cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19

The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home.


Eligibility Criteria:
Inclusion Criteria:

* Are hospitalized or in the process of being admitted to hospital and have an initial laboratory determination of current COVID-19 infection less than or equal to (≤)72 hours prior to randomization
* Are men or non-pregnant women
* Women of childbearing potential must agree to use at least one highly effective form of contraception for the entirety of the study
* Agree to the collection of nasopharyngeal swabs and venous blood

Exclusion Criteria:

* Require mechanical ventilation or anticipated impending need for mechanical ventilation
* Received convalescent COVID-19 plasma treatment prior to enrollment
* Were resident in a nursing home or long-term care facility immediately prior to current hospitalization
* Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product
* Have an oxygen saturation (SpO2) less than (\<)88 percent (%) while breathing room air at rest at randomization.
Pulmonaryhypertension in Copd at Different Levels of Smoking

To identify Predictors of pulmonary hypertension in COPD patients and its relation to different levels of smoking

COPD is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.It is also the most common cause of deaths in patients with chronic respiratory disease, the fatality rate in USA is 0.41%.Pulmonary Hypertension is the most common serious complication in COPD patients ; which occurs in up to 30% of patients and increases the mortality rate.Smoking is the leading cause of chronic obstructive pulmonary disease (COPD) Smoking is also a trigger for COPD flare-ups.Smoking damages the air sacs, airways, and the lining of your lungs. Injured lungs have trouble moving enough air in and out, so it's hard to breathe

Eligibility Criteria:
Inclusion Criteria:

* 1.All patients admitted to chest department or presented to our outpatient clinic with clinical and functional diagnosis of COPD among both sexes will be included 2.Age \>18 years Old

Exclusion Criteria:

* 1.Patients under 18 years old. 2.pregnant patients. 3.patients with history hypertension or valvular diseases 4.Cardiomyopathic patient 5.Patients with concomitant obstructive sleep apnea 6.Patients with collagen vascular disease 7.Patients with thrombo-embolic disease 8. Patients with any chronic chest disease other than COPD
Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662

This study will compare the pharmacokinetic performance of film-coated tablet and granule formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized, four-period, four-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation either with or without food.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers, 18 to 60 years of age, inclusive

Exclusion Criteria:

* A history of epilepsy, convulsions or significant head injury
* Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis

The norepinephrine and vasopressin for rescue versus early vasopressin for vasopressor dependent sepsis (NoVa) is a phase 3, multicenter, open-label, randomized controlled trial comparing an early vasopressin initiation strategy versus norepinephrine plus vasopressin initiation only as a rescue strategy for hemodynamic management of critically ill patients with vasopressor dependent sepsis.

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated body response to infection. Its most severe form, septic shock, occurs when underlying circulatory and cellular metabolic abnormalities are pronounced, indicating greater severity and higher mortality. Vasopressor use is a cornerstone aspect in the treatment of critically ill patients with sepsis-associated hemodynamic dysfunction, with norepinephrine, a catecholamine, being the vasopressor of choice.

Vasopressin is an endogenous peptide hormone with potential advantages over norepinephrine in a catecholamine-sparing strategy for treating sepsis-associated hemodynamic dysfunction.

This is a phase 3, multicenter, open-label, randomized controlled trial. Adult patients with sepsis-associated hemodynamic dysfunction in the ICU may be eligible to participate. We aim to enroll 2,800 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with vasopressor dependent sepsis, defined by infection suspicion and antibiotic administration plus hypotension with the need of vasopressors for at least one hour;
* Admitted or expected to be admitted to the ICU in the next 12 hours
* Adequate volume resuscitation in the opinion of the attending physician
* Use of norepinephrine \> 0.05μg/Kg/min and ≤ 0.25μg/Kg/min for at least 1 hour and at most 24 hours at the time of inclusion

Exclusion Criteria:

* Use of norepinephrine \> 0.25μg/Kg/min in the last 24 hours, except when administered transiently in the context of sedation for a procedure or the initial phase of volume resuscitation for a period of less than one hour
* Dialysis-dependent chronic kidney disease or acute kidney injury that received renal replacement therapy during current hospitalization or are expected to receive renal replacement therapy in the next 24 hours
* Use of other vasopressors (except norepinephrine) at the moment of inclusion
* Use of vasopressors for sepsis in the last 7 days
* Suspected or confirmed acute mesenteric ischemia
* Anaphylaxis or known hypersensitivity to the study drug
* Expect to die in the next 24 hours
* Medical team not committed to full support at the time of inclusion
* Previous inclusion in the study
Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease

A study of outpatient participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Prazosin is a medication that is commonly used to treat people with high blood pressure. Research with prazosin has shown that it may be effective in treating behavioral problems by reducing excess adrenalin effects in the brain.

This is a 24 week study with 14 visits to the research clinic. Approximately 6 of these visits may be done by phone. Additional phone checks are scheduled at the beginning of each 12 week part of the study. Participants will have a 50:50 chance of being on prazosin or placebo in the first 12 weeks of the study. For the second 12 weeks, all participants will take prazosin.

Study visits include a physical and neurological exam; memory testing; interviews with the caregiver about behaviors; and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* No age limit
* Probable or Possible Alzheimer's Disease
* Disruptive agitated behaviors at least twice a week (overly anxious or excited, making offensive comments.....)
* Stable medications for 2 weeks
* Must have a caregiver who spends 10 hours per week caring for the participant and agrees to participate in all evaluation sessions

Exclusion Criteria:

* Cardiovascular: unstable angina, recent myocardial infarction, preexisting hypotension (systolic BP less than 110) or orthostatic hypotension (≥20 mmHg drop in systolic BP following 2 minutes of standing posture)
* Any unstable medical condition
* Exclusionary medications: current treatment with prazosin, other alpha-1 blockers (trazodone, sildenafil, vardenafil or tadalafil)
* Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
* Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.


Eligibility Criteria:
Inclusion Criteria:

* The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty

The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age≥30) patients with knee osteoarthritis (OA)
* Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at the Edmonton Bone and Joint Centre
* Understands, speaks and reads English; and
* Able to provide informed consent.

Exclusion Criteria:

* Individuals who have had prior total knee arthroplasty
* Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.
Trial of Safety, Tolerability and Efficacy of Trametinib (SNR1611) in Patients With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to evaluate the safety, tolerability and efficacy of trametinib (SNR1611) in the treatment of amyotrophic lateral sclerosis.

Trametinib (SNR1611) is a MEK inhibitor that downregulates the MAPK/ERK pathway. In this study, the potential of MAPK/ERK pathway downregulation through trametinib (SNR1611) as a therapeutic treatment for amyotrophic lateral sclerosis (ALS) will be evaluated.

Eligibility Criteria:
Main inclusion criteria:

* Patients diagnosed as definite, probable or probable-laboratory-supported ALS according to El Escorial Criteria.
* Patients of less than 2 years after the onset of ALS.
* Patients who meet the criteria of K-ALSFRS-R score and forced vital capacity.

Main exclusion criteria:

* Patients with primary lateral sclerosis, progressive muscular atrophy or lower motor neuron disease.
* Patients who have history of ALS treatment of edaravone or stem cell therapy within 16 weeks before screening.
* Patients who have permanently ceased the administration of riluzole due to lack of tolerability and/or efficacy.
* Patients in Class II to IV according to the New York Heart Association functional classification. Patients with myocardial infarction, unstable arrhythmia, and/or significant cardiovascular disease such as unstable angina within 12 weeks before screening.
* Patients who do not meet the criteria of laboratory tests and medical/operation history.
VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study

The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia.

This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* IC 1 Male or female the ages of ≥ 18 years
* IC 2 Planned ablation procedure according to the indication for use of the Adagio VT Cryoablation System
* IC 3 Subject willing to comply with study requirements and give informed consent
* IC4 Subject has or will be receiving an ICD prior to hospital discharge

Exclusion Criteria:

* EC 1 In the opinion of the investigator, any known contraindication to a ventricular tachycardia procedure with the Adagio VT Cyroablation System as indicated in the device Instructions For Use (IFU)
* EC 2 Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor
* EC 3 Any other condition that, in the judgement of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than six months, extensive travel away from the research center)
Stepping Into Lifestyle Changes

The purpose of this study is to promote healthy weight loss among African American women, age 30 or older, who are pre-diabetic and/or have high blood pressure and who live, work, or worship in select rural communities throughout Alabama and Mississippi. The goal of the study is to help reduce the burden of obesity, diabetes, and high blood pressure for these women and to collect information on the reach, effectiveness, adoption, implementation, maintenance, and cost effectiveness of our two evidence-base weight loss programs.

This study leverages two evidence-based interventions (EBIs) that have been culturally-adapted for the target population and have previously achieved clinically-relevant weight loss and other clinical outcomes (educational group weight loss intervention) along with improvements in diet and physical activity (home gardening intervention). Combining these EBIs addresses multiple domains (behavioral, personal environment, sociocultural) and levels (individual, interpersonal, community) of influence on risk factors for obesity and other cardiometabolic diseases prevalent in the Deep South. These interventions, delivered by local lay staff and non-academic partners, have a high potential for sustainability; however, there is a need to further evaluate the external validity and implementation-related barriers and facilitators to maximize reach, adoption and implementation. The investigators will employ a pragmatic, multilevel, cluster-randomized, type 1 hybrid effectiveness-implementation trial. A total of 264 Black women (age ≥ 30 years) with overweight or obesity and pre-diabetic or hypertensive from 12 rural counties (6 Alabama, 6 Mississippi) will receive either the combined educational group weight loss intervention plus a home gardening intervention or the educational group weight loss classes alone. The specific aims are to compare interventions on: (1) primary outcomes related to implementation effectiveness (reach, adoption, maintenance of health behaviors), (2) secondary outcomes on clinical effectiveness, and (3) cost effectiveness. Findings will inform discussions with coalition partners to achieve our long-term goal of widely disseminating and sustaining multi-level interventions to reduce the multiple chronic disease burden and health disparities in the Deep South.

Eligibility Criteria:
Inclusion Criteria:

* self-identifies as Black and/or African American
* ≥ 30 years old
* a measured BMI \>25 kg/m2 and at least one other cardiometabolic risk factor (physician diagnosis of pre-diabetes and/or hypertension within past 2 years)
* lives, works, or worships in one of the 12 intervention communities and expresses no intentions to move outside of that community in the 18 months following enrollment
* a willingness to participate in the study for the 18-months duration.

Exclusion Criteria:

* being or planning to become pregnant during the 18-month study duration
* a baseline blood pressure and/or glucose that is outside of the normal range and a medical provider does not provide clearance to participate
* medical contraindications
Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease(NIID)

To discover the microstructure, macrostructure and functional changes with 7T multi-modal magnetic resonance imaging of Neuronal Intranuclear Inclusion Disease, and to explore new biomarkers for evaluating the severity and the progression of Neuronal Intranuclear Inclusion Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with NIID
2. Older than 18 years;
3. Sign the informed consent form.

Exclusion Criteria:

1. The informed consent is withdrawn by the subject;
2. Contraindications or intolerance to MRI: metallic foreign bodies, instability of vital signs, epilepsy, claustrophobia, etc.
Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer

The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.

Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A\*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A\*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

1. locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
2. measurable disease by CT scan

PATIENT CHARACTERISTICS

1. ECOG performance status 0-2
2. Life expectancy \> 3 months
3. Laboratory values as follows

   * 2000/mm3 \< WBC \< 15000/mm3
   * Platelet count \> 75000/mm3
   * Bilirubin \< 3.0 mg/dl
   * Aspartate transaminase \< 150 IU/L
   * Alanine transaminase \< 150 IU/L
   * Creatinine \< 3.0 mg/dl
4. HLA-A\*2402
5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Active or uncontrolled infection
4. Concurrent treatment with steroids or immunosuppressing agent
5. Prior chemotherapy of gemcitabine
6. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
7. Serious or nonhealing wound, ulcer, or bone fracture
8. Active or uncontrolled other malignancy
9. Ileus
10. Interstitial pneumonia
11. Decision of unsuitableness by principal investigator or physician-in-charge
Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery

The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (NAT).


Eligibility Criteria:
Inclusion Criteria:

* Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram
* Surgery (mastectomy or BCT) planned within 60 days of the MRI

Exclusion Criteria:

* Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level \> 1.3 or eGFR ≥45)
* Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy
* Pregnant women
* Male patients
* Presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
* Known or suspected renal impairment. Requirements for GFR prior to MRI as determined by local site standard practice
* Women who have already had their standard of care post-NAT mammogram and/or breast MRI
A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.


Eligibility Criteria:
Inclusion Criteria

* Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
* Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
* ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1
* Dermatology Life Quality Index (DLQI) score \> 5 at the Screening Visit and Day 1
* Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1

Exclusion Criteria:

Target Disease Exceptions:

* Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1

Other protocol-defined inclusion/exclusion criteria apply.