Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of convalescent plasma transfusion for patients with covid-19

Conditions: COVID-19

Summary: this is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from covid-19 recovered individuals to treat hospitalized patients with severe covid-19 disease. the study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. the primary endpoint will be improvement on the 8 point who scale over 28 days. mortality at day 28 will be a secondary endpoint. an interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.

a total of 410 patients with covid 19 who fulfill inclusion criteria will be invited to receive: human convalescent plasma from recovered patients in two infusions of 200 ml separated with 24 to 72 hours or normal saline solution in a similar plasma bag. both products will be covered in an identical material to avoid identification of the infused product. primary endpoint: improvement on the 8 point who scale over 28 days. secondary endpoints. mortality at day 28 * presence of antibodies against sars-cov-2 in serum on days 0, 3, 7, 14, 21 y 28 after plasma administration, as long as the patient remains in the hospital. * disease progression to a worse stage compared to the baseline on admission to the study according to sofa scale. * disease progression to a worse stage defined as worsening in at least two categories in the oms disease scale on different timelines in comparison to baseline on admission to the study * number of hours on mechanical ventilation in those who enter the study on mechanical ventilation. * number of days with fever defined as temperature \>38°c on at least one occasion during the day inclusion criteria: 1. adults older than 18 years. 2. confirmed sars-cov2 infection 3. patient hospitalized for covid 19 4. severe disease or risk for severe disease 5. informed consent from patient or responsible person. exclusion criteria 1. history of allergic reactions to blood products 2. sofa scale \>12 points 3. absolute contraindication for administration of plasma 4. participation in other blinded clinical trial 5. projected life expectancy less than 3 months 6. any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

Eligibility criteria:
inclusion criteria: 1. adults 18 years of age and older. 2. confirmed sars-cov2 infection 3. hospitalized for covid 19 4. severe disease or risk for severe disease 5. informed consent from patient or responsible person. exclusion criteria: 1. history of allergic reactions to blood products 2. sofa scale \>12 points 3. absolute contraindication for administration of plasma 4. participation in other blinded clinical trial 5. projected life expectancy less than 3 months 6. any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

Keywords: sars-cov-2 convalescent plasma randomized clinical trial
epidural steroid injection versus epidural steroid injection and manual physical therapy and exercise in the management of lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: lumbar spinal stenosis (lss) is a prevalent and disabling condition in the rapidly growing aging population. people with lss often have a substantial physical and psychosocial burden as well as significant healthcare costs affecting both the individual and society. it has been reported that patients with lss over the age of 65 are more likely to undergo spinal surgery than any other condition with an estimated total annual inpatient expense of one billion. individuals undergoing surgical treatment for lss tend to be older, therefore operative morbidity and mortality are a particular concern. functional benefit derived from conservative treatment may increase the health and quality of life for individuals suffering from lss and avoid or delay the need for surgery in some subjects. as the population continues to age, identifying effective non-surgical treatment options for older patients with lss is an important research priority. ultimately, the information gained from this study will help fill a significant void in medical literature regarding non-surgical options for this patient population.


Eligibility criteria:
inclusion criteria: 1. lumbar spinal stenosis unidentified by mri or ct scan and interpreted by a radiologist independent of the study. the criteria of boden et al will be used to define lss on mri: non-discogenic loss of signal in the epidural fat with compression of neural tissues. 2. chief complaint of pain in the low back, buttock, and/or lower extremity. the patient must have le symptoms consistent with neurogenic claudiation. 3. patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping. 4. rates sitting as a better position with respect to symptom severity compared to standing or walking. 5. consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions. 6. individuals with no language barrier, that are cooperative, have transportation to the spine center, and who sign an informed consent form. 7. age greater than or equal to 50 years. exclusion criteria: 1. patients with organic brain syndrome or dementia. 2. severe vascular, pulmonary or coronary artery disease which limits ambulation. 3. recent myocardial infarction (within last 6 months). 4. spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage). 5. previous spinal surgery that included fusion of two or more vertebrae. 6. severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis. 7. metastatic cancer. 8. excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
placebo response of different types of sham acupuncture for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques.

this study aimed to recruit 150 patients with knee osteoarthritis from the hospital outpatient department. random coding was generated using a computer network-based random system, and the subjects will be divided into five groups: real acupuncture, non-acupuncture at real-acupoint, shallow acupuncture at real-acupoint, shallow acupuncture at non-meridian and non-acupoint, and waiting treatment group in a 1:1:1:1 ratio. acupuncture sessions were conducted three times a week for two weeks. patients in the waiting treatment group did not receive acupuncture therapy during the study period but received acupuncture treatment after the trial. outcome measures included western ontario and mcmaster universities osteoarthritis index (womac) score, visual analogue pain (vas) score, massachusetts general hospital acupuncture sensation scale (mass) needle sensation score, and blind evaluation scale. data collection occurred at baseline, one week, and two weeks.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee osteoarthritis. * age over 40 years old. exclusion criteria: * tuberculosis, tumors, rheumatism of the knee joint, and rheumatoid arthritis. * sprain or trauma in the lower limb. * mental disorders. * severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease. * pregnancy or lactation. * use of physiotherapy for osteoarthritis knee pain in the past month; use of intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months; received knee-replacement surgery; and positive floating patella test.

Keywords: sham acupuncture randomized controlled trial blinding effect placebo acupuncture
agaric case control study

Conditions: First Recently-diagnosed Colorectal Cancer

Summary: the aim of the study is to establish the existence of a relationship between the dietary intake of polyunsaturated fatty acids (pufa) and the risk of colorectal cancer in humans, using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte phospholipids.


Eligibility criteria:
inclusion criteria: cases * patients aged ≥ 45 years * with a first recently-diagnosed colorectal cancer * due to undergo elective surgical resection with curative intent (in practice, stage i, ii, iii or iv if there was only one hepatic nodule that was resected with curative intent) in one of the 5 following digestive surgery units: chu de dijon, chu de nancy, chu de strasbourg, chu de reims et chu and besançon. * who have given their informed consent controls * patients aged ≥ 45 years * due to undergo surgery for a benign abdominal disease (sigmoid diverticulitis, appendectomy, hiatal hernia ...) * matched for abdominal site with cases for age (± 3 years), sex and hospital * who have given their informed consent exclusion criteria: cases * pre-operative anticancer treatment (chemo or radiotherapy) * existence of visceral metastases except a single hepatic nodule resected with curative intent * familial adenomatous polyposis and hnpcc syndrome (when suspected: inclusion after complementary tumor phenotype study: screening for microsatellite instability and/or immunohistochemistry study of the expression of dna mismatch repair proteins. * known inflammatory disease of the intestine (ulcerative colitis, crohn's disease) * personal history (recent or not) of colorectal cancer * emergency treatment for the presenting complication (perforation, occlusion...) * significant modification in dietary habits during the previous three months * other evolving neoplastic disease * psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship) * pregnant or breast-feeding women controls * personal history of cancer or adenomatous colorectal polyps, * emergency intervention * known inflammatory disease of the intestine (ulcerative colitis, crohn's disease) * personal history (recent or not) of colorectal cancer * emergency treatment for the presenting complication (perforation, occlusion...) * significant modification in dietary habits during the previous three months * evolving neoplastic disease * psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship) * pregnant or breast-feeding women
clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy

Conditions: Heart Failure; Left Bundle Branch Pacing

Summary: this is a two-center, prospective randomized controlled trial. the aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.

early-resync is a two-center, prospective randomized controlled trial that is designed to determine whether early left bundle branch pacing has a better impact on lv function improvement as compared with traditional guideline-directed medical therapy in heart failure with mild-reduced ejection fraction（36%≤lvef≤50%） and complete left bundle branch block (clbbb). patients with symptomatic heart failure,36%≤lvef≤50%, nyha function class ii-iv, and clbbb（according to strauss criteria) will be 1:1 randomized to lbbp+gdmt or gdmt group after enrollment and be followed at 3 and 6 months after randomization. lbbp will be performed by a double-chamber device in lbbp+gdmt group. all patients will receive gdmt. the primary endpoint is the change in the lvef at 6 months after randomization from baseline.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, nyha class ii-iv, with an ef between 35% and 50%; 3. complete lbbb meeting strauss's standard definition 4. signed informed consent. exclusion criteria: 1. expected survival less than 24 months; 2. indicated for icd or pacing therapy; 3. history of vt, vf, or hemodynamic instability; 4. history of mechanical tricuspid valve replacement; 5. ischemic cardiomyopathy scheduled for cabg and pci within 3 months; 6. severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year; 7. pregnancy or planning for pregnancy; 8. hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of lbbp is anticipated to be challenging; 9. severe renal dysfunction (egfr \< 15ml/min\*1.73m\^2).

Keywords: heart failure left bundle branch pacing guideline-directed medical therapy
expanded access protocol of givosiran for patients with acute hepatic porphyria

Conditions: Acute Hepatic Porphyria

Summary: the purpose of this study is to provide expanded access of givosiran to patients with acute hepatic porphyria (ahp).

choosing to participate in an expanded access program is an important personal decision. talk with your doctor and family members or friends about deciding to join a research study. to learn more about this study, please have your doctor contact the study research staff using the contacts provided. for general information, see the link provided in more information.

Eligibility criteria:
inclusion criteria: * diagnosed with acute hepatic porphyria (acute intermittent porphyria, hereditary coproporhyria, variegate porphyria, ala dehydratase deficient porphyria) * have adequate venous access for program sample collections as judged by the investigator for study sample collections exclusion criteria: * previously or currently participating in a givosiran clinical trial * has any of the following laboratory parameter assessments at screening: 1. alanine aminotransferase (alt) \>2×uln 2. total bilirubin \>1.5×uln. patients with elevated total bilirubin that is secondary to documented gilbert's syndrome are eligible if the total bilirubin is \<2×uln 3. estimated glomerular filtration rate (egfr) \<15 ml/min/1.73 m2 * on an active liver transplantation waiting list

Keywords: acute hepatic porphyria (ahp) acute intermittent porphyria (aip) porphyria acute intermittent acute porphyria hereditary coproporphyria (hcp) variegate porphyria (vp) ala dehydratase deficient porphyria (adp) givosiran expanded access eap
a study of visual effects of erectile dysfunction medications dosed daily for six months

Conditions: Erectile Dysfunction

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil compared with placebo.


Eligibility criteria:
inclusion criteria: * healthy male subjects or males with mild erectile dysfunction (ed). * between the ages of 30 and 65 years, inclusive. exclusion criteria: * phosphodiesterase type 5 (pde5) inhibitor therapy (tadalafil, sildenafil, or vardenafil) within 6 weeks of the start of the study. * diagnosis of diabetes mellitus. * any chronic illness or medication that is a risk factor for eye disease or any medication that causes retinal toxicity or affects visual function. * certain chronic medical conditions including unstable angina pectoris, severe renal \[kidney\] insufficiency, clinically significant hepatobiliary \[liver, bile duct\] disease, cancer, and aids/hiv. * a history of clinically significant chronic ophthalmologic disease or any significant visual abnormality identified at the start of the study.

Keywords: healthy volunteers
the role of gut microbiota in hypertension

Conditions: Hypertension

Summary: hypertension is the single most prevalent risk factor for heart diseases, heart failure, kidney failure and stroke. about 1 in 3 adults in the united states have hypertension. approximately 28-30% of hypertensive patients suffer from resistant hypertension (rh). inflammation has been implicated in the pathogenesis of the hypertension. additional data suggests the involvement of gut microbiota in host normal cardiovascular functions and pathophysiology. accumulating evidence demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular events. even though these studies did not address effects of antibiotic treatment on the gut microbiota, it is possible that gut microbiota could affect neurologic inflammation. finally, intestinal microbiota has recently been proposed to modulate blood pressure (bp) through production of short-chain fatty acids. in order to investigate this, the investigators hypothesize that gut microbiota is involved in the neuroinflammation-mediated initiation and establishment of rh, and targeting gut microbiota by minocycline would produce beneficial outcomes in rh.

this is a prospective cohort design. this study will enroll 388 subjects: 81 patients without htn as a reference group, 81 patients with controlled htn, 55 patients with uncontrolled htn, 55 with remodeled rh, and 81 patients with rh to characterize gut microbiota composition. subjects will provide stool samples for analysis. subjects will also provide a blood sample for inflammatory marker and stem cell analysis.

Eligibility criteria:
inclusion criteria: * age \>18 and \<80 * is competent and willing to provide consent inclusion criteria for each subject group: * control subjects will have a systolic bp \<140mmhg with no cardiovascular disease * patients with controlled hypertension * patients with uncontrolled hypertension * resistant hypertension subjects will have systolic blood pressure (bp) ≥140 mmhg despite ≥3 anti-hypertensive medications of different classes one of which should be a diuretic * patients who are no longer rh subjects and have normal blood pressure * subjects participating in nct 02133872 will be eligible to participate exclusion criteria: * currently pregnant or have been pregnant in the last 6 months; * antibiotic treatment within 2 months of study enrollment; * currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications); * unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection); * history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.

Keywords: resistant hypertension (rh) uncontrolled hypertension
extension study of long-term safety and efficacy of tulisokibart in participants with crohn's disease or ulcerative colitis (mk-7240-011)

Conditions: Crohn Disease; Colitis, Ulcerative

Summary: researchers want to learn more about tulisokibart (also known as mk-7240) in an extension study. tulisokibart is a medicine designed to treat active, moderate to severe crohn's disease (cd) and ulcerative colitis (uc). an extension study is a type of study where people who received tulisokibart in certain other studies for cd or uc (called a parent study) may be able to join this study. the goals of this study are to learn about the safety of tulisokibart over time in people with cd or uc, and if people tolerate it.


Eligibility criteria:
inclusion criteria: * has participated in a qualifying tulisokibart phase 2 or phase 3 parent study for cd or uc * the investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study * a participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention * a participant of childbearing potential (pocbp) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention * a pocbp uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) exclusion criteria: * has prematurely discontinued study intervention in their parent study * has received any protocol-specified prohibited medications during their parent study * has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
pulsatility aneurysmal evaluation process by cerebral dynamic cta (computed tomography angiography)

Conditions: Aneurysm, 4D CT Scan

Summary: intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general population. these are focal dilatations occuring in the cerebral vessels. they usually remain silent until complications occur. complications associated with intracranial aneurysms include mass effect on adjacent structures and rupture. rupture is the most severe complication with a mortality rate of 35-50% and a high rate of morbidity including long-term disability. it incidence is estimated about 1% per year for aneurysm smaller than 1 cm. however, preventative treatments have their own risk of complication and morbi-mortality rate including stroke and hemorrhage. actual guidelines for treatment planning are mainly designed with the size, the location and the age of the patient. this is why working on the identification of imaging markers of aneurysmal instability is relevant. dynamic cta (computed tomography angiography) acquisition allow to study the variation of metrics such as dome height, dome length, ostium width, ostium area, and volume during the cardiac cycle. the goal of this study is to assess different aneurysmal metrics to determine those which may vary the most during the cardiac cycle and to assess it as an imaging marker of aneurysmal instability.


Eligibility criteria:
inclusion criteria: * patient with an intracranial aneurysm assessed with a 4d cta exclusion criteria: * minor * refusal to participate
efficacy of stretching on pain sensitivity

Conditions: Pain Threshold

Summary: the primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. it is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching. the secondary objective of the study is to determine the effect after four-week cessation of the stretching protocol on regional and distant pain sensitivity. if regional and distant pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic effect will abate following four-week cessation.


Eligibility criteria:
inclusion criteria: * healthy men and women aged 18-65 years are recruited. as part of the screening, volunteers will also be asked to indicate known medical issues or diseases. participants are included if they have no known medical conditions such as * cognitive impairments, * neurological, * orthopaedic, * or neuromuscular problems that might affect the somatosensory system or preclude stretching exercises or range of motion testing at the knee. exclusion criteria: * individuals who regularly engage in flexibility training (e.g., stretching, tai chi, pilates or yoga) * or use any medication that might affect the somatosensory system, such as pain medication, are excluded.

Keywords: stretching pain sensitivity range of motion exercise adherence