cyrilzakka/clinical-trials huggingface dataset:
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy

Indication: Subjects with chronic venous leg ulcers

Primary Objective:

• To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers

Secondary Objective(s):

* To evaluate the percentage of wound healing every two weeks
* To evaluate the complete ulcer healing every two weeks
* To evaluate the time to complete ulcer healing
* To evaluate the recurrence rate at the end of the follow-up period
* To evaluate pain
* To evaluate the quality of life

Study Design and Treatment Scheme:

This is a Kingfisher Healthcare NV sponsored, national, multicenter, randomized, prospective study in which data will be collected of subjects with chronic venous leg ulcers receiving standardized conventional therapy (SCT). Subjects will be randomized into two groups receiving SCT + placebo or SCT + bio-electrical stimulation therapy (BEST) to evaluate the effect of BEST on the wound healing process.

Patients answering the eligibility criteria will receive standardized conventional therapy during 4 weeks before actual study start and will then again be evaluated on eligibility according to wound healing rate. Only patients with a wound surface that has not significantly changed (both increased or decreased) will be randomized in the treatment period.

During the treatment period patients will receive SCT with placebo or SCT in combination with bio-electrical stimulation therapy on a daily basis for two hours, during 8 weeks.

Patients will be in follow-up period for a maximum of 8 weeks after treatment period.

see above

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥ 18 years old, male or female
* Before any subject data is collected, the appropriate written informed consent must be obtained (see appendix H).
* Confirmation of venous insufficiency during the last 5 years by Duplex examination
* Chronic venous leg ulcers (\>12 weeks) not healing with conventional therapy
* Study ulcer size between 8 to 20 cm² and without clinical signs of infection
* No presence of other ulcers in a radius of 5 cm around the study ulcer
* No surgery for venous insufficiency within the last 6 months
* No arterial insufficiency (ABI between 0,7 and 1,3)
* BMI \< 40
* No uncontrolled diabetes or any uncontrolled systemic condition that might impair wound healing
* No decubitus wounds
* Ambulant subject
* Written informed consent

Exclusion Criteria:

* Subjects with implanted electrical devices (e.g. cardiac pacemakers)
* Subjects having a concurrent malignancy or being less than 3 years after the end of their cancer therapy
* Subjects with active osteomyelitis
* Pregnant or breast-feeding women
Crossover Study With MultiHance vs a Comparator for Peripheral MRA

This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* At least 18 yrs of age
* Moderate to severe peripheral arterial disease
* Willing to undergo two MRA procedures within 14 days

Exclusion Criteria:

* Pregnant or lactating
* Known allergies to one or more ingredients in the products
* Therapeutic intervention in the arterial territory of interest between the two MRA exams
* Changes in symptoms between the two exams
* Vascular stent in area of interest
* Severe claustrophobia
* Congestive heart failure class IV
* Scheduled to undergo surgery for PAOD between the two exams
* Scheduled to undergo DSA between the two exams
Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury

To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance.

70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from these patients in the first day, the third day and the seventh day, detect ESM-1 level in plasma by ELISA. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the prognosis of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h
2. Patients age between 18 years old and 80 years.

Exclusion Criteria：

1. Pregnant women,
2. Patients with malignant tumor,
3. Immunosuppression or immunocompromised patients.
Comparison of the Efficacy of Paclitaxel-releasing Balloon Catheter System Versus the Everolimus-Eluting Stent System for Treatment of In-Stent Restenosis Lesions - Harmonizing Optimal Strategy for Treatment of In-Stent Restenosis Lesions (The HOST-ISR Trial) -

In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era. The current consensus in treating ISR is implantation of another DES into the restenosed segment. However the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions. HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES. The primary endpoint will be in-segment late luminal loss at 9 months angiographical follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18y
* Significant ISR lesion (\>50% by visual estimate) of previously stented de novo coronary artery
* Evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia) or ISR with diameter stenosis \> 70%
* Written, informed consent
* Target lesion(s) located in a native coronary artery within a previously stented lesion with previous stent diameter of ≥ 2.5 mm and ≤ 4.00 mm
* Target lesion(s) amenable for percutaneous coronary intervention

Exclusion Criteria:

* Hypersensitivity to aspirin, clopidogrel, heparin, sirolimus, paclitaxel or radiocontrast media
* Systemic sirolimus use within 12 months
* Female of childbearing potential
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia)
* Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
* Non-cardiac co-morbid conditions present with life expectancy \<1 year or that may result in protocol non-compliance
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
* ISR of left main coronary artery
* Restenosis of two stented bifurcation lesion
Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years
* Declaration of informed consent signed by patient
* Patients with a solid tumour or with a malignant haematological tumour
* Patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle
* GCSF-naïve patients or patients pre-treated with GCSF who received no GCSF in the last three months before enrolment
* Patients starting primary prophylactic treatment using NivestimTM either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced FN

Exclusion Criteria:

* Patients with chronic myeloid leukaemia (CML) or with myelodysplastic syndrome (MDS)
* Patients who are hypersensitive to one of the excipients of NivestimTM
* Patients not undergoing chemotherapy
* Patients being treated curatively or as secondary prophylaxis with G-CSF
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma

The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Males or females who were ≥ 12 years old at the time informed consent was obtained
* Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria
* Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).
* Patients whose level of asthma control according to GINA 2010 guideline was "Partly Controlled" or "Uncontrolled" at screening (Visit 2).
* Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2).
* Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5.
* Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit 5.

Key exclusion criteria included:

* Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated 2010.
* Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.
* Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
* Patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator.
* Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
* Patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
* Patients who have ever required intubation for a severe asthma attack/exacerbation.
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1, or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

Other protocol-defined inclusion/exclusion criteria may apply
Visual Attention to Text and Pictorial Food Labels: An Eye Tracking Experiment

The goal of this study is to examine attention elicited by icon, text-only, and control front-of-package food labels. The study also aims to explore whether English language proficiency moderates the impact of icon vs. text-only labels on attention.

In this study, participants will attend one in-person visit, lasting approximately 15 minutes after signing informed consent. First participants will complete an eye tracking task where their attention to study stimuli is measured objectively via an eye tracker (i.e., eye tracking task). The eye tracking task will take \~5 minutes. Then, participants will complete a brief \~10 minute self-administered survey on a computer.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18 or older
* Self-identifies as Hispanic or Latino

Exclusion Criteria:

* Less than 18 years old
* Does not identify as Hispanic or Latino
* Has one of the following conditions: (Wears bifocals, glaucoma, permanently dilated pupils, eye implants \[artificial lenses, not contact lenses\], less than 2 eyes, or blindness)
Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants

it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight infants. The likelihood of ductal closure with only one or two doses of treatment is a secondary objective.

We calculated that a study group of 62 patients would be necessary for the study to be able to detect a difference of at least 25 percentage points in the closure rate between the oral ibuprofen and intravenous ibuprofen groups, assuming a closure rate of 65 percent with intravenous ibuprofen, with a p value of 0, 05 and a power of 80 percent.Patients (gestational age, 25 to 32 weeks) with echocardiographically confirmed patent ductus arteriosus and respiratory distress will randomly be assigned to receive one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of either intravenous ibuprofen (group I, n = 32) or oral ibuprofen (group O, n = 32), starting on the third day of life. The rate of ductal closure, side effects, complications, and the patients' clinical course will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* a gestational age \< 32 weeks
* a birth weight \< 1500g
* a postnatal age between 48 and 96 hours, a respiratory distress requiring more than 25 % of oxygen supplementation
* an echocardiographic evidence of left to right significant shunting PDA

Exclusion Criteria:

* a right-to-left shunting
* major congenital anomalies
* IVH grade 3-4
* a tendency to bleed (defined by the presence of blood in the endotracheal aspirate, gastric aspirate, stools or urines and / or oozing from puncture sites)
* a serum creatinine level \>140µmol/l, a serum urea nitrogen \> 14 µmol/l and a platelet count \< 60000/mm3.
Therapeutic Effects of Insoles on Patients With Knee Osteoarthritis

Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ready-made full-length lateral wedged shoe insoles and customized full-length lateral wedged shoe insoles to patients with knee osteoarthritis, under the basis of International Classification Functioning, Disability and Health.

A total of 90 patients will be collected. The participants will be randomized into two groups, including ready-made full-length lateral wedged shoe insoles group and customized full-length lateral wedged shoe insoles group. The psychological function (Hospital anxiety and depression scale, Graded chronic pain scale, Multidimensional fatigue inventory, Fear-avoidance belief questionnaire), physical activity (CHAMPS physical activity questionnaire), functional performance (Western Ontario and McMaster Universities Osteoarthritis index、Knee injury and Osteoarthritis Outcome Score) and quality of life (World Health Organization-Quality of life-Brief Vision、Osteoarthritis Quality of Life、Osteoarthritis- Knee and Hip Quality of Life) will be evaluated. Physical functional ability (10 meter normal and fast walk, up and down stairs, and 5 repeated chair-rising time), pain (Visual analog scale, pain pressure threshold ) and balance performance (static postural stability and dynamic stability by Biodex Stability System, including postural stability, dynamic limits of stability and fall risk) will be evaluated before and immediately after the ready-made full-length shoe insoles and customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, pain, balance, psychological, physical activity, functional performance, and quality of life, will be re-evaluated at one month after and three months after modified shoe insoles wearing. Subjects and evaluator were both blinded to the group's classification during the whole course of study.

Eligibility Criteria:
Inclusion Criteria:

* fulfill the combined clinical and radiographic criteria for knee osteoarthritis, as established by the American College of Rheumatology
* with Kellgren-Lawrence scores of 2 or higher in the isolated medial compartment

Exclusion Criteria:

* with a history of previous knee surgery with an implant
* reduced lateral compartment and/or combined medial and lateral compartments in knee joints were excluded
* pregnant or planning to become pregnant
* self-reported history of vertigo, malignancy, stroke, or other conditions that may impair vestibular function
Epigenetic Markers of B-Cell Function in Low Birth Weight Infants

Low birth weight (LBW) status (\< 10% for gestational age at birth) is associated with increased risk for diseases such as type II diabetes mellitus, hypertension, chronic obstructive pulmonary disease and coronary artery disease in adults, and represents one example of the "fetal onset of adult disease" hypothesis. Recent data strongly associates LBW status with impaired innate and adaptive immunity leading to increased risk for severe infections during adolescence or early adulthood. Animal studies suggest that the ratio of certain B lymphocyte subpopulations, the B1a and B1b cells, determines whether deficits in immunity occur.

This study will determine the ratio of B1b to B1a lymphocyte subpopulations in the cord blood of infants born LBW in the late preterm to term gestations (\> 34 weeks at birth) and compare those ratios with those of normal birth weight (NBW) controls in a nested case control study design.

Furthermore, animal studies suggest that the expression patterns of CD5 and CD19 proteins determines the cellular phenotype of the B lymphocyte, that of a B1a or a B1b cell, and that the regulatory regions controlling their expression are epigenetically vulnerable. The investigators will therefore isolate DNA and RNA from both B lymphocyte subpopulations and determine whether epigenetic changes to the regulatory regions of the genes coding for CD5 and CD19 protein expression occur in LBW lymphocyte subpopulations as compared to the lymphocytes from NBW infants.

This proposal will be the first human study to examine epigenetic determination of a maladaptive phenotype following LBW status at birth in a specific cell type leading to a specific impairment of innate and adaptive immunity.


Eligibility Criteria:
Inclusion Criteria:

* Infants delivered at University of Utah Health Sciences Center
* For LBW group:

  * Gestational age \> or = to 34 0/7 weeks
  * Birth weight \< or = to 10% for gestational age
* For NBW group:

  * Term infant controls delivered without complication
* Adequate cord blood sample obtained directly after birth
* Parents or guardians must have signed informed consent

Exclusion Criteria:

* Infants with major congenital anomalies will be excluded
International Hernia Mesh Registry

This is an open-label, multi-center, long-term, prospective hernia mesh registry. A minimum of 4,800 hernia patients will be enrolled from approximately 60 active sites globally

Patients will be followed for 2-years post-implantation, in a post-market setting to help identify best practices leading to lower recurrence rates and decreases in chronic pain, associated with the hernia repair procedure.

Eligibility Criteria:
Inclusion Criteria

Patients must satisfy the following criteria before entering the registry:

1. Provide written informed consent prior to surgery;
2. Male or female patients that are \> 18 years of age;
3. Be literate and able to understand a language available in the Registry Patient Questionnaires;
4. Scheduled to receive a surgically implanted ETHICON synthetic mesh using any fixation method or a non-ETHICON synthetic mesh which must be fixated with SECURESTRAP® or SECURESTRAP® Open for repair of a hernia defect;
5. Agree to provide long-term, outcomes data to Quintiles Outcome;
6. Agree to provide contact information;
7. Two or more pieces of the same mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from participating in the registry:

1. Patients that are \<18 years of age;
2. Patients who have been entered into the registry previously;
3. Employees of the investigator or registry center with direct involvement in the proposed registry or other studies under the direction of that investigator or registry center and employees of ETHICON;
4. Patients suffering from and currently receiving medication for chronic pain (defined as suffering pain for greater than 3 months);
5. Patients known to be suffering from pre-existing chronic depression;
6. Patients currently known or suspected to abuse drugs or alcohol;
7. Patients suffering from a terminal illness (e.g. cancer);
8. Patients requiring multiple hernia repairs (including bilateral inguinal/femoral);
9. Patients requiring any other (concomitant) surgical procedure;
10. Patients suffering from an ongoing infection, sepsis, contaminated mesh or fistulas;
11. Patients who require hiatal, paraesophageal or diaphragmatic hernia repair;
12. Patients requiring two different types of meshes;
13. Patients requiring two or more meshes not sewn together
14. Patients scheduled to receive a surgically implanted biologic mesh product for repair of a hernia defect
Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis

To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy.

This is a single-center retrospective cohort study. Patients included were consecutive patients from June 2012 - July 2017 who received standalone Xen45® or standalone trabeculectomy. The primary outcome was time to failure, defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling). Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 30-90
* primary or pigmentary/pseudoexfoliative open angle, primary closed angle, narrow angle or combined mechanism glaucoma
* IOP of 18-40 on maximum tolerated medical therapy
* received a gelatin stent 45 with MMC or a trabeculectomy with MMC at Prism Eye Institute from June 2012 to July 2018, and have at least 3 years of follow-up.

Exclusion Criteria:

* Other forms of glaucoma
* prior incisional glaucoma surgery
* CPC
* combined surgery (cataract, cornea, or retina)
* prior corneal graft (PKP, DALK, DSAEK, DMEK)
Urological Management of Complications of Penile Constriction Devices:

Wearing a penile ring is justified by international societies of Urology (AFU, EAU, AUA) only for the treatment of erectile dysfunction with vacuum. In this case, it is a constriction rubber band that can only be worn for 30 minutes.

Nowadays, wearing a cockring device for recreational purposes can lead to complications secondary to ischemia caused by strangulation of the penis and/or scrotum.

The variety of devices and materials used (metallic and/or alloys in particular) sometimes makes it difficult to remove them, requiring expensive surgery and dedicated equipment.

There is no official recommendation for the management of these complications.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years old
* Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
* Any patient care for this pathology in public or private healthcare hospitals in France

Exclusion criteria:

- Refusal to participate