Kornimate/medical-research-clean huggingface dataset:
senicapoc in covid-19 patients with severe respiratory insufficiency

Conditions: ARDS, Human; COVID

Summary: sars-cov-2, one of a family of human coronaviruses, was initially identified in december 2019 in wuhan city. this new coronavirus causes a disease that has now been named covid-19. the virus has subsequently spread throughout the world and was declared a pandemic by the world health organisation on 11th march 2020. as of april 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. there is no approved therapy for covid-19 and the current standard of care is supportive treatment. key markers implying a fatal outcome are acute respiratory distress syndrome (ards)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ards-like disease. in cells, there is an antiviral effect of senicapoc.

the investigators discovered that in an animal model with a knockout of a potassium channel with intermediate conductance (kca3.1), the knockout protected against lung damage and accumulation of liquid in the lung. in subsequent studies, the investigators have developed a mouse model showing that genetic deletion of the kca3.1 channels and senicapoc, a blocker of kca3.1 channels, protects against the accumulation of liquid in the lung. moreover, senicapoc treatment possesses anti-inflammatory effects illustrated as lower leukocyte accumulation inside the lungs after injury. importantly, it also increases the fio2/pao2 ratio (ratio of inhaled to blood oxygen), hence preserving lung function in mice with an ards-like disease. in addition, there is evidence that senicapoc has antiviral properties. aarhus university has patented senicapoc for use in the treatment of acute respiratory disease. in this case, respiratory disease is caused by an infection with a coronavirus. senicapoc has been developed for the treatment of sickle cell disease and has been administered to 500 patients without observation of major treatment-related adverse effects.

Eligibility criteria:
inclusion criteria: * covid-19 positive * age ≥18 years * respiratory insufficiency * icu admission exclusion criteria: * severe heart failure (ejection fraction \< 30%) * severe renal insufficiency (egfr \< 30 ml/min/1.73m2) * severe hemodynamic instability (noradrenalin dose \> 0.3 μg/kg/min) * prior enrollment in the trial * pregnancy * allergy to senicapoc * inability to take enteral medication * more than 24 hours since icu admission * limitations of care * anticipated death within 24 hours

Keywords: senicapoc severe acute respiratory distress syndrome sars-cov2 corona virus infection
the use of ultrasound detection of lipohypertrophy to improve glycemic control

Conditions: Diabetes Mellitus; Lipohypertrophy

Summary: lipohypertrophy is swelling of the fatty tissue located below the skin ("subcutaneous tissue") where many patients with diabetes inject their insulin. lipohypertrophy can sometimes be felt as firm swelling, lumps or small bumps near insulin injection sites. previous studies have shown that injecting insulin into areas of lipohypertrophy can affect how insulin is absorbed, and can increase insulin requirements in patients. new data suggest that lipohypertrophy can be detected using ultrasound technology. the ultrasonographic presence of changes to the subcutaneous tissue without swelling that can be felt ("subclinical lipohypertrophy") and the effect of injecting insulin into these sites is unknown. 100 people will participate in the phase 1 of this study. in the second phase of the study, 40 patients identified with subclinical lipohypertrophy in phase 1 will be asked to participate in the randomized study using crossover design by checking your glucose levels.

purpose: in phase 1: to use computer based technology to detect lipohypertrophy on portable ultrasound images. in phase 2: to demonstrate that injecting insulin into areas to be free of lipohypertrophy will have better glucose control as compared to injecting into areas demonstrated to have lipohypertrophy. eligibility: you can participate in this study if: * you have been diagnosed with type 1 or type 2 diabetes * you are currently using injection of insulin daily or insulin pump for at least 2 years * you are 19 years of age or older you should not participate in this study if: * you are taking a glucagon-like peptide medication * you are currently using a systemic steroid agent (e.g. prednisone) * you have history of a non-lipohypertrophic skin disease in the insulin injection area * you are not fluent in english (unless accompanied by a translator)

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of type 1 or type 2 diabetes mellitus * current treatment with a minimum of one insulin injection daily or insulin pump for at least 2 years exclusion criteria: * subjects taking a glucagon-like peptide-1 agonist or a systemic glucocorticoid * past history of a non-lipohypertrophic dermatological condition in the insulin injection site area
visual function and patient satisfaction after bilateral implantation of acrysof natural restor (model sn60d3) or acrysof natural monofocal (model sn60at)

Conditions: Cataract

Summary: the purpose of the study is: * to compare visual parameters (subjective refraction and visual acuity (va)) and safety (tilt, decentration and posterior chamber opacification (pco)) in a prospective series of 40 patients after bilateral implantation of acrysof natural restor (model sn60d3) or acrysof natural monofocal (model sn60at) * to assess patient satisfaction before and after implant


Eligibility criteria:
inclusion: * written informed consent * age: ≥ 50 years ≤ 75 years * bilateral age related cataract, to be extracted and followed by the implantation of posterior chamber intraocular lenses (iols) * pre-operative and post-operative astigmatism ≤ 1 diopter (d), as from keratometry readings * potential post operative visual acuity (va) ≥ 20/40 * second eye surgery to take place no longer than 45 days after the first implant exclusion: * irregular optical aberrations; * pupil diameter in scotopic conditions more than 6 mm * degenerative visual pathologies (ex: age-related macular degeneration (amd)) * other exclusions as from restor directions for use (dfu)
a megastudy of single-session interventions for depression

Conditions: Depression - Major Depressive Disorder

Summary: this project aims to learn if new kinds of digital single-session interventions (ssis) for depression could be effective for american adults. many existing ssis are delivered in a simple text-based format. however, it might be that different kinds of ssis (in terms of both content and style) also have potential for scalable impact. specifically, this study will investigate the effectiveness of 11 innovative ssis by comparing them to a passive control and to an existing ssi with established efficacy.


Eligibility criteria:
inclusion criteria: * at least 18 years old * able to read and write fluently in english * have enough access to the internet to complete two sessions over four weeks * score at least 10 on the phq-9 screen (suggesting moderate depression; kroenke et al., 2001) * pass the bot check during the screening survey all participants who are randomized to an experimental condition (and therefore completed all baseline measures) will be included in analyses, except for participants who indicate at the end of either the baseline or week 4 session that they did not participate in the study seriously. researchers will only keep data from the first survey session a participant begins.

Keywords: single-session intervention depression megastudy digital mental health intervention experiment randomized clinical trial
real-time continuous glucose monitoring (rt-cgm) in patients with type 1 diabetes at high risk for low glucose values using multiple daily injections (mdi) in germany (hypode-study)

Conditions: Diabetes

Summary: demonstrate that usage of rt-cgm (real time continuous glucose monitoring) reduces the frequency of low cgm-recorded glucose events in patients using mdi (multiple daily injections) that are at risk for hypoglycemic events.

in a randomized controlled trial the primary hypothesis is tested if the usage of rt-cgm in the intervention group (cgm group) reduces the frequency of glucose values \<55 mg/dl in patients with hypoglycemia problems (hypoglycemia unawareness or documented previous severe hypoglycemia) significantly more than in the control group receiving usual care (without cgm). secondary is tested if patients in the cgm group showed a significantly more favorable change in the below defined secondary endpoint than patients in the control group after 26 weeks follow up.

Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes for at least 12 months on multiple daily injections (mdi). mdi is defined as prandial insulin injections at each major meal (excludes pre-mixed insulin) with doses determined by smbg and carbohydrate counting, and basal insulin injection(s) * age ≥ 18 years * hba1c ≤ 9.0 % performed within 4 months before begin of the study * high risk for severe hypoglycemia (defined as a score of 4 or higher on the hypoglycemia unawareness scale (hus) or a history of at least one severe hypoglycemic event in the last 12 months (required third part assistance, not able to treat themselves)) * willing to not use paracetamol or drugs containing it * signed and dated informed consent form exclusion criteria: * use of personal real-time-cgm 3 months prior to study entry and during the study (except study devices) * use of a flash-glucose monitoring system 3 months prior to study and during the study * alcoholism or drug abuse * unable to comply with the protocol at the investigators discretion, such as known psychiatric diagnosis, cognitive / physical decline * pregnancy or lactation period * severe known allergies, e.g. against plaster * mental incapacity or language barriers precluding adequate compliance with the study procedures * limited or no legal capacity or legal guardianship * dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor or the clinical research center or their families) * participation in another study at the same time with a non-approved drug or a non-ce-labelled medical device.

Keywords: cgm hypoglycemic events
stereotactic body radiotherapy for the treatment of solitary bone plasmacytoma

Conditions: Plasmacytoma

Summary: this project aims to propose a new approach in the treatment of solitary plasmacytoma: hypofractionated irradiation alone with stereotactic technique that may contribute to the successful treatment of this disease. this work aims to apply this new technique with the primary objective of reducing the progression-free survival for multiple myeloma of patients treated for solitary plasmacytoma, as well as quantify overall survival, local control, toxicities and quality of life in a phase i trial / ii.

solitary plasmacytoma is a rare disease whose treatment has not evolved much in the last decades. the role of radiotherapy in the curative treatment of this entity was defined in a major publication in the 1980s and has since been proven to be the best practice in several other comparative trials, mostly retrospective. the radiotherapy dose of curative intent has also been described over the same period and remains unchanged to this day. thus, local control, disease cure rate, and rate and progression time for multiple myeloma have been unaffected for almost 30 years. radiobiology of plasmacytoma cells is also not widely studied. the alpha / beta ratio, which defines the pattern of response of this disease to radiotherapy fractions and its response time, is also not well described. however, it is believed to be smaller in comparison to other hematological malignancies due to reports of cases of intrinsic radioresistance and late recurrence and reports of success with hypofractionated dose in isolated cases where stereotactic techniques were used such as base of skull and spine.

Eligibility criteria:
inclusion criteria: * biopsy proven plasmacytic for the index lesion; * age between 18 and 85 years; * ecog scale performance of 0 to 2 exclusion criteria: * refuse to sign or inability to understand the term of free and informed commitment (tcle); * technical limitations for treatment with sbrt among which is cited, but not limited to, weight greater than 115 kg, inability to abduct limb to be treated in appendicular bone plasmocytomas, intolerable pain to remain in treatment position; * criteria for multiple myeloma at diagnosis: more than 10% of plasma cells in bone marrow biopsy, hypercalcemia greater than 11.5 mg/dl, serum creatinine greater than 2mg/dl, creatinine clearance less than 40ml/min , hemoglobin less than 10g/dl. * previous cancer diagnosis and treatments; * previous bone events such as fractures and osteomyelitis in the bone in which the index lesion is found; * prior autoimmune diseases, even if controlled; * extra-medullary plasmacytoma requiring elective treatment of lymph node drainage; * current pregnancy

Keywords: stereotactic body radiotherapy
study to evaluate the efficacy and safety profile of pf-06651600 and pf-06700841 in subjects with alopecia areata

Conditions: Alopecia Areata

Summary: this is a phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. the study will have a maximum duration of approximately 113 weeks. this includes an up to 5 weeks screening period, a 24 week treatment period, a 4 week drug holiday (#1), an up to 12 month single blind (investigator open, sponsor open and subject blind) extension period, a 4 week drug holiday (#2), a 6 month cross over open label extension period and a 4 week follow up period.


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 75 years of age, inclusive, at time of informed consent. * must have moderate to severe alopecia areata: exclusion criteria: * history of human immunodeficiency virus (hiv) or positive hiv serology at screening, * infected with hepatitis b or hepatitis c viruses. * have evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb) * have received any of the following treatment regiments specified in the timeframes outlined below: within 6 months of first dose of study drug: any cell depleting agents within 12 weeks of first dose of study drug: any studies with jak inhibitors; other biologics within 8 weeks of first dose of study drug: participation in other studies involving investigational drug(s) within 6 weeks of first dose of study drug: have been vaccinated with live or attenuated live vaccine. within 4 weeks of first dose of study drug: use of oral immune suppressants; phototherapy (nb uvb) or broad band phototherapy; regular use (more than 2 visits per week) of a tanning booth/parlor. within 2 week of first dose of study drug: topical treatments that could affect aa; herbal medications with unknown properties or known beneficial effects for aa.

Keywords: phase 2 randomized double-blind placebo alopecia areata safety efficacy jak janus kinase moderate severe
use of blood flow restriction therapy following acl tear

Conditions: Anterior Cruciate Ligament Tear; Knee Injuries; Sport Injury

Summary: evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear

the purpose of this study is to examine the effect of utilizing blood flow restriction (bfr) therapy both before and after anterior cruciate ligament reconstruction (aclr) following a tear. bfr has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. muscle atrophy occurs following acl tear and reconstruction. thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity. the goal of this investigation is to determine if using bfr during perioperative therapy would lead to increased and expedited strength gains. additionally we would like to determine if bfr helps patients to pass the standard rehabilitative functional tests and return to play sooner. we will also look at patient reported outcomes metrics and pain scores to determine if bfr has a significant impact on the patient experience surrounding acl tear and reconstruction.

Eligibility criteria:
inclusion criteria: * acl tear undergoing reconstruction exclusion criteria: * history of pulmonary embolism * history of deep vein thrombosis * family history of pe/dvt * hypercoaguable disorder * multiligamentous knee injury * neurovascular injury * peripheral vascular disease * unable to complete physical therapy * unable to tolerate blood flow restriction
abemaciclib plus darolutamide in prostate cancer that has spread after initial treatment

Conditions: Prostatic Neoplasms

Summary: the main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. participation may last up to 32 months.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate. * metastatic castration-resistant prostate cancer evidenced by: * prostate-specific antigen (psa) or radiographic progression despite castrate levels of testosterone * at least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (ct/mri) * participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (lhrh) agonists/antagonists throughout the study. * have adequate organ function. * eastern cooperative oncology group (ecog) performance status (ps) 0-1. exclusion criteria: * prior treatment with cyclin-dependent kinase 4 and 6 (cdk4 and cdk6) inhibitors or darolutamide. * prior systemic therapy for metastatic castration-resistant prostate cancer(mcrpc) with cytotoxic chemotherapy, parp inhibitors, novel hormonal agents (nhas) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals. * serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. * clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (new york heart association class iii or iv) within 6 months of assignment to treatment.
hemp-derived botanical dietary supplementation during recovery from brain injury

Conditions: Traumatic Brain Injury

Summary: the objective of the proposed research is to evaluate adult subjects currently taking phytocannabinoid hemp-derived botanical supplements (hds) during recovery from traumatic brain injury. this study seeks to answer whether subjects taking hds formulations experience relief from self-reported symptoms or improved subjective well-being, sleep quality, cognitive benefits, side effects and/or quantifiable changes in brain state neuronal activity or stress biomarkers. we seek to answer whether regular users (once/week to multiple uses/day) of hds experience signs of dependence, addiction or physiological withdrawal. to accomplish this we will use survey questions, quantitative eeg, cognitive testing and salivary biomarkers to determine the effectiveness of self-initiated hds administration. in addition, we are interested in whether our objective measures allow us to understand why some people are responders to hds health benefits while others are not.


Eligibility criteria:
inclusion criteria: adult male or female volunteers between the ages of 18-55 who have experience a head trauma/ concussion resulting in the diagnosis of mild to moderate tbi (glasgow coma scale score between 9-14) with less than 30 minutes of unconsciousness and post-traumatic amnesia lasting less than 24 hours more than 1 month ago will be considered for participation in the study. volunteers must be able to move about the community of the denver metro area and speak fluent english. they must be able to leisurely ride a stationary recumbent bicycle without assistance for 10 minutes and sit stationary for 15 minutes without discomfort. they must be familiar with the brand and dosing of hds and been regular users, defined as once /week up to multiple uses per day for at least 1 month in the past year. they must be able to hear a 25 decibels in at least one ear and respond verbally to questions while remaining still. exclusion criteria: medications. most subjects may continue to take medications for other conditions. however, subjects should be on stable doses of these medications for a specified period prior to beginning the study. a stable dose means that there have been no changes in the drug dosage during the past 2 months. subjects may not be current users of illegal drugs (e.g., cocaine, methamphetamine) subjects may not have an immune-relevant disease (e.g. hiv, ms, lyme disease) females may be pregnant or lactating and taking hds supplementation. in the consent form we will include a warning that taking cannabis related products during pregnancy or while nursing could pose a danger to the development of the infant. -

Keywords: cannabinoid cbd