cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

This pilot study's intended purpose is to evaluate the efficacy, safety, and tolerability of sarecycline for periorificial dermatitis. Sarecycline, a third-generation tetracycline, is currently only indicated to treat acne vulgaris. However, the investigator has used sarecycline to treat periorificial dermatitis and would like to capture and report on this efficacy in a pilot study. The investigator hypothesize's that not only will the subjects respond well to sarecycline treatment, but that it will be well-tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of POD by both the principal investigator and a blinded observer
* Have a PODSI score of 3.0 or greater at baseline by clinical investigator
* Must not be dysphagic.
* Patient is male or female, 18-55 years of age inclusive at Screening.

Exclusion Criteria:

* Allergy to tetracyclines.
* Immunocompromised.
* Pregnancy or planning a pregnancy during the study period.
* Lactating subjects.
* Ongoing use of any of the following treatments to the face throughout study; oral or topical steroids, oral or topical calcineurin inhibitors, topical retinoids, topical antibiotics, - oral or topical metronidazole, or topical azelaic acid.
* Facial hair or skin dermatoses that interfere with evaluation of the perioral dermatitis.
Treatment of Foot and Leg Ulcers Using a Laser

The investigators plan to do a retrospective chart review on patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic.

The investigators plan to do a retrospective chart review on patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic starting on May 17, 2018 to November 13, 2018. The investigators chose this date because that is the first time laser treatments were performed in the clinic. The investigators will collect the following data points:

* Ulcer etiology
* Ulcer location
* Prior ulcer treatment type and duration, and wound measurements/characteristics
* Wound size 4-6 weeks prior to laser treatment; at treatment time; and then each follow up measurement healed or x weeks
* eGFR
* Albumin
* Last A1c-Presence/absence of DM
* Amputation history
* Vascular status via ABI's
* Identify comorbidities
* Identify associated encounters in the patients such as complications (i.e. infection), related readmissions The investigators will identify this information from patient charts (EPIC EMR).

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent laser treatment for their foot ulcer at the UT Southwestern wound clinic starting on May 17, 2018 to November 13, 2018

Exclusion Criteria:

* not meeting inclusion criteria
Study Evaluating Single Doses of GAP-134

The purpose of this study is to assess the safety and tolerability of ascending single oral doses of GAP-134 in healthy subjects, to provide the initial pharmacokinetic profile of the oral formulation of GAP-134 in healthy subjects, and to evaluate the effect on the pharmacokinetic profile of a high-fat meal of 450 mg of GAP-134 administered to healthy subjects.


Eligibility Criteria:
Inclusion Criteria

* Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
* WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle stimulating hormone \[FSH\] level ≥38 mIU/mL) and must have a negative pregnancy test result within 24 hours before administration of the study drug or placebo.
* Women who are surgically sterile must provide documentation of the procedure by an operative report or by an ultrasound scan report.
* Sexually active men must agree to use a medically acceptable form of contraception during the study and continue using it for 12 weeks after study drug or placebo administration.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram (ECG).
* Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.)
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study drug or placebo.
* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before administration of study drug or placebo.
* Any history of clinically important cardiac arrhythmias.
* Familial history of long QT syndrome or unexpected cardiac death.
* History of drug abuse within 1 year before before administration of study drug or placebo.
International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice

Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in daily practice in an international, multicenter and vendor-independent trial.

Prospective analysis of cardiac CT angiographies enrolled over 1 month

Collection of 1 axial data set and the "patient dose protocol" (including kV, mAs, CTDI, DLP, etc.) on a CD

Dose estimation in dose/cm with the use of a method proposed by the European Working Group for Guidelines on Quality Criteria in CT.

Assessment of diagnostic, qualitative image quality on a per-vessel basis by the participating study sites and in randomly selected cases by the primary study investigators (approximately 5-10% of patients to "spot check" interobserver variability of image quality assessments)

Assessment of image quality with the use of quantitative parameters including image noise, signal-to-noise and contrast-to-noise ratios

Eligibility Criteria:
Inclusion Criteria:

* assessment of coronary arteries
* acute chest pain or "triple rule out"
* evaluation after PCI (stents)
* evaluation of bypass grafts
* before or after EP study
* cardiac anomalies

Exclusion Criteria:

* pregnancy
* contraindications against contrast media
ART - Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial

Acute respiratory distress syndrome (ARDS) is a common scenario in intensive care unit. Discussions about it is exponentially growing up due its high mortality rates all over the world and low quality of life among survivors. Mechanical ventilation is recognized to play an important role in treatment of patients with ARDS. However, mechanical ventilation itself has the potential to produce or worsen alveolar injury if inadequate strategies are chosen. Several studies compared different mechanical ventilation strategies in ARDS but the results remain uncertain regarding their influence on survival in patients with ARDS. Thus, this is a multicentric randomized controlled trial, with allocation concealment and intention to treat analysis to investigate if maximum alveolar recruitment maneuver in association to Positive end-expiratory pressure (PEEP) titrated by static compliance of respiratory system (ART strategy) is able to increase 28 days survival in patients with moderate to severe ARDS compared to conventional strategy proposed by the ARDS Clinical Network (ARDSNet strategy). Patients considered to this trial are those in mechanical ventilation with diagnosis of moderate to severe ARDS less than 72hours. Patients included will be randomized to receive ART strategy or ARDSNet strategy and will be followed until hospital discharge, 28 days and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* intubated, mechanically ventilated patients with diagnosis of moderate to severe ARDS less than 72 hours

Exclusion Criteria:

* age less than 18 years
* use of vasopressor drugs in increasing doses over the last 2 hours or mean arterial blood pressure less than 65mmHg
* presence of any contraindication to hypercapnia as intracranial hypertension or acute coronary syndrome
* pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele
* patient with no therapeutic perspective, candidates for palliative care exclusively
* patient previously randomized in the ART
Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.


Eligibility Criteria:
Inclusion Criteria

1. Hodgkin's or non-Hodgkin's Lymphoma.
2. ≥ 1 prior therapy and currently requiring therapy.
3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
4. ≥ 18 years of age.
5. ECOG performance score ≤ 2 (see Appendix 2).
6. Life-expectancy ≥ 2 months.
7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
8. No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
9. The following clinical laboratory values \< 2 weeks before Baseline:

   * Creatinine ≤ 2X upper limit of normal (ULN).
   * Total bilirubin ≤ 2X ULN.
   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.

Exclusion Criteria

1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥grade-2 atrioventricular (AV) block or left bundle branch block (LBBB).
2. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
3. Uncontrolled infection.
4. Prior seizures ≥ grade-3 in CTC v.3 criteria.
5. Arsenic allergy.
6. Significant neuropathology, defined as grade \> 2 per CTCAE Version 3.0.
7. Confusion or dementia.
8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.
Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation

Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and accounts for approximately 30 % of preterm births.

The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines. Conservative management to prolong a pregnancy is a classical approach to treat PPROM before 34 weeks' gestation in association with antibiotic therapy and corticosteroids.

Maternal and neonatal data were collected from maternal and newborns medical records.


Eligibility Criteria:
Inclusion Criteria:

* Women with PPROM between 22 weeks and 27 weeks and 6 days are eligible for this study

Exclusion Criteria:

* Therapeutic abortion / terminaison of pregnancy
* Intra uterine demise
* active labor with cervical dilatation of 3 cm with regular contractions.
* Triplet pregnancies
Safety of CERE-120 (AAV2-NTN) in Subjects With Idiopathic Parkinson's Disease

This is a Phase I dose escalating open-label study designed to assess the safety, tolerability and biologic activity of an in vivo AAV2 mediated delivery of the gene encoding NTN (CERE-120).

Twelve (up to 18) subjects will receive one of two open-label doses of CERE-120 via bilateral stereotactic injections targeting the putaminal region of the brain. Subjects will be enrolled in one of two cohorts, a low-dose cohort of six subjects followed by a high dose cohort of six subjects.

The design of this study is such that the primary objective, the evaluation of safety and tolerability, will be assessed by frequent observations for adverse events, clinical laboratory test results, imaging (MRI), neuropsychometric testing, and evaluations of disease status.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bilateral idiopathic Parkinson's Disease of at least 5 years duration since diagnosis with motor fluctuations, despite adequate oral antiparkinsonian therapy.
* Diagnosis of moderate to severe Parkinson's Disease based on clinical rating scales.
* Males or nonpregnant females 35-75 years of age, inclusive.
* Stable medication requirements, and clear response to antiparkinsonian medications during the 60-day eligibility evaluation period.
* No conditions that would render the subject unsuitable for surgery, or that would interfere with any of the assessments of safety or efficacy in this trial.
* Subject's informed consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

* A history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would pose a safety risk to the subject.
* History of treatment of Parkinson's disease by any procedure involving intracranial surgery or implantation of a device.
* MRI of the brain within 12 months before the anticipated dosing procedure that indicates the presence of an abnormality that may interfere with the assessments of safety or efficacy or would, in the judgment of the investigator, present a surgical risk to the subject.
* Any disorder that precludes a surgical procedure or alters wound healing.
* A score of less than or equal to 25 on the Folstein Mini-Mental examination performed during the eligibility evaluation period.
* Chemotherapy, cytotoxic therapy, or immunotherapy within 6 weeks prior to CERE-120 administration.
* Vaccinations within 30 days prior to CERE-120 administration.
* History, within two years before the anticipated dosing procedure, of drug or alcohol abuse.
* Treatment with nonantiparkinsonian agents that may affect symptoms of Parkinson's disease within 60 days before the anticipated dosing procedure.
* Any medical disability that would interfere with the assessment of safety and efficacy in this trial or would compromise the ability of the subject to undergo study procedures (e.g. MRI, PET) or to give informed consent.
* History of prior gene transfer therapy.
* Treatment with an investigational agent within 60 days before the anticipated dosing procedure.
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis

The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.

As secondary objectives, the study aims to

* demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.
* evaluate tolerance of treatment by grip strength measurement and adverse event collection.

This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.

All patients will be randomized in 3 following parallel treatment groups:

Group A : botulinum toxin + corticoid

Group C : placebo of toxin + corticoid

Group T : botulinum toxin + placebo corticoid

The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 18 and 60 years;
* Physical disability or not;
* Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os;
* Signed consent obtained;
* Covered by health insurance.

Exclusion Criteria:

* Central nervous system disorders result in spasticity in epicondylitis limb;
* History of severe psychiatric disorder;
* History of myasthenia gravis;
* Pregnant or breastfeeding woman;
* Unable to understand or respond to questions;
* Contraindication to botulinum toxin or corticoid;
* Treatment with botulinum toxin 3 months prior to baseline;
* Anticoagulant theraphy;
* Difficult to follow-up in the study;
* Patient under guardianship, or deprived of liberty by a judicial order.
Effect of Ivabradine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients

Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure (CHF) patients. CHF patients when treated with Ivabradine reported 39%, and 30% reduction in mortality and hospitalization rate respectively. Patient were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate and the Quality of Life (QOL) in Chronic Heart Failure patients

A prospective, post-marketing observational study was conducted in 50 chronic heart failure patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily. Heart rate was evaluated through ECG \& quality of life was measured by a validated questionnaire EuroQol-5 Dimension 3 level version (EQ-5D-3L). Baseline demographic includes age, gender, height, weight, Body Mass Index, temperature, blood pressure and respiratory rate were recorded and patients were followed at week 4 and week 8. Safety and tolerability was assessed by adverse drug reaction (ADR) monitoring. Results were analyzed by statistical software SPSS version 20.0.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Known case of Chronic Heart Failure (New York Heart Association (NYHA) functional class II to III)
* Clinically stability (at least for 4 weeks)
* Resting heart rate of more than 70 beats/ min (bpm) as assessed from the 12-lead electrocardiogram.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Resting heart rate below 70 beats per minute prior to treatment
* Cardiogenic shock
* Acute myocardial infarction
* Severe hypotension (\< 90/50 mmHg)
* Severe hepatic insufficiency
* Sick sinus syndrome
* Sino-atrial block
* Unstable or acute heart failure
* Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
* Unstable angina
* Atrioventricular Block of 3rd degree
* The combination with a strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
* The combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
* Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures
Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly

Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged over 75 years
* Admission for a scheduled surgery (i.e. all oncologic digestive surgery , ureterostomy, nephrectomy or cystectomy, total hip or knee replacement)
* Participation agreement

Exclusion Criteria:

* Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)
Comparison of 3 Diagnostic Strategies of PE: Planar V/Q Scan, CTPA, and V/Q SPECT.

Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes patient to the risk of potentially fatal recurrence. False positive testing exposes patients to potentially fatal unduly side effects of anticoagulants.

Current diagnostic strategies rely on the sequential use of pretest clinical probability, Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan. Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA are its higher radiation dose and contraindications (renal failure).

In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30% increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis of over-diagnosing and over-treating PE when using CTPA.

V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has been reported to improve the diagnostic performances of the test, which could reduce the number of non-conclusive tests and allow simplified diagnostic algorithms.

The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to the two usual approaches responding rightly to the two mains issues and combining the advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower radiation exposure, no contraindication).

Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with a clinically suspected PE (defined as an acute onset of new or worsening shortness of breath, chest pain, hemoptysis, presyncope, or syncope) without another obvious apparent cause.
* High pretest clinical probability of PE or a non-high pretest clinical probability but a positive D-Dimer test.

Exclusion Criteria:

* Age less than 18 years
* Patients with already confirmed PE
* Patients with a clinically suspected high-risk pulmonary embolism (hypotension or shock)
* Use of therapeutic doses of anticoagulants for more than 48 hours
* Other indication for long-term use of anticoagulants
* Contraindication to contrast media (including renal insufficiency with a creatinine clearance lower than 30 ml/min)
* Life expectancy less than 3 months
* Unable/unwilling to give informed consent
* Unlikely to comply with study follow-up
* Ongoing pregnancy or breastfeeding