Kornimate/medical-research-clean huggingface dataset:
chemotherapy for resectable colorectal liver metastases

Conditions: Metastatic Colorectal Cancer; Metastatic Liver Cancer

Summary: there is a degree of uncertainty regarding the role of perioperative chemotherapy (ctx) in the treatment of resectable colorectal liver metastases (crlm). in the clinical practice, the combination of surgery and ctx is increasingly accepted as treatment for crlm, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. however, controversy exists whether all patients with resectable crlm benefit from perioperative ctx. there is paucity of good quality studies on this topic. a pooled analysis of two phase iii randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant ctx. nevertheless, long term results of the epoc trial founded benefit in disease free survival (dfs) with no difference in overall survival (os) when perioperative ctx with folfox4 was compared with surgery alone for resectable crlm. furthermore, a retrospective series from ayez et al showed that patients with a high crs benefit from neo-adjuvant ctx while in patients with a low risk profile did not. on the other side, another retrospective series from the mskcc showed the timing of additional ctx for resectable crlm was not associated with improved outcomes. the ongoing charisma trial is currently comparing the outcomes of neo-adjuvant ctx followed by surgery versus surgery alone in high-risk patients with resectable crlm. this uncertainty regarding crlm management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous crlm, not stratified by clinical risk score (crs) as described by fong et al.


Eligibility criteria:
inclusion criteria: * patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma. * minimum follow-up of five years. exclusion criteria: * patients with extrahepatic disease

Keywords: colorectal liver metastases liver resection hepatectomy
post-market clinical follow-up study on the safety and performance of ennovate® complex

Conditions: Hyperkyphosis; Hyperlordosis; Congenital Scoliosis; Neuromuscular Scoliosis; Idiopathic Scoliosis

Summary: multicenter, multinational post-market clinical follow-up (pmcf) study on the safety and performance of ennovate® complex - a prospective, pure data collection of all ennovate® scoliosis patients in selected centers (not interventional, multicentric)

this clinical study is one of the post-market clinical follow-up (pmcf) measures that enables the manufacturer to monitor the clinical safety and performance of the ennovate® complex system. the study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. it includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in deformity disorders.

Eligibility criteria:
inclusion criteria: * informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old * informed consent in the documentation of clinical and radiological results of patients and legal representative (parent) for patients who are younger than 18 * patient's indication according to ifu * patient is not pregnant exclusion criteria: * patient's clear unability or unwillingness to participate in follow-up examinations

Keywords: upper-thoracic spine
long-term safety, efficacy, and durability of en3835 in the treatment and retreatment of plantar fibromatosis

Conditions: Plantar Fibromatosis

Summary: assess the long-term safety and efficacy of en3835 in participants who have participated in a parent placebo-controlled study of en3835 (en3835-222, nct05152173) and assess the efficacy and safety of en3835 in the treatment and retreatment of plantar fibromatosis.


Eligibility criteria:
inclusion criteria: 1. have been enrolled and completed a sponsored-clinical study of en3835 (for the en3835-222 study, participants who completed the study are those that completed the day 57 visit, were assessed for safety and received at least 1 dose of study intervention). 2. willing and able to comply with all protocol required visits and assessments. 3. agree not to use opioids during the study period and has not used opioids 2 weeks prior to the observational day 1 visit. 4. agree to not initiate or change use of orthotics or inserts designed to relieve symptoms of plantar fibromatosis during the study period. 5. willing and able to comply with all protocol required visits and assessments. 6. be adequately informed and understand the nature and risks of the study and be able to provide consent 7. if female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the day 1 visit), or, if of childbearing potential, be nonpregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period. 8. have no significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for en3835 administration. exclusion criteria: 1. has any musculoskeletal, neuromuscular, neurosensory, or other neurological or related disorder that affects the participant's use of his or her feet and/or would impair his/her completion of study assessments as determined by the investigator. 2. any other significant medical condition or had an sae in the parent study which in the investigator's opinion, would make the participant unsuitable for enrollment in the study. 3. received or plans to receive surgical or non-surgical treatments on the foot or nodules that were treated. 4. has a known systemic allergy to collagenase or any other excipient of en3835. 5. has a known bleeding disorder that would make the participant unsuitable for treatment or retreatment in the study. 6. has significant medical history or examination findings related to the participant's plantar nodules, which in the investigator's opinion, would make the participant unsuitable for en3835 administration. 7. has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except \<150mg of aspirin daily, 7 days prior to first injection and for the duration of the study.
non-invasive monitoring in transcathether aortic valve implantation

Conditions: Aortic Valve Disease

Summary: in patients with severe aortic stenosis (as) undergoing transcatheter aortic valve implantation (tavi) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management. the aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called clearsight for monitoring during tavi procedures compared with standard invasive measurements.

in patients with severe aortic stenosis (as) undergoing transcatheter aortic valve implantation (tavi) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management. the aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called clearsight for monitoring during tavi procedures compared with standard invasive measurements. the clearsight monitoring system works non-invasively by utilizing an inflatable finger cuff which adjusts automatically to measure the arterial blood pressure which enables the calculation of parameters such as cardiac output or index. multiple studies have demonstrated the reliability and feasibility of continuous non-invasive monitoring, in different settings, however it was never performed in patients undergoing tavi. the clearsight monitoring system will be directly compared to invasive measurements of hemodynamic parameters during the procedure. in addition, information regarding baseline hemodynamics and its changes during/after procedure may give important information on peri- and post-procedural management and short-term outcomes and discharge planning. a tool, providing this information non-invasively with the same accuracy might result in a major improvement in daily practice..

Eligibility criteria:
inclusion criteria: • adult patients (\>18 years old) with severe aortic stenosis undergoing elective tavi. exclusion criteria: * emergency indication for tavi * severe tricuspid regurgitation * severe mitral stenosis or severe regurgitation * invasive right heart catheterization impossible * dependency on right ventricle pacing immediately after tavi implantation * vulnerable subjects * known or suspected non-compliance, drug or alcohol abuse * participation in another investigation with an investigational drug or another md within the 30 days preceding and during the present investigation affecting this study * previous enrolment into the current investigation

Keywords: transcatheter aortic valve implantation hemodynamic parameter
precise care for cancer related fatigue

Conditions: Cancer-Related Condition

Summary: this project expects to enroll 200 cancer patients and their subjective-objective measurements on fatigue, stress, symptoms, and total steps will be validated so that the information can be used in further care and improvement of life of quality of the patients.


Eligibility criteria:
inclusion criteria: - age ≧ 20 years old; one group had a cancer diagnosis, one group no cancer diagnosis; can continuous wearing bracelet for 7 days or more exclusion criteria: - unclear and unable to answer the questionnaire

Keywords: cancer-related fatigue smart bracelet device symptoms for subjective and objective
a prospective, randomized trial comparing same day discharge and overnight hospital stay among total hip arthroplasties done by the direct anterior approach

Conditions: Osteoarthritis of the Hip

Summary: the purpose of this study is to identify differences in satisfaction, pain and length of stay between patients undergoing hip replacement who are discharged from the hospital on the day of surgery compared to patients who stay one night in the hospital.


Eligibility criteria:
inclusion criteria: * primary tha without acute hip fracture or prior hardware that would need to be removed at the time of surgery * unilateral tha * pre-operative body mass index (bmi) \< 40 kg/m2 * age \< 75 years at time of surgery * pre-operative hemoglobin \> 10 g/dl if pre-operative hemoglobin data is available * no history of cardiopulmonary disease that would necessitate inpatient monitoring after surgery * pre-operative ambulatory status does not require the use of a walker or wheelchair * no chronic pre-operative opioid medication use or opioid addiction * assistance available at home after discharge from hospital * no other condition or circumstance that would preclude rapid discharge from the hospital after surgery * subject's english proficiency allows understanding of study and informed consent * subject consented to participate in this study exclusion criteria: * revision tha * bilateral tha * pre-operative bmi ≥ 40 kg/m2 * age ≥ 75 at time of surgery * pre-operative hemoglobin ≤ 10 g/dl if pre-operative hemoglobin data is available * history of cardiopulmonary disease requiring acute inpatient monitoring * pre-operative ambulatory status requiring the use of a walker or wheelchair * chronic pre-operative opioid medication use or opioid addiction * limited or no assistance available at home after discharge from hospital * any other condition or circumstance that would preclude rapid discharge from the hospital * subject not proficient in english * subject did not consent to participate in this study
effects of oral steroid in mycoplasma pneumoniae pneumonia

Conditions: Mycoplasma Pneumoniae Pneumonia

Summary: mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. the clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. the investigators aim to study the effects of prednisolone on severe m. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.

mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. the clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. the investigators aim to study the effects of prednisolone on severe m. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. the primary endpoint was fever duration and analysed by intention to treat.

Eligibility criteria:
inclusion criteria: * evidence of mycoplasma pneumoniae infection * lobar pneumonia or pneumoniae with pleural effusion exclusion criteria: * immunosuppresant host * chronic cardiovascular/pulmonary disease * hospital acquired infection
comparing epidural versus general anesthesia for less cholecystectomies

Conditions: Cholelithiasis

Summary: this study is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder removal. the objective of this study is to compare epidural versus general anesthesia for postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy patients.

this is a prospective, comparative, controlled, blinded study that will enroll a total of 70 adult patients that require an elective cholecystectomy. patients will be randomized 1:1 to receive either general anesthesia (group a) or epidural anesthesia (group b) for their laparoendoscopic single site incision (less) gallbladder removal surgery (cholecystectomy). randomization will be achieved using a computer-generated list. the patient will know what are they are randomized to before entering the operating room because an epidural will need to be placed preoperatively. standards for basic anesthetic monitoring approved by the american society of anesthesiologists will occur intraoperatively. postoperative evaluations will be completed by a medical professional that is blinded to the type of anesthesia used during the less surgery. postoperative evaluations include a physical exam, adverse events, medication administration, vital signs and post-anesthesia recovery score for ambulatory patients (parsap) scores will be taken every 15 minutes until the patient has a score of at least 18. patients will be followed 90 days postoperatively to collect pain scores, analgesic use, adverse events, and quality of life questionnaires.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 65 years of age * asa i or ii * patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic gallstones, polyps by imaging or biliary dyskinesia with documented ef \< 30% * no cardiopulmonary disease * normal coagulation profile exclusion criteria: * any female patient, who is pregnant, suspected pregnant, or nursing * contraindication for pneumoperitoneum * contraindication for epidural anesthesia * allergy to local anesthetic agents * any patient with acute calculus or acalculous cholecystitis * any patient who has had an upper midline or right sub costal incision * any patient with preoperative indication for a cholangiogram * any patient with asa ≥ 3 * any patient who is undergoing peritoneal dialysis (pd) * history of long term analgesic use requiring pain management (\>1 week) * any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair * any patient with obstructive sleep apnea (osa), history of osa or at high risk of osa as determined by the stop questionnaire * bmi \> 35 kg/m2 * any patient with a history of severe, uncontrolled gerd
hemodynamic mechanisms of abdominal compression in the treatment of orthostatic hypotension in autonomic failure

Conditions: Orthostatic Hypotension; Pure Autonomic Failure; Multiple System Atrophy; Autonomic Failure

Summary: compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. the purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. the investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt.

patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing) due to severe impairment of the autonomic nervous system. compression garments such as waist-high stockings and abdominal binders have been shown to improve orthostatic hypotension in these patients. the purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. the investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt. this study will help us better understand the contribution of the abdominal veins to orthostatic hypotension and the mechanisms underlying this non-pharmacological therapeutic approach. participants will be studied in a tilt table in two separate days in a randomized, crossover fashion with sham abdominal compression (\~5 mmhg) and active compression (\~40 mmhg).

Eligibility criteria:
inclusion criteria: * male and female patients, * between 18-80 yrs., * with neurogenic orthostatic hypotension associated with primary autonomic failure (parkinson disease, multiple system atrophy and pure autonomic failure). orthostatic hypotension will be defined as ≥20 mmhg decrease in systolic bp or ≥10 mmhg of diastolic bp within 3 minutes on standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes (freeman et al., 2011). * patients able and willing to provide informed consent. exclusion criteria: * pregnancy. * significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded. * clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months, and; other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing

Keywords: autonomic failure orthostatic hypotension compression garments treatment
safety and efficacy study of sitaxentan sodium (thelin™) in patients with pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of this study is to evaluate the safety and efficacy of thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (pah).

the purpose of this study is to evaluate the safety and efficacy of thelin™ (sitaxsentan sodium) as compared to placebo in the treatment of patients with pah. a cohort of patients will be randomized to usual treatment with tracleer® (bosentan) for observational comparisons of safety and efficacy.

Eligibility criteria:
inclusion criteria: * have a current diagnosis of symptomatic pah classified by one of the following: 1. primary pulmonary hypertension (pph) - also known as idiopathic pulmonary arterial hypertension (ipah); 2. pah associated with connective tissue diseases; 3. pah associated with one of the following congenital heart defects: 1. repaired asd, vsd or pda greater than one year post-operative 2. un-repaired secundum asd (with resting oxygen saturation greater than 88 percent in room air measured by oximeter) * world health organization (who) functional class ii, iii, iv * greater than 12 and less than 75 years of age * women of childbearing potential must be using two forms of medically acceptable contraception (at least one barrier method) * have a cardiac catheterization within 6 months before study entry that shows the following values: 1. mean pulmonary artery pressure (papm) greater than 25 mmhg (at rest), 2. pulmonary capillary wedge pressure (pcwp) or left ventricular-end diastolic pressure less than 15 mmhg, and 3. pulmonary vascular resistance (pvr) greater than 3 mmhg/l/min. exclusion criteria: * portal hypertension or chronic liver disease * alt or ast levels greater than 1.5 times the upper limit of normal at the screening visit * contraindication to treatment with an endothelin receptor antagonist * recent history of abusing alcohol or illicit drugs * chronic renal insufficiency * pregnant or breastfeeding * atrial septostomy within 30 days before study entry * previous failure on bosentan because of safety concerns of the lack of clinical response

Keywords: primary or secondary pulmonary arterial hypertension scleroderma connective tissue disease congenital heart defects lupus pulmonary arterial hypertension
mcg discovery study in emergency departments

Conditions: ACS - Acute Coronary Syndrome; NSTEMI - Non-ST Segment Elevation MI

Summary: this prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile mcg device in an emergency department (ed) setting. the main question it aims to answer is whether interpretable data can be reliably collected as part of an ed workflow.


Eligibility criteria:
inclusion criteria: * presents to ed with symptoms of acute coronary syndrome (acs) * can provide written consent exclusion criteria: * presents to ed with st-elevation myocardial infarction (stemi) * presents to ed with atrial fibrillation * clear non-ischemic cause for symptoms (i.e. trauma) * active thoracic metal implants

Keywords: magnetocardiography mcg