Kornimate/medical-research-clean huggingface dataset:
sofosbuvir/velpatasvir fixed dose combination in participants with chronic hepatitis c virus infection who have received a liver transplant

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (sof/vel) fixed-dose combination (fdc) in participants with chronic hepatitis c virus (hcv) who have received a liver transplant.


Eligibility criteria:
key inclusion criteria: * history of chronic hcv infection (≥ 6 months) * hcv genotype 1, 2, 3, 4, 5, 6, or indeterminate * liver transplant ≥ 3 months prior to screening * male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis key exclusion criteria: * history of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol, * co-infection with hiv or hepatitis b virus * known hypersensitivity to study medication, * use of any prohibited concomitant medications as within with window before the day 1 visit. * de novo or recurrent hepatocellular carcinoma posttransplant note: other protocol defined inclusion/ exclusion criteria may apply.
characterization of acute myocardial damage with spectral computed tomography. (cadami-spectral)

Conditions: Myocarditis; Acute or Subacute; Takotsubo Cardiomyopathy; Infarction, Myocardial; Myocardial Injury

Summary: clinical management of patients with chest pain and elevation of biomarkers of myocardial injury require an accurate diagnosis. until now, cardiac magnetic resonance imaging (cmri) is the gold standard for the diagnosis among myocarditis, stress cardiomyopathy, or inapparent ischemic damage. the development of spectral ct has opened up the possibility of characterizing the coronary anatomy and the myocardium in a single procedure. our aim is to assess the diagnostic ability of differential patterns in first- pass perfusion and delayed iodine enhancement obtained by spectral ct in patients with acute myocardial injury. this study is designed as a prospective multicenter observational study with diagnostic intervention in 150 patients admitted with clinical indication of a cmri due to suspicion of myocardial infarction with normal coronary arteries (minoca), myocarditis or stress cardiomyopathy who will undergo a ct study with double detector technology in two reference centers. a control group (n=150) with an indication for cardiac ct for another cause without coronary or structural heart disease will be included. the iodine maps obtained by spectral ct will be compared with the findings obtained with cmri, both with conventional techniques and with artificial intelligence algorithms (deep learning). a year follow-up of the cohort will be carried out to assess whether the findings derived from the ct in this group of patients provide prognostic information


Eligibility criteria:
inclusion criteria: * age ≥ 18 year. * hospital admission due to chest pain and acute myocardial injury. * clinical indication for cardiac mri (cmr) due to suspected acute myocardial infarction with coronary angiography showing no significant lesions (\<50%) (minoca), acute myocarditis, or stress-induced cardiomyopathy. * signed informed consent. exclusion criteria: * contraindications to undergo cardiac mri and ct with administration of gadolinium and/or iodine-based contrast, respectively. * pre-existing cardiomyopathy. * pre-existing chronic ischemic heart disease. * invasive coronary angiography showing coronary lesions ≥50%.
igm-enriched immunoglobulin attenuates systemic endotoxin activity in early severe sepsis

Conditions: Sepsis

Summary: the purpose of this study is to evaluate the effect of igm-enriched immunoglobulins (pentaglobin) on the endotoxin activity, conventional coagulation parameters, viscoelastic and aggregometric measurements of patients with severe sepsis.

before the change of the standard operating procedure (sop) with the implementation of the application of igm-enriched immunoglobulins to patients with severe sepsis and septic shock conventional inflammatory and coagulation parameters, viscoelastic and aggregometric measurements as well as the endotoxin activity was measured in 15 patients. after the change of sop the same parameters were recorded for additional 15 patients.

Eligibility criteria:
inclusion criteria: * age \>18 years * proven or suspected severe sepsis or septic shock * written consent of the patient or a legal person in charge exclusion criteria: * pregnancy * anticoagulation other than heparin * inherited coagulopathy or thrombophilia

Keywords: igm-enriched immunoglobulins endotoxin activity assay thrombelastometry aggregometry
methenamine hippurate following intradetrusor onabotulinumtoxina injection

Conditions: Overactive Bladder (OAB); Urinary Tract Infection (Diagnosis)

Summary: the goal of this clinical trial is to compare methenamine hippurate prophylaxis to routine antibiotic prophylaxis following onabotulinumtoxina (botox-a) injections in women with overactive bladder (oab). participants will be randomly selected to receive one of the two post-procedural prophylaxis medications. the primary outcome measure will be urinary tract infection (uti) rates within 30 days from the botox-a procedure. secondary outcomes will assess patient satisfaction with the two post-procedural prophylaxis medications.

the purpose of this randomized controlled non-inferiority study is to determine if methenamine hippurate is non-inferior in regards to uti rate when compared to routinely prescribed antibiotic prophylaxis following intradetrusor botox-a injections for women with oab. as a secondary aim, this study will also compare patient medication satisfaction, as measured by the functional assessment of chronic illness therapy-treatment satisfaction-general (facit-ts-g) for the two prophylactic medication arms. comparators: methenamine hippurate versus routinely prescribed antibiotic prophylaxis methenamine hippurate is an oral non-antibiotic antiseptic medication widely used in the prevention of recurrent utis. 164 women will be randomly assigned to each treatment option: 82 to methenamine hippurate and 82 to routinely prescribed antibiotic prophylaxis. the primary outcome of uti rates within 30 days of the botox-a procedure will be calculated for each study arm. the facit-ts-g will be administered to participants at the conclusion of the 30-day period.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * undergoing intradetrusor botox-a injections in the office setting for overactive bladder exclusion criteria: * cisgender male individuals * neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.) * known allergy and/or contraindication to methenamine hippurate * currently already taking methenamine hippurate at the time of the procedure * taking antibiotics for any reason on the day of their botox-a procedure * positive uti at time of procedure (positive dip at time of procedure) * history of bladder cancer * history of pelvic radiation * surgically altered detrusor muscle * pre-procedural need for catheterization * diagnosis of interstitial cystitis/painful bladder syndrome (ic/pbs) * pregnant or lactating individuals

Keywords: overactive bladder onabotulinumtoxina methenamine urinary tract infection botox-a uti oab
the effect of pelvic proprioceptive neuromuscular facilitation techniques in patients with sacroiliac joint dysfunction

Conditions: Sacroiliac Joint Dysfunction

Summary: the sacroiliac joint dysfunction (sijd) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. in 2020, the number of patients with low back pain (lbp) worldwide was more than half a billion and is expected to exceed 800 million by 2050. although sijd has been shown to be related with lbp in more than 30% of patients with lbp, sijd is still often overlooked as a cause of lbp. once the diagnosis of sijd is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. the proprioceptive neuromuscular facilitation (pnf) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. however, despite the major role of sijd among the causes of lbp, there are limited studies investigating the efficacy of pnf in sijd and its effectiveness remains unclear. thus, the aim of this study was to investigate the effect of pelvic pnf techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with sijd.


Eligibility criteria:
inclusion criteria: * having a diagnosis of sijd * being between the ages of 18 and 40 * volunteering to participate in the study exclusion criteria: * having a history of any neurological, psychiatric and/or orthopedic disease * being pregnant or having a suspicion of pregnancy * having one or more of disc herniations, spondylosis, spondylolisthesis and/or similar lumbar pathologies that may cause low back pain * having a history of previous spine/hip/lower extremity surgery * having a history of active malignancy and/or infection * having a history of any injection and/or surgical procedure for the sacroiliac joint within the last 3 months

Keywords: flexibility mobility pain proprioceptive neuromuscular facilitation sacroiliac joint dysfunction
transanal decompression tube versus stent for acute malignant left-sided colonic and rectal obstruction

Conditions: Colonic Cancer; Rectal Cancer

Summary: the purpose of this study is to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.

approximately 8-47 % of patients with colorectal cancer will present with colonic obstruction. left-sided colonic and rectal cancer is responsible for nearly 70% of acute colonic obstruction. emergency colonic surgery for acute obstruction is associated with a higher mortality and morbidity rate than elective surgery. preoperative decompression results in a less dilated bowel that is more amenable to an elective surgery. both transanal decompression tube and stent can serve a good preoperative decompression effect and serve a good bridge to surgery. investigators aim to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.

Eligibility criteria:
inclusion criteria: 1. definite diagnosis of left-side colonic or rectal obstruction; 2. symptomatic colonic obstruction for less than 1 week; 3. colonic obstruction caused by a histologically proven malignant colonic tumor exclusion criteria: 1. suspected benign colonic or rectal obstruction; 2. right-side colonic obstruction; 3. patients with signs of peritonitis; 4. dysfunction of blood coagulation, active bleeding, active infection, and significant cardiac or pulmonary disease; 5. patients who do not want to undergo surgery.
building better caregivers: development and evaluation

Conditions: Providing Care for People With Memory Problems

Summary: the program consists of a 6-week small-group workshop for caregivers of people with memory problems. the goal of the study is to evaluate in a one year longitudinal study, program effectiveness in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving sleep, healthful behaviors and self-efficacy

the building better caregivers workshop meets for 2.5 hours per week for 6 weeks in small groups of 10-16. it is peer-led (leaders already trained in the stanford model must take a 2-day cross-training before leading a bbc workshop). participants will learn self-management skills such as decision making, goal setting, action planning, stress management, dealing with difficult behaviors, working with the health care system, planning for the future,building an exercise program, communication skills, healthy eating, etc. all participants will complete follow up questionnaires and 6 and 12 months. they will have the option of completing the questionnaire by mail or telephone interview. once a particular workshop site is identified by a partner organization, stanford will provide packets of consents and questionnaires to the site coordinator(non-stanford). the site coordinator will either schedule an extra hour for the first meeting of the 6-week series, or an orientation meeting held a week or so before the workshop begins. during this time, the coordinator will announce to the prospective subjects that this study is being conducted and that they are invited to participate, and will pass out a consent, questionnaire and consent copy to each prospective participant. the consent and questionnaire are self-administered. this study is longitudinal, so no randomization will take place. stanford holds no meetings, but receives the data. the site coordinators hold the orientation meetings. the workshops are scheduled by the various organizations, and they determine when and how the orientation time is scheduled. it will vary from site to site.

Eligibility criteria:
inclusion criteria: * family or friend caregiver of someone with cognitive impairment for at least 10 hours per week * 18 years of age or older * able to attend a workshop 2.5 hours per week for 6 weeks * speaks english exclusion criteria: * professional caregiver * under 18 years of age * non-english speaking

Keywords: caregiving chronic illness patient education self management
cast off trial: one versus four-five weeks of plaster cast immobilization

Conditions: Distal Radius Fracture

Summary: distal radius fracture (drf) is a common fracture of which the incidence appears to be increasing worldwide. on average, a total of 17% of all diagnosed fractures are drf's. in the dutch guideline for drf the treatment advice for drf, without reduction, is treatment with plaster cast or brace for one-three weeks. despite the advice in the guideline and despite several studies from the 90's showing that plaster cast treatment of a stable drf for one week is safe, the usual length of plaster cast treatment for stable drf is four-six weeks. in addition, recent studies have also shown that a long period of immobilization can lead to more post traumatic pain by increasing disuse and kinesiophobia. this evidence suggests that the usual duration (4-6 weeks) of plaster cast treatment for drf is unnecessary. the aim of this feasibility study is to define whether one week of plaster cast treatment is possible and can lead to better functional results, with at least the same patient satisfaction and complications. in addition, this feasibility study will be used to define the sample size of the future rct.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * isolated acute distal radius fracture * closed reduction is not performed * non-operative treatment with cast immobilisation * understanding of dutch language exclusion criteria: * under the age of 18 or older than 75 years * multiple injured patient * reduction is indicated/performed * operative treatment * not understanding of dutch language

Keywords: distal radius fracture conservative treatment patient rated outcome (pro)
how astigmatism influences corneal biomechanics and intraocular pressure

Conditions: Corneal Astigmatism; Intraocular Pressure; Cataract Senile

Summary: the aim of the study was to identify whether preoperative corneal astigmatism can influence corneal biomechanics and the assessment of intraocular pressure (iop) following micro-incision phacoemulsification.


Eligibility criteria:
inclusion criteria: * diagnosis and qualification for cataract surgery, corneal astigmatism of equal to or less than 2.25 dcyl exclusion criteria: * corneal astigmatism higher than 2.25 dcyl, history of any other corneal disease (infection, trauma, ulceration, autoimmune inflammation, fuchs dystrophy, keratoconus, corneal scars, preoperative insufficiency of corneal endothelium), glaucoma and chronic use of non-glaucoma eye drops, blepharitis, dry eye, use of contact lenses diabetes or a history of corneal refractive surgery

Keywords: corneal astigmatism cataract surgery corneal hysteresis corneal resistance factor intraocular pressure
zonisamide sr plus bupropion sr combination therapy in subjects with obesity

Conditions: Obesity

Summary: the purpose of this study is determine if the combination of zonisamide sr and bupropion sr are is more effective than either drug given alone or placebo in the treatment of obesity.


Eligibility criteria:
inclusion criteria: * female or male subjects, 18 to 65 years of age * have body mass index (bmi) ≥ 30 kg/m2 and ≤ 45 kg/m2 for subjects with uncomplicated obesity, and bmi of ≥ 27 kg/m2 and ≤ 45 kg/m2 for subjects with obesity and dyslipidemia and/or controlled hypertension * non-smoker and no use of tobacco or nicotine products for at least 6 months prior to screening * normotensive (systolic ≤140 mm hg; diastolic ≤90 mm hg). anti-hypertensive medications are allowed with the exception of adrenergic blockers and clonidine. medical regimen must be stable for at least 6 weeks prior to randomization * triglycerides \<400 mg/dl. medications for treatment of dyslipidemia are allowed with the exception of cholestyramine and cholestypol as long as medical regimen has been stable for at least 6 weeks prior to randomization * no clinically significant laboratory abnormalities * negative urine drug screen * negative serum pregnancy test in women of child-bearing potential * women of child-bearing potential must be non-lactating, and agree to use acceptable contraception throughout the study period and for 30 days after discontinuation of study drug * able to comply with all required study procedures and schedule * able to speak and read english * willing and able to give written informed consent exclusion criteria: * obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, cushing's syndrome, polycystic ovary syndrome) * serious medical condition * history of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer. * history of suicide attempt or serious psychiatric illness * history of major depressive disorder within the past 2 years * in need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization * type i or type ii diabetes * history of alcohol or drug abuse or dependence as determined by the investigator within 1 year prior to randomization * history of surgical or device (e.g. gastric banding) intervention for obesity * history of seizures or predisposition to seizures * history of hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide * history of treatment with bupropion sr (wellbutrin, zyban) or zonisamide (zonegran) within previous 12 months * history of nephrolithiasis (renal calculi) * loss or gain of more than 4.0 kg within 3 months prior to randomization * women of child bearing potential not adhering to a medically acceptable form of contraception * pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug

Keywords: obesity zonisamide bupropion
prospective master-protocol for evaluation of systemic therapeutics in elderly with thoracic malignancies

Conditions: Non Small Cell Lung Cancer; Lung Cancer

Summary: the objective of the study is to prospectively generate real-life data in patients aged ≥70 years treated in first line for a thoracic tumor (non-small-cell lung carcinoma) according to best standard of care as defined by the european society for medical oncology (esmo). this cohort will aim to: * characterize participants in terms of geriatrics, biology and carcinology * describe the treatment modalities by stage, as well as the results in terms of efficacy, safety and impact on quality of life. at the same time, exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule, and/or the same innovative strategy. participants will be followed in accordance with investigator's usual clinical practice at the corresponding site. they will be asked to: * visit the clinic as per physician's request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment. * perform the necessary regular para-clinical examinations (lab testing, imaging, re-biopsy). * provide blood samples for bio-bank repository * perform assessments specific to older adults * answer three quality of life questionnaires


Eligibility criteria:
inclusion criteria: * patient ≥70 years * non-small-cell lung cancer for which the multidisciplinary consultation required systemic treatment regardless of tumor-node-metastasis (tnm) stage * patient naïve to systemic anticancer treatment for bronchial neoplasia * patient covered by social security * patient eligible for systemic treatment * systemic treatment with marketing authorization in the indication, available in routine care early access or compassionate access. * patient able to understand the protocol * patient not opposed to the collection of data concerning him/her * signature of study consent form. exclusion criteria: * patients under guardians or curators * patient not under the care of the investigating center and not monitored by the investigating center * patient already treated with systemic therapy for nsclc