cyrilzakka/clinical-trials huggingface dataset:
Beacon Sensors and Telerehabilitation to Assess and Improve Use of Devices (BeST-AID) for Low Vision

One goal of this research is to conduct a non-inferiority trial of telerehabilitation versus in-office care to provide follow-up training to individuals with low vision to enhance their quality of life by using magnification devices and/or visual assistive mobile apps for important daily activities, such as reading and/or other valued tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, which can be essentially eliminated with telerehabilitation. Another goal of this project is to determine whether significant changes in environmental data collected by Bluetooth low energy beacon sensors can be used as a solution to monitor and indicate when low vision patients' have abandoned the use of their magnification devices, which has the potential to substantially enhance patient management by providing timely low vision rehabilitation services.


Eligibility Criteria:
Inclusion Criteria:

* adults with any level of vision loss due to any ocular disease who are age 18 and older, and who have received new magnification device(s) for the first time (i.e., hand-held optical magnifiers, portable electronic video magnifiers, high near add powers of +4.00 or greater, visual assistive mobile apps for their smartphone/tablet, some stand magnifiers and CCTVs) from one of our participating low vision rehabilitation sites at the four academic centers and one private practice.

Exclusion Criteria:

* schedules not permitting participation in planned study visits (including planning to move far from their clinical provider's office within the first 4-months of the study (i.e., cannot attend in-office visits) or take extended vacation that would not allow them to complete study procedures during the first four months of the study period),
* inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (greater than mild cognitive impairment as per TICS),
* substance abuse,
* significant hearing loss (unable to hear communication by phone or via videoconferencing),
* significant medical condition likely to limit participation or lifespan,
* individuals who require other types of LVR training or intervention (e.g., psychosocial).
* For Bluetooth low energy beacon sensors, exclusion would occur if their magnifier device has features that would not work in conjunction with the beacon sensors: (1) hands-free and do not have a place where the patient's hand is holding the device during use (therefore, they would not register a significant change in temperature), (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device, or (3) use of visual assistive mobile apps only.
A Safety Study in Healthy Volunteers of the Single-Use Autoinjector Containing Placebo of BG9418 Interferon Beta-1a With a 25-Gauge × 1-Inch Needle

This is a single-arm, single-center study in healthy volunteers. This study is designed to evaluate the safety of IM injections using single-use autoinjectors with a 25G × 1" needle. The purpose of this study is not to evaluate study treatment; therefore, all injections will be performed with Avonex placebo only; no active IFNβ-1a will be administered.

This is a single-arm, single-center study in healthy volunteers. The study is designed to evaluate the safe use of the single-use autoinjector with a 25G × 1" needle in subjects of varying body mass indices (BMIs). Because this is a safety study of the injector, the injections contain Avonex excipients only; no active IFNβ-1a will be administered.

During the study, each subject will self-administer 4 IM injections using single-use autoinjectors.

Subjects will self-administer the first 2 injections (1 in each thigh) and then repeat the process approximately 60 to 90 minutes later. A Trainer/Observer will prepare the autoinjector for each injection, monitor each injection, and assess the subject for AEs during the injection process and up to the time of discharge from the unit. The Trainer/Observer will also visually inspect the needle pre- and post-injection and record their findings. The Investigator or designee (physician or nurse) will assess injection sites for erythema, induration, tenderness, or warmth.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, aged 18 to 65 years, inclusive, at time of informed consent
* Able to understand and comply with the protocol
* Must be English or French speaking
* At the investigator's opinion, must be willing and able to perform self-injections into the right and left thighs with the single-use autoinjector

Exclusion Criteria:

* Abnormal screening blood tests determined to be clinically significant by the Investigator
* Treatment with any systemic anticoagulant within the previous 30 days
* Treatment with aspirin within the previous 7 days or nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous 3 days
* History of severe allergic or anaphylactic reactions
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, pyschiatric, renal, and/or other major disease including bleeding disorders
* Current enrollment in any other investigational study
* Female subjects who are currently pregnant
* History of alcohol or substance abuse or a positive drug screening test on day 1

Other protocol-defined inclusion/exclusion criteria may apply.
Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection

This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI seen in an academic medical center's specialty outpatient clinic.

This specialty clinic is a unique practice setting where patients with ≥1 recurrent CDI and/or refractory disease are referred. The study will represent real-world data on the clinical use of bezlotoxumab as adjunctive therapy in combination with vancomycin or fidaxomicin for the treatment of patients with recurrent CDI. Retrospective chart review will be conducted for patients who visited the specialty CDI clinic between 1/1/2005 through 12/5/2019. Case patients will be defined as patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. Controls will be defined as patients who have received only standard CDI treatment and will be enrolled in a 2:1 ratio to cases. The primary outcome is recurrence of CDI. Recurrence is defined as a new episode of C. difficile infection that occurs after the initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or standard CDI treatment. Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy. Recurrent CDI will be diagnosed via clinical signs and symptoms and CDI diagnostic assay.

Eligibility Criteria:
Inclusion Criteria (Cases):

* Age 18 years and older
* Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
* Received bezlotoxumab in addition to standard CDI treatment

Inclusion Criteria (Controls):

* Age 18 years and older
* Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay
* Received only standard CDI treatment

Exclusion Criteria:

* Diarrhea due to causes other than C. difficile
* Incomplete documentation in the electronic medical record
Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus

OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701) in women with prednisone-dependent systemic lupus erythematosus.

II. Describe the pharmacokinetics of GL701.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

Patients are randomly assigned to 1 of 2 doses of oral dehydroepiandrosterone or placebo, administered daily for a minimum of 7 months. A prednisone taper is attempted each month in patients with stable or improving disease. Therapy continues until a successful prednisone taper is achieved and sustained for at least 2 months, or until a maximum of 9 months.

Patients are followed for 1 year after entry.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Systemic lupus erythematosus by American College of Rheumatology criteria Mild to moderate disease characterized as follows: Prednisone dose (or equivalent) 10 to 30 mg/day No daily dose 1 mg/kg or greater No alternate-day regimen Failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to entry OR No attempt to taper in last 12 months and dose stable for at least 3 months prior to entry No prior participation in double-blind dehydroepiandrosterone (DHEA) study at Stanford University --Prior/Concurrent Therapy-- No concurrent immunosuppressants No concurrent participation in other clinical studies No investigational agents within the longer of 30 days or 10 half lives of the agent At least 3 months since the following: Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune globulin Other immunosuppressants At least 1 month since any change in dose of concurrent nonsteroidal anti- inflammatory drugs or hydroxychloroquine --Patient Characteristics-- No hypersensitivity to DHEA or inactive ingredient in DHEA, i.e.: Cornstarch Lactose Magnesium stearate No condition that would prevent adequate compliance with study No history of breast cancer or reproductive tract malignancy Negative pregnancy test required within 2 weeks prior to entry Reliable contraception required of fertile women No estrogen-containing oral contraceptive
Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.

Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.

In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants born before or at 3032 weeks of gestation
* For whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit.

Exclusion Criteria:

* Other type of thyroid dysfunction (including, but not exclusively: mother with Basedow disease, congenital hypothyroidism, hyperthyroidism)
* Associated polymalformative sindrome
Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After TNF Alfa Inhibitors Therapy

The efficacy of TNF alfa inhibitors in the treatment of psoriasis has been documented in many studies.

Their effect on dendritic cells has been scarcely studied. TNF- α has a central role in dendritic cell biology, both for their maturity and mobilization of peripheral tissues to secondary lymphoid organs.

The primary objectives of this study are:

* To document absolute number, density of immune infiltrate and dendritic cells and inflammatory cytokines expression pattern (particularly IFN α and IL-32) in psoriasic lesions vs normal skin of the same patient
* To describe changes in such cell numbers and expression patterns upon 16 weeks treatment with TNF alfa inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects \> 18 years of age, affected by moderate to severe psoriasis
* Subject has had clinical diagnosis of psoriasis for at least 12 months, stable plaque psoriasis for at least 2 months before screening (subjects with concurrent psoriatic arthritis may be enrolled).
* Subject is naıve to TNF-antagonist therapy and efalizumab.
* Subjects are considered eligible according to the following tuberculosis screening criteria:

  1. Have no history of latent or active TB prior to screening;
  2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
  3. Within 1 month prior to the first administration of study medication, have negative diagnostic tuberculin skin test.
* Normal chest X-ray within 3 months prior to screening with no evidence of malignancy, infection, current or old TB.
* Subjects' screening and baseline clinical data must be within the normal limit, including the results of medical history, physical examination and laboratory evaluation (complete blood count, serum values for liver enzymes, bilirubin, glucose, albumin, creatinine and urine analysis).
* Willing and able to comply with the protocol requirements for the duration of the study.
* Women of childbearing potential must be using adequate birth control measure throughout the study and for 150 days (5 months) after study completion.

Exclusion Criteria:

* Pregnant or breast-feeding women, or women who are planning pregnancy.
* Patients not suitable for TNF alfa inhibitors therapy
Study if the Presence of Functional FcERI/RII on the Surface of Human Blood Platelet

Anaphylactic shock is the most severe expression of immediate hypersensitivity reactions. The mechanisms leading to these reactions are still poorly understood and may involve platelets, especially in the most severe forms.

The IgE ( ImmunoglobulineE)-mediated mechanism, involving the FcERI(the high-affinity receptor for the Fc region of immunoglobulin E (IgE) receptor present on the surface of mast cells and basophilic cells, is the most common mechanism. The receptors FcERI and FcERII are also described as being present on the surface of blood platelets, which would imply their activation along with the other cells involved. However, studies showing the presence of the FcERI/RII receptors on blood platelets suffer from many biases.

The main objective of the research is to study whether the FcERI/RII receptors are present and functional on the surface of blood platelets from allergic patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years-old
* With a protein/drug allergy (hymenoptera, arachide, amoxicillin)
* Confirmed by skin tests and/or challenge test
* With specific IgEs

Exclusion Criteria:

* Patients who refuse to participate to this study
* Patients unable to consent
Study Examining the Effects of Mindfulness and Similar Audio-guided Exercises.

This study aims to examine whether greater length of mindfulness practice results in more beneficial outcomes.

This study will randomise participants to one of three groups: (1) four sessions of medium length mindfulness practice (lasting 20 mins) and 5 mins of an audio book; (2) four sessions of brief mindfulness practice (lasting 5 mins) and 20 mins of an audio book; and (3) a control group who just receive 4 sessions of audio book (lasting 25 mins). In the mindfulness arms, in each session, the participants will receive the audio book prior to the mindfulness practice. Mindfulness levels, and depression, anxiety and stress will be measured by self-report at baseline, session by session, and at post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Members of the general public, especially university students or staff.
* Adequate understanding of spoken and written English

Exclusion Criteria:

* Currently experiencing significant difficulties with their mental wellbeing.
* Currently have a personal mindfulness practice.
* Currently participating in a mindfulness-based intervention.
Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin

The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.

Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

* 19\~55 years healthy male
* BMI measurement 19.0kg/m\^2\~ 28.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.

Exclusion Criteria:

* History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* SBP\>140mmHg or \<90mmHg, DBP\>90mmHg or \<60mmHg.
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* History of drug abuse
* A alcohol consumer(alcohol\>140g/week) or smoker(cigarette\>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
* Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
* Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
* Glomerular filtration rate\<60mL/min
* Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .
A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

This research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. Chemotherapy agents such as gemcitabine, cytarabine, chlorambucil, fludarabine, or the immunotherapeutic agent, rituximab, may be proposed. Thus, the aim is to search for new treatments that may improve the prognosis of patients with relapsed mantle cell lymphoma.

The present clinical study aims at determining if lenalidomide is safe and active in patients with mantle cell lymphoma who are refractory to their treatment or have relapsed once, twice or three times. Enrollment goal was met on March 7th 2013 and thus enrollment was stopped.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven mantle cell lymphoma
* Patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease
* Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2
* Willing to follow pregnancy precaution

Exclusion Criteria:

* Any of the following laboratory abnormalities
* Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 (1.5 x 10\^9/L)
* Platelet count \< 60,000/mm\^3 (60 x 10\^9/L)
* Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) \>3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
* Serum total bilirubin \> 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
* Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL/min
* History of active central nervous system (CNS) lymphoma within the previous 3 months
* Subjects not willing to take deep venous thrombosis (DVT) prophylaxis
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
Knowledge About Covid-19 Infection in Pregnant Women

Covid 19 is a pandemic infection developed in late 2019

It developed in China Then spread worl wide

Eligibility Criteria:
Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* non pregnant women
Compare Propofol to Fentanyl and Midazolam for Colonoscopy

The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.

Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects.

Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects

Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure.

Other Variables of Interest.

* Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
* Difficulty of procedure rated by the physician on a scale of 0-10
* Colonoscopy completion rates (intubation of cecum).
* Complications including oxygen desaturation or hypotension.
* Cost of the two medication regiments

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Elective outpatient colonoscopy
* American Society of Anesthesiology Class (ASA) \< IV

Exclusion Criteria:

* Age \< 18
* Inpatient status
* Emergency procedure
* History of colonic or rectal resection
* History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam
* ASA of IV
* Neurological deficit
* Acute gastrointestinal bleeding
* On anticoagulation agents
* Noncompliance with bowel regiment
* Pregnant women
* Prisoners