cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Data Obtained With the LuGENE® Multiparameter Transcriptomics Blood Test and Clinical and Standard Laboratory Features of Patients With SLE (ReLATE)

This is an open label study to determine the association of the data obtained with LuGENE®, a transcriptomic-based LDT, with standard evaluation of patients diagnosed with SLE, including clinical involvement, SLEDAI score, Physician Global Assessment (PGA) and standard laboratory measures, including ANA, anti-DNA, anti-RNP and complement components C3 and C4, as well as Patient Reported Outcomes capturing pain, fatigue and Health-Related Quality of Life. The test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. This trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of LuGENE® laboratory results do not exceed more than 7 business days.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged at least 18 years old.
2. Capable of giving written consent on an IRB-approved Informed Consent Form prior to any study-specific evaluation
3. Have a clinical diagnosis of SLE determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician
4. On a stable SLE treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing

Exclusion Criteria:

1. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk
2. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
3. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
4. Pregnant or lactating.
5. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer
6. Any condition that in the opinion of the treating physician might interfere with the performance of the LuGENE® test
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)

This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Competent to self-administer the subcutaneous injections of PEG-IFN
* Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria
* Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
* Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start
* For a female subject who is of childbearing potential or male participant with female sexual partner who is of childbearing potential, agree to use acceptable methods of contraception for at least 2 weeks prior to study start and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations

Exclusion Criteria:

* Mucous membrane melanoma or ocular melanoma
* Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
* Evidence of distant or non-regional lymph node metastases or in-transit metastases
* Disease that cannot be completely surgically resected
* Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
* Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
* Hepatic decompensation
* Thyroid dysfunction not responsive to therapy
* Uncontrolled diabetes mellitus
* Clinically active autoimmune disease
* Clinically active and/or uncontrolled infection, including active hepatitis
* Human immunodeficiency virus (HIV)
* History of neuropsychiatric disorder requiring hospitalization
* Actively abusing alcohol or drugs
* Pregnant, lactating, or of reproductive potential and not using an effective means of contraception
* Medical condition requiring chronic systemic corticosteroids
* Received any experimental therapy within 30 days prior to enrolling in this study
* Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
* Previously received interferon-α for any reason
* Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b
Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana

While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. The investigators propose a randomized controlled trial of cellular phone text message reminders to improve medication adherence. Our pilot study will be set in a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on research projects in the past. The primary study outcome will be antiretroviral medication adherence.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* 21 years of age or older

Exclusion Criteria:

* Subjects who do not intend to have continuous follow-up care and monthly medication refills at Independence Surgery for at least the next six months
Cognitive and Emotional Factors in Visual Exploration Among Patients With Schizophrenia

Background:

Patients with schizophrenia are abnormally disturbed by information onsets, which may result in a disadvantage in filtering relevant information. It seems that they accord the same importance to all objects in a scene without taking into account the relevance of objects (cognitive salience) or their emotional charge (salience emotional).

The paradigm of change blindness offers the interesting possibility of studying sensitivity to the sudden irruption of visual information with ecological stimuli in schizophrenia. An increased attentional capture by the irruption of visual information would suggest better performance in patients than in healthy controls. Moreover, patients are disturbed to processing of emotional information, in this way we would like to measure the impact of emotional salience on the visual exploration.

Main aim:

The main objective is to evaluate, if patients with schizophrenia quickly detect changes occurring on irrelevant objects in the understanding of the scene.

Secondary objectives:

To evaluate in patients with schizophrenia the impact of emotional salience using the same paradigm.

To separate an explicit response (motors responses) with an implicit response (eye tracking measures).

Methodology:

30 patients with schizophrenia and 30 healthy controls were asked to detect changes in 96 scenes with 0 or 1 change (neutral or emotional changes). We will measure the participants' speed and accuracy in explicitly reporting the changes via motor responses and their capacity to implicitly detect changes via eye movements.

This study will include one visit:

* Written consent will be obtained from all participants
* Inclusion and exclusion criteria will be checked
* An ophthalmologic test, a pregnancy test, a alcohol test and a salivary test will be realized
* Various symptoms will be assessed with the PANSS (Positive And Negative Syndrome Scale for schizophrenia) and the UPDRS (Unified Parkinson Disease Rating Scale for patients, the MOCA (Montreal Cognitive Assessment), The HAD (Hospital Anxiety and Depression Scale) and the MINI (Mini International Neuropsychiatric Interview) for all participants.
* The task will be divided in two parts:

A visuo-spatial task allowing to record saccadic eye movements (approximately 10 min).

The change blindness session lasted approximately 20 min.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected vision
* Affiliate to a social security system
* For group of patients with schizophrenia : diagnosis of schizophrenia based on the standard DSM-IV criteria and patients will be clinically stable at the testing time

Exclusion Criteria:

* History of neurological illness
* Pregnant and nursing women
* Drugs use in the last 24 hours
* Acute ocular disorder
* Under tutorship, curatorship or deprived of liberty
* For controls group : be free DSM-IV axis-I diagnoses according the MINI test.
Effects of High-intensity Interval Training in Combination With Side-alternating Whole-body Vibration

Investigation of the training effects following 8 weeks of high-intensity interval training (HIT)in combination with side-alternating whole-body vibration compared to conventional HIT or side-alternating whole-body vibration. The adaptations are investigated on a molecular (muscle biopsy of the M. vastus lateralis) and systemic (e.g. cycling, jumping mechanography, dynamometry) level. In addition, the acute effects of the first and last training session will be investigated on a molecular (e.g. satellite cell activation, mRNA abundance) and systemic (e.g. ventilatory ga exchange, heart rate, rating of perceived exertion) level.


Eligibility Criteria:
Inclusion criteria: - male

* no fever / no common cold at the beginning of the study
* between 18 and 35 years of age
* non-smoker
* no known cardiovascular or orthopedic problems
* no cardiac pacemaker
* fullfills healts questionnaire's requirements

Exclusion criteria: - female

* fever / common cold at beginning of study
* age under 18 oder above 35y
* smoker
* cardiovascular or orthopedic problems
* cardiac pacemaker
* does not fullfill health questionnaire's requirements
Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter

Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with need of an intravenous therapy on peripheral line
* Unsuccessful attempts at establishing a peripheral intravenous line by nurse
* Age over 18 YO
* Written informed consent obtained

Exclusion Criteria:

* pregnant woman
* local contra-indication for venous puncture
* unconscious patient
* need of intravenous therapy requiring central line
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.

Urinary incontinence is the involuntary loss of urine and can affect both men and women throughout their lives. Women are more likely to develop incontinence as a result of pregnancy and childbirth. There are approximately 11 million cases of incontinence in the US contributing to several different types of incontinence including :

* Urge - 30% of the market
* Stress - 30% of the market of which 85% are women
* Combination urge and stress - 40%

Despite advances in behavioral therapy, pharmacological advances as well as development of minimally invasive surgical procedures, only one out of every twelve people affected actually seek help.

Prolapse

Globally, approximately 1 million women suffer uterovaginal prolapse annually and this condition can be associated with urinary incontinence. The breakdown of treatments for uterovaginal prolapse includes:

* 20% - no treatment
* 20% - non surgical management (pessary)
* 60% - receive a surgical procedure of a suture repair or mesh repair

There were greater than 600,000 surgeries performed globally to treat prolapse. These numbers are projected to increase due to rapid, easy, and less costly methods as well as new products that facilitate the easier procedures.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be female and \>18 years of age.
* Subject must have genuine stress or mixed incontinence AND/OR evidence of pelvic organ prolapse.

Exclusion Criteria:

* Any subject with clotting defects, bleeding disorders or receiving anticoagulant treatments AND is determined to be at risk for minimally invasive surgery as determined by the investigator
* Subjects who currently have an untreated urinary tract infection
* Subject is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent.
* Subject is pregnant or desires future pregnancies.
Irreversible Electroporation(IRE) For Unresectable Urinary Bladder Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Urinary Bladder Neoplasms.

By enrolling patients with unresectable Urinary Bladder Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Urinary Bladder Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Head and Urinary Bladder diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert

To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Had prior bilateral treatment and completion, through a minimum of week 12, of the OTX-16-002 trial
* Are informed of the nature of the study and subject is able to comply with study requirements and visit schedule for one year
* Have provided written informed consent, approved by the appropriate Institutional Review Board

Exclusion Criteria:

* Had more than 1 replacement, per eye, during participation in the OTX-16-002 trial
* Had punctal or canaliculi related adverse events during the OTX-16-002 trial which required discontinuation (e.g., canaliculitis)
* Used prohibited medications during the OTX-16-002 study, or the period between OTX-16-002 and this trial (with the exception of short term medication used to treat an adverse event or rescue therapy)
* Missed more than 2 visits during participation in the OTX-16-002 trial
Observation of the Comfort and Efficacy of CO2 Laser Combined With Cryo 6 for Burn or Linear Scars.

To investigate the effect of 10,600 nm CO2 laser combined with Zimmer Cryo 6 forced cold air device on the comfort and efficacy of patients with burn scars or post-operative linear scars, and to provide a safer, more effective and more satisfactory program for clinical treatment of burn scars or post-operative linear scars.

Objective: To investigate the effect of 10,600 nm CO2 laser combined with the cold-air cooling device Zimmer Cryo 6 on the comfort and efficacy of patients with burn scars or post-operative linear scars, and to provide a safer, more effective and more satisfactory program for clinical treatment of burn scars or post-operative linear scars.

Secondary objective: To investigate the adverse effects of the cold-air cooling device Zimmer Cryo 6 in combination with the 10,600 nm CO2 fractional laser treatment for patients with burn scars or post-operative linear scars.

Eligibility Criteria:
Inclusion Criteria:

1. Age 14-60 years;
2. The patient agreed to participate in the experiment and signed the informed consent by himself/herself or his/her legal representative;
3. The clinical diagnosis was burn scar or post-operative linear scar, and the total area was more than 5 cm2.
4. No other treatment such as laser or chemical exfoliation was performed on the lesion within the recent half year.
5. Skin lesions were free of bleeding, ulceration, infection and other conditions affecting the visual field of laser treatment.

Exclusion Criteria:

1. Patients with an active or established sun tan;
2. Patients with history of allergic reaction to to topical anesthesia;
3. Patients with history of keloid scarring, abnormal wound healing and/or prone to bruising;
4. Skin malignant tumors or precancerous lesions;
5. Patients with diabetes, heart disease, epilepsy, connective tissue disease, etc.;
6. Pregnant or breastfeeding patients;
7. Patients with recent skin infections (such as viral and bacterial infections);
8. Patients who are using other methods to treat similar diseases;
9. Patients who had taken isotretinoin within the past year;
10. History of cryoglobulinaemia;
11. History of cold agglutinin disease and cold haemolysis;
12. History of cold urticaria;
13. Parts of the body with impaired circulation;
14. Raynaud's disease;
15. Parts of the body with impaired sensitivity;
16. Trophic disorders;
17. Hypersensitivity to cold;
18. Patients with mental illness;
19. Other ineligible patients.
Driving Ability in Patients With CMT 1A

Charcot Marie Tooth 1A (CMT 1A) is a common inherited disorder of the nerves in the body. The disease can result in difficulties with strength and balance as well as in foot deformities such as high arches, hammer toes, and tight ankles. Because of these difficulties, the disease may affect driving, especially because driving requires quick responses at times such as slamming on the brakes or turning the steering wheel quickly. The following study determines driving performance in individuals who have CMT 1A.

Individuals with CMT 1A will drive in a driving simulator, which involves a car located in a room in the University of Iowa Hospitals and Clinics (UIHC). Individuals will drive in the car as if they are driving in real life and the whole experience is like playing a car video game with a big animated screen. The driving results will be compared to similar aged patients who don't have CMT 1A and have also taken the driving test. If patients with CMT 1A do have driving difficulties compared to those who do not have CMT 1A, the results of the study will try to help patients with CMT1A drive better by ultimately creating devices that might help them use the steering wheel or brake pedal in a safer way.

Eligibility Criteria:
Inclusion Criteria:

* Have CMT 1A
* Have a valid driver's license

Exclusion criteria:

* History of other types of neuropathy (other than CMT 1A)
* History of blindness, seizures, or stroke, dementia/cognitive dysfunction
Prospective, Multi-center, Non-interventional, Open Label, Randomized (Depth of Focus Testing Sequences), Clinical Study

The purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL:

1. Trial lens method
2. Chart testing at appropriate focal distances (or viewing distances)


Eligibility Criteria:
Study Eye Inclusion Criteria:

1. Patients unilaterally or bilaterally implanted with a TECNIS non-toric/toric monofocal or TECNIS non-toric/toric Eyhance IOL;
2. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws in U.S.;
3. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures.
4. Adults (Minimum 22 years of age or older at the time of participation in the study);

Study Eye Exclusion Criteria

1. Patients within 30 days postoperative from surgery;
2. BCDVA worse than 20/32;
3. Posterior capsular opacification or other medical findings affecting best-corrected distance visual acuity (BCDVA) in the opinion of the investigator;
4. Clinically significant ocular surface disease that would affect study measurements based on investigator medical opinion;
5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
6. Known ocular disease or pathology that, in the opinion of the investigator may affect visual acuity (macular degeneration, cystoid macular edema, diabetic retinopathy, glaucoma, retinal detachment etc.);
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
Scalp Nerve Block on Emergence Agitation

Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.

Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled. Anesthesia was induced with thiopental sodium and rocuronium, and maintained with sevoflurane. Patients were randomly assigned two groups: the control group received IV remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine 2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and Watcha behavior scale for emergence agitation were assessed.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for nevus surgery

Exclusion Criteria:

* developmental disorder
* neurologic disorder
* coaguloparthy
* allergy to local anesthetics