cyrilzakka/clinical-trials huggingface dataset:
Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study

The purpose of this study is to compare revascularization strategy and its immediate results after augmented-reality computed tomography angiography (CTA) guided vs. standard angiography guided percutaneous coronary intervention (PCI) in native coronary lesions.

While stand-alone angiography is the first-line imaging modality for guidance of PCI, it has some inherent limitations which may result in suboptimal stent placement related to residual reference segment disease and stent underexpansion. Coronary CTA, on the other hand, can provide reliable measurements of the vessel size and lesion length as well as the visualization of the morphological features of coronary plaque, and has been suggested as potentially valuable for changing PCI technique. The AR-PCI trial has been designed as a single-center, investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective clinical trial. It is hypothesized that the review of CTA datasets using augmented-reality glass in the catheterization laboratory could influence PCI treatment strategy and its immediate results by more adequate lesion coverage with less residual disease and better stent expansion as compared to traditional angiography-guided PCI alone.

Eligibility Criteria:
Inclusion Criteria:

* patients with documented obstructive CAD defined as the presence of at least 1 stenosis ≥70% in a native coronary artery in whom PCI is considered based on clinical grounds

Exclusion Criteria:

* refusal or inability to provide written informed consent
* subjects in whom the quality of coronary CTA is insufficient
* bifurcation lesions, by which strategies other than a single cross-over stent technique are anticipated
* left main coronary artery stenosis
* chronic total occlusion
* in-stent restenosis
* chronic renal failure (estimated glomerular filtration rate \<30 ml/min)
* known allergy to contrast
* untreated hyperthyroidism
* pregnancy
Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

A single-center, open-label, Phase 1, drug-drug interaction study to investigate the effect of voclosporin on the pharmacokinetics of simvastatin and simvastatin acid in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Healthy male or female subjects aged \>=18 and \<=55 years
* Body mass index \>=18.0 and \<32 kg/m2

Exclusion Criteria:

* Abnormal ECG and/or prolonged QT interval
* Subjects using nicotine products within 3 months prior to screening
* Subjects who have lost or donated \>450 mL of whole blood or blood products within 30 days prior to the Screening Visit.
* Use of any prescription medication within 14 days prior to the first dose of study medication, or any over-the-counter products (including natural health products, e.g., food supplements, vitamins, herbal supplements) within 7 days prior to the first dose of study medication, except for topical products without significant systemic absorption.
* Use of any drugs or substances known to induce or inhibit hepatic drug metabolism within 28 days prior to administration of the study medication
* Consumption of grapefruit or grapefruit juice, pomelo or star fruit within 7 days of first dose of study drug on Day 1
* Use of hormonal contraception or hormone replacement therapy within 14 days prior to first dose of study drug.
* No COVID-19 vaccines are allowed within 28 days prior to first dose of study drug.
* History of or current alcohol abuse or drug addiction
* Subjects who are pregnant or breast feeding
* Subjects who have received any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to screening.
* Subjects who have any significant health issues as deemed by their treating physician/investigator
NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables

The effects of different foods to normal bowel function in adult population will be investigated. A randomised controlled intervention trial will be conducted on about 120 (30 per group) adult (18-70 years) subjects with functional constipation and irritable bowel syndrome with constipation according to the IV. Rome criteria. At least one week before inclusion in the study, patients will stop taking laxatives and other anti-constipation medications. Subjects will be randomly selected to consume one of the test foods (fresh apples, dried apples, sauerkraut) or the active control (psyllium) in the equivalent amount of 3 g of fiber per day for 4 weeks. Subjects will be asked not to change their lifestyle habits, such as diet and physical activity level, and not to take oral laxatives during the period of participation in the study.


Eligibility Criteria:
1. Inclusion criteria:

   * Signed informed consent of the participant to participate in the study
   * Age between 18 and 70 years
   * Functional constipation or irritable bowel syndrome
   * Expressed willingness to eat the investigated food daily (sauerkraut, apples, dried apples or psyllium; period of four weeks)
2. Exclusion criteria:

   * Known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium)
   * Pregnancy or breastfeeding
   * Previous gastrointestinal surgery with the exception of cholecystectomy and appendectomy
   * Other gastrointestinal diseases (chronic inflammatory bowel disease, celiac disease, gastroparesis, etc.)
   * Serious chronic diseases
   * Introduction of extensive changes in diet or physical activity in the last 4 weeks before the inclusion examination
   * Regular use of laxatives or inability to stop using laxatives for the duration of the study
   * Concurrent participation in another study
Mycophenolate Mofetil in Gastrointestinal Henoch-Schonlein Purpura

Henoch Schönlein purpura (HSP) is the most common type of vasculitis in children, with an incidence of \~10/100,000, whereas \>90% of the patients develop symptoms at \<10 years of age. Although HSP is generally a self-limiting disease, it may also lead to severe complications, such as intestinal intussusception, infarction and perforation, as well as end-stage renal disease. The management of HSP includes symptomatic treatment and immunosuppressive therapy in certain patients. Previous retrospective studies have reported that most patients with gastrointestinal (GI) symptoms may benefit from early usage of glucocorticoid, whereas there are still a part of HSP patients with GI did not achieved remission after administering of steroid. Therefore, the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.

the aim of the present study was to investigate the clinical features of refractory GI HSP and the clinical outcome of mycophenolate mofetil in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Ages range from 3 to 18 years old;
2. Patients who meet the diagnostic criteria for HSP and involve the digestive tract: acute diffuse abdominal colic, including intussusception and gastrointestinal bleeding, appears during the course of the disease or is found on physical examination;
3. Refractory gastrointestinal type HSP: treated with Intravenous corticosteroid 2 mg/kg/d for 3 days without effecacy or relapsed during the attenuation of corticosteroid
4. Parents or guardians agree to treatment and sign a written informed consent form.

Exclusion Criteria:

1. Patients who are allergic to MMF;
2. Patients with severe diseases: such as systemic malignancies, heart failure, liver and renal failure, Immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery;
3. Patients with other digestive system diseases;
4. Those who have previously used MMF clinical trials;
5. Other situations the researcher thought inappropriate to participate in the study.
Cryo-Touch II for the Treatment of Wrinkles

This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-70 years
* Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)\*
* Subject has signed IRB-approved informed consent form

Exclusion Criteria:

* Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
* Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
* The investigator is unable to substantially lessen facial lines by physical separation
* Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
* Subject is participating in another facial cosmetic research study

Patient has any of following conditions:

* History of facial nerve palsy
* Marked facial asymmetry
* Ptosis
* Excessive dermatochalasis
* Deep dermal scarring
* Thick sebaceous skin
* History of neuromuscular disorder
* Chronic dry eye symptoms
* Allergy or intolerance to lidocaine
Biomarker Development for Response Prediction by DNA Mutational Analysis

The purpose of this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational profile of the tumor.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a metastatic solid tumor who have failed at least one line of palliative chemotherapy and are irinotecan naïve.
2. Patients who are, as per local protocol, eligible for palliative treatment with (standard of care) irinotecan.
3. Measurable metastatic lesion(s), according to RECIST 1.1 criteria.
4. Radiological measurable metastatic lesion(s) of which a histological biopsy can safely be obtained:

   1. Patients with safely accessible metastases.
   2. Patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
   3. Patients not using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID's, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted.
   4. Adequate coagulation status on the day of biopsy as measured by:

      * PTT \< 1.5 x ULN
      * APTT \< 1.5 x ULN
      * Platelet count 100 x 10\*9 / L or higher
      * PT-INR \< 1.6
      * HB \> 6
   5. Biopsies should be performed at least four weeks after last bevacizumab administration.
5. Patients age 18 years or up, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.

Exclusion Criteria:

Patients not meeting all of the above inclusion criteria.
Acquired Syphlis by Non Sexual Contact

Syphilis is classically described as a sexually transmitted disease. As this source of contagious has been described long ago -mainly though by observation- when children presents with acquired syphilis, child abuse is always considered and must be ruled out by specialists in a careful evaluation.

However, muco-cutaneous lesions can be a contagious source for congenital syphilis; therefore the possibility of non-sexual transmission through intimate contact with infected people through humid lesions (such as in kisses, breastfeeding, food-handling) or contaminated fomites (towels, bed sheets, underwear, cups, pacifiers, cutlery) could be considered. Experts worldwide have observed this non-sexual transmission, as described in many reports in literature.

The investigators will study retrospectively patients from a cohort with non-sexual transmission. The diagnosis criteria used for acquired syphilis were as follows: age under 18 years with treponemic and nontreponemic positive tests, secondary-syphilis suspicious lesions and negative maternal syphilis serology. Nonsexual contagious was defined as contacts without physical and psychosocial indicators of sexual abuse according to current guides. In this cohort, in every case a psychosocial evaluation was completed with a written report in order to evaluate sexual contact probability.

The teamo will describe these patients clinical and laboratory findings, family and close acquaintances serologies and probable source of contagious.


Eligibility Criteria:
INCLUSION CRITERIA:

- Children with treponemic and non-treponemic positive tests with primary or secondary-syphilis suspicious lesions

EXCLUSION CRITERIA:

- Children with diagnose criteria positive for Congenital syphilis
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.

The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SPRING THREAD® elastic tensor thread. The study will evaluate the outcome of the SPRING THREAD® elastic tensor thread range over a period of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Men / women aged 35 to 75 with facial ptosis (cheekbones, jowls) with or without a history of aesthetic treatment (botox, filler, surgical lift).
* Patient able to understand the explanations given.
* Patient informed and not objecting to participate in the study.
* Patient able to comply with protocol requirements, including follow-up visits.
* Patient affiliated to social security.

Exclusion Criteria:

* Patient unable to understand study information and attend study visits.
* Patient did not give consent to participate.
* Patients who have had a previous facial rejuvenation treatment in the 3 months prior to the study.
* Patients treated with long-term systemic corticosteroids.
* Patients with visceral failure, chronic immunological pathology, pregnant or breasfeading women.
* Patient participating or having participated in another clinical trial protocol, drug or medical device within 30 days of inclusion.
* Patient refusing to participate in the clinical investigation.
Reverse Total Shoulder Arthroplasty in Patients Who Exceeded Their Life-expectancy: a Retrospective Study

Reverse total shoulder arthroplasty (RTSA) has become an established treatment for cuff arthropathy, severe osteoarthritis and in certain fracture cases. Due to the increasingly aging population, patients who have already exceeded their life-expectancy pose a significant challenge to the shoulder surgeon. Therefore, we wanted to investigate patient demographics, hospital stay length, complication rate functional outcome, patient reported outcome scores and mortality retrospectively for patients, who were older than 83 years at time of implantation of a RTSA.

This is a retrospective single institution study. All patients older than 83 years who received a reverse shoulder arthroplasty from 2008 until 2019 are included. Elective cases are compared to fracture cases (patient demographics, length of hospital stay, complication rate, functional outcome, patient reported outcome scores and mortality).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 83 years at time of surgery
* Patients who received a reverse total shoulder arthroplasty

Exclusion Criteria:

* Patients younger than 83 years at time of surgery
Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation

We want to examine the effect of multidisciplinary interventions in asthma patients who had experienced acute exacerbation of asthma.

In our previous observational studies, elderly asthma patients had a some distinct features such as impairment of cognitive function, deficiency of micronutrient and absence of caregiver compared with young adult asthmatics.

We wanted to evaluate whether the long-term course of asthma could be modified by intervening deficienies which were found in elderly patiensts.

So, we designed a interventional study to correct above risk factors in elderly asthma patients, which could be aggravating their asthma. Followings are our specific multidiciplinary items that we want to correct.

1. popularize and educate the asthma action plan
2. run a emergency call system for acute exacerbation
3. educate the proper techniques using inhalers
4. correct the deficiency of magnesium (magnesium 500 mg per day)

After 1 years, we will measure the numbers of acute exacerbations, lung function including FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study patients.


Eligibility Criteria:
Inclusion Criteria:

* elderly asthma patients who had experienced acute exacerbation of asthma

  1)aggravations of any of major criteria
* dyspnea
* cough
* wheezing
* increase or purulent changes of sputum
* nocturnal symptoms

  2)aggravation of more than one of following criteria
* a reduction of forced expiratory volume at one second or peak expiratory flow rate more than 20% compared than one's best score
* unscheduled clinic or emergency department visit or admission
* step-up of dose of asthma medications or any intake of systemic steroids
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series

The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing reduction mammoplasty.

Ten patients had serratus posterior superior intercostal plane block (SPSIPB) as the intervention. Patients had SPSIPB with 0.25% bupivacaine (total volume of 30 ml) before the surgery in operating room. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated by using patient-controlled analgesia (PCA) device. Patient satisfaction was assessed by using quality of recovery-15 (QoR15) scale. Paracetamol was planned as resque analgesic drug (maximum dose: 3 gr/day).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age who underwent reduction mammoplasty under general anesthesia and are American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation.

Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.


Eligibility Criteria:
Inclusion criteria

* Left atrial flutter1 inducible during electrophysiological evaluation.
* Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.
* Informed consent.

  1. Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above.

Exclusion criteria

* Previous ablation of LAFL.
* Previous linear ablation in the LA except for pulmonary vein isolation.
* Absolute contraindication for oral anticoagulation.
* Stroke or acute coronary syndrome less than 3 months before ablation.
* Complex congenital heart disease.
Influence of the Coloring of a Complex Form on Anxiety Associated With Care.

Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations: in day hospitalization service in psychiatry, in hemodialysis service and in an ambulatory consultation waiting room.

Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations.

Eligibility Criteria:
Inclusion Criteria:

Psychiatric Day Hospital Group:

* Men or women over the age of 18 and under the age of 65.
* Admitted to psychiatric day hospital for at least 10 consecutive days of care.
* Person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator.
* Patient with stabilized schizophrenia (F20.0).

Hemodialysis Service Group:

* Men or women over the age of 18 and under the age of 65.
* Person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator.
* Person having had at least 6 hemodialysis sessions.
* Valid dominant arm (allowing coloring - no fistula).
* Person currently on dialysis treatment.

Group Ambulatory consultation waiting room:

* Men or women over the age of 18 and under the age of 65.
* Person able to perform a coloring and answer a questionnaire, without severe deterioration of the general condition according to the assessment of the investigator.
* Consultant a practitioner at the hospital.

Exclusion Criteria:

* Person with advanced cognitive impairment that alters the questionnaire response or coloring as assessed by the investigator.
* Opposition of the volunteer.
* No affiliation to a social security scheme (beneficiary or beneficiary).
To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days

To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing and able to provide informed consent.
* Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.

Exclusion Criteria:

* Subjects with any condition affecting drug absorption.
A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin

This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of \[14C\]-plazomicin in healthy, adult male subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings

Key Exclusion Criteria:

* Use of tobacco- or nicotine-containing products
* Has received radio-labeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe
* History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
* History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
* History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness