Kornimate/medical-research-clean huggingface dataset:
evaluation of the analytical performance of allegro™ instrument

Conditions: Diabetes Mellitus; Kidney Diseases; Metabolic Disease

Summary: to assess the performance of the allegro in the hands of clia-waived point-of-care users in at least three distinct point-of-care clinical settings and compare the performance characteristics to other accepted point-of-care methods and central laboratory reference methods. to assess the ease of use of the allegro in the hands of the intended clia-waived point-of-care users. clia-waived operators will be provided with all package insert sheets, a quick reference guide poster and instructions for use. no training, coaching, or prompting will be provided other than clarifying the protocol.

blood and urine tests are used in the assessment of diabetes and to guide clinical management. in the traditional model of care, blood samples are taken from patients at the clinic and are sent to the laboratory for analysis and the results may not be available for a number of hours/days after the clinic visit. a new analyser has been developed (allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes. this means that patients can get immediate feedback and that the doctors/nurses can adjust treatment before the patient leaves the clinic. it is obviously important that this analyzer performs to a similar degree of accuracy to the laboratory analyses. the aim of this research study is to assess the accuracy of the allegro™ analyzer compared to laboratory analyses on capillary and venous whole blood samples and urine samples. three hundred sixty (360) patients with diabetes will be invited to give a venous blood sample, finger prick capillary blood sample and urine sample. the venous blood sample, finger prick capillary blood sample and urine sample will be analysed by both the allegro™ analyser and laboratory analyses and the results compared. the allegro™ results will not be used in the management of the patients' diabetes.

Eligibility criteria:
inclusion criteria: * patients with ordered hba1c, lipid profile, and uacr exclusion criteria: * pediatric

Keywords: hba1c, lipids, uacr
guarana (paullinia cupana) for breast cancer chemotherapy-related fatigue

Conditions: Signs and Symptoms; Neoplasms; Neoplasms by Site; Fatigue; Breast Neoplasms; Breast Diseases

Summary: the investigators hypothesize that guaraná, a native plant from the amazon, might improve chemotherapy-induced fatigue in breast cancer patients undergoing treatment. in order to assess this, the investigators randomized patients to either guaraná extract or to placebo, switching the assigned treatment mid-term through the cycles of chemotherapy.

the aim of this study is evaluate the favourable effects of guaraná in quality of life and fatigue in patients undergoing chemotherapy treatment for breast cancer. after approval by our institutional review board, we included consenting patients with a histological diagnosis of breast cancer for whom chemotherapy was indicated. patients who agreed to participate in the study were submitted initially to a screening interview with the brief fatigue inventory questionnaire from md anderson. if the patient presented with a severe fatigue, anemia (hb\<11.0), hypothyroidism or psychiatric disorders she was excluded. if she presented with a mild or moderate fatigue the follow up continued and the patient was assessed 21 days later after her first cycle of chemotherapy with the same questionnaire. if an increase in fatigue levels occurred from mild to moderate, mild to severe or moderate to severe the patient was randomly assigned to receive either guaraná 50mg or a placebo p.o. q12 for 21 days. at this moment the patient answered a general questionnaire, facit-f, facit-es, hads, pittsburgh sleep quality index and chalder fatigue questionnaire (day 1). after the second cycle of chemotherapy the patient underwent a "wash out" period of 7 days without any intervention, and after that period she received placebo or guaraná according to the cross over design after answering for the second time the questionnaires above (day 29) and also the common terminology criteria for adverse events v3.0 (ctcae). after 21 days (day 42) she was assessed again with the same questionnaires used in the second interview. the patient's cancer diagnosis, treatment history, concurrent medication was recorded during the pretreatment and the brief fatigue inventory was answered before each assessment.

Eligibility criteria:
inclusion criteria: * histological diagnosis of breast cancer * patients undergoing chemotherapy (first cycle) * 18 years old or older exclusion criteria: * hypothyroidism * clinical depression * prior chemotherapy * anemia * unable to sign informed consent * severe fatigue

Keywords: fatigue breast neoplasms quality of life paullinia
insulin resistance in patients with major depression

Conditions: Depression; Bipolar Disorder; Mood Disorders; Insulin Resistance; Depressive Disorder, Major; Depressive Disorder

Summary: the purpose of this study is to study the relationship between insulin and glucose action and neuropsychological functioning (memory, attention, general thinking abilities) in persons with depression.


Eligibility criteria:
inclusion criteria:1)willingness to sign the human subject protection consent form prior to enrollment into the study. 2)men and women ages 20 to 65 years of age. 3)diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (mdd) or depressive episode of bipolar disorder (bipolar i, ii or nos), based on a structured clinical interview for dsm-iv axis i disorders (scid) and confirmed by a psychiatrist. 4) depression severity as defined by score of \<17 on the 21-item hamilton rating scale for depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months. 5)adequate visual and auditory acuity to allow neuropsychological testing. 6)stable regime of psychiatric medications for 1 month prior to insulin test. exclusion criteria:1)diagnosis of possible or probable cognitive impairment. 2)for women only: pregnancy, breastfeeding. 3)personal history of type i or type ii diabetes. 4) unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year. 5)significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure \> 170 or diastolic blood pressures \> 100). 6) current drug or alcohol abuse. 7)history of neurological disorder, e.g. multiple sclerosis, stroke etc. 8)use of any drug that may significantly affect psychometric testing, or the insulin testing
gua sha therapy for chronic low back pain

Conditions: Low Back Pain

Summary: chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. gua sha is a traditional east asian therapy traditionally used in the treatment of spinal pain. this study aimed to test the efficacy of gua sha therapy in patients with chronic low back pain a total of 50 patients with chronic low back pain were randomized to either two gua sha treatments (n=25) or a waitlist control group (n=25). primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (oswestry disability index), movement-related pain (modified pain on movement questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

chronic low back pain is a major public health burden with only limited evidence of effectiveness for complementary and traditional therapies. gua sha is a traditional east asian therapy traditionally used in the treatment of spinal pain. this study aimed to test the efficacy of gua sha therapy in patients with chronic low back pain a total of 50 patients with chronic low back pain were randomized to either two gua sha treatments (n=25) or a waitlist control group (n=25). primary outcome measure was current pain intensity on a 100-mm visual analog scale; secondary outcome measures included back-related function (oswestry disability index), movement-related pain (modified pain on movement questionnaire), as well as pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

Eligibility criteria:
inclusion criteria: * non-specific low back pain at least once weekly for at least the previous 3 months * average back pain intensity hat least 40mm on a 100mm visual analog scale (vas) exclusion criteria: * specific low back pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, or oncologic disease * dystonia * pregnancy * invasive treatment of the spine or spinal surgery within the previous 4 weeks * oral steroids or anticoagulants * hemophilia or a skin condition in the area to be treated * started a new treatment for low back pain within the previous month or planning to start a new treatment within the next month
aspirin use and postoperative bleeding from dental extractions in a healthy population

Conditions: Bleeding Complication

Summary: the purpose of this study is to determine if aspirin is associated with bleeding complications following a single tooth extraction

aspirin is a common chronically administered preventive treatment for cardiovascular disease, but is often discontinued prior to invasive dental procedures because of concern of bleeding complications. as the goal of aspirin is often to prevent mi and stroke, the risk of these cvd outcomes with discontinuation of aspirin must be weighed against the perceived adverse event of bleeding during or following an invasive dental procedure with continuation of aspirin. the current study is a randomized controlled trial evaluating bleeding complications of aspirin vs. placebo in healthy patients schedule for a single tooth extraction.

Eligibility criteria:
inclusion criteria: * healthy * require a simple tooth extraction exclusion criteria: * use of previous aspirin or nsaid

Keywords: aspirin bleeding clinical trial dental extraction
efficacy and safety study of human-cl rhfviii in ptps with severe hemophilia a

Conditions: Severe Hemophilia A

Summary: this study will determine the efficacy of human-cl rhfviii in previously treated patients with severe hemophilia a during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.


Eligibility criteria:
inclusion criteria: * severe hemophilia a ((fviii:c \<= 1%) * male subjects \>= 12 years of age * previously treated with fviii concentrate, at least 50 eds * immunocompetent (cd4+ count \> 200/ul) * negative for anti- hiv; if positive, viral load \< 200 particles/u; or \<400,000 copies/ml exclusion criteria: * other coagulation disorder than hemophilia a * present of past fviii inhibitor activity (.= 0.6 bu) * severe liver and kidney disease * receiving of scheduled to receive immuno-modulating drugs
genetic studies in familial dementia

Conditions: Dementia of Alzheimer Type; Alzheimer Disease, Late Onset; Alzheimer Disease, Early Onset; Mild Cognitive Impairment; Dementia

Summary: the purpose of this study is to identify genetic factors that contribute to or cause dementia (loss of memory) and related disorders across all ages and ethnic groups. this includes a number of neurological diseases such as early and late-onset alzheimer disease, mild cognitive impairment, and other dementias.


Eligibility criteria:
inclusion criteria: 1. 18 years and older 2. patients diagnosed with dementia, their family members and unrelated healthy controls without dementia. exclusion criteria: 1. individuals with competing diagnosis such as: amyotrophic lateral sclerosis, frontotemporal lobar degeneration, multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc. (unless family members of a dementia affected individual).

Keywords: memory loss
predictability of the ability to perform an emergency stop with disorders of the hip

Conditions: Osteoarthritis; Total Hip Arthroplasty

Summary: several studies exist on patient performance in drive simulators especially around and after surgery. recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. however, in all the datasets driving performance remains highly individual. since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. this study aims at evaluating different possibilities how such performance might be predicted. patients with hip osteoarthritis and patients who have received total hip arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.


Eligibility criteria:
inclusion criteria: * 18-85 y * valid driving license * male and female * hip osteoarthritis, total hip arthroplasty * capability to walk with or without a walking stick exclusion criteria: * myocardial infarction/apoplexia \< 6 months * total hip arthroplasty \<5 weeks * new york heart association 3/4 * lacking drivers' license * peripheric sensomotor deficit \<3/5 british medical research council * new fracture of the lower extremity or spine * systemic or metastasised cancer * drug intake with centrally acting substances known to affect reaction time (opioids, e.g. tramadol, oxycodone, morphine, til
triiodothyronine for the treatment of critically ill patients with covid-19 infection

Conditions: Pulmonary Infection; Covid-19

Summary: this study is a phase ii, parallel, prospective, randomized, double-blind, placebo controlled trial. the present study will aim to address the efficacy and safety of acute administration of triiodothyronine on icu patients diagnosed with pulmonary infection due to covid-19 and require mechanical respiratory support or ecmo.

it seems that thyroid hormone is critical in the response to body injury and is now considered as potential pharmaceutical intervention to limit acute tissue injury. th (via its regulation of stress induced p38 mapk activation) exerts antiapoptotic action and protects tissue from injury, with additional favorable effects on immune system and on viral load in infected tissue. this may be a novel and more effective treatment for critically ill viral infected patients. thyrepair is the first study which is underway and investigates the safety and efficacy of high dose t3 treatment in patients with acute myocardial infarction undergoing primary angioplasty. the preliminary reports show that this treatment is safe and the efficacy on tissue repair is promising. this therapeutic modality could also be tested in the acute setting of sepsis in which thyroid hormone is involved in the pathophysiology of multi-organ dysfunction. the safety and efficacy of t3 on heamodynamics in sepsis has been previously demonstrated in a small trial. the present study is phase ii, parallel, prospective, randomized, double-blind, placebo controlled trial which aims to investigate the potential effect of t3 intravenous use in the recovery of critically ill patients admitted in icu due to covid19 infection.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pulmonary infection due to covid-19, admitted in icu and require mechanical ventilation or ecmo * male and female with age\>18 years old * signed informed consent from patient or relatives exclusion criteria: * pregnant or breast-feeding women * severe systemic disease (cancer, auto-immune etc) before infection accompanied by reduced life expectancy \<6 months * participation in another trial of an investigational drug or device * corticosteroid use before initiation of treatment * sympathomimetic use before initiation of treatment (epinephrine, norepinephrine, dobutamine, dopamine, phenylephrine)

Keywords: covid-19 pulmonary infection t3 triiodothyronine sars-cov-2
dialogue to empower traditional and faith healers to deliver mhgap-ig adapted psychosocial interventions in kenya

Conditions: Depressive Disorder, Major

Summary: the project aimed to create a dialogue between the informal sector (traditional and faith healers) and the formal sector (trained health care workers) in order to increase synergy and communication between the two systems, by minimizing any harmful practices and enhancing complementary practices. the informal sector will also be trained on how to use who mhgap-ig component on depression for routine screening in order to ameliorate functional and social outcomes and refer complicated cases to the formal sector for biological interventions

this study seeks to empower, supervise, support and include the informal traditional and faith healers to deliver evidence-based mhgap-ig adapted psychosocial interventions to reduce mental health treatment gap in kenya. this will be achieved through establishing a dialogue and collaboration between the formal and the informal sector and training the informal sector on the use of mental health gap action programme intervention guideline (mhgap-ig) to identify and manage depression. it will take place in makueni county among 100 randomly selected th/fh. a descriptive (prospective cohort) study will be used to determine the impact of training th/fh on the use of mhgap-ig in the identification and management of depression. a mental health specialist will also determine the accuracy of diagnosis made by the informal sector using randomly selected patients (true positives and true negatives for depression) by an independent person. moreover, patients identified to have depression will be followed up at 6 and 12 weeks to assess their health outcomes using becks depression inventory scale, suicidality scale and who quality of life.

Eligibility criteria:
inclusion criteria: 1. traditional and faith healers residing in kibwezi west constituency 2. traditional and faith healers who are willing to participate in the study. 3. traditional and faith healers' patients' above 18 years who agree to participate in the study exclusion criteria: 1. traditional and faith healers not residing in kibwezi west constituency 2. traditional and faith healers who are not willing to participate in the study. 3. traditional and faith healers' patients' above 18 years who do not agree to sign an informed consent

Keywords: traditional healer faith healer depression mhgap kenya
memantine for post-operative pain control

Conditions: Pain, Post-operative

Summary: pain is a common element of surgery. opiates (morphine, oxycodone, hydrocodone, methadone, fentanyl) are very helpful in decreasing pain after surgery. unfortunately, with repeated use opiates lose their effectiveness, such that patients need to utilize more opiates to achieve adequate pain relief - a phenomenon called tolerance. sometimes tolerance to a pain reliever's effects can develop in just a few hours. it is thought that activation of the n-methyl d-aspartate (nmda) receptor, a "switch" found on the surface of nerves, is partially responsible for opiate tolerance. memantine is a medication that limits the activity of nmda receptors in the brain and spinal cord. it has been used for years to help patients with alzheimer's disease. in this study, we will study the effects of memantine when combined with opiate medications to see whether it can increase the effectiveness of opiates for pain after surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).


Eligibility criteria:
inclusion criteria: * surgery for total hip replacement, knee replacement or lumbar spinal fusion * taking no opiate medication or taking opiate medication for at least 6 weeks exclusion criteria: * history of alcohol or drug abuse * clinical diagnosis of alzheimer's disease * prior adverse reaction to memantine * severe renal impairment (creatinine clearance \<30 ml/min) * inability to give informed consent

Keywords: adjuvants, pharmaceuticals receptors, n-methyl-d-aspartate drug tolerance pain measurement
tapinarof for cutaneous lupus erythematosus

Conditions: Cutaneous Lupus Erythematosus

Summary: the investigators hypothesize that topical application of tapinarof, an fda-approved topical aryl hydrocarbon receptor (ahr) agonist for the treatment of plaque psoriasis, would inhibit lupus-causing t cells and lead to improvement of cutaneous lupus lesions. to test this hypothesis, the investigators will perform a prospective, interventional clinical trial in patients with chronic and/or subacute cutaneous lupus. this trial will include outcomes analyzing the change in cutaneous lupus lesions using standardized assessments, but also analyze pre- and post-treatment skin and blood immune parameters to elucidate the immune effects and changes in lupus as a result of topical ahr agonist application. the goals are to 1) identify if topical ahr agonism leads to improvement in cutaneous lupus, and 2) examine the immunopathology of cutaneous lupus and its alteration with topical ahr agonist treatment.


Eligibility criteria:
inclusion criteria: * age 18 years and older * patients with a histopathological or clinical diagnosis of chronic and/or subacute cle * patients with at least one active cutaneous lupus lesion with a diameter ≥ 1cm and cla-iga-r score of ≥ 3 at screening and baseline exclusion criteria: * unwillingness or inability to complete informed consent process or comply with the study protocol * patients who are pregnant or breast-feeding * other dermatologic diseases whose presence or treatments would interfere with evaluation of the study drug or interpretation of participant safety or trial results * history of allergy, hypersensitivity reaction, or anaphylaxis to any component of the study drug * application to cutaneous lupus lesion(s) being assessed of topical corticosteroids, topical calcineurin inhibitors, or topical janus kinase inhibitors within 1 weeks of study drug initiation * application to cutaneous lupus lesion(s) being assessed of topical tapinorof within 4 weeks of study drug initiation * prior use of anifrolumab within the last 6 months * new initiation of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 12 weeks of study drug initiation * for patients already on the following treatment(s) prior to enrollment: unstable or changing of dosing of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 4 weeks of study drug initiation * patients with active infections.