Kornimate/medical-research-clean huggingface dataset:
a clinical trial of prax-114 in participants with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of prax-114 in participants with moderate to severe major depressive disorder (mdd). participants will be randomized to receive 28 days of either 40 mg prax-114 or placebo in a 1:1 ratio.


Eligibility criteria:
inclusion criteria: 1. recurrent mdd diagnosis with a current episode duration of at least 8 weeks and no more than 24 months. 2. ham-d17 total score of ≥23 at screening and baseline. 3. body mass index (bmi) between 18 and 38 kg/m2 (inclusive). exclusion criteria: 1. lifetime history of seizures, including febrile seizures. 2. neurodegenerative disorder (eg, alzheimer's disease, parkinson's disease, multiple sclerosis, or huntington's disease). 3. lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years. 4. any current psychiatric disorder (other than mdd). 5. lifetime history of treatment resistant depression. 6. received electroconvulsive therapy (ect) or vagus nerve stimulation (vns) within the last year or transcranial magnetic stimulation (tms) within the last 6 months prior to screening. 7. daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Keywords: mood disorders depressive disorder depression depressive disorder, unipolar depressive symptoms agents, gaba receptors, gaba-a allosteric regulation
total knee arthroplasty analgesia: single-shot femoral nerve block or epidural?

Conditions: Postoperative Pain Treatment for Total Knee Arthroplasty

Summary: single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty


Eligibility criteria:
inclusion criteria: * elective total knee arthroplasty exclusion criteria: * coagulopathy * neuropathy * morbid obesity * local anesthetics allergy
3-d transcranial ultrasound analysis study

Conditions: Cerebrovascular Accident; Intracranial Hypertension

Summary: the purpose of this study is to investigate real time 3-d ultrasound imaging of the brain for the diagnosis and evaluation of stroke.

the objective of this proposal is to extend our previous advances to investigate real time 3-d ultrasound imaging of the brain for the diagnosis and evaluation of stroke. over the last decade, with the availability of color flow doppler combined with effective ultrasound contrast agents, a renaissance has occurred in transcranial sonography as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull. our hypothesis is that we can combine new generations of 2d array transducers with ultrasound contrast agents and phase aberration correction to enable real time 3d ultrasound imaging and 3d color flow doppler of the brain with a factor of 10 improvement in spatial resolution compared to conventional transcranial sonography for improved diagnosis and evaluation of stroke.

Eligibility criteria:
inclusion criteria: exclusion criteria: * persons \<18 years old * pregnant or nursing women * history of neurological disease * congenital heart defect * severe liver dysfunction * respiratory distress syndrome * hypersensitivity or an allergic reaction to blood products.

Keywords: cerebrovascular accident intracranial hypertension
acl repair and multimodal analgesia

Conditions: Pain

Summary: this study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for anterior cruciate ligament (acl) repair using hamstring graft for patients having surgery in our outpatient surgicenter.


Eligibility criteria:
inclusion criteria: * patients of orthopedic surgeons on the study team scheduled for acl repair using hamstring graft from the same leg will be considered for inclusion in this study. other inclusion criteria are as follows: * american society of anesthesiologists (asa) physical status 1-3 * bmi of \< 40 kg/m2 * consents to general anesthesia and pre-operative femoral nerve block for case exclusion criteria: * any contraindication to a femoral nerve block * allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone * peripheral or central nervous system disease * renal or hepatic impairment * history of opioid dependence or current regular narcotic use * significant psychiatric disease * pregnancy or lactation (by verbal report) * seizure disorder * history of post-operative nausea and vomiting * latex allergy * clinically significant cardiac or pulmonary disease
a study of deoxycoformycin(dcf)/pentostatin in lymphoid malignancies

Conditions: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma; Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to deoxycoformycin (dcf)/pentostatin.

deoxycoformycin(dcf)/pentostatin is a t-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.

Eligibility criteria:
inclusion criteria: * histologic proof of lymphoid malignancy with an expected complete response rate of less than 20 percent or have failed at least one prior therapy. * no chemotherapy within 3 weeks of entry into study and must have recovered from acute toxic effects of prior therapy. * life expectancy of at least 12 weeks. * performance status equal to or less than zubrod 2. * signed informed consent. * patients with measurable disease. * age at least 16 years. * adequate bone marrow function (unless involvement of bone marrow by lymphoma) defined as agc greater than 1500 and platelet count greater than 100,000. * adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and sgpt less than or equal to 4 times the upper limits of normal. * adequate renal function defined as serum creatine less than or equal to 1.5 mg %. exclusion criteria: * no serious intercurrent illness. * adequate contraception (if applicable). * no patients with significant cardiac disease, i.e. new york heart association (nyha) class iii or iv. * no experimental clinical trial within 3 weeks of study entry. * no patients with active cns disease. * full recovery from any prior surgical treatment. * no active active infections.

Keywords: mycosis fungoides lymphoma chronic lymphocytic leukemia deoxycoformycin pentostatin all other lymphomas nucleoside analogue adenosine deaminase inhibitor t-cells
use of a novel radiopaque embolic agent in prostatic artery embolisation for symptomatic benign prostatic enlargement

Conditions: Benign Prostatic Hyperplasia

Summary: this is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract symptoms (luts) with prostatic artery embolisation (pae). this study will allow us to evaluate the safety and efficacy of this embolic in pae along with giving us a better understanding of embolic distribution.

this is a study protocol for the use of a novel radiopaque embolic agent in the treatment of lower urinary tract symptoms (luts) with prostatic artery embolisation (pae). this study will allow us to evaluate the safety and efficacy of this embolic in pae along with giving us a better understanding of embolic distribution. it would also give us answers to: * how does embolic efficacy compare to current available embolic agents? * does enhancement on rotational ct correlate with embolic distribution? * how does embolic distribution compare with tissue infarction? * does the density of embolic packing correlate with degree of infarction and volume loss? * how predictable is superselective target embolisation? * does embolic distribution vary with anatomy and gland size? * does embolic distribution tally with glandular enhancement/ transitional zone vascularity? * if visible, what is the effect and significance of non target embolisation? this is a cohort study aiming to recruit 22 patients to power a non-inferiority assessment comparing the novel embolic agent against current available embolics. data will be added to our on going local registry of patients who have undergone this procedure . this will provide information about how safe and effective it is for patients and how it compares to the other established embolic agents such as polyvinyl alcohol (pva) and other spherical agents such as embospheres and embozenes.

Eligibility criteria:
inclusion criteria: * age 50-80 moderate to severe lower urinary tract symptoms secondary to benign prostatic enlargement (bpe) ipss\>14, qol≥4 prostate volume ≥ 40 cc maximum urinary flow rate \ 6 months (or unable/ unwilling to tolerate medical treatment due to side effects) exclusion criteria: * atherosclerosis of the prostatic arteries surgical indications (chronic retention, bladder diverticulae, urethral stenosis), detrusor instability, neurogenic bladder malignancy (trus/ mri/ biopsy proven). psa \> 4 or high swop risk need prostate biopsy urodynamics - non-obstructed egfr ≤ 45ml min-1m-2

Keywords: pae embolization non-surgical prostate artery embolization radio-opaque embolic
in-hospital diabetes management with flash glucose monitoring (iscgm) - the indigo study, part b

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Diabetes Mellitus

Summary: the aim of the study is to investigate the applicability of a flash glucose monitoring sensor (freestyle libre, iscgm) for in-hospital glucose monitoring in patients with diabetes and hypoglycemia (\<3,9 mmol/l) during the hospitalization

all patients who meet study criteria will be invited to participate in the study. all patients included in the study will be followed by a trained clinical diabetes specialist and a trained study nurse (study personnel) for glucose management during their hospitalization. all patients included in the study will receive a freestyle libre iscgm. the patients will be randomized to control (blinded iscgm glucose values to patient and study personnel and poc (point-of-care) plasma glucose will be used for adjusting diabetes treatment) or intervention (iscgm blood glucose values will be used to aid with glucose management during the hospitalization). the study personnel will work with the patient's care team.

Eligibility criteria:
inclusion criteria: * expected length of hospital stay of at least 48 hours * diagnosed with diabetes * literate in danish * in-hospital hypoglycemia with at least one poc glucose \< 3,9 mmol/l (current hospitalization) * in-hospital treatment with insulin or sulfonylurea * admission to department of gastrointestinal surgery or department of heart-, lung-, and vascular surgery, both at aarhus university hospital, denmark. exclusion criteria: * pregnancy * patient unable to provide informed consent * patient unable to use mobile phone for reading iscgm sensor * known allergy to adhesives * anticipated mri during the hospital admission * patients using cgm prior to hospital admission

Keywords: hypoglycemia continuous glucose monitoring hospitalization
a survey to collect treatment experience feedback from patients, physicians, nurses and carers after switching to paliperidone palmitate 3-monthly

Conditions: Schizophrenia

Summary: the purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (pp3m) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.


Eligibility criteria:
inclusion criteria: * have a diagnosis of schizophrenia (according to international classification of diseases \[icd\]-10) * be currently receiving pp3m and have previously received 4 to 6 injections of pp3m * have the required language skills to participate in the online questionnaire, in the opinion of the physician * be able and willing to provide their informed consent for study participation exclusion criteria: * has received involuntary treatment with pp3m * was switched to pp3m treatment within a clinical trial
passive microwave radiometry (mwr) and ai for covid-19 complications early diagnostics of lungs

Conditions: Covid19

Summary: world health organization (who) declared covid-19 it as a global pandemic. it becomes clear that the virus spreading mostly deadly due to limited to access to diagnostics tests and equipment. traditional radiography and ct remain the main methods of the initial examination of the chest organs. now, most of the diagnostics has been focused on pcr, chest x-ray/ct manifestations of covid-19. however, there are problems with ct due to infection control issues, the inefficiencies introduced in ct room decontamination, and lack of ct availability in lmic (low middle income countries). passive microwave radiometry (mwr) is a cheap, non-radioactive and portable technology. it has already been used for diagnostics of cancer, and other diseases. the investigators have tested if mwr could be used for early diagnostics of pulmonary covid-19 complications. this was a randomized controlled trial (195 subjects) to evaluate the effectiveness of diagnostics using mwr in patients with pneumonia caused by covid-19 while they are in hospitals of kyrgyzstan, and healthy individuals. the investigator have measured skin (ir) and internal (mwr) temperature by recording passive electromagnetic radiation through the chest wall in the projection of the lungs at 30 symmetrical points on both sides. pneumonia and lung damage were diagnosed by x-ray/ct scan and doctor's final diagnosis (pn+/pn-). covid-19 was determined by pcr test (covid+/covid-). overall, the study suggests that the use of mwr is a convenient and safe method for screening diagnostics in covid-19 patients with suspected pneumonia. since mwr is an inexpensive, it will ease the financial burden for both patients and the countries, especially in lmic


Eligibility criteria:
inclusion criteria: * male and female gender, age 18-75 years * positive rt-pcr result of covid-19 * place of birth and residence (\<800m above sea level) * informed consent exclusion criteria: * - lack of fever in a healthy group * exacerbation of copd, very severe copd with hypoxia (fev1 \<40%, saturation \<92% at an altitude of 760 m). * co-morbidities, such as cardiovascular diseases, i.e. unstable systemic arterial hypertension, coronary heart disease; stroke; sleep apnea; pneumothorax last 2 months. * neurological, rheumatological or psychiatric illnesses, including excessive smoking (\> 20 cigarettes per day) * kidney failure

Keywords: ct - scan x-ray mwr
magnetic resonance imaging diffusion tensor tractography for early osteoarthritis assessment

Conditions: Knee Osteoarthritis

Summary: the aim of this study is the evaluation of new mri tractography maps for early knee osteoarthritis assessment.

knee osteoarthritis (oa) is a common and chronic degenerative disease of the articular cartilage. despite recent progress in the field of cartilage imaging, no routinely used clinical imaging modality has the ability to evaluate and monitor changes in cartilage degeneration. more and more studies report the benefits of magnetic resonance (mr) diffusion tensor imaging (dti) in the study of early knee osteoarthritis and in particular the new mri contrasts generating the track weighted imaging (twi) technique. this observationnal, pilot, prospective, unrandomized and uncontrolled study aim to evaluate, for the first time, the new mri tractography maps for the assessment of early knee osteoarthritis. this study doesn't modify the medical care of the patient.

Eligibility criteria:
inclusion criteria: over 18 years of age knee prosthetic surgery indication with cartilage excision exclusion criteria: refusal to sign a non-objection form

Keywords: knee cartilage early osteoarthritis mri tractography diffusion tensor imaging
prediction of early postoperative right ventricular failure in mitral valve replacement/repair patients

Conditions: Right Heart Failure; Right Ventricular Dysfunction; Right Ventricular Failure; Mitral Valve Disease

Summary: the prepare-mvr (prediction of early postoperative right ventricular failure in mitral valve replacement/repair patients) study aims to evaluate those preoperative factors which can predict the early postoperative right ventricular failure or determine the functional shift seen in right ventricular function after mitral valve replacement/repair. the prepare-mvr study focuses mainly on echocardiographic (both conventional and advanced) parameters and includes right heart catheterization intraoperatively and in the early postoperative period as gold standard method.


Eligibility criteria:
inclusion criteria: * patients admitted for mitral valve replacement/repair * severe mitral valve insufficiency exclusion criteria: * preoperative right ventricular dysfunction * cardiac surgery in medical history * infective endocarditis * primary cardiomyopathies * congenital heart disease * decreased left ventricular ejection fraction * pulmonary embolism in medical history * severe chronic obstructive pulmonary disease * primary pulmonary hypertension * any malignancy affecting right heart
network to control atherothrombosis (neat registry)

Conditions: Coronary Artery Disease; Peripheral Arterial Disease; Atherothrombosis

Summary: neat is an observational cohort (prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting.

national multicenter registry in brazil with initial plan of 25 sites from the 5 brazilian regions. it will be coordinated by hcor research institute which will perform regulatory, data and site management beyond academic leadership.neat is an observational cohort (prospective registry of real world data) of patients with coronary and peripheral artery disease in an outopatient setting with 12 months of follow-up with collection of data at baseline, 6 months and 12 months.

Eligibility criteria:
inclusion criteria: patients ≥45 years followed in ambulatory setting with ≥1 of the following 3 criteria: 1. documented coronary disease (≥1 criteria must apply): * stable angina * history of unstable angina * history of coronary angioplasty/stenting * history of coronary artery bypass graft * myocardial infarction within the last 20 years 2. documented symptomatic peripheral arterial disease (≥1 criteria must apply): * previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infra-inguinal arteries, or * previous limb or foot amputation for arterial vascular disease, or * history of intermittent claudication and one or more of the following: 1) an ankle/arm blood pressure (bp) ratio \< 0.90, or 2) significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound. exclusion criteria: * patients from institutions that don't provide the institutional authorization term, * incapacity of follow-up in one year according to investigator judgment (severe neuropsychiatric condition, life expectancy \< 12 months)
cd34+ enriched transplants to treat myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes; Graft Vs Host Disease; Graft-versus-host-disease

Summary: this study will evaluate whether processing blood stem cell transplants using an investigational device (the clinimacs system) results in fewer complications for patients who undergo transplant to treat a blood malignancy (cancer) or blood disorder. the clinimacs system will be used to remove immune t-cells from the transplant donor's blood. immune t-cells contribute to graft versus host disease (gvhd) - a serious complication that can happen after transplant. gvhd occurs when a patient's immune system attacks the donor's cells. the study aims to reduce the number of the donor immune t-cells thereby preventing or reducing the severity of gvhd.


Eligibility criteria:
inclusion criteria: * myelodysplastic syndrome (mds): refractory anemia/refractory anemia with ring sideroblasts/refractory cytopenia with multilineage anemia (ra/rars/rcma) with high-risk cytogenetic features or transfusion dependence, as well as refractory anemia with excess blasts type 1 and 2 (raeb-1 and raeb-2) * karnofsky (adult) performance status of at least 70% * adequate organ function measured by: * cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (lvef) at rest must be 50% and must improve with exercise. * hepatic: \< 3x upper limit of normal (uln) aspartate aminotransferase (ast) and: 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant \[e.g., acute myeloid leukemia (aml) chloroma obstructing the biliary tree\]. patients with higher bilirubin levels due to causes other than active liver disease is also eligible with pl approval e.g., patients with paroxysmal nocturnal hemoglobinuria (pnh), gilbert's disease or other hemolytic disorders. * renal: serum creatinine: \ 5940 ml/min (measured or calculated/estimated). * pulmonary: asymptomatic or if symptomatic, diffusion capacity of lung for carbon monoxide (dlco) 50% of predicted (corrected for hemoglobin). * willing to participate and must sign an informed consent form exclusion criteria: * pregnant or breast-feeding * active viral, bacterial or fungal infection * patient seropositive for human immunodeficiency virus (hiv)-i /ii; human t-lymphotropic virus (htlv)-i /ii * presence of leukemia in the central nervous system (cns)

Keywords: stem cell transplant allogeneic transplant
a 52 week open label trial of memantine for frontotemporal lobar degeneration

Conditions: Frontotemporal Lobar Degeneration

Summary: this is a 52-week, multicenter, open label trial of memantine (namenda) for frontotemporal lobar degeneration (ftld). the goal is to determine the safety and tolerability of this fda-approved medication for alzheimer's disease in patients with ftld. secondary outcome measures include cognitive batteries, rating scales for activities of daily living and neuropsychiatric symptoms. all patients receive the fda-approved dose of this medication for alzheimer's disease.


Eligibility criteria:
inclusion criteria: * neary et al. criteria for frontotemporal lobar degeneration * age 40 -80 * cdr \ 15 * english speaking * study partner exclusion criteria: * concurrent use of antipsychotic drugs or acetylcholinesterase inhibitors