potential;
* Has at the Screening Visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;
* The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the Screening Visit
* Has adequate venous access and able to receive IV therapy;
* Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;

Exclusion Criteria:

* Prior exposure to any experimental or marketed uricase;
* History of any allergy to pegylated products,
* Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;
* History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
* Has participated in a clinical trial within 30 days of the Screening;
Capillary Versus Suction Needle Aspiration for Endobronchial Ultrasound (EBUS) Biopsies.

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration is a procedure used to obtain tissue samples (biopsies) of lymph nodes near the airways or of lung tumours growing in close proximity to the airways. Briefly, an endoscope with an ultrasound probe which is inserted through the mouth and into the airways. Once in the airways, the ultrasound allows for identification of the optimal biopsy site; a hollow biopsy needle is then inserted into the tissue under real-time ultrasound visualization and a sample is extracted.

In the investigator's centre, the extracted sample is then immediately subjected to rapid on-site evaluation (ROSE). During the ROSE procedure, a cytotechnologist uses part of the sample to make a limited number direct smears which are then rapidly stained and evaluated under a microscope by the cytotechnologist. The cytotechnologist provides an assessment of the adequacy of the sample for diagnosis. The respirologist performing the EBUS then uses this information to: i) determine whether additional sampling is required, and ii) triage any additional samples for ancillary studies as needed. A final cytopathological diagnosis is established several days later, when all of the material from the procedure (including the material not evaluated at ROSE) is examined by a cytopathologist.

There are different techniques which are utilized to perform the needle aspiration biopsy. Suction aspiration (where pressure suction is applied to the needle to draw out material) which is the standard at many centres around the world and capilliary suction (where a tiny wire is drawn back slowly to create more gentle suction force) which is utilized often at LHSC.

The purpose of this study is to evaluate for differences in ROSE adequacy between these two methods.


Eligibility Criteria:
Inclusion Criteria:

* Patient age greater to or equal than 18 years old
* Receiving an endobronchial ultrasound for any diagnostic reason

Exclusion Criteria:

* Patients under 18 years old
* Patient refuses consent to undergo endobronchial ultrasound or is incapable of decision making.
Satisfaction Survey - Cicaplast Mains

The participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. They are evaluated before and after treatment.

The international, open, observational survey is conducted in 3 different countries.

Regarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes "Satisfied + Very satisfied" vs. "Neither satisfied nor dissatisfied + Not so satisfied + Not at all satisfied". The 95% Confidence Interval (CI) of the percent of "Satisfied + Very satisfied" is also given.

On patients who already used cream at the inclusion, the following analyses are performed:

* Cross-tabulation between both visits,
* Test of the evolution between both visits using a special procedure for ordinal data with repeated measures,
* Description of a summary variable in 3 classes (Improved / No change / Worsened).

For the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. The difference Evaluation-Inclusion is also given. The evolution of the sign is performed by a Wilcoxon test for matched samples.

Eligibility Criteria:
Inclusion Criteria:

* professionals that work on different activities related to hair in a beauty salon
* professionals presenting with current hand problems such as dryness, redness, irritations, cracks and fissures

Exclusion Criteria:

- professionals that do not meet the inclusion criteria
Trabeculectomy With Ologen Collagen Implant vs Trabeculectomy With Provisc in Steroid Induced Glaucoma

The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.

Steroid induced glaucoma is a well known and widely described disastrous clinical condition. However the subject of selection of most effective and safe treatment modality is still being discussed.

Sihota R et al reported that 26.5% cases required surgical treatment to control IOP. Unfortunately survival rate of successful blebs in 10 years after trabeculectomy varies from 40% to 60%. Anti-fibrotic agent MMC as adjunct to filtration surgery was used to prevent postoperative scarring that could compromise surgical success of trabeculectomy. Additional use of MMC in trabeculectomy leads to low final IOP but could be associated with such complications as cataract formation, intraocular toxicity, avascular filtering blebs, wound leakage, subsequent blebitis and endophthalmitis. Tissue-engineered biodegradable and biocompatible implant Ologen® Collagen Matrix may be used as an alternative to MMC. Ologen® is CE Mark and FDA approved artificial porcine extracellular matrix for modulating wound healing. Ologen® has been tested in animal models and has triple action:

1. prevent the collapse of the subconjunctival space;
2. guides the fibroblast to grow through the matrix pores thus preventing scar formation;
3. may act as an aqueous reservoir (avoids post-op hyperfiltration and shallow anterior chamber).

The filtering blebs scoring was performed by using Moorfields Bleb Grading System and Visante anterior segment optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 16 years (inclusive)
* Patients with medically uncontrolled steroid induced glaucoma

Exclusion Criteria:

* Primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic, neovascular, or dysgenetic glaucoma
* Known allergic reaction to porcine collagen
* Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)
Neurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults

It is now widely accepted that autism is linked to a developmental disorder and cerebral function.

Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F Bonnet-Brilhault is responsible for team "Autism") hypothesizes that atypical sensory information processing, especially auditory and / or visual information, could underly the symptoms observed in autism. A better knowledge of the typical development of the sensory and cognitive processes must therefore make it possible in the long term to identify the abnormalities linked to the autism spectrum disorders (ASD).

Studies in healthy subjects are therefore necessary in order to identify neurophysiological indices of cerebral functioning and to study their evolution during normal development, making it possible in the future to compare with populations of subjects with ASD.

The investigators intend to study the development of all the cognitive processes involved in the processing of sensory and, in particular, auditory and visual information in humans: from low-level perception processes to higher-level cognitive processes (attention, emotion, language, prediction, ...). For this the investigators will use non-invasive neurophysiological explorations (EEG, eye tracking) as well as neuropsychological explorations (Questionnaires or spontaneous language recording).

A better understanding of the pathophysiological mechanisms underlying the symptoms observed in autism could ultimately lead to the development of new specific therapeutic strategies, particularly in the field of exchange and development therapy or cognitive remediation .


Eligibility Criteria:
Inclusion Criteria:

* Between 1 and 60 years-old
* Able to understand and apply instructions for a task
* Information of subject or legal representant
* Informed written consent of subject or legal representant
* Affiliation to the social security system

Exclusion Criteria:

* Abnormal corrected vision
* Abnormal audition
* Known personal neurological pathology
* Known personal psychiatric problems
* Identified difficulties for walking, language, or learning
* Exclusion period because of participation to another experimental protocol
* Adult with legal protection
A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of trazodone hydrochloride prolonged-release tablets for treatment of depression in Chinese population.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65, males and females, outpatients or inpatients;
2. Single episode or recurrent depression according to DSM-IV (Version 4) criteria;
3. Scores \> 18 on 17-item HAM-D at screening and baseline visits with a decrease not exceeding 20% between the two visits;
4. Symptoms of depression for at least 1 month;
5. Patients or their dependents/guardians providing signed informed consent forms.

Exclusion Criteria:

1. Serious suicide attempts (≥ 3 on item 3 'Suicide' of HAMD);
2. Depressive episode, with psychotic symptoms;
3. Refractory depression;
4. Depressive episode secondary to other mental or physical disorders;
5. Bipolar disorder;
6. Significant reduction in body weight and malnutrition induced by major depression;
7. Serious or unstable heart, hepatic, renal, endocrine and hematologic disease or malignant tumors;
Cryoprobe Versus Forceps for Transbronchial Biopsy

The purpose of this study is to compare the effectiveness of transbronchial biopsy done by a 1.1mm cryoprobe versus the standard 2.0mm forceps.

A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe.

For this study, patients will be randomized in a 1:1 fashion to transbronchial biopsy using a 1.1 mm cryoprobe versus 2.0 mm forceps, stratified by indication (evaluation of lung transplant allograft, diffuse parenchymal lung disease or pulmonary parenchymal lesion). Blinding of the proceduralist is not possible due to the nature of the procedure. Pathologists interpreting the biopsy samples will be blinded to the biopsy device used.

Patients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, ≥ 18-years-old
* Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care

Exclusion Criteria:

* Pregnant or nursing woman or woman of child-bearing potential who refuse to take a pregnancy test prior to enrollment
* Severe pulmonary hypertension (RVSP \> 60 mmHg)
* Stroke within the last 6 months or myocardial infarction within the last 3 months
* Presence of bleeding disorder
* Platelet count \< 50,000 per mL at time of enrollment
* Use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended time prior to invasive procedure (aspirin monotherapy is acceptable)
* Do Not Resuscitate (DNR) status
* Do Not Intubate (DNI) status
The Effect of Acupressure on Fatigue

In this study, it is aimed to determine the effect of acupressure on fatigue in nursing students.

In this study, 68 nursing students were randomly assigned to the acupressure and placebo (sham) acupressure groups. In the acupressure group (n=34), compression was applied to the 7th point of the heart meridian (HT7), the 4th point of the large intestine meridian (LI4), the 36th point of the stomach meridian (ST36), and the 6th point of the spleen meridian (SP6). Depending on the preparation and compression time at each point, the session duration of each student lasted an average of 20 minutes. In the sham group (n=34), pressure was applied approximately 1-1.5 cm away from the HT7, LI4, ST36, SP6 points. In the sham group, the acupressure application time lasted for an average of 20 minutes. At the end of the application, after the data collection process was completed, the sham group was taught the correct acupuncture points. Students applied acupressure three times a week for a total of 12 sessions for four weeks. Data were collected before and four weeks after the application in the acupressure and sham acupressure groups.

Eligibility Criteria:
Inclusion Criteria:

* Students studying at Mersin University Faculty of Nursing as 4th grade during the data collection date,
* Those who agree to participate in the study,
* No deformity or lesions in the areas where acupressure will be applied
* No acupressure experience
* No sleep disorder diagnosis and no medical treatment
* No diagnosis of anxiety disorder and no medical treatment No diagnosis of depression and no medical treatment
* Coffee, cigarette and alcohol-free,
* No mental illness,
* Able to understand and speak Turkish and
* Those who signed the Informed Consent Form will be included in the study.

Exclusion Criteria:

* Students studying at Mersin University Faculty of Nursing outside the 4th grade during the data collection date,
* Those who do not agree to participate in the study,
* Those who have any deformity or lesion in the areas where acupressure will be applied
* Experienced with acupressure
* Diagnosed with sleep disorder and receiving medical treatment
* Diagnosed with anxiety disorder and receiving medical treatment
* Diagnosed with depression and receiving medical treatment
* Coffee, cigarette and alcohol addiction,
* Having mental illness,
* who cannot understand or speak Turkish
* Those who do not sign the Informed Consent Form will not be included in the study.
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence

This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.


Eligibility Criteria:
Primary Inclusion Criteria:

1. Women and men between 18 and 80 years old.
2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months.
3. Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
4. Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.

Primary Exclusion Criteria:

1. Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
2. Clinically significant bladder outlet obstruction.
3. Clinically significant pelvic organ prolapse beyond the hymenal ring.
4. Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
Single Dose Flecainide for Early Sinus Rhythm Conversion of Perioperative Atrial Fibrillation After Noncardiac Surgery

Investigator-initiated pilot study of single dose oral flecainide versus no flecainide for the early conversion of perioperative atrial fibrillation to sinus rhythm after noncardiac surgery.

FLIP-AF is a prospective, randomized, open-label trial of single dose flecainide versus no flecainide in patients with perioperative atrial fibrillation after noncardiac surgery. The primary objective is to determine whether it is feasible to conduct a large randomized controlled trial assessing the efficacy and safety of single dose flecainide in this population.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Noncardiac surgery in the last 30 days requiring an overnight hospital admission;
* Presence of AF (i.e., atrial fibrillation and/or flutter) with a ventricular heart rate of ≥ 100 beats per minute at any time within 12 hours prior to randomization;
* In AF at the time of randomization; AND,
* Provided written informed consent.

Exclusion Criteria:

* History of AF without normal sinus rhythm documented within 90 days prior to randomization;
* Hemodynamic instability;
* Have any one of the following contraindications to flecainide:

  1. known left ventricular ejection fraction ≤ 40%;
  2. myocardial infarction within the last 30 days;
  3. QRS interval \>140ms;
  4. allergy to flecainide;
  5. severe uncorrected hypokalemia (\<2.5 mEq/L) or hyperkalemia (\>6.5 mEq/L) at the time of randomization;
  6. severe acute liver dysfunction or history of advanced cirrhosis;
  7. severe renal insufficiency (eGFR ≤ 30ml/min or dialysis); OR,
  8. second or third degree atrioventricular block within the last 30 days, in the absence of a pacemaker device;
* Unable to take oral medication;
* Previously enrolled in the trial.