Kornimate/medical-research-clean huggingface dataset:
diaphragm training post-cardiac surgery

Conditions: Diaphragmatic Paralysis

Summary: diaphragm paralysis is a possible complication of cardiac surgery. the spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. we hypothesize that a program of diaphragm muscle training by means of the threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.

inclusion criteria: all consecutive patients aged from 18 to 80 years old with rx-defined diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve substitution or both. exclusion criteria: acute cardiac failure, copd, chronic respiratory failure with indication to home oxygen therapy, neuromuscular diseases. outcome measures: mip, mep, diaphragm function recovery assessed by chest x-ray, lung function tests.

Eligibility criteria:
inclusion criteria: * post-cardiosurgical diaphragmatic paralysis recent cardiosurgical intervention for by-pass and/or valve replacement exclusion criteria: * heart failure * copd * neuromuscular disease

Keywords: diaphragmatic paralysis cardiac surgery respiratory muscle training
safety of furosemide in premature infants at risk of bronchopulmonary dysplasia (bpd)

Conditions: Bronchopulmonary Dysplasia

Summary: this study will describe the safety of furosemide in premature infants at risk of bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics (pk) of furosemide. funding source - fda oopd

infants will receive a placebo or furosemide for 28 days. blood samples will be collected for pharmacokinetic analysis.premature infants will be randomized to receive placebo or furosemide in a dose escalating approach. follow up information will be collected up to 7 days after the last dose and at 36 weeks post menstrual age. the final study assessment will occur at the time of discharge, early termination or transfer.

Eligibility criteria:
inclusion criteria: 1. receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow \> 1lpm) or mechanical ventilation (high frequency or conventional) 2. \< 29 weeks gestational age at birth 3. 7-28 days postnatal age at time of first study dose exclusion criteria: 1. exposure to any diuretic ≤ 72 hours prior to first study dose 2. previous enrollment and dosing in current study, "safety of furosemide in premature infants at risk of bronchopulmonary dysplasia" 3. hemodynamically significant patent ductus arteriosus, as determined by the investigator 4. major congenital anomaly (e.g. congenital diaphragmatic hernia, congenital pulmonary adenomatoid malformation) 5. meconium aspiration syndrome 6. known allergy to any diuretic 7. serum creatinine \>1.7 mg/dl \< 24 hours prior to first study dose 8. bun \>50 mg/dl \< 24 hours prior to first study dose 9. na \<125 mmol/l \< 24 hours prior to first study dose 10. k ≤2.5 mmol/l \< 24 hours prior to first study dose 11. ca ≤ 6 mg/dl \< 24 hours prior to first study dose 12. indirect bilirubin \>10 mg/dl \< 24 hours prior to first study dose 13. any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
electrophysiologic hv-interval as a predicor for permanent pacemaker implantation after tavi

Conditions: Symptomatic Aortic Valve Stenosis

Summary: the development of a high grade av-block is a frequent complication associated with transcatheter aortic valve implantation (tavi). patients who were suitable for tavi will be enrolled in this study. the hv-interval will be determined before and immediately after implantation. the hypothesis is that a prolonged hv-interval is associated with a high rate of complete av-block following tavi.


Eligibility criteria:
inclusion criteria: * symptomatic aortic valve stenosis * patients screened for tavi * written informed consent exclusion criteria: * unconsciousness, not able to consent * \< 18 years * permanent pacemaker

Keywords: tavi complete av-block hv-interval permanent pacemaker
dual time point fdg pet/mri scan in improving the imaging cancer patients with brain metastases

Conditions: Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm

Summary: this phase iv trial studies how well delaying positron emission tomography (pet)/magnetic resonance imaging (mri) scan after injection of fluorodeoxyglucose (fdg) can improve the imaging of patients with cancer that has spread to brain (brain metastases). fdg is a type of imaging agent that doctors use to help "see" the images on a scan more clearly. delaying pet/mri scan after injecting fdg may improve how well doctors can tell the difference between healthy and unhealthy tissue.

primary objective: i. to assess the optimal fludeoxyglucose f-18 (fluorodeoxyglucose) positron emission tomography (fdg pet) imaging time post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background \[l/b\] ratio) in patients with brain metastasis. secondary objective: i. to identify genotypic factors in fdg tumor metabolism derived from metrics, including maximum standard uptake value (suvmax), mean standard uptake value (suvmean), total lesion glycolysis (tlg), mean tumor volume (mtv), and l/b ratio. exploratory objectives: i. to identify patterns of metabolism derived from metrics, such as suvmax, suvmean, tlg, mtv, and l/b ratio, and magnetic resonance imaging metrics, such as regional perfusion abnormalities, apparent diffusion coefficient values, fractional diffusivity measures, and magnetic resonance spectroscopic finding. ii. to identify if post treatment changes in lesion metabolism from baseline correlate with treatment success. outline: patients receive fludeoxyglucose f-18 intravenously (iv) over approximately 1 minute and undergo a pet/mri scan over 70 minutes. within 5 hours of receiving fludeoxyglucose f-18, patients undergo a repeat pet/mri scan over 30 minutes. scans take place within 2 weeks before scheduled surgery and within 4-6 weeks after radiation treatment.

Eligibility criteria:
inclusion criteria: * pre-treatment adult patients with any solid organ metastasis and at least three intraaxial brain metastases including at least one enhancing \> 10 mm lesion * rim or solid enhancing lesion(s) with a history of non-central nervous system (cns) pathologic proven metastatic disease will be considered as a consensus between the referring radiation oncologist or neurosurgeon and a neuroradiology * planned surgery or radiation to the metastases * ability to undergo pet magnetic resonance (mr) examination exclusion criteria: * known allergy to fdg or gadolinium based contrast agents * history of impaired renal function (glomerular filtration rate \[gfr\] \< 30) * pregnant women are excluded
pain after preoperative ultrasound guided hip injections for total hip arthroplasty (push)

Conditions: Total Hip Replacement; Arthroplasty

Summary: the purpose of the study is to assess the accuracy of butterfly iq ultrasound for intra-articular hip injections, and to see if an injection given intra-articular before incision provides any benefit in preemptive pain relief or blood loss reduction.

this study is designed to be prospective randomized (1:1) controlled independent trial. subjects are male and female, aged 18 and above, who are suitable candidates for either a unilateral (i.e. single) total hip replacement. subjects that are scheduled with a single, extensively trained physician assistant assisting in their surgery will be exclusively included. this is single site study with projected enrollment of 150 subjects

Eligibility criteria:
inclusion criteria subjects meeting all of the following specific criteria will be considered for participation in the study: 1. subject is between 18-80 years of age. 2. subject is a suitable candidate for total hip replacement. 3. subject scheduled for surgery with the butterfly iq trained pa providing surgical assistance 4. subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to aahs ri 5. subject, in the opinion of the clinical investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures. 6. subject must be comfortable with speaking, reading, and understanding questions in english and providing an appropriate response. exclusion criteria subjects will be excluded from participation in the study if they meet any of the following criteria: 1. subject is a woman who is pregnant or lactating 2. subject from the vulnerable groups: prisoners, adults unable to consent, children, non-english speaking, illiterate, and/or visually impaired) 3. subject who is not comfortable with speaking, reading, and understanding questions in english and providing an appropriate response. 4. subject who cannot or refuses to give voluntary, written informed consent to participate in this clinical trial 5. subject has contraindications for any of the following: ropivicaine, epinephrine or methylene blue 6. previous hip surgery 7. history of infection in hip 8. morbid obesity defined as bmi\>40

Keywords: tha thr
comparison of sofosbuvir/velpatasvir fixed dose combination for 12 weeks with sofosbuvir and ribavirin for 12 weeks in adults with chronic genotype 2 hcv infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) for 12 weeks compared to treatment with sofosbuvir (sof) plus ribavirin (rbv) for 12 weeks in participants with chronic genotype 2 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * hcv rna ≥ 10\^4 iu/ml * hcv genotype 2 * chronic hcv infection (≥ 6 months) * females of childbearing potential must have a negative serum pregnancy test * males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * must be of generally good health, with the exception of chronic hcv infection, as determined by the investigator. exclusion criteria: * current or prior history of clinically-significant illness (other than hcv that may interfere with treatment, assessment or compliance with the protocol; * screening electrocardiogram (ecg) with clinically significant abnormalities * laboratory results outside of acceptable ranges at screening * pregnant or nursing female or male with pregnant female partner * chronic liver disease of a non-hcv etiology (e.g., hemochromatosis, wilson's disease, alfa-1 antitrypsin deficiency, cholangitis) * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)

Keywords: hepatitis c hcv cirrhosis sofosbuvir sovaldi sof/vel gs-5816 gs-7977 liver treatment naive treatment experience genotype 2
a study of tocilizumab in combination with an oral contraceptive in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this open-label, randomized, cross-over study evaluated the effect of tocilizumab (tcz) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (oc) in female patients with active rheumatoid arthritis (ra) and in healthy female volunteers of child bearing age. the ra patients received oc in combination with tcz, whereas the healthy volunteers received oc only. the ra patients received oc in 3 cycles of 21 days each; tcz 8 mg/kg was administered once as an intravenous infusion on the first day of cycle 2. the healthy volunteers received oc for only one 21-day cycle.


Eligibility criteria:
inclusion criteria: * adult patients with child bearing potential, 18-44 years of age. * rheumatoid arthritis (ra) for over 6 months duration. * on oral contraceptive without interruption for at least 3 months with normal cycle control. * treatment with disease-modifying anth-rheumatic drugs (dmard) for at least 12 weeks prior to study start. * body weight \< 150 kg. exclusion criteria: * functional class iv rheumatoid arthritis (american college of rheumatology \[acr\] classification). * history of amenorrhea (unrelated to pregnancy). * history or current inflammatory joint disease other than ra. * rheumatic autoimmune disease other than ra.
impact of pacing output and cycle length on qrs morphology

Conditions: PVC - Premature Ventricular Complex; Catheter Ablation

Summary: current recommendations for pacemapping are based on expert opinion and animals models. present study sought to evaluate the influence of different parameters of pacemapping on qrs morphology. pacemapping is performed with different cycle length (fixed burst vs. coupling interval) and stimulation output (maximum output vs. threshold) and resulting qrs complexes are compared to clinical pvc and the standard of care to determine the optimal parameter setting in pacemapping.

pacemapping is a common technique to determine to origin of ventricular ectopy during catheter ablation of premature ventricular contractions (pvc). during the pacemapping process an electrical pacing stimulus is applied via the ablation catheter and the resulting qrs complex is compared the clinical target pvc. the higher the consistency between the stimulated qrs complex and the clinical pvc, the nearer the catheter is located to the origin of ectopy. current recommendations for the execution of pacemapping are based on expert opinion and animals models. the investigators sought to assess for the first time in a clinical real life setting the different parameters for pacemapping (i.e. cycle length and stimulation output). therefore during the pacemapping process in routine pvc ablation pacing is performed with different cycle length (fixed burst vs. coupling interval of pvc) and different electrical output (maximum output vs. stimulation threshold). the resulting qrs morphologies are on the one hand compared to the ablation target (clinical pvc) and on the other hand to the suggest standard of care (coupling interval at pacing threshold) to determine the optimal setting of parameters in pacemapping.

Eligibility criteria:
inclusion criteria: * all patients undergoing pvc ablation exclusion criteria: * patients \<18 years * patients not able to consent * pregnancy * contraindication for pvc ablation * unavailability of vascular access * patients with complex congenital heart disease * expected hemodynamical instability during pacemapping

Keywords: catheter ablation of pvc pacemapping
impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery

Conditions: Delirium in Old Age; Anaesthetic

Summary: postoperative delirium in older adults is a common and costly complication after surgery. propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. the aim of this trial will be compare the impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery.

spine surgery is the third most common surgical procedure in older patients. with the increasing number of older patients undergoing spinal surgery, the risk of delirium after spinal surgery is currently expected to increase. the pathophysiological mechanisms of delirium remain poorly understood, leading models include neurotransmitter imbalance and neuroinflammation. among precipitating factors, drugs (especially sedative hypnotic agents and anticholinergic agents), surgery, anesthesia, high pain levels, anemia, infections, acute illness, and acute exacerbation of chronic illness are the most commonly reported. propofol and sevoflurane are commonly used anesthetics to maintain sedation during spinal surgery, and induce unconsciousness through different mechanisms. meanwhile, previous studies have found that propofol and sevoflurane have different anti-inflammatory effects. given their different sedative and anti-inflammatory effects, propofol and sevoflurane may have different effects on postoperative delirium. there are many studies to explore the effects of propofol and sevoflurane on postoperative delirium, but the conclusions are controversial. therefore, a randomized, controlled, double-blind clinical study was designed to compare the impact of propofol and sevoflurane on delirium after spine surgery in elderly patients.

Eligibility criteria:
inclusion criteria: 1. age ≥65 years and ≤90 years; 2. scheduled to undergo surgery for spinal, under general anaesthesia; 3. american society of anesthesiology (asa) i-iii; 4. agree to participate, and give signed written informed consents. exclusion criteria: 1. family history or history of malignant hyperthermia; 2. history of propofol or sevoflurane allergy; 3. demonstrated cognitive impairment on the modified mini-mental state examination (score, \<24of 30 or \<20 of 30 if the patient's education year was less than 6 years or\<17 if the patient is illiterate); 4. planned postoperative intubation or transferred to icu; 5. severe visual or auditory handicap; 6. prior diagnoses of neurologic diseases or mental disorders (e.g., stroke, parkinson's disease, dementia, schizophrenia, or depressive illness) 7. take anticholinergic drugs or other drugs acting on the central nervous system for a long time before operation 8. participating in other clinical studies in recent 3 months

Keywords: delirium spine surgery anaesthetic propofol sevoflurane
gf-gs 01: comparing conventional axillary dissection versus sentinel node resection in clinically node-negative operable breast cancer

Conditions: Breast Cancer

Summary: sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer. the gf-gs 01 study, sponsored by a national hospital research program, compares this new surgical method with a classical method in patients having a negative sentinel node. the duration of the follow-up is 5 years.


Eligibility criteria:
inclusion criteria: * women older than 18 years with clinically node-negative operable unifocal n0 breast cancer (clinical tumour size \< 30 mm). * written consent is obtained from all patients before randomization.

Keywords: breast cancer sentinel node resection survival breast cancer unifocal n0
patient-reported outcome measures in patient underwent total hip and knee arthroplasty

Conditions: Hip Osteoarthritis; Knee Osteoarthritis; Prosthesis Survival

Summary: registry of galeazzi orthopedic institute: provides for the regular and systematic collection of all data (clinical and some proms) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (knee injuryosteoarthritisoutcomescore (koos-ps) and hip injuryosteoarthritisoutcomescore (hoos-ps) but also the sphere of general health (shortform health survey-12 (sf-12) and visualanaloguescale (vas)) , in addition, of course, to the satisfaction rate.


Eligibility criteria:
inclusion criteria: * male and female * age more than 18 * patient underwent hip or knee arthroplasty exclusion criteria: * age less than 18 * comorbidity that can results in the difficulty to come back for the follow up
group exercise after hip replacement surgery

Conditions: Osteoarthritis, Hip

Summary: the purpose of this study is to determine which group exercise one should choose when hip osteoarthritis patients have undergone hip replacement surgery. to determine this, we want to answer the following research question: are there differences in function and muscle strength in osteoarthritis patients who conduct group training either on land or in water in the rehabilitation phase following hip replacement surgery?


Eligibility criteria:
inclusion criteria: * hip osteoarthritis patients who undergo surgery with total prosthesis at st. olav's hospital, department orkdal. * participants must live in commuting distance from the hospital, as the training is organized as outpatient training * participants must be able to take instruction and master the norwegian language exclusion criteria: * patients who experience serious complications after surgery * if a person has a disease that causes that one can not complete the planned training

Keywords: exercise hydrotherapy
btrx-246040 administered once daily to patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study will determine the efficacy, safety, and tolerability of a once-daily (qd) dose of up to 80 mg of btrx-246040 for 8 weeks in participants with mdd.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of mdd as defined by dsm-5 criteria and have had at least 1 prior major depressive episode in the past 10 years * patients must present with a new current episode of mdd and the duration of the current episode must be at least 4 weeks but not longer than 18 months. * at visit 1 (screening) and visit 2 (baseline), patients must have clinically significant depressive symptoms defined by tandem (investigator- and computer-administered) montgomery-asberg depression rating scale (madrs) total scores ≥ 26 with a difference of ≤ 7 points between the investigator- and computer-administered madrs total scores * patients must have a cgi-s score ≥ 4 at visit 2 (baseline). exclusion criteria: * patients who present with any current dsm-5 disorder other than mdd which is the focus of treatment. * patients who are homicidal in the opinion of the investigator or are at suicidal risk (any suicide attempts within 12 months prior to visit 1 \[screening\] or any suicidal intent, including a plan, within 3 months prior to visit 1 \[screening\]; c-ssrs answer of "yes" on item 4 or 5 \[suicidal ideation\]; investigator- or computer-administered madrs score of ≥ 5 on item 10 \[suicidal thoughts\]; by investigator clinical evaluation). * patients cannot have any history of substance or alcohol use disorder within 12 months prior to visit 1 (screening) per dsm-5 criteria * patients must not have a clinically significant comorbid disease.

Keywords: major depressive disorder anhedonia antidepressant nociceptin nopr