cyrilzakka/clinical-trials huggingface dataset:
Study of the Efficacy and Safety of Ruxolitinib to Treat COVID-19 Pneumonia

The purpose of this study is to determine the safety and efficacy of the drug ruxolitinib in people diagnosed with COVID-19 pneumonia by determining the number of people whose conditions worsen (requiring machines to help with breathing or needing supplemental oxygen) while receiving the drug.

This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network and other centers.

Multifocal interstitial pneumonia is the most common cause of deterioration in people with COVID-19. This is attributed to a severe reaction where releases too many cytokines (proteins that play an important role in immune responses) which rush into the lungs resulting in lung inflammation and fluid buildup. This can lead to damage to the lungs and leading to breathing problems. Ruxolitinib when given early in the disease, may prevent the overproduction of cytokines which, in turn, may prevent lung damage.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 infection diagnosed by nasopharyngeal sample
* Need for supplemental oxygen to maintain oxygen saturation \> 93%
* 12 years of age or older

Exclusion Criteria:

* Neutrophils \< 1 x 10\^9/L
* Platelets \< 50 x 10\^9/L
* Serum total bilirubin \>2.0 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) \> 5x ULN
* Creatinine clearance (CrCl) \< 15 mL/minute
* Pregnant women
* Known HBV or HIV infection
* Signs and symptoms of Varicella Zoster Virus (VZV) infection
* Patients requiring invasive mechanical ventilation. Patients requiring non-invasive mechanical ventilation (e.g., BiPAP) are eligible.
* Patients who require supplemental oxygen support prior to COVID-19 infection.
* Patients who are on ruxolitinib or similiar drugs.
Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients

Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.


Eligibility Criteria:
Inclusion Criteria:

* Patient planning DMPA for post-abortion contraception.

Exclusion Criteria:

* Patient cannot speak and read English.
Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis

Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand.

Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\> 14 years) with suspected severe leptospirosis
* patients who presented with acute fever (oral temperature more than 38.00 C for \<15 days) in the absence of an obvious focus of infection
* In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).

Exclusion Criteria:

* pregnant or breastfeeding
* those with history of bleeding disorder
* those who had underlying diseases such as chronic liver disease, diabetes mellitus
* those who received diuretic or glucocorticoid
Patient Aligned Care Team (PACT) Intensive Management (PIM) Project

Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting.

Goal:

* Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
* Improve Veteran and staff satisfaction

Objectives:

* Maintain the patient in the home setting as much as possible
* Secure appropriate home environment to facilitate health and well-being
* Utilize comprehensive team-based care
* Engage appropriate Veteran Health Administration (VHA) programs to provide interdisciplinary, coordinated, and timely management of complex medical issues


Eligibility Criteria:
Inclusion Criteria:

* selected for intensive management

Exclusion Criteria:

* enrolled in other intensive case management at VA
Early Imaging Biomarkers in NSCLC

The purpose of this study is to investigate if cardiac MRI, blood biomarkers, and lung CT scans can detect early changes to the associated with radiation therapy in patients receiving radiation treatment for thoracic cancer.

This study seeks to investigate the utility of novel imaging biomarkers, namely whole lung volumetric CT scans and cardiac MRI, to non-invasively identify early pathologic changes in pulmonary and cardiac function resulting from thoracic radiation. The ability to identify these changes during the course of treatment offers a powerful tool to optimize radiation dose distributions within uninvolved normal tissue by adapting treatment to the individual patient response. In addition it may lead to other therapeutic interventions designed to reduce long term cardiopulmonary toxicity.

The cardiac MRI will be performed using Aminophylline, Gadopentetate Dimeglumine and Regadenoson. These are not FDA approved for this purpose, but are being used off label and are IND exempt. Additionally, patients will be consented with an optional choice to retain research blood samples for 15 years after the completion of the study. This will allow cutting edge analysis for biomarkers that may be discovered in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving once daily fractionated intrathoracic radiation therapy for:
* Stage IIA-IIIB non-small cell lung cancer
* Limited stage small cell lung cancer
* Stage I-III esophageal cancer (neoadjuvant or definitive)
* Patients must be 18 years of age or older
* Must not be claustrophobic
* Must have adequate kidney function

Exclusion Criteria:

* Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation
* Patients with esophageal cancer receiving trastuzamab
* Pregnancy or lactation
* Claustrophobia
* Inability to lie flat for 60-90 minutes
* Renal dysfunction with eGFR \<60 mL/min/1.73 m2
* Allergy to gadolinium containing contrast media
* Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac MRI
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant

This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including

  * Ultra Version V2 newly implanted on this side (Group 1)
  * Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2)
* Informed consent signed

Exclusion Criteria:

* no exclusion criteria
Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel


Eligibility Criteria:
Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

Exclusion Criteria:

* Location of the treatment area (trunk (except chest) or extremities)

  * within 5 cm of an incompletely healed wound,
  * within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate within the selected treatment area
* Lesions in the treatment area that have:

  * atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous horns) and/or,
  * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
Comparison of Ultrasonographic and Anthropometric Measurements in Difficult Airway Evaluation

In this study, anthropometric measurements (clinical measurements) will be applied in all patient groups; expected (to be difficult to provide airway patency as a result of detailed history, physical examination and evaluation tests performed by an experienced anesthesiologist), and unexpected (although it was not predicted that a difficulty was encountered). And ultrasounographic measurements will be applied in all patients. The aim of this study is to evaluate the predictive accuracy of ultrasonographic measurements.

In the preoperative period, the following clinical tests will be performed before the patient arrives in the operating room and when the patient arrives, the measurements will be made by ultrasonography.

1. Mallampati classification
2. Determination of mouth opening (interinsizer distance)
3. Thyromental distance
4. Sternomental distance

Preoperative evaluation of the patients and clinical results of the airway tests (mentioned above) will be recorded. The cervical soft tissue thickness will be measured and recorded at 3 levels (thyrohyoid membrane, vocal cord, hyoid bone) with the help of ultrasonography (mentioned above). In addition, since all patients will be under general anesthesia, laryngoscopic images (laryngoscopic evaluation according to Cormack Lehane classification) routinely recorded on the anesthesia follow-up sheet will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients under general anesthesia
* ASA 1-2-3

Exclusion Criteria:

* Patients who will undergo emergency surgery,
* pregnant women,
* children,
* patients who may have difficulty in airway management due to cervical instability,
* patients with trauma or malignancy in the neck region
Increasing Activity in Liver Transplant Patients

Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?


Eligibility Criteria:
Inclusion criteria:

* Adult patients 18-65 years of age who receive a liver transplant at Mayo Clinic Jacksonville.
* Adult patients who are 5-21 days post liver transplant.
* Must be followed by Mayo Clinic Jacksonville at 4 months postoperatively.
* Approved by a hepatologist and/or transplant surgeon to participate.

Exclusion criteria:

* Patients with active infections
* Patients with encephalopathy or cognitive dysfunction
* Patients who receive a combined liver-kidney transplant
* Patients with severe debility
* Patients who require assistance to ambulate.
Effect of Rifampin on the Pharmacokinetics of BAY73-4506

The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Age: 18 to 45 years (inclusive) at the first screening examination / visit
* Body mass index (BMI): 18 to 32 kg/m² (inclusive)
* Ability to understand and follow study-related instructions
* Subjects enrolled in this study must use adequate barrier birth control measures prior to, during the course of the study, and 3 months after the last administration of regorafenib. An adequate contraception includes the use of condoms or a vasectomy. In addition, adequate birth control measures for the subject's partner is required, such as a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, or hysterectomy.

Exclusion Criteria:

* Clinically significant disease or condition
* Recent serious infection
Chemoprevention of Oral Premalignant Lesions

Reduction in size and number of oral premalignant lesions


Eligibility Criteria:
Inclusion Criteria:

* 8mm oral premalignant lesion that has not been biopsied in the past 6 months

Exclusion Criteria:

* Taking \>100mg daily dose of NSAIDS (Non-steroidal anti-inflammatory drugs)
A Pressure Relted Study Comparing a Compression Device and Profore® on Healthy Volunteers

This phase I Healthy Volunteer study will evaluate the pressure interface between the devices (a compression device and Profore®) and the skin, using the PicoPress(TM) pressure transducer at specified time intervals in three distinct locations on the leg, in both the sitting and standing position. It will also assess the variability of interface pressure following application under each test device for each subject over a period of three days (three separate applications).


Eligibility Criteria:
Inclusion Criteria:

* over 18 years, willing and able to provide written informed consent.
* able to wear the compression device and Profore® and follow the requirements of the clinical investigation plan
* an ankle to brachial pressure index (ABPI) of 0.9 or greater
* CEAP classification C0-C2
* healthy volunteers

Exclusion Criteria:

* history of skin sensitivity to any of the components of the study product
* participated in a previous clinical study within the past 3 months
* active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
* exhibited any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
* leg sizes outside the following range:

  * Ankle - 12cm to 44cm
  * Calf - 22cm to 60cm
  * Below knee - 22cm to 68cm
Chatbot to Maximize Hereditary Cancer Genetic Risk Assessment

In this study, the investigators aim to compare a mobile health platform, known as a 'chatbot,' that leverages artificial intelligence and natural language processing to scale communication, to 'usual care' that patients would receive. This comparison will enable the investigators to determine if the chatbot system can improve rates of recommendation for genetic testing among patients at elevated risk of harboring a familial cancer syndrome in an all-Medicaid gynecology clinic. Furthermore, the investigators aim to evaluate facilitators of inequity in regard to patient access to and utilization of genetic testing services.


Eligibility Criteria:
Inclusion Criteria:

* 8 years of age or older.
* Scheduled for a New Patient appointment in the gynecology clinic. Speaks and reads in English.
* Access to a telephone with texting capacity.
* Has not had prior genetic testing for hereditary cancer syndromes.

Exclusion Criteria:

* Under 18 years of age
* Has had previous genetic testing for hereditary cancer syndromes
* Does not read/speak in English
* Does not have access to a phone with texting capabilities
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment

To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

All subjects

* Able to provide written informed consent to participate in this study after reading the ICF
* Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements
* A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2

Renal impaired subjects (in addition)

* Subjects with mild renal impairment defined as eGFR 60-89 mL/min/1.73m2 and subjects with moderate renal impairment defined as eGFR 30-59 mL/min/1.73m2
* Chronic and stable renal impairment

Healthy subjects (in addition)

* Subject with normal renal function defined as eGFR≥90 mL/min/1.73m2
* Good health and free from clinically significant illness or disease

Exclusion Criteria:

All subjects

* Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
* Subjects were previously administered MCI-186
* Positive urine drug screen (if not due to concomitant medication) or alcohol test
* History of alcohol abuse or drug abuse
* Presence of active infection requiring antibiotics
* Positive test for human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb)

Renal impairment subject (in addition)

* Acute renal failure
* History of renal transplantation
* Aspartate aminotransferase (AST) activity, or an alanine aminotransferase (ALT) activity of at least 3 times the upper limit of normal (ULN) range
* Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)\>180 mmHg and/or diastolic blood pressure (DBP)\>110 mmHg
* Start of any new medication or new any changes to a current dosage

Healthy subject (in addition)

* History or presence of any renal disease
* Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)\>160 mmHg and/or diastolic blood pressure (DBP)\>100 mmHg
Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

The investigators are studying the initial autonomic alterations in participants recently diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the baroreceptor sensitivity and on the peripheral sympathetic innervation.

Until now the autonomic dysfunction in Diabetes Mellitus type 2 (DM2)has been broadly studied in long term patients. Thus, clinical features as cardiac autonomic neuropathy (CAN) and the lack of the baroreceptor reflex were widely described in patients with a long standing Diabetes. However, there hasn´t been a description of the initial autonomic imbalance in both Pre-Diabetes and recently diagnosed DM2 patients. This is the goal of the present research study, to assess the autonomic dysfunction among these sets of patients.

Yet CAN is finding mostly happening in late stages of DM2 and so the lack of Baroreceptor reflex sensitivity there are other subtle indicators of dysautonomia which hasn't been extensively analyzed. In fact, rest tachycardia and orthostatic intolerance may point to an early dysautonomia. A description of the impairment of the cardiovascular autonomic regulation is still missing. Therefore, the investigators intend to evaluate this regulation through the means of a Task Force System.

Eligibility Criteria:
Inclusion Criteria:

* patients who have not suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity nor Ischemic Stroke

Exclusion Criteria:

* Those older than 55 years old, or younger than 18 years old.
* Those who have suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity or Ischemic Stroke
Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers

This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).


Eligibility Criteria:
Inclusion Criteria:

* Males and females healthy volunteers aged 18-65 years will be included in the study.
MD1003-AMN MD1003 in Adrenomyeloneuropathy

The primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day over placebo in the clinical improvement (walking tests) of patients with adrenomyeloneuropathy

AMN and progressive multiple sclerosis share some similarities including progressive spastic paraparesis and secondary energy failure leading to progressive axonal degeneration. Therefore, it was hypothesized that high doses of biotin might be efficient in patients with AMN.

Eligibility Criteria:
Inclusion Criteria:

* ABCD1 gene mutation identified
* Elevated plasma VLCFA
* Clinical signs of AMN with at least pyramidal signs in the lower limbs and difficulties to walk
* EDSS score ≥ 3.5 and ≤ 6.5
* Normal brain MRI or brain MRI showing :
* abnormalities that can be observed in AMN patients without cerebral demyelination with a maximum Loes score of 4
* and/or stable (≥6 months) cerebral demyelination without gadolinium enhancement with a Loes score ≤12.
* Appropriate steroid replacement if adrenal insufficiency is present
* Likely to be able to participate in all scheduled evaluation visits and complete all required study procedures
* Signed and dated written informed consent to participate in the study in accordance with local regulations
* Affiliated to a Health Insurance

Exclusion Criteria:

* Brain MRI abnormalities with a Loes score \> 12 or with gadolinium enhancement
* Any progressive neurological disease other than AMN
* Impossibility to perform the walk tests and the TUG test
* Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or any progressive malignancy
* Any new medication for AMN including Fampridine initiated less than 1 month prior to inclusion
* Contra-indications for MRI procedure such as subjects with paramagnetic materials in the body, such as aneurysm clips, pacemakers, intraocular metal or cochlear implants.
* Inclusion in another therapeutic clinical trial for ALD
* Not easily contactable by the investigator in case of emergency or not capable to call the investigator