cyrilzakka/clinical-trials huggingface dataset:
A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder

All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. The study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.

Following completion of the NS2014-1 final study visit procedures, Subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of NSI-189.

The Enrollment Visit begins when informed consent is signed.The duration of the follow-up period will be up to 6 months, until the start of a new antidepressant treatment. Subjects who provide consent will be seen for in-person visits every 8 weeks, with bi-monthly phone visits occurring between in-person visits. Safety assessments and efficacy assessments will be performed at each visit. No study drug will be taken during the Longitudinal Observational Cohort study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has the ability to understand the purpose, potential benefits and risks of the study and to provide signed and dated informed consent, authorizing the use of protected health information in accordance with national and local Subject privacy regulations.
2. Subject completed the 12-week randomized treatment period and final study visit for the NS2014-1 clinical study.

Exclusion Criteria:

1. Subjects taking excluded medications.
2. Subject who, in the opinion of the Site Investigator, are unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
3. Subject who, in the opinion of the Site Investigator, are unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up and improbability of completing the clinical study.
Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream 1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.


Eligibility Criteria:
Inclusion Criteria:

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion Criteria:

* Greater than 3 inflammatory lesions on the face
* Current treatment with monoamine oxidase (MAO) inhibitors
* Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Development of an Intelligent Balance Training System Providing Weight-bearing Feedback in Stroke Patients

The sit-to-stand and dynamic weight-shifting ability of stroke patients is highly associated with walking performance. Therefore, in order to improve the dynamic weight-shifting ability in sit-to-stand and parallel or tandem standing, a real-time visual or auditory feedback is used in our design to allow patients to realize the weight-bearing condition (by using load cells) in both sound and affected legs immediately. It can help patients to learn to control muscle to shift weight effectively which will improve patients' walking performance. By integrating physical therapy planning with electro-mechanical technology, the goal of this study is to develop a standing balance training system by requiring patients to control their center of pressure (COP) in performing sit-to-stand and maintain a standing posture via the use of their core and lower extremity musculature.

1. Written informed consent must be obtained before any study specific procedures are undertaken.

1. For healthy group: Participants will be recruited from the staffs and students in Kaohsiung Medical University (including Learning University), and healthy families of CVA patients in the university affiliated hospital.
2. For stroke (CVA) group: We will ask the physical therapists in the university affiliated hospital to nominate the potential CVA participants . The physicians will determine if they would meet the inclusion criteria before participating the present study.

2. The process of the experiment (brief describe)

1. Written informed consent must be obtained before any study specific procedures are undertaken.
2. Subjects who are recruited to participate in this experiment should provide the personal information forms first (ex: sex, age, height, weight, post-stroke duration, stroke type, hemiplegic side, ambulation devices etc.). Then, assessment (PASS, Berg Balance Scale, Timed Up and Go) will be conducted by a physical therapist at baseline.
3. While the stroke patients after completing the 4 -times, and 8-times training program, the above-mentioned assessment conducted again by the same physical therapist. The healthy will not receive balance training, thus .only receive one assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults

   a. Their age should be ranged between 20 - 75 years
2. Stroke patients

   1. diagnosed with unilateral ischemic or hemorrhagic stroke
   2. a minimum of six months post stroke
   3. able to stand without support for 1 minutes
   4. medically stable with physician release

Exclusion Criteria:

1. Healthy adults

   1. neurological diseases
   2. musculoskeletal diseases
   3. rheumatic diseases
   4. history of orthopedic surgery on spine or lower extremity
2. Stroke patients

   1. other injuries or illnesses that affect standing or walking
Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus.

Various study data available suggest that intraperitoneal (IP) delivery of insulin in type 1 and type 2 diabetic subjects provides an appropriate therapy that allows subjects to achieve acceptable glycemic control without increasing the inherent risk of severe hypoglycemia observed when intensive insulin treatment is pursued. Up till now little research has been done to investigate the efficacy of intraperitoneal (IP) therapy compared to subcutaneous administration. In this study we aim for safety and non-inferiority or superiority for IP therapy concerning glycemic control with less episodes of hypoglycemia compared to intensive subcutaneous (SC) therapy in intermediate or poorly controlled Type 1 patients and/or patients with frequent severe hypoglycemic events.

Subjects will be randomized to insulin treatment using the Medtronic Minimed Implantable Pump or to subcutaneous insulin therapy during the first study arm. After the first arm of the study, subjects will be crossed over to the second arm and will receive the treatment whichever they had not received in the first treatment phase. Subjects with the MIP already implanted will retain the pump but will receive diluent intraperitoneally for the second study arm.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week.

Exclusion Criteria:

* renal function impairment: creatinin ≥ 150 micromol/L or a creatinin clearance \< 50 ml/min
* Cardiac problems: decompensated heart failure (NYHA III and IV); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months
* Known or suspected allergy against insulin or any component of the composition
* Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
* Severe untreated proliferative retinopathy.
* Insufficient knowledge of the Dutch language to understand the requirements of the study.
* Current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year.
* Substance abuse, other than nicotine
* A history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma
* Participation in other trials, involving investigational products within 30 days prior to trial entry.
* Plans to engage in activities which require them to go below 25 feet below sea level.
* Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results.
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Provide signed written informed consent
* Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration
* Prior treatment in the study eye with any intravitreal anti-VEGF medication
* At least one lesion in the study eye that meets minimal pathology criteria
* Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye
* Best corrected visual acuity of 20/200 or better in the fellow eye
* Reasonably clear media and some fixation in the study eye

Exclusion Criteria:

Ocular

* Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1
* Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
* Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
* Need for ocular surgery in the study eye during the course of the study
* Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform required study assessments in either eye and/or confound study results

Non-Ocular

* Allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications
* Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
* Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study
* Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
* Unable to comply with study procedures or follow-up visits
The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years

It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All preterm infants born at 35 weeks or less
* Underwent at least 1 brain ultrasound
* Diagnosed with IVH Grades 1-2
* Had no other severe illness in NICU
* Had neurodevelopmental follow-up

Exclusion Criteria:

* All others
Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma

This is a pilot study to assess the ability of \[F-18\]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. \[F-18\]fluciclovine. PET will be obtained at the time point in the 12 week interval in which MRI demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. At the same time point (at least 6 hours after \[F-18\]fluciclovine or up to 3 days) F-18 FDG will also be performed consistent with standard clinical practice. The verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent MRI imaging obtained as part of standard care.

In this pilot study the investigators propose to image 10 participants who have been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.

All glioma cases undergoing resection at UPMC are evaluated by immunohistochemistry for mutations in p53, nuclear localization of ATRX, and the presence of IDH1R132H mutation as part of standard neuropathologic integrated diagnosis using the WHO 2016 diagnostic criteria. All glioma cases resected at UPMC undergo genetic profiling using next generation sequencing.

MRI imaging will be obtained as part of standard clinical care. The MRI sequences include T1 pre and post contrast, T2 FLAIR, DWI, ADC and perfusion sequences using the imaging algorithm for evaluating treatment response in glioma treatment trials. Radiogenomic analysis will be performed using the MRI imaging sequences obtained as standard clinical care.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years old.

  2. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.

  3. Agree to use adequate contraception as indicated in this protocol.

  4. Consent to PET scanning and receipt of one injection of 18F-fluciclovine.

  5. Able to comply with study procedures.

  6. Able to give written consent.

  7. Subject has had a standard of care, diagnostic MRI study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression.

Exclusion Criteria:

* 1. Are a pregnant or breastfeeding female.

  2. Are participating in a clinical trial of another unlicensed product.

  3. Are undergoing 18F-fluciclovine PET for reason(s) other than newly diagnosed or recurrent glioma.

  4. Have a hypersensitivity to 18F-fluciclovine.

  5. Have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines.

  6. Have a non-MRI compatible implantable device or another contraindication for MRI scan.

  7. Are deemed ineligible to participate for other reasons by an investigator.
Vitamin E or Lipoic Acid on Serum Oxyphytosterol Concentrations

Background of the study:

We now know that plant sterols can oxidize, which results in the formation of oxyphytosterols. Animal studies have suggested that oxyphytosterols are atherogenic components, however this relation has not yet been studied in humans. In our previous study (METC 09-3-088) we have shown in healthy volunteers that serum oxyphytosterol concentrations are linked to oxidative stress status (i.e. we were able to identify high and low sterol oxidizers). From the literature is known that especially type II diabetics and IGT subjects are characterized by increased oxidative stress markers and reduced antioxidant capacity. For this reason we also want to evaluate the oxyphytosterol concentrations in this population. Moreover, we know propose to evaluate the effect of antioxidant supplementation, i.e. vitamin E or lipoic acid, on serum oxyphytosterol concentrations in type II diabetic patients. If possible to lower oxyphytosterol concentrations in these populations this is obviously beneficial in case oxyphytosterols turn out to be atherogenic. The major objective of the present study is to examine the effect of consuming vitamin E (804 mg) or lipoic acid (600 mg) for 4 weeks on fasting oxyphytosterol concentrations in subjects with impaired glucose tolerance or type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 75 years
* Body Mass Index (BMI) between 20-35 kg/m2
* Mean serum total cholesterol \<8.0 mmol/L
* Mean serum triacylglycerol \<3.0 mmol/L
* Diagnosed with diabetes mellitus type 2 on a clinical basis or impaired glucose tolerance (defined as blood glucose \>7.8 mmol/l and \<11.0 mmol/L, two hours after ingesting 75 gram glucose in 150 ml water)

Exclusion Criteria:

* Unstable body weight (weight gain or loss \> 3 kg in the past two months)
* Active cardiovascular diseases like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebral vascular incident)
* Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
* Use of medication such as corticosteroids, diuretics or lipid lowering therapy
* Use of insulin therapy
* Abuse of drugs or alcohol (\>21 units per week)
* Not willing to stop the consumption of vitamin supplements, containing lipoic acid and/or vitamin E, 1 month before the start of the study (wash-in period)
* Use of an investigational product within another biomedical study within the previous month
* Pregnant or breast-feeding women
* Current smoker
RhEumatoid Arthritis MEDIcation Adherence

Rheumatoid arthritis (RA) is a public health issue because of its frequency, its functional consequences, the risk of morbidity and mortality and the costs incurred. A collaborative multiprofessional intervention initiated during hospitalization and continued after hospital discharge (ambulatory care ) would improve medication adherence in RA and therefore the health status of patients.

Main objective:

To compare, 12 months after the index hospitalization or consultation, the impact of pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician) on medication adherence to disease-modifying treatments of patients with RA compared to usual care without pharmaceutical care and specific multi-professional collaboration.

Medication adherence to disease-modifying treatments will be assessed by the rate of coverage of disease-modifying treatments (or Medication Possession Ratio (MPR)).

METHODOLOGY: Interventional, multicenter, controlled, randomized, open label study, comparing in parallel 2 groups of patients with rheumatoid arthritis initially hospitalized in a rheumatology department (pharmaceutical care provided in multiprofessional collaboration (pharmacist-physician), initiated in the hospital and continued after hospital discharge (ambulatory care) vs traditional follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosed rheumatoid arthritis (RA),
* Patient, male or female, aged 18 or over,
* Patient hospitalized or coming for a consultation in a rheumatology department, and returned home at hospital discharge
* Patient having DMARDs for RA (continuation or initiation) comprising at least methotrexate and/or a tsDMARD (targeted synthetic DMARD, JAK inhibitor) and/or subcutaneous bDMARD (biologic DMARD),
* Autonomous patient in the management of his drug treatment,
* Patient understanding and speaking French,
* Patient affiliated to the French general national health insurance or similar,
* Patient having given his free, informed and signed consent.

Exclusion Criteria:

* Patient whose usual pharmacy already has a patient included in the study,
* Patient with obvious significant cognitive or psychiatric disorders incompatible with the study (according to the judgment of the investigator),
* Patient whose management of his drug treatment at home is carried out exclusively by a carer,
* Patient participating in another research that may interfere (investigator's judgement) with the results of the present study,
* Adult patient protected under the terms of the law (Public Health Code),
* Patient not fit to carry out the follow-up, according to the judgment of the investigator,
* Pregnant or breastfeeding women.
Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion Criteria:

* patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening
Visual Acuity After the Combined Binocular Implantation of +2.75 Diopters and +3.25 Diopters Tecnis Multifocal Intraocular Lenses.

The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.75 D and +3.25 D full-diffractive multifocal intraocular lenses.

Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Eligibility Criteria:
Inclusion Criteria:

* clinically significant cataract
* endothelial cell count: patients aged 18-75 years: \> 1000 cells/mm2; patients \> 75 years: \> 750 cells/mm2
* absence of vision-limiting corneal or retinal comorbidities
* capability to understand the informed consent

Exclusion Criteria:

* expected postoperative astigmatism \> 0.75 diopters
* irregular astigmatism
* dilated pupil diameter \< 3 mm
* corneal and fundus abnormalities that might cause visual impairments
* inability to attend follow-up visits
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease

The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Vasospastic angina diagnosed by provocation test including ergonovine provocation coronary angiography or ergonovine echocardiogram
* No-ischemia producing moderate coronary artery disease(stenosis\>50%, FFR\>0.8)

Exclusion Criteria:

* Ischemic coronary lesion
* Organic heart disease associated with myocardial ischemia or sudden cardiac death
* History of percutaneous coronary intervention
* Cerebrovascular diseases or peripheral disease
* NYHA III and IV
* Cardiac pacemaker or implantable defibrillator
* Pregnancy or breast feeding
* Life expectancy less than 2 years
To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine

To assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential.

Exclusion Criteria:

* virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding