Kornimate/medical-research-clean huggingface dataset:
goal-directed fluid therapy for patients undergoing oro-maxillofacial surgery

Conditions: Blood Pressure, Low

Summary: orthognathic surgery, one kind of oro-maxillofacial surgery, is a complicate surgery that undergoes several hours with nasotracheal intubation general anesthesia. to limit blood loss during operation, the patients are often under intentional hypotension. however, the intentional hypotension may confuse with hypovolemic induced low blood pressure. the hypothesis is using flotrac (to measure stroke volume variation) to keep the patients hemodynamics stable under tridil and propofol infusion and avoid over-infusion of crystalloid or colloid and prevent hypovolemia induced postoperative nausea and vomiting.

orthognathic surgery, one kind of oro-maxillofacial surgery, is a complicated surgery that undergoes several hours with nasotracheal intubation general anesthesia. patients without premedication undergo orthognathic surgery with nasotracheal intubation general anesthesia. patients without premedications monitoring of patients with entropy for consciousness, ecg, with noninvasive bp and invasive blood pressure through redial artery, train-of-four monitor, target controlled infusion of propofol, infusion tridil, and sevoflurane for mainly anesthesia maintenance. ventilator setting as volume control (8-12ml/kg), frequency respiratory rate (8-12/min), i/e ratio: 1/2, positive end expiratory pressure: 4 mmhg, fraction inspiratory o2: 60%. to maintain the map \>60-55 mmhg, urine output 0.5-1ml/kg, and body core temperature \> 36 celsius degree. closely observation of patients postoperatively for adverse events or complications.

Eligibility criteria:
inclusion criteria: * patients undergo orthognathic surgery, asa i\~iii, 20 to 65 years old, no mouth limitation exclusion criteria: * ankylosing spondylitis, limited mouth opening \ 35kg/m2), patients refused

Keywords: oromaxillofacial surgery nasotracheal intubation stroke volume variation
curative effect study of endostatin combined with chemoradiotherapy to non-small-cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: to evaluate the efficacy and safety of endostar combined with concurrent chemo-radiotherapy (ccrt) in patients with unresectable stage iii non-small-cell lung cancer (nsclc).

objectives: primary:to assess the treatment response rate (rr) of endostar in combination with ccrt secondary * the progression-free survival (pfs) * the overall survival(os). * the failed treatment modality. * the toxicity of this regimen. outline ccrt:patients receive chemotherapy comprising docetaxel(65mg/m2,iv gtt duration\>1h) and cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3d-crt five days a week for total dose 60-66gy. endostatin:patients receive endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks. patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. physical examination and ct scans of the thorax and upper abdomen are performed routinely.

Eligibility criteria:
inclusion criteria: * 18 years of age * untreated pathologically confirmed inoperable stage iiia or iiib nsclc * weight loss of less than 10% in the past 6 months * performance status (ps) of 0 to 1 * forced vital capacity in 1 second (fev1) higher than 0.8 l * measurable disease by response evaluation criteria in solid tumors (recist). * absolute neutrophil count (anc) of ≥ 1500/μl * hemoglobin ≥ 10 mg/dl * platelet ≥ 100,000/μl * serum creatinine ≤ 1.25 times of upper limit of normal (uln) * calculated creatinine clearance (crcl) of ≥ 60 ml/min * bilirubin 1.5×uln * ast and alt less than 2.5×uln * alkaline phosphatase less than 5×uln. exclusion criteria: * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * malnutrition (loss of ≥ 20% of the original body weight) * sensor or motor neuropathy \> grade i * second primary malignancy, except for non-melanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women * preexisting bleeding diatheses or coagulopathy * prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway

Keywords: stage iii unresectable non-small cell lung cancer
psilocybin therapy for depression in bipolar ii disorder

Conditions: Bipolar II Disorder

Summary: the purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy in people with bipolar ii disorder.

the primary goal of this study is to examine the safety, tolerability, and feasibility of psilocybin therapy in people with bipolar ii disorder (bd ii). fourteen participants, ages 18 to 70 with clinically diagnosed bd ii with active depression, in active outpatient mental health treatment, and who meet all other inclusion and exclusion criteria at screening will be enrolled. after baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by an initial drug administration of oral psilocybin,supervised by the facilitators and a clinician who will conduct safety monitoring throughout. participants will complete assessment and integration sessions with the facilitators subsequently in order to help process the experience. participants who tolerated the first dosage may be asked to complete a second psilocybin dosing session, involving the same preparation, procedures, integration, and supervision as the first. primary outcome measures will assess safety, tolerability, and feasibility of study procedures. efficacy will be measured by change in depression as measured by the madrs three weeks after the final psilocybin administration. exploratory outcome measures will assess changes in sleep, quality of life, and therapeutic engagement.

Eligibility criteria:
inclusion criteria: * age 18 to 70 * comfortable speaking and writing in english * diagnosis of bipolar disorder ii with current depression * have a care partner/support person available throughout the study * able to attend all in-person visits at ucsf as well as virtual visits * having tried at least one previous medication trials for their bipolar disorder, each lasting at 6 weeks or more. exclusion criteria: * current or previous diagnosis of bipolar i disorder * history of schizophrenia spectrum or psychotic disorder * use of psychedelics within the past 6 months, including mdma * current diagnosis of cancer * seizures that continue to the present * fear of blood or needles * regular use of medications that may have problematic interactions with psilocybin, including but not limited to antidepressants (bupropion allowed), serotonin antagonists, some antipsychotics, dopamine agonists/antagonists, stimulants, opioids, and lithium. * a health condition that makes this study unsafe or unfeasible, determined by study physicians

Keywords: bipolar depression psilocybin psychedelic psilocybin therapy bipolar ii safety
augmented effects of virtual-reality cycling training on upper limb motor functions by nibs in patients with cp

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is the most common childhood motor disability. weakness, spasticity, and loss of dexterity are the major problems in patients with cp. a novel virtual-reality cycling training (vct) program was to enhance promising muscle strength and motor function through promoting the participant compliance and motivation. non-invasive brain stimulation (nibs), such as repetitive transcranial magnetic stimulation (rtms) and transcranial electric stimulation (tes) has potential to augment the training effects in motor neurorehabilitation via the modulation on neuroplasticity. therefore, this study propose a novel intervention protocol to induce superior benefits on upper extremity (ue) motor function in patients with cp.

this study aims to investigate the augmented effects of vct on neuromotor control and ue motor function by nibs in patients with cp. we hypothesize that nibs can augment the vct effects on neuromotor control and ue motor function in patients with cp because combined therapy integrated peripheral modification techniques (vct) and central modulation (nibs). these effects may further enhance the activity of daily living (adl), participation, and health related quality of life (hrqol). this project is executed in the following two phases: to investigate the augmented effects of vct on neuromotor control and ue motor function in patients with cp by rtms in phase 1 (0-1.5 years) and tcs in phase 2 (1.5-3 years).

Eligibility criteria:
inclusion criteria: * diagnosis of cp according to clinical criteria * age 5-20 years * no use of botulinum toxin in the past 4 months * no significant perceptual or communication disturbances * no other peripheral or central nervous system dysfunction * no active inflammatory or pathologic changes in upper limb joints during the previous 6 months * no active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection * no active problems of epilepsy and eeg without epileptiform discharge exclusion criteria: * metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders * active infectious disease, such as meningitis and encephalitis * patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection * poor compliance or intolerance for the tms therapy * subjects with metallic implants or pregnancy. * eeg show epileptiform discharge * patients with family history of epilipsy * patients with symptoms that are restricted from tdcs, such as epilepsy, migraine and unstable health condition

Keywords: virtual cycling training non-invasive brain stimulation repetitive transcranial magnetic stimulation transcranial electric stimulation
borderline covid-19 pcr test result

Conditions: Covid19; Virus

Summary: follow-up of patients with a borderline pcr result. data of patients that were re-tested within 96 hours after receiving a borderline covid-19 pcr result are reviewed. this is a retrospective study.


Eligibility criteria:
inclusion criteria: * every individual that delivers a nasopharyngeal lysate for sars-cov-2 rna determination by pcr. exclusion criteria: * patients without a previous borderline covid-19 pcr result within 96 hours are excluded for the follow-up study.
pelvic floor physical therapy-biomarkers project

Conditions: Pelvic Pain

Summary: this study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.the biomarkers will be analyzed for cytokines and proteomics at various time points.

collection points will be baseline, and at the last pt visit.

Eligibility criteria:
inclusion criteria: * women in the beaumont women's urology center who have pelvic pain and are starting pelvic floor pt in our center. exclusion criteria: * all others

Keywords: pelvic pain pelvic floor physical therapy biomarkers
study to evaluate the efficacy of lithium carbonate in spinal cord injury patients with neuropathic pain

Conditions: Neuropathic Pain; Neuralgia; Spinal Cord Injuries

Summary: to investigate the efficacy of lithium carbonate in the treatment of neuropathic pain of patients with spinal cord injury.

this is a randomized, placebo-controlled, double-blinded trial. sixty spinal cord injured subjects with neuropathic pain will be randomized into two groups. the subject in the treatment group will receive lithium carbonate tablet, while the control group will receive placebo tablet. neither the subjects nor the physicians know which group the subjects are allocated. each subject will receive 6 weeks of oral lithium carbonate or placebo. in the treatment group, the dose will be adjusted according to the serum lithium level. while in the control group, the dose will be adjusted based on the dummy serum level report. the outcome will be assessed during visits at 1 week, 2 weeks, 6 weeks and 12 weeks, and a phone call follow-up at 24 weeks from the start of the medication. the primary outcome measure is the severity level of pain. the efficacy and safety will be analyzed by comparing the results of the treatment group with those of the control group

Eligibility criteria:
inclusion criteria: * age 18 - 65; * diagnosis of traumatic spinal cord injury; * clinically diagnosed neuropathic pain; * pain severity is at least 4 on a 11-point numeric rating scale at screening; * pain present regularly for at least 6 weeks before enrollment; * able to understand instructions and provide reliable pain assessments; * subjects who are voluntarily signed and dated an ethics committee approved informed consent form; exclusion criteria: * significant renal, cardiovascular, hepatic, infectious or psychiatric disease; * significant brain injury with neurological deficits; * debilitation or dehydration; * addison's disease; * recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines; * a history of substance or alcohol abuse within past 1 year; * a need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period; * current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control; * participation in any drug study in the last three months; * history of oral lithium intake for any reason; or * any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
fixed-dose combination of valsartan + rosuvastatin versus their isolated components for hypertension and dyslipidemia.

Conditions: Hypertension; Dyslipidemia

Summary: noninferiority trial to assess efficacy of fixed-dose combination of valsartan + rosuvastatin versus their isolated components in treatment of hypertension and dyslipidemia.

* open-label,randomized, multicenter; * maximal experiment duration: 8 weeks; * 04 visits; * safety and efficacy evaluation

Eligibility criteria:
inclusion criteria: * participants of both sexes aged between 18 and 65 years; * participants diagnosed with uncontrolled hypertension; * participants with intermediate and high risk dyslipidemia, according to the v brazilian guidelines on dyslipidemia and prevention of atherosclerosis; * ability to understand and consent to participate in this clinical study, manifested by signing the informed consent and informed ( ic) . exclusion criteria: * participants with a previous diagnosis of familial hypercholesterolemia (homozygous); * concomitant use of angiotensin ii receptor blocker (arb) or inhibitor of angiotensin converting enzyme (ace); * participants with isolated hypertriglyceridemia (tg ≥150 mg / dl) according to v brazilian guidelines on dyslipidemia and prevention of atherosclerosis; * research participants with total cholesterol (tc) above 500 mg / dl or triglyceride (tg) above 400 mg / dl; * participants with systolic blood pressure ≥180 mmhg or diastolic ≥110 mmhg; * research participants with postural hypotension (sbp decrease ≥20 mmhg or dbp ≥10 mmhg in orthostatic position in relation to the sitting position); * history of congestive heart failure (chf) functional class iii or iv (nyha);; * any clinical, laboratory and electrocardiographic that, in the judgment of the investigator, may interfere with the safety of research participants; * creatine phosphokinase (cpk) levels above the established laboratory normal range; * transaminases (alt and asl) serum above 2 times the established laboratory normal range; * body mass index (bmi) ≥35 kg / m²; * immunocompromised participants (eg .: malignancies, patients with acquired immunodeficiency syndrome etc); * chronic use of drugs that may interact with the drugs of the study; * patients on concomitant lipid-lowering therapy; * history hypersensitivity to the active ingredients used in the study; * participants who are pregnant, nursing or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception; * history of alcohol abuse or illicit drug use; * adherence to uniformization medication \<80%; * participating in the research that has participated in clinical trial protocols in the last twelve (12) months (cns resolution 251 of august 7, 1997, part iii, sub-item j), unless the investigator considers that there may be direct benefit to it;
vestibular caloric stimulation and the modulation of pain in fibromyalgia

Conditions: Fibromyalgia

Summary: the management of chronic pains is challenging and fraught with limitations. fibromyalgia is a common pain disorder characterized by chronic widespread pains, associated with fatigue and impaired quality of life. fibromyalgia affects millions of people and is among the most common reasons for consulting with a rheumatologist. the food and drug administration (fda) approved three medications to treat fibromyalgia, though there are many patients for whom these medications are ineffective, poorly tolerated or cost-prohibitive. accordingly, there exists a need for novel therapeutics. the researchers would like to test the therapeutic efficacy of a non-pharmacologic non-interventional bedside technique called vestibular caloric stimulation (vcs). vcs, irrigating the external ear canal with water, is a simple, non-invasive, cost-free procedure with preliminary data suggesting potential for improving pain. vcs is a form of neuromodulation and there are anatomically defined pathways elucidated to help explain how this works. there currently exists limited data on the topic, only case reports and case series. given a clear need for additional therapeutics in many patients with fibromyalgia, the researchers have elected to conduct this trial.

this is an open label pilot study testing the potential therapeutic efficacy of vestibulocortical stimulation via cold water calorics in fibromyalgia. the trial will entail 6 weeks of total involvement for each participant including 3 weeks of active participation, with 4 weeks follow up: the irrigation happens at the beginning of week 2, so 4 weeks later is week 6.

Eligibility criteria:
inclusion criteria: * at least 18 years old with ability to comprehend and consent to protocol. * diagnosis of fibromyalgia by american college of rheumatology (acr) criteria (questionnaire). * at least a 4/10 baseline on the visual analogue pain scale (vas). * stable fibromyalgia medications for at least 4 weeks. * owns or has access to a smart phone or computer to complete outcome measures. exclusion criteria: * use of opioids * otitis externa or media within the past six months. * current ear pain with or without other symptoms of otitis externa. * history of tympanic membrane rupture or surgery. * current pregnancy. * inability to lay supine for 30 minutes. * limited decision making capacity. * engaged in litigation, currently or prior, related to fms. * inability to commute to clinic once. * primary language not english. * clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study * treatment with the medication meclizine for vertigo * history of seizures * diagnosis of bipolar disorder (treated or untreated)
surgical treatment of type 2 diabetes mellitus in <35 body mass index (bmi)

Conditions: Type 2 Diabetes Mellitus; Bariatric Surgery; Biliopancreatic Diversion; Gastric Bypass

Summary: thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * duration of diabetes ≥ 3 years * poor glycemic control (i.e., hba1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (gcp) exclusion criteria: * specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass * pregnancy * medical conditions requiring acute hospitalisation * severe diabetes complications or associated medical conditions \[such as blindness, end-stage renal failure (i.e. serum creatinine \>2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (nyha class iii and iv)\] * recent (within preceding 12 months) myocardial infarction, stroke or tia * unstable angina pectoris * psychological conditions which may hamper patient's cooperation * geographic inaccessibility * any condition which, in the judgment of the investigator, may make risky the participation in the study or bias the results
study of arosod-1 in adult participants with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: in this phase 1 adult symptomatic patients with amyotrophic lateral sclerosis (als) carrying a superoxide dismutase 1 (sod1) gene mutation thought to be causative of als, will receive single ascending doses of aro-sod1 administered by intrathecal (it) infusion. the study is primarily intended to evaluate safety, but will also evaluate the effect of aro-sod1 on sod1 cerebrospinal fluid (csf) levels as a biomarker of pharmacodynamic (pd) effect, therefore lumbar punctures will be required at timepoints throughout the study. after each participant has completed their individual final visit, participants whose sod1 csf levels have recovered to a satisfactory level may rescreen and enroll into higher dose cohorts; or if unable or unwilling to rescreen may enroll into an open-label study to be added by amendment when supported by nonclinical data for multidose administration.


Eligibility criteria:
inclusion criteria: * diagnosis of als based on source-verifiable medical record and meets the gold coast criteria * pathogenic or likely pathogenic sod1 mutation based on source-verifiable medical records or genetic testing during screening * slow vital capacity (svc) ≥ 50% of predicted value adjusted for sex, age, and height (from a sitting position) at screening * body mass index (bmi) ≥ 18.0 kg/m2 at screening * able to complete at least 6 months of follow-up * if taking any medication or supplement to treat als or als symptoms, must be on stable dose for ≥ 4 weeks prior to day 1 and expected to remain at that dose until final study visit and not expected to start these medications after the first dose of aro-sod1 * able and willing to provide written informed consent and to comply with all study assessments * participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last dose of study drug, whichever is later. males must not donate sperm and females must not donate eggs during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. exclusion criteria: * current or anticipated need of a diaphragm pacing system (dps) during the study * participants using tofersen can be enrolled only after a washout period of approximately 20 weeks from the last tofersen dose to the first planned dose of aro-sod1 * history of having received stem cell therapy for als treatment * any current or anticipated contraindications to lumbar puncture (lp) * the presence of an implanted shunt for drainage of csf or an implanted central nervous system (cns) catheter * human immunodeficiency virus (hiv), seropositive for hepatitis b virus (hbv), seropositive for hepatitis c virus (hcv) * uncontrolled hypertension * severe cardiovascular disease * history of drug abuse or alcoholism within 6 months of study enrollment * inability to comply with study requirements note: additional inclusion/exclusion criteria may apply per protocol