Kornimate/medical-research-clean huggingface dataset:
detecting postoperative recurrence in crohn's disease

Conditions: Crohn's Disease

Summary: up to ¾ of patients who have been diagnosed with crohn's disease (cd) will have to undergo bowel resection during their lifetime despite modern medical therapies. unfortunately, disease recurrence is common and endoscopic detection of recurring inflammation precedes clinical relapse. endoscopic investigation is therefore recommended to manage these patients. this multi center, prospective study compares the conventional endoscopic method, ileo-colonoscopy to a new technique, i.e., colonic capsule endoscopy (cce). cce enables investigation of the small bowel and the large intestines by using a double-sided video camera with about 10 hours acquisition time. this study aims to evaluate the performance of cce to detect postoperative recurrence of cd and detection rate of colonic and anastomotic recurrence is compared to ileo-colonoscopy. proximal (small bowel) lesions are additionally recorded and impact on clinical management of the findings is accounted for. moreover, safety aspects and influence of the findings on progress of the disease are monitored. all consecutive patients who are operated for cd in any of the participating study centers are eligible. included are patients with segmental small bowel, ileocecal or segmental colonic resection. in some cases capsule retention has been reported at an average of 2-3% with cd patients at elevated risk. therefore, patency capsule is performed before application of the video cce to exclude bowel obstruction. sample size estimation results in n = 70, requiring each 140 capsule endoscopes and 140 patency capsules for performance of postoperative screening (ca 4-8 weeks postoperatively) and detection of postoperative recurrence (ca 4-8 months postoperatively).


Eligibility criteria:
inclusion criteria: * segmental bowel resection for crohn's disease * ileocecal resection * small bowel resection * segmental colonic resection * informed consent * age ≥ 18 years exclusion criteria: * intestinal obstruction as suspected by anamnesis or clinical/technical investigation * dysphagia or ileus * non-passage of the intact 'agile patency capsule' within 72 hours * pregnancy

Keywords: colonic capsule endoscopy crohn's disease capsule endoscopy
a single oral ascending dose study of bia 9-1067 in healthy male subjects

Conditions: Parkinson Disease

Summary: the purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-o-methyltransferase (comt) activity of bia 9-1067 in healthy male subjects after single oral ascending doses.

single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.

Eligibility criteria:
inclusion criteria: * a signed and dated informed consent form before any study-specific screening procedure was performed. * aged between 18 and 45 years, inclusive. * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ecg. * non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay. exclusion criteria: * any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease. * acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1. * history of drug abuse within 1 year before study day 1. * history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day (12.5 cl glass of 10° \[10%\] wine = 12 g; 4 cl of aperitif, 42° \[42%\] whiskey = 17 g; 25 cl glass of 3° \[3%\] beer = 7.5 g; 25 cl glass of 6° \[6%\] beer = 15 g * positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies. * positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma \[3,4-methylenedioxy-methamphetamine; ecstasy\]). * history of any clinically important drug allergy. * prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (imp) administration. * consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1. * use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before imp administration. * donation of blood (i.e. 450 ml) within 60 days before study day 1

Keywords: bia 9-1067
effectiveness study of occupational therapy in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine the effectiveness of occupational therapy in parkinson's disease.

parkinson's disease is a complex disabling condition progressively affecting activities and participation of patients. occupational therapy aims to optimise functional performance and engagement in meaningful roles and activities. the lack of scientific evidence for the effectiveness of occupational therapy (ot) in parkinson's disease (pd) highlights the urgent need for high quality intervention studies. the dutch clinical practice guideline for ot in pd (2008)offers a good basis for conducting an intervention study. the completed otip pilot underscored the feasibility and the need for a large scale trial. the otip study evaluates the effectiveness of ot in improving daily functioning of patients with pd.

Eligibility criteria:
inclusion criteria patients: * idiopathic parkinson's disease * indication for referral to occupational therapy * home dwelling inclusion criteria caregivers * available for informal support minimal two times a week to a patient who participates in the study * available to take part in the intervention exclusion criteria: * not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_mmse score \< 24). * co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). or limitations in activities are dominated by the co morbid condition rather than by parkinson's disease. * current participation in other allied health research (i.e. parkfit) * having received occupational therapy intervention in the last 3 months

Keywords: occupational therapy parkinson's disease effectiveness rct activities of daily living participation caregiver's burden economic evaluation
preemptive analgesia of dexmedetomidine reduces per-operation pain

Conditions: Pain Management; Noncardiac Surgery

Summary: background:preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. preemptive analgesia of dexmedetomidine (dex) in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation. objective: to investigate the per-operative effects of dex preemptive analgesia. method:the patients scheduled noncardiac surgery undergoing general anesthesia were selected and divided into dex group and placebo group randmized. the dex group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and 15min after induction. the placebo group was infused with equal amounts of normal saline.the coprimary efficacy outcome was a composite of analgesia effect, one is the compliance rate of ioc2 target in intra-operation, another is the the rate of none-to-slight post-operative pain assessed with the p-nrs≦3 at 12 hours after surgery \[pain numeric rating scale was assessed with the (numeric rating scale, p-nrs)\].

background:preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. preemptive analgesia of dex in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation. objective: to investigate the per-operative effects of dex preemptive analgesia.

Eligibility criteria:
inclusion criteria: * 18 years to 85 years old, * body mass index (bmi,calculated as weight in kilograms divided by height in meters squared): 18.5\~35. * asa (american society of anesthesiologists) grade i- iii; * scheduled for non-cardiac surgery undergoing general anesthesia * expected duration of operation 0.5\~3 h. exclusion criteria: * disagreed to participate; * body mass index (bmi) of greater 35 * american society of anesthesiologists (asa) classification 4 or above; * previous severe central nervous systemheart, liver, kidney or and lung dysfunction ; * diagnosed neuropsychological disorders, that is, schizophrenia, epilepsy, parkinson's disease, myasthenia gravis，alzheimer's disease and other autonomic disorders of patients affecting eeg outcomes; * comatose, dementia, or language barrier which impeded communication and assessment; * history of neurosurgical procedures; * systolic blood pressure continuously lower than 85mmhg or higher than 180mmhg; heart rate continuously lower than 45 times / min; sever arrhythmia need intervation and implantable pacemaker.
beta-alanine supplementation and its effects on performance, muscle carnosine content and safety in athletes with spinal-cord injury

Conditions: Spinal Cord Injuries

Summary: paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines. previous studies from our group have shown that upper-body exercise is very sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional supplements capable of increasing buffering capacity. in line with this, have shown that upper-body muscle groups benefit more from artificially induced alkalosis than lower-body muscle groups. although β-alanine appears to be an interesting and potential ergogenic supplement for paralympians, no study to date has assessed its potential in wheelchair athletes.in this study, we will evaluate the effects of β-alanine supplementation on upper-body performance in wheelchair athletes.


Eligibility criteria:
inclusion criteria: * paralympian training for any exercise modality for at least one year; * a weekly training volume of 6 hours or more; * have a spinal cord injury accompanied by loss of motor function in the lower limbs for at least one year; * available for carrying out the experimental procedures. exclusion criteria: * use of creatine or beta-alanine for at least 3 and 6 months before the trial; * cardiovascular or respiratory disease; * clinical condition that result in malabsorption of nutrients; * any other medical condition that prevents the realization of experimental procedures.
bladder displacement during abdominal and pelvic floor exercises

Conditions: Postpartum Disorder

Summary: this study evaluates the bladder base displacements during abdominal and pelvic floor exercises in postpartum women comparing to nulliparous women

postpartum women are at increased risk of suffering pelvic floor dysfunctions. however, only a few researches are focused on the exercises physiological effect at the postpartum recovery period. a prospective observational study was designed to evaluate the protective or the prolapsed effect of abdominal and pelvic floor exercises in postpartum women. two groups were established: group a was composed of primiparous women during postpartum period and group b of nulliparous women. both groups practiced the same set of 6 abdominal and perineum exercises. the bladder descent was registered by ultrasonography, and the correct execution was controlled in both groups by superficial pelvic floor and abdominal electromyography. a graphical user interface on matlab software has been developed for aiding in offline measurement process.

Eligibility criteria:
inclusion criteria: * women at postpartum period (more than 6 and less than 12 weeks after vaginal birth) * willingness to participate in the study * ability to contract pelvic floor muscles correctly * written consent to participate. exclusion criteria: * pregnancy * caesarean birth * pelvic floor disorders * neurological diseases

Keywords: pelvic floor abdominal muscles ultrasonography postpartum
genetic data collection in adult participants to identify genetic variants of known importance in non-alcoholic steatohepatitis (nash)

Conditions: Non-alcoholic Steatohepatitis (NASH)

Summary: collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in non-alcoholic steatohepatitis (nash)


Eligibility criteria:
key inclusion criteria: one or more of the following: 1. a prior diagnosis of nash with a clinical research network (crn) fibrosis score of f1 to f4 based on liver biopsy 2. evidence of nafld by imaging or liver histology as described in the protocol * the possible imaging modalities to assess historic evidence of nafld may be based on thresholds as described in the protocol 3. known high-risk genotype for hsd17b13 (t/t or t/ta) and/or pnpla3 (c/g,or g/g) 4. a clinical suspicion of nash based on presence of 2 or more elements of the metabolic syndrome defined by: 1. waistline that measures \>35 inches (89 centimeters) for women or \>40 inches (102 centimeters) for men 2. historic fasting triglycerides \>150 mg/dl within the prior 6 months 3. historic fasting hdl cholesterol \<40 mg/dl in men or \<50 mg/dl in women, or on cholesterol-lowering medication within the prior 6 months 4. historic fasting blood glucose \>100 mg/dl or on diabetes medication within the prior 6 months 5. historic blood pressure \>130/85 mmhg, or on anti-hypertensive medication within the prior 6 months key exclusion criteria: 1. known history or clinical evidence of drug abuse, within the 12 months before screening. drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms. 2. excessive alcohol intake for ≥3 months during the past year prior to screening (\>3 units/day for males and \>2 units/day for females is generally considered excessive (unit: 1 glass of wine \[approximately 125 ml\]=1 measure of spirits \[approximately 1 fluid ounce\]=½ pint of beer \[approximately 284 ml\]). 3. history of liver transplant, current placement on a liver transplant list, or model for end-stage liver disease (meld) score \>12. 4. history of viral and resolved hepatitis or human immunodeficiency virus (hiv). 5. any malignancy within the past 5 years except for basal cell or squamous epithelial cell carcinoma of the skin, or any carcinoma in situ. note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: nonalcoholic fatty liver disease (nafld)
gender dysphoria: epidemiological data

Conditions: Gender Dysphoria

Summary: retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in chru de nancy


Eligibility criteria:
retrospective analysis of available data as a part of the regular care of subjects with gender dysphoria. all measurements were made at the time of the routine follow-up visits
mild® percutaneous image-guided lumbar decompression: a medicare claims study

Conditions: Lumbar Spinal Stenosis

Summary: this prospective longitudinal study will compare incidence rates of medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the mild procedure, at 24 months post-treatment with mild, tested against a control group of similar patients that have had a comparable procedure. this study will start with patients treated with a study procedure having an index date on or after january 1, 2017, and enrollment will continue until stopped by the sponsor.

in this study the treatment group will include all patients receiving mild, and the control group will include all patients receiving ipd for the treatment of lss during the enrollment period. reoperation and harms data will be studied for the mild and ipd procedures for a 24-month follow-up period after the index procedure using medicare claims data. this study is exempt from irb oversight (department of health and human services regulations 45 cfr 46) and does not require prior enrollment nor patient consent. the inclusion of the study's nct number on mild medicare claims is required and results in enrollment.

Eligibility criteria:
inclusion criteria: * medicare beneficiaries receiving mild or interspinous process decompression * diagnosis of lss with nc exclusion criteria: * patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or mild in the lumbar region during the 12 months prior to the index date

Keywords: lumbar spinal stenosis interspinous process decompression mild medicare medicare advantage
impact of 80 w ktp laser vaporization prostatectomy on severity of obstruction in benign prostatic hyperplasia

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Summary: the purpose of this study is to compared the efficacy of 80w ktp photoselective laser vaporization prostatectomy (pvp) and transurethral resection of the prostate (turp) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (bph) on non-randomized controlled design.


Eligibility criteria:
inclusion criteria: * symptomatic bph * international score prostate symptom (ipss) of 13 or greater * prostate volume of 30 to 100 ml * peak urinary flow rate (qmax) less than 15 ml/s with a voided volume of \>125 ml and a pvr \<350ml * able to give fully informed consent exclusion criteria: * subjects with histological diagnosis of prostate cancer * subjects with history of chronic urinary retention * subjects with urethral stricture, * subjects with bladder neck contracture * subjects with urinary tract infection * subjects with prostate volume on trus of \>100 ml * subjects with suspected neurogenic bladder dysfunction * subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason

Keywords: benign prostatic hyperplasia ktp laser transurethral resection of prostate urinary bladder neck obstruction
multicenter registry of atrial fibrillation ablation with radiofrequency balloon catheter

Conditions: Atrial Fibrillation

Summary: all consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (rfb) "heliostar" (biosense webster) will be included in a multicenter observational registry. the aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the rfb in a real-world setting.

all consecutive atrial fibrillation patients undergoing pulmonary vein isolation (pvi) with the novel radiofrequency balloon catheter (rfb) "heliostar" (biosense webster) will be prospectively included in a multicenter observational registry. pvi with the rfb will be performed as previously described. briefly, after optimal rfb positioning, confirmed through the correct alignment between the rfb and the pulmonary vein and sufficient electrode-tissue contact, ablation is performed in temperature-controlled mode with unipolar radiofrequency energy. typically, \>2 posterior electrodes are identified on the rfb. the power setting is 15 w and the target electrode temperature is 55° c. the same energy is simultaneously delivered to all electrodes, with a duration of 15-20 s for the posterior and 45-60 s for the non-posterior electrodes. during ablation, pulmonary vein potentials are monitored on the circular diagnostic catheter to evaluate real-time isolation. in the case of pulmonary vein acute reconnection, additional applications are delivered to achieve durable pvi. an esophageal temperature probe will be used to monitor any increase in esophageal temperature. follow-up will be performed according to each standard institutional protocol. safety endpoints include any major periprocedural complications \[e.g. death, atrioesophageal fistula, stroke/transient ischaemic attack, pericardial effusion/tamponade with/without surgical treatment, myocardial infarction, and persistent phrenic palsy\] occurring within 7 days post-procedure (except for atrioesophageal fistula). minor complications will also be reported, including vascular access complications requiring treatment, pericarditis, and transient phrenic palsy. efficacy outcome is defined as arrhythmia-free survival during the follow-up. arrhythmia recurrence is defined as any atrial tachyarrhythmias ≥30 s after a 90-day post-ablation blanking period.

Eligibility criteria:
inclusion criteria: * symptomatic atrial fibrillation with indication to catheter ablation exclusion criteria: * age \<18 years old * pregnancy * any contraindications to catheter ablation

Keywords: radiofrequency, ablation, single-shot
impact of virtual reality hypnosis before an invasive medical procedure for patients with chronic pain

Conditions: Chronic Pain

Summary: management of chronic pain involves an array of tools, such as radiofrequency thermocoagulation (rf-tc). like many other invasive procedures, rf-tc can generate an increase in pain perception and anxiety levels. virtual reality hypnosis (vrh) is a promising tool in managing anxiety and pain. nevertheless, its effectiveness has not been investigated in patients with chronic pain goig througha rf-tc procedure. the goal of this study is to evaluate the effectiveness of vrh on self-assessed anxiety in patients with chronic pain having to undergo an act of tf-rc. patients were randomly assigned into two groups: vrh or control (usual care). assessment were carried-out at 4 periods of time: t0 (the week before the rf-tc); t1 (pre-intervention the day of the rf-tc); t2 (post-intervention the day of the rf-tc); and t3 (post-rf-tc). medical and socio-demographic data, immersive tendencies pain, anxiety, and satisfaction were assessed at each time points.


Eligibility criteria:
inclusion criteria: * suffering from chronic pain * \>18 years old * french speaking * no claustrophobia * no head or face wounds * sufficient auditory and visual acuity for an effective use of the vrh technique

Keywords: virtual reality hypnosis radiofrequency thermocoagulation chronic pain anxiety complementary approach
open-label study of intravitreal icon-1 in patients with choroidal neovascularization secondary to age-related macular degeneration (amd)

Conditions: Choroidal Neovascularization; Wet Macular Degeneration

Summary: the purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of icon-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.


Eligibility criteria:
inclusion criteria: * males or females of any race, ≥50 years of age * active primary cnv secondary to amd in the study eye exclusion criteria: * any prior treatment of cnv or advanced amd in the study eye, except for dietary supplements or vitamins * any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months * vitrectomy in the study eye