Kornimate/medical-research-clean huggingface dataset:
clinical trial comparing conventional and robot-assisted(da vinci®)laparoscopic interventions for hysterectomy

Conditions: Laparoscopic Technique no Switch to Open; Duration of Surgery; Intraoperative Complications; Postoperative Complications

Summary: the aim of this study is to compare conventional with robot-assisted (da vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

during the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited. several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. for better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. this randomized clinical trail intends to compare conventional with robot-assisted(da vinci®-system) laparoscopic hysterectomy regarding specific parameters. the focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.

Eligibility criteria:
inclusion criteria: * indication for laparoscopic hysterectomy * patients bmi \< 40 * signed consent exclusion criteria: * estimated uterus weight \>400 g * no combination with other procedures * no underlying malignant condition

Keywords: laparoscopic hysterectomy robot-assisted laparoscopic hysterectomy robot-assisted surgery
mitomicin c for prevention postoperative endoscopic sinus surgery synechia and qol in chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis; Postoperative Nasal Synerchia

Summary: primary objective * to compare the incidence of postoperative nasal synerchia between mitomicin c and placebo in patients at 6 months after endoscopic sinus surgery * to validate the thai version of disease-specific quality of life tool snot-22 secondary objectives * to compare the clinical signs and symptoms of crs in patients who receive mitomicin c with those who receive placebo * to compare the disease-specific quality of life in patients who receive mitomicin c with those who receive placebo * to compare the side effects of mitomicin c versus placebo


Eligibility criteria:
inclusion criteria: * all thai adults (18 years and older) patients undergoing bilateral endoscopic sinus surgery for crs * patients must not have following diseases or conditions * cystic fibrosis based on positive sweat test or dna test * gross immunodeficiency (congenital or acquired) * congenital mucociliary problem (eg. primary ciliary dyskinesia) * altered immune function such as patients with systemic vasculitis, systemic lupus erythematosus, end stage renal disease, cirrhosis, currently taking immunosuppressant or granulomatous disease * severe comorbidity with life expectancy of less than 1 year, such as advanced stage malignancy patient, or severe infection * patients are willing to participate and provide written informed consent exclusion criteria: (none)

Keywords: chronic rhinosinusitis mitomicin c postoperative nasal synerchia
healing through affective self-awareness in fibromyalgia: a randomized controlled trial

Conditions: Fibromyalgia

Summary: the investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. the investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.

the affective self-awareness approach presumes that many chronic pain states, such as fibromyalgia (fm), can be effectively treated by encouraging self-awareness of emotional tension. while anecdotally effective in selected patients, this approach has thus far not been tested in a randomized controlled trial. our purpose is to determine whether an affective self-awareness approach significantly improves pain, tenderness, and other fm symptoms in a random sample of fm patients; and to determine what psychosocial factors predict a favorable response. comparisons: changes in ratings of pain, tenderness, and other symptoms between two arms of the study: * three weekly 2-hour small-group meetings supplemented with daily writing and meditative exercises to enhance affective self-awareness * usual care

Eligibility criteria:
inclusion criteria: * fibromyalgia, as defined by american college of rheumatology 1990 criteria. * at least 18 years of age. * have access to transportation to and from providence hospital, southfield, mi. exclusion criteria: * co-morbid medical conditions capable of causing a worsening of physical functional status independent of fm, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, copd, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, type i diabetes), pregnancy, and malignancy within the preceding 2 years. * any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. note: subjects with mood or anxiety disorders otherwise will not be excluded. * changes in medication regimen within one month prior to enrollment.

Keywords: fibromyalgia affect pain fatigue sleep stress quality of life stress, psychological psychophysiology randomized controlled trials
gallium-68 psma-11 pet in intermediate to high-risk preprostatectomy patients

Conditions: Prostate Cancer

Summary: the investigators are imaging patients with prostate cancer using a new pet imaging agent (ga-68-psma-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.

imaging and staging of prostate cancer is critical for surgical and treatment planning. patients with suspected metastatic prostate cancer will be imaged using gallium-68 labeled psma-11 in order to demonstrate its utility. the investigators plan to utilize this data to obtain further approvals of the ga-68-psma-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. in the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. this compound has been shown to be superior to choline based pet agents for the staging of prostate cancer, both carbon-11 and fluorine-18 compounds. but this compound was not patented and therefore no company or private entity will make the investment required to bring ga-68-psma-11 to market. in the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future fda approval.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate adenocarcinoma. * planned prostatectomy with lymph node dissection. * intermediate to high-risk disease (as determined by elevated prostate-specific antigen (psa) \[psa\>10\], t-stage \[t2b or greater\], gleason score \[gleason score \> 6\] or other risk factors). * diagnostic ct or mri as part of the pet study or performed within one month of psma pet. * karnofsky performance status of greater than 50 (or eastern cooperative oncology group (ecog) /world health organization (who) equivalent). * age \> 18. * ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: * patients not capable of getting pet study due to weight, claustrophobia, or inability to lay still for the duration of the exam. * neoadjuvant chemotherapy or radiation therapy prior to prostatectomy. * including focal ablation techniques (hifu). * androgen deprivation therapy or other neoadjuvant treatments prior to pet imaging and surgery.
ambulatory ultrasound for heart failure management

Conditions: Heart Failure

Summary: ambush study is a multicenter randomized, controlled, open-label clinical trial (probe (prospective randomized open blinded end-point) type). the main objective of ambush study is to assess the effect of therapeutic management guided by pulmonary ultrasound and the assessment of the inferior vena cava in patients with heart failure seen in an ambulatory (outpatient) setting on a mixed clinical-biological endpoint (including variations of natriuretic peptides - ntprobnp) at 30 days.

secondary objectives are: a. to assess the effect of therapeutic management guided by pulmonary ultrasound and inferior vena cava assessment on the risk of cardiovascular death and hospitalization for heart failure at 30 days. b. describe the proportion of ultrasound congestion (pulmonary and inferior vena cava data) in patients free from clinical congestion at baseline in the intervention group and in all patients at d30 visit. c. evaluate the association of ultrasound congestion (pulmonary and inferior vena cava assessment) with serum concentrations of natriuretic peptides at baseline and d30 visit. d. evaluate the association of variations in ultrasound congestion (pulmonary and evaluation of the inferior vena cava) and variations in natriuretic peptides between baseline and d30 visit. e. compare the proportion of ultrasound and clinical congestion in patients in the intervention group and in the control group at baseline and on d30 visit.

Eligibility criteria:
inclusion criteria: * male or female aged 18 and over * heart failure (regardless of left ventricular ejection fraction) * diagnosis of heart failure established more than 3 months ago * absence of significant clinical signs of congestion on clinical examination (absence of crackles and lower limbs oedema greater than perimalleolar oedema) * affiliation to social security * receiving complete information about research organization and signed informed consent. exclusion criteria: * natriuretic peptides result, carried out during the previous 30 days, available at the inclusion consultation * pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis. * suspicion of cardiac amyloidosis or proven amyloidosis, * patient with severe primary heart valve disease * pregnant woman, parturient or nursing mother * adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * person deprived of liberty by a judicial or administrative decision, * person subject to psychiatric care pursuant to articles l. 3212-1 and l. 3213-1 of the public health code.
evaluation of microcirculation of peripheral vascular disease in diabetes

Conditions: Peripheral Vascular Disease in Diabetes

Summary: the main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.


Eligibility criteria:
inclusion criteria: * 1.patients with peripheral vascular disease with or without diabetes. 2.rutherford class 2-6. 3.target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention. 4.target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length. 5.written informed consent signed by the patients or representatives exclusion criteria: * 1.previous bypass surgery or stent placement at the ipsilateral lower limb 2.history of intolerance to antiplatelet therapy, heparin, or contrast media. 3.bleeding diathesis; 4.active systemic bacterial infection; 5.severely impaired renal function (serum creatinine level \> 2.5 mg/dl. expected survival time of less than 24 months

Keywords: diabetes peripheral vascular disease microcirculation
a study of shr6508 in secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: the study is being conducted to evaluate the efficacy and safety of shr6508 for chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. diagnosed with end stage renal disease receiving stable hemodialysis 3. male or female 4. meet the body mass index standard 5. stably use of concomitant medication of other therapies of shpt 6. meet the standard of ipth level, cca and hb exclusion criteria: 1. subjects with a history of malignant tumor 2. subjects with neuropsychiatric diseases 3. subjects with a history of cardiovascular diseases 4. subjects with gastrointestinal diseases 5. subjects with a history of surgery 6. subjects with a history of blood loss 7. subjects with a history of kidney transplant 8. abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 9. subjects with a treatment history of similar drugs 10. allergic to a drug ingredient or component 11. pregnant or nursing women 12. no birth control during the specified period of time 13. subject with a history of alcohol abuse and drug abuse 14. participated in clinical trials of other drugs 15. the investigators determined that other conditions were inappropriate for participation in this clinical trial
repetitive phrenic nerve stimulation in critically ill patients under mechanical ventilation

Conditions: Phrenic Nerve; Electrical Stimulation

Summary: subjects: patients aged 19 and older who are currently in the icu and undergoing invasive mechanical ventilation. methods: the study involves performing non-invasive repetitive phrenic nerve stimulation in icu patients on mechanical ventilation. stimulation protocol: the intensity and position of phrenic nerve stimulation were individualized. the frequency was set to 10hz, 15hz, and 20hz. the duration of stimulation was adjusted according to the set inspiration time of mechanical ventilation.


Eligibility criteria:
inclusion criteria: * adult patients aged 19 and older who are admitted to the icu at seoul national university hospital * patients receiving invasive mechanical ventilation (via endotracheal tube or tracheostomy) * patients who have been on invasive mechanical ventilation (via endotracheal tube or tracheostomy) for more than 48 hours * patients who have listened to and understood the explanation of the purpose and procedures of the study and have voluntarily agreed to participate. in cases where the patient has impaired consciousness or cognitive function and is unable to consent, the patient's legal representative has agreed to the patient's participation in the study. exclusion criteria: * patients with implanted or externally applied electrical devices (such as pacemakers, defibrillators, implantable defibrillators, vagus nerve stimulators, spinal cord stimulators, gastric stimulators, diaphragm stimulators, etc.) * patients with a history of neck tumors, cervical spine instability, or neck surgery * patients with internal jugular vein catheters, infections, or inflammatory signs at the electrical stimulation site, making percutaneous phrenic nerve access impossible * patients with neurological or neuromuscular diseases that significantly affect respiratory muscle function * patients currently receiving neuromuscular blocking agents * patients already diagnosed with or suspected of having phrenic nerve paralysis * patients with elevated hemidiaphragm observed on chest x-ray * patients with pleural effusion occupying more than one-third of the pleural space or pneumothorax requiring chest tube insertion, as seen on chest x-ray * patients who are confirmed or presumed to be pregnant * patients with a body mass index (bmi) ≥ 40 * patients for whom life-sustaining treatment has been decided to be withdrawn and who have no plans for active treatment
in vitro fertilization (ivf) and acupuncture for infertility

Conditions: Infertility

Summary: the aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing in vitro fertilization (ivf). the investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.


Eligibility criteria:
inclusion criteria: * females between 21 and 42 years old * primary or secondary infertility * no more than 2 previously failed ivf cycles * undergoing ivf * fsh \< 11 exclusion criteria: * fsh \> 11 * using an egg donor * using pgd * using heparin or lovanox protocols * estradiol level less than 20 or over 80 * taking herbal therapy

Keywords: infertility ivf acupuncture
sensitivity and specificity of urinary dipstick in emergency departments

Conditions: Proteinuria

Summary: urinary dipsticks are commonly used in emergency departments since they are a cheap and quick diagnostic tool. however the sensitivity and specificity of urinary dipsticks might be compromised in emergency departments due to fluid imbalance and acute illness itself.

the study is designed as a prospective observational study on the emergency department in sonderborg, southern denmark. all patients above 18 years of age who have given their consent are included. urinary dipstick and albumin creatinine ratio is obtained simultaneously within 48 hours after admission on the emergency department. patient with a positive urinary dipstick will be asked to deliver another urinary dipstick and albumin creatinine ratio 3-8 weeks later. to our knowledge has the specificity and sensitivity of urinary dipstick for protein not been described, yet. our design will give us the possibility not only to quantify specificity and sensitivity in the acute phase on the emergency department but in the non-acute phase after discharge from the emergency department, as well.

Eligibility criteria:
inclusion criteria: * all patients above 18 years of age who were admitted to the emergency department in sonderborg and who gave their consent exclusion criteria: * anuria

Keywords: urinary dipstick emergency department
observational trial on the impact of hypnose used as a sedation in oncology surgery in breast cancer

Conditions: Early Stage Breast Carcinoma

Summary: the investigators will compare the operated patients for a beginning breast cancer in the hypnose arm and the patient in the classical general anesthesia arm. it is a observational study as we cannot randomized patient, (they need to be compliant with hypnose). patient will be informed that some parameters, about his recovery, will be collected from their medical file. they will not have another particular treatment because they are in the study. it is just a prospective data collection. the patient will be compared on several items after the surgery ( as pain and pain killer intake, the heal process of the scar, etc...) also the investigators will compare the impact of hypnose on the other treatments the patient received. the investigators need approximately 150 patients (half in each arm).


Eligibility criteria:
inclusion criteria: * signed informed consent form * in situ breast cancer (early stage) * infiltrated breast cancer (early stage) exclusion criteria: * no hypnoses is possible for this patient surgery
a study of the safety, tolerability, pharmacokinetics, and immunogenicity of intravitreal injections of fcfd4514s in patients with geographic atrophy

Conditions: Geographic Atrophy

Summary: the phase ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (itv) injection of fcfd4514s in patients with geographic atrophy (ga).


Eligibility criteria:
inclusion criteria: * ability and willingness to undertake all scheduled visits and assessments * agreement to use an effective form of contraception for the duration of the study * geographic atrophy (ga) at least 0.75 disc areas in the absence of choroidal neovascularization (cnv) exclusion criteria: * treatment for active systemic infection * predisposition or history of increased risk for infection * active malignancy * history of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications * ga in either eye due to non-amd causes * active or history of ocular and intraocular conditions in the study eye (except ga) * history of vitreoretinal surgery or laser photocoagulation in the study eye * prior treatment for amd (except vitamins and minerals) * history of intravitreal (itv) drug delivery * intraocular surgery (including cataract surgery) in the study eye within 3 months preceding day 0 * previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals)

Keywords: ga
heart rate variability and postoperative nausea vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: propofol and sevoflurane have different effects on heart rate variability. it has not yet been reported whether this difference in effect remains at recovery time after anesthesia and the difference is related to postoperative nausea and vomiting has not been studied. the aim of this study is observe whether propofol and sevoflurane have different effects on heart rate variability during recovery and the differences can predict the occurrence of postoperative nausea and vomiting.

different types of anesthetics have different effects on heart rate variability. however it has not yet been reported whether this difference in effect remains at recovery time after anesthesia. several studies have been reported that preoperative heart rate variability predicted the occurence of postoperative nausea and vomiting. however, whether the difference in heart rate variability after anesthesia is related to the difference in postoperative nausea and vomiting has not been studied. therefore, this study aims to observe whether propofol and sevoflurane have differences during recovery period after anesthesia in heart rate variabiliy. in addition, we want to examine that these differences during recovery period in heart rate variability can predict the occurrence of nausea and vomiting within 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * scheduled breast surgery under general anesthesia exclusion criteria: * arrhythmia * uncooperative with the measuring heart rate variability * diabetes * hypertension on medication * patients taking psychiatric drugs * thyroid disease

Keywords: postoperative nausea and vomiting heart rate variability propofol sevoflurane