Kornimate/medical-research-clean huggingface dataset:
study of electrical bioimpedance in heart failure.

Conditions: Heart Failure; Dyspnea

Summary: the purpose of this study is to determine how electrical impedance is modified in relation to extracellular space body fluid retention detected by an electrical bioimpedance method in patients with heart failure.

heart failure (hf) is a clinical syndrome presenting currently a high prevalence, morbidity and mortality. the lack of sensitivity of symptoms and signs used to make the diagnosis of the exacerbation of hf, and the knowledge in recent years about the relevance to detect congestion before consulting a specialist or go to the emergency department, support the need of more aggressive management of these patients. bioimpedance monitoring devices for bioimpedance can provide useful data for the detection of congestion onset and help the decision-making in treatment. because patients with heart failure suffer alterations in body composition, mainly due to the amount of extracellular water, the bioimpedance can objectify these variations. in heart failure, bioimpedance has been tested in two studies with small samples of patients estimating total body water. in other studies , the monitoring of intrathoracic impedance has been performed by measurement systems implanted in cardiac defibrillators or in cardiac resynchronization devices. they have proven to be useful for early detection of decompensation in these patients and to detect changes in impedance before the patient begins the clinical manifestations. furthermore, it has been correlated the detection of decompensation by these devices with significant increases in nt- probnp (diagnostic and prognostic marker for hf). the purpose of our study is to observe these changes in impedance from the patient's skin surface and non-invasively.

Eligibility criteria:
inclusion criteria: * outpatients \> 18 years of age, male or female exclusion criteria: * patients treated with renal substitutive treatment such as hemodialysis or peritoneal dialysis * patients with automatic implantable devices or pacemakers. * patients with metal prosthesis in right side of the body

Keywords: heart failure electric bioimpedance body composition diagnosis monitoring prognosis total body water
insomnia and cognitive performance in chronic pain

Conditions: Chronic Pain; Insomnia

Summary: the aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself.

almost 20 % of the adult european population suffers from chronic pain of moderate to severe intensity, and clinical insomnia has been reported in 53-73% of chronic pain patients. insomnia seems to be correlated with small to moderate impairments in several cognitive functions involved in working and episodic memory and in attention tasks, and chronic pain has been shown to be associated with objective deficits in memory and executive functioning. the aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself. inividuals with complex chronic pain are assessed with a neuropsychological test battery examining different aspects of memory and executive functioning: the digit span subtest from wechsler's adult intelligence scale iii (wais-iii): verbal working memory. claeson-dahl inventory of learning and memory (cd): verbal retention. the rey complex figure test (rcft): visuospatial retention. the wisconsin card sorting test (wcst): cognitive flexibility. the trail-making test (tmt): sustained attention. the presence of insomnia is examined with the bergen insomnia scale (bis) , and insomnia severity with the insomnia severity index (isi). present pain level at the time of the neuropsychological assessment is quantified using the visual analogue scale (vas). pain medication is transformed to the morphine equivalent daily dose (medd). anxiety and depression are assessed with the hospital anxiety and depression scale.

Eligibility criteria:
inclusion criteria: * attending tertiary chronic pain management exclusion criteria: * none

Keywords: cognitive impairment
surgical treatment of high perianal fistulas

Conditions: Anal Fistula; Rectal Fistula

Summary: perianal fistula is a chronic phase of anorectal infection that occurs predominantly in the third and fourth decade of life. according to parks classification fistulas have been divided into intersphincteric, transsphincteric, suprasphincteric and extrasphincteric. simple fistulotomy can be performed with satisfactory outcomes in low fistula tracts but in high (transsphincteric) fistulas it may affect anal continence seriously. therefore sphincter preserving procedures should be preferred in these cases. rectal advancement mucosal flap (raf) is one of the methods used in surgical fistula eradication with high success rate in cryptoglandular fistulas. however, this technique is technically demanding and results can be expert depended with wide spread of healing rates (24-100%) in individual studies as referred in recent systematic review. ligation of the intersphincteric fistula tract (lift) has been presented in 2007 as a simple sphincter preserving technique. the success rate varies between 40-95% with low overall incontinence rate (6%). the aim of the study is to compare the efficacy of the lift and raf procedure for treatment of high perianal fistulas.


Eligibility criteria:
inclusion criteria: * patients aged 18 years old or older * diagnosis of simple intersphincteric or transsphincteric fistula * patients able to comply with the study protocol as per investigator criteria * signed and dated informed consent by the patient * absence of any exclusion criteria exclusion criteria: * recurrent anal fistula * suprasphincteric, low subcutaneous fistula * multiple fistulas * posttraumatic fistula * perianal hidradenitis * fistula arises from other than cryptoglandular origin * previous anal surgery except of abscess * inflammatory bowel disease * history of fecal incontinence * rectal prolapse * malignant disease and life expectancy of less than 1 year, or chemotherapy and radiotherapy less than six months prior enrolment * hiv infection * pregnancy * participation in another clinical trial less than one month prior to enrolment, or involvement in another trial

Keywords: anal fistula rectal fistula intersphincteric fistula perianal fistula
montefiore opioid and pain study

Conditions: Acute Pain

Summary: this study will determine pain and opioid outcomes 3 \& 6 months after an emergency department visit for acute pain. this is an observational study. patients are enrolled during an ed visit and followed by telephone 3 \& 6 months later. opioid databases will also be reviewed.


Eligibility criteria:
inclusion criteria: * adults seen in the emergency department for acute, new-onset pain, defined as: 1)localized pain duration \< 10 days and 2) prior to the acute episode, the patient has not had this type of pain in the preceding six months * upon emergency department discharge, the patients is prescribed an opioid for pain exclusion criteria: * any prescribed opioid use within the previous six months including methadone and buprenorphine * frequent use of any analgesic medication (use of any analgesic \>10 days per month prior to the onset of acute pain) * not available for follow-up
the dubousset functional test in lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: the aim of this study is to investigate the validity and reliability of dubousset functional test in the patients with lumbar spinal stenosis.


Eligibility criteria:
inclusion criteria: * patients aged 18-65 years, diagnosed with chronic pain (more than three months) due to lumbar spinal stenosis. exclusion criteria: * those with fractures, pregnancy, a disease that would prevent physical exertion, those with a body mass index (bmi) of 40 kg/m2 and above, and those with major musculoskeletal or neurological disorders that cause gait disturbance will be excluded from the study.

Keywords: lumbar spinal stenosis functional status dubousset functional test reliability validity
evaluate the efficacy and safety of interferon-α combined with ato in the treatment of arsenic-resistant apl

Conditions: Tumour

Summary: this study was a single-arm, open study. after the screening period, arsenic-resistant apl patients were treated with interferon α-2b, arsenic and venetoclax. the efficacy (orr) and safety were evaluated.

eligible apl patients with arsenic-resistant relapse will enter the run-in period, and the subjects in the run-in phase will be treated with arsenic combined with venetoclax. after the run-in period, the patients were treated with interferon α-2b, arsenic trioxide for injection and venetoclax until the outcome of cr/pr/pd/ death/withdrawal/loss to follow-up occurred. tumor assessments were performed every 4 to 6 weeks (as determined by the investigator) during trial treatment. those who achieved cr/pr/pd/ withdrawal were then returned to standard treatment (treatment regimen was determined by the clinician), and those who completed the combination treatment period of the trial entered the survival follow-up period.

Eligibility criteria:
inclusion criteria: * 1. must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. * 2. age 18-70 years old (including boundary value); * 3. the presence of promyelocytic leukemia-retinoic acid receptor alpha (pml-rarα) confirmed by morphological features, cytogenetic analysis, and real-time quantitative polymerase chain reaction (qpcr); * 4. arsenic relapse resistant patients: patients who had relapsed (including molecular relapse) after remission with ato in the previous treatment, and could not be relieved after standard treatment; * 5. eastern cooperative oncology group (ecog) performance status score 0-2; * 6. the expected survival time is more than 3 months. exclusion criteria: * 1. allergy or contraindication to any study drug involved in the protocol; * 2. physical examination, electrocardiogram, laboratory examination, vital signs and test related abnormalities are clinically significant (subject to clinician's judgment); * 3. other serious conditions that may limit the patient's participation in the trial, such as severe liver or kidney disease; "patients with advanced infection, uncontrolled diabetes mellitus, severe cardiac dysfunction (e.g., clinically significant prolongation of the qt interval, potentially fatal torsades de pointes) or a history of angina or major heart disease, autoimmune diseases (as judged by the clinician);" * 4. pregnant or lactating women; * 5. epilepsy and central nervous system dysfunction; * 6. active hepatitis b, active hepatitis a, hiv positive; * 7. participate in other clinical trials at the same time * 8. any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Keywords: apl arsenic-resistant relapse interferon α-2b
prospective clinical trial comparing infraclavicular versus axillary approach to brachial plexus block

Conditions: Scaphoid Fractures; Distal Radius Fractures; Wrist Injury Arthrodesis

Summary: the brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. to get the brachial plexus block, several routes can be used, including the axillary and infraclavicular approach. few studies have compared these techniques, considering the time to perform the block, the onset time and success rate, with conflicting results. furthermore, there is little information in the literature comparing the length of postoperative analgesia provided by these techniques. therefore, the investigators designed this study in order to elucidate the differences between these two techniques to assist the anesthesiologist to choose the best of them in clinical practice.


Eligibility criteria:
inclusion criteria: * age older than 18 years and less than 70 years * consent informed signed by the patient * candidates for surgical intervention of scaphoid fractures, distal radius fractures and wrist arthrodesis * american society of anesthesiology physical status i, ii and iii * body mass index (bmi) \<35 kg / m². exclusion criteria: * cognitive impairment or active psychiatric condition * infection at the puncture site * bleeding disorders * history of allergy to ropivacaine
diaphragmmatic muscle strength and balance in women with dysmenorhea

Conditions: Dysmenorrhea Primary

Summary: analysis of stabilometric and respiratory variables in patients with dysmenorrhea during the first day of the menstrual cycle and any other day outside the cycle.

sociodemographic variables such as age, height, body mass index. respiratory variables such as maximum inspiratory pressure (mip), mip reference %, and mip predictive value. stabilometric variables we will measure the balance in condition of eyes open and eyes closed bipodal support and eyes open in monopodal support

Eligibility criteria:
inclusion criteria: * adult women with primary dysmenorrhea. * not having had any type of childbirth (natural, caesarean section, etc). * not be positive in covid. antigen test in the last 24 hours or negative pcr in the last 48 hours. exclusion criteria: * receive medical treatment during research. * have any orthopedic, neurological or systemic disease diagnosed other than primary dysmenorrhea. * be in follow-up with any medical treatment that does not be primary dysmenorrhea * women with a history of trauma or surgical treatment who involve the musculoskeletal system in the last year. * use of analgesics in the last 48 hours. * consumption of alcohol in the last 24 hours. * have a history or suspicion of pregnancy.

Keywords: dysmenorrhea diaphragm balance muscular strength
cryoablation for advanced bone and soft tissue tumors

Conditions: Sarcoma; Cryoablation

Summary: this is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. all eligible patients were enrolled. basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

this is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. clinical data of eligible patients were scheduled to be retrospectively collected from december 2016 to february 28, 2022. all patients eligible for inclusion. basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

Eligibility criteria:
inclusion criteria: no age restriction, male or female. the pathological diagnosis was a subtype of bone and soft tissue sarcoma. the clinical stage was determined to be metastatic or locally unresectable bone and soft tissue sarcoma. at least one cryoablation of tumor lesions was performed in our hospital. target lesions can be evaluated according to the efficacy evaluation criteria for solid tumors (recist; version 1.1) measure diameter changes. follow-up data were complete. exclusion criteria: not applicable.
optimal prostate study

Conditions: Prostate Cancer

Summary: to compare the toxicity, rate of local control, biochemical failure rate and quality of life of three different radiotherapy techniques (moderate hypofractionation, stereotactic body radiotherapy (sbrt) and standard radiotherapy plus 2 fractions of sbrt (booster)

participants must have histologically proven prostate adenocarcinoma, good performance status and suitable for high dose radiotherapy. there are two groups of participants: group 1: eligible participants will be randomised to have either moderate hypofractionation or standard radiotherapy plus sbrt (booster). participants in this group must be able to have mri, prostate fiducial markers (gold markers)and hydrogel insertion. fiducial markers will be used to locate the prostate accurately during radiation treatment. hydrogel is a temporary gel being injected into the space between the prostate and rectum to reduce the dose of radiation received by the rectum to minimise side effects from the treatment. group 2: eligible participants will be randomised to have either moderate hypofractionation or sbrt. participants will be reviewed for side effects. a safety committee will be formed containing multi-disciplinary team members. all serious adverse will be reported to the principal investigator and human research ethics committee within 24 hours.

Eligibility criteria:
inclusion criteria * histologically proven prostate adenocarcinoma * psa obtained within three months prior to enrolment * ecog performance status 0 to 2 * ability to understand and the willingness to sign a written consent * suitable for high dose irradiation to the prostate to be eligible for the arm containing stereotactic booster alone approach patient must have the following * no contraindication to mri such as pacemaker and severe claustrophobia * patient must be able to have fiducial markers placed in the prostate * patient must be able to have hydrogel insertion at the same time as fiducial markers * must have ipss less than 15 exclusion criteria * previous pelvic radiotherapy * prior total prostatectomy * unwilling or unable to give informed consent
urine metabolomics and colorectal cancer screening

Conditions: Colorectal Cancer; Colorectal Polyps

Summary: this is a prospective, multi-centered study to assess whether urine metabolomics can play a role in the screening of colorectal cancer (crc). urine samples will be collected from 1000 patients going through an established crc screening program, and from a further 500 patients who already have a diagnosis of crc. using nuclear magnetic resonance (nmr) spectroscopy, the 1h nmr spectrum of urine samples will be analyzed for specific metabolites, and establish the metabolomic signature of colorectal cancer. the results from metabolomic urinalysis of this screening cohort will be compared with results from colonoscopy, histological descriptions, fecal occult blood testing (fobt), and fecal immune testing (fit) to assess the accuracy of urine metabolomics in identifying patients with polyps and malignancies. the urine metabolomic results from the colorectal cancer group will be correlated with operative, histological and clinical staging to define the role of urine metabolomics in assessing colorectal cancer type, location and stage. additionally approximately 300 urine samples from breast cancer patients and 300 from prostate cancer patients will be collected to validate that the colorectal cancer signature is unique.


Eligibility criteria:
inclusion criteria: for screening group (normal colonoscopy \& colonic polyps): * asymptomatic, 50-75 year old, without personal or family history of crc/polyps * asymptomatic, 40-75 year old, known personal or first-degree family history of either crc or polyps for cancer group: * any patient with diagnosis of colorectal cancer * any patient with diagnosis of prostate cancer * any patient with diagnosis of breast cancer exclusion criteria: for screening group: * hematochezia * inflammatory bowel disease * on anticoagulation for reasons other than atrial fibrillation * significant co-morbidities for cancer group: * already had neoadjuvant treatment at time of urine collection * no invasive cancer at time of urine collection
transverse thoracic plane block in the pediatric cardiac patient

Conditions: Pain, Acute; Congenital Heart Disease

Summary: postoperative pain after cardiothoracic surgery can be a significant problem interfering with recovery, yet difficult to manage due to the sedating effects of opiates. these patients frequently have associated postoperative pulmonary changes and are at risk of respiratory depression with opioid analgesia. the ultrasound-guided transversus thoracic muscle plane block (ttmpb) is a recently described regional anesthetic technique showing improvements in postoperative pain management. further investigation is needed to establish the potential of the ttmpb as an analgesic modality in congenital cardiothoracic surgery in patients under the age of 18.


Eligibility criteria:
inclusion criteria: * congenital heart surgery exclusion criteria: * over 18
a study to compare the blood levels of mim8 in healthy men when administered with the dv3407-c1 pen injector or a syringe and cartridge

Conditions: Haemophilia A

Summary: novo nordisk is developing the study medicine mim8 for the treatment of haemophilia a. the study aims to show similar levels of mim8 in blood when using a new pen injector, called dv3407-c1 pen injector, and when using a syringe and cartridge. the new pen injector is intended to facilitate the administration of mim8 for patients with haemophilia a. the participants will get mim8 as injection under the skin (subcutaneously) of the belly using the dv3407-c1 pen injector and a needle (hereinafter referred to as pen injector) or using a needle and syringe from a cartridge (hereafter called syringe and cartridge). the participants will receive one injection with mim8, either with the dv3407-c1 pen injector or with a syringe and cartridge. the study participation will last up to 20 weeks. only healthy men can take part in the study.


Eligibility criteria:
inclusion criteria: * male aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) between 18.5 and 29.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening. * body weight between 60.0 and 100.0 kg (both inclusive) at screening. * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * increased risk of thrombosis, e.g., known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis. * any clinical signs or established diagnosis of venous or arterial thromboembolic disease. * factor viii activity greater than or equal to (≥) 150 percent (%) at screening. * thrombophilia as identified by any of the below laboratory markers at screening: * protein c, protein s or antithrombin less than (\<) lower limit of normal (lln) * factor ii activity or activated protein c resistance \>upper limit of normal (uln).
dose-finding, safety, pharmacodynamic effect study of sodium nitrite inhalation solution in normal, healthy volunteers

Conditions: Pulmonary Arterial Hypertension

Summary: this study is designed to investigate the safety and tolerability of air001 inhalation solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.


Eligibility criteria:
inclusion criteria: * normal male and female volunteers * age 18-55 * demonstrate a rise in pulmonary artery pressure to low inspired oxygen concentration (a normal response to breathing a low level of oxygen) exclusion criteria: * significant medical illnesses * risk factors for pulmonary hypertension * g6pd or cytochrome b5 reductase deficiencies * history of any form of altitude sickness * current prescription or over the counter medication use